Opinion
MDL Docket No. 1203, CIVIL ACTION NO. 99-20593
February 13, 2004
Peter L. Zimroth ARNOLD PORTER LLP New York, NY, for WYETH
Robert D. Rosenbaum Steven G. Reade ARNOLD PORTER LLP N.W. Washington, D.C., for WYETH
Michael T. Scott Paul B. Kerrigan REED SMITH, LLP Philadelphia, PA, for WYETH
CLAIMANTS TAMMY R. WESTMORELAND AND SHELA K. BRIERY'S MOTION TO EXTEND DEADLINE TO RESPOND TO POST AUDIT DETERMINATION
COME NOW Claimants Tammy R. Westmoreland, claim number 8183735, and Claimant Shela K. Briery, claim number 8183730, by and through their counsel, and file this their Motion to Extend Deadline to Respond to Post Audit Determination. In support of such Motion, Claimants would respectfully show the Court the following:
1. On December 16, 2003, the AHP Settlement Trust ("Trust") sent a Post Audit Determination Letter to Claimant Tammy R. Westmoreland and Claimant Shela K. Briery denying their requests for Matrix benefits.
2. Due to the holiday seasons, which occurred during Claimants' sixty day time period to respond, Claimants have had difficulty obtaining the necessary documentation from sources in order to respond to the denial of claims. Claimants respectfully request a thirty (30) day extension of time to respond.
3. This request is made not for the purposes of delay but for good cause and so that justice may be done. The request is made prior to the expiration of Claimants' deadline to respond.
WHEREFORE, Claimants respectfully request that the Court grant Claimant Tammy R. Westmoreland and Claimant Shela K. Briery's Motion to Extend Deadline to Respond to Post Audit Determination. Claimants request such other relief to which they may show themselves justly entitled.
MEMORANDUM AND PRETRIAL ORDER NO.
Before the court is the appeal of Jacqueline Carter and her adult son Stephen Carter II under §§ VI.C.4.i. and 1. of the Nationwide Class Action Settlement Agreement ("Settlement Agreement") in this diet drug litigation from a report and award of an arbitrator denying them certain benefits from the AHP Settlement Trust (the "Trust").Under the Settlement Agreement, any class member may appeal the Trust's final determination of benefits to a single arbitrator appointed by the court. Any party may then appeal the arbitrator's report and award to the court whose decision shall be "final and binding." See Settlement Agreement § VI.C.4.h.-1.
The Settlement Agreement provides for various levels of so-called matrix benefits, depending on the seriousness of the injury from ingesting Pondimin and/or Redux and on the age of the class member. Benefits are significantly higher for class members who ingested either of these drugs for 61 days or more than for those class members who ingested them for 60 days or less. See Settlement Agreement § IV.B.2.d.1.; Pretrial Order ("PTO") No. 1415 at 49 (E.D. Pa. Aug. 28, 2000).
Ms. Carter asserts that the arbitrator erred in affirming the Trust's finding that she used Redux for less than 61 days. As a result, she was awarded benefits under Matrix B-l/Level II in the amount of $85,383. Had she been found to have ingested Redux for more than 60 days, she would have been paid $426,912 under Matrix A. We will review the findings of the arbitrator under a clearly erroneous standard. See PTO 2153, Rule 5 of the Rules Governing Arbitration Process.
Ms. Carter submitted to the Trust what is known as a Pink Form, in which she claimed diet drug usage in excess of 60 days. Section VI.C.2.d. of the Settlement Agreement delineates what proof she needed to provide to the Trust to substantiate her claim:
In order to complete the submission of a Claim and to qualify for any benefits under the Settlement Agreement, each Class Member must submit documentary proof to the Trustees and/or Claims Administrator(s) of the period of time for which the Diet Drugs Pondimin® and/or Redux™ were prescribed and dispensed to the Diet Drug Recipient who is the subject of the Claim. This proof must include one of the following:
(1) If the diet drug was dispensed by a pharmacy, the identity of each pharmacy that dispensed Diet Drugs to the Diet Drug Recipient, including its name, address, and telephone number, and a copy of the prescription dispensing record(s) from each pharmacy, which should include the medication name, quantity, requency, dosage and number of refills prescribed, prescribing physician's name, assigned prescription number, original fill date and each subsequent refill date; or,
(2) If the diet drug was dispensed directly by a physician or weight loss clinic, or the pharmacy record(s) is unobtainable, the identity of each prescribing physician, including the prescribing physician's name, address, and telephone number and a copy of the medical record(s) prescribing or dispensing the diet drug(s). The medical record(s) must include records which identify the Diet Drug Recipient, the Diet Drug name, the date(s) prescribed, the dosage, and duration the drug was prescribed or dispensed.
Settlement Agreement § VI.C.2.d.(1)-(2).
The Settlement Agreement further provides for the situation where a class member is unable to obtain the required documentation. In § VI.C.4.b, it states:
If the Class Member seeking a Matrix payment is unable to obtain the documentation described above through the exercise of reasonable efforts, the Trustees and/or Claims Administrator(s) shall have the right to consider other supporting documentation including but not limited to declarations of other Qualified Physician(s) under penalty of perjury setting forth opinion(s) to a reasonable degree of medical certainty to support the claim that the Class Member's condition entitles him or her to a Matrix payment, subject to review by the Court as set forth in Section VIII.D. If this evidence establishes the Class Member's condition to the satisfaction of the Trustees and/or Claims Administrator(s), the Class Member shall be entitled to receive the appropriate Matrix Compensation Benefits.
Settlement Agreement § VI.C.4.b.
The record is undisputed that Ms. Carter had two 30 day prescriptions for Redux for a total of 120 pills. The prescriptions directed her to take one pill twice a day. Ms. Carter, however, submitted an affidavit stating that while her prescriptions admittedly covered a period of only 60 days, she actually took these 120 pills over a span of more than 60 days. In her affidavit, she declares that "There were some days that instead of taking 2 Redux pills, I only took one (1) Redux pill . . . I am certain that I took the Redux pills for 61 days or more. "
The arbitrator considered her affidavit along with the prescriptions themselves. In his analysis, he referred to the internal Claims Processing Procedures which had been approved by the Trust and class counsel. They provide in relevant part:
1. The prescription/pharmacy record creates a rebuttable presumption that the drug was ingested for the period reflected in the record. A record indicating a prescription for 60 days or less creates the rebuttable presumption that the claimant is in that category. A record showing a prescription for longer than 60 days creates the presumption that the claimant is in the 61 days or more category.
2. A claimant may rebut the presumption that the claimant ingested the diet drugs for 60 days or less with credible proof that the drug was ingested on more days than shown in the prescription. This proof must demonstrate by credible proof the number of days the claimant took the drug, if it differs from the duration of the prescription. The standard would not turn on the total time span in which the claimant says the drug was used, but instead on the actual number of days on which the drug was taken.
3. The Trust should develop procedures for what constitutes credible proof, who makes that decision, and a process for an appeal from that decision. The parties agree that a medical record contemporaneous with use indicating longer-term use would be sufficient to rebut the presumption. An affidavit under oath from the claimant prepared solely to submit with the claim, if not corroborated by other credible evidence, such as a reliable affirmation of another person with knowledge of the subject matter, would not be sufficient to rebut the written prescription, but the Trust may consider a claimant's affidavit standing alone in the totality of the circumstances presented by that claimant to assess its weight in the rebuttal analysis.
Ms. Carter challenges the arbitrator's and Trust's use of these internal procedures on the ground that she did not have proper notice of them. We need not reach that issue here. It is clear that the arbitrator ultimately rejected the affidavit as "inherently self-interested" and lacking credibility, regardless of any presumptions.
Ms. Carter concedes that her prescriptions instructed her to use Redux twice a day for 60 days only. Her bare bones affidavit states that she did not follow her prescriptions and instead took these 120 pills over a period in excess of 60 days. The arbitrator acted properly in refusing to credit her affidavit without any further substantiation. Her self-interest is overwhelming. Based on the prescriptions and without the affidavit, she is entitled to an award of $85,383. If her uncorroborated affidavit is accepted, she would receive $426,912, a five-fold increase. Regardless of any internal procedures, neither the Settlement Agreement nor the court requires an arbitrator to forego his or her common sense when evaluating evidence or credibility. The arbitrator's finding against Ms. Carter was not clearly erroneous.
Finally, Stephen Carter II, the adult son of Ms. Carter, appeals the denial of his status as a derivative claimant. However, he does not point to anything in the record or the Settlement Agreement in support of his position. He was born in 1964 and lives at a separate address with a separate zip code from his mother. There is nothing in the record to suggest he was dependent on his mother for services or support. Again, the arbitrator's finding was not clearly erroneous.
Ms. Carter is not entitled to Matrix A benefits because the arbitrator properly found that she ingested Redux for less than 61 days. Her son, Stephen Carter II, is not entitled to any benefits for lack of proof. Consequently, we will deny their appeals and affirm the decision of the arbitrator.
PRETRIAL ORDER NO.___________
AND NOW, this ___ day of February, 2004, for the reasons set forth in the accompanying Memorandum, it is hereby ORDERED that:(1) the denial of Matrix A benefits for class member Jacqueline Carter is AFFIRMED; and
(2) the denial of benefits for Stephen Carter II, son of class member Jacqueline Carter, for lack of proof is AFFIRMED.
WYETH'S REPLY IN SUPPORT OF ITS MOTION FOR AN INJUNCTION TO ENFORCE THE NATIONWIDE CLASS ACTION SETTLEMENT AGREEMENT AS TO CLASS MEMBER SHIRLEY WATTS-PAYNE The brief in opposition to Wyeth's Motion for an Injunction To Enforce the Nationwide Class Action Settlement Agreement As To Class Member Shirley Watts-Payne ("Motion") filed by plaintiffs counsel, O'Quinn, Laminack and Pirtle, raises only arguments that have already been presented to this Court and rejected. More importantly, it provides no reasons why this case should be treated any differently from other cases in which this Court has issued injunctions identical to the one requested in this case. The assurances of plaintiffs counsel that they do not intend to prosecute settled claims or to violate the Settlement Agreement do not vitiate the need for an injunction, especially in light of their stated position that the Settlement Agreement places no restrictions on the evidence they may present at trial in an Intermediate Opt-Out case.ARGUMENT
Plaintiff's response brief raises only arguments that have been previously made and rejected by the Court. For example, plaintiffs counsel maintain that the Settlement Agreement prohibits class members only from expressly asserting claims for punitive damages, but does not bar them from seeking to introduce evidence related to punitive damages. This debate was resolved when the Court entered PTO 2828, which concluded that the Settlement Agreement bars introduction of evidence directly or indirectly related to punitive damages; it does not merely prohibit the assertion of claims for punitive damages. PTO 2828 at 1.Plaintiff's brief also questions the authority of this Court to issue injunctions that affect state court proceedings, claiming, for example, that the Anti-Injunction Act prohibits a federal court from interfering with a state court's proceedings. This argument also was previously made unsuccessfully in briefing and hearings prior to PTO 2828 and other similar injunctions. This Court explained in PTO 2828, "Our Court of Appeals has repeatedly recognized the power of the federal court overseeing a nationwide class action settlement to issue an injunction under the `in aid of its jurisdiction' exception to the Anti-Injunction Act," (citing In re Prudential Ins. Co. of Am. Sales Practices Litig., 314 F.3d 99, 104 (3d Cir. 2002)). More recently, this Court affirmed once again its authority to enforce the Settlement Agreement's ban on certain kinds of evidence: "Because the offer of such evidence would clearly be in breach of the Settlement Agreement, we have authority to prevent plaintiff from doing so." PTO 3088 at 2.
Id. at 6-8.
Most importantly, plaintiffs opposition brief gives no reason why this case should be treated any differently from other cases such as Clark, Eichmiller, or Gatlin, in which this Court has issued injunctions just like the one requested in this case. PTOs 2828, 3088, and 3123. Like the plaintiffs in those cases, Shirley Watts-Payne is a class member who has filed an Intermediate Opt-Out and who is subject to the terms of the Settlement Agreement and to this Court's orders interpreting the agreement. There is no reason that she should be exempt from the provisions of the Settlement Agreement. This Court noted in the Gatlin case that there have been several occasions "when we have been forced to restrain a violation of the contractual provisions against punitive damages in lawsuits brought by class members." It promised to "continue vigorously to enforce this provision of the Settlement Agreement." PTO 3123. It should do so once more in Ms. Watts-Payne's case.
It does not matter that plaintiffs counsel state that they have no intention of violating the Settlement Agreement by prosecuting settled claims. Their brief itself makes plain that they disagree with the Court's interpretation of the Settlement Agreement and, absent an injunction, intend to present evidence at trial that the Court has held is barred by the Settlement Agreement. Mr. Fleming similarly argued in the Clark case that he would not assert settled claims, even as he was simultaneously proffering lists of exhibits on evidence related to settled claims. See PTO 2625 at 2-5. This Court did not accept that position in the Clark case and should not accept it now. In any case, Mr. Pirtle has expressly refused to agree to abide by the prior rulings regarding evidence that may be presented at an IOO trial. Therefore, an injunction similar to those issued in PTOs 2828, 3088, and 3123 should be entered in Ms. Watts-Payne's case.
Id. at 8.
See January 6, 2004 Letter from Thomas Pirtle to Conrad Guthrie, attached as Ex. 2 in Wyeth's Motion.
CONCLUSION
For the foregoing reasons and for the reasons set forth in its opening brief, Wyeth respectfully requests that the Court grant its motion and enter an injunction prohibiting plaintiff and her counsel from using evidence of the kind that it has already barred in Orders in the Clark, Eichmiller, and Gatlin cases.
WYETH'S JOINDER IN THE AHP SETTLEMENT TRUST'S MOTION TO STAY PAYMENT OF ALL CLAIMS WITH WHICH GEORGE FLEMING IS OR HAS BEEN ASSOCIATED AS COUNSEL
Wyeth hereby joins in, and supports, the motion of the AHP Settlement Trust (the "Trust") to stay payment of all claims with which George Fleming is or has been associated as counsel ("Trust's Motion to Stay").ARGUMENT
The Trust has demonstrated "good cause" under § VI.E.8. of the Settlement Agreement to stay claims submitted by Fleming Associates. Yet there is even more information justifying the Trust's inquiries into the Fleming firm's practices in submitting Matrix claims than that provided with the Trust's motion.
For example, in addition to Fleming Associates' use of EchoMotion to screen its clients, in two state court diet drug cases in Tucson, Arizona, the firm has identified yet another apparent "echo mill" company called "Sonic Imaging" as the company that performed echocardiograms on their clients. See Letter from Laura V. Yaeger to Craig W. Phillips, dated Nov. 11, 2003 (Exh. 1 hereto). Sonic Imaging is based in Las Vegas, Nevada, but the echocardiograms on the two plaintiffs were performed at a Residence Inn in Tucson. Natay-Curley Tr. at 111-14 (Exh. 2 hereto); Lussier Tr. at 46, 174-77 (Exh. 3 hereto). The president, secretary and resident agent of Sonic Imaging is an individual named Stephen Dubin. See Corporate Info. for Sonic Imaging (Exh. 4 hereto). According to the State of Nevada Board of Medical Examiners, in 1997 the State of Nevada revoked Mr. Dubin's license to practice medicine after he was charged with two counts of obtaining a license to practice medicine by fraud (violation of Nev. Rev. Stat. 630.304(1)) and two counts of engaging in conduct intended to deceive (violation of Nev. Rev. Stat. 630.306(2)(a)). See Nevada Bd. of Med. Exam'rs Newsletter (Exh. 5 hereto). These facts justify further inquiry into the source of the echocardiograms used by the Fleming firm to support its clients' Matrix claims.
Putting aside how echocardiograms of the Fleming firm's clients were acquired, there is also good reason to inquire about the firm's practices in submitting Green Forms for its clients. As the Court is aware, a doctor signing a Green Form under penalty of perjury must identify whether certain "reduction factors" are present. Those factors — which are indicative of alternative causes of valvular regurgitation such as rheumatoid arthritis — reduce a claimant's Matrix payments by 80% if present. But the Fleming firm was apparently unwilling to allow independent doctors — or even their hired echocardiogram readers — to reach their own conclusion concerning these "reduction factors." Instead, the Fleming firm hired nurses who conducted telephone interviews with the claimants. The Court will recall the concern about such phone interviews that it expressed when an attorney-nurse with Mr. Fleming's office explained to the Court her firm's practice in that regard. Tr. of Mar. 19, 2003 Hr'g at 132-138 (Exh. 6 hereto).
Thus Dr. Ira Polukoff who supplemented echocardiogram reading and Green Form fees totaling nearly $700,000 by an additional $400,000 annual "retainer" that he received for generally advising Mr. Fleming on his Green Form program — testified that he did not generally review medical records when completing Green Forms, but typically relied on a questionnaire that was completed by nurses from a "medical-legal consulting" firm retained by Mr. Fleming. Polukoff Tr. at 7-9, 11, 14-15, 17-21 (Exh. 7 hereto). It was Dr. Polukoff's understanding that the questionnaires were based on the nurses' interviews done over the phone with the claimant. Id. at 18-19.
For at least one doctor who has completed hundreds of Green Forms, not only did the Fleming firm's hired nurses — rather than the doctor who was required to certify the Green Form under penalty of perjury — administer the questionnaires, but the Fleming firm itself completed portions of the Green Forms for the certifying doctor. Dr. Joshua Perm stated in his deposition that the Fleming firm's hired nurses filled out Green Forms for him based on their interviews with the claimants. Perm Tr. at 55-58 (Exh. 8 hereto). He testified that "it's very possible that I signed the Green Forms having part of it blank when there was no questionnaire, meaning I filled out what I could fill out based on the echo, and then signed it for that information." Id. at 56. Although Dr. Perm "was not entirely comfortable with that plan," Mr. Fleming's office "assured [him] that it really made no difference and that their . . . nurse and they had the Green Forms — the questionnaires there and they had interviewed the patients directly and that that was okay." Id. at 57-58. Dr. Perm testified that he could not remember whether the Fleming firm ever sent him the forms back for him to check against the questionnaires after he had signed these Green Forms under penalty of perjury. Id. at 58-59.
Under the circumstances set forth above and in the Trust's Motion to Stay, the Trust is plainly justified in suspending payment of Matrix claims submitted by the Fleming firm pending its further investigation of the firm's practices concerning the acquisition of echocardiograms and submission of Matrix claims.
EXHIBITS TO WYETH'S JOINDER IN THE AHP SETTLEMENT TRUST'S MOTION TO STAY PAYMENT OF ALL CLAIMS WITH WHICH GEORGE FLEMING IS OR HAS BEEN ASSOCIATED AS COUNSEL Table of Exhibits 1. Letter from Laura V. Yaeger to Craig W. Philips, dated Nov. 11, 20032. Deposition of Cindy June Natay-Curley, Lussier v. Wyeth (Ariz. Super. Ct.) (Sept. 22, 2003), at 111-14
3. Deposition of Donald Lussier, Lussier v. Wyeth (Ariz. Super. Ct.) (Sept. 23, 2003), at 174-77
4. Corporate Information for Sonic Imaging
5. Nevada Board of Medical Examiners Newsletter
6. Transcript of Mar. 19, 2003 Hearing Before The Hon. Havey Bartle, III, J., at 130-38
7. Deposition of Gerald I. Polukoff, M.D., In Re: Diet Drugs (E.D. Pa.) (Aug. 26, 2003)
8. Deposition of Joshua Perm, M.D., Kerr v. American Home Prods. Corp. (E.D. Pa.) (Oct. 7, 2003)
EXHIBIT 1 LAW OFFICES FLEMING ASSOCIATES, L.L.P. 1330 Post Oak Boulevard, Suite 3030 Houston, Texas 77056-3019 Tel 713-621-7944 Fax 713-621-9638
LAURA V. YAEGER Email: laura_yaeger@fleming-law.com Internet: http:/www.fleming-law.com
November 11, 2003
Via Facsimile (602) 734-3795 And Regular Mail Craig W. Phillips LEWIS AND ROCA, L.L.P. 40 North Crawl Avenue Phoenix, Arizona 85004-4429
Re: No. C2002-5686; Donald Lussier v. Wyeth, et al.; consolidated with No. C2002-5688; Cindy Nascy-Curley v. Wyeth, et al.; In the Superior Court of Pima County. Arizona
Dear Craig:
I am in receipt of your Amended Notice of Deposition as to Dr. Brenda Neufeld for November 14, 2003 at 9:30am. As you are aware, under Rale 30(a). you are required to consult with counsel prior to setting deposition(s). Further, per the court's order dated October 27, 2003, counsel must stipulate to depositions.
I was not consulted prior to your re-noticing Dr. Neufeld's deposition. I am unavailable on November 14, 2003. If you wish to call me to discuss dates of availability, I will be more than willing to agree to a date.
The name of the company that performed Cindy Natay-Curley and Donald A. Lussier's echoeartliagrams is Sonic Imaging of Henderson, Nevada.
I am still working on providing you dates for Dr. Marshall's deposition. As soon as I am able to contact my expert, I will contact you regarding his deposition.
Yours Truly,
Laura V. Yseger
EXHIBIT 2
DONALD A. LUSSIER, Plaintiff v. WYETH and DR. MARCO SPRINTIS, M.D., Defendants; CINDY NATAY-CURLEY, Plaintiff v. WYETH and DR. MARCO SPRINTIS, M.D. Defendants No. C20025686, No. C20025688 United States District Court, D. Arizona September 23, 2003HARVEY BARTLE, III, District Judge
beyond your control, bat spin someone might pat on it is that that recollection or the failure to recall right now is a little bit disingenuous. And for someone to say they can't tell me, as they sit here today, whether it was days, weeks, months or years before they had their echo that they first talked to a lawyer I think really stretches all credibility, but if that's the answer you want to live with before we take the break, that's fine.
MS. YAEGER: You may want to relook at the record. She told you she did not understand that question. You have not actually asked that question again. Maybe we should have the court reporter read it back and ask her that specific question and see what she says, because that's not what you have done.
MR. PHILLIPS: I think I did.
MS.YAEGER: No.
Q. Let's ask the question right now. Was it days, weeks, months or years before you had your echo that you first talked to a lawyer in response to this advertisement on TV?
A. I don't remember.
MR. PHILLIPS: There we go.
MS.YAEGER: Let's break. (Recess taken from 3:17 to 3:30.)
Q. I just want to revisit this for just a very, very brief moment, ma'am. We were talking earlier about this advertisement that you saw on TV and you called the number in response to it Is it your understanding that the lawyers of the law firm that you called were Ms. Yaeger's law firm, Mr. Fleming law firm or Gerry Maltz's firm locally, another lawyer who has appeared on your behalf, or was it someone else?
A. I believe it was Fleming Associates.
Q. So it was through that call that you ended up hiring the lawyers that represent you; is that right?
A. Right?
Q. Okay. Now, do you remember roughly when it was that you saw that advertisement on TV?
MS.YAEGER: Object to form.
Q. Okay. Ill ask it a different way. You told us about seeing an advertisement on TV. You responded to the number, and you believed that was Mr. Fleming's firm. Do you remember when you saw that advertisement on TV and then placed the call to the firm?
MS. YAEGER: Object to form.
A. No.
Q. Do you remember roughly when it was that you first talked so my lawyer in this case?
MS.YAEGER: Object to form.
A. If was I quit taking the drag. I don't remember when.
Q. I said, "in this case." What I'm curious about, do you remember when you first talked to any lawyer about your exposure to Fen-Phen and possibly making a claim?
A. No.
MS.YAEGER: Object to form.
Q. Do you remember how long it was after you placed the call after seeing the TV advertisement before you had your echo, which was apparently done in June of 2002?
MS.YAEGER: Object to form.
A. How long between then and that?
Q. Yeah.
A. No, I don't remember.
Q. Okay. Do you remember about how long it was after you first talked to a lawyer about possibly making a claim as a result of your exposure to Fen-Phen — how long was it between that conversation, roughly, and when you had your echo performed in — I believe it was the summer of 2002?
A. Probably would be from the time I quit taking the drug sometime in `98 to 2002. I don't remember.
Q. So it could have been as early as `98 that you first talked to a lawyer?
MS.YAEGER: Object to form.
A. I don't remember.
Q. Okay. Well, well just let the record stand on your testimony. How is it, Ms. Natay-Curley, that you eventually got to the point where you had an echo performed? Tell me what led you to having an echo performed.
A. Fleming Associates advised me to take one.
Q. Okay. And Fleming Associates is your law firm?
A. Yes.
Q. Did a physician ever advise you to have an echo performed?
A. No.
Q. Okay. Did any of the healthcare providers that you saw between 1997 and the summer of 2002 ever advise you to have an echo?
A. No.
Q. Would it be fair to say that, if it hadn't been for Fleming Associates telling you to get an echo, you would not have gotten an echo?
MS.YAEGER: Object to form.
A. Probably not.
Q. Is that accurate?
A. Oh, yes.
Q. Okay. Now, where is it that your echo was taken or obtained?
A. At — I don't remember if it's a Residence Inn — or I think it's a Marriott Residence INN where they were set up.
Q. And was that in Tucson?
A. Yes.
Q. And while we have the date of the echo interpretation by Dr. Daller, I don't think we have the date that the actual echo was taken or obtained. Do you remember roughly when it was that the echo was obtained?
A. No.
MR. PHILLIPS: Counsel, can you help us with that? Would you know off the top of your head?
MS. YAEGER: No, I do not
MR. PHILLIPS: Do you know if it was days, weeks, months or years? I'm joking. Do you know how long it was, roughly, before the report was written by Dr. Daller?
MS. YAEGER: Not off the top of my head, no.
Q. The echo that was obtained on you was interpreted by a Dr. Alien Daller. Have you ever seen Dr. Daller?
A. No.
Q. Have you ever talked to Dr. Daller?
A. No.
Q. Do you even know who Dr. Daller is?
A. No.
Q. Were you given instructions by someone regarding where to go and what time to go to that location to have your echo taken?
A. Yes.
Q. Was that your lawyers that gave you those instructions?
MS. YAEGER: Object to form.
A. I don't remember.
Q. Okay. It wasn't a medical care provider, was it?
A. I. don't remember.
Q. Describe for me, if you would, please, what happened to you or the process that you went through when you showed up at what you believe is a Residence Inn from the time that you arrived until the time that you left.
A. I went in and I signed in and waited until they called my name, and I went into a marked-off room with petitions — partitions, whatever you want to can them, where somebody did the echocardiogram.
Q. And then what happened?
A. He took the echocardiogram and told me, "We will let you know the results in about two to three weeks."
Q. When you went to this Residence Inn, how many people did you talk to who were involved in the process of processing you through the echo?
A. There was one parson at the sign-in table and then the person who took it, and that was it.
Q. You indicated that you signed in. Did you just sign your name, or did you fill out paperwork? Did you respond to a questionnaire or what?
A. I signed in, and I don't remember if I did a questionnaire or not.
Q. Okay. So the only thing that you have a clear recollection of regarding anything that you may have written is when you signed your name when you arrived at the facility?
A. Yes.
Q. Okay. You indicated that you then sat down and waited. Were there other people there getting echoes?
A. We were all there for the same reason.
Q. And that was to get echoes?
A. Yes.
Q. What's your recollection as to roughly the number of people at this Residence Inn who were waiting to get echoes?
A. I don't know.
Q. Was it a dozen? More? Less?
A. I don't know. I didn't sit there and count everybody who was coming and going
Q. I'm sorry. I'm not trying to give you a hard time, but I'm wondering if it was an auditorium full of people or a waiting room.
A. It was like a conference room type of place.
Q. You indicated that you waited until they called your name, and you went in and had the echo obtained. About how long did you have to wait?
EXHIBIT 3 THE DEPOSITION OF DONALD LUSSIER
Q. Okay. Fair enough. With respect to the call that you made to the lawyers after seeing the advertisement on TV, once again I am going to push you a little bit, and if you don't know, you can say you don't know.Do you know if that call, the initial call that you made to the lawyers was made in 2002, 2001, 2000 or some other time?
A. I can't remember.
MS. YAEGER: Object to form. THE WITNESS: I really can't. BY MR. PHILLIPS:
Q. Would you have any documents or paperwork or anything else at your home or at your office that might shed some light on when it was that you first contacted the lawyers who currently represent you?
MS. YAEGER: Object to form. THE WITNESS: No.
BY MR. PHILLIPS:
Q. Okay. You told us about seeing the commercial on TV and responding to the 800 number; is that right?
A. Yes.
Q. Okay. Was that the first time that you contacted a lawyer regarding anything related to Phen-Fen?
A. Yes.
MS. YAEGER: Object to form.
BY MR. PHILLIPS:
Q. Okay. I don't want you to give me the details, but usually when people retain lawyers they sign some sort of retention agreement.
MS. YAEGER: Object to form. THE WITNESS: Yes.
BY MR. PHILLIPS:
Q. Or a contingency agreement.
Have you done that in this case?
MS. YAEGER: Object to form. THE WITNESS: I believe I have.
BY MR. PHILLIPS:
Q. Do you know when it was that you signed that agreement?
MS. YAEGER: Object to form. THE WITNESS: No idea.
BY MR. PHILLIPS:
Q. And you can't tell us the how soon or far after your initial telephone contact with your lawyers it was before you signed that agreement?
MS. YAEGER: Object to form. THE WITNESS: No.
BY MR. PHILLIPS:
Q. You have no idea?
MS. YAEGER: Object to form. THE WITNESS: No idea.
BY MR. PHILLIPS:
Q. The first echo that you obtained at the Residence Inn in Tucson, please describe for me how it is that you came to — or strike that.
The first echo that you obtained at the Residence Inn, how did that echo come about, why did you have that echo done?
MS. YAEGER: Object to form.
THE WITNESS: I received a letter from her law firm that they were going to set up an echo test, and that I should call and make an appointment to see if there has been damage to my heart.
BY MR. PHILLIPS:
Q. And when you said "her law firm", you meant Ms. Yaeger; is that right?
A. Yes.
Q. Do you still have the letter that was sent to you by Ms. Yaeger's office regarding this echo?
MS. YAEGER: Object to form. THE WITNESS: I don't know.
BY MR. PHILLIPS:
Q. Okay. No doctor recommended that you obtain that initial echo; is that right?
A. Right.
Q. That was a recommendation from your lawyers?
A. Right
MS. YAEGER: Object to form.
BY MR. PHILLIPS:
Q. All right. I think you said something to the effect they indicated that — did you need to call to set it up, or what?
A. I needed to call.
MS. YAEGER: Object to form.
BY MR. PHILLIPS:
Q. Were you told to call?
MS. YAEGER: Object to form.
THE WITNESS: They gave me a time period that the people would be in town at the Residence Inn and I was to call and make an appointment between those dates.
BY MR. PHILLIPS:
Q. And did you do that?
A. Yes.
MS. YAEGER: Object to form.
BY MR. PHILLIPS:
Q. And who was it that you called —
MS.YAEGER: Object to form.
BY MR. PHILLIPS:
Q. — regarding the echo? A. I have no idea.
MS.YAEGER: Object to form.
THE WITNESS: The company who gave the cardiogram, their receptionist, I am assuming.
BY MR. PHILLIPS:
Q. Do you know if that was a local number?
A. It was not.
Q. Okay. When you called that number, were you then given a date and time for the echo?
MS. YAEGER: Object to form. THE WITNESS: Yes.
BY MR. PHILLIPS:
Q. Did you have one or more than one telephone conference with the people at the company regarding setting up your echo?
MS. YAEGER: Object to form. THE WITNESS: One.
BY MR. PHILLIPS:
Q. Do you remember about how long it was between the time that you called the company to schedule your echo and when it was that your echo occurred? MS. YAEGER: Object to form. THE WITNESS: No idea.
BY MR. PHILLIPS:
Q. All right. You indicated that the echo was actually obtained at the Residence Inn?
A. Yes, sir.
Q. All right. So stating the obvious, the Residence Inn is a hotel and not a medical facility?
A. Yes.
Q. You don't know the name of the company that did the echo?
A. I don't
MS.YAEGER: Object to form.
BY MR. PHILLIPS:
Q. Describe for me, if you would, please, what happened from the time that you arrived at the Residence Inn to get the echo until the time that you left that day.
MS. YAEGER: Object to form.
THE WITNESS: I was taken into a room that had a echogram machine set up, and they gave me the test right then.
BY MR. PHILLIPS:
Q. Okay. When you arrived at the Residence Inn for the echo, were you given any paperwork to fill out?
MS.YAEGER: Object to form.
THE WITNESS: I am sure I signed in, but I don't remember any paperwork. I am sure I signed in, my name, address.
BY MR. PHILLIPS:
Q. Okay. Were you given at the Residence Inn any literature or paperwork describing what was about to happen to you?
MS.YAEGER: Object to form.
THE WITNESS: I don't believe so.
BY MR. PHILLIPS:
Q. Were you given any literature or paperwork at the Residence Inn to take home with you after the echo?
MS. YAEGER: Object to form.
THE WITNESS: I don't believe so.
MR. PHILLIPS: What's wrong with the form of these questions?
MS. YAEGER: I think you are getting into some privileged areas.
MR. PHILLIPS: I will be more than happy to show a continuing objection, if I would like —
MS. YAEGER: Okay.
MR. PHILLIPS: Okay. — with respect to the echo.
MS. YAEGER: Okay.
MR. PHILLIPS: Okay.
Thank you.
BY MR. PHILLIPS:
Q. All right. So you show up and you think you signed your name and gave your address, and did you immediately go in for the echo or do you have to wait for a while?
A. I Immediately went In.
Q. Okay. Did anyone interview you prior to the echo, during the echo or after the echo, at the Marriott regarding your health history or any other personal information?
A. No.
Q. Okay. Was this echo obtained at the Residence inn in a conference room or a hotel room or something else?
A. I think it was a divided conference room.
Q. Okay. Do you know if there was one echo machine or multiple echo machines there?
A. At least two.
Q. Why do you say that?
A. Because there was somebody next door getting one, well there was curtain.
Q. Did you talk with any other people who were
EXHIBIT 4 Dean Heller Nevada Secretary of State Corporate Information Name: SONIC IMAGING
Type: Corporation File Number: C14598-1999 State: NEVADA Incorporated On: June 14, 1999 Status: Current list of officers on file Corp Type: Regular Resident Agent: STEPHEN DUBIN (Accepted) Address: 2359 CLIFFWOOD DR. HENDERSON NV 89014 President: STEPHEN DUBIN Address: 2359 CLIFFWOOD HENDERSON NV 89014 Secretary: STEPHEN DUBIN Address: 2359 CLIFFWOOD HENDERSON NV 89014 Treasurer: Address: GENERAL INFORMATION PARCEL NO. 77-35-B15-036 OWNER AND MAILING ADDRESS DUBIN STEPHEN P 3096 MAPLE RIDGE CT HENDERSON NV 89052-4016 LOCATION ADDRESS CITY/TOWNSHIP 3096 MAPLE RIDGE CT HENDERSON ASSESSOR DESCRIPTION SEVEN HILLS-PARCEL B-2 PLAT BOOK 75 PAGE 67 LOT 84 BLOCK C RECORDED DOCUMENT NO. [*]20031014:01075 RECORDED DATE 10/14/2003 VESTING NO STATUS[*] Note: Only documents from September 15, 1999 through present are available for viewing. ASSESSMENT INFORMATION AND SUPPLEMENTAL VALUE TAX DISTRICT APPRAISAL YEAR FISCAL YEAR SUPPLEMENTAL IMPROVEMENT VALUE SUPPLEMENTAL IMPROVEMENT ACCOUNT NUMBER REAL PROPERTY ASSESSED VALUE FISCAL YEAR LAND IMPROVEMENTS PERSONAL PROPERTY EXEMPT GROSS ASSESSED TAXABLE VALUE LAND+IMP ESTIMATED LOT SIZE AND APPRAISAL INFORMATION ESTIMATED SIZE ORIGINAL CONST. YEAR LAST SALE PRICE MONTH/YEAR LAND USE DWELLING UNITS PRIMARY RESIDENTIAL STRUCTUREM TOTAL LIVING SQ. FT. CARPORT SQ. FT. ADDN/CONV NONE 1ST FLOOR SQ. FT. STORIES POOL NO 2ND FLOOR SQ. FT. BEDROOMS SPA NO BASEMENT BATHROOMS TYPE OF CONSTRUCTION FRAME STUCCO GARAGE SQ. FT. FIREPLACE ROOF TYPE CONCRETE TILE GENERAL INFORMATION PARCEL NO. OWNER AND MAILING ADDRESS LOCATION ADDRESS CTTY/TOWNSHIP ASSESS DESCRIPTION RECORDED DOCUMENT NO. RECORDED DATE VESTING
505 2003 03-04 2002-03 2003-04 14000 15750 27800 27657 0 0 0 0 41800 43407 119430 124020 .15 Acres 1997 179900 10/03 RESIDENTIAL TOWNHOUSES 1 1195 1195 TWNHOUSE (1) 3 NO 2 FULL 439 1 177-35-815-036 DUBIN STEPHEN P 3096 MAPLE RIDGE CT HENDERSON NV 89052-4016 3096 MAPLE RIDGE CT HENDERSON OR SEVEN HILLS-PARCEL B-2 PLAT BOOK 75 PAGE 67 LOT 84 BLOCK C [*]20031014:01075 10/14/2003 NO STATUS[*] Note: Only documents from September 15, 1999 through present are available for viewing. ASSESSMENT INFORMATION AND SUPPLEMENTAL VALUE TAX DISTRICT APPRAISAL YEAR FISCAL YEAR SUPPLEMENTAL IMPROVEMENT VALUE SUPPLEMENTAL IMPROVEMENT ACCOUNT NUMBER REAL PROPERTY ASSESSED VALUE FISCAL YEAR LAND IMPROVEMENTS PERSONAL PROPERTY EXEMPT GROSS ASSESSED TAXABLE VALUE LAND+IMP ESTIMATED LOT SIZE AND APPRAISAL INFORMATION ESTIMATED SIZE ORIGINAL CONST. YEAR LAST SALE PRICE MONTH/YEAR LAND USE DWELLING UNITS PRIMARY RESIDENTIAL STRUCTURE TOTAL LIVING SQ. FT. CARPORT SQ. FT. ADDW/COMV NONE 1ST FLOOR SQ. FT. STORIES POOL NO 2ND FLOOR SQ. FT. BEDROOMS SPA NO BASEMENT BATHROOMS TYPE OF CONSTRUCTION FRAME STUCCO GARAGE SQ. FT. FIREPLACE ROOF TYPE CONCRETE TILE
505 2003 03-04 2002-03 2003-04 14000 15750 27800 27657 0 0 0 0 41800 43407 119430 124020 .15 Acres 1997 179900 10/03 RESIDENTIAL TOWNHOUSES 1 1195 1195 TWNHOUSE (1) 3 NO 2 FULL 439 1EXHIBIT 5 Board of Medical Examiners Newsletter
REX T. BAGGETT M.D., President SUSAN S. BUCHWALD, M.D. ARNE D. ROSENCRANTZ, Vice President VICTOR SCARAMOSINO DIPAK K. DESAI, M.D, Secretary-Treasurer PAUL A. STEWART M.D. JACULINE C. JONES, Ed.D. CHERYL A. HUG-ENGLISH, M.D. JOEL N. LUBRITZ, M.D.NEVADA STATE BOARD OF MEDICAL EXAMINERS NEWSLETTER VOLUME 18 OCTOBER 1997 PRESIDENT'S MESSAGE By: Rex T. Baggett, M.D., President
The end of the biennial registration on June 30, 1997 revealed an important fact: some physicians do not know the contents of NRS 630, the Nevada Medical Practice Act. This is the law that governs the practice of medicine in the State of Nevada, including licensing. Unfortunately, several physicians lost their licenses to practice because of ignorance of the licensing law. The Nevada State Board of Medical Examiners staff endeavored to overcome registration deficiencies, such as inaccurate current addresses, to inform physicians of impending problems with their registration, but the staff is unable to change the law with respect to CME requirements, fees and registration deadlines to accommodate physicians. If you don't know the licensing law, contact the board office to obtain an updated copy of NRS 630.NEW BOARD MEMBER AND OFFICERS TAKE OFFICE
Joel N. Lubritz, M.D, was appointed by Governor Miller to a four-year term on the board effective September 1, 1997, replacing M. Nafees Nagy, M.D, who completed eight years service on the board on August 30, 1997. Dr. Lubritz practices Otolaryngology in Las Vegas.
At its August meeting, Rex T. Baggett, M.D, was elected President of the Nevada State Board of Medical Examiners for the next year. Dr. Baggett practices in Carson City and has served on the board since December 18, 1992. During his tenure on the board, he has served as a member of the Investigative Committee and as Vice President. annual medical examination; and (v) Provide a copy of the annual medical certification to the employer for retention in the driver's qualification file and retain a copy of the certification on his/her person while driving for presentation to a duly authorized federal, state or local enforcement official. (b) The provisions of (391.41(b)(10) do not apply to a driver who was a participant in good standing on March 31, 1996, in a waiver study program concerning the operation of commercial motor vehicles by drivers with visual impairment in one eye; provided: (1) The driver is physically examined every year, including an examination by an ophthalmologist or optometrist attesting to the fact that the driver: (i) Is otherwise qualified under (391.41; and (ii) Continues to measure at least 20/40 (Snellen) in the better eye. (2) The driver provides a copy of the ophthalmologist or optometrist report to the medical examiner at the time of the annual medical examination. (3) The driver provides a copy of the annual medical certification to the employer for retention in the driver's qualification file and retains a copy of the certification on his/her person while driving for presentation to a duly authorized federal, state or local enforcement official.
BOARD DISPLINARY ACTIONS APRIL THROUGH SEPTEMBER, 1997
CAMPBELL, ROBERT E., P.A.-C Complaint Filed: 8/7/96— Charged with 1 count of violation of NAG 630.380(1)(b) holding himself out to be a licensed physician; 1 count of violation of NAC 630.380(1)(c) performing medical services otherwise than at the direction or under the supervision of the supervising physician; and 1 count of violation of NAC 630.386(1)(e) engaging or having engaged in the performance of medical services when he is unable to do so with reasonable skill and safety to patients because of his excessive use of alcohol or any other controlled substance or because of any mental or physical condition or illness.
Order of Summary Suspension of License to Practice Medicine in the of Nevada: 8/11/97 — The board determined that the continued practice of medicine by Mr. Campbell during the pendency of the time necessary for a hearing on the complaint filed on August 7, 1997 against him would endanger the health, safety, and welfare of his patients and summarily suspended his license pending the hearing. Board Action: 9/20/97 — Revoked Mr. Campbell's certificate to practice as a physician assistant in the State of Nevada.
CHOMIAK, BRAYNT D., M.D.
Complaint 4/22/97 — Charged with 1 count of violation of NRS 630.306(1) the inability to practice medicine with reasonable skill and safety because of illness, a mental or physical condition or the use of alcohol, drugs, narcotics or any other substance; 1 count of violation of NRS 630.306(2)(b) engaging in any conduct which the board has determined is a violation of the standards of practice established by regulation of the board; and 1 count of violation of NAC 630.230(1)(d), a standard of practice, rendering professional services to a patient while the physician is under the influence of alcohol or any controlled substance.
Order of Summary of License to Medicine in the of Nevada: 4/24/97, — The board determined that the continued practice of medicine by Dr. Chomiak during the pendency of the time necessary for a hearing on the complaint filed on April 22, 1997 against him would endanger the health, safety, and welfare of his patients and summarily suspended his license pending the hearing. Board Action: 7/16/97 — Revoked Dr. Chomiak's license to practice medicine in the State of Nevada.
DUBIN Stephen, P., M.D.
Complaint 4/22/97 — Charged with 2 counts of violation of NRS 630.304(1) obtaining a license to practice medicine by fraud or misrepresentation, or by any false, misleading, inaccurate or incomplete statement; and 2 counts of violation of NRS 630.306(2)(a) engaging in conduct intended to deceive; 1 count of violation of NRS 630.304(1) Action: 07/15/97 — Revoked Dr. Dubin's license to practice medicine in the State of Nevada.
EVANGELISTA, Luislto A., M.D.
Complaint Filed: 9/16/96 — Charged with 1 count of violation of NRS 630.3062(4) failure to make the medical records of a patient available for inspection and copying as provided in NRS 629.061; 2 counts of violation of NRS 306(2)(a) engaging in any conduct intended to deceive; 1 count of violation of NRS 630.3065(2)(a) willful failure to comply with a subpoena of the board; 14 counts of violation of NRS 630.306(2)(b) engaging in any conduct which the board has determined is a violation of the standards of practice established by regulation of the board; 14 counts of violation of NAC 630.230(1)(c) engaging in the practice of writing prescriptions for controlled substances in such excessive amounts as to constitute a departure from prevailing standards of acceptable medical practice; 26 counts of violation of NAC 630.245 malpractice defined as the failure of a physician, in treating a patient, to use the reasonable care, skill, or knowledge ordinarily used under similar circumstances; 1 count of violation of NRS 630.301(4) gross or repeated malpractice; 12 counts of violation of NAC 630.205(1) and (a) or (b) prescribing an appetite suppressant to control weight under certain circumstances set out in paragraphs 1(a) and (b); 12 counts of violation of NAC 630.205(4) failure to obtain a medical history and perform a physical examination of the patient and conduct appropriate studies to determine if there are any contraindications to the use of the appetite suppressant by the patient; and 1 count of violation of NRS 630.301(4) gross or repeated malpractice. Action: 9/20/97 — Revoked Dr. Evangelista's license to practice medicine in the State of Nevada.
HOSSAIN M., M.D. Board Action: 4/24/97 — Reconsidered and accepted Dr. Hossain's application for licensure, and Dr. Hossain was issued a license to practice medicine in the State of Nevada.
LEVINGER, William A., M.D. Complaint Filed: 4/16/97 — Charged with 1 count of violation of NRS 630.306(11) failure by a licensee or applicant to report, within 30 days, the revocation, suspension or surrender of his license to practice medicine in another jurisdiction, namely, the State of Idaho.
Board Action: 6/20/97 — Entered into a Stipulation for Settlement and Ordered Dr. Levingerto: 1) pay $500.00 as reimbursement to the board for costs of investigation in the matter; and 2) enter into an agreement with the Nevada Health Professionals Assistance Foundation, which agreement will provide, among other things, that the Idaho Physicians Recovery Network be authorized to provide — and that Dr. Levinger authorize the Idaho Physicians Recovery Network, in writing, to provide — the Nevada Health Professionals Assistance Foundation with any and all reports, conclusions, or recommendations concerning Dr. Levinger's monitoring by the Idaho Physicians Recovery Network.
ONG Teng C., M.D.
Findings of Fact, Conclusions of Law and Order Entered Pursuant to Stipulation for
EXHIBIT 6
IN RE: DIET DRUGS (PHENTERMINE/ FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION; SHEILA BROWN, ET AL. v. AMERICAN HOME PRODUCTS CORPORATION MDL NO. 1203, CIVIL ACTION NO. 99-20593 United States District Court, E.D. Pennsylvania March 19, 2003G. SEAN JEZ, ESQ., FLEMING ASSOCIATES, LLP., Houston, Texas, For the Plaintiff
PETER GROSSI, ESQ., ARNOLD PORTER, Washington, D.C., For the Defendant
PRODUCTS LIABILITY LITIGATION
HARVEY BARTLE, III, District Judge
MR. BALSER: I plan on doing that and also send them a copy of it. I just hope it's actually implemented and that is what is being done.
THE COURT: Thank you.
MS. PRICE: Hi, Your Honor. Good afternoon. My name is Diane Price. I represent approximately 800 Green form clients all over the United States. I wanted to speak last, because I also have a clinical background.
THE COURT: I don't know that you are last.
MS. PRICE: I wanted to speak last because I'm also an R.N. So I kind of give this a little bit of a different perspective. And I guess basically I want to say that our clients, like the gentleman before us, 15 months. And as Ellen said, this is a slow moving barge. Possibly another 21 months. And I guess what I'm saying is, that these new audit rules are excessive, they are burdensome, and they are going to cause a lot of more time delay.
Under the old audit rules, 15 percent was the audit. Obviously they must have worked. Dr. Crouse, Dr. Mueller, they were ferreted out. But now we have the 100 percent audit. Now, we are looking at more increased rules. I guess basically I just want to say that my clients call every day wanting to know, what is going on, what to tell them. I write them letters. I say, this is what is going on in Philadelphia. Just more delay. It could be up to three years that they have been waiting for. However —
THE COURT: What do you think the time table would be if we continued with the old rules?
MS. PRICE: I think it would be at least Ellen said 90 days was what was contemplated —
THE COURT: But we need a lot more cardiologists; isn't that right?
MS. PRICE: Yes.
THE COURT: That would get it done in 90 days.
MS. PRICE: There is no doubt. Nobody is questioning the fact that we need more cardiologists. But the old rules at least had set limits of approximately 90 days.
Now, we are looking, I'm going to go back and tell my clients all over the United States oh, by the way, this may take another two years. Nobody seems to have said anything about how, you know, stop, wait, why new audit rules. We are doing 100 percent audit. The 15 percent audit ferreted out Napoli. Excuse me, ferreted out Dr. Grouse and Dr. Mueller.
Anyway, didn't want to say that. Anyway, in light of that, nobody has really ever said stop, there is 100 percent audit. That is enough. That is what I think I'm here to tell you, and the Court, that that is what my clients are saying. When is enough? When is enough enough? Stop the bleeding.
Anyway, I just want to comment on a couple of things. With my medical background, the medical history that they are proposing, that it should be taken by the board certified cardiologists Level II training.
The board certified cardiologist is given the Green form with the appendix. Right on page two, part — or page seven of the Green form, Part II, it states, if you — you know, you say, okay, read these, make sure that you fill this out correctly and in accordance. It says that you may consider. The wording says, you may consider, rely upon and use. It does not say, you must take that patient's medical history, and you must be there in their office — they must be in your office. And then also that verification form —
THE COURT: What about lawyers taking the medical history?
MS. PRICE: Well, I've said this for quite awhile. I will tell you how we do it. I sit down with several nurses, several cardiologists, and made out a medical history, just like a doctor's office would do, you know.
THE COURT: You sit down with several cardiologists and several nurses for each of your clients?
MS. PRICE: For our Green form clients, what we did was, we made up a medical history and then we had nurses call. We had our nurses call the clients and say, you know, to all the page Part II questions that were pertinent, so that we knew that every one, so that the cardiologists felt comfortable. He had their medical history right in front of them, just like in a doctor's office.
THE COURT: You mean, you would just call somebody —
MS. PRICE: A nurse.
THE COURT: Call somebody at one's home and just take a medical history that way?
MS. PRICE: Certainly. That would — you know, you've asked them every question that is on that Green form. That is pertinent.
THE COURT: Let's put aside the Trust for a moment.
Is that customary where you come from, for patients to sort of, before they even see the doctor, to give sort of a medical history over the phone? I have never heard of that. Maybe it's done.
MS. PRICE: It may not be standard. What they are proposing —
THE COURT: Normally, patients are at least in the doctor's office. They don't do it over the phone.
MS. PRICE: That's true. It's not normally done over the phone.
THE COURT: Why do you think that is?
MS. PRICE: Well, as a nurse, typically the patient is waiting in line to see the doctor.
THE COURT: No, but I'm talking about why isn't it done over the phone, why is it customary to do that?
MS. PRICE: Why wouldn't it be customary in the regular practice?
THE COURT: Yeah.
MS. PRICE: Because they are coming in to see the doctor, so they take it while they are coming in —
THE COURT: Let's say I have an appointment May 15th to see the doctor. So the nurse calls me at home and says, judge, I want to get your medical history down before. We can save a lot of time. That is not done, is it?
MS. PRICE: No, but he is anticipating that you are coming to his office. And so at that time, while you are waiting for him in that —
THE COURT: Why not do it — wouldn't it be a lot more efficient to do it over the phone, get it done, get it done early? Instead of getting one of these calls to buy something at 6 o'clock, when you are about to have dinner, 6:30, the nurse calls and you give her all — give your medical history.
MS. PRICE: I think in some instances, cardiologists probably not. But there are some specialists, Judge, that send out their —
THE COURT: Wouldn't you feel a little uneasy as a patient to have — you were going in for heart surgery, you thought you had a heart problem, the doctor's office calls and says, give me a half hour of your time, I'm going to take your medical history over the phone, sight unseen?
MS. PRICE: Certainly that is a large degree different than what we are talking. These folks are not going to be having heart surgery from the person that is reading their echocardiogram. But I think that the main point —
THE COURT: It is subject to abuse, don't you think, to do it that way? Misunderstanding —
MS. PRICE: I think that is why there is an audit.
THE COURT: Misunderstanding about what people are saying, you are not able to look at the person who is giving the history. Isn't that important? To be able to look at somebody to see whether they are —
MS. PRICE: I think if you have a nurse conducting the interview that it's different than just having a paralegal or a lawyer do it.
THE COURT: What happens if somebody has the T.V. on at home, you know, what are you going to do? Tell them to turn the T.V. down, or you don't know whether the person is hard of hearing or anything else. It's fraught with a lot of problems, don't you think, doing it over the phone?
MS. PRICE: There are some situational problems. I think that if you have a medical personnel conduct — a nurse — conduct the medical history, then I think that you are — you are putting that person —
THE COURT: You don't even know who it is on the other end. I would be loathe to give medical history over the phone. There is a privacy. If somebody calls you, you don't know whether it's a Charlatan or not.
MS. PRICE: I think if you identify yourself and tell them, you know that —
THE COURT: I think I have explored this sufficiently. But go ahead. I just think —
MS. PRICE: My basic argument on the Green form itself it says that including the form you may consider, rely upon and use. It does not say that there has to be a face-to-face meeting, it does not ask for a certain length of time, that they are requiring on their medical verification forms or physician verification forms.
THE COURT: Face-to-face is how it is normally done, isn't it, in life?
MS. PRICE: Yes, it is. It necessarily is not done by the cardiologist or the physician. THE COURT: It's usually done with someone with medical training.
THE WITNESS: That's correct.
THE COURT: Not with the lawyer. You could not have your lawyer send in the medical history to your doctor. You have never heard of that, have you Give your medical history to your lawyer, he gives it to your doctor.
MS. PRICE: Never heard of that one.
I think the only other point that I want to make is the facility requirements. And I think I heard one gentleman say that we want it to be in a serious facility. As a nurse, I have given well health physicals at health clubs. I don't know if that is considered a serious facility. But I agree — I don't agree that it has to be at a hospital or in their office.
And the other issue there is that when we have clients all around the United States, Dodge City, Kansas, you know, everywhere, it is not practical also.
I think that's all.
THE COURT: Thank you.
How many more speakers?
MR. DRIGGS: I will be fast.
THE COURT: Go ahead.
MR. DRIGGS: My name is Matthew Driggs.
I just want to just — I don't want to be redundant but it's on the issue of the medical history taken in an office or medical facility. And we are in a position where there are a lot of outlying areas.
THE COURT: Where exactly are you located?
MR. DRIGGS: Utah. And we do cases in
EXHIBIT 7 PROCEEDINGS
BE IT REMEMBERED that on the 26th day of August, 2003, the videotaped deposition of GERALD I. POLUKOFF, M.D., produced as a witness herein at the instance of the Defendant, in the above-entitled action now pending in the above-named court, was taken before Jerry Martin, Registered Professional Reporter and Notary Public in and for the State of Utah, commencing at the hour of 10:00 a.m. of said day at the Park City Marriott, 1895 Sidewinder Drive, Park City, Utah. GARCIA LOVE 801.538.2333
THE VIDEOGRAPHER: This is the videotape deposition of Dr. Gerald Polukoff, being held at the Marriott Hotel in Park City, Utah, on August 26th, 2003, at 10:02 a.m.
My name is Jason Bone, legal videographer. The court reporter is Jerry Martin. We are in association with Esquire Deposition Services.
Will counsel please state their appearances for the record, and the witness will be sworn.
MR. JEZ: Sean Jez on behalf of plaintiff Patricia Stafford.
MR. GROSSI: Peter Grossi on behalf of defendant Wyeth.
GERALD I. POLUKOFF, M.D. was called as a witness, having been first duly sworn, was examined and testified on his oath as follows:
EXAMINATION
BY MR. GROSSI:
Q. Good morning, Dr. Polukoff.
A. Good morning.
Q. We've met before, but for the record I'm Peter Grossi from Arnold Porter for defendant Wyeth. I know you've had your deposition taken many, many times, including many times in diet drug cases, so I won't go through any of the preliminaries.
MR. GROSSI: Let me mark as Deposition Exhibit 1 an article that I believe bears your name.
(Whereupon, Exhibit 1 was marked.)
For the record, Exhibit 1 is a research article entitled "Risk of valvular heart disease associated with use of fenfluramine." The authors are stated to be Paul N. Hopkins and Gerald I. Polukoff.
Q. Dr. Polukoff, do you recognize this document?
A. Yes, sir.
Q. Is this in fact an article that you coauthored?
A. Yes.
Q. And you authored it with Dr. Hopkins?
A. That's correct, sir.
Q. He's also in Utah?
A. Yes.
Q. He also works for plaintiffs in diet drug cases?
MR. JEZ: Objection, form.
A. I believer he does, sir.
Q. The article states, does it not, he is a consultant for plaintiff attorneys representing persons who have taken fenfluramine and dexfenfluramine?
A. Yes, it does.
Q. Has he appeared as an expert witness in any of those cases?
MR. JEZ: Objection, form.
A. I don't believe so, sir.
Q. Did he receive money from the plaintiffs' attorneys for writing this article?
MR. JEZ: Objection, form.
A. He did not that I'm aware of.
Q. Not that you're aware of.
A. No, sir.
Q. You think he may have received it, but you're not aware of it? You just don't know his arrangement with the plaintiffs?
MR. JEZ: Objection, form.
A. No, sir. Would you please restate the question.
Q. Yeah, my question was the way you answered the question I left open the possibility that he might have an arrangement with plaintiff attorneys about this article that you might not be aware of. You just don't know what his arrangement was.
MR. JEZ: Objection, form.
A. He did not receive any funds or monies or compensation for writing this article that I'm aware of.
Q. Does he receive a retainer from plaintiff attorneys?
MR. JEZ: Objection, form.
A. You'd have to ask Dr. Hopkins that.
Q. Well, that was my question. I mean, you receive — you have received in the past a lump sum of $400,000 from Mr. Fleming that was not directly related to your testimony in the cases, correct?
A. I've never been paid for my testimony. I'm only compensated for the time and effort that I put into evaluation of the medical-legal aspects of fenfluramine, related valvular heart disease, and pulmonary hypertension.
Q. And I think you've testified previously when you make those evaluations you're paid on an hourly basis, correct?
A. That is correct.
Q. Okay. And just for the record so it's all in one place, what was the hourly basis over the various years, if it's changed?
A. It's generally been $350 per hour.
Q. Is it currently more because of inflation?
A. No, sir.
Q. Okay. So you receive $350 an hour when you look at cases that plaintiffs bring to you that may be involved in litigation proceedings, correct?
A. That's correct.
Q. And you billed a certain sum of money for those consultations, right?
A. Yes, sir.
Q. But in addition you received $400,000 that was above and beyond those individual consultations, correct?
A. No, sir. The $400,000 was related to my work for a period of one year, and during that year I worked well over 20 hours a week, sometimes 40 hours a week on matters relating to fenfluramine that involved Mr. Fleming and his firm, so essentially rather than having to keep track of every conversation and every document review, every minute of time, I received this $100,000 per quarter to bill against more or less, and as it turned out it was well within my usual and customary fees on this matter.
Q. Those 20 to 40 hours a week that you spent working for Mr. Fleming involved with fenfluramine matters. Okay. I want to exclude, though, what that didn't include. That did not include the consultations on the individual cases, correct? If you did that, you billed some additional sum, correct?
A. For the most part during their time there really wasn't individual cases. That was mostly during the time of the echo screening program, and most of the matters related to general activities rather than case specific.
Q. Okay. But just so we're clear, the kind of thing that we're doing today, where you have determined an opinion about an individual plaintiff, had you done that during the period of time when you were covered by the $100,000 a quarter retainer, you would have billed separately for that.
A. I'm not sure that I would have. I don't really think that I had individual cases during that time.
Q. Okay. What year was that by the way?
A. It covered part of 2001 and 2002.
Q. Is it the later half of 2001, first half of 2002?
A. I think so.
Q. All right Now, during that `01-`02 period you were also involved in making evaluations of claimants for matrix benefits in the fenfluramine area, correct?
A. Yes.
Q. Did you bill that separately, or was that also covered by the 400,000 lump sum? A. I'm not exactly sure. I don't think Mr. Fleming had his, quote, matrix benefit program up and running for most of that time. I think it was generally in the development of an echocardiographic screening program and evaluation of the litigation as a whole.
Q. Okay. I think you're correct about that, and let me make a suggestion to you, that in the later half of 2001 but especially in the first half of 2002 your activities with respect to the matrix benefit program consisted of Consulting with firms such as Echo Motion in North Carolina on how they might conduct the echoes. Do you remember that? A. Well, I did have frequent communication with firms such as Echo Motion regarding the quality of their echocardiograms during that period of time.
Q. And is that something that you would not have billed separately for but would have been covered by this hundred thousand dollars a quarter arrangement?
A. I had pretty wide discretion during this retainer period, so the retainer allowed me to pursue quality issues such as echocardiograms and not worry about keeping track of individual billing hours.
Q. In the later half of 2002 you got involved in also reading individual tapes either for 100 cases, such as we're involved in today, or green form matrix cases, correct?
A. Yes, sir.
Q. Were you paid — now, this is after — assuming it was after maybe July 1 of 2002, this is after the hundred thousand dollar retainer arrangement was terminated. I take it you did bill separately for those individual interpretations.
A. Yes, sir.
Q. And what was your fee for an individual interpretation?
A. It varied. I worked with various firms, including Mr. Fleming's firm, and depending on the volume of studies that were anticipated I had different rates ranging anywhere from $125 per study to $250 per study.
Q. Do you remember where Mr. Fleming's firm fell in that continuum?
A. Initially $125 per study and then later in the program $200 per study.
Q. Okay. You also from time to time filled out green forms. You know what those are, right?
A. Yes, sir.
Q. Did you receive any separate fee for the activity of filling out the green form?
A. Yes.
Q. And how much was that fee?
A. $250 per evaluation.
Q. And was that consistent for all the firms?
A. Yes, sir.
Q. Do you have any idea how many echo interpretations you did with respect to matrix benefits as opposed to the lOO's, or is that not a proper question because you didn't know what they were going to use them for?
A. Well, I think it is a fairly compound question, but I'd be pleased to answer it as best I can.
Q. Please.
A. I organized a reading program with several of my colleagues in the area, and the group of physician echocardiographers and I probably read close to 10,000 echoes.
Q. Were these billed in some arrangement that you would know exactly, or are we talking about you and this group while meeting together and starting out together individually accounted for what you read and what you billed?
A. No, sir. I took care of all the correlation, filing, distribution and billing.
Q. Who are the other doctors in the Utah area that did this?
A. It would be Dr. Bruce Bray, Dr. Marcus Brann, B-R-A-N-N, Dr. Sheldon Litwin, and Dr. —
Q. Can you spell that one for us, please?
A. L-I-T-W-I-N. — and Dr. Fred Anderson.
Q. And of course you.
A. Yes, sir.
Q. No one else, those five.
A. Yes, sir.
Q. Okay. And you believe that the five of you together read approximately 10,000 echoes as part of the matrix program.
A. Yes, sir.
Q. Do you have any idea how many green forms were submitted as a result of those 10,000 reads?
A. I couldn't give you a specific, but probably somewhere in the range of three to four hundred.
Q. Would you be surprised to hear that you alone have submitted more than nine hundred?
A. That's possible.
Q. Do you recall, did you ever keep any running tally on — the first step on a green form is to have an FDA positive, right?
A. Yes, sir.
Q. Do you have any idea what the FDA positive rate was out of the 10,000?
A. I haven't ever done a correlation. In fact, I intentionally avoided a correlation because I didn't want to get into an estimation of positives. I didn't want to introduce any unnecessary bias. I just called them like I seen them and so did my group. But my general gestalt or feeling is probably somewhere around 10 to 20 percent positive, FDA positive, the majority of those being moderate mitral regurgitation.
Q. Can you give me any estimate, since you are the one who divided them up, of the 10,000 the approximate number that each of the five read?
A. Yes.
Q. Okay.
A. I read the most. I read mostly negative studies. And my colleagues read in order probably Dr. Brann, Dr. Bray, Dr. Litwin, and Dr. Anderson all about the same.
Q. Well, let me ask you two questions on that. When you say you read more, I think at one point you did estimate about 3,000. Is that still your best estimate, between three —
A. It could be. It could be even more. It could be less. I don't have a specific number. It was pretty busy for that period of time post final judicial approval and the one day and one year available for obtaining an echocardiogram, so during that time it was pretty fast paced.
Q. If you read about 3,000 and there were 10,000, then the other four split 7,000, and you think Dr. Bray read a little more than the others? Is that what you said?
A. I think Dr. Brann read —
Q. Brann. Okay.
A. — read more.
Q. So perhaps — and that is just for an estimate. I want to get a sense of it. So perhaps you read three, Dr. Brann read two, and the other three read maybe 1,500. That would get up to the order of around 10,000.
MR. JEZ: Objection, form.
A. This is somewhat speculative, but I would say it was somewhat around there.
Q. Let me ask this: Are there specific records we could get that would tell us the answer to this?
A. Yes.
Q. All right. So I will think about whether we want to get the specific answers. And let me just ask this: If you read about 3,000 and it turns out that you have submitted in your own name about a thousand green forms, would that surprise you, that it might be as high as 33 percent?
MR. JEZ: Objection, form.
A. Yes, because what you're failing to calculate is the fact that I performed the green form — or completed the green form — for the entire batch.
Q. I see. You did the green forms for all of them.
A. Yes, sir.
Q. Okay. That makes it clear then. So we won't — well, the reason I ask is we've seen green forms with Dr. Brann's name on them. Could that be from another source?
A. Yes, I believe Dr. Brann had some independent relationships.
Q. Okay. So out of these 10,000 all the green form results would have been filed in your name.
A. Yes, sir.
Q. That helps. So you would take, let's say, a read by Dr. Brann of FDA positive. Would Dr. Brann also be responsible in that scenario for filling out the chamber sizes and the ejection fraction and things like that?
A. Yes, sir.
Q. So you would get from Dr. Brann some type of report that would indicate what he found in terms of what the echo showed?
A. Correct, sir.
Q. And then if they fit the criteria you would fill out the green form?
A. Yes, I would.
Q. And who filled out the portion — you filled out the portion of the green form that talked about the reduction factors?
A. Yes.
Q. When you filled that out you didn't have any medical records, did you?
A. I did.
Q. What kind of medical records did you have for those people?
A. I had a patient questionnaire that I designed to specifically address the, quote, reduction factors that you mentioned.
Q. Did you have the underlying medical records?
A. Yes.
Q. Okay. You were given comprehensive underlying medical records for these people?
MR. JEZ: Objection, form.
A. I'm not sure of that. That would be quite impossible.
Q. What sort of medical records did you have?
A. The patient questionnaire.
Q. Other than the patient questionnaire, did you have any medical records?
A. The echocardiogram.
Q. Other than the patient questionnaire and the echocardiogram, did you have any medical records?
A. No, sir.
Q. The patient questionnaire is something that you designed?
A. Yes, sir.
Q. And did you meet with these patients?
A. No.
Q. Who filled out the questionnaire?
A. Mostly nurses filled out the questionnaires, other times the patient themselves filled out the questionnaires, and on occasion I filled out the patient questionnaire.
Q. On those occasions you met with the patient.
A. Yes.
Q. And that was rather infrequent, though, I take it
A. Yes.
Q. One percent of the time?
A. Yes, sir.
Q. With respect to the other 99 percent, where were these nurses?
A. They were wherever they worked out of. Most of the nursing was done by Pat Hecker.
Q. Is that a man or a woman?
A. That's a woman.
Q. H-E-C-K-E-R?
A. C-K-E-R, yes. She employed a staff of RNs that would essentially take the patient history and complete the questionnaire by phone.
Q. Not in person.
A. No, sir.
Q. Okay. Ms. Hecker works for Mr. Fleming?
A. No, sir.
Q. Who does she work for?
A. Indirectly she works for Mr. Fleming. She is a registered nurse and she does medical-legal consulting.
Q. She has her own organization?
A. Yes, sir.
Q. What is that called?
A. I don't know.
Q. Where is it located?
A. She lives in Texas.
Q. Can you be — big state — a little bit more specific?
A. She lives in Houston.
Q. Houston. And do you recall from — did she send you correspondence from time to time on her letterhead or whatever?
A. Not really. We spoke many times.
Q. And you don't know the name of her organization?
A. Pat Hecker, RN.
Q. So you do believe she just trades under her own name.
A. I believe so.
Q. So Ms. Hecker is located in Houston, she has nurses working for her, and they talk on the phone to the claimant and fill out the medical questionnaire.
A. Yes, sir.
Q. So the questionnaires were not signed by the patient or claimant.
MR. JEZ: Objection, form.
A. There were several different ways that I accept it I accepted questionnaires completed by the nurse, the registered nurse, questionnaires completed by the patient themselves, or questionnaires completed by myself.
Q. But the vast majority were in the first category, the patient — I'm sorry — the ones where the nurse filled them out.
MR. JEZ: Objection, form.
Q. (BY MR. GROSSI) Based on the telephone interview.
A. I would say that was the majority. There were various legal firms that had the patients themselves complete the questionnaires, so I would receive a signed copy of the questionnaire from the patient.
Q. Okay. Let's stick with Mr. Fleming. He typically worked through Ms. Hecker's phone interviews?
A. Yes, sir.
Q. What are the other firms you worked for?
A. I worked for many firms.
Q. In all those cases, though, you didn't actually have underlying medical records other than the echo tape and some sort of questionnaire; is that right?
A. That's correct.
Q. And those other firms would sometimes send in questionnaires that were done by law firm employees?
A. Yes, they would.
Q. Not necessarily RNs.
A. That's correct, but I would not accept those.
Q. Okay. Your rule was that you wanted to see something that was taken by a nurse even if it was a nurse who worked for a law firm.
MR. JEZ: Objection, form.
A. Yes, and I think that, you know, any registered nurse that was taking the patient questionnaires would be adequate.
Q. Okay. And some work directly for law firms, some were independent contractors that worked for a law firm such as Mr. Fleming.
A. Yes, sir.
MR. JEZ: Objection, form.
Q. (BY MR. GROSSI) When you read the echoes for the matrix project, approximately how long did you spend on the interpretations? And you can give me a range if you'd like.
A. As you know, it depends on the quality of the study. Poor quality studies take a lot longer to read than clean studies — what I mean by clean is clean images — so I would say anywhere from a few minutes to 20 minutes.
Q. Okay. How about for filling out the green form, how long does that take? You have the questionnaire. What do you do then?
A. It takes about 15 minutes.
Q. Let me — I gave you — side tracked a little bit there. Let me go back to the $400,000. Other than talking to Echo Motion and perhaps talking with Mr. Fleming and other attorneys about how to set up these matrix benefit programs, what other activities in the latter part of 2001 and the first part of 2002 did you undertake that you felt in your mind were covered by the retainer, or the hundred thousand a quarter payment?
A. Well, Mr. Fleming has a large staff of attorneys and paralegals, and pretty much any question that had anything to do with the medical-legal aspects of Fen-Phen was directed my way, so during that period of time I would spend several hours per day on the phone with his staff.
Q. Anything else other than consulting with Mr. Fleming's people that you felt was covered? I mean, obviously it wasn't the individual cases and it wasn't the green forms.
A. Well, pretty much anything was covered that occupied my time. There was a variety of information exchanges between myself and the staff, all kinds of interesting cases, findings, procedures that we would constantly discussed.
Q. The article that we've marked as Exhibit 1, did Mr. Fleming's staff or Mr. Fleming himself know you were working on it when you were working on it?
A. I'm sure that they knew in one way or another. This is what I've dedicated years of my life to looking at, and since the original Internet publication in 1997 I've been working on Fen-Phen.
Q. The article was submitted to BMC Cardiovascular Disorders, it indicates, on January 24th, 2003. Before it was sent to BMC Cardiovascular Disorders was it sent to any other publication?
A. No, sir.
Q. When did you and Dr. Hopkins sort of complete the article?
A. Right proximal to that time.
Q. Okay. How long had you worked on the article?
A. Several months.
Q. Could you have worked on it as long as a year?
A. No, I don't think so.
Q. When did you start, do you think, then, given the fact that it was submitted in January 2003?
A. I would say several months prior to that. I don't have an exact date.
Q. Sometime in the earlier part of 2002?
A. Probably. It's something in the middle of 2002 I would say. It's something that's an evolutionary process where, you know, you begin with the concept and you have a meeting and you discuss your ideas and your experience and the literature, and you start accumulating literature and reviewing studies, and it takes a great deal of time and effort to move forward with that.
Q. Was one of your motivations that you had testified and participated in other litigations, and you had learned that in a litigation context, at least in some states, the courts are unwilling to accept causation conclusions unless the odds ratio is at least 2 to 1?
MR. JEZ: Objection to form.
A. It was not a motivating factor.
Q. It was something that you knew before you did this article, correct?
A. Yes, I do understand the Daubert rulings as best as a layperson and non-legal person can understand them.
Q. So we're clear, what the courts are looking for is that if, let's say, a drug has been associated with some adverse event, the courts will accept or permit testimony only if there's at least twice as much incidence among people who have taken the drug than among others, correct?
MR. JEZ: Objection, form.
A. You know, my understanding, not being a lawyer, of Daubert had much greater thought and much greater intellect than boiling it down to simple relative risk. That's one criteria. There are several others. Generally accepted medical knowledge is the main criteria. It was a ruling, as I understand it, that was developed to keep junk science out of the courtroom, and clearly Fen-Phen is strong, clean science.
Q. You understood, though, that some courts, especially in Texas under the Havner decision, are looking for that 2 to 1 factor without regard to these other scientific factors that you've just mentioned, correct?
MR. JEZ: Objection, form.
A. That is not my understanding.
Q. But you had in the back of your mind — you and Dr. Hopkins had in the back of your mind that it might be important to show for legal purposes that the excess risk ratio, let's say, on mitral regurgitation and Fen-Phen was greater than 2 to 1.
A. No, we did not have that as a motivating factor or in the back of our minds while writing this paper.
Q. It never occurred to you that one of the important things about this paper would be to show that the mitral regurgitation rate was 2 to 1 or greater for those legal considerations?
A. It occurs to me at this time that you mention it that it is a significant finding, but that was not a preconceived notion or understanding prior to accumulating this research and performing the analysis.
Q. Do you think it would be illegitimate for a scientist to mention or even consider the fact that a scientific finding if it was greater than 2 to 1 could have legal significance?
MR. JEZ: Objection, form.
A. I'm not sure I really understand that question. Do I think it would be illegitimate?
Q. Well, would a scientific journal, for example, be more interested in publishing a paper because it has a 2 to 1 finding if it were advised that that 2 to 1 finding would then have legal significance?
MR. JEZ: Objection, form.
A. Many times the relative risk is less than 2, and papers are published many times.
Q. Mm-hmm. In fact, papers have been published showing that the relative risk of fenfluramine ingestion and mitral regurgitation were about 1 ½ to 1 based on all the studies that were reviewed in your article, correct?
A. That is correct, and that is one of the reasons that Dr. Hopkins and I looked at the individual studies, to determine why there was tremendous variation in the reported relative risk and the experience, my common experience for example, and we discovered there was a form of nondifferential misclassification bias flawed design in these studies that served to dilute the relative risk.
Q. But you're aware that even meta-analyses of all the studies as a group pooling them together, Dr. Loke for example, came up with a relative risk of about 1 ½ to 1.
A. That's correct, and Dr. Loke did not factor in the misclassification bias.
Q. And one of the motivations in doing your study was to do it a different way than Dr. Loke had done it, correct?
A. No, that wasn't my motivation. My motivation was simply to look at all the data and see if I can find a common thread, and that's what we did.
Q. Okay. And you found a risk ratio of greater than 2 to 1, correct, for mitral regurgitation?
A. Yes, sir.
Q. And did it ever occur to you or Dr. Hopkins that one reason it was important to have that article published was because by finding a risk ratio of greater than 2 to 1 you would satisfy the legal requirement of some courts?
A. No, sir.
MR. JEZ: Objection, form.
Q. (BY MR. GROSSI) Do you think it would be improper to have that as one of the bases for wanting to publish this article in a scientific journal?
A. I don't think that that should be the motivation for publishing the article.
Q. You wouldn't say to a scientific journal, One of the important things about our paper that distinguishes it from prior papers is that we cross the 2 to 1 legal threshold.
A. No, that's not something that I would say.
Q. The article — this BMC Cardiovascular Disorders, that's actually a website; is that correct?
A. Yes.
Q. There's no hard copy. No one receives a copy of this journal in the mail, correct?
A. That's the beauty. Everybody who wants to receive a hard copy can for free.
Q. By printing it off their own personal computer.
A. That's correct, sir.
Q. It has no paid subscribers, this organization, correct?
A. It's open access. It's widely distributed. This is the journal — this journal is here and now, it's gaining momentum, and this type of open access medical literature is the future. I mean, this is where we're going. This is the way journals should be published.
Q. This BMC Cardiovascular Disorders, this is one of a group of 57 pages on that website, and they all have different names, BMC Neurological Disorders, BMC Allergy Disorders, all the different possibilities, right?
A. All the different disciplines?
Q. Mm-hmm.
A. Yes, sir.
Q. And again, you just go to the BMC website and you can click around and get groups of articles that exist only on the Internet based on these various subcategories, right?
A. Absolutely. It's just like the New England Journal of Medicine. You can go to their internet website and you can click on various articles, and if you have the money you can purchase those articles.
Q. The New England Jouran, of course, also sends out hard copies to hundreds of thousands of doctors, correct?
A. Think about the trees.
Q. Is the answer correct? I know we're in Park City and ecology is important, but we have to get through this. The New England Journal of Medicine does sends out hard copies, right?
A. Make no mistake about it. The New England Journal of Medicine is a fine, highly reputable journal.
THE COURT REPORTER: I'm sorry. Can we pause for a minute so we're not picking that up?
THE WITNESS: Let's take a break for a minute.
MR. GROSSI: No, let's not take a break, please. Let's keep going. We can live with a little noise.
Q. Doctor, the New England Journal of Medicine, does it charge to publish in its pages?
A. Yes.
Q. You have to pay the New England Journal a fee to publish your article?
A. I think so. Most journals require a publication fee and they also require a review fee. Most journals do. I'm not really all that familiar with it, because my focus has been clinical medicine in the past and teaching clinical skills currently as opposed to publication. There's a world of doctors out there who's focus is publications and expanding the database. But it is my understanding and my experience that other journals do require fees for review and fees for publication. Now, the beauty of BMC is it waives fees if you're affiliated with an academic institution.
Q. Was the fee waived in this case?
A. Yes, sir.
Q. So you didn't pay a fee to have this article published.
A. No, sir. Can we take a break now that you're through with your line of questioning?
MR. GROSSI: I'm really not.
THE WITNESS: Well, I'm going to take a break.
MR. GROSSI: Go ahead and take a quick break. Let's not have any consultations during the break, though.
(Off the record.)
THE VIDEOGRAPHER: On record, 10:41.
Q. (BY MR. GROSSI) Dr. Polukoff, before the break we were talking about the publication of the article, and you mentioned that other journals THE VIDEOGRAPHER: Hold on, please.
My power just went out.
(Off the record.)
THE VIDEOGRAPHER: On record, 10:42.
Q. (BY MR. GROSSI) Dr. Polukoff, before the break we were talking about the article you had published on the BMC website. You said, I think, that you thought that other journals, such as the New England Journal of Medicine, also had a fee that they charged the authors. Is that something you're really sure about, or is that —
A. Yes.
Q. — the best you can recall?
A. I don't know particularly about New England. I've never submitted to New England. But there is generally a review fee and a publication fee.
Q. Can you tell me what journals you've submitted articles to where you know absolutely there is a review fee or a publication fee?
A. The only time I really submitted an article to a journal previously was to the American Journal of Cardiology, and I believe they had a review fee. It is my understanding generally that most journals have a publication fee.
Q. Okay. But to your knowledge the only one you can really testify about is the American Journal of Cardiology and of course BMC?
A. I think that most journals have a reviewer and/or publication fee, and that's just my understanding. I could be wrong.
Q. How about that coastal state thing that you published your other Fen-Phen article in, did they charge you to publish it?
A. What do you mean "coastal state thing"?
Q. I just don't know the last name. Coastal State Medical Journal?
A. Oh, Coastal Bend Medicine.
Q. I'm sorry. Coastal Bend Medicine.
A. Right. No, They did not.
Q. They did not. Okay. And the American Journal of Cardiology, when did you make your submission to them?
A. Years ago.
Q. We talked a little bit about Dr. Lokee or Loke (phonetic). I'm not sure how it's pronounced. You've read his article, correct?
A. Yes.
Q. And that article was published also in BMC prior to yours, correct?
A. Yes.
Q. And it's similarly considered all of the existing studies, correct?
A. Yes.
Q. And it applies statistical tests to them, correct?
A. Yes, it did.
Q. And it came up with overall risk ratios for both aortic regurgitation, and as a shorthand we all know we're talking about sort of the FDA positive definition of mild or greater and moderate or greater mitral, right?
A. Yes.
Q. So as a shorthand he came up with an excess risk ratio for that type of aortic regurgitation and also for that type of mitral regurgitation, correct?
A. Yes.
Q. And the mitral one from recollection — we can take a look at it if you'd like, or you may have a copy of it — was something like 1.5 to 1.
A. I'd have to look, but I think it was something in that magnitude.
Q. And there was another article published toward the end of 2002 by a group at Duke that was headed or the lead author was a Molly Sachdev. Do you remember that article?
A. Yes.
Q. That's also referenced in your article, right?
A. Yes.
Q. And that was a similar thing, where they did a meta-analysis of all of the various studies, correct?
A. Yes, they did.
Q. And her finding was essentially the same as Dr. Loke's, that it was about 1.5 to 1 for the mitral regurgitation fenfluramine risk, correct?
A. I have it with me.
Q. Sure, take it out. I have one too.
A. Well, it will take me a minute to get it, so why don't you just flow me a copy of yours, please.
Q. All right. Just so we're on the same page, literally, is that the article by Molly Sachdev? And let me put it in for the record. "Effect of Fenfluramine Derivative Diet Pills on Cardiac Valves."
A. Yes. Guest editor was Dr. Robert Minot, yes.
Q. Do you know him?
A. Yes.
Q. Is he a pretty important guy in the cardiology community?
A. Yes, he is.
Q. So did she find and her group find — I'll point it to you — the bottom of Page 1068, top of 1069 — that the odds ratio or excess ratio was 1.8 to 1?
A. Well, now you're telling me 1.8. A minute ago you said 1.5.
Q. Right. I was wrong.
A. Well, that's a relief to me because you're human.
Q. So they say.
A. You're reading a little faster and going a little faster —
Q. Take your time, please. Let's get it straight for the record.
A. So you're saying 1.8.
Q. Mm-hmm.
A. Okay. Now, I think, as I recall, that she broke things down into less than 90 days and greater than 90 days, so I'm looking here at her accumulative relative risk, and it looks to be about 1.8 in the greater than 90 day group.
Q. You want to confirm also that Dr. Loke was 1.55?
A. Well —
Q. Let's do that for the record, okay?
A. That's about my recollection, somewhere in there. If it was —
Q. We're looking at Dr. Loke's article "Appetite Suppressants in Valvular Heart Disease." On Page 3 of 10 he says, "The pool's relative risk ratio for FDA MR was 1.55." Do you see that?
A. Yes, sir, I do.
Q. So now we're clear that by the end of 2002 Dr. Loke had analyzed the various studies and found that the excess risk ratio was 1.55, and Dr. Sachdev's group had looked at the studies and found it was 1.8. Do you recall whether they looked at exactly the same universal studies?
A. I think it was pretty close.
Q. Okay. And then you looked at that same universe of studies, correct?
A. Yes, I did.
Q. And you got a substantially higher number because you did a different statistical technique, correct?
A. Well, we accounted for various problems they had with the interpretation of the data.
Q. And you did that by including data from the Framingham study, correct?
A. We did use the Framingham study to give us a time domain. We used the internal case controls of the various studies analyzed for the calculation of relative risk.
Q. But even in the calculation of relative risk one of the differences is that you extrapolated those actual data over time based on what you saw or perceived you saw in the Framingham data, correct?
A. We did so in a manner that if anything we would be underestimating the severity of risk.
Q. Okay. So you took what Dr. Sachdev and Dr. Loke did and what all of the authors of the various individual studies did, was they simply compared the relative risk and the relative incidence of valvulopathy among people who had taken the drug with a control group who had not taken the drug, correct?
A. Essentially, yes.
Q. And you actually show that data in your study as well, at least for one of the studies, on Page 5 of 13 in Figure 2, correct?
A. Yes.
Q. And we'll be able to show this in court, but so it's clear, the controls for this particular factor, which was mild to greater aortic regurgitation, were found in that study to occur about 3.6 percent of the time among people who hadn't taken the drugs, correct?
A. Yes, sir.
Q. And if you took the drugs for 90 days or less the answer was 4.0 percent, correct?
A. Please restate that question.
Q. Yeah, that was a poor question. This data shows that in this particular study among people who had taken the drugs for 90 days or less, the finding was 4.0 percent had FDA positive aortic regurgitation, correct?
A. Yes, sir.
Q. And what the authors in that study did was they compared the 4.0 to the 3.6 background rate, and they got just a very, very small excess risk ratio, correct?
A. Yes.
Q. So, for example, one way to express that would be of the 4 percent of the people in the treated group who had FDA positive aortic, it was assumed that 3.6 percent were similar to the control group and they had it as a matter of background rate, correct?
A. And there within lies the flaw in these studies.
Q. But it is correct, right? That's how they did it.
A. What is correct is that that is a misclassification of attributable risk to the toxin, because you should not have people with the disease you're studying in the population to begin with, and you're starting to understand or demonstrate the strength of our interpretation of the data.
Q. Now, that particular study, that Jollis study which is reference 13 that you've shown the data from, that was published in the journal Circulation, correct? Do you want to check the reference?
A. Yes, sir.
Q. And that's a pretty important publication in the cardiology field, correct?
A. Yes, sir.
Q. It's the official journal of The American Heart Association?
A. Yes, sir.
Q. And it is certainly a peer-reviewed journal.
A. It is.
Q. But when they published the data they published it in that fashion, comparing the incidence among the treated group to the incidence among the control group, correct?
A. Yes, they did.
Q. And similarly, the Gardin study that is also one of the studies that was underlying your paper was published in the Journal of the American Medical Association, correct? It's reference 12.
A. Yes, sir, that's the way I remember it.
Q. Another very important journal?
A. Yes, it is.
Q. Another peer-reviewed journal.
A. Yes.
Q. And they compare the data in that fashion, comparing treated risk to control incidence, correct?
A. Yes, they did.
Q. Another paper was the Weissman paper, correct?
A. Yes, sir.
Q. That was published in the New England Journal of Medicine, correct?
A. Yes.
Q. It doesn't get any better than that, does it?
A. No.
Q. And that journal also published it in terms of treated incidence versus controlled incidence, correct?
A. Yes.
Q. And that's true of every study that you use as the basis for your meta-analysis, correct?
A. Yes, sir.
Q. And it's also the way Sachdev did it in her publication and the way Dr. Loke did it in his publication, right?
A. That is correct, sir.
Q. And your study then did it a different way.
A. Yes, it did.
Q. And what it did is took the controlled data, but it extrapolated it based on findings from the Framingham study, correct, about age?
A. Say that again.
Q. About the increase in the incidence of valvulopathy as people age.
A. Yes, that was one way we looked at the data.
Q. Now, the Framingham study was not a longitudinal study, correct? In other words, the same people weren't followed in their twenties, thirties, forties, fifties and sixties.
A. Well, many of them were.
Q. But not for that data.
A. I think you're right.
Q. That data was a snapshot in time, correct?
A. That's correct.
Q. So your assumption was that a 70-year-old in that study was no different from a 20-year-old in that study except that they had aged over time, and you made the assumption that that's the way valvulopathy increased over time.
A. Yes.
Q. But, for example, a 70-year-old grew up at a very different time than the 20-year-old in that same study that was conducted in 1997, correct?
A. Right, they didn't have Fen-Phen back when the 70-year-old was 20.
Q. But they did have rheumatic fever, didn't they?
A. They did.
Q. So a lot of the 70-year-olds who had valvulopathy got it from having rheumatic fever back in the `20s and `30s when they were growing up, right?
A. Perhaps.
Q. That wouldn't be nowhere near as true of the 20-year-olds who grew up in the `70s and `80s, correct?
A. That's correct.
Q. We've done a pretty good job on rheumatic fever.
A. In this country.
Q. Did you consider that that type of factor might have made a big difference in terms of your assumption that a 70-year-old and a 20-year-old had the same prospect of valvulopathy except that the 70-year-old was older?
A. Yes.
Q. And that is the core assumption of your paper, right?
A. That is one, yes.
Q. Did you review the peer review that was done of your paper?
A. Yes.
Q. Did you see Dr. Loke's review?
A. I did,
MR. GROSSI: I'm going to mark as Exhibit 2 Dr. Loke's review.
(Whereupon, Exhibit 2 was marked.)
Q. Do you know, by the way, whether I'm pronouncing it correctly, whether it's Lokee or Loke?
A. No, I don't.
Q. We'll go with Lokee then. Now, your paper was submitted in late January of `03, correct?
A. Yes.
Q. And Dr. Loke wrote this review, apparently, on March 20th of `03, correct?
A. Yes.
Q. And he recommended rejection of the article, correct?
A. He did.
Q. And he says that was because he did not accept the statistical approach that you had taken, correct?
A. That's one of the things he said.
Q. In the first paragraph — or the first numbered paragraph on the first page he called it simply a play on numbers, correct? Do you see that?
A. Which paragraph are you looking at?
Q. Right down there.
A. Oh, yes.
Q. And then he goes on at the bottom of that page by saying, quote, "I cannot therefore see the value of this additional correction beyond generating much more impressive relative risk figures." Do you see that?
A. Yes, I do.
Q. You were aware he was making that criticism.
A. Yes, I was aware, and I appreciate his criticism.
Q. Then in the paragraph numbered 2 on the second page he points out that there are several big assumptions involved in evaluating incidence rates based on historical controls and extrapolation rates of progression to unexposed study participants. That's the issue we were just talking about, correct?
A. Yes, it is.
Q. He says, quote, "The historical series were cross-sectional surveys and not long-term follow-up of a single cohort through the years." That's the point you just acknowledged a moment ago, right?
A. Yes, I did.
Q. And he then says, quote, Differences in the rates of valvular heart disease in each age category may arise simply because of different environmental exposure. For example, those aged over 70 may have the highest rates because they were widely exposed to rheumatic fever, while the declining incidence of rheumatic fever means that few under the age of 40 have been exposed, unquote. That's again the point you made, right?
A. Yes, it is.
Q. And you accept that as a valid criticism.
A. Yes, I do.
Q. He then says — skipping down he says, quote, I believe, therefore, that one would be on very shaky ground in basing calculations on the linear progression of unexposed incidences of 555 percent per year for AR and 219 percent per year for MR." He's saying that because of that problem he won't accept the fact, as you did, that people increased with age in that particular numerical way, right?
A. That's what he's saying.
Q. And he says, "This is a fundamental problem that undermines the entire basis of the elegant statistical work," correct?
A. That's exactly what he said.
Q. And you would agree if that assumption in fact turns out to be false or not valid, not supportable, that the extrapolation and the incidence figures that you've come up with would not be correct, right?
A. I would say that when you do a scientific experiment like this and develop a model that the goal of the model is to reproduce reality. If you want to find out, you know, why the shuttle crashed, you develop a statistical and mathematical model for trying to understand a real world event, and when you're doing these models you recognize that they're imperfect, and it may turn out that your model is exactly precise, or it may turn out that the model does not actually duplicate a real world event.
Q. And you say in your article, I think, candidly toward the end that with respect to mitral regurgitation you don't really know whether this model has come up with accurate figures or not, right?
A. Well, we recognize that there are limitations. I think, so the ladies and gentlemen of the jury can understand this, that one of the goals of our study was to determine if and how fenfluramine could attack simply the aortic valve and not the mitral valve, and we found that there was an inherent problem with the design of all the previous studies, which we demonstrate, and we use this demonstration to model certain assumptions, and when a scientist does that there are vulnerabilities. One can accept or reject the models based on how it fits their practice or their life.
Q. Have you written to Circulation, the American Journal of Cardiology, JAMA, New England Journal of Medicine, any of the publications that published the original articles, indicating that you now believe that their publications and studies were flawed in this matter?
A. Well, their studies reached a valid conclusion, and the conclusions that their studies reached was very similar to the conclusion our study reached. What we've tried to do is bring a common thread to all these studies and tried to smooth out the inconsistencies and explain inconsistencies, and I think we have done that by including — or removing — pardon me — removing the for of bias that entered into the designed of the various studies. So, no, I didn't write Circulation and JAMA and New England and tell them they were wrong. I'd like to do quite the contrary and say they are right, that they did a good job by bringing to light the fact that there was a product that was manufactured by your company that caused harm to people's heart valves, and they've clearly and convincingly published articles that demonstrate so. What we have done is tried to find the common thread in these studies and determine a more even-keeled representation of risk and harm.
Q. In your article on Page 2 — take a look at that, please — you talk about the studies, and these are the studies we've just talked about, references 7 through 15, and then you summarize them and refer to review articles that summarize them on Page 2 where you say, quote, "Some recent review articles conclude that the risks associated with fenfluramine and dexfenfluramine are similar, real but modest for aortic valve disease, and barely detectable for mitral valve disease." Do you see that?
A. I recall that. Where are you reading?
Q. It's the upper right-hand portion, right there.
A. Yes, mm-hmm.
Q. And what you're referencing there, among others, is the Sachdev article, reference 20. Do you want to double check that?
A. Okay.
Q. Okay. So Dr. Sachdev and the others who commented on all the studies in your view came up with the notion that it was, quote, "real but modest for aortic valve disease and barely detectable for mitral valve disease." Do you see that?
A. Yes.
Q. That was where the playing field was before your article, correct?
A. Yes.
Q. Now, in your conclusion with respect to mitral valve disease please take a look at Page 11. Now, first, you did find a higher risk for aortic than for mitral, correct?
A. Yes, sir.
Q. You found that the aortic risk was related to the duration of use, correct?
A. Yes.
Q. And that along with the point you were making earlier, that has a certain biologic plausibility. If you believe that something is having an effect, generally it would have more of an effect if you took it for longer, correct?
A. Yes.
Q. And you comment on that as making one of the points as why you continue to believe and are confirming the relationship with aortic valve disease, correct?
A. Yes.
Q. But then on the bottom of that page in the left-hand column you make the point that you did not find a durational effect with respect to mitral valve regurgitation, correct?
A. Correct.
Q. And that led you in the upper right-hand corner to then say that, quote, "While we cannot claim such a relationship does exist, the relatively low incidence seen generally for moderate or greater mitral regurgitation makes establishing correlations difficult." Do you see that?
A. Where are you? I recall that. I just don't see it
Q. It's in the upper right-hand corner of Page 11.
A. Yes.
Q. So in a sense you were coming up with to some extent the same conclusion of some of the reviews, that the relationship and causation with mitral valve regurgitation was still unclear.
A. With respect to duration of exposure, yes, sir.
Q. Okay. And the difference is that you believe that your study doing the statistics differently does come up with a higher excess risk ratio for mitral regurgitation than Dr. Loke who pegged it at 1.55 and Dr. Sachdev who pegged it at 1.8.
A. Yes.
Q. And that's why you disagreed with Dr. Loke's review that the article should be rejected for publication.
A. Yes.
Q. Then it was given to another reviewer, a Dr. Palmieri?
A. Yes.
(Whereupon, Exhibit 3 was marked.)
Q. And he wrote a very brief review indicating that he believed that the article should be accepted; is that right?
A. Yes, sir.
Q. Dr. Palmieri had previously —
MR. JEZ: What number did you mark this? I'm sorry.
MR. GROSSI: No. 3.
Q. Dr. Palmieri had previously participated with Dr. Hopkins on a study concerning valvular regurgitation and Fen-Phen, correct?
A. Yes, sir.
Q. Dr. Palmieri is also a retained expert by plaintiff attorneys, correct?
MR. JEZ: Objection, form.
A. I don't know that.
Q. Okay. Do you remember that study, the HyperGEN study?
A. Yes, sir.
Q. Is that one of the studies that you mentioned in your article?
A. It is mentioned.
Q. Okay. That study was not included in the analysis in your article, was it?
A. Correct, sir.
Q. Why?
A. I don't think that the HyperGEN reported duration of use, and I think for that reason we could not include it in our analysis.
Q. With respect to mitral regurgitation, what was the excess risk ratio in the HyperGEN study between the controls and the people who took the drugs?
A. I don't recall offhand. I'd have to look at that. I do have the article with me, but —
Q. Go ahead, pull it out, and I'll mark it at the same time.
A. Okay.
(Whereupon Exhibit 4 was marked.)
Q. I was looking at Page 713, if you want to take a reference there.
A. 1.5.
Q. On Page 713 I'm referring to the risk of mitral regurgitation.
A. I'm sorry.
Q. FDA positive.
A. Right.
Q. What was the risk ratio? Well, let me ask it this way: What was the percentage of people in the fenfluramine group who demonstrated that degree of regurgitation? It's in the table. I think it's 11 percent, Table 1.
A. Okay. Table 1, mitral regurgitation. Yes, sir, 11 percent.
Q. And what was the percentage of the control group that demonstrated that level of regurgitation?
A. Nine percent.
Q. Nine or —
A. Sorry. Nineteen Percent.
Q. Okay. So, in other words, in this particular study more people happened to have the mitral regurgitation in the control group than in the fenfluramine group, correct?
A. Correct.
Q. If this study had been included in your analysis, it would have reduced the excess risk ratio for the mitral regurgitation that you would have found, correct?
A. I suspect it would have.
Q. It would have had to, because in this particular study it was actually a negative risk ratio, correct?
A. Correct.
Q. Do you know why Dr. Hopkins didn't include his own study in this analysis?
A. As I recall, because the duration of exposure was not reported.
Q. Why was duration of exposure important for your model in terms of the excess risk ratio?
A. Why was duration of exposure important? It's one of the things that we were evaluating, one of the entry criteria for the studies.
Q. When you published your ultimate conclusions with respect to the excess risk ratio, you lumped together all of the studies with respect — even though they had varying durations of use, correct?
A. Yes.
Q. And even within the studies there were very substantial differences in duration of use, correct?
A. Correct.
Q. For example, you used the Kahn study, and in the Kahn study people ranged from only about three months three years, correct?
A. Yes.
Q. But you used the single number that he provided, because that's all he provided, for that one finding as to his statistics, correct?
A. I don't recall offhand.
Q. Take a look at your article and tell me if there are durational categories for the Kahn study.
A. I don't believe there are.
Q. That's what I'm saying. You lump them all together for Kahn, right?
A. Correct.
Q. The Kahn data was the Kahn data. It was presented even though people ranged from three months to three years, right?
A. Yes.
Q. And you used it.
A. Correct.
Q. But you didn't use the HyperGEN study, did you?
A. We did not.
Q. But you had it available to you, because in fact Dr. Hopkins had worked on it, right?
A. Yes.
Q. And had you included it, it would have reduced your numbers for the excess risk for mitral regurgitation, correct?
A. It may have reduced it. It may not have reduced it significantly. I have not looked at that.
Q. Doctor, on the first point there's no question. It absolutely would have reduced it somewhat because it was a negative number.
A. It would reduce it somewhat. It may not be significant. I have not looked at that.
Q. By the way, when you found a negative number, when you found a study sample where the fenfluramine group was actually lower than the control group, did you use the negative number or did you set it at zero?
A. I don't recall.
Q. Take a look at your article. Take a look at Page 6 in the lower left-hand column where you're talking about the incidence rates of AR and MR, and you make the point that you subtracted the controlled number from the treated number, and then you say, quote, "Any negative numbers were set to zero." Do you see that?
A. Yes.
Q. Doctor, is that a little bit like saying we're playing a baseball game, and if you score two runs in the first inning and I score one we count the score as 2 to 1, but if in the next inning I score two runs and you score one we'll count that zero-zero?
A. No, it's not like that at all. It's like saying nobody scores negative runs in baseball. It doesn't exist. You don't have a negative run in baseball.
Q. You can't even admit to the possibility that in random sample there will be more mitral regurgitation among the control group than among the treated group? Isn't that what the negative number means the way you have set it up?
A. Could you repeat that question, please?
Q. Yeah. Are you saying you can't even admit to the possibility that if we take a hundred people who have been treated with the drug and a hundred similar people who have not been treated with the drug that random error being what it is we may get a situation where there's more mitral regurgitation in the hundred control group than in the hundred treated group?
A. Yes, you could.
Q. And isn't that exactly what happened in the HyperGEN study?
A. Yes.
Q. And isn't that why you left it out, because you just don't believe in those results?
A. No.
Q. But when you did have the results in some of the other studies, you set it at zero even though in that particular subgroup there was more valvulopathy in the control group than in the treated group.
A. I think it's a common statistical method to set it to zero when you have a negative relationship, although I'm not entirely sure about that.
Q. I'm was going to ask, are you a biostatistician?
A. Well, that's not all I do. I mean, doctors have to be familiar with statistics, but —
Q. Can you think of a textbook that you consult that probably says set it at zero?
A. I think that that would be a better question to ask Dr. Hopkins.
Q. Okay. We will. Now, then, Dr. Palmieri said publish it. He didn't say much more about it. But he, of course, had worked with Dr. Hopkins on the other paper, right?
A. Yes, sir.
Q. So then it was submitted to a third reviewer, a Dr. Ludbrook, and I'll mark his review as No. 5.
(Whereupon Exhibit 5 was marked.)
Do you know Dr. Ludbrook?
A. No, sir.
Q. Do you know where he's located or anything about him?
A. Yes, sir, I do.
Q. Where is he?
A. I think he's in New Zeland or Australia.
Q. Is he a cardiologist?
A. I don't know. I think he's a medical doctor and a statistician.
Q. And he commented that he had reviewed the manuscript, and he had consulted some though not all of the references. Do you see that?
A. Yes.
Q. And he also read the appeal by the authors?
A. Yes.
Q. That was an appeal you had written along with Dr. Hopkins?
A. Yes.
Q. Then he makes the points that we discussed, that Dr. Palmieri was a coauthor with Dr. Hopkins. On the other hand, he said that Dr. Loke was a coauthor of an article which concluded that the risk was low of AR and MR, correct?
A. Correct.
Q. And those were the points we were just talking about. He then says that he would accept the publication without revision because it seems sound, well written. And No. 3 is, "Publication of the manuscript, together with the reviewer's report (and, I would hope Hopkins' appeal), would seem to me to be entirely in line with BioMed Central's policies." Do you see that?
A. Yes, sir, I do.
Q. And I think you were commenting on those earlier, that BioMed Central being a website can publish a lot more than the hard copy journals.
A. I didn't say that.
Q. Okay. That they publish more freely? You said something about open access.
A. I didn't say that either.
Q. Okay. Do they in fact publish articles that other journals reject?
MR. JEZ: Objection, form.
A. I have no idea.
Q. Do they say —
A. Although, in fact — let me finish my answer.
Q. Yeah.
A. Although I think it's not uncommon for any particular journal to publish a given article that may have been previously rejected by another journal.
Q. Have you looked at the BioMed website?
A. Yes.
Q. Do you know they have a thing called "Frequently asked questions"?
A. Yes, I do.
Q. I have marked and I will mark as Exhibit 6 a discussion of "Frequently asked questions" from the BioMed website. Do you see what it says about publishing studies that other journals reject? I'll read it into the record. Quote, "The set of 57 BMC journals only publishes peer reviewed research. These journals welcome submission of high quality research papers but have a policy of being prepared to consider data that traditional journals may reject on the grounds of space or relevance to their readers. Examples include: Negative studies; Studies that confirm previous work; Studies with findings of regional interest; Clinical trial protocols; Papers that include full experimental data sets; Method papers." Do you see that?
A. Yes.
Q. And so, in other words, BioMed Central, because it doesn't have to kill all the trees as you put it earlier, is able to publish articles that other traditional journals may reject, correct?
A. Yes.
MR. JEZ: Objection, form.
Q. (BY MR. GROSSI) And when they publish that, one of the reasons they publish it is because they let this kind of debate out there more freely. Rather than try to resolve the issues themselves, they just let the readers decide who is right.
MR. JEZ: Objection, form.
A. I'm not sure it says that on this page, but you probably have another page that explains that.
Q. Well, was that your understanding when you got involved with this outfit?
A. No.
MR. GROSSI: Okay. Let's have this one you have in front of you as 6.
(Whereupon, Exhibit 6 was marked.)
Now we will mark this as No. 7.
(Whereupon, Exhibit 7 was marked.)
Q. Have you seen No. 7 before?
A. Yes.
Q. Now, it's a little confusing because it says "Editor's comment," but this was taken off the website. The author of this document is Dr. Hopkins?
A. Yes.
Q. Did he also show it to you, though, before he sent it?
A. Yes, he did.
Q. Because he's obviously sending it about your article, correct?
A. Correct.
Q. And is this what the other editor referred to as "the appeal"?
A. Yes.
Q. Was there any other correspondence with BioMed Central or with any of the reviewers about these issues we've just been discussing?
A. No, not that I'm aware of.
Q. All right. And this was sent — according to the information it was sent on April 22d 2003. It says, "The following rebuttal was received from the authors of the manuscript."
A. Yes, sir.
Q. Take a look at Page 2, or the second page of this document, and down toward the bottom they're referring to Dr. Loke and this question of whether you subtract the background rates or whether you do some other statistical factor, and he says, "The circumstance he cites reduced the ability to detect statistical significance is precisely the situation for mitral valve regurgitation. This is a key point. In his meta-analysis, MR showed very mild association with fenfluramine when using the prevalence odd ratio (not relative risks as reported) with p = 0.02. None of the studies were individually significant. Further, the prevalence odds ratio was 1.55. This is another key point, the implications of which Dr. Loke is likely well aware. In legal arguments, the difference between a relative risk above and below 2.0 is extremely important. Since the risk ratio is calculated by Dr. Loke are not relative risks at all and give the impression of very modest, barely detectable risks, many courts would not consider a person with mitral valve damage from fenfluramine as having a strong case. However, when considering even a conservatively estimated true relative risk, the case would be very strong indeed. These legal implications do bring in a certain controversy to the issue, but the further issues raised by Dr. Loke make our case even stronger as discussed below."
Doctor, do you now recall that when you and Dr. Hopkins sent information to BMC in an effort to get them to publish the article one of the points that you made was that it was an important and key difference between your article and Dr. Loke's that Dr. Loke's 1.55 risk ratio for mitral regurgitation would not be accepted by many courts whereas your risk ratios of greater than 2.0 would be accepted by courts?
A. I recall that discussion, yeah. Yes.
Q. Thank you. Doctor, do you know whether the Framingham study on which you've relied for an aspect of your statistical analysis measured the aortic and mitral regurgitation using the same type of machines, the same type of methodologies, or the same type of trained observers as the actual Fen-Phen studies that were done a number of years later?
MR. JEZ: Objection, form.
A. For the most part, yes.
Q. You think they used the same type of machines?
A. I think so.
Q. Were there not advances in echocardiography between the mid-`90s and latter `90s that would make machines more sensitive to mitral regurgitation?
A. Yes.
Q. So it wouldn't be surprising that higher rates were found among the general control or the general population in the Fen-Phen studies than in the Framingham study, correct?
A. I think that that is one potential difference.
Q. And, of course, people who are trained differently in what they were going to look for when they looked in the Fen-Phen studies as what was happening in the Framingham studies, correct? MR. JEZ: Objection, form.
A. I'm not sure that that's correct.
Q. You don't know one way or the other. You've never compared the protocols for the Framingham study to the protocols for the Fen-Phen studies, correct?
A. I think I have.
Q. You've seen —
A. The methodology for interpretation? Is that what you're referring to?
Q. I'm referring to the detailed protocols where Dr. Singh, for example, instructed his observers as to what would constitute, let's say, mild aortic regurgitation and what, let's say, Dr. Gardin in the Fen-Phen studies did. There might be differences.
A. There might be.
Q. And you haven't looked at either of those two sub-documents.
A. I believe the extent my understanding is in the methodology, and not every study explains, you know, the guidelines to the interpreting physicians. However, most of the studies do advise standard operating procedure.
Q. In fact, you indicate on Page 12 that even within the Fen-Phen studies themselves you recognize that there were differences in machines and methodologies and obviously observers, right?
A. Yes.
Q. Also, you were looking for — you were interested in the effect of what might happen over time with these people, correct?
A. Yes.
Q. But you did not use as any part of your analysis the follow-up studies that had been done to that point in time with respect to the same control studies either with respect to the Weissman study or the Gardin study or the Kahn study, correct?
A. Right.
Q. All three of those studies were included in your analysis, but only the initial observation which was generally taken a few months after they stopped taking the drug, correct?
A. Correct.
Q. You had available to you the data from follow-up studies that were done a year later in each of those three cases, correct?
A. Yes, we did.
Q. You could have factored that in as one element of your durational — strike that — not durational but your progression analysis, correct?
A. I don't think we did a progression analysis.
Q. Well, you did a progression analysis with respect to the controls to get an incidence rate over different ages, right?
A. Yes.
Q. And you could have factored that in and used that actual data with respect to the actual Fen-Phen people to determine what really happened to them a year or so later, correct?
A. We could have factored it in.
Q. So your study goes to the issue of what you observe the first time someone is looked at after they've stopped taking the drug, not what may be their situation a year or two or five years later, right?
A. Yes.
Q. And, in fact, you note in your article and you're aware that all three of those studies the second Weissman study, the second Gardin study, and the second Kahn study — all showed that there was actually less valvulopathy among the treated group a year or so later than there was when they were initially tested, right?
A. Yes.
Q. There was some reversibility or regression, correct?
A. Let me refer to the article.
Q. Yeah, I think you used the phrase "reversibility." You can take a look at Page 12.
A. "Potential reversibility," yes.
Q. Right. And you say it's a potential in your mind. It's an actuality in those studies, correct, that it does show lower rates?
A. Yes.
Q. You also left out the Wee paper, W-E-E. Do you know why you did that? It's mentioned in your article, but it isn't included in the analysis.
A. Is that the paper published in Archives of Internal Medicine.
Q. I don't believe so. Let me see. Let me get it for you.
(Whereupon, Exhibit 8 was marked.)
It's published in Annals of Internal Medicine.
A. Right.
Q. Now, Ms. Sachdev, for example, in her analysis included the Wee paper, and so did Mr. Loke. Do you know why you omitted it?
A. I can't recall.
Q. Did you note that in fact it has a lower incidence rate than the other studies that you included for the treated group?
A. Rephrase that question, please. Did I notice where, just now or in the paper?
Q. Well, either time. She found only two cases out of 76, one of which she attributed to another factor. She says on Page 873, "When patients with existing valvulopathy were excluded, the risk was 2.6 percent," and that's a lower number than you typically were using in the other studies.
A. Right.
Q. So if that number had been included, that also would have reduced somewhat the excess risk ratios that you found.
A. It may have.
Q. Okay. Can I go back just a second? I want to just clear something up from a prior deposition. I believe you testified when we met last in about late April that you estimated that you had made over $2 million from your legal work on diet drugs.
A. Yes, sir.
Q. Now, does that include the $400,000 retainer?
A. Yes, sir.
Q. And does that include the monies you received from green forms —
A. Yes.
Q. — and for that process?
A. Yes, sir.
Q. And obviously for testifying as an expert here today.
A. Yes.
Q. I mean in this kind of case. How much have you made in the last three or four months since we talked in April whether you billed it or not?
A. I'm not sure.
Q. Can you give us some idea?
A. Not without guessing.
Q. More than a couple hundred thousand dollars?
A. In the last three months?
Q. Three or four months since April.
A. I'm not sure.
Q. It could be. I mean, that's not outrageously high, a couple hundred thousand? MR. JEZ: Objection, form.
A. I don't think it was quite that high, but it could be.
Q. Other than whatever you're owed for the last month or two, have you been paid all the money with respect to the matrix work, or is there some arrangement by which some of your payments or your colleagues' payments are deferred until the trust pays those claims?
A. No, there's no arrangement like that, I have been compensated for the work I've done.
(Whereupon Exhibit 9 was marked.)
Q. I want to turn now to the manner in which you read some of these studies, because we're getting into those with respect to Ms. Stafford. I've marked as Exhibit 9 some e-mail traffic between — I believe it's you and people at Echo Motion. Can I ask, were most of the 10,000 tapes that you and your colleagues in Utah read for Mr. Fleming and the others — were they Echo Motion tapes?
A. Many of them were, but they use several different companies.
Q. Do you recall any of the other scanning companies that they used?
A. Yes.
Q. Can you give us those names?
A. Woodlawn, Dunbar.
Q. I know Woodlawn is in Georgia. Where is Dunbar?
A. In Texas, Houston.
Q. Did you ever read tapes from an outfit in Tampa — I forget the name now — they sound familiar — Diagnostic Medical or something like that?
A. Say that again.
Q. Do you remember an outfit in Tampa, Florida?
A. No.
Q. Okay. Other than Dunbar in Houston and Echo Motion in Woodlawn, any others that come to mind?
A. There were a lot of independent tapes that were submitted from various referring attorneys that had their own echo companies.
Q. Okay. The document, Exhibit 9, begins with an e-mail, and the address is polycough@aol. That's you, correct?
A. Yes.
Q. And Mr. Winans is a business manager of Echo Motion?
A. Yes.
Q. The first one is dated May 28th, 2002. You were making a suggestion. You say, quote, "I suggest the techs trace the MR jet area and the LA area in the same frame as often as possible. This creates a solid record." Just for clarity, MR, of course, is mitral regurgitation?
A. Yes.
Q. And LA is the left atrial area.
A. Yes.
Q. And the methodology that's used in the settlement and that you've used in others of these cases is to compare the ratio of the area of the mitral jet to the area of the left atrium and get numbers like 20 percent, correct?
A. Correct.
Q. This was your suggestion to Echo Notion?
A. It appears so, yes.
Q. Up until this time they weren't doing it that way; they were measuring the left atrium in an independent separate frame?
A. And I believe they continue to do so. There is some controversy as to when it's appropriate or where it's appropriate to take the measurement, and I think this slice of communication was suggesting that it be done in the same frame in addition to the way it had previously been done. And I'll give you the rationale behind this. If one takes the largest mitral regurgitation jet and the smallest left atrial area, that's going to artifactually create a high ratio, and if inversely — or conversly, if one takes the largest left atrium, then that would artifactually create a smaller ratio.
In theory, during mitral regurgitation, during systole, the left atrium should be at its largest — in theory — so I recommended here that it be done as often as possible in as many planes — I think I said planes.
Q. Well, actually, here you just say in the same frame.
A. Yeah, but what I'm saying is often as possible meaning in multiple views, so in the apical view, the parasternal view, to do it —
Q. I'm sorry. Where in Exhibit 9 does it talk about multiple views or multiple planes?
A. It really doesn't. This is just a slice of an ongoing communications that I had with this company.
Q. Did you understand, though, that what they understood was that for Fleming reads — not for the others — they wouldn't do it — but for Fleming reads they would determine it based on the same frame, the same single frame?
MR. JEZ: Objection, form.
A. First of all, no, I didn't understand that, and, secondly, I don't understand the implication for others they wouldn't do it.
Q. Well, take a look at the next document in this little pile. This is something — that and I'm having a little hard time understanding it myself, but what it looks like is that you're in some e-mail fashion copying something that you were aware of that Ms. McCulloch had written the same day. You're sending the message, but you're sending it back to Ms. McCulloch commenting on her letter, and then you've included, quote, For Fleming only — this is her comment "For Fleming only, measure the MR and LA in the same frame and try to get the jet in the center plane so that the LA is a good representation of the LA plane. Otherwise, measure the MR off axis and the LA central plane but same part of systole as the MR." Does this refresh your recollection that Ms. McCulloch based on what you had said instructed her technicians that for Fleming only, because you were involved, that they would measure the MR and LA in the same frame?
A. Yeah, to me I think this suggests that it required additional work from them, and that in order to add this additional view and image to create a better, more comprehensive echocardiogram that they would have to do this additional work. That's what it suggests to me.
Q. When you read the Echo Motion tapes after this point in time, though, you relied on the single frame as you had suggested?
A. No, sir, I didn't.
Q. So you suggested a single frame but then you didn't rely on it?
A. I tried to interpret as many frames and as many views as possible to get a generalized understanding to make a determination as to how severe the jet was.
Q. Take a look at the next one. This is a memo from you to Mr. Winans. You say "Subject: Low yield. KT forgot to quantify the juicy MR jet in a matrix level case — Ann Geesaman, for SWA. This is a relatively low yield batch." Is KT the initials of one of the sonographers?
A. Yes.
Q. And what does SWA mean?
A. I don't know.
Q. Is that a law firm perhaps?
A. It could be.
Q. What did you mean "a relatively low yield batch"?
A. Meaning that KT was not comprehensively evaluating these echoes, and she was not identifying the degree of regurgitation that was present.
Q. And by "low yield" you meant there weren't very many FDA positives.
A. Correct.
Q. So you were keeping track.
A. Well, in so — not necessarily, not in a one to one or mathematical fashion, but what I was implying, or as I recall, was that this tech was not adequately identifying the lesions that were present. For example, she did not quantify — you know, when I say "juicy" that's a layman's term for a large, bubbling over mitral regurgitation jet. She didn't quantify it and accordingly was not able to demonstrate the matrix level lesion, and this is what accounted for a much lower than expected prevalence. That's what I'm saying.
Q. And you wanted Mr. Winans, the business manager, to know that KT had given you a low yield batch.
A. No. I wanted him to know that this technician who is being entrusted with the responsibility of identifying valvular heart disease in patients that took fenfluramine was not doing her job adequately.
Q. And that's what you meant by low yield batch.
A. Yes, sir.
Q. Okay. The last one in this group is another memo you sent to — I guess you sent it to everyone at Echo Motion. You say, quote, "You have set the end limit so dang low that you're" — that you're, Y-O-U'R-E — "into signaling the annuli and walls and artifactual creating 100 percent MR." Is the end limit there the Nyquist limit?
A. Yes.
Q. How often in the Echo Motion tapes had one of their technicians set the Nyquist limit in your view improperly low?
A. Not very often.
Q. Give me some idea?
A. I think that overall their echoes were extremely good. In this particular batch of echoes the technician was, you know, off. She had set the machine settings to where it was creating artifact and appearing that mitral regurgitation was present in a hundred percent of the cases.
Q. And in those cases you did your best to read those levels and try to figure out what was really going on?
A. Well, I probably just tossed them, said, These need to be redone.
Q. How often did you tell Echo Motion that one of their tapes needed to be redone?
A. Infrequently but from time to time.
Q. Did you have records of how often you did that?
A. No, sir.
Q. Did you keep records to determine whether or not those were in fact redone?
A. No, sir.
Q. You don't know whether Echo Motion ever redid them.
A. I do not know.
Q. They might have just given the tape to somebody else.
A. They could have. I don't know that they did that or they didn't do that.
Q. With respect to the work that you did for Mr. Fleming in either 100 cases or green form cases and if there's a difference please tell me — is there any documentation that discusses whether or not you had a doctor-patient relationship with these individuals?
A. Not that I can recall.
Q. There's nothing on your forms of the reports that indicate whether or not there's a doctor-patient relationship?
A. Which forms are you referring to, sir?
Q. Well, I'm talking how did you get your information back to these people.
A. Through the individual echo patients that had echocardiograms?
Q. Right.
A. I didn't provide them with a copy.
Q. You provided the report to Mr. Fleming's law firm.
A. Yes, sir.
Q. And that had various technical information. Did it also from time to time explain that you thought the person had some sort of serious cardiac problem?
A. From time to time, yes.
Q. Okay. In those cases did you take the responsibility to call up the person and say, I've looked at your echo and you have a serious cardiac problem of some sort?
A. On occasion I did. More often I advised the law firm to contact the patient.
Q. Did you get information from the law firm that they had in fact contacted the patient?
A. No.
Q. Did you consider yourself to have a doctor-patient relationship with these individuals? I'm talking about the ones that you never met and you didn't take the echo and you just had their questionnaires.
A. Not in the traditional sense, but in a unique, more or less, artificially created sense. You know, it's a daunting task to get everybody that took fenfluramine, well over six million users, studied in a relatively short period of time. So, yes, I felt I had a doctor-patient relationship with them but not the traditional doctor-patient relationship.
Q. One of the aspects of the traditional doctor-patient relationship is if you find that there's something wrong with someone you tell them, and you tell them to get medical treatment, and you did not do that directly in the majority of the cases, correct?
A. I wouldn't say the majority. For example, sometimes I would see a ventricular septal defect or an atrial septal defect, in which case it was a congenital, ongoing abnormality whereupon I would recommend medical follow-up and sometimes write on the echocardiographic report, you know, "Recommend medical follow-up," and in other few cases I saw maybe a dissecting aneurism and did contact the patient. Hey, I see something on your echo that I would like you to get evaluated.
Q. So if it was emergent, if it was —
A. Life threatening.
Q. — if it was life threatening you did try to talk to the patient directly.
A. Yes, sir.
Q. But in the case of like a defect that required monitoring and follow-up, that you left to the lawyers to tell them.
A. Yes, sir.
Q. In a traditional doctor-patient relationship, if you were over here at the University of Utah and someone comes in with a septal defect, you're going to talk directly to a referring physician, aren't you?
A. It depends on the context, but I would — if I were reading echoes at the heart station on a given day and saw an emergent situation, I would do no differently than I did in these echocardiograms. I would try to contact the patient. In a non-emergent abnormality, such as a septal defect, I would note it in the report and move on.
Q. You carry malpractice insurance?
A. Yes, sir.
Q. Did you consider that your reads in these cases would subject you to the normal risks or problems with malpractice? In other words, if you get it wrong, did you expect that these people would be entitled to sue you for malpractice?
A. Yes.
Q. And did you notify your malpractice carrier that you were doing this type of work?
A. Yes, I did.
MR. GROSSI: I'm sorry. What was the last one?
MR. JEZ: No. 9.
(Whereupon, Exhibit 10 was marked.)
Q. I'm going to mark as Exhibit 10 the portion of the Journal of the American Society of Echocardiography. What I've marked as No. 10 is Volume 16, Number 7, Journal of the American Society of Echocardiography, beginning on Page 777, and this is a special report in the American Society of Echocardiography entitled "Recommendations for Evaluation of the Severity of Native Valvular Regurgitation with Two-dimensional and Doppler Echocardiography." Are you familiar with this article?
A. Yes, sir, I am, and I have included it in my updated reference list, which I brought you a copy of if you would like.
Q. Because this came out very recently?
A. Yes, it did.
Q. Do you know any of the authors on this paper either by reputation or personally?
A. Yes.
Q. Dr. Catherine Otto, is she an acknowledged expert in the field?
A. Yes.
Q. Dr. Miguel Quinones, is he an acknowledged expert?
A. Yes, sir.
Q. The purpose of this paper was for this study group to make recommendations to all the ASE members on how they would evaluate the severity of valvular regurgitation using echoes, correct?
A. Yes, sir.
Q. It's sort of an update or best thinking on what the facts are.
A. Yes.
Q. Do you think this is an authoritative paper now in how to evaluate valvular regurgitation? A. Yes, sir, I think it's quite a nice compilation of the various studies and techniques.
Q. I would like to ask you just about a couple of the comments. On Page 781 under heading 4 in the lower right-hand corner it talks about the importance of characterizing the severity of regurgitant lesions, and it then states, quote, "Such a determination is important since mild regurgitation does not lead to remodeling of cardiac chambers and has a benign clinical course, whereas severe regurgitation is associated with significant remodeling, more morbidity and mortality." Would you agree with that statement?
A. Yes.
Q. And by remodeling we're talking about generally the expansion of the chamber size that occurs if someone has a significant case of regurgitation.
A. Well, I wouldn't necessarily say significant. I would say severe.
Q. Okay. What about moderate? Will moderate regurgitation lead to noticeable changes in cardiac chamber size?
A. Yes.
Q. So mild will not, but moderate and severe will.
A. Mild over time progresses to moderate and severe, so every case is severe except for a few unique presentations, such as ruptured papillary muscle during a myocardial infarction started at some time as mild and it progressed to severe.
Q. But not every mild case will progress to severe, right?
A. That's correct.
Q. As a matter of fact, in Fen-Phen cases more likely than not the mild case will tend to regress based on the data we have.
A. Well, I think based on the data we have more likely than not over the short period of time studied mild cases remain mild.
Q. Although some have been studied as long as 15 years, right? The Ikelburger (phonetic) study —
A. Not that I had seen published in a manuscript format.
Q. But you are familiar with the Ikelburger abstract.
A. Yes, sir.
Q. And you have a problem with that because it hasn't been published as a complete paper?
A. Correct.
Q. But you do rely on abstracts.
A. I wouldn't say that I rely on them, but I don't disregard them.
Q. You've included them in your study that we've talked about, right? Want to check the references?
A. Just tell me which one you're referring to.
Q. Let's see. Do you have them numbered in front of you there the way they are in the article?
A. I don't understand the question.
Q. Well, take a look at —
A. Do I have them numbered where?
Q. You have them numbered in your article as in a certain fashion, and that's how I've collected them too. Take a look at item No. 13, I believe,
A. Yes.
Q. Do you see reference No. 13? Can you read that for the record?
A. "Fenfluramine and phentermine and cardiovascular findings, effect of treatment duration on prevalence of valve abnormalities."
Q. Is that an abstract only?
A. I don't recall.
Q. Let me show it to you. I'm showing you a page on the International Journal of Obesity, and can you take a look at the abstract that is shown?
MR. JEZ: Watch the water there.
MR. GROSSI: Sorry.
A. Okay. I see it is an abstract.
Q. So you cited an abstract. Take a look at the next one, which is reference 25. Is that an abstract?
A. Yes.
Q. Can you confirm for the record that item 25 in your paper is only an abstract?
A. Well, at the time it was only an abstract. I'm not sure the reference I'm providing is not a manuscript.
Q. Can you read the reference there?
A. "Natural history of valvular regurgitation one year after discontinuation of dexfenfluramine therapy."
Q. And what is the actual citation?
A. Annals Med 2001. Okay. I think that one might be an abstract.
Q. And there's one more I would like to ask you about. Take a look at reference, in your paper, 27, and read for the record what you're relying on as you've cited it.
A. "Prevalence of clinical correlates of aortic mitral regurgitation in young adult population," the Cardia study abstract, yeah.
Q. So three of the articles that — three of the studies that you relied upon in your study were only in abstract form when you relied upon them, correct?
A. Yes.
Q. Now let's go back. Ikelburger and the others do say that with respect to Fen-Phen as best anyone can say that tends to stay the same or to get better over time in the majority of the people, correct?
A. Say that one more time, please.
Q. The Ikelburger study of 15 years and the others — Weissman, Kahn, Gardin — all say that in the majority of people mitral regurgitation or aortic regurgitation tends to stay the same or get better in the majority of people.
A. That's correct.
Q. Okay. Let's go back now to the ASE publication. I would like to ask you about a comment on Page 782 and see if you agree with it. They're discussing several factors in hemodynamics that affect aortic regurgitation in the upper left-hand column and then they give an example. They say, quote, For example, an increase in blood pressure will increase all parameters of aortic or mitral regurgitation, be it assessed as regurgitant fraction or angiographic grade, unquote. Do you agree with that statement?
A. Yes, I do.
Q. And just so it's clear, we're saying that if a person has higher blood pressure their apparent degree of aortic or mitral regurgitation will be assessed higher, will appear to be higher if you look at it as a regurgitant fraction, which is at least one of the ways that we've done this, correct?
A. Not just they're apparent but they're actual.
Q. Right. But if they lowered the blood pressure then their actual regurgitation would be lower, correct?
A. Sure, and if we lowered their blood pressure all the way down to zero they would have no regurgitation.
Q. But if they were hypertensive it would be a good idea to lower their blood pressure anyway, right?
A. Yes, sir.
Q. Now, it goes down in terms of practical advice in the lower left-hand column. It makes the same point that then gives a practice tip, and it says, quote, It has been clearly demonstrated that the severity of regurgitation may be influenced by hypodynamic conditions. Therefore it is essential to record the patient's blood pressure at the time of the study and note the patient's medications whenever possible, unquote. Do you see that?
A. Yes.
Q. Do you agree with that?
A. Totally.
Q. In any of the studies that you got from Echo Motion that you were evaluating, was the person's blood pressure recorded?
A. No, sir.
Q. Are you aware that on the beginning of the Echo Motion tape there is actually a place for the recording of blood pressure?
A. Yes.
Q. And it was empty, wasn't it?
A. Yes.
Q. Did you ever tell them that they should be recording blood pressure?
A. I never specifically mentioned that. Unfortunately, I think across the board even at major universities blood pressure is not recorded contemporaneously with the echocardiogram, and I think it is an oversight and I think it should be changed.
Q. Do you think — let me ask about Utah. When you see an echocardiogram in Utah, is it in the context of a person who is in there for a general cardiac consultation?
A. Can be.
Q. If it's a general cardiac consultation, their blood pressure is recorded on that day, right?
A. Unfortunately, no.
Q. In Utah they don't record blood pressures?
MR. JEZ: Object to form.
A. Sometimes we do, but not routinely, and it's something that I would through experience tell you that it's not routinely done in most institutions, and it should be routinely done.
Q. What about in this case, where people were coming in off the street and going into hotel rooms without any referring physicians? Would that have increased the importance of knowing their hemodynamic state?
MR. JEZ: Objection, form.
A. Not necessarily. I mean, the goal of these echocardiograms were to define or to determine whether or not a person has regurgitant valvular heart disease, and in fact if your goal is to identify everybody that has the condition, you know, hypertension would serve to improve your sensitivity.
Q. A little hypertension would make the regurgitation appear more prominent.
A. Yes, easier to detect.
Q. So if a patient were a hypertensive patient and they were being treated with medication that kept their blood pressure borderline but acceptable, you know, 135/85, 90, something like that, but they were taken off their blood pressure medication and their blood pressure were allowed to increase to a level of 160 or 170 over, let's say, 100, that might push them over the line into moderate mitral regurgitation as opposed to moderate mitral regurgitation, correct?
A. It could.
Q. And in your judgement that would be an appropriate thing to do because that way we would be picking up people who had a certain level of regurgitation when they were off their blood pressure medication?
A. No, sir, it would not be appropriate, and I would not recommend that.
Q. That was my question. If you don't know what the person's blood pressure condition is, it isn't really correct to say that it would appropriately, increase the sensitivity of the study, is it?
A. No, I was pointing out to you that indeed your questioning was correct, that you would pick up more people with more significant severe grades of regurgitation in a population that was hypertensive or uncontrolled.
Q. You understand, for example, that whether or not a person can sue is dependent on whether they are FDA positive.
A. Yes, sir.
Q. Or whether they can qualify for, let's say, $400,000 in matrix benefits has as its initial threshold whether they are FDA positive.
A. Yes, sir.
Q. And with respect to mitral regurgitation that's defined as a 20 percent regurgitant jet.
A. Yes, sir.
Q. If a person is walking around perfectly fine day to day on a hypertensive medication which they have to be on because they have hypertension, and if you looked at them then they would be at, let's say, 15 percent, that person would not qualify for a lawsuit or matrix benefits, correct?
A. Correct.
Q. But if they stopped taking their medications for a day or two their blood pressure would probably increase substantially in a day or two, right?
A. Yes.
Q. That's how antihypertensives work.
A. Yes.
Q. It only takes a day or two to get your blood pressure back up.
A. Yes, sir, generally.
Q. And you've agreed that that might then push them on an echocardiogram over 20 percent.
A. Yes, sir.
Q. Do you believe that it would be appropriate to qualify people as FDA positive if the only reason they crossed the 20 percent line was because they had taken themselves off or been told to take themselves off hypertensive medications?
A. Well, the appropriateness issue is different from the fact of the matter that the settlement agreement was designed exclusive of blood pressure. Do I think it would be appropriate to stop one's medicine simply to boost your level of mitral regurgitation? No, I don't.
Q. If you knew that a person's blood pressure had increased because they had been taken off hypertensive medications, and you were fairly confident because you read it at 20 or 21 percent, that it was that level of hypertension that was pushing them over the line, would you certify that person as FDA positive?
A. Well, all I have for guidelines is what they've told me to do in the documents provided by the settlement. There was never any feedback or mechanism for feedback from the AHP Settlement Trust to the physicians. I contacted the trust several times for guidelines and guidance and was never once given an answer as to how to fill out ejection fraction or whether to use the same frame or a different frame or what technique do you want to use for evaluation of regurgitant jet areas. It was a complete lack of feedback from the AHP Settlement Trust and absolutely no guidance from physicians, so all I could do was call them like I see them. If someone comes in with an echocardiogram, I don't know — all I know is that's their echocardiogram, and I have to read it based on what's presented in front of me.
So in answer to your question does antihypertensive medication improve mitral regurgitation, yes, it does, and anybody that has mitral regurgitation should be certain that their hemodynamics are optimized in effort to prevent or delay the natural history of the disease.
Q. In other words, you never asked the trust about this question on blood pressure, I take it.
A. No, that's one question I didn't ask.
Q. Now, going back, just so I can understand your position, you didn't know the blood pressures of these people.
A. No, I didn't.
Q. You didn't know whether they were on their medications or not.
MR. JEZ: Objection, form.
A. Right.
Q. And you never asked Echo Motion about this?
A. I don't recall really having that specific discussion. The thing that's apparent to me as a physician and to the echocardiographers, experienced echocardiographers at Echo Motion — and there were a couple that needed to be replaced, obviously, through those e-mails, or educated — understand that in clinical medicine we don't really give a dang whether it's 20 percent, 21 percent, or 15 percent. It's irrelevant. You created the need for categorizing people in their specific levels of regurgitation, so it was your wisdom that decided to quantify these jets according to a dogma outlined in the green form.
Q. And in your view did that dogma exclude the clinical observation that it was important to know a person's blood pressure?
A. Yes, it did.
Q. So if you can answer my question, if you had been told or if you had suspected that a person was off their medications and that that had spiked their blood pressure and that that was what pushed them over the 20 percent, in your judgment that was not relevant because blood pressure and hemodynamics was not specified as one of the things you should be concerned about in this particular settlement context.
MR. JEZ: Objection, form.
A. I mean, I'm always concerned about it, and it's certainly something that should have been taken into consideration. If we could go back and rewrite the settlement agreement, we probably would have done it differently. Although I do remember a discussion one time when I called the settlement trust and spoke to Luke Pepper, and I don't even know who Luke Pepper works for, the trust, AHP, Plaintiffs Management Committee. But there were a lot of questions I had because I wanted to do the best for the patients possible and identify the best — you know, the most people that were injured, and I wanted to be specific. I wanted to exclude people that didn't have those serious injuries. And what Mr. Pepper explained to me was that the settlement is an imperfect document, and it was designed to benefit the most people possible, and there are some people that the settlement does not provide for and it should, and then there are other people that the settlement does provide for and maybe it shouldn't. So that was the best I could do at the time.
Q. Are you aware that the settlement agreement says that in terms of doing these observations you should be guided by the Weyman and Feigembaum text?
A. Yes, sir.
Q. Are you aware that Dr. Weyman makes the point about the relationship between blood pressure and regurgitation?
A. I'm sure he does. It's something that we all know. It's something that has been overlooked across the board, and it was certainly overlooked in the settlement agreement, and the settlement agreement should perhaps have a provision stating that FDA positive includes normal hemodynamic circumstance, but all these studies from the very beginning with the FDA and all the studies through time have not made a requirement of ideal hemodynamics. It was simply take it as they come.
Q. What does the Weyman text say about hemodynamics being a consideration?
A. It is a consideration. It's an important consideration.
Q. So the Weyman text tells you that you need to have consistency in hemodynamics to get an accurate reading, correct?
A. Yes, sir.
THE VIDEOGRAPHER: Excuse me. Can we go off record?
MR. GROSSI: No, keep going.
Q. And you didn't consider that when you did these studies, correct?
A. No, I considered it.
Q. But you didn't make any request that blood pressures be taken.
A. I don't recall making any specific requests to take blood pressures, no. It's certainly something that was manifestly evident to myself or anybody else that has a basic understanding of the signs.
Q. But you didn't do anything to have Echo Motions simply take blood pressures,
A. It wouldn't have made a difference, sir, It would still be 20 percent.
Q. Because even if you had someone who was abnormally high you would still call it 20 percent.
A. Absolutely would.
Q. And that would be true even if a lawyer told the person to go off their hypertension medications?
A. If a lawyer told a person to do that, I wouldn't work with that lawyer. I would think that that would be unconscionable.
Q. You have heard that that's happened from time to time?
A. I have not heard that, not once.
MR. JEZ: Okay. Off the record.
THE VIDEOGRAPHER: Thank you.
(Off the record, 12:10 to 12:19 p.m.)
THE VIDEOGRAPHER: This is videotape No. 2 in the deposition of Dr. Gerald Polukoff. We're on record. The time is 12:19.
Q. Dr. Polukoff, just a couple quick follow-up questions by way of background in terms of Mr. Stafford's echo read.
When you worked for Mr. Fleming — and again please tell me if there's any difference between IOO cased and green form cases — how did you physically or electronically measure the regurgitant jets? And by that I mean to include the possibility that you're simply, as we would say, eyeballing them.
A. Well, mostly eyeball. It's usually pretty obvious whether you're dealing with a small tomato or large tomato. The techs also do a lot of tracing, so it was on the screen and it was basically do I agree or disagree with that tracing, and then finally when push comes to shove I could do a tracing which can be done with a computer package or can be done with a piece of tracing paper.
Q. When you receive the scans, I'll say, from Echo Motion, how did you receive them, videotape, digital disc, or what?
A. The preponderance were videotapes.
Q. And when you had a videotape from Echo Motion you put it into one of your machines?
A. Yes, sir.
Q. That's a machine that obviously had a videotape player of some sort.
A. Yes.
Q. And that videotape player then plays it onto a screen.
A. Correct.
Q. Does it play it through a computer first?
A. No, sir.
Q. Okay. So in that case you did not have an electronic curser that would allow you to electronically trace.
A. Correct.
Q. What, then, were the cases when you had the capability of electronically tracing, if any? And maybe I misunderstood you.
A. Well, it never really required that I did electronic tracing. You asked how they could be done, I think. There are some echoes that I have read that come with software that allows you to do measurements, plus some of the discs — or all of the discs use the Dicom standard, and I have software that will enable me to do that.
Q. But for clarity, in the case of the 10,000 or so Fleming tapes — and they were almost all tapes — you wouldn't be doing electronic tracing.
A. Let me correct you here. It wasn't 10,000 Fleming tapes.
Q. All right.
A. In fact, the Fleming firm was a large part of our business, but it was not the majority of our business.
Q. Okay. Actually, maybe it makes more sense to even talk about Echo Motion, because they would be working for different law firms, including Mr. Fleming.
A. Yes, sir.
Q. Okay. So on the Echo Motion tapes you didn't do electronic tracing.
A. I didn't need to, no, sir.
Q. Okay. On Woodlawn, was that the second biggest provider as you remember it?
A. Yes.
Q. Okay. Did they provide tapes or discs?
A. Tapes.
Q. So again you wouldn't be re-electronically tracing a Woodlawn tape.
A. Not necessarily. Woodlawn didn't always do, especially early on, on-line analysis. They didn't trace.
Q. They didn't trace themselves. All right. The Echo Motion tapes did come with tracings.
A. Yes, sir.
Q. And you recall that the vast preponderance of the Echo Motion tracings came with a single tracing of a single regurgitant jet.
A. No, sir.
Q. They had more than one.
A. Well, I think that was one of the issues in my e-mail, that make a substantial recording, make it clear and convincing, make it many frames using many techniques, meaning independent of left atrium or — and also including the measurement that has jet and left atrium in this same frame.
Q. Okay. Let me just make a suggestion to you, and you can check this record yourself if you'd like. I just want to help you out. We've taken the Echo Motion deposition. They indicated that from January of `02 through August or September of `02 their people were selecting a single frame, at least for purposes of making the measurements and making the tracings, and that they did change that sometime around August or September of `02 to do three frames. Now, is that consistent with your recollection of how that changed?
A. No, it's not. I had frequent dialogue with Echo Motion in effort to obtain a high quality echocardiogram to where interpretation was clear and convincing and not based on a single frame. Now, it may turn out that a single frame was adequate to represent a given study, but what I wanted to avoid, and feel like I did avoid, in my interpretations was including an artifact being traced as significant regurgitation, which can be done. I wanted to make sure that when we were interpreting the echocardiograms that there was sufficient recordings to verify the quantification algorithm as prescribed by the matrix.
Q. Which you were looking for the maximum level of regurgitation.
A. Yes, sir.
Q. So if you saw a frame, a single frame that in your judgment was not an artifact but that frame was 20 percent, and there were many, many other frames when it was 15, 16, 17 percent, in your judgment that would qualify as FDA positive, correct?
A. Generally it's not that cut and dry. You know, a reader gets a feeling for the quantification. But based on what you just said, if I were reading an echocardiogram where there was 16, 17, 15 multiple tracings, and then one came along that was clearly more than 20 percent and I thought it was not artifact, that it was a true heart beat regurgitating more than 20 percent of the area, then, yes, I would call that positive.
Q. And by artifact are you referring only to technical artifact, or, for example, would you consider a heart beat after a PVC to be representative?
A. You know, it's actually not.
Q. PVC. So if you saw a PCV and the next frame was 20 percent, you wouldn't include that or you would?
A. I would try to integrate as much data about the study as I could before making a determination. I tried to be as reasonable as possible while interpreting these studies. Once again, it's not an issue in the clinical world. It's an issue in the medical-legal world.
Q. Okay. In the medical-legal word as you understood it, if the only frame that was beyond 20 percent was one following a PVC, would you certify that as FDA positive or not?
A. I don't know that I ever saw that example, but what I would do if there was a post extra systolic accentuation of the degree of mitral regurgitation in one frame and only one frame, I don't think I would call that as FDA positive.
Q. The issue of backflow, do you know what we're talking about in terms of backward displacement of the blood when the mitral valves close?
A. Yes, sir.
Q. Would you consider a frame that was traced as backflow — if the technician had traced it, would that be part of the consideration? Would you permit that to be a basis for an FDA positive finding?
A. No, sir, I would not.
Q. So if we look at your tapes, if Echo Motion has traced backflow, then you should have certified that as not FDA positive.
A. I should have. I'm affirming your negative. I should have verified that as not positive.
Q. Did you ever discuss the backflow or backward displacement issue with Echo Motion?
A. Yes, I did.
Q. Are there e-mail traffic on that?
A. I don't have any.
Q. That's what I'm wondering. We've gotten Echo Motions. I'll represent there's nothing from you on the backflow issue. Do you keep your e-mail?
A. No, sir.
Q. Do you have a hard disc?
A. Yes, I do.
Q. Is it possible that we would be able to retrieve from the hard disc the e-mail?
A. No, I don't think so.
Q. Okay. But you are aware that that's possible even though us laymen don't know how to do that.
A. So I'm told. You can send it to the CIA.
Q. But in any event, you don't think you ever wrote e-mail about backflow.
A. Backflow wasn't an issue for me at all. I mean, my trained eye knows what artifact is and so do my readers. Well —
Q. You didn't see Echo Motion technicians tracing backflow? Is that what you're saying?
A. Oh, I might have from time to time.
Q. And you never told them not to.
A. Oh, yeah. I mean, I would not accept backflow.
Q. That's what I'm trying to understand. Is it your testimony that you saw backflow being traced and you actually told Echo Motion in some fashion, You guys are tracing backflow; You shouldn't be doing it?
A. Echo Motion didn't trace backflow. I mean, it might have happened from time to time over the course of several thousand echocardiograms that a tech like KT, for example, was tracing flash, meaning just the walls are moving and the anulus is moving, and this particular tech thought that was mitral regurgitation. But backflow as I recall was not a problem on the Echo Motion studies.
Q. Was it a problem on the studies from some of the other echo mills?
MR. JEZ: Objection, form.
A. By echo mill, high volume, you know, let's get this done so these people can be screened before the deadline is up and they lose any chance at recovery for their damages. Is that what you mean by an echo mill?
Q. I guess what I was defining as an echo mill was an outfit that had no existence prior to these cases, has had no existence since these cases, has never done an echo of a single individual in the world except a lawyer-referred fen-phen echo.
A. That's — that's —
Q. That applies to Echo Motion, correct?
A. No, no.
Q. Is it your understanding Echo Motion has ever done an echo for anybody but a legal Fen-Phen claimant?
A. My understanding working with Echo Motion is that Michael McElroy is an outstanding tech that could work in any echo lab anywhere and would be an asset, and the same goes for his chief technician, Marty, who I believe you have correspondence from. They're both awesome sonographers —
Q. My question is —
A. — and they don't have a problem with backflow.
Q. Do you know that Echo Motion was created solely for Fen-Phen echoes?
A. I didn't really know their background.
Q. Do you know that their telephone is 1-800-FEN-ECHO?
A. That's catchy. No, I didn't know that.
Q. Do you know that they didn't do any echoes before this Fen-Phen issue, that there was no Echo Motion before this? Had that been explained to you?
A. Well, I didn't know that, but like I said, I do know that Mike and Marty are incredibly well trained and excellent sonographers.
Q. Do you know that since the deadline they've basically gone out of business, that they're not conducting business any longer?
A. I would suspect — no, I don't know that, but I don't see the need for them to be in business any longer. Who was going to do those echoes? Certainly, you know, the settlement trust offering the echoes got so far behind they had to extend the deadline.
Q. Was it of any concern to you that Echo Motion was hiring technicians that you didn't know?
A. No. I don't need to know them as long as I can see that their work is good.
Q. And you can see that because the Nyquist settings are either set correctly or not?
A. It's more than that. That's one thing, but it's just looking at the study. It's pretty readily apparent to most cardiologists whether or not they're dealing with a, quote, good study or not.
Q. How do you know whether the gain is properly set?
A. Well, you can override the gain setting, but for the most part the gain settings are — actually, I was not speaking about gain. I was speaking about the Nyquist limit. You can override the Nyquist limit on these machines, but for the most part it's done automatically by depth and by frame rate. Gain can easily be adjusted. It's a knob or a slider. It's easy to determine when something is overgained. It's more difficult to determine if something is undergained. But it's a visual appreciation.
Q. On the Nyquist, when you were talking about so dang low, how low was that?
A. It was way low.
Q. What numbers?
A. You know, commonly a Nyquist limit of about 5 meters per second is what's used, 5 to 6 in most settings. What I mean by settings, scenario, not by equipment setting. It was something that was just obvious to me, I mean something I could tell by looking without really having to read a number or study the tape. I mean, the walls were flashing color everywhere and the Nyquist limit being set low. And it may be something that was overlooked, because this tech obviously didn't have the right experience and he or she was not adequate.
Q. Did you ever meet with any of the Echo Motion techs that were out in the field?
A. Just Michael and Marty.
Q. They ran the operation. I'm talking about the people who did the scans out in the field.
A. No, sir.
Q. Did you ever send anything? Did they ever ask you to send anything directly to those technicians?.
A. They asked me to be very critical, and they, you know, welcomed the criticism. In fact, you know, they have told me — or during the dialogue told me that I was the only reader that would give them criticism.
Q. Did they understand at that time that you were on this $400,000 retainer to Mr. Fleming?
MR. JEZ: Objection, form.
A. I doubt they did, because it wasn't any of their business. I don't go advertising that.
Q. Okay. So getting back to the question of tracings or not tracings, generally almost always you didn't electronically trace. What percentage of the cases do you think you traced with tracing paper?
A. I can't give you an estimate. It wasn't very often. When we look at these with the eyeball method it's pretty rudimentary. I mean, one of the things that we didn't explore is the variability of interpretation in mitral regurgitation. With aortic it's quite simple. It's either there or it's not there. I mean, there is trace aortic regurgitation which I would define as lack of confluence. You know, pixels don't organize. There's a pixel here, a pixel there, but it's not a confluent jet. So the gradation of aortic regurgitation is something that is manifestly evident. It's there or it isn't.
Q. To qualify it has to be 10 percent, right?
A. Yes, sir.
Q. And where do you measure the jet height?
A. The recommended place is just below the valve leaflets and as the jet begins to organize.
Q. Is that where you measured it?
A. Yes.
Q. Where do you measure the outflow track?
A. You measure the outflow track just — in the same area, just below the aortic leaflets.
Q. And those came from Echo Motion with an electronic calculation, correct?
A. Yes.
Q. Someone put calipers on someplace and expressed that as a percentage, correct?
A. That's true.
Q. And you received the Echo Motion tech worksheets that would give you both the regurgitant area, the left atrial area, and a percentage, correct?
A. Yes.
Q. And even the percentage was calculated out for you, correct?
A. Yes.
Q. Do you remember there were times when it wasn't calculated and people were told to go back and actually do the mathematical calculation because the cardiologists like you didn't want to be bothered making the actual calculation?
A. Never.
Q. You don't remember that happening.
A. I don't.
Q. Okay. I'll represent to you that it did happen, and that they did actually go back and tell techs to add the calculation.
A. Yeah, I'm sure it did, and —
Q. And you got them with calculations.
A. Yes, I did. I didn't hang my hat on their numbers. That's a fact.
Q. But you were aware of their numbers when you made your eyeball.
A. Sure.
Q. And it was your job to determine whether by eyeball their calculation was reasonable.
A. Yes.
Q. And basically it was two things. It was to make sure it wasn't an artifact and to make sure that it seemed close to that number.
A. Well, it was more than just that. It was to interpret the echocardiogram. And you mentioned a red herring, if there was one PVC and the one frame that was measured was post-PVC, and this particular frame it showed 21 percent or 20 percent but all others it was barely detectible, what would you do. It was in my job to interpret these type of peculiarities. The vast majority of the studies were straightforward. It's significant or it isn't.
Q. What percentage of the time would you say you agreed with the positive finding?
A. Much less than half.
Q. You think that the record will show that more than half of the time you rejected the Echo Motion tech's finding?
A. Yes, sir.
Q. That's possible.
A. Yes.
Q. In other words, I'm talking about that group that he said or she said was positive. Your testimony is that when we check the records about half of the time you said no.
A. Yes, sir.
Q. Does that concern you, that this group was out there doing 70,000 echoes and getting it wrong more than half of the time?
A. Well, the whole thing concerns me. Yes, it does concern me. However, you know, the technician's read and the doctor's read are often discrepant.
Q. Did you ever tell the people at Echo Motion that, you know, You're over stating it by about half of the time, more than half of the time?
A. I think they knew that there was significant disagreement in my interpretation and several of their techs.
Q. But it was consistently overstated. In other words, far more often they thought it was positive and you thought it was negative than the other way around.
A. You know, I'm not certain if that holds true just for Echo Motion. I'm talking about across the board. You know, I've read a lot of bad echoes with this Fen-Phen litigation. I've seen many overcharacterizations of regurgitant jets and pulmonary pressures.
Q. And my question, then, is: Do you recall ever stating to anyone at Echo Motion, specifically Mr. Winans, Ms. McCulloch, or Mr. McElroy, anybody else, that, you know, you, like other outfits, are generally overstating the degree of regurgitation and maybe you need some more training?
A. Yeah, let me back up. As far as specifically for Echo Motion, I'm not saying that theirs was 50 percent or more than half the time. As a whole, all the echoes I looked at, I had disagreement with the FDA positive often.
Q. The FDA positive assessment by the technician.
A. Yes, sir, that's precisely what I mean. As far as Echo Motion goes, they were the best quality outfit out there. They did the best echoes available. Their echoes were clearly better than everybody else's echoes. That being said, they had some techs that weren't as good as others. Even with Echo Motion, yes, they did tend to overstate the regurgitant volumes or jet areas.
Now, as to why that happened, I think that they were doing their best to identify the most jets possible, the most lesions possible. And then sitting in the room and reading, you know, it became evident to me that, well, maybe some of these issues that you brought up, not specifically the PVC but overtracing, off axis, et cetera, would pull these away from the moderate criteria for mitral regurgitation. I think mitral was the problem. Aortic is not a problem. Like I said, it's an on and off switch. By mitral regurgitation, interpreting mitral regurg quantification as to whether it's a small, medium, or large tomato is quite difficult.
Q. And you're saying this has to do with the way settlement in FDA positive is defined.
A. Yes, sir.
Q. And also you worked with Mr. Fleming with respect to left atrial size and ejection fraction, correct?
A. Yes.
Q. And you told Mr. Fleming and his colleagues that the settlement had a problem in that they had defined left atrium at 4.0 such that many, many people who are perfectly healthy but large would have a 4.0 atrium, right?
A. Absolutely.
Q. And so if a person has mitral regurgitation and they're very large, as many of these people are, and they have a 4.0 or a 4.1, there's nothing abnormal or unusual about that, right?
A. Well, yeah, it's a real conundrum, because the settlement defined 40 millimeters as the cut point and, yes, you can be healthy and have a 41.
Q. And it's normal for a large person to have a 41.
A. Yes, sir.
Q. Just like, you know, if a person has a size 14 shoe that's a large shoe size for many of us, but if they're 6'4" or 6'5" you're not surprised to see it at all, right?
A. Correct.
Q. That's a perfectly normal shoe size for a person of that size.
A. That's correct, sir.
Q. And on ejection fraction the cut point was 60 percent, correct?
A. Mm-hmm.
Q. But many people —
A. Pardon me. Yes.
Q. But many people have 58's and some 59's and they're perfectly healthy.
A. Well, I think it's even more basic than that.
Q. Okay.
A. I think that, you know, simply normal or abnormal would have been quite adequate. The way the matrix was developed with check yes or no, I believe, for ranges 50 to 60, 40 to 50, et cetera, I mean, there was an inherent problem with that. There was not an affirmative response for a normal ejection fraction, so it made filling out this form a little confusing.
You know, doctors are trained two ways. A normal ejection fraction is 55 percent or greater or 60 percent or greater, so many readers would call 55 percent a normal ejection fraction. They would write in their report, You have 55 percent, and that would be the complicating factor that would tip a patient into a matrix of a claim. I didn't do that. My readers didn't do that. In fact, very, very few of our reads were based on low ejection fraction as the complicating factor.
Q. Much more often it was the left atrial size.
A. Correct, sir.
Q. And if a person had a 41, you'd check that box as being above 4.0.
A. Yes, sir.
Q. Even though in your own mind you might think that was perfectly normal.
A. They never asked what I thought.
Q. About whether it was normal or abnormal.
A. That's correct.
Q. All they cared about was whether it was 4.0.
A. Yes, sir.
Q. And that's all you cared about.
A. Well, I mean, I care about a lot of things, but —
Q. That's the only thing that you focussed on in that particular factor.
A. Like we said, the settlement agreement was designed to help the most people it possibly could, providing the greatest benefit and the greatest good to all. We all developed these cut points. The echoes were performed, they were read — at least mine were read, and I speak for my group — in a fashion to be straightforward and honest in our interpretations, and if it was 41 millimeters as opposed to 40 millimeters, or even 40.5, if the measurement was correct leading edge to leading edge on axis, appropriate views, then that's the box that was checked.
Q. And you made no inquiry about whether that was normal or abnormal for a person of a given size. I guess you didn't even know what size the person was.
A. Well, I made many inquiries. I got nowhere talking to the AHP Settlement Trust.
Q. Did you talk to them about this left atrial issue specifically?
A. I talked to them about numerous issues.
Q. Can I ask about the left atrial, though? Do you remember that and who it was?
A. First of all, I don't have specific recollection. I would say I had so many questions initially that I may or may not have asked that. I mean, that's just one question I have. And who did I speak to? Representatives. I don't know what their credentials were. They wouldn't give you their credentials. They would say that they are working for the AHP Settlement Trust and they're claims review people. I don't know if they're doctors. I don't know if they're nurses. They wouldn't answer. They wouldn't give you their names. They would give you their first names.
Q. Just one last question on the green forms. Did anybody else ever put any information on the green forms that you signed? Did they in any way, shape, or form come in pre-filled out or checked? Did any clerical staff assist you in putting on that information?
A. I would not accept those.
Q. Now, your testimony is that every green form that you signed came to you totally blank.
A. Well, I think that the overwhelming majority came to me totally blank. There was an effort to automate the green forms in the Fleming firm and make it more convenient for the cardiologist, and some did come pre-checked. Now, I asked for them not to come pre-checked, and after I made that clear they weren't. They were all blank. That being said, if there was one or two pre-checked green forms that I reviewed and signed until I decided this was not a good idea, I wouldn't want you to call me a liar.
Q. To your knowledge did the Fleming firm change that procedure with respect to the forms that they were sending to other people?
A. I have no knowledge of that.
Q. They didn't say, Jury, you're right and we will not do that again, or they just sent them to you in a certain form?
A. Mine came unchecked after this discussion.
MR. GROSSI: Let me now mark — we're up to Exhibit 11 now, I think.
(Whereupon, Exhibit 11 was marked.)
Q. I would like to turn now to that background with Ms. Stafford. Have you ever met Ms. Stafford or examined her?
A. No, sir.
MR. GROSSI: Let me mark two things while I'm at it.
(Whereupon, Exhibit 12 was marked.)
Q. Exhibit 11 is a discharge summary that summarizes Ms. Stafford's condition, and Exhibit 12 is your expert report. Let's begin with your expert report, which is No. 12. You say in the first paragraph — this is dated June 22d 2003 — that you reviewed various records and you mentioned various physicians. Did you review the echo tapes of those various physicians?
A. No, sir.
Q. Okay. You've only reviewed their reports.
A. Yes, sir.
Q. So you will not be testifying at trial that you disagree with their evaluations because you haven't looked at the tapes.
A. That's evident, yes, sir.
Q. Okay. Fine.
A. I would like to look at those tapes if you can make them available to me.
Q. Well, I'm sure that plaintiff's counsel has the tapes. You haven't asked plaintiff's counsel for the tapes?
A. Yes, I have. They do not have the tapes.
Q. Well, I brought one with me today that we'll look at, because you specifically say that you have not had a chance it look at her transesophageal echo.
A. Yes, sir.
Q. I guess when I interpreted your report I was — maybe I shouldn't assume, but I assumed you looked at the other tapes and were noting the one that you had not. You believe she has aortic regurgitation second to fenfluramine toxicity?
A. May I clarify this? It says, "The results of Ms. Stafford's intraoperative transesophageal echocardiogram are not currently available," the results. So I don't know why you assume the tape, but the results are not in my records.
Q. I see. Well, I think I do have, actually, the commentary on the results.
A. I have that too, and it didn't mention the aortic valve.
Q. Right. It talks about minimal mitral.
A. Yes, sir.
Q. That's my first question, just so we can cut through it. You're not making any claim that she has any type of mitral regurgitation which you consider to be clinically significant, correct?
A. Some of the echo reports identify her as having moderate mitral regurgitation, and the cath report demonstrates that she had moderate to severe MR, but it could be related to catheter placement.
Q. Excuse me there, but you would accept that possibility? In other words, sometimes catheterization can itself induce mitral regurgitation?
A. Yes, sir.
Q. Okay. So when they said that, that made sense to you as well.
A. It sure did.
Q. Okay. So there are these reports, and then there's a transesophageal echo taken during her operation, her coronary bypass operation, in which they describe it as minimal or mild.
A. Yes.
Q. And we're agreed that if it is in fact minimal or mild you do not consider that to be clinically significant, correct?
A. Yes.
Q. Because minimal or mild mitral regurgitation is a very common finding, especially in ladies who are 56 years old.
A. With the one caveat that you've so eloquently pointed out, that it depends on the loading status, so when you're vasodilated under anesthesia you may not load up your mitral valve like you had, you know, previously during a transesophageal echocardiogram. So she may have a mitral valve defect that is manifestly evident under high loading conditions and inapparent under low loading conditions. So I suspect that her mitral valve has Fen-Phen on it, and what I mean by that is I don't think that the disease process discriminates between aortic mitral or pulmonary vasculature to be specific. I think that various people respond differently. Some respond as mitral leakers and some respond as aortic leakers, and some respond as pH and some don't get the disease.
Q. Okay. You were aware that — I can mark it. Let me mark as exhibit. . .
A. Thirteen.
Q. Thirteen, right.
(Whereupon Exhibit 13 was marked.)
Thirteen is the consultation report dated June 7, 2002, following her operation, correct?
A. Yes, sir.
Q. Just so we're clear, the operation she had was coronary artery bypass graft?
A. Yes.
Q. She had a double bypass?
A. Yes.
Q. And that was due to her, to use a layman's term, clogged arteries?
A. Yes, sir.
Q. And that was as a result, probably, of her high cholesterol, hyperlipidemia?
A. Well, it's multifactorial.
Q. So we're clear, Fen-Phen has nothing to do with that.
A. That's correct.
Q. All right. And she also had hypertension.
A. Yes, sir.
Q. So here we have a lady who has clotting arteries, hypertension, and that's of concern to a cardiologist. That could result in a heart attack somewhere down the road.
A. Yes, sir.
Q. And that's why you think that the folks in Oklahoma did a good job of giving her a coronary artery bypass graft.
A. I do think so, but I didn't say that. I guess you're reading my mind.
Q. Okay. Fair enough.
A. Yes.
Q. You have no criticism of their care.
A. No, sir.
Q. All right. And one other things they did was because there was some issue about Fen-Phen and possibly some issue about mitral regurgitation when they went in quite literally, when they opened her up in order to give her the coronary artery bypass graft, they at least considered the possibility of doing some sort of valve repair or replacement if in fact they determined that she had valvular regurgitation that might necessitate that, correct?
A. We're speaking of the mitral valve.
Q. Well, mitral or aortic, but they were focussing on mitral.
A. Exactly, and even without a twofold incidence in relative risk.
Q. So what they were saying to themselves was, Since we're in there any way, since we've had to do the incision and all of that, if there's a need for a valve repair, we will do it.
A. Yes, sir.
Q. And that's why they placed — that is one of the reasons at least they placed the transesophageal echo, in order to evaluate that.
A. Yes, sir.
Q. But according to the report following the surgery it states on the first page, quote, "An intraoperative transesophageal echocardiogram was performed and mitral regurgitation was found only to be mild. The structure of the valve was apparently normal or near normal." That's the history of the procedure, and then under "Impression" on Pages 2 and 3 there's a similar comment. Quote, "The mitral valve shows only minimal regurgitation. Left ventricular function is preserved. The risk factors include hypertension and hyperdemia." Do you see all of that?
A. I do, sir.
Q. And that was the report that you were referring to as the best report you have of this particular echo.
A. Yes, sir, the — yes.
Q. And you would agree that if the mitral regurgitation was only mild or minimal, if the valve was apparently normal or near normal, and if left ventricular function was preserved there would be no need to do a mitral valve replacement.
A. Yes, I agree.
Q. So your only question at this moment is did they read the echo correctly. I don't mean to say you're critical, I'm just saying it's still an issue in your mind.
A. No.
Q. That is not an issue.
A. No. I believe that her mitral regurgitation at the time of the intraoperative transesophageal echocardiogram was mild.
Q. And I believe that's the last one we have chronologically.
A. The last one I have, yes, sir.
Q. So you will not be testifying at trial that in your view she has anything other than mild and therefore not significant mitral regurgitation.
A. If I look at it and know something different or think something different, I will let you know.
Q. Actually, I brought it with me. If you'll give me a second, I will try to cue it up and you can take a look at it.
A. Sure.
Q. I would like to clarify that. It's probably very dangerous for me to be doing this without legal assistants, but we're going to do our best.
MR. JEZ: You shouldn't say that, Pete. They're going to know you depend on them. MR. GROSSI: There is no question that I depend on my legal assistants.
Off the record.
(Comments off the record.)
MR. GROSSI: Just for the record, we're looking at Patricia Stafford on June 7th, `02.
THE WITNESS: I'm seeing mild mitral regurgitation.
Q. (BY MR. GROSSI) Has this played all the way?
A. And it stops there.
Q. Okay. So now that you've seen it, you don't disagree either with what the report says.
A. Is that all there is?
Q. That's all there is on — yes, that's al! we've been provided with. Okay?
A. Okay. Are you going to turn it off?
Q. Yes, that's what I want to do.
A. Just close that, top right.
Q. I think it just turned it off.
A. Now you have your laptop back. Close that one.
Q. Okay. Thank you.
A. All the secrets. We have no secrets. We're both just pursuing the truth here.
Q. He's recording all of this. All right. So we're going to focus now on aortic regurgitation, and you have not in fact looked at any echo tapes of her to indicate that she has aortic regurgitation, correct?
A. Right.
Q. So for the moment you're relying entirely on the reports that have been generated.
A. Yes, sir.
Q. Are you aware of any report that indicates that she has greater than mild aortic regurgitation?
A. No, sir.
Q. So it is your opinion, because you're simply reading what they said, that she has mild aortic regurgitation.
A. Yes, sir.
Q. That will be your testimony at trial, that it's just mild. I mean, we're not —
MR. GROSSI: Mr. Jez, I'm not sure. What is the trial date on this case?
MR. JEZ: There is no trial date.
MR. GROSSI: There's a remand we're fighting against the deadline?
MR. JEZ: No, not at this point, or at least none that I can recall right now.
Q. (BY MR. GROSSI) Did you see anything in the medical records that indicated to you something that was telling or telltale about the mild aortic regurgitation reported that enhanced your opinion that it was fenfluramine related? In other words, anything about thickened valves or anything like that?
A. No, sir.
Q. So your assumption is that because she has aortic regurgitation and because she took Fen-Phen that the two are related.
A. Yes, sir.
Q. Are you aware that in 2001 she had an echocardiogram that at that time, according to Dr. Leahey, was viewed as only trace aortic regurgitation?
A. Yes, I did notice that.
Q. So it would be your assumption that four or five years after she stopped taking the drug she had trace regurgitation, and that a year or two later it had progressed to the point of mild regurgitation.
A. I believe that there was an echocardiogram that antedated Dr. Leahy's that also showed mild. I could be wrong about that, but . . .
Q. Is it your assumption that there were just — that the inconsistency there is simply a matter of variability, or do you believe that she had mild regurgitation from Fen-Phen, it truly went down to trace, and that subsequently went back to mild?
A. I believe it's probably she just had mild aortic regurgitation perhaps on Dr. Leahy's interpretation, and I'm assuming based on the medical record that he's a hundred percent correct, and that time it only appeared as trace. Drawing a line of reason through this, it appears as if Ms. Stafford has mild AR.
Q. So your assumption would be that — and I believe you're correct — that from April of 2000 when a Dr. Spooler said she had mild AR through April of 2001 where Dr. Leahey classified it as trace ER, and then May of 2002 when Dr. Wright classified it as mild AR, that that really is probably just consistently mild AR with inter-reader variability.
A. Well, that's one explanation. Not to do any discredit to Dr. Leahey, even assuming that Dr. Leahey is 100 percent correct and that on that day it was only identified as trace or she only had trace, I believe that there is variation in the lesion, and I believe that the orifice is dynamic, the oral orifice is dynamic, and that her aortic valve damage results in a mild leakage at this time.
Q. And, for example, as we talked earlier, depending on her hypertension condition it might be trace or mild. It might just fluctuate over that line a little bit.
A. It could.
Q. Okay. So either we have a slight inter-reader variability, which is quite understandable among good physicians, or we have slight differences perhaps in her hemodynamics that one day makes her a little bit higher than lower. That's why in your judgment it's not a big deal that it technically goes mild, trace, mild.
A. Correct.
Q. Would that indicate to you that it's probably on the lower side of the mild?
A. No, sir.
Q. In other words, closer to the trace than to the moderate.
A. Not necessarily, sir. It would be really speculative.
Q. Are you aware of any indication anywhere in her medical records that any of her physicians are treating her for aortic regurgitation?
A. No.
Q. Are you critical of that?
A. I'm not critical. I think these are great doctors. I think that they, you know, identified coronary artery disease, and they went through a period of medications and watchful waiting and continued to pursue her as a patient and identified that it was time to do her bypass surgery. That being said, you know, they saved her life. I'm not critical that they didn't really look at her aortic valve, but I think that in retrospect that they may have wished that they would have studied her aortic valve a little further. It's unlikely that it would result in surgery, but it wasn't commented on she should be receiving bacterial endocarditis prophylaxis with her mild aortic regurgitation. Again, I'm not being critical. I might do things slightly differently.
Q. Are you aware of any report in which anyone has heard the aortic regurgitation as an audible murmur?
A. No — mitral regurgitation, yes, not aortic.
MR. GROSSI: Let me mark as Exhibit 14 what I believe is the last medical record that I have received very recent.
(Whereupon, Exhibit 14 was marked.)
Q. This is an office encounter by the Oklahoma Cardiovascular Associates. Do you know the Oklahoma Cardiovascular Associates as a firm?
A. No, sir.
Q. Do you know Dr. William D. Wright?
A. No, sir.
Q. A moment ago you said that these were great doctors because they had picked up on her coronary artery problem, correct?
A. Yes.
Q. And when you referred — I think it was clear to me, but I want it to be clear for the record. When you talked about them engaged in watchful waiting and engaged in medication, you were talking exclusively about their treatment of the coronary artery disease, correct?
A. Yes, sir.
Q. Okay. This particular document explains that about a year earlier she had had the coronary artery bypass, correct?
A. Yes, sir.
Q. And there are other reports of her having pains in her chest following the procedure that are described as neuropathic. Those are the pains from the incision and from the trauma of the operation, correct?
A. Yes, sir.
Q. Nobody has suggested that she is currently having any sort of chest pains that are cardiac in nature, correct?
A. Correct.
Q. In fact, there are comments in this and subsequent the reports in 2002 that she's doing quite well in their opinion from a cardiovascular perspective, correct?
A. Yes, sir.
Q. They think they have solved the problem, which is the coronary artery disease, correct?
A. Well, I don't think that they — you know, I can't tell you what they're thinking, but I can tell you that coronary artery disease doesn't just go away with the bypass surgery, and I think that's why they did their Cardiolite on her in January.
Q. Fair enough. I think it was a very poor question on my part. What I meant was — let me ask it again — they believe they had a successful surgery in at least ameliorating for the moment her coronary artery disease. It was a good surgery.
A. That's what I think.
Q. I mean, from reading the records you would agree.
A. Yes.
Q. As you read about her progress over the year and a month since the bypass surgery.
A. Yes, sir.
Q. She's healing well and there seems to be good signs of cardiac improvement because of the surgery.
A. Yes, sir.
Q. Okay. But the further point that you make — and I think you're correct with the records here — is that she still has a hypertension problem, correct?
A. Yes.
Q. And they describe it as suboptimally controlled. Do you see that?
A. Yes, I do.
Q. And you would concur in that.
A. Yes.
Q. And she's going to have to be monitored to make sure she not only takes medications but perhaps the medications will need to be changed or strengthened in order to maintain her hypertension at a good level?
A. Yes.
Q. Hypertension tends to be a lifetime disease of these types of people.
A. Yes, sir.
Q. Same with the hyperlipidemia. She's got some sort of problem with the way she processes her lipids that may be genetic or whatever. It's going to be a problem with her for the rest of her life probably.
A. She does have a remarkably low HDL.
Q. And she needs to take certain drugs for that.
A. Yes, sir.
Q. Okay. They list the medications there. Which of the medications are related to the hyperlipidemia problem?
A. The Zocor.
Q. And which are related to the blood pressure problem?
A. Diovan and — just Diovan.
Q. Well, Lasix is a diuretic that can also be helpful?
A. It can be helpful, but she's taking it as needed for edema, I believe, venous harvest.
Q. The baby aspirin, that's also related to the coronary artery disease?
A. Yes, sir.
Q. And Prilosec, that has nothing to do with cardiac.
A. Correct.
Q. So she's not taking any medications for the regurgitation.
A. Well, yes and no.
Q. In that she might be taking — she's taking medications for hypertension as the primary issue that would have a good effect on regurgitation as well.
A. That's correct.
Q. Do you have any indication that Dr. Wright is in fact prescribing it with the regurgitation in mind as opposed to the hypertension?
A. Not really, although one could ask Dr. Wright that specific question. I believe that, as you've pointed out over and again, hemodynamic control is a good thing for people with regurgitant valvular heart disease and in general, and the use of Diovan may indeed be helpful in reducing her ventricular volumes and progression of aortic regurgitation.
Q. And under his impression, taking all this history into account, he still lists mitral regurgitation as one thing that she has, correct?
A. Yes, he does.
Q. He doesn't say it's bad or needs to be treated. He just mentions it, correct?
A. Yes, sir.
Q. He never mentions aortic, does he?
A. No, he doesn't.
Q. You've never seen any of the doctors from Oklahoma or Texas who actually are her treating physicians put as one of her diagnoses or impressions aortic regurgitation.
A. Only the echocariographers.
Q. They simply note that it's there.
A. Yes.
Q. But the doctors, the cardiac doctors who are taking care of her, appear not to be concerned about it, correct?
A. Or aware.
Q. Or even aware. You're not aware that they've seen the echocardiograms?
A. I believe they have.
Q. Are you aware that Dr. Wright in fact took one of the echocardiograms?
A. Yes.
Q. So he noted it as an echocardiographer would note, but he doesn't seem to be at all concerned about it in terms of treatment, correct?
MR. JEZ: Objection, form.
A. There does appear to be a disconnect there.
Q. Are you critical of that? Do you think Dr. Wright should be treating her aortic regurgitation in a more aggressive fashion?
A. Well, I think he already is.
Q. Because he's giving her blood pressure medications.
A. Yes, sir.
Q. But he's giving her those primarily to watch out for strokes and heart attacks.
A. Well, he may be doing the right thing for different reasons, and the use of vasodilator therapy for valvular regurgitation is not universally accepted. I believe it's a very good idea, and I believe there's data to suggest that it's a good idea. I think that by looking at these records that Dr. Wright — and I may be a different type of practitioner — that he's extremely good at what he does and he's taken nice care of her. I think I could sit down with Dr. Wright and say, you know, Let's look at her aortic valve. You mentioned that she had a little aortic regurgitation before. And, Should we be giving her antiobiotic prophylaxis? And, Should we be following that as recommended by the college from time to time? And, Should we be concerned about progression? And he may have his own opinions, but I don't think that he would view me as being critical of him, because I'm not critical of him. I think he saved her life.
MR. GROSSI: Let me mark as No. 15 one of the echocardiograms, the one from 2001.
(Whereupon, Exhibit 15 was marked.)
Q. I'd like to ask you about her chamber size. You see there are a number of M-mode measurements there?
A. Yes, I do.
Q. Let me run through the first four, and the right ventricular diastolic is 1.48 centimeters. That's shown as being within the normal range according to this lab?
A. It is, sir.
Q. And you would agree in general that's a normal reading?
A. Yes, sir, I do.
Q. I'm not going to read them all into the record, but on left ventricular diastolic is that a normal reading, 4.7?
A. Yes, it is.
Q. Left ventricular systolic at 2.60, is that a normal reading?
A. Yes.
Q. Now, I want to focus you because I want to be very fair with you. You may have anticipated this question. The left atrium, it's shown as 4.01 centimeters. There is then a normal — and it does have a plus sign, I will note, 1.9 to 4.0. Do you consider a 4.01-centimeter left atrium in a lady who, it's been stated to be, weighs approximately 170 pounds at 5-foot-1, I think — is that an abnormal reading in your opinion?
A. You know, I've got to speculate here for a second, but I don't think that plus sign is really a plus. I think it's an equal and they just hit the shift-equal and forgot to hit the shift.
Q. I think you're right about that, but let me get your opinion. What would you say about a lady who is 170 pounds, 56 years old, who had a 4.01 centimeter in terms of her left atrial size?
A. Well, I'm glad you give me the opportunity to explain this, because if this were a matrix claim — and we're not talking about a matrix claim.
Q. That's correct,
A. We're talking about a human being with all her, you know, issues and valves and bypasses. We're talking — but if we were talking about a matrix claim, if we felt that 1/100th of a centimeter was an accurate measurement and that that digital machine was calibrated to where it was accurately measuring the difference between 4.00 and 4.01, then you would be compelled and mandated to check the box "Enlarged," 4.01, greater than 4.0, and this is the discussion we had earlier, so I'm deviating. I'm sorry, but I felt like I had to tell you that. As far as do I consider that abnormal, no.
Q. It's quite normal for a lady of that size.
A. Quite normal for, you know, normal range individual. It's within the normal range, 4.01, and you have to — we don't have to draw that line in medicine, but when you're making settlements and trying to help people, help compensate them for the damage that may have been caused by a certain issue, whether it's a drug or a vehicle accident or something, and you make criteria, I guess you've got to hold to them.
Q. And in your mind when you did the green forms 4.0 is 4.0. It doesn't matter whether it's normal or not.
A. It matters, but I wasn't given the opportunity to comment. No one asked me.
Q. When you say it matters, it mattered to you as a physician perhaps, but it wouldn't matter for the green form. 4.0 is 4.0 is 4.0.
A. As long as it's accurately measured, and I truly believe that 4.01 was greater than 4.0, yes.
Q. And even if in your mind it was a perfectly normal reading for a person.
A. Or I don't think the human body knows the difference between a half of a — or a 5/100ths of a centimeter. That's, you know, a couple hairs.
Q. Right. Let's just finish up on this document. Is there anything on this document — and I'd also refer you to the RVSP of 29 milligrams of mercury, but do any of the other numbers strike you as abnormal?
A. No, sir.
Q. Let me just ask — you can drag them out if you'd like — as you sit here are you aware of any abnormality of concern in terms of her cardiac vessels or ejection fraction in any of the echo reports?
A. No. She's got a normal ejection fraction to the best of my understanding. What do you mean cardiac vessels?
Q. I meant chambers.
A. No.
Q. So there's been no remodeling in her case.
A. Well, I disagree with that. I don't believe her heart likes mild aortic regurgitation. I don't believe that it's a healthy thing for her. Given her druthers and her choice she would say, No thank you. I don't want any aortic regurgitation. I've got to use this heart for the rest of my life. So is remodeling occurring? Yes. To the point where it's clinically manifest? No. At a molecular/cellular level is her heart responding to the added volumes of mild aortic regurgitation? Yes.
Q. But we haven't seen it yet in terms of an abnormal chamber size.
A. That's correct, sir.
MR. GROSSI: Give me one second. THE WITNESS: Do you mind if we take a break? I need to use the restroom. Well, I'm going to take a break.
MR. GROSSI: Yes, go ahead and do it, and I'll let you know if I've got anything more.
THE VIDEOGRAPHER: Off the record, 1:22.
(Off the record.)
THE VIDEOGRAPHER: On record, 1:30. MR. GROSSI: Back on the record. On behalf of Wyeth, thank you, Doctor, and we're done.
MR. JEZ: I just want to mark as Exhibit 16 Plaintiff's objections to Wyeth's subpoena tecum, "Plaintiff Patricia Stafford's Objections to Defendant Wyeth's Subpoena Duces Tecum," and that is all we have. We'll reserve the remainder of ours until trial.
MR. GROSSI: Thank you.
THE WITNESS: That's great Thank you.
THE VIDEOGRAPHER: Off the record at 1:30 p.m.
(Concluded at 1:30 p.m.)
(Whereupon, Exhibit 16 was marked.)
EXHIBIT 8
IN RE DIET DRUGS (PHENTERMINE/FENFLURAMINE/ DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION, ANNETTE KERR, ET AL. v. AMERICAN HOME PRODUCTS CORPORATION, ET AL MDL Docket No. 1203, Civ. No. CA-03-20014 United States District Court, E.D. Pennsylvania October 7, 2003HENRY DALTON, KELLER, KELLER DALTON, Oklahoma City, Oklahoma, for Plaintiffs
KERI L. HOWE, ARNOLD PORTER, New York, New Yorkfor Wyeth
SANDY L. SCHOVAHEC, PHILLIPS McFALL McCAFFREY McVAY MURRAH. P.C., Oklahoma City, Oklahoma, for Wyeth
HARVEY BARTLE, III, District Judge
Videotaped deposition of JOSHUA PENN, M.D., Volume 1, taken on behalf of Wyeth, at 777 South Figueroa Street, Suite 4400, Los Angeles, California, beginning at 10:23 A.M. and ending at 11:53 A.M. on Tuesday, October 7, 2003, before LORI SCINTA, RPR, Certified Shorthand Reporter No. 4811.
INDEX
WITNESS: EXAMINATION JOSHUA PENN, M.D. Volume 1BY MS. HOWE 6
EXHIBITS (None) 9 INFORMATION REQUESTED (None) 12 REFERENCE REQUESTED (None) 15 INSTRUCTION NOT TO ANSWER (None) 18
THE VIDEOGRAPHER: Good morning. Here begins videotape No. 1 in the deposition of Joshua Penn, M.D., in the matter of In Re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability litigation, also in the matter of Annette Kerr, et al., versus American Home Products Corporation, et al., in the United States District Court for the Eastern District of Pennsylvania, the case number of which is CA-03-20014.
Today's date is October 7th, 2003. The time is 10:23 A.M.
This deposition is being taken at 777 South Figueroa Street, Los Angeles, California and was made at the request of the law offices of Arnold Porter.
The videographer is Stan Beverly here oh behalf of Esquire Deposition Services.
Would counsel and all present please identify yourselves and state whom you represent.
MR. DALTON: This is Henry Dalton of Keller, Keller Dalton of Oklahoma City. We're here on behalf of the Plaintiffs Angela Hartley, Annette Kerr, and Roberta Raines.
MS. HOWE: Keri Howe for Wyeth.
MS. SCHOVANEC: Sandy Schovanec with Phillips McFall for Wyeth.
THE WITNESS: Joshua Penn.
THE VIDEOGRAPHER: Would the reporter please swear in the witness.
JOSHUA PENN, M.D., having been first duly sworn, was examined and testified as follows:
MR. DALTON: I just want to make this clear, for our stipulations. This is not a trial deposition but a discovery deposition, that we're reserving all objections until the time of trial and that this witness has not been endorsed by either side as a Rule 26 expert. I will therefore be making any objections. I didn't have a standing objection, if we get into Rule 26-type opinions regarding causation and whatnot.
Is that agreeable with the parties?
MS. HOWE: Absolutely.
EXAMINATION
BY MS. HOWE:
Q Good morning, Dr. Penn.
A Hello.
Q Mr. Dalton wont over some of the ground rules of a deposition before we got started.
Do you recall that?
A Yes.
Q And do you understand those rules?
A Yes.
Q Okay. If at any time you'd like to take a break, let me know and we can go ahead and take care of that.
Okay?
A Thank you.
Q Would you please state your full name for the record.
A Joshua Penn.
Q What is your business address?
A 250 North Robertson Boulevard, No. 601.
Q Have you given a deposition before, Dr. Penn?
A Not of this type.
Q Have you given a deposition of any type?
A I have given come deposition as an expert witness.
Q Okay. So there has been a situation where there has been a court reporter and people asking you questions on the record?
A Yes.
Q What kind of case were you named as an expert witness in?
A It was a case of — it was a cardiology case. I can't remember very much about it. It was quite a while ago.
Q But you were the expert witness?
A Yes.
Q For the plaintiff or the defendant?
A Plaintiff.
Q Do you recall what the person's injury was?
A The person passed away —
Q Okay.
A — after having had a heart attack and a stroke.
Q Was it a medical malpractice case?
A I believe so.
Q When did you give that deposition?
A In the year 2002.
Q Did you testify at trial, as well?
A No. I have never testified at a trial.
Q Did that case settle?
A I believe it did.
Q Have you given any other deposition?
A I don't believe so.
Q Have you been named as an expert witness in any other case?
A Yes, I have.
Q How many cases?
A Approximately four over the last five years.
Q What kinds of cases were those?
A They were all cardiology cases. One involved a claim for disability, one involved a two that I can recall involved a wrongful death and one involved an adverse outcome after an angiogram.
Q Were you testifying on behalf of the plaintiffs in each of those cases?
A No. On at least one occasion I was testifying on behalf of the defense.
Q But you never gave depositions in those cases?
A I gave interviews with the lawyers, but I don't believe I gave formal depositions. Perhaps I did once several years ago.
Q Another deposition?
A Perhaps so.
Q Was that in one of the wrongful death cases?
A I believe so, yes. Actually, I believe it was the adverse-event-following-angiogram case.
Q Have you ever given a —
A Can I change that, again? I'm sorry. Now I do remember.
Q Okay.
A It was actually a case of death by from pericardial tamponade.
Q That was the case you gave a deposition in?
A Yes, I did.
Q Have you ever given a deposition in a case involving fenfluramine or dexfenfluramine?
A No.
Q Would you believely describe your education for me.
A I went to college at Brown University. I went to medical school at Brown University. I then did three years of internal medicine at the Mt. Sinai Hospital in New York and then three years of cardiology at Mt. Sinai Hospital in New York,
And then I came to — returned to California and have been in practice here since 1993.
Q What year did you receive your medical degree from Brown?
A 1986.
Q And then did you proceed directly into your internal medicine and cardiology training?
A Yes, I did.
Q So you would have finished your training in 1993?
A No. I finished in June of 1992. I took a year off. I had just been married and I took a year off and I did not do medicine during that year.
Q Then you started your practice here in California in `93?
A I joined a practice in 1993.
Q Are you licensed to practice medicine in any other states besides California?
A I have previously been licensed to practice in the states of New York and North Dakota but, to tell the truth, I'm not sure if those are active or not.
Q If anything, you've just let them lapse because you're not working there —
A — because I'm not working there.
Q Do you have privileges in any hospitals?
A I currently have privileges at Cedars-Sinai Hospital in Beverly Hills and Midway Hospital in Los Angeles.
Q You're board-certified in internal medicine; is that correct?
A Yes.
Q Are you board-certified in cardiology?
A Yes.
Q When did you receive your board certification in cardiology?
A Probably — probably in 1991 or `92.
Q And that's still current, correct?
A I'm actually in the process of re-certification.
Q What does that mean?
A That means that you have to take an exam, which I have taken and passed, and they also have what they call modules that you have to fill out and send in. And so I've done the exam. There is a total of four or five modules. I have completed two of them, and so I guess I have two or perhaps three more to go.
Q So currently is your board certification — is it currently in place?
A I don't know if it lapses or it just continues. You'd have to ask the Board.
Q The Board of Medical Examiners here in California?
A Or nationally
Q Okay. When did you take the exam?
A For cardiology?
Q Yes.
A Again, that would be either `91 or `92.
Q Okay. And then did you just take it again recently?
A Yes.
Q Okay. When was that?
A That would have been in May of — probably May of this year.
Q Is that just routine, that cardiologists have to be re-certified at certain points in their career?
A You know, the rules changed right about when I took the exam. It used to be that there was no certification. For example, in internal medicine, I don't have any re-certification. But in cardiology, now you are required to re-certify every 10 years.
Q And that's the process you're going through now?
A Right.
Q Are you board-certified in echocardiography?
A No.
Q Any other board certifications?
A No.
Q Are you familiar with the levels of training in echocardiography I, II, and III?
A Yes.
Q Do you know what level you are?
A I believe I'm level III.
Q Are you a member of the American Society of Echocardiography?
A No.
Q Where are you currently employed?
A Currently, I'm self-employed.
Q Okay. At your own practice?
A Yes.
Q What is the name of that practice?
A Joshua Penn, M.D., a medical corp.
Q How long have you been self-employed there?
A Since July of 2000.
Q Would you describe your employment history from `93 when you came to California until July of 2000.
A I was an employee of Cardiovascular Medical Group of Southern California.
Q What kind of practice was that?
A A single-specialty cardiology group. There were seven or eight doctors there at that time.
Q And why did you make the switch over to your own practice?
A I was happier in solo practice. The group and I had some disagreements regarding a number of issues, and it was appropriate at that time for me to go.
Q Describe your current practice.
A My current practice is located at 250 North Robertson. I am a noninvasive cardiologist, which means I see patients in the office, in consultation and in follow-up and I do a variety of diagnostic testing in the office, the — which would include echocardiology, stress echo, Holter monitoring, EKGs.
I also see patients in the hospital — both hospitals that I mentioned earlier, again in consultation and follow-up.
I do some hospital-based procedures, although I do them less frequently now, such as Swan-Ganz catheter, pericardial centesis.
But, again, these procedures have become uncommon in my practice in the last few years.
Q You mentioned that you read echocardiograms in your practice. Approximately how many do you read per week?
A There is another aspect of — which isn't directly my practice but which I do read echos for i-Cardio, which is an echocardiography company.
Q Let me stop you there. I do want to ask you questions about i-Cardio in a bit.
In your clinical practice, how many echocardiograms do you read per week?
A Per week?
I would say 30.
Q How long —
A Maybe 20 to 30 would be a better — per week.
Q You are the only cardiologist in your clinic, correct?
A That's true.
Q Okay. How long does it take you to read an echo in your clinical practice?
A Just to read the echo would take five to ten minutes.
Q Now, are these echos in your practice performed in your clinic?
A They are.
Q They're performed by a sonographer that is employed by you?
A The sonographer at this time is actually employed by Cedars-Sinai Medical Group, but I know. him. And he and the machine is also owned or leased by Cedars-Sinai Medical Group, but I read the echos.
Q You have worked with the sonographer for a while?
A Yes.
Q And you trust his or her work?
A Yes.
Q How long does it take to perform an actual echocardiogram, in practice?
A The sonographer?
Q Yes.
A My sonographer is perhaps quicker than average. I would say it takes him for a — for an uncomplicated resting echo would probably take him 15 minutes, maybe 20.
Q Now, you mentioned that you also read echocardiograms for i-Cardio?
A Yes.
Q What kind of organization is that?
A I-Cardio is a mobile echocardiography company. They have techs in a variety of places and they perform echocardiography in many locations around the country.
And they — typically, those echos are acquired digitally and then they're sent to one of the reading cardiologists, myself included, for reading.
Q Does i-Cardio perform echos on individuals who are involved in the diet drug litigation?
A i-Cardio has, yes.
Q Do you know if that is the extent of their practice? Is that all they do?
A No. i-Cardio was formed in July of 2000 before any — anyone connected with i-Cardio knew anything about Fen-Phen. It was set up as a mobile digital echocardiography service, and it operated in that fashion without doing any Fen-Phen work at all until somewhere in the middle of 2002.
And, at that time, we, i-Cardio, began to do some Fen-Phen work. As you know, the Fen-Phen work — we got into the Fen-Phen work later than many other people. And then, of course, as you know, the echo portion of that whole case stopped on January 3rd of 2003.
And, so, i-Cardio continues to operate doing clinical echos, obviously not doing any Fen-Phen work.
Q You keep saying "we." Are you an owner of i-Cardio or involved —
A Yes.
Q Are you the sole owner?
A No. I am the principal owner.
Q Okay. Who else owns i-Cardio?
A There are some stock options to some of — to at least one employee.
Q So i-Cardio got started just when you started your individual practice; is that correct?
A That's correct. That was one of the motivations for leaving the practice, is I wanted to pursue other sorts of enterprises like this and found it difficult to do that in the context of a group.
Q Does i-Cardio perform diagnostic tests on patients involved in any other kind of litigation?
A I don't know. What I mean by that is our echos could in theory be. To my knowledge, they have not been. That's really the right answer. They could in theory be used by someone pursuing some action or another but I'm not aware of anyone who has contacted us specifically for that purpose.
Q What percentage of i-Cardio's work was occupied 3 by Fen-Phen from mid-2002 to January 2003?
A Oh, I'd say quite a bit. The volume was — was very heavy.
As a percentage, I would be — it would be a little bit of a guess. I would guess 70 percent, something like that.
Q Now, you mentioned that you were one of the reading cardiologists for i-Cardio.
A Uh-huh.
Q Are there others, as well?
A Yes, there are.
Q And who are those?
A Okay. There's Dr. Tina Wu, Dr. Jacques Benisty, Dr. Paul Phillips, Dr. Bruce Kimura, Dr. Harry Peled, Z.J. Xu. Last name, X-u.
There is also Jake Patel and Michelle Hamilton.
I think that's everybody.
Q Are those — those are all cardiologists, I assume.
A Yes.
Q And do they have any ownership interest in i-Cardio, or are they simply people who you refer or send echos to for interpretation?
A They do not have an ownership interest in i-Cardio.
Q Are they paid by i-Cardio to read these echos, or are they paid by law firms?
A They were paid by i-Cardio to read the echos.
Q How did i-Cardio get involved in the Fen-Phen litigation?
A I believe a law firm named Fleming Associates contacted us and asked us to do some echos for them at a location in Los Angeles.
They apparently had clients — they're a firm in Texas, I gather, and they apparently had clients in Los Angeles and asked us to do echos for them.
Q And you agreed?
A And we agreed.
Q Okay. And since then have you worked for other attorneys, as well?
A We have.
Q Such as?
A We work for Tim Sates Associates. We work for Baron Budd, Levin Law, Cuddy Latham, Johnson Barton.
There are others, but I can't recall their names.
Q Was it just sort of. through word of mouth that you came up with this other business?
A Yes. There is a — i-Cardio does have a full-time marketer whose primary job is to market the services to clinical entities. However, he may have contacted law firms, also.
Q What is his name?
A Kip Theno.
Q How many employees does i-Cardio have?
A If you include independent contractors — most of the techs are independent contractors —
Q I see.
A — but if you include those as people who work with i-Cardio, it would be nine, not counting myself —
Q Okay.
A — or 11, if you count myself and my wife, and we do perform other functions for i-Cardio.
Q Is your wife a doctor, as well?
A No. She's a dentist, actually.
Q What is her role in i-Cardio?
A She primarily does the bookkeeping and some of the billing and, you know, bank checks and that sort of thing.
Q Of the nine remaining employees, if you will, how many are echocardiographers?
A Six.
Q And what are the other three positions?
A One is Kip Theno, this marketer who I mentioned —
Q Okay.
A — one is Karma Pemba, who essentially is the office manager, and one is Alan Hammelstein, who is essentially the administrator of i-Cardio.
Q Did all six of the sonographers perform echos on Fen-Phen patients?
A No. We have hired one — we've hired two of the echocardiographers since the Fen-Phen finished.
Q Uh-huh,
A One of them happened to have done Fen-Phen but not for us. The other, as far as I know, has no experience in Fen-Phen.
Q Do you know where the other — do you know whether the one had prior experience with Fen-Phen?
A She was with a company called "EchoMotion."
Q What was her name?
A Gail Flynn.
Q You described i-Cardio as a mobile diagnostic service. Does that mean you go to hotels or various locations —
A We do go to various locations. The machinery, the actual echo machine, is very small. It is only about 19 pounds, and so it's very mobile and portable. And so we do go wherever the need is.
Q And in the Fen-Phen litigation, was it typically hotels or attorneys' office?
A It varied. It was doctors' office sometimes. It was hotels sometimes.
I would say hotels is probably the majority, but it was really at the discretion of the client.
It's really — we, typically, were not in the business of setting up hotels or anything. Typically, the client would set up the physical plant and the — arrange for the you know, the clients, the patients, whatever you want to call them, would come. And we would just come to do the echos. But some of them were done in hotels, if that's the question.
Q What kind of machine did you use for the echos?
A The Acuson Cypress.
Q Did you also bring beds for the patients to lay on for the echos? Or what else was provided as part of your service?
A We brought everything associated with the machine: The probes, and electrodes and gel and things like that. We brought rolls of paper for the tables.
Again, Karma handled those arrangements. My understanding is that typically the hotel would supply some sort of examination table.
I know that — would supply some sort of examination table. And I don't believe that we — or, actually, that's not true.
On occasion I know that we rented hospital beds to put in there for a few days, whatever may have been required.
Q Were you ever actually onsite when echos were being performed?
A Sometimes, yes.
Q And in what situations?
A Weil, typically, in the earliest — in the early appointments when we would do these, particularly if they were in the Los Angeles area. And I went down to one hotel near Los — LAX to really see what was going on, see if the setup was going to work, see that the techs had what they needed, see that the patients were properly taken care of because it was — that was the first time we had done anything in a hotel and there was a lot of unknowns for me, so I went down to look and see that it was set up properly.
Later, either Karma would go or Michael Crowley, my chief tech would go. And then later still other techs that had already worked with us in Fen-Phen for a period of time would, be able to go.
Q And were you —
A Particularly if they weren't in Los Angeles.
Q Were you comfortable with the arrangements you saw on your first visit?
A I was.
Q Approximately how many times after that first visit were you actually onsite?
A I would say a few.
Q Okay.
A Between two and eight is a few.
Q Okay. I assume that i-Cardio performed echocardiograms in areas outside of Los Angeles, as well.
A Yes.
Q Where else?
A Many cities across the country. That would include a large number of cities. Seattle, Oklahoma, Portland, some cities in Florida, Philadelphia. There are more cities, but I can't remember all of them.
Q That's a good start. Approximately how many echos has i-Cardio done for the Fen-Phen litigation?
A i-Cardio probably performed — we never counted.
I would guess a few thousand and that would be 3 to 6,000, would be my best guess.
Q How many sonographers were typically on location?
A One, two or three, depending on the volume and the need.
Q I understand that you were on location a couple of times with these sonographers.
At any other time were there cardiologists onsite with the sonographers?
A Typically, no.
Q Were the four sonographers who performed Fen-Phen echos for i-Cardio ones that worked with you before you were involved in the litigation?
A Some had worked for me before and others were added as we ramped up to meet the demand.
Q Okay. Were there any sorts of qualifications 23 that you required for the sonographers?
A We hired almost all of our sonographers based on word of mouth, meaning we almost always knew them before we hired them, so we were familiar with their echocardiography and their abilities.
Most commonly, one of our techs would know another tech who was well qualified who had experience and who could get the kind of images we would want.
Sometimes, if a tech didn't work out well, we would ask them — we would not continue with them.
Q Did that happen with one of the techs who did Fen-Phen echos?
A There was no tech who performed echos so badly that we asked them to leave.
We did sort of choose not to rehire some techs. Those were usually based on issues not relating to the technical quality of the echo. It was usually relating to things like punctuality or schedule flexibility, or things like that.
Q Okay. Was there any training program the techs had to go to before they were sent out onsite to do Fen-Phen echos?
A The techs that had been with us before learned about the requirements of the Fen-Phen echo with me. And, subsequently, we had several different kinds of training that would go on.
Michael Crowley, again, my chief tech, would train some of the techs.
We also hired some outside techs from EchoMotion to train some of our newer techs.
And we also, once MaryAnn became very — she was basically identified as the best of our techs by the training techs that we had hired from EchoMotion. And after that, she would also train the techs and that would mean typically that they were onsite with them the entire time.
Q What is MaryAnn's last name?
A Collier.
Q Who were the techs that you hired from EchoMotion to do training for you?
A Carol Mortier.
I misspoke. I didn't mean to say plural. It was really Carol Mortier who helped us.
Q Okay.
A I knew Carol for years from before the Fen-Phen. She and I had worked together at Cardiovascular Medical Group, so I had known her for years. Then she became involved in Fen-Phen echos through EchoMotion and had done work with them and had been trained with them.
And so when we started to do — when it seemed like there was going to be a fair amount of work to do in the Fen-Phen arena, I asked her to spend some time with my techs on the site making sure — you know, looking at them, viewing their echos, making sure they did what they were supposed to do and that the echos were done the way they were supposed to be.
Q Did i-Cardio actually hire Ms. Mortier?
A Yes.
Q Okay. So she stopped working for EchoMotion and switched over to —
A It didn't really work that way. She worked on a per diem basis, so she had some days free and so we hired her for those days.
In between working with us. she would continue to do days for EchoMotion.
Q So she wasn't conflicted out from working with you at all?
A No.
Q What kind of training process would the techs actually have to go either with — through with Ms. Mortier or Mr. Collier [sic] or yourself?
A Well, they would have to go through the protocol and understand the — it was actually several things. Typically, they were already — in all cases, they were already experienced echocardiographers. So we understood that they knew what angle — the proper setup of their machine, the proper angles, the proper windows, and all of the — what we would consider basic echocardiography skills, and that was reviewed with Michael Crowley, typically.
Q At a sit-down-meeting type thing?
A Either a sit-down meeting or, more often, with patients. They would usually bring them to my office. And while we were doing clinical echos, we would have one of the techs there.
Michael would show them how to do it. They we're doing it. It was a typical teaching sort of environment, make sure their windows were good, their angles were right, to make sure that they understood the proper, you know, setup and knobs of the Cypress.
Many of them had had experience on the Cypress but not all of them, and so those that didn't have experience on the Cypress got trained on that specific machine.
And then we would spend time on the special requirements of Fen-Phen, which were these — typically revolved most intensively around measurements of mitral regurgitation and aortic regurgitation. Left atrial measurement was also reviewed and —
Q Dimension of the left atrium?
A Right, because many of the things that one does for Fen-Phen are not typically done in a clinical echo. So those things that are new or different or not normally done were reviewed not usually in the classroom setting but usually at the patient's bedside with the patient
Q So all of the techs before they went out in the field had some sort of training session in your office where the —
A It was either — in my office. Sometimes — several different possibilities. Some of them were trained in my office before they went out. Some of them came to us from EchoMotion, already having done hundreds or in some cases thousands of echos for EchoMotion. In that case, we did not typically engage in a training session.
And some were trained at the Fen-Phen sites.
Q Who else from EchoMotion came over to your group?
A In terms of — it was really only Carol Mortier. I had conversations with other people in EchoMotion. Particularly when we were — when we were getting started, we really had conversations with several different people to try to understand what exactly was the requirement.
Q Does that include Mike McElroy?
A I definitely had many conversations with Mike McElroy and I appreciated his expertise.
He had been doing Fen-Phen long before I started and I really regarded — I regarded it then and I regard now him as the real expert in Fen-Phen from a technical point of view.
Q Okay. So Ms. Mortier and I guess Ms. Flynn, those are the only two techs that you ended up working with that had previously worked with EchoMotion?
A No. There were others that we had hired on a — that we hired on a per diem basis during the Fen-Phen work that were trained by EchoMotion.
Q And that's in addition to the — i-Cardio's sonographers?
A Right. There were those people who did not want to work for us full time and who wanted just per diem work, and we hired them per diem sometimes.
Q How many of those individuals were there?
A Probably about four or so.
Q Do you recall any of their names?
A I recall Donna Yap and there were a couple more down in San Diego, but — I mean I could get the names. But I remember Donna off the top of my head.
Q Did you ever speak to a woman named Marti McCullough?
A Possibly. Can't remember.
Q Doesn't ring a bell, though?
A No.
Q Okay.
A Oh, and Kanoe Williams should by mentioned, too. I know that she did work for EchoMotion.
She also did her own — she sort of started her own company. I don't know what she did exactly. I don't want to say. But I know she did some independent work for Fen-Phen and so she helped us also with some training and some per diem techs when we needed them.
Q How much were the per diem techs paid per day?
A My recollection was that they were paid $50 an echo and sometimes there was sort of a minimum payment, maybe a thousand dollar minimum, or something like that.
Q For a week?
A No, for a day.
Q Oh, okay.
A Depending if they had to travel, you know, and things like that.
Q So they were paid on a per echo basis with a minimum?
A Right.
Q Okay.
A Sometimes there was not a minimum but if they had to travel and stuff, we gave them . . .
Q And approximately how many echos did each sonographer perform per day?
A It would vary between — it would depend on the tech, too. Some were just a lot faster than others.
I would say between 15 and 25 was common.
Q And you mentioned earlier that an echo in your clinical practice usually takes about 15 to 20 minutes?
A Right.
Q Was it about the same for the Fen-Phen echos?
A I think so. Sometimes it would be a little bit shorter because they were focusing — well, the vast — they were focusing on specifically the mitral regurgitation and the aortic regurgitation, but I think that's a fair estimation.
I think we would schedule them three an hour or sometimes four, but the client often determined that.
And I took my cues there also from Mike McElroy, since I really didn't have any experience in how it runs. I listened to him, because he had experience.
Q So sometimes the client — and by "client," you mean the attorney firm would ask you to perform a certain number per day or —
A We would try to get a sense of how many there were. We needed that, for example, to know how many techs to send.
Q Okay.
A If they had, you know, many echos, you couldn't do it with one tech. We'd send two or three, depending on the need.
They would overbook to some degree because there was always no-shows, and sometimes a tech would come and there would be four people would show up the whole day and sometimes the tech would come and they'd end up staying until very late because more would come.
So it was never that predictable but we tried to the extent we could know how many people would show so we could send the right number of techs.
Q Now, you mentioned with the Fen-Phen echos you were focussing on aortic and mitral regurgitation, correct?
A Not exclusively, but that was a big part of it.
Q Okay. And then did you consider that i-Cardio was performing full clinical echos on the Fen-Phen patients or something less than that?
A I would say that we were performing a focused and directed echo exam.
If there were other — we did definitely find other echo abnormalities that were not related to Fen-Phen issues. And when would found them, we would make a note of them, or we would put them in the report is what I mean.
But we — any echo is done based on the clinical indication. For example, if you're looking specifically for an atrial septal defect, you direct your examine and focus your examine in that way.
You might, for example, add a bubble study and you might do different things. Since we knew these were Fen-Phen echos, the focus was on certainly on the aortic and mitral regurgitation, as well as pulmonary pressure, because we knew that that was the purpose of the echo.
Q Was the purpose of the echo are you familiar with the term "FDA-positive"?
A Yes.
Q And that's mild or greater aortic regurgitation and moderate or greater mitral, correct?
A Yes.
Q Was the purpose of the echos to determine whether these patients were FDA-positive?
A The purpose of the echo was to determine if there were regurgitant lesions and to what extent those were.
In my report, I would typically classify, them as FDA-positive or not. Again, that was something I would not do in a regular echo because it's not part of the normal reporting. But since we all knew that we were there for that purpose, then if they met those criteria, then we would report it as FDA-positive.
Q What do you mean you all knew that you were there for that purpose?
A In other words, the purpose of the echos was to determine if there were regurgitations in these patients or if there was elevated pulmonary pressures and to assess left ventricular function and, if so, to what extent or degree those were present.
Q And you understand that those were factors that may or may not enable a patient to sue Wyeth, correct?
A We understood that.
Q Or to bring a claim for benefits against the trust?
Did you understand that, as well?
A Yes.
Q Were the echos performed regardless of how the echo was going to be used by the patient and his or her lawyer?
A We made no differentiation.
Q You mentioned that Mr. Fleming was the first attorney to contact you.
Did you have a meeting initially with him or
A We did not meet face to face. We did have face-to-face meetings with Tim Bates and his associates. He came out to California.
I can't exactly remember which meetings happened before one or before the other. I know we actually performed echos for Fleming before we performed any for Bates, but one or the other of those meetings took place.
Q Okay. Did Mr. Fleming or Mr. Bates ever talk to you about the protocol that was to be used —
A Yes.
Q — for the Fen-Phen echos?
And what did they tell you?
A We actually reviewed the Green Form.
Q Okay.
A And we understood really, what they wanted to be sure was that we understood the regurgitation measurements, for example, were not visual estimations and were not clinical estimates, that they really were just specific numerical criteria.
And they wanted to make sure, for example, that, you know, these — they were documented well on the tape and that they were reported well on the tape and those kinds of things. And those — those were the focus of the discussions.
Q You said they asked you to sort of differentiate between clinical criteria and — and I 4 assume it's the Singh criteria you're talking about.
A Yes. Weyman, Dr. Weyman?
THE REPORTER: I'm sorry?
THE WITNESS: Weyman.
BY MS. HOWE:
Q Dr. Weyman? LO A Yeah.
Q It's my understanding that when cardiologists are quantifying degrees of valvular regurgitation, they typically eyeball a jet and take into account a number of factors and then give them trace, mild, moderate rating.
Is that correct?
A On a clinical echo, yes.
Q And that's something you did not do in the Fen-Phen echos; is that right?
A That is correct. We relied on quantitative measurements.
Q Okay. And for mitral regurgitation, that was the regurgitant jet area to left atrial area ratio?
A Yes.
THE REPORTER: Wow. You'll have to say that slower. "Regurgitant" —
(Discussion off the record.)
BY MS. HOWE:
Q And for the aortic, it's the jet height —
A Jet height versus LVO — over LVOT height, yes.
Q Did they give you any — besides the Green Form, any other written material discussing the protocol that would be used in the cases?
A I don't believe the lawyers did. I may have gotten some materials from EchoMotion or from other cardiologists that I spoke to, but I don't believe that the lawyers gave us any other written information.
Q And did you ever discuss i-Cardio's protocol with any other lawyers besides Mr. Fleming and Mr. Bates?
A Oh, with other lawyers who were clients, yes, we did.
Q And did the protocol vary at all by the lawyer or client?
A No.
Q It was the same for all Fen-Phen patients?
A Same.
(Discussion off the record.)
BY MS. HOWE
Q You mentioned a list of cardiologists who read i-Cardio tapes. Were those cardiologists recruited by you and i-Cardio or did the lawyers bring in their own cardiologists to have tapes read?
A No. They were recruited by me and i-Cardio.
Q So it was part of i-Cardio's service that you would perform the echo, have it interpreted and give the report to the lawyer?
A Sometimes
Q Okay.
A If the client wanted someone else to read, we would just provide them with the study and they would have their own readers.
But if they wanted us to do the reading, as well, then we would do that too.
Q How much did i-Cardio charge if you were just going to perform the echo?
A In the neighborhood of $250 per study.
Q And if you were going to have it interpreted, as well?
A In the neighborhood of $450.
Q Now, you personally reviewed a number of these echocardiograms and created reports, correct?
A Yes.
Q Do you know approximately how many Fen-Phen echos have you interpreted?
A Well, I interpreted echos that were done by i-Cardio and I also read echos that were done by other services or people.
Q Okay. How many did you read for i-Cardio?
A I would estimate around 2,000.
Q And for those 2,000, did you charge I guess $200 for your interpretation?
A For those we didn't charge separately. We charged a single fee of 450.
Q Okay. How many echos have you read in addition to the ones you read for i-Cardio?
And I'm talking again about Fen-Phen patients.
A Another several hundred, maybe a thousand.
Q Okay. You said that these were echos performed by other companies.
A The lawyers would typically supply us with the studies and the worksheets, but we didn't always — we rarely knew who — we rarely knew the people specifically who had performed them.
Q Do you know if any of the tapes were — any of the echos were performed by EchoMotion?
A I know that some of them were.
Q You said that they provided the tapes and the worksheets. Are you talking about sonographer worksheets?
A Usually, yes. Sometimes they provided worksheets. My recollection is almost always they did. 3 Q Would you rely on those worksheets when you were making your own interpretation?
A Not exclusively. Partially, yes. But particularly in the measurements of mitral regurgitation, aortic regurgitation and left atrial size, we would very commonly not be in agreement with the tech worksheets and would put our own numbers in.
Q What were some of the reasons that you were not agreeing?
A There were a couple of different kinds of disagreements: One is when they would freeze a regurgitation and measure it, we would believe that their measurements weren't accurate.
For example, they would think that the height of the aortic regurgitation was 0.3 and they would measure it at 0.5, for example. And we felt that the calipers were, for example, going outside the boundaries of the color.
Q All right.
A That would be —
Q Were there other situations where a sonographer was measuring the jet height too distal from the orifice of the valve?
A Sometimes that would occur, also.
Q Now, when you strike that.
Were there cases where you found that the techs had overtraced the regurgitant jet area?
A Yes.
Q Were there cases where you found they had undertraced the left atrial area?
A Yes.
Q Are you familiar with the concept of backflow?
A Yes.
Q What is that?
A Backflow refers to very brief periods of mitral regurgitation that has to do with mitral closure and also swirling in the left atrium from left atrial inflow, and those can look like mitral regurgitation but are not truly regurgitant lesions.
Q Backflow Is something you would see in very early systole, correct?
A Typically, yes.
Q And it would last less than one-tenth of a second at the beginning of systole?
A Yes.
Q And you would expect to see — you would not expect to see turbulent alias flow as part of backflow?
A Right.
Q It would be low velocity or laminar blue-colored flow?
A Usually, yes.
Q And there are instances where sonographers had 5 selected backflow and used that to measure mitral regurgitation?
A Yes.
Q Okay. When that occurred, did you redo the planimetry or measurements yourself?
A There were many cases, probably hundreds, where I re-did the planimetry myself when I was unsatisfied with the measurement for whatever — for any of those above reasons that you talked about.
On videotape, it was more difficult to do, since planimetry really isn't available.
The — there were many occasions where I also reduced the amount of regurgitation to zero where I felt that the whole jet they had measured was not a genuine regurgitant lesion, and so I reported the mitral regurgitation as zero or trivial and just discounted the whole measurement.
Q Okay. The thousand — excuse me, approximately 1,000 echos that were sent to you from other companies, were most of those videotapes or CDs?
A It was a mix.
Q So the CDs you were able to re-do the planimetry?
A Yes.
Q And do you —
A Sometimes they were on magneto-optical disks, which is the same, meaning it's still digital, similar to a C.D.
Q When you did re-do the planimetry, did you record that work in any way?
A Only on my worksheet
Q Okay.
A my report sheet.
What I tried to do, instead of just generating a percentage number for mitral regurgitation, I tried to include the calculation, meaning I would write down the actual mitral regurgitant area and the left atrial area.
Q Okay. But we wouldn't — there wouldn't be any document that would show us the planimetry you made at that time on the screen?
A No. I'm not aware of any way to alter that 21. original echo.
Q Were there any cases where you felt the echocardiogram was so poorly done that you suggested it be redone on a patient?
A Yes.
Q Did that occur with respect to the i-Cardio echos and the echos that were sent to you from outside?
A I don't know if it occurred with any of the i-Cardio echos. The cases I'm remembering were typically, on videotape. Perhaps they were a dub or other reasons where the quality was just difficult.
Q And would you let the lawyer know that those should be redone?
A Yes.
Q And do you have any personal knowledge that those echos were in fact repeated?
A I have no knowledge.
Q Okay. How much did you charge lawyers to read an echo when they weren't from i-Cardio?
A Between 150 and 225.
Q Did it just vary by client?
A It varied by client.
Q Okay.
A Also, it varied by what format we received the echoes. Some echos were received
(Beeper interruption.)
THE WITNESS: — in Cypress format and had to be converted to DICOM format to be read, and so there was a charge for that conversion.
Could we take a one-minute break?
MS. HOWE: Absolutely.
THE VIDEOGRAPHER: The time is 11:12 A.M. and we're going off the record.
(Recess taken.)
THE VIDEOGRAPHER: The time is 11:26 A.M. and we're back on the record.
BY MS. HOWE:
Q Did i-Cardio create sonographer worksheets on the Fen-Phen patients?
A Typically, not. We typically had the sonographer enter the data directly in the echo on the study.
Q Were there cases where they did create worksheets?
A Yes.
Q In what situations would a worksheet be created?
A If a tech wasn't comfortable entering the data digitally or if they were timed — they were under time pressure and found it faster to write it down, sometimes they would include tech sheets with the written-down measurements.
Sometimes if the tech wasn't familiar with the digital portion of what we do and were a per diem tech, they were more used to writing it down, so we would have it written down.
Q Was the preference, though, for them to record it digitally?
A My preference was that, because it was — you couldn't lose it.
Q Right. Now, I have looked at the echos on these plaintiffs we're here to talk about today, I don't see any of the Singh measurements directly on that C.D.
Would that indicate they must have done a worksheet?
A Possibly.
Q Okay.
A I'll have to see.
Q We'll look at them later.
Of the 3 to 6,000 echos that i-Cardio did, what percentage were sent to cardiologists for review by i-Cardio —
A Well, we —
Q — versus —
A — versus —
Q — versus the lawyer sending it to the cardiologist themselves?
A The big majority were done by i-Cardio readers.
Q Okay.
A Probably 90 or more percent.
Q Okay. Did you also fill out Green Forms —
A Yes.
Q for patients?
Approximately how many Green Forms have you filled out?
A A few hundred.
Q Would it be over 500?
A It's possible.
Q Okay. And did you fill out Green Forms for any particular attorney or were there numbers?
A Oh, any attorney.
Q Were the vast majority done for any one particular attorney?
A There are some attorneys for whom we did more work than others. The two biggest accounts we had I think were Bates and Johnson Barton.
Q How long did it take you to fill out a Green Form?
A Meaning I've already read the echo and done the report?
Q Yeah.
A Maybe 10 minutes. That's assuming it was — it was unremarkable.
Q What do you dean by that?
A Meaning chat the — that 1 had all of the history data that I needed right there and that there was nothing unusual in the history. 4Q On the Green Form, you're required to rule out certain conditions, correct? 6 A Yes.
Q How is that history information made available to you?
A The lawyer would supply a patient questionnaire that had the relevant questions on it and the patient or the client would fill in the answers and sign the patient questionnaire.
Q Did you ever have medical records available to you on any of the patients?
A Rarely.
Q A handful of cases?
A Correct.
Q And in what situations would you end up with medical records?
A Sometimes I would request them because I wasn't able to tell from the questionnaire what was really happening with the history. And sometimes the lawyer would just send them on their own.
Q But that was in very few cases?
A Yes.
Q Did you charge an additional amount to fill out a Green Form?
A No.
Q That was included in the price for reading the echo and doing the report?
A Yes.
Q How did it work? Would you read the echo, do a report, send it back to the lawyer and then they would send you a Green Form?
How did that process go?
A Well, I just want to say we charged a single fee, because we didn't want anybody, either our reading cardiologist or the techs, to be incentivized to do a Green Form or to create pathology when it wasn't there.
But in terms of how we did it, it depended if the information was there, meaning if the study came and we had the patient questionnaire there at the same time, what I would do is I would read the study, create the report, and fill out the Green Form at one time.
Q Assuming they met certain criteria?
A Yeah. Assuming they qualified for a Green Form, right. If they weren't positive, then they wouldn't get a Green Form.
There were many cases, however, where we didn't have the patent information, so we wouldn't fill out a complete Green Form
What we would often do is fill out that part of the Green Form that had the echo information on it and that was all
Q Would the form then come back to you with a patient questionnaire?
A What our preference was was to have the form — what most of the lawyers did, was that they actually often months later would send back our own report and our own Green Form and the patient questionnaire, and we would finish it.
Q And was there ever a case in that situation where they sent back the patient questionnaire and there was a confounding factor that you found in — and, therefore, described they didn't qualify for Green Form benefits?
A Sometimes. More often, there was confusion on the patient questionnaire and we would have to either call the lawyer or communicate with them somehow that the patient may have answered "yes" or "no" on the same — you know, marked both boxes.
There was different kinds of things that could happen on these patient questionnaires where the information would be unclear.
In some cases, they would mention a previous echo having been done but we I wouldn't know whether it was before Fen-Phen or after Fen-Phen or what the date was.
And, so, very often we would have to communicate with the lawyer in one fashion or another to clarify the information.
Q Did you ever review any other echocardiograms on the patients as opposed to the i-Cardio echos?
A Sometimes I was sent several echos on a single patient but, typically, I was not sent any echo on a patient who was done by i-Cardio.
Q Did you ever meet any of these patients, personally?
A Very few.
Q And the ones that you did meet, now did that come about?
A Most commonly, they would be referred to me for general cardiology follow-up because of their pathology, and I would see them as their doctor.
Q At that point, you became their treating physician?
A Yes,
Q But for all the others, you never examined them you never gave them a medical exam?
A Typically, no
Q Did the Green Forms ever come pre-checked by the lawyer, or filled out already?
A. No.
Q For the patients who weren't sent to you well, let me rephrase that.
A Could we go back to that last question again?
Q Sure.
A I want you to ask that again.
Q What was it? I don't remember.:
(The record was read as follows:
"Q Did the Green Forms ever come pre-checked by the lawyer, or filled out already?
"A No.")
THE WITNESS: Let me modify the answer a little bit.
I never received the Green Form that was all filled out for me.
However, as I mentioned before, in some cases, we were forced to leave a good part of the Green Form blank, because we didn't have the patient history information.
One law firm would have their nurse fill in the remainder of the Green Form based on the — on their interview with the patient and/or patient questionnaire.
So aside from that one caveat, the answer is still no.
BY MS. HOWE:
Q And they would send the completed form back to you for signature?
A I think so. I think that's how they did that.
Q Did you physically sign all of the Green Forms —
A Yes.
Q — that were submitted under your name?
A Yes.
Q So they must have sent it back to you for signature, somehow?
A I would certainly hope so, because it's very possible that I signed the Green Forms having part of it blank when there was no questionnaire, meaning I filled out what I could fill out based on the echo, and then signed it for that information.
Now, there — as far as I know, everybody else would send it back to me half-completed, you know, the same way I gave it to them, with the patient questionnaire so that I filled in the rest of it.
But, as I said, this one film — this one firm filled in the test of it with, their nurse.
Q Okay. And did you ever see those Green Forms again?
A I'm not sure. I had several — I was not entirely comfortable with that plan, and so I had called them on at least two occasions and spoken to them about what they were doing to be reassured that that was the way it was supposed to be done.
It was the first firm we worked with.
Q And who was that?
A That was Fleming. So we didn't really have any experience with the Green Forms at that time. We didn't really know — let's put it this way. There was no directions on the Green Form about how it was supposed to be done.
(Addressing the videographer) Do you need me to stop?
There was no direction on the Green Forms about how it was supposed to be done, so we relied on the 19 experts who were, you know, in our world were those plaintiff attorneys. And so we did it in whatever fashion they told us to do in terms of filling out the Green Form.
So, again, with that one firm, I have to say I don't recall. But I remember we had several discussions about exactly what we were supposed to do and what was the right way to do it and so we just wanted to do what we were supposed to do.
Q I don't want to put words in your mouth. You mentioned you were a little bit uncomfortable with that situation?
A Well, right. Again, I'm not a lawyer and I don't really know what's supposed to be done with these kind of forms.
I was just — what made the basis of my concern was that some law firms were very specific that they had to send the whole thing back to me uncompleted [sic] in its original state and then have me fill it all out.
In some cases, they made me do a whole sort of fresh Green Form, and so that made me wonder why Fleming didn't really seem to have a problem with that.
But I called them and I spoke to their people, and they assured me that it really made no difference and that their, you know, nurse and they had the Green Forms — the questionnaires there and they had interviewed the patients directly and that that was okay.
Q I just want to make sure I understand this correctly.
For Mr. Fleming's law firm, there were situations when you would review an echo, fill out the portion of the Green Form related to the echo, sign your name to the Green Form, return it to Mr. Fleming; Mr. Fleming's firm would fill out the sections about the medical history and you would never —
A And I can't remember whether they sent the Green Form back with the — with the questionnaire so that I could check it or not.
Q Okay. And you weren't paid any extra for filling out a Green Form?
A No.
Q You mentioned that in your clinical practice an echo takes about 15 to 20 minutes
A To perform.
Q To perform.
A Yeah. Michael may say something different. He's the one who actually does them. I'm not typically in the room when they're performed.
Q How many minutes of data is recorded on an echocardiogram that you review in your clinical practice?
A Well, we do digital, so you can't talk about how many minutes.
With the videotapes that I received, they're typically six, seven, maybe eight minutes of tape there.
Q Okay.
A But in a digital there is no timeline, there's just clips and stills, so there is no way to tell how much time data is on there.
Q Can you tell from looking at those loops the start time of the echo in realtime and the ending time based on the first and last loop or frame?
A No, you really can't, because you don't know which clips are saved and which clips are not.
Q I see.
A They may have only saved clips from the middle of the exam and there might be five minutes of exam on either side that you don't see.
Q I'm not familiar with this process as much. Does the sonographer record the entire echocardiogram tape, then select the loops or frames that he wants to for you to review?
A Typically not, no. The sonographer performs the echo. The echo is appears on their screen in realtime, and they capture whatever loops or clips they want —
Q Okay.
A — when they see what they like.
Now, they also can go back at the end of the exam and delete dips that are of poor quality or irrelevant or whatever the story may be, but that's how they do it
Q So there's no recording of the entire echo study anywhere using this procedure?
A No.
Q Okay. How many, loops or frames are typically recorded on one of these digital CDs?
A An entire study is usually between 20 and 30 total frames, but that would include loops and stills.
Q And is there a protocol that you use in your practices to — you know, how many loops of MR to tape, how many loops of aortic regurgitation —
A No. That's really left to the technician. It's really however many they feel they need to do in order to get an image that is optimal.
Q I guess in reviewing the tapes, you're assuming that the sonographer has selected with mitral regurgitation, for example, a representative picture of that regurgitant jet, correct?
A Well, in a Fen-Phen case, they'll typically do many mitral regurgitation captures, and — yeah, that's what they do.
Q In your clinical practice, though, you're trusting your sonographer to select a frame representative of what's going on in that person's heart?
A Yes.
Q Okay.
A Typically, it's loops and clips — loops and stills.
Sorry.
Q Did you know all of the sonographers who were performing i-Cardio echos?
A I knew almost all of them.
Q Okay. Were you — okay. So there were some —
A There were some i did not know.
Q Whose work you were not familiar with? a True.
Q Now, in the Fen-Phen echos, was there a protocol as to how many loops of aortic and mitral regurgitation to record?
A No, just however many the tech feels they needed to do in order to get the best imaging.
Q So if a tech felt that they selected one loop of MR, that's all they felt was necessary?
Your interpretation assumes that they selected something representative from the person's heart?
A Yes.
MR. DALTON: Object to the form of the question.
Go ahead and answer.
THE WITNESS: Okay.
Yes, I always assume that what the tech gave me is the optimal images that they could get.
BY MS. HOWE:
Q Was there a written protocol that you gave to the i-Cardio techs who performed Fen-Phen echos?
A No.
Q Did you give them any literature or studies to review?
A We did have them review some echo studies of — of patients so that they could get a feel for the protocol and understand what they were looking for.
Q Were those examples provided by EchoMotion?
A That's possible.
Q Were they asked to review Dr. Weyman or Dr. Feigenbaum's textbooks at all before they went out into the field?
A No.
Q Were they asked to review Dr. Singh's article?
A No.
Q And are you familiar with an article by Dr. Helmcke who defines the RJA/LAA procedure?
A If that's the article I'm thinking about, probably —
Q Okay. And were they asked to review Dr. Helmcke's article?
A No.
Q Are you familiar with Dr. Perry's article regarding aortic regurgitation?
A I don't think so.
Q So I assume they weren't asked to review it.
A Probably not.
Q On the Fen-Phen echos, were there an average of 20 to 30 loops or frames recorded, as well?
A I would say so.
Q How many seconds of data is usually recorded on one loop?
A One loop is usually one heartbeat, so it depends on the heart rate but if, for example, the heart rate was 60 beats a minute, then it would be one second.
It can be longer. There is a setup to do two or four heartbeats at a time and there is also a setting on the machine to do a two-second loop that's not dependent on the heart rate.
Q In the Fen-Phen echos, were they just getting one heartbeat per loop?
A Most commonly, yes.
Q We talked about how you measured the mitral and aortic regurgitation and also the size of the left atrium in the Fen-Phen echos, correct?
A Yes.
Q Did you also determine ejection fraction?
A Did I also determine ejection fraction?
Yes, all my reports contained ejection fraction.
Q What method did you use to make that determination?
A There — the most common method was by visual estimation.
There are also other calculations that can be made, TISHOLZ, Cube, and Simpsons. Sometimes the techs did those, and sometimes they didn't.
But the majority of the time, as is common in clinical practice, we, all of us, relied on visual estimation of ejection fraction.
Q And that's sort of an eyeball method?
A Yes.
Q I'm sorry. You have to say "Yes" or "No."
A I keep doing that. Sorry.
Q Did you also grade pulmonic and tricuspid regurgitation as part of the Fen-Phen echos?
A Usually not.
Q Did you look for any congenital or structural problems in the Fen-Phen echos?
A Yes.
Q Any ones in particular?
A Well, particularly those that might involve the aortic or mitral valve. The most common thing we would look for would be bicuspid aortic valve or other congenital aortic valve abnormality.
With the mitral valve, actually, the most common abnormality was previous mitral replacement, so we would look — or note that.
Very rarely there can be cleft valves or other mitral congenital problems, but those are usually associated with other abnormalities such as ASD.
We did find a few ASDs during the Fen-Phen echos.
Q And would you have noted those on your reports?
A Typically, yes.
Q What view on the echocardiogram allows you to see an ASD?
A There are several views that can show you the ASD. Apical four chamber can show you. The most commonly helpful is subcostal.
Q Was a subcostal view taken in the Fen-Phen 24 echos?
A Typically, yes.
Q Is that at the end of the study, typically?
A Usually, yes.
Q Can you estimate what percentage of diet drug patients you were finding to be FDA-positive?
A That would be hard. Of the ones I read, taking all comers, I would guess between 10 and 20 — maybe 10 to 20 or a few percentage points more.
Q Did any lawyers ever talk to you about what FDA-positive rate you should be looking for?
A No.
Q Did you make any efforts to track the rate of FDA-positive patients you found?
A No.
Q Did i-Cardio?
A No.
Q For your echo reports on the Fen-Phen patients, did you dictate those reports or write them yourself?
A I wrote them myself.
Q And then did someone type them up for you?
A No.
Q You just typed them?
A We sometimes submitted typewritten reports, in which case I typed them myself. We sometimes submitted handwritten reports, really a form that we filled out, in which case we submitted a handwritten.
Q Okay. And then was it typed up by the attorney's office?
A I don't think so.
Q Okay.
A I never saw anything that I had handwritten turn into a typewritten document.
Q Okay. Did the i-Cardio techs out in the field make any effort to track medical history of the patients?
A No.
Q Were there usually lawyer representatives onsite with the i-Cardio techs?
A Yes.
Q And what was their role there?
A My understanding was that their role included logistical support and checking people in.
For example, they had a list of patients who had appointments, they had to see the patients who really came, logged in.
If there were some legal documents for them to sign, then they would get them to sign them at that time, but we never saw them.
And if there were. I don't know. I don't know if there's anything else that they had to do.
Q Okay. Was there some sort of a system of quality control in place at i-Cardio?
A All of the cardiologists were empowered and encouraged to give feedback to the techs if echos needed to be altered in any way and also certainly had full authority to say an echo was of insufficient quality to tell or to make a diagnosis, I should say.
Q Did that ever happen?
A Yes.
Q And were those echos done again?
A That would be the decision of the lawyer.
Q How would you notify the lawyer that one of the cardiologists felt it was an insufficient study?
A On the report, it would say.
Q How did the cardiologists pass on their feedback to the sonographers? Did they call them directly?
A The cardiologist could call the sonographers directly and if they weren't, you know, sure who they were, how to contact them, they could get ahold of them through Karma Pemba, who is the office manager.
Q What were some of the common problems that they noted?
A Well, Fen-Phen people, some of them are very obese.
Q Yes.
A And the single most common problem is just that there's so much tissue between the transducer and the heart that it's hard to see the structures clearly.
If there was a problem in measurement, then typically the reading cardiologist would just re-planimeter the regurgitation and put his own measurement in there.
If for — as sometimes happens, the tech didn't or forgot to measure the left atrium, then we as the reading cardiologist would do that with our planimetry calipers.
Other technical problems would include sometimes there weren't enough loops and there were only stills. And if — if that's the case, then sometimes it can be difficult to tell what you're looking at.
On some occasions, the tech may measure either backflow or even diastolic flow and be at the wrong place in the cardiac cycle.
So I think those were some of the commons things that we encountered.
Q And, again, would those studies be re-performed or was it based or it would be the attorney's call at that point?
A It would be the attorney's call.
Q. And so you agree it would be inappropriate to diagnose mitral aortic regurgitation based on a single freeze frame?
A No, I didn't say that. I said that it can be difficult. It would not be my first choice, but it would not necessarily — it would not completely eliminate the possibility of making a diagnosis.
Q Because it's possible that the frames selected followed a PVC or an arrhythmia or something else going on in the heart?
A Right, but just because there may be insufficient data about that regurgitation. I'll say that globally.
Q Or it could represent artifact?
A Yes.
MR. DALTON: Just doctor, it's about five till, eight till.
THE WITNESS: Oh, I'm late again.
Would it be okay if we stopped here?
MS. HOWE: Yes.
THE VIDEOGRAPHER: The time is 11:53 A.M. and we're going off the record.
(At the hour of 11:53 A.M., the deposition was adjourned until 5:45 P.M.)
I, JOSHUA PENN, M.D., do hereby declare under penalty of perjury that I have read the foregoing transcript of my deposition; that I have made such corrections as noted herein, in ink, initialed by me, or attached hereto; that my testimony as contained herein, as corrected, is true and correct.
EXECUTED this ___ day of ____________, 20__, at __________________, (City) _______________________, __________________. (State)
I, the undersigned, a Certified Shorthand Reporter of the State of California, do hereby certify:
That the foregoing proceedings were taken before me at the time and place herein set forth; that any witnesses in the foregoing proceedings, prior to testifying, were placed under oath; that a verbatim record of the proceedings was made by me using machine shorthand which was thereafter transcribed under my direction; further, that the foregoing is an accurate transcription thereof.
I further certify that I am neither financially interested in the action nor a relative or employee of any attorney, of any of the parties.
IN WITNESS WHEREOF, I have this date subscribed my name.
Deposition of JOSHUA PENN, M.D., Volume 2, taken on behalf of Wyeth, at 777 South Figueroa Street, 44th Floor, Los Angeles, California, beginning at 6:08 p.m. and ending at 8:10 p.m. on Tuesday, October 7, 2003, before LYNN ZINK, Certified Shorthand Reporter No. 9466.
INDEX
WITNESS EXAMINATION JOSHUA PENN, M.D. Volume 2 4BY MS. HOWE 78
EXHIBITS
DEPOSITION PAGE
1 Excerpts from "Principles and Practice of Echocardiography" by Arthur E. Weyman, M.D. 80
2 Pretrial order No. 2640 by Judge Bartle 92
3 Subpoena issued to Joshua Penn, M.D. and i-Cardic in the matter 107
4 Transthoracic echocardiogram report for Angela Hartley 114
5 Transthoracic echocardiogram report for Annette Kerr 121
6 Transthoracic echocardiogram report for Roberta Rains 126
Los Angeles, California, Tuesday, October 7. 2003 6:08 p.m.-8:10 p.m. 3
VIDEOGRAPHER: The time is 6:08 p.m., and we're back on the record.JOSHUA PENN, M.D.,
having been previously administered an oath, was examined and testified as follows:
EXAMINATION (Continued)
BY MS. HOWE:
Q Doctor, I understand there's a clarification you'd like to make about your testimony from earlier this morning.
A Yes. I'd like to go over the question you asked me about backflow.
Q Okay.
A If you could. Q Unfortunately, we can't go back and read the question again. Do you recall what the clarification is you wanted to make?
A Well, you asked me about backflow. And after that I seem to recall that you gave me some definitions about duration and perhaps anything else. I don't remember exactly.
My testimony here is that backflow is a gray area and is subjective. I don't believe — I have not seen any textbook that gives specific criteria for backflow. I don't believe that the Green Form mentions anything about backflow. I don't believe that the Green Form mentions anything about duration of mitral regurgitation either. The Singh article that's referenced in the Green Form, I don't believe that makes any reference to duration of mitral regurgitation either.
So if you're asking about backflow, does it exist, the answer would be probably. What — on a clinical echo — and again, we've already talked about the idea that the Fen-Phen echoes are different than clinical echoes. But on a clinical echo sometimes what you see is that the entire left atrium will flash blue early, very early, in systole. And then, you know, slightly later you will see a more conventional looking jet of MR.
When I see that, then I would virtually always discount that flash of blue. I would not, for example, think that the entire left atrium was full of mitral regurgitation. But I'm not aware of any specific criteria regarding timing or duration of MR. Certainly there exists mitral regurgitation that's early that really is mitral regurgitation.
Q Let me see if I can clarify that a little bit. You're familiar with a textbook by Dr. Weyman; correct?
A I heard of it, yes.
Q And you understand that Fen-Phen echoes, according to settlement agreement, are required to be performed in accordance with his standards.
A Yes.
Q Let me show you, and I'll mark as Exhibit 1, some excerpts from Dr. Weyman's textbook "Echocardiography."
(DEPOSITION Exhibit 1 marked for identification by the reporter.)
BY MS. HOWE:
Q And if you would, Doctor, turn to page 431 of that excerpt.
A I think I'm on page 431.
Q Okay. And do you see the heading Estimation of Severity on the right side?
A I see it.
Q The paragraph just above that heading defines what — at least I've been referring to as backflow. Would you read that aloud for us?
A "Regurgitant blood flow," that paragraph?
Q Starting with "Backward displacement of blood," the paragraph ahead of that heading.
A "The severity of regurgitation can be viewed in terms of both regurgitant volume" —
Q Wait. Let me stop you there. I'm sorry. The paragraph just before that one.
A Before that one. Okay. Sorry. "Backward displacement of blood into the left atrium that is due to the closure of the valve leaflets can also be recorded. The motion" — "This motion of the blood pool immediately behind the valve is usually of short duration (less than 1 seconds) and does not reach velocities usually associated with regurgitant jets. Therefore, it is not considered to represent regurgitant flow."
Q Is that an accurate definition of backflow as far as you're concerned?
MR. DALTON: Objection to the form of the question. Go ahead and answer.
THE WITNESS: Its one definition. It is clear from my reading of this paragraph that it is not meant to be a definitive definition to exclusion of others. It is also clear from reading this paragraph that it does not exclude the possibility that there's mitral regurgitation even when that mitral regurgitation is confined to early in the — early in systole; BY MS. HOWE:
Q If you saw — if you saw what appears to be mitral regurgitation in the left atrium within the first 10th of a second of systole and then that color disappeared throughout the rest of systole, is there any circumstance under which you would quantify those frames as mitral regurgitation?
A Yes.
Q What circumstances would those be?
A It would include the location of the jet, the shape of the jet, the presence or absence of velocity markers in the jet, and the associated visualization of those structures throughout the cardiac cycle.
Q I understand that some people might have some mitral regurgitation and backflow; is that right?
A Yes.
Q And that in a frame you might see both phenomenon backflow and mitral regurgitation; is that right?
A I suppose that would be possible. I will mention, if I could, that the motion of the blood pool immediately behind the valve is what — or the textbook is referring to, that refers to the space immediately behind the valve meaning close to the vaive. So again, the jet that was shaped deeply into the left atrium or that was coming from the coaptation, c-o-a-p-t-a-t-i-o-n, leaflets or that had sufficient velocity might easily be regarded as mitral regurgitation even if its duration was confined to the early portion of systole.
Q Mitral regurgitation, you agree, has to be high velocity flow; is that right?
A Well, as is known, mitral velocity — mitral regurgitation velocity flow can be variable. It is generally of higher velocity than backflow. That is true.
Q And so mitral regurgitation would appear to have an aliased — excuse me. — would appear to be aliased as opposed to backflow which would be lam (phonetic) in a blue color?
A Sometimes but not always. Backflow is very often seen as a — for better word, a puff of blue that is often of indistinct shape immediately behind the mitral valve at mitral valve closure. It generally does not show itself to be coming from the mitral leaflet coaptations.
Q So is it your testimony that true mitral regurgitation does not necessarily need to extend more than one tenth of a second into systole?
A I'm not aware of any specific criteria that demands that that be true.
Q Mitral regurgitation is a result of blood squeezing from the left atrium back into — excuse me. — from the left ventricle back into the left atrium during systole; right?
A Yes.
Q Through some sort of lesion or, I guess, hole in the mitral valve.
A A functional hole.
Q How would — how would there not be — why would — how is it possible that mitral regurgitation could only last in the first instant of systole and not throughout systole?
A Well, the mitral valve itself is a very complex anatomic structure. And the shape of the mitral leaflets and even the actual mitral annulus, the ring in which the leaflets are set, changes dynamically during the cardiac cycle. For that reason, you can have early mitral regurgitation.
And as the cardiac cycle progresses, the coaptation — you already have that word. — the coaptation of the leaflets and/or the geometry of the mitral annulus or indeed the geometry of the chordae tendinae, c-h-o-r-d-a-e space t-e-n-d-i-n-a-e, can also change dynamically.
For that reason, it is my understanding that, based on the textbooks that I have read and the articles that I have read, no author has stated definitively a duration that is required for mitral regurgitation.
Q And, in your opinion, Dr. Weyman's definition is not definitive. — a definitive one of backflow.
MR. DALTON: Object to the form of the question. Go ahead and answer.
THE WITNESS: l think the simple reading of this paragraph is not to make a black-and-white determination of exactly what constitutes blood flow. I think the sense of the paragraph is to caution the reader that backflow should be considered when these events are seen.
BY MS. HOWE:
Q But when these events are seen, it's not necessarily backflow.
A Backflow should be considered in the context of the entire echo.
Q Doctor, do you agree that blood pressure can affect the degree of regurgitation?
A Yes.
Q And in some cases can it increase the apparent level of regurgitation on echo?
A Yes.
Q Do you — in your clinical practice, do you take the blood pressure of your parents before an echocardiogram?
A Typically not.
Q Is their blood pressure taken when they come into your office for preliminary examination before the echo?
A If they're being examined by me, then a blood pressure is part of that exam, that's correct.
Q But there's situations in your clinical practice when a blood pressure is not taken?
A Yes.
Q Was blood pressure taken for any of the Fen-Phen echoes?
A Not to my knowledge.
Q Did i-Cardio give plaintiffs — or excuse me. — diet drug patients any instructions as to what they should or should not do before the echocardiogram?
A Did i-Cardio give instructions to the people who were going to be echoed?
Q Yes.
A No.
Q Do you know if the lawyers or their representatives did?
A I wouldn't know.
Q Okay.
A Other than the obvious, you know, scheduling when to show up. That sort of thing.
Q Have you ever heard of a situation where diet drug patients were instructed to stop taking their blood pressure medication before the echocardiogram?
A I have never heard of such a thing, no.
Q Are there techniques that you can — or that a patient can do physically during an echo that will increase the apparent level of regurgitation?
A That's a good question. I don't know.
Q Such as squeezing their muscles in a certain way or —
A Right. I think I understand what you're alluding to, and my answer is I don't know —
Q Okay. So I —
A — if that would materially affect the MR or not.
Q I assume from your answer, then, that the i-Cardio — no one was asked to do anything like that during the i-Cardio echoes.
A Never any such thing.
Q Did you consider yourself to have a doctor-patient relationship with the patients for whom you simply interpreted an echocardiogram?
A I did not. In fact I specifically inquired about this before undertaking Fen-Phen echoes. In my discussions with the plaintiff attorney, I as an individual, and I think i-Cardio as a company, made it clear that we did not understand that we were entering into a doctor-patient relationship.
Q So is your malpractice carrier aware of your work in the Fen-Phen litigation?
A My malpractice carrier is aware that I do echoes in many states. I don't know what to tell you specific about Fen-Phen. I don't know chat — I don't know.
Q Okay. What lawyers did you ask about that?
A About what?
Q About the doctor-patient relationship.
A The lawyers with whom we engaged to do the echoes.
Q So you just make clear to them that there would be no doctor-patient relationship with those individuals?
A Yes.
Q Was there any documentation reflecting the lack of a doctor-patient relationship that you either had the patient sign or that you distributed?
A Not that I know of. Although I received repeated assurances from the law firms that that was the case.
Q Why was that important to you?
A Because I didn't actually see the patients. And as a result I didn't actually have a doctor-patient relationship with them.
Q Did i-Cardio provide copies of the echo reports to the patients themselves?
A No.
Q They were just returned to the lawyers?
A That's correct.
Q Do you personally know whether those echoes reports were given to the patients?
A I don't have specific knowledge of what the lawyers did with the reports. I do — I can tell you that if patients would call our office asking for reports, we would refer them to their lawyers.
Q Did that happen frequently that patients would call asking about the reports you had issued?.
A No. Not frequently.
Q But when it did, you'd simply refer them to the lawyers.
A Yes.
Q In your clinical practice, if you diagnose a patient with FDA-positive, regurgitation, do you recommend that they take antibiotics before dental or surgical procedures?
A Usually, yes.
Q Did you make that recommendation to any of the diet drug patients who you found were FDA-positive?
A No. I did not make any recommendations. I didn't have any communication with them.
Q What is the Nyquist limit?
A Nyquist limit refers to a setting in a colorflow Doppler that sets a limit on the velocity of blood flow that's detected and color coded by the colorflow Doppler.
Q Do you agree generally that the higher the Nyquist setting, the better the image on the echocardiogram?
A No. The Nyquist limit does not affect the imaging of the echocardiogram.
Q Does it affect the appearance of the color Doppler?
A Yes, it does.
Q Do you agree that the higher the Nyquist limit, the more — the better representative picture you get on color Doppler?
A No. It's not a better or worst. It's just a different.
Q Where do you typically set the Nyquist limit in your clinical practice?
A The tech is responsible for setting the Nyquist limit based on his machine and the patient and the quality or difficulty of the imaging. Generally speaking, it would be between 4, 45 and in the 6's range.
Q And that's 45 centimeters per second to 60 centimeters per second?
A 40 to 45 to 60 to 65. Something like that.
Q Do you agree that if a Nyquist setting is too high, it can create phantom jets?
A I'm not sure.
Q You don't know?
A I'm not sure what you mean by phantom jet.
Q It will assign incorrect colors to the regurgitant jet which may therefore make it look, like regurgitation when it's not really?
A Say that again.
Q Will you read it back? (Record read.)
BY MS. HOWE:
Q Doctor, are you aware that in fall of last year there was a hearing before the federal judge in Philadelphia who resides over this litigation?
A Yes.
Q And were you aware that he issued an order as a result of that hearing?
A No.
Q I'm going to show you what is the order which was the result of that hearing, which I'll go ahead and mark as Exhibit No. 2. And that's PT2640.
(DEPOSITION Exhibit 2 marked for identification by the reporter.)
BY MS. HOWE:
Q If you would, Doctor, turn to page 11 for me. Well, first of all, have you seen this document?
A I nave not.
Q Okay. The last paragraph on page 11 Judge Battle states, "One setting that is particularly important to the image displayed on an echocardiogram machine is the Nyquist limit." Skipping down a couple sentences, he says, "It is the highest velocity of blood flow that an echocardiogram machine can accurately measure in the colorflow Doppler modality." Do you agree with that definition of the Nyquist limit?
MR. DALTON: I just want to state an objection for the record.
You can go ahead and answer.
THE WITNESS: Let's see. "It is the highest velocity of blood flow that an echocardiogram machine can accurately measure in the colorflow modality." I'm not sure what the judge means. You can usually see the jet regardless of the setting. BY MS. HOWE:
Q Regardless of the Nyquist setting?
A Yes.
Q If you would turn the page, please. The second full —
A He's giving an example here.
Q Yeah.
A He or she is.
Q Go ahead and look at the example.
A Okay. I have read the paragraph.
Q Okay. Do you agree that if the Nyquist limit is set, for example, at 70 centimeters per second, the machine can only accurately record and display velocity of blood moving at that — slower than that speed?
A If the velocity of blood exceeds the Nyquist limit, then you can get changes in the color. You can get — I think I'm going to quote here — "splotchy and broken up."
Q Okay. And those are Judge Bartle's words that you're quoting?
A Those are Judge Bartle's words that I'm quoting. That can happen, yes.
Q Do you agree with Judge Bartle that the generally accepted practice is the higher the better?
A No.
MR. DALTON: Objection to form.
Go ahead and answer.
THE WITNESS: I would have to say that that was not a fair characterization. The Nyquist limit is almost always set by the tech on that — on that specific machine and for that specific patient. So it tends to be variable.
BY MS. HOWE:
Q Okay. Do you agree that with taking into consideration variations for the patient and the machine, that the higher the Nyquist the better?
A Well, what a higher Nyquist limit does is it does reduce the risk of color aliasing or producing color that's opposite what you want or color that appeared — that can appear splotchy and broken up. But it can also limit the sensitivity of seeing the regurgitation.
Q Having a higher Nyquist limit would do that?
A It can.
Q Judge Bartle says, "a Nyquist limit in the 30's or 40's may not be as ideal for identifying and measuring a mitral regurgitant jet as would a limit in the 60's or 70's."
MR. DALTON: And again, I'm just — anytime you're reading in a summary, I have an objection to foundation and other things.
So, Doctor, let me make my objection. You go right ahead and answer afterwards.
MS. HOWE: Fair enough.
THE WITNESS: I would say what he says, "Accordingly, a Nyquist limit in the 30's or 40's may not be as ideal for identifying and measuring a mitral regurgitant jet as would a limit in the 60's or 70's," that can be true.
BY MS. HOWE:
Q Okay. Do you think that that's generally true?
A It's often true.
Q Is it also important to have the gain set properly on an echocardiogram?
A Yes.
Q And do you agree that if the gain is set too high, there's background noise that can make the image unreadable?
A Yes.
Q How do you tell a gain is set too high?
A The most common way to tell is to see if there's any color back-speckling appearing in a place where blood movement is expected to be near zero.
Q Under the settlement agreement, mitral regurgitation is required to be measured in the apical view, or any apical view; is that right?
MR. DALTON: Again I object to the form of the question.
Go ahead and answer.
THE WITNESS: I'm not aware that it — they're saying that it has to be measured only in the apical view?
BY MS. HOWE:
Q Yeah. For the Fen-Phen echoes performed in accordance with the settlement agreement.
A If you say so.
Q Okay. You're not aware of that requirement?
A I am not sure.
Q Okay. Were there cases where you assessed regurgitation based on — excuse me. — assessed mitral regurgitation based on parasternal long axis view?
A There could have been, but I don't believe so.
Q You can't rule out that possibility sitting here today?
A Correct. But that would be clearly evident on the study.
Q Aortic regurgitation is determined under the settlement agreement according to the jet height-LVOT ratio; correct?
A Yes.
MR. DALTON: I'm going to make objections to all these where you're citing other outside sources. Can I just have a continuing objection —
MS. HOWE: Absolutely.
MR. DALTON: — so I don't have to interrupt all the time?
MS. HOWE: Yes. That would be great.
Q Would you describe where specifically the jet height is to be measured.
A In a parasternal long axis view, the jet height is measured in the left ventricular outflow tract, which is the tubular or cylindrical portion of the heart just below, meaning on the ventricle side of the aortic valve.
Q And do you agree that jet height must be measured at the orifice of the valve?
A At the orifice. Well, within the left ventricular outflow tract. I would agree that if it's measured out in the left ventricle, that that would be inappropriate.
Q It should be measured just beneath the aortic valve, though.
A Just beneath the aortic valve. you can't really measure it at the orifice. That doesn't really work.
Q Did you know — or let's see. Are you aware that the settlement agreement requires aortic regurgitation to be measured in the parasternal long axis view if it's available?
A My understanding with regard to aortic regurgitation is that specifically it should be measured in the parasternal long axis view if possible. But if those views are difficult or suboptimal, then you can use parastern — apical views.
Q Did you do that in any of the Fen-Phen cases?
A Yes.
Q Would that be reflected on the echocardiogram as well?
A I would think so.
Q For estimating PASP, did you use the Bernoulli equation?
A Yes.
(Discussion held off the record.) BY MS. HOWE:
Q For the Fen-Phen echoes did you always use a right atrial pressure of 10?
A Yes.
Q What do you use in your clinical practice for right atrial pressure?
A Most commonly you use 10. If there is evidence of elevated right atrial pressures, I use 15 or possibly even 20.
Q What evidence —
A Statistically 15.
Q What evidence would indicate a high right atrial pressure?
A The most common finding would be dilated hepatic veins that don't display respiratory variation.
Q Do you ever use the IVC to help you evaluate the right atrial pressure or collapse of the IVC?
A Right. That hepatic veins and IVC are essentially in communication.
Q Okay. What is your cut point for pulmonary hypertension using PASP on echo?
A For Fen-Phen studies or —
Q Let's start with Fen-Phen studies.
A For Fen-Phen studies I only added 10. I. — to the Bernoulli equation.
Q Okay.
A I didn't make any — I never added any different number.
Q Okay.
A Regardless of what may or may not have been shown in JVC or hepatic veins.
Q So if you saw evidence of elevated right atrial pressure, you still added 10 for the Fen-Phen patients.
A That's correct.
Q And I don't think I made my other question very clear. What's your cutoff as far as the PASP that you use before you diagnose someone with pulmonary hypertension on echo?
A Are you talking about in my clinical practice or —
Q Let's do your clinical practice first.
A I regard pulmonary pressures between 35 and 45 as borderline and will typically report them as such. And I regard pressures greater than 45 as hypertensive.
Q Did you use the same cut point for the Fen-Phen echoes?
A I only used one cut point for the Fen-Phen echoes and that was 45.
Q Did you only use M-mode measurements for chamber sizes in the Fen-Phen echoes?
A No.
Q Did you use 2-D measurements as well?
A Yes.
Q Did you rely on one over the other?
A No.
Q It just varied from study to study?
A Yes.
Q Should there be 2-D measurements on all of the i-Cardio echoes?
A Yes. If there were instances where they're not there, then I could measure them afterwards by the calipers with a freeze of the — of the 2-D view, either parasternal or apical.
Q And if they weren't recorded on the echo, would you always remeasure the 2-D's —
A Yes.
Q — upon your review?
A Yes. I would often remeasure them even when they were measured by the tech.
Q What is i-Cardio's business address? Is it the same as your business address?
A No.
Q What is it?
A 1531 Glenville, G-l-e-n-v-i-l-l-e, Drive.
Q You mentioned earlier this morning that i-Cardio sent echoes to other cardiologists to interpret; is that right?
A Yes.
Q How much were those cardiologists paid per echo?
A I believe it was $60 per echo. Yeah.
Q Were the i-Cardio. sonographers instructed not to inform patients of the results of their echo during the study?
A I'm not aware that they received specific instructions in that regard.
Q Would it be improper for them' to do so?
A Generally speaking, yes.
Q Do you know whether the lawyers or their representatives were giving results to the patients on-site?
A I do not know.
Q If that happens —
A I do not believe that my techs were routinely giving results to patients.
Q When you reviewed echoes for — when you reviewed non-i-Cardio echoes, were you paid personally or was i-Cardio paid by the lawyers?
A i-Cardio was paid.
Q How long did it take you to, on average, review a diet drug echocardiogram?
A Seven to ten minutes.
Q And if I recall your testimony correctly, you became involved in the diet drug litigation in mid 2002, and it dropped off around January, 2003; is that right?
A Yes.
Q During —
A A little before that. I don't think we did much in December.
Q Okay.
A I don't recall.
Q During that time frame, approximately how many echoes were you interpreting per week?
A That's a good question. Let me think about that.
100 to 150.
Q Did you have to cut down on your clinical practice at all during that time frame?
A Yes.
Q How much did you cut down in your clinical practice?
A I'm not sure what "how much" means. You mean how many days — I continued — I cut down the hours, I would say, rather than cutting out specific days. Does that make — is that whet you were asking?
Q Sure. What percentage of hours do you think you cut down during that time frame?
A 25 percent. There was also one or two occasions where I took an entire week of vacation and didn't — and just did echoes.
Q And the vacation was taken for that purpose?
A Principally, yes.
Q How many — and I assume then the number of echoes you reviewed during those weeks would have —
A Was probably higher. I would say — yeah. Well, yes. I would say yes.
Q Okay. Can you estimate for me how much i-Cardio has grossed from its work in the diet drug litigation?
A Grossed means before we pay the tax or the doctors or anybody.
Q Sure.
A Let me think. About $2.5 million.
Q And do you have — can you estimate how much i-Cardio has profited from the same work?.
A Not offhand, no.
Q But If we wanted to figure it out, we'd take out the cost of the sonographers.
A Yes.
Q The cardiologists who reviewed the echoes.
A Yes.
Q Any other expenses?
A Well, there is some ancillary staff. There's plane fare, hotel fare — I mean hotel, transfers from hotel and sort of travel expenses globally. There's some consumable expenses — electrodes, gel, paper for the tables, renting of tables. Sometimes, you know, whatever other sort of logistical help or materials they might need in the hotel.
I remember one time we had to rent pipes and curtains to sort of curtain off the exam rooms. So different kind of expenses like that — you know, telephone, FedEx — spent a fair amount of money on FedEx, as you might imagine — shipping machines or replacement machines, you know, if one became damaged.
So there were a fair bit of expenses.
Q Have you — has i-Cardio been paid in full all the amount that it's due?
A No.
Q Is there a significant amount outstanding?
A Yes.
Q Is that with any part — is the outstanding amount with any particular law firms?
A It is with more than one.
Q Is any of the payment contingent upon those law firms collecting payment from the trust or from their plaintiffs in litigation?
A Not that I know of We certainly never made any sort of deal like that, no.
Q Do you have an understanding as to when you'll be paid the outstanding amount?
A No. The majority of cases we have been paid at least a significant portion Of the bill, and there's been some delay in payments of remainders. But there's been — but I'm not aware of specific dates. There is one specific law firm with whom I worked out a specific payment plan, a certain amount of money per month. But aside from that one case, no.
Q Do you expect that you will be paid the full amount?
A I certainly hope so.
MS. HOWE: We need to take a break to switch the tape.
THE WITNESS: Okay. Are we off record now?
MS. HOWE: Yes.
VIDEOGRAPHER: This marks the end of videotape No. 1 in the deposition of Joshua Penn. The time is 6:48 p.m., and we're going off the record.
(Recess.)
VIDEOGRAPHER: This marks the beginning of videotape No. 2 in the deposition of Joshua Penn. The time is 6:52 p.m., and we're back on the record. BY MS. HOWE:
Q Dr. Penn, you mentioned this morning that you talked to Mr. McElroy about the Fen-Phen criteria, so to speak. Were there any other cardiologists who you talked to about the same issue?
A Yes.
Q Was this before you sort of got started in the process when you were educating yourself?
A Both before and during.
Q Okay. Who were those individuals?
A The cardiologists?
Q Yes.
A That would include Michele Hamilton, Bruce Kimura, and Dr. Levine at Massachusetts General Hospital.
MS. HOWE: I'll have the subpoena in this case marked as Deposition Exhibit No. 3.
(DEPOSITION Exhibit 3 marked for identification by the reporter.)
BY MS. HOWE:
Q Dr. Penn, have you seen this document before?
A Yes. I think I have.
Q Do you see that there's a list of documents requested as Exhibit A?
A It says, "See Exhibit A."
Q Right.
A Okay.
MR. DALTON: You gave me two copies of this.
MS. HOWE: Oh, okay. Good.
Q Did you review that document request before the deposition?
A Honestly I may not have.
Q Okay. Did you make any efforts before the deposition to determine if you had documents relevant to these cases?
A Not really.
Q in that case, we're going to have to go through and see what kind of documents you might have that are responsive. Paragraph 1, if you could just review that silently to yourself and let me know if you have anything in your possession in response to that request.
A No. I don't think so. Typically we send everything back in the law firm that engaged us.
Q Anything in response to paragraph No. 2?
A We may have some correspondence, but I don't know for sure if we would have saved it. We probably have some kind of receipt, you know, or invoice. That we probably do have. We probably have canceled checks if they paid us.
Q Did you nave written agreements with any of the plaintiffs lawyers that you worked for?
A I don't think so.
Q Did you have correspondence with the law firms setting out the terms of your agreements?
A You mean like written letters back and forth?
Q Yes.
A Typically not.
Q These were all done orally?
A Usually, yes.
Q And after you were retained by a certain law firm, you didn't have ongoing correspondence with them about the process?
A We did, but that was usually by phone. It was occasionally by e-mail and pretty rarely by, if ever, by letter.
Q Okay. Is it possible that you have some of that correspondence at your office?
A Its possible, but to be honest, I don't think it is that likely. Because if it was phone, there wouldn't be anything. If it was e-mail, it's probably long gone by now from our records. And the letters, if there's letters and if Carma saved them, we might have them.
Q Paragraph No. 3 asks for any time sheets or time records relating to your work in this litigation
Do you have anything like that?
A No,
Q No. 4 asks for any documents relating to instructions, protocols, procedures that you have for performing the diet drug echoes.
A We may have some of that.
Q Paragraph No. 5 asks for any documents relating to the technicians who performed the echoes on the plaintiffs we're here to talk about today.
A Do you want to tell me who the technician was?
Q I guess I'm not sure. We may know when we go through the tapes.
A Okay. It will be hard to answer that without knowing who the tech was.
Q Okay. Do you keep files on each of your techs?
A Well, we probably have — we have files on techs who were employed by us full time before or after Fen-Phen. But on the per diems typically we don't.
Q No. 6 asks for any advertisements or promotional materials that you used in the diet drug litigation. Anything like that?
A No.
Q Any other documents or data that support the opinions that you have in these cases?
A I don't know. Do you think I need any?
Q Well, we've got the echo reports and the actual echocardiograms. Would there be anything else?
A I don't think so.
Q Have any of the plaintiffs ever provided any materials to you?
A I don't have any specific recollection of these people or their names. I would say it would be very unlikely that I ever spoke to them. I probably did get a patient questionnaire signed by them. But aside from that, I would not have likely have had any contact of this with them.
Q And that patient questionnaire would have been returned to the attorneys?
A That's correct.
Q And we also requested a copy of your most recent resume and C.V. Is that something you can provide to us?
A Yes.
Q The things that we've just talked about that you said you might have at your office, what I'd ask is that you go back and check and if you find it, produce it to us at your earliest convenience.
A Where should I send it?
Q The same person who you're sending the bill. is that okay?
A That would be all right.
Q Thank you very much.
MR. DALTON: And you guys will send a copy to me; is that correct?
MS. HOWE: Yes.
MS. SCHOVANEC: We will. BY MS. HOWE:
Q I just want to clarify you don't have any specific recollections of the plaintiffs in this case.
A No.
Q To the best of your knowledge, you've never met them personally.
A No.
Q And have never reviewed any medical records on them.
A No.
Q All you did is perform an echo on these people and interpret it.
A Yes.
Q So sitting here today — and, again, I think it's clear — you can't express an opinion about what caused these plaintiff's valve regurgitation, if any.
A Probably not.
Q And you don't have an opinion about their 25 prognosis or treatment?
A No.
Q Do you know Dr. William Jones from Oklahoma City?
A Not personally.
Q What do you know about him?
A I know that he's a doctor in Oklahoma and that he got in touch with i-Cardio to do echoes for him. I believe, although I could be mistaken, that initially he contacted us to do some clinical echoes for him, but I do know for a fact that he had us do some Fen-Phen echoes for him.
I think he may have heard of us because we were doing clinical echoes for another clinical entity either in his building or nearby or something like that. We had had clinical clients in Oklahoma City from before we 6 became involved in Fen-Phen litigation.
Q So i-Cardio did go ahead and end up performing some Fen-Phen echoes for him?
A Yes.
Q Is he a cardiologist?
A I don't think so. No, he is not.
Q Would he have had any involvement in the i-Cardio echoes themselves?
A Unlikely.
Q Did he actually pay i-Cardio for any echoes?
A Yes.
Q Those were Fen-Phen echoes?
A Yes. And they may have been some clinical echoes too. Also.
Q I'd like to go through your echo reports on the three patients at this point. I'll mark as Deposition Exhibit No. 4 what appears to be your report on Angela Hartley.
(DEPOSITION Exhibit 4 marked for identification by the reporter.)
BY MS. HOWE:
Q Am I right? Is this your report on Ms. Hartley?
A This does look like my report.
Q Okay. Is this the standard form that you used for the diet drug cases?
A Yes. We use this form for many but not all of the cases.
Q Okay. What would — I mean what — why were certain forms used for some and not for others?
A Some clients wanted a typewritten form; some clients wanted a handwritten form. So our typewritten form looks like this. It underwent a couple of revisions, you know, in formatting and things over time And then it took a little longer to make a typewritten form because you have to type it up.
Q Uh-huh.
A But if the client wanted a typewritten form, we gave a typewritten form. If they wanted a handwritten form —
Q Did you create this form?
A Yes.
Q I notice at the top there's blanks for Ms. Hartley's Social Security number and her date of birth. Was that data that i-Cardio typically collected from plaintiffs?
A I don't think so. I think it was put in there as, you know, a possibility for later use.
Q I notice on this form there's no section for your conclusions and impressions. Where would — well, strike that actually.
Where on this form would you note any congenital abnormalities that you would have found?
A Well, in two places. Under valvular imaging where it say mitral valve morphology, it would typically say something other than norm, abnormal, or whatever the story may be. And then you can't see it on the final printed form, but underneath, between where it says aortic root size and FDA criteria, in there there are actually two spaces, two blank spaces for writing comments, whatever comments might need to be added.
Q And you said we can't see it. Is this a bad copy or —
A No. It's just a — it's the typing template It doesn't come out on the printout.
Q I see. And if there were any technical problems with an echocardiogram, would that also be noted in the comments section? 9 A Typically, yes.
Q For Ms. Hartley's M-mode measurements, would you — let's see. Her aortic root, that's normal; correct?
A Yes.
Q And the left atrial dimension is normal as well; correct?
A Yes.
Q I notice there's no measurement indicated there for the left atrium and the apical four-chamber. A True.
Q Why is that?
A I'm not sure. I would have to see the study. Either it wasn't measured, or it wasn't measured well or — those would be the two common ones.
Q Okay. For the left atrium and the parasternal long axis view, in the Fen-Phen echoes the cutoff is 4.0; is that right?
A Yes.
Q And in the apical four it's 5.3?
A Yes.
Q The left ventricular dimensions are normal; correct?
A Yes.
Q And the ejection fraction 63 percent is normal; correct?
A Yes.
Q And I notice, or you told me earlier, that you typically eyeball the ejection fraction?
A True.
Q I notice the fraction of the systolic and diastolic measurements come out to be 63 percent. Is that a technique you also used?
A Say that again.
Q If you take —
A 3.1 divided by 4.9 —
Q Yeah.
A — is 63?
Q I think so. Yes.
A Remarkable. But, no, that would not be a technique. I think we have to call that coincidence on this report.
Q Okay. So you did use the eyeball technique.
A Yes.
Q Okay. Under the Doppler measurements you said mitral regurgitation was trace; correct?
A Correct.
Q And that's not clinically significant in any way; correct?
A Correct. —
Q I notice there is no percentage indicated there.
A Correct.
Q Why is that?
A Typically when the amount of mitral regurgitation is seen to be trivial, we didn't bother to measure it.
Q Under aortic regurgitation you have a jet height of 54; correct?
A Uh-huh.
Q And LVOT of 2.01
A Yes.
Q Which gives you ratio of 26 percent.
A Yes.
Q And that's mild aortic regurgitation; correct?
A Is that mild or moderate? I think that's moderate.
Q I'm sorry. You're right. It is moderate. My mistake. Moderate.
A Yes.
Q Are these measurements we should see on the actual echo itself?
A Gee, I hope so.
Q Okay.
A Although I will tell you that if there are some — on some occasions I did measure these measurements with calipers later if the measurements either weren't done well or were — or there was some other problem with them.
Q And we'll look at the C.D. in a minute. I've looked and I haven't seen any of the measurements recorded there.
A Do you say there's no measurements made at all?
Q That's right.
A That would be unfortunate, but I will take a look.
Q All right. We'll take a look at it.
If there are any measurements, should we assume that you would have recallipered them yourself when reviewing the echo?
A Definitely.
Q There would be no way for us to see those measurements that you made on the actual tape; correct?
A No. But you could probably replanimetry them yourself too.
Q Okay. The PAP is blank; is that right?
A Yes, it is.
Q And why is that?
A The most common reason for that is — would have been that there was an insufficient amount of tricuspid regurgitation to create a good measurement.
Q Okay. Under your finding section you note that everything is normal except the moderate AR; correct?
A Yes.
Q Your FDA criteria you say is present. That again is in reference to the moderate AI?
A Yes.
Q And settlement matrix criteria is not present.
A Correct
Q That means that one of the — there's no confounding factors here.
A Correct.
Q In your signature line I notice there's no signature.
A I noticed that too.
Q Why is that?
A I don't know. I don't know why anybody would have a copy of my report without a signature. That would not — I printed out my reports, and I signed them.
Q So you have no idea why this one is unsigned.
A That is correct.
Q It would be your practice to sign echocardiogram reports.
A That is also correct.
MS. HOWE: I'll mark as Exhibit No. 5 the echo report of Annette Kerr.
(DEPOSITION Exhibit 5 marked for identification by the reporter.)
THE WITNESS: Is this a different patient? BY MS. HOWE:
Q This is a different patient.
A All right.
Q This is a different format; correct?
A Correct.
Q And it's also typed; right?
A Correct.
Q Is this just a different — why is-this one different than Ms. Hartley's form?
A The reason, this form of Annette Kerr is our form for clinical echoes.
Q Okay. Do you know why it would have been used in this case?
A If I didn't know that the patient was being — that we were asked to do a Fen-Phen echo and if it was presented to me as a clinical echo, then that would be the reason.
Q So you would have used your clinical practice for quantifying regurgitation as opposed to the Singh method in this case; is that correct?
A Typically, yes.
Q In the top left corner it says Ben Velez, V-e-l-e-z?
A Yes.
Q Does that mean that's the tech who performed this echo?
A Yes.
Q Is that one of i-Cardio's employee technologists?
A Yes. He's not currently employed, but he was employed at that time.
Q Do you know why he left?
A He left to start his own mobile echo business just a few weeks ago.
Q Oh, really.
A As it happens.
Q Okay. Now, I notice this report was electronically signed; is that right?
A Yes.
Q Is that something you did for the Fen-Phen echoes?
A No.
Q Usually you actually sign the reports for the Fen-Phen echoes.
A Correct.
Q The electronic signature is something you did in your clinical practice?
A Correct.
Q The first grid of measurements, are those all M-mode measurements?
A Yes.
Q The left ventricular measurements are both normal; correct?
A Yes.
Q The left ventricular thickness is normal; correct?
A Yes.
Q The interventricular septum is normal; correct?
A Yes.
Q You indicate within normal range for the left atrium is 1.9 to 3.8; right?
A Yes.
Q Is that the range you use in your clinical practice?
A Yes.
Q You found a dimension of 4.0; correct?
A Yes.
Q So but 4.0 is normal in the Fen-Phen echoes; correct?
A Correct.
Q It would have been, I guess, slightly above normal in your clinical practice?
A Yes.
Q Aortic root diameter is normal?
A Yes.
Q Ejection fraction is normal again.
A Yes.
Q You indicate that everything is normal in the M-mode and 2-D measurements under the interpretation section with the exception of the left a trial enlargement; correct?
A Yes.
Q Which, again, would be normal in the Fen-Phen world.
A Yes.
Q Under the colorflow and Doppler section, you say that she has moderate mitral regurgitation; correct?
A Yes.
Q That would have been based on your eyeball assessment as opposed to the Singh criteria.
A Typically, yes.
(Dr. Penn's beeper sounded.)
MS. HOWE: Do you need to take a break?
THE WITNESS: You can keep going. BY MS. HOWE:
Q Okay. The RVSP is 35 millimeters of mercury; correct?
A Yes.
Q Which is within normal using the Fen-Phen criteria; correct?
A Yes.
Q Under the impression you say it's an abnormal study. Is that referring to the moderate MR?
A Yes. And the left atrial enlargement.
Q You say it may meet DHS — DHHS criteria for the presence of anorectic-associated valvulopathy.
A Right. That's a line that I put in there when the — I'm specifically given the diagnosis of Fen-Phen exposure. And it says that there is moderate regurgitation present, and therefore, that what you call FDA-positive may be present.
Q Was Ms. Kerr a patient of yours?
A No.
Q And you never would have reviewed any medical records on her.
A Unlikely.
Q Okay.
A Unless you show me that I did. But I did review medical records on a few people, but I can't remember which ones I did.
Q I have no evidence that you did. I'm just trying to figure out why this clinical report was used in her case.
A Well, what's clear is when I read this echo, I understood that it was a clinical echo. Perhaps in someone with Fen-Phen exposure, but not specifically for the purpose of a matrix submission.
MS. HOWE: I'll mark as Exhibit 6 the echo report on Roberta Rains.
(DEPOSITION Exhibit 6 marked for identification by the reporter.)
BY MS. HOWE:
Q Now, we're back to your, quote, unquote, Fen-Phen report; is that right?
A Yes.
Q Under Ms. Rains's M-mode measurements, her aortic root is normal.
A Yes.
Q Her left atrium size is normal.
A Yes.
Q Her left ventricle sizes are normal.
A Yes.
Q Her ejection fraction is normal.
A Yes.
Q You indicate that she has no mitral regurgitation.
A Correct.
Q And the aortic insufficiency ratio is 15 percent.
A Yes.
Q Which is mild?
A Yes.
Q Everything on the study is normal with the exception of her mild aortic regurgitation.
A Yes.
Q And again, I noticed you — there's no signature here on this report.
A I see that too.
Q And you're just as stumped with this case as to why that occurred.
A It would — it is not my practice, or was it my practice at all during that time, to submit any Fen-Phen styled reports without a signature. I'm wondering if this was a copy, you know, perhaps made at some other time from — you know, off the computer. But it's speculation. I really don't know.
Q Okay. Does the lack of a signature suggest any possibility that you didn't actually review this echo?
A Well, it suggests that I — this is not a signed copy. It looks like the kinds of reports I do. Does that help you? Does that answer your question?
Q Yeah: If that's the best that you can do.
Okay. If we can go off the record for a few minutes. What I'll do is have everyone adjust so that we can look at echoes over here.
VIDEOGRAPHER: The time is 7:17 p.m., and we're going off the record.
(Discussion held off the record.)
VIDEOGRAPHER: The time is 7:30 p.m., and we're back on the record.
MR. DALTON: I just want to note for the record that we're attempting to videotape a laptop computer screen. We're not sure how clear it's going to appear on this videotape at this point in time. BY MS. HOWE:
Q Doctor, we pulled up on my computer the echocardiogram of Angela Hartley; correct?
A Yes.
Q And is this what an i-Cardio echocardiogram looks like?
A Yes.
Q Okay. We've got a number of still frames and loops recorded; correct?
A Yes.
Q All right. On this particular echo I've counted 25 still frames or loops.
A Yes.
Q Is that right?
Okay. And do they proceed chronologically from the beginning of the study to the end of the study?
A Usually.
Q Okay. I'm going to pull up the first —
A Just click on that box. It will come up.
Q I'm going to — I just pulled up the first loop on this echo.
A Excuse me. Let me just do this for you. It will make your life a little easier. Can I do that?
Q Sure. Okay. I just pulled up the first loop on Ms. Hartley's echo; correct?
A Yes.
Q Okay. And this is the parasternal long axis view 2-D mode; correct?
A Yes.
Q What is the real time on this loop?
A 023134.
Q I'm now going to pull up the last loop on this echocardiogram. What's the real time on that loop?
A 024048.
Q So does that indicate that this echocardiogram took approximately nine minutes?
A No, it does not.
Q Tell me why.
A Because that just tells you when the loop No. 1, and loop No. 25 were captured. There may have been more echocardiography to be done before or after — before the first loop or after the last loop.
Q Is that typical for your sonographers to record things before and after?
A Sometimes. What they may also do is they may throw out — they may delete frames that are not suitable.
Q At the beginning or the end of the echo?
A Possibly.
Q We'd have to ask the tech about that.
A Yes, we would.
Q Okay.
A It would be unlikely that the tech would have a specific memory of that one echo done a year ago, but you could ask him.
Q Is there any way that we can tell what tech performed this echo?
A You told me that it was Ben Velez.
Q I think that was on the next plaintiff. We're talking about Angela Hartley right now.
A We probably could find that information. This may have been Ben Velez.
Q Would it be on this C.D.?
A I don't believe so.
Q How would we find that information?
A We'd have to go back and check which tech did the echo on that date.
Q Would you have records of that?
A Possibly.
Q That would be something else we'd ask that you look for —
A Okay.
Q — at your office and provide again to the attorneys in Oklahoma.
A It seems likely to me that it was Ben Velez since it is my recollection that he did all or almost all of the Oklahoma echoes in that era.
Q Okay. That's helpful.
You concluded that Ms. Hartley had moderate aortic regurgitation; correct?
A Yes.
Q And we talked earlier that under the settlement agreement, the aortic regurgitation has to be measured in the parasternal long axis view if it's available; correct?
A Yes.
Q On this study how many — how many loops are available in the parasternal long axis view using color Doppler?
A There's one. I'm not sure — I can't tell exactly what that one is.
Q Okay. Why don't you pull it up.
A That's an apical. That's an apical too. Also. It looks like there's one.
Q So your diagnosis of moderate aortic regurgitation was based on the data contained in this one loop; is that right?
A Not necessarily. If I got better views in the apicals, I would have used those too. Also.
Q Okay. But those are not recorded on the C.D.; right?
A Oh, sure. There's apical color views.
Q Oh, I'm sorry. In the apical. Okay. Under the settlement agreement, though, it's required to be measured under parasternal long axis; correct?
A If possible. If that's the best view.
Q Is it your understanding that if the para-if there is aortic regurgitation available in the parasternal long axis view, that you're required to use that?
A No. That is not my understanding.
Q Your understanding that you —
A My understanding is that that view should be preferred if it presents an optimal view.
Q Okay. Not just if it's available.
A "Available" covers an awful lot of ground. I would call that a very nonspecific term.
Q All right. Can you show me, if anywhere, where the jet height and LVOT measurements are on this study?
A Is this turning — okay. No, I cannot
Q Does that mean that you personally would have taken those measurements —
A Yes.
Q — during your review of this tape, or of this echo?
A Yes.
Q And we have no way — you have no way of — let's see. There's no way that you could save that work.
A Not on this study, no.
Q And you wouldn't have saved it on a disk or printed it out at all.
A No.
Q Okay. Do you feel — okay. We are now — we're in page 3 of 25; correct?
A Yes.
Q And this is the parasternal long axis view using color Doppler?
A Yes.
Q Is this a loop that you would rely on to diagnose moderate aortic regurgitation?
A Yes.
Q I'm going to pause this loop, starting at frame 1, if you could identify a frame for me that shows moderate aortic regurgitation.
A Sorry. I blinked my eyes:
This is the frame I would most likely have measured.
Q And this is frame 12 on page 3; correct?
A Yes.
Q Okay. Would you show me with the curser the points at which you would have put the — made the measurements of a jet height.
A I would have made the measurements of jet height approximately here and here.
Q Okay. You would not have made them closer to the origin of the jet.
A No.
Q Why not?
A Because — well, the jet doesn't really get started here. In other words, if you measure here, your jet is zero. And if you measure here, your jet is clearly not real because it's out in the LVOT. And so you measure a little bit below the origin of the jet, which would be here, where you have a good well-defined signal, still well within the LVOT by any criteria.
Q And that's — I'm sorry. You said the jet didn't get started right at the beginning of the color there?
A Right. The jet has to — I mean the jet — it's a cone. So it always starts from zero.
Q Uh-huh.
A So I would measure a little bit below the origin of the jet where it was — it's what looks to be its best representation of real height.
Q What is the Nyquist setting on this loop?
A 41.41.
Q Do you agree that that is less than the ideal Nyquist limit?
A Well, I wasn't there with the patient. So it's hard to say what's the ideal Nyquist limit. I would say it's a little on the low side but not outside the realm of practice.
Q Do you agree that with a higher Nyquist limit the aortic regurgitation may appear to be less?
A That is possible.
Q I've just pulled up frame 18 on Ms. Hartley's echo. Is this a measure of her tricuspid jet velocity?
A I do not believe so.
Q What is it?
A Well, I need to see the frame before if that's permitted. Where are you? Okay That's pretty clear. Do I move? Did it change?
Q Uh-uh.
A You'll have to forgive me because I don't read like this at home. I don't know how to make that —
MR. DALTON: Do you use a different program, Doctor?
THE WITNESS: Well, I use — I use Access Point, but it's configured very differently. It's just funny. I have full loops, and they go frame by frame. But that's okay.
Oh, it did that again. I can't see it bigger. I'm sorry. I don't mean to be giving you trouble. BY MS. HOWE:
Q No. Actually —
A No. You just changed — big mistake. You just changed the whole gain setting of everything.
Q I did?
A Yeah. You just made everything a lot darker.
Q Okay. Do you know how to fix it?
A Not precisely but — see how that gets darker and brighter? So that's something you can do with the — what frame were you referring to again?
Q Well, I think it moved now, but it was page 18.
A You want to look at page 18. Is this page —
Q Yeah.
A This is page 18.
Q Oh. Weil, it changed, then.
(Discussion held off the record.) BY MS. HOWE:
Q You know what? We'll move on to the next echo, actually.
A Okay. I'm not going to touch the mouse. I'm going to let you do everything, and we'll see how it goes.
VIDEOGRAPHER: Do you want to go off the record?
MS. HOWE: No. That's okay.
THE WITNESS: Let me get out of your way a little bit.
MS. HOWE: I'm just going to switch this.
(Discussion held off the record.)
MS. HOWE: Okay. We're back, in business. Sorry, guys. Okay.
Q Dr. Penn, we just pulled up the echocardiogram of Annette Kerr; is that correct?
A Yes.
Q Okay. There are 23 loops or still frames recorded here?
A Yes.
Q Under the settlement agreement, mitral regurgitation — let me step back a second. You diagnosed Annette Kerr or your report indicates moderate mitral regurgitation; correct?
A Correct.
Q And again, you told me you did not use a Singh criteria for that patient.
A Correct.
Q So we wouldn't expect to see planimetry here.
A Correct.
Q Would your assessment of mitral regurgitation have been based on anything but apical views?
A Yes. It would be based on all the views.
Q All right. How many apical views are recorded on this echo that would allow you to assess mitral regurgitation?
A It looks like one, two, three, four, five — I can't tell about that one. Five or six.
Q Okay. Let me pull up the first one you mentioned. That's page 14; correct?
A Yes. Yes. That's correct.
Q And is this an apical four-chamber view?
A No. It's an apical three-chamber view.
Q And can you assess mitral regurgitation in this view?
A Not very well.
Q Would you rely on it in your clinical practice?
A Not exclusively.
Q Would you rely on it at all?
A It has some validity, but it does not tell you everything about the mitral regurgitation.
Q Can you identify any frame showing mitral regurgitation on this view?
A You can see a tiny bit of mitral regurgitation here, but the majority of it is out of plane. I would certainly not make a diagnosis on this frame alone.
Q And you're at frame 6 on page 14.
A I haven't looked at all the frames.
Q Okay.
A If you give me just a second. Okay. That's frame one? Just page through.
I have looked at all the frames, and the ore 4 you identified is the one that shows a little bit of mitral regurgitation.
Q Okay. This is the left atrium?
A Yes.
Q Is this — what is — is that a heart chamber over there?
A Yes. That is the right ventricle.
Q Okay. So this is flipped around from what I'm used to seeing; is that right?
A Right. That was an apical three-chamber that's a little overrotated to catch a little part of the right ventricle. You have left ventricle here, left atrium here, left ventricular outflow tract here.
Q Okay. This frame, do you agree, does not represent moderate mitral regurgitation?
A I agree.
Q The next page is page 15.
A Yes.
Q This is a still frame; correct?
A Yes.
Q Would you rely on this for a diagnosis of any MR?
A No.
Q So we'll —
A That should end that discussion.
Q Yeah. Page 16, what view is that?
A This is an apical four-chamber.
Q Okay. Would you identify a frame that you feel represents mitral regurgitation.
A Okay. Let me look at it moving first. Okay. I would identify these three frames, frame No. 1, No. 2, and No. 3. Let me look at the rest of them. Yes. 1, 2, and 3.
Q Okay. Do you know how many frames per second are recording using the machine that i-Cardio used?
A Right here it says 16 frames per second.
Q Okay. I understand that you used an eyeball approach to this echocardiogram.
A True.
Q Is it your opinion that if you traced or cal — traced, planimetered and determined chat RJA/LAA ratio, you would come up with a ratio of greater than 20 percent?
A I don't have an opinion about that.
Q You would have to actually trace it yourself?
A Yes.
Q Okay. Okay. Just pulled up page 17, and if you could do the — excuse me What view is this?
A This is also — it looks like an apical four. Let me look at it in motion. It is a foreshortened apical four. This view is left ventricle, right ventricle, right atrium. There's left atrium here, but it's really oriented primarily at the aortic valve. I, would not make a mitral regurgitation diagnosis on this frame.
Q Okay. Let me ask you one question. Did you — was the — when you were using the Singh criteria, was the left atrium always traced in the same frame as the regurgitant jet area, or did you use the maximum left atrial area?
A It wasn't always in the same frame.
Q You used the maximum, whichever frame it may have been in?
A Most commonly I used whatever frame the tech measured, but I can't say that I looked at every single frame to find the maximum. The tech would find whatever frame seemed most appropriate to them.
Q And were they instructed to find the largest left atrium for their LAA measurement?
A That's a good question. I did review with them how to measure left atrial enlargement and where in the cardiac cycle it should be and that the apical four should be with the correct orientation and not off to one side or foreshortened or similarly off kilter. But I don't recall ever specifically directing them to find the maximum.
Q And I think we've got one more loop. Oh, it just happened again.
A It wasn't me.
Q I know it wasn't.
A Perhaps go to a different frame and. then come back to it. Yes.
Q Oh, you're brilliant. All right. And what view is this?
A Well, look see. It looks — well, it is a still frame.
Q Okay.
A It is again a slightly modified apical four, and it focuses primarily on tricuspid regurgitation.
Q You would not rely on this frame to diagnose mitral regurgitation.
A That is correct.
Q So as it turns out, there are two loops or cycles that you would use to diagnose this woman's mitral regurgitation; is that right?
A Correct.
Q What is — what is the Nyquist limit on this study?
A 46.
Q Do you agree that that's less than any idea! Nyquist limit?
A That may be less than ideal in this case.
Q Do you agree that if the Nyquist limit was higher, the mitral regurgitation may appear to be mild or even trace?
A That is possible.
Q Is frame 18 a measurement of her tricuspid jet velocity?
A Yes.
Q Do you agree with the placement of the curser in this case?
A Well, it's kind of tricky. If you look at this one, it looks like the line is a little bit below. Although if you look at this one, you could make a case that the line is a little bit above. See that?
Q I don't — I don't see that in the loop.
A You could make the argument that the line is too low in this — too high in this case. You could make an argument that the line is too low in this case. And this one looks just about right.
Q Okay. So is the measurement of 2.51 meters per second accurate in your opinion?
A I think it's pretty close, yes. I think it's reasonable.
Q In your practice do you usually take an average of a number of tricuspid jet velocities?
A No. One typically takes the maximum, provided you have a decent view.
MS. HOWE: We'll switch the C.D.
(Discussion held off the record.) BY MS. HOWE:
Q I just pulled up the C.D. of Roberta Rains; is that correct?
A Yes.
Q And you concluded that she had mild aortic regurgitation.
A Yes.
Q Again, I've looked and I can't find any of the measurements on this tape. Would you confirm that they're not there for me?
A I can confirm that the tech does not have measurements on this study.
Q Okay. So again, you would have done the planimetry yourself and recorded that on your report.
A Yes.
Q I just want to make sure I understand. It was i-Cardio's procedures in most cases to record the planimetry on the actual echo.
A Yes.
Q And you are unclear as to why they're not on these particular studies.
A I'm disappointed that they're not on the study.
Q Am I correct that page 2 is the only loop of color Doppler in the parasternal long axis view?
A Yes.
Q And if you blow up that page —
A You want me to push here; right?
Q Yeah. Look at that. Now we got this whole —
A Okay. Now you have it down.
Q Okay. Is this loop on page 21 that you would use to diagnose mild aortic regurgitation?
A I think not.
Q Okay. Why not?
A Well, I see a little flash here. Let me page through it a minute. Where am I? Frame 1. I would not use this to make a determination of mild aortic regurgitation.
Q Is there any aortic regurgitation reflected on this loop?
A The answer is — well, let me look before I talk. How's that?
Q So I'm safe to assume the measurements on your report were not taken in the parasternal long axis view.
A I would think not
Q Could you identify for me which frame they would have been taken.
A It's not moving anymore. Here we go. Oh, great. Let's look at this one.
Q We're on page 13 of 16; is that right?
A Yeah. Where does it say that? Yeah, right, 13 of 16.
Q And what view is that?
A This would be the apical three-chamber view. Frame 7 of loop 13 does appear to show some aortic regurgitation.
Q Could you measure the jet height and LVOT in this frame?
A That would be a challenge. The jet height would be from there to there. I would have difficulty measuring the LVOT in this frame.
Q Is this the origin of the jet?
A Let me take a — move your pen for a minute there.
(Discussion held off the record.)
THE WITNESS: Yes, it could be because this is a fairly foreshortened view. And so it's not — it looks different than either a parasternal long or an apical three would normally look. BY MS. HOWE:
Q Where is the left ventricle in this view?
A Here-ish.
Q Is it possible that you used this frame to measure the jet height that's recorded in your report?
A That is possible.
Q But the LVOT is not — it's not possible that you used that frame.
A That would seem very unlikely.
Q Okay. Are there any other frames on this C.D. that you would have used to measure the jet height and/or the LVOT?
A Let me look. This is frame 13. Did we talk about this one already?
Q No.
A This is new to us. Okay. This, again, is a little bit foreshortened.
Q What view is this?
A This is, again, an apical three-chamber view. Here again you can see aortic regurgitation in a couple of frames. Frame 9 — 10 is a little tricky, but, again, in frame 11 and frame 12 which is just a tiny little dot of AI.
Q Will you go back it frame 9 for me? Where is the aortic regurgitation there?
A It looks like this element here is aortic regurgitation.
Q Are you talking about blue splotch specifically?
A Yeah, this little cone-shaped splotch here, both orange and blue.
Q Would you use that frame to measure jet height?
A Typically not.
Q Okay.
A It would be — it might be a tricky thing to do.
Q Is there a frame on this loop you would use to measure jet height?
A I might use this frame here.
Q Frame 11?
A Frame 11.
Would you point for me where you would take those measurements?
A From here to here.
Q Would you measure —
A You see it's sort of a cone going out this way. So it's pretty — really a judgment call where to measure. Something there to there clearly is a velocity of blood going backwards from the aortic valve.
Q Would you measure the LVOT using this frame?
A You could here. You could measure from here, for example, to here and get a pretty good estimation of LVOT.
Q is it possible that you used that frame to come up with —
A That is possible.
Q — 2.6?
A Yes.
Q Okay. Are there any other frames on the C.D. that you could have used to come up with these measurements?
A Which ones?
Q I'm sorry. The jet height and LVOT.
A Okay.
Q I think that was a parasternal we looked at earlier
A This is the parasternal. Now, this is not a color as you can see. But I believe that LVOT height can be measured quite reasonably in this view.
Q Is it appropriate to measure the jet height and LVOT in different views?
A It's unclear. I'm not aware of any specific article that addresses that.
Q Is it possible you did that in this case?
A It is possible.
Do you have any other questions?
Q Again, I just want — if there are any other frames you would have used to come up with these measurements on this echo that we haven't talked about.
A Okay. Fair enough. This is confirming a bit of AI, but I would not have made those measurements on this frame.
Q You're talking about frame 12?
A Yes. It's a continuous wave Doppler through the aortic valve, I think, showing a normal left ventricular outflow velocity and a little bit of AI. That's it.
Q What is the Nyquist setting on this study?
A You should have asked me that a second ago. Hold on. Let me blow that up again. You can't read that, can you? 41. 41.
Q Do you agree that the Nyquist is less than ideal in this case?
A That is possible.
Q And do you agree that with a higher Nyquist, the aortic regurgitation may appear to be less or even trace?
A Yes.
MS. HOWE: I don't have any more questions for you today. But if you do find documents, I may have questions about those and would ask to reconvene the deposition at that point. But for tonight I am done.
MR. DALTON: And you'll only reconvene it if the documents lead to something else. Is that what you're saying?
MS. HOWE: Yes.
MR. DALTON: Okay. I don't have any questions either.
The court reporters have taken down everything that's been said today. They're going to make that into a little booklet, and you have the right to read that over. If there's anything that you thought was taken down incorrectly, they give you a separate sheet of paper, and you can make corrections on that separate piece of paper, or you can waive that right. These are certified court reporters and typically they do take things down correctly. The option's up to you.
THE WITNESS: I'll review.
MS. HOWE: Thank you, Dr. Penn, for your time.
VIDEOGRAPHER: This concludes today's proceeding and the deposition of Joshua Penn, M.D. The total number of videotapes used was two. We're going off the record. The time is 8:10 p.m.
I, JOSHUA PENN, M.D., do hereby declare under penalty of perjury that I have read the foregoing transcript; that I have made such corrections as noted herein, in ink, initialed by me, or attached hereto; that my testimony as contained herein, as corrected, is true and correct.
EXECUTED this __________ day of ______________, ______________, at _______________, ___________________ (City) (State)
I, the undersigned, a Certified Shorthand reporter of the State of California, do hereby certify:
That the foregoing proceedings were taken before me at the time and place herein set forth; that any witnesses in the foregoing proceedings, prior to testifying, were placed under oath; that a verbatim record of the proceedings was made by me using machine shorthand which was thereafter transcribed under my direction; further, that the foregoing is an accurate transcription thereof.
I further certify that I am neither financially interested in the action nor a relative or employee of any attorney of any of the parties.
IN WITNESS WHEREOF, I have this date subscribed my name.