Opinion
MDL No. 1203, Civ. No. 99-20593
September 19, 2003
Peter L. Zimroth, ARNOLD PORTER, New York, NY, for Defendant Wyeth
Peter T. Grossi, Daniel S. Pariser, ARNOLD PORTER, Washington, DC, for Defendant Wyeth
Orran L. Brown, BROWNGREER PLC, Richmond, VA, for Defendant Wyeth
Michael T. Scott, Paul B. Kerrigan, REED SMITH LLP, Philadelphia, PA, for Defendant Wyeth
PRETRIAL ORDER NO.___
AND NOW, this __ day of September, 2003, upon consideration of Certain Class Members' Expedited Motion for an Order Suspending the Claims Integrity Program and the Medical Practices Questionnaires Deadlines, it is hereby ORDERED that said motion is DENIED.
WYETH'S OPPOSITION TO CERTAIN CLASS MEMBERS' EXPEDITED MOTION FOR AN ORDER SUSPENDING THE CLAIMS INTEGRITY PROGRAM AND THE MEDICAL PRACTICES QUESTIONNAIRES DEADLINES INTRODUCTION AND SUMMARYWyeth has recently uncovered evidence of the systematic abuse of the Matrix Claims process on a scale beyond anything that could have been imagined by the parties to the Settlement Agreement. This evidence has been obtained from a number of depositions, taken in Intermediate Opt-Out cases, of physicians who have collectively certified about 15, 000 Green Forms at the behest of plaintiffs' counsel. Wyeth has similarly deposed the employees of a few of the "echo mill" companies that have conducted more than 100, 000 echocardiograms on diet drug patients. Even that limited discovery suggests that the corruption in the Matrix claims process is so pervasive that it cannot be remedied either by the 100% audit program (which is not designed to cure the many violations of the Settlement Agreement that have been uncovered) or the step under attack here.
The Trust needs to design remedies for what is plainly a major problem; and it needs to do so quickly before more of the Trust's limited assets are squandered. The step taken by the Trust under attack here, sending questionnaires to certain doctors, is clearly authorized by the Settlement Agreement. Wyeth's concern, however, is that that step does not go far enough to ensure that the only claimants paid are those who meet the requirements of the Settlement Agreement.
There are three parts of the problem. First, as set forth in further detail below, there are the echo mills that have generated huge numbers of echocardiograms that now appear to form the basis of tens of thousands of Green Form claims. Those echocardiograms were typically conducted by unsupervised technicians — a clear violation of the Settlement Agreement. The echo mills were an immensely profitable business — but they had nothing to do with providing medical care to the claimants.
Second, there are the Green Form certifiers retained by plaintiffs' counsel to read the echocardiograms and sign the forms. As discussed below, they have likewise earned millions of dollars pursuant to exorbitant fee arrangements which typically rewarded the doctors with huge additional compensation for finding that a claimant was entitled to Green Form benefits. They were not reviewing the echocardiograms for any medical purpose — in many cases even expressly denying the existence of any doctor-patient relationship. Rather, the certifying doctors were generating readings solely for litigation purposes. And, while these doctors then signed thousands of Green Forms, they almost never saw the patients or reviewed any of the claimants' medical records but instead relied entirely on information provided by the claimants' attorneys to make tens of thousands of unsupported representations about the medical history of the claimants. That was yet another violation of the Settlement Agreement.
Third, there are the lawyers themselves who set up these operations and matched the illegitimately acquired echocardiograms with the litigation doctors — and then provided massive financial incentives such that the scans, readings and certifications were clearly biased.
The Court had a brief glimpse into the workings of one of these operations — as it turns out one of the smaller operations — when it heard testimony on the practices of the Hariton/Napoli consortium, and their retained experts Dr. Grouse and Dr. Mueller, in September 2002. Following that hearing, and faced with a wave of Matrix claims far in excess of that predicted by the sound epidemiological evidence, the parties then asked the Court to require the Trust to audit 100% of the Matrix claims. The Court granted that relief, holding — based only on information presented regarding the number and characteristics of the claims submitted to the Trust — that "something may be seriously amiss" in the claims filing process. PTO 2662, at 12.
Based even on the limited deposition evidence from this summer, it is clear that something is seriously amiss. Orchestrated by plaintiffs' counsel, echo mills and litigation doctors have abused the Matrix claims process on a scale that makes the Hariton/Napoli operation look quaint by comparison. Echocardiograms that are created by technicians who are not supervised by a board-certified cardiologist cannot qualify Class Members for Matrix benefits. Echocardiogram readings rendered solely for litigation purposes, rather than for the medical care of the plaintiffs, cannot constitute "diagnoses" of PDA Positive regurgitation by "medical" personnel as those terms are employed in the Settlement Agreement. And physicians cannot properly certify Green Forms without reviewing Class Members' medical records or taking a bona fide medical history. In sum, the parties to the Settlement Agreement did not intend to allow the Matrix claims process to be hijacked by lawyers stamping out tens of thousands of baseless claims solely for litigation purposes, outside of the context of the medical care of the Class Members.
Given what is now known about the practices of these physicians and echo mills, it is plainly not sufficient to rely on audits to weed out the thousands of invalid claims. The audit process defers to the sound judgment of a physician whose opinion has a "reasonable medical basis." Settlement Agreement § VI.E.7. But the audit system was premised on the expectation that the claims would be based on echocardiograms taken in the course of bona fide medical practice by properly supervised technicians, and then certified by doctors who have some responsibility for the medical care of their patients. That rationale for deference is absent when the echocardiogram on which a claim is based was conducted and interpreted as part of a "mass production" process that violates the Settlement Agreement.
Nor should the Trust's valuable time and resources be spent auditing such claims that are facially invalid under the terms of the Settlement Agreement. The parties bargained for the requirements in the Settlement Agreement that echocardiograms be supervised by qualified doctors, and that bona fide "diagnoses" be rendered by "medical" personnel, so that there could be some threshold level of reliability in those Matrix claims submitted to the Trust for further medical review. The medical doctors and properly supervised technicians were supposed to act as a screen; and the audit process was only intended to check that screen. It was never supposed to be a substitute for what the claimants, their doctors and lawyers were supposed to be doing in the first place.
ARGUMENT
I. THE SETTLEMENT AGREEMENT'S REQUIREMENTS FOR THE CONDUCT AND EVALUATION OF ECHOCARDIOGRAMS AND THE SUBMISSION OF GREEN FORMS
As the Court is well aware, the Settlement Agreement requires that Class Members seeking Matrix benefits meet specified medical criteria. A Class Member must have the medical conditions — such as specified levels of regurgitation and certain "complicating factors" — required under the Settlement Agreement to qualify him or her for the Matrix. But there are other requirements that the Settlement Agreement also imposes on Class Members seeking Matrix benefits that, in effect, must precede the question of whether those medical measurements are satisfied.
Specifically, to serve as a basis for a Matrix claim, the echocardiogram upon which the claim is based must first have been conducted in a manner meeting certain requirements — including that it be conducted under the supervision of a board-certified cardiologist or cardiothoracic surgeon. In addition, a qualified doctor acting in a medical capacity must render a "diagnosis" of PDA Positive regurgitation — not merely provide the claimants' counsel with a "reading" of an echocardiogram obtained solely for litigation purposes in exchange for exorbitant fees. And the Settlement Agreement requires that a physician certifying a Green Form must actually have reviewed the claimants' medical records or taken a bona fide medical history. Because plaintiffs' counsel have so ignored those provisions, they warrant a brief review.
First, the Settlement Agreement requires that the echocardiogram tape be acquired in a specified manner to serve as the basis of a Matrix claim. Settlement Agreement § Vl.C.l.b.(1), (3)-(4). As this Court has previously noted, the echocardiogram must be "conducted in accordance with the standards and criteria as outlined in Feigenbaum (1994) or Weyman (1994)," two seminal medical texts. Id. § VLC.l.b.(1) (footnotes omitted). The Settlement Agreement further requires that the echocardiogram be "conducted under the supervision of . . . a Board-Certified Cardiologist or Board-Certified Cardiothoracic Surgeon with level 2 training in echocardiography as specified in the Recommendations of the American Society of Echocardiography Committee on Physician Training in Echocardiography." Id. § VI.C.l.b.(4) (emphasis added). See also PTO 2640, at 9-10 (discussing the Settlement Agreement's requirements for acquiring an echocardiogram).
These requirements are critically important because the manner in which an echocardiogram tape is recorded can dramatically affect the results of the examination. As the Court recognized in PTO 2640, "by adjusting even slightly the settings on the [echocardiogram] machine, a cardiologist or sonographer can influence and even distort the quality of the image that he or she sees. Over-manipulated settings can produce false images, including artifacts and phantom jets." Id. at 11. And while some errors in creating echocardiographic images are so apparent that an invalidly acquired tape can be rejected as such by a reviewing cardiologist, that is not always the case. For example, a technician may artificially inflate the degree of regurgitation shown on the tape by improperly setting the "gain" or "Nyquist" levels on the machine, and yet a reviewing cardiologist may not be able to say whether those settings were justified if it was a truly unusual case — such as an exceptionally obese patient. That is why proper supervision of the technician is so important and was therefore required by the Settlement Agreement.
Second, to assert a proper Matrix claim, a plaintiff who has a Matrix level condition must first have been "diagnosed" by a cardiologist with a specified level of training as having FDA Positive regurgitation. Settlement Agreement § TV.B.I.a. (stating that otherwise eligible Class Members "who have been diagnosed by a Qualified Physician as FDA Positive or as having Mild Mitral regurgitation by an Echocardiogram performed between the commencement of Diet Drug use and the end of the Screening Period" are eligible for Matrix benefits if they also reach a Matrix level condition). The drafters used the term "diagnosed" in Section IV. B. I. a of the Settlement Agreement in order to require something more than having an echocardiogram read by a retained litigation expert, without any connection to the medical care of the patient. The act of rendering a diagnosis under the Settlement Agreement is inextricably linked to the treatment of a patient. As one authority has explained, reflecting the intent of the Agreement in this regard, "physicians diagnose patients as a means to the end of identifying the most appropriate therapy." Lars Noah, Pigeonholing Illness: Medical Diagnosis as a Legal Construct, 50 HASTINGS LJ. 241, 246 (1999) (citing Edmund D. Pellegrino David C. Thomasma, A PHILOSOPHICAL BASIS OF MEDICAL PRACTICE 211 (1981)). See also Robert A. Aronowitz, MAKING SENSE OF ILLNESS 246 n. 20 (1998) ("[D]iagnosing disease is an act with consequences, not merely a cognitive exercise that matches a particular patient to a specific disease criteria.").
A Class Member who is timely diagnosed with only Mild Mitral regurgitation is also eligible for Matrix benefits if he or she later reaches a Matrix level condition. Settlement Agreement § IV.B. 1. a. However, such a Class Member may recover only on the 20% payment "Matrix B."
Id. § IV.B.2.d.(2).
The Settlement Agreement's definition of PDA Positive regurgitation confirms that echocardiograms must be evaluated in the context of a patient's medical care — and not merely for litigation purposes — to qualify a Class Member for Matrix benefits in the event that he or she reaches a Matrix level condition. The Agreement provides that diagnoses of PDA Positive regurgitation must be "measured by an echocardiographic examination performed and evaluated by qualifiedmedical personnel" following the specific protocols outlined in the Weyman and Feigenbaum texts. Settlement Agreement § L22.b. (emphasis added).
Evaluation of an echocardiogram by qualified "medical" personnel means something more than a sign-off by a cardiologist who happens to hold an appropriate medical degree. The section of the Settlement Agreement addressing qualification to assert a Matrix claim already requires that a diagnosis be rendered by a "Qualified Physician," id. § IV.B.l.a., which is in turn defined as a "Board-Certified or Board-Eligible Cardiologist" Id. § 1.47. Rather, the additional requirement that echocardiograms be evaluated by "medical" personnel means that the cardiologist must evaluate the echocardiogram in his or her capacity as a physician practicing medicine — not as a hired litigation expert who never sees or speaks to the Class Member and has no responsibility for the Class Member's medical care.
The Settlement Agreement's requirement that diagnoses of FDA Positive regurgitation be grounded in bona fide medical practice is further confirmed by the manner in which the Screening Program within the Settlement was supposed to operate. The Screening Program benefits offered under the terms of the Agreement include more than the performance of the echocardiogram test itself. Those benefits also include an "interpretive physician visit" that permits the evaluating doctor to see and talk to the patient regarding the test results and what those results mean for the patient's care. Id. § IV. A. 1. a. In other words, the Settlement Agreement requires that the physician evaluating the echocardiogram be involved in the medical care of the patient.
Just as importantly, the echocardiograms performed in the Screening Program are not intended to be performed for purposes of maximizing a claimant's potential recovery in litigation, but rather to enable the patient to obtain necessary medical treatment. As Judge Bechtle explained in his opinion approving the Settlement Agreement, the Screening Program benefits the health of Class Members because "early diagnosis will permit . . . individuals to receive antibiotic prophylaxis when having dental and surgical procedures" to minimize the risk of endocarditis. In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig., MDL No. 1203, 2000 WL 1222042, at *25 (E.D. Pa. Aug. 28, 2000). Moreover, the Settlement Agreement provides that, if a Class Member is timely diagnosed with PDA Positive regurgitation through the Screening Program or otherwise, the Class Member is entitled to an election of either "medical services" to cover the cost of further monitoring or treatment of the patient or cash that the claimant may use for that purpose. Settlement Agreement § IV. A. 1. c.; IV.A.2.C. When taken together with these continuing medical surveillance benefits, Judge Bechtle found that the Screening Program will "permit [diet drug users] to obtain medical and surgical treatment of their valve disease" if necessary. In re Diet Drugs, 2000 WL 1222042, at *25.
While the Settlement Agreement permits claimants to elect to obtain echocardiograms outside of the Screening Program, it did not intend for dramatically different standards to apply to individuals who obtained private echocardiograms. The same definition of PDA Positive regurgitation applies to individuals who obtain echocardiograms through the Screening Program and those who obtain echocardiograms outside of the Program. Settlement Agreement § I.22.b. And the Settlement Agreement thus requires privately obtained echocardiograms to be performed and evaluated within the context of providing bona fide medical care to the patient, just as the Agreement intended for echocardiograms performed within the Screening Program.
The Settlement Agreement's requirement that a diagnosis be rendered in the context of clinical practice in order to qualify a Class Member for Matrix benefits also makes common sense. When a diagnosis is rendered and communicated to the patient in the course of medical practice, the physician owes a duty of care to the patient — a duty that, if breached, can lead to an action for malpractice. But a litigation expert owes no such duty of care to the patient. When a physician is hired by an attorney solely to evaluate an echocardiogram for litigation purposes, he or she is not constrained by any such duty from rendering an opinion that is unreasonable simply to accommodate the financial interests of his or her employers. See Ervin v. Am. Guardian Life Assurance Co., 545 A.2d 354, 357 ( Pa. Super. 1988) ("[A] physician who is retained by a third party to conduct an examination of another person and report the results to the third party does not enter into a physician-patient relationship with the examinee and is not liable to the examinee for any losses he suffers as a result of the conclusions the physician reaches or reports.") (quotation omitted), appeal denied, 562 A.2d 826 (Pa. 1989); Felton v. Schaeffer, 279 Cal.Rptr. 713, 716 (Cal Ct. App. 1991) (noting "overwhelming agreement" among other jurisdictions that "a physician has no liability to an examinee for negligence or professional malpractice absent a physician/patient relationship, except for injuries incurred during the examination itself). The Settlement Agreement did not intend for a Class Member to be qualified for Matrix benefits on the basis of such an opinion unconstrained by any duty owed to the patient, and formed solely for purposes of litigation in return for the payment of millions of dollars from a lawyer.
Third, assuming that an echocardiogram is properly acquired and then interpreted in the context of the medical care of the patient, a cardiologist who certifies a Green Form on behalf of a Class Member must actually take the claimant's medical history in a manner that would be deemed acceptable in the world of clinical practice — and certify under penalty of perjury that he or she has done so. The Green Form — the text of which was attached as an Exhibit to the Settlement Agreement and approved by the Court — explains: "[i]n completing the form you may consider, rely upon and use the patient's echocardiograms, medical records and reports, hospital records or reports, the patient's medical history or other sources of information you regularly and routinely use in your practice." Green Form at 7 (Exh. 1 hereto) (emphasis added). There is simply no justification for giving deference to the echocardiographic and medical conclusions of doctors who routinely make false or misleading certifications.
The audit system established in the Settlement Agreement affords substantial deference to claims that are submitted in accordance with these three requirements precisely because it was assumed that thosemedical requirements would act as a constraint on invalid Matrix claims. See Settlement Agreement § VI.E.7 (providing that claims in audit are affirmed if they have a "reasonable medical basis"). In effect, the parties presumed a certain level of reliability inherent in Green Form claims based upon echocardiograms that were conducted under the supervision of a cardiologist practicing medicine, that resulted from bona fide diagnoses of the patients rendered by qualified doctors in the context of the medical care of their patients, and that included a review of the patients' medical histories as would be conducted in the course of ordinary clinical practice. But, as set forth below, the basis for this deferential claims administration regime has been dramatically undermined by certain claimants' lawyers and the lucrative "industry" of echo mills and assembly-line readers they have spawned.
II. HUGE NUMBERS OF MATRIX CLAIMS HAVE BEEN GENERATED THROUGH "ECHO MILL" SCREENING OPERATIONS DESIGNED FOR LITIGATION PURPOSES RATHER THAN FOR THE MEDICAL CARE OF THE CLASS MEMBERS
In depositions taken this summer in a few Intermediate Opt-Out cases, physicians and echo mill owners responsible for generating tens of thousands of Green Forms have testified to a pattern of gross negligence and biased conduct that has infected the entire Matrix claims process. It should be noted that these facts have been gathered as part of a limited inquiry into the financial bias and general practices of these doctors who were also serving as experts in those litigation cases. The depositions did not focus on these physicians' procedures for completing Green Forms per se — and, in fact, were limited by plaintiffs' counsel who would not permit extended questioning on such issues.
The following transcripts containing relevant testimony are attached as exhibits: Deposition of Stephen A. Bloom, MD, Brinkley v. Wyeth (Pa. Ct. Com. PL) (July 26, 2003) (Exh. 2 hereto); Deposition of Paul Braum, Eichmiller v. American Home Products Corp. (Ga. Super. Ct.) (Aug. 19, 2003) (Exh. 3 hereto); Deposition of Richard Callihan, MD, Montague v. Wyeth (E.D. Pa.) (July 1, 2003) (Exh. 4 hereto); Hearing Testimony of Linda Grouse, MD, Brown v. American Home Products Corp. (E.D. Pa.) (Sept. 9, 2002) (Exh. 5 hereto); Deposition of Winston Gandy, MD, Brand v. Wyeth ( Pa. Ct. Com. PL) (July 23, 2003) (Exh. 6 hereto); Deposition of Byron Griffith, Splettstosser v. Wyeth (Tex. Dist. Ct.) (Sept. 12, 2003) (Exh. 7 hereto); Deposition of Alfred Eugene Hutcheson, MD, James v. Wyeth (Miss. Cir. Ct.) (May 22, 2003) (Exh. 8 hereto); Deposition of Bradley M. Leonard, MD, Hazel wood v. Wyeth (E.D. Pa.) (June 26, 2003) (Exh. 9 hereto); Deposition of Sharon Lilley, In re: Diet Drugs (N.D. Tex.) (June 24, 2003) (Exh. 10 hereto); Deposition of Marti McCulloch, In re: Diet Drugs (S.D. Tex.) (July 26, 2003) (Exh. 11 hereto); Deposition of Michael McElroy I, Smart v. American Home Products Corp. (Tex. Dist. Ct.) (Nov. 21, 2002) (Exh. 12 hereto); Deposition of Michael McElroy II, In re: Diet Drugs (S.D. Tex.) (July 26, 2003) (Exh. 13 hereto); Deposition of George G. Miller, MD, In re: Diet Drugs (S.D. Tex.) (July 11, 2003) (Exh. 14 hereto); Deposition of Waenard Miller, MD, In re: Diet Drugs (N.D. Tex.) (June 27, 2003) (Exh. 15 hereto); Deposition of Gerald I. Polukoff, MD, In re: Diet Drugs (E.D. Pa.) (Aug. 26, 2003) (Exh. 16 hereto); Deposition of Robert W. Scruggs, Eichmiller v. American Home Products Corp. (Ga. Super. Ct.) (Aug. 19, 2003) (Exh. 17 hereto); Deposition of Abdur Razzak Tai, MD, Andro v. Wyeth (Pa.Ct.Com.Pl.) (July 17, 2003) (Exh. 18 hereto); Deposition of Malcolm Taylor, MD, Aldrich v. Wyeth (Pa.Ct.Com.Pl.) (July 16, 2003) (Exh. 19 hereto); and Deposition of Timothy Winans, In re: Diet Drugs (S.D. Tex.) (July 26, 2003) (Exh. 20 hereto).
But even from this limited glimpse into these doctors' conduct, it is plain that they, working with various echo mills, have not "diagnosed" Class Members with heart valve regurgitation entitling them to Matrix benefits under the terms of the Settlement Agreement. Instead, they were engaged in an "assembly-line" echocardiogram reading process implemented solely for litigation purposes, pursuant to excessive payment arrangements that often rewarded them for finding significant valvular regurgitation. Their readings were typically based on echocardiograms conducted at immensely profitable "echo mills" by itinerant and unsupervised technicians operating in non-medical facilities such as hotel rooms. And neither the doctors nor their medical staff reviewed the claimants' medical records or took a medical history, but rather relied on the information provided to them by the Class Members' lawyers to certify Green Forms on their behalf.
A. The Green Form Certifiers Deny Any Doctor-Patient Relationship With The Claimants
The impropriety of the certifying doctors' assembly-line process begins with something as basic (but profound) as the fact that the certifiers do not even claim to have a doctor-patient relationship with the claimants. To the contrary, they typically deny that any such relationship ever existed.
For example, Dr. Bradley Leonard — who has certified approximately 900 Green Forms — testified that "[m]y understanding was that there was not a doctor-patient relationship with respect to my reading and interpreting the echocardiograms." Leonard Tr. at 57-58. Dr. Razzak Tai, who has signed nearly 1500 Green Forms, similarly testified that he did not consider himself to have a doctor-patient relationship with the plaintiffs whose echocardiograms he read. Tai Tr. at 54.
Another cardiologist who has himself certified nearly 3000 Green Forms, Dr. Waenard Miller, went as far as to expressly disclaim on the face of numerous of the echocardiogram reports that he authored, "INTERPRETATION OF THIS STUDY BY THE ABOVE-NAMED PHYSICIAN DOES NOT CONSTITUTE A DOCTOR/PATIENT RELATIONSHIP." E.g., Exh. 21 hereto. See also W. Miller Tr. at 40-41; Lilley Tr. at 55-56. Dr. Miller testified that he included this language on the advice of his personal lawyers. W. Miller Tr. at 43-44. Dr. Miller likewise testified that he never reported to his malpractice carrier his participation in the mass echocardiogram screenings he performed for the lawyer who hired him, Mr. Kip Petroff. Id. at 44.
As discussed below, Ms. Lilley was a technician hired by attorney Kip Petroff to train other technicians who then created echocardiogram scans directly for Mr. Petroff and his clients. As such, she saw the interpretation forms of not only Waenard Miller, but also George Miller and Robert Rosenthal — other doctors retained by Mr. Petroff who together certified approximately 3000 more Green Forms. Ms. Lilley recalled that their forms had similar denials of a doctor-patient relationship. See Lilley Tr. at 218.
Indeed, at his deposition, Dr. Miller testified that he believed his lack of any direct contact with Mr. Petroff s clients negated not only such a relationship, but also any responsibility on his part to transmit any adverse findings directly to the claimant. Dr. Miller's relationship was with the lawyer, not the client:
Q. What does it mean when it says that this interpretation does not constitute a doctor/patient relationship?
A. It means that there has been no face-to-face encounter with the client by a physician — by the physician that read that.
Q. Is that, in your judgment, essential to the establishment of a doctor/patient relationship?
A. Yes, it is, actually.
* * *
Q. Doctor, would you agree that if you felt that there was significant valvular disease in any of these people, the 13, 000 people that this group evaluated, that you were under some sort of obligation to be sure that at least their primary care physician was alerted to that fact?
MR. PETROFF: Object to the form.
A. If I have a doctor/patient relationship with them, absolutely correct. If I don't have a doctor/patient relationship with them, I don't have a means of doing that.
Q. . . . What —
A. I don't have a means of going to the patient and saying, yes, you need to have a cardiologist, or, yes, you need to see a primary care physician and — I just — I don't have a means of doing that.
Q. Did you ever tell any of the representatives of any of the lawyers for whom you've worked in this area that as to any patient, it was important that they be sure that the patient took your report to another specialist so that they could be appropriately monitored from a cardiac perspective?
A. What I did was I would raise the issue of significant valvular disease, but I did not direct anyone about how to proceed or notify. I — I did not do that.Id. at 41, 130-131 (emphasis added).
This acknowledged disregard for any direct physician contact with the patient is obviously contrary to any standard of clinical practice in which a doctor — be it the echocardiogram reader or a referring cardiologist consulting with the echocardiogram reader — provides the results and recommended treatment directly to the patient.
In sum, these retained Green Form certifiers were not practicing medicine on patients but were rather solely engaged in a legal process at the behest of their "customers" — the claimants' law firms. Litigation readings by such doctors cannot suffice to constitute "diagnoses" by "medical personnel" sufficient to qualify the claimants for Matrix benefits. Such readings should not be given the deference due to readings made by doctors who owe a duty of medical care to the claimant.
B. The Green Form Certifiers Earned Huge Fees For Reviewing Thousands Of Echocardiograms For Only A Few Minutes Each, Under Fee Arrangements Biasing Them To Inflate Their Readings
Another indication of how the "echo mill" approach of these cardiologists differed from clinical practice is the sheer volume of their echocardiogram reviews and Green Form filings — as well as the payment arrangements that accompanied their work for plaintiffs' counsel.
As the Court will recall, Dr. Linda Crouse testified at the Hariton/Napoli hearing that, by spending only minutes on each "interpretation, "she was able to complete some 10,000 echocardiogram reads working part-time for less than a year — thereby earning some $2.5 million. Crouse Tr. at 34-35, 135-36. But we now know that neither Dr. Crouse's rapid-fire approach nor her inflated fees was unique.
For example, Dr. Waenard Miller admitted that, with only a small amount of help from others in his practice, he signed some 13, 000 interpretations working part-time on weekends. W. Miller Tr. at 11, 46. By his own estimate, Dr. Miller spent only 10-25 minutes per read and 10-15 minutes on each Green Form — ultimately generating about $2.5 million in fees. Id. at 23, 47-48.
Dr. Eugene Hutcheson similarly testified that he reviewed approximately 9000 echocardiograms at about 10 minutes per study. Hutcheson errata sheet. And Trust records show that he submitted more than 1800 Green Forms. At the piece-work rates of $250 per echocardiogram and $1500 per completed Green Form to which he has now testified, this part-time work over 17 months netted him approximately $5 million. Id.
At his deposition, Dr. Hutcheson testified that he had read "roughly 3000" tapes for $125 per reading. He could not testify as to exactly how many Green Forms at $750 per form he had completed. Hutcheson Dep. at 185-86. But when he reviewed his deposition transcript, he changed his testimony to increase the number of readings to 9000 — and recalled that he had charged $250 for each interpretation and $1500 for each of the 1868 Green Forms the Trust has received from him alone. (The errata sheet reflecting this change is included at the end of Dr. Hutcheson's deposition transcript which is attached as an exhibit.) Hence the $5 million estimate of his fen-phen earnings.
In addition to these doctors, it appears — from their own best estimates of the number of readings they made and Trust data on the number of Green Forms certified — that at least three other physicians have made in excess of $1 million each for their work churning out echocardiogram reports and Green Forms — Winston Gandy ($1.7 million) (Gandy Tr. at 31-32, 67-68); Malcolm Taylor ($1.2 million) (Taylor Tr. at 17-19, 60-61); and George Miller ($1.1 million) (G. Miller Tr. at 60-61). Two other doctors that Wyeth has deposed, Stephen Bloom and Gerald Polukoff, appear to have made almost $1 million from their Green Form and echocardiogram reading work. Bloom Tr. at 124-25; Polukoff Tr. at 10-14. And a number of the other doctors who have filed huge numbers of Green Forms for some of the larger plaintiffs' firms — for example, Dr. Mark Levinson who alone has certified over 2000 Green Forms primarily for firms in Mississippi — no doubt have made similar amounts of money, but have never been questioned on these topics.
Not only did the doctors earn outrageously large payments for reviewing thousands of echocardiograms in an assembly-line fashion, many of them worked under skewed fee arrangements that provided them with substantial additional compensation for completing and signing Green Forms based on their echocardiogram findings.
For example, Dr. Waenard Miller was paid $150 for the interpretation of an echocardiogram, which he estimated took him between 10 and 25 minutes. W. Miller Tr. at 20-21, 46-47. Significantly, Dr. Miller was paid substantially more to complete the Green Form — $250 — than to read an echocardiogram, even though he admitted that it took him only 10-15 minutes to complete the form. Id. at 20-21. Based on his own estimates, Dr. Miller was thus paid on average $1250 per hour to fill out Green Forms — more than twice the $500 per hour rate he was paid to interpret echocardiograms. His fee arrangement was thus structured to pay him substantially more money per hour if he found a claimant to have the levels of regurgitation that warranted completion of a Green Form.
Dr. Hutcheson's arrangement was even more outrageous. He testified that he was typically able to review and complete a Green Form in only 5 minutes, half as long as it took him to interpret an echocardiogram. Hutcheson Tr. at 188. Given that he was paid $250 for each echocardiogram interpretation, but $1500 for each Green Form he filled out for claimants who ostensibly qualified for Matrix benefits, Dr. Hutcheson was biased in favor of Matrix claim readings by the tantalizing prospect that he could spend his spare time signing Green Forms at the almost unbelievable rate of $18,000 an hour — as opposed to a "mere" $1500 or so per hour on echocardiogram interpretations. Id. at 185. Such a financial arrangement plainly biased the certifying doctor to find Matrix benefits and should, without more, render those readings illegitimate.
C. Echocardiograms Reviewed By The Certifiers Were Typically Conducted By Unsupervised Technicians In "Echo Mill" Operations Established Solely For Litigation Purposes
Consistent with their "mass production" world, these Green Form certifiers admit that neither they nor anyone else in a normal medical practice conducted the echocardiograms that they reviewed. Indeed, they typically did not even know, much less supervise, the technicians who set the machines, made the scans, and then measured the relevant jets and chamber sizes. Tai Tr. at 170-72; G. Miller Tr. at 67; W. Miller Tr. at 33. Rather, the echocardiograms were taped in hotel rooms or lawyer offices by itinerant technicians sent out by either an ad hoc, "fen-phen echo mill" — with no history or purpose other than diet drug litigation — or hired directly by the lawyers themselves.
One such mill — an outfit called EchoMotion — conducted more than 70, 000 echos on diet drug claimants in about a year. Winans Tr. at 19-20. According to its principals, EchoMotion has never conducted a single echocardiogram on any non-diet drug claimant and is now essentially out of business. See id. at 18-19; McElroy II Tr. at 42; McCulloch Tr. at 105-106.
EchoMotion (whose phone number was the memorable "866-FEN-ECHO") was founded by an echocardiogram technician who had done a few fen-phen scans for Dr. William Shell for no purpose other than the diet drug litigation. Winans Tr. at 18; McElroy II Tr. at 6-10. EchoMotion recruited its technicians from a list of its founder's friends and then scheduled scanning sessions for them around the country. See McElroy II Tr. at 16, 44. The technicians were required to scan about 30 echocardiograms each day in hotel rooms or lawyer offices; a lawyer or legal assistant sat in the adjoining room to create and collect all the paperwork. Winans Tr. at 31-32, 42, 49-51; McCulloch Tr. at 43. Needless to say, there was no doctor present. Winans Tr. at 33.
According to its general manager, Mr. Winans, through this operation EchoMotion generated approximately $15 million for 70-75, 000 echocardiograms conducted over a little more than a year in business — resulting in about $10 million in net profits for its two principals. Id. at 20, 41-47.
As best as can presently be determined, EchoMotion paid the itinerant technicians who actually conducted the exams about S3 million and spent no more than $1 million more on equipment and office expenses. Winans Tr. at 42-47. The remaining expenses of the operation (hotel rooms, travel, etc.) were covered by the law firms (Winans Tr. at 51) — leaving the two owners with perhaps $10 million to split on an 80%-20% basis. Indeed, the minority partner admitted that his 20% share for a year's work was "in the vicinity" of $3 million. Id. at 47. The 80% partner subsequently refused to answer the same question on advice of his counsel. McElroy n Tr. at 44-48.
Contrary to the express requirements of the Settlement Agreement, EchoMotion itself had no cardiologist on staff to supervise the tapings or to provide instruction directly to the technicians. Winans Tr. at 33-37; Settlement Agreement § VLC.l.b.,(4) (providing that echocardiograms conducted after September 30, 1999 must be "conductedunder the supervision of . . . a Board-Certified Cardiologist or Board-Certified Cardiothoracic Surgeon with level 2 training in echocardiography. . . .") (emphasis added). In fact, one of the EchoMotion principals testified that he could not recall even one specific instance where a cardiologist ever visited any of the sites where echocardiograms were being conducted. Winans Tr. at 33.
That is not to say that the EchoMotion owners were totally without instruction on how to conduct "diet drug" echocardiograms. In fact, the founders of EchoMotion were originally advised as to how to conduct "fen-phen" echos by Drs. William Shell and Linda Crouse (McCulloch Tr. at 14, 85, 162-163, 180-81; McElroy II Tr. at 10-13, 18)— both of whom have now been repudiated even by plaintiffs' counsel following the Court's rejection of over-reading through the "single frame" technique that they both used. (Dr. Shell's use of this single frame technique, and the problems with that technique, are addressed in Wyeth's pending Motion Challenging Plaintiffs' Eligibility To Sue In 71 Cases Where Medical Eligibility Is Based On Echocardiogram Readings By Dr. William Shell, filed on September 2, 2003.) Consistent with the "single frame" approach of Drs. Shell and Crouse, during most of its work on these claims, the EchoMotion worksheet told the itinerant technicians (whose e-mail alias was "jethawks") to record only one, maximum regurgitant jet. McCulloch Tr. at 118-19, 130-33. Sometime around September 2002, shortly after Dr. Dent's criticisms of Dr. Crouse's single, maximum frame approach were made public in August 2002, EchoMotion told the technicians to record the measurements of three jets. Id. at 131-32. But even then, the maximum jet was invariably used in the EchoMotion calculations. Id. at 132-33.
Rather than supervision by cardiologists, the "quality control" of EchoMotion consisted of occasional site visits by a single "science officer" — who in reality was merely another technician who was not paid anything for this function beyond her daily fee as one of the sonographers. McCulloch Tr. at 21, 72. And she apparently made only a few such visits because her husband did not want her to travel extensively. Id. at 22.
As the EchoMotion "science officer" in charge of "quality control" testified, the technicians at EchoMotion understood that their work was solely for litigation, and not for clinical purposes:
Q. In your normal clinical practice, there would be a relationship between people providing the echo under the supervision of a doctor and the patient, correct?
A. Correct, unless it was from a referral.
Q. Did you consider — but even in a referral, you would consider you were providing healthcare services to a patient?
A. Exactly, yes.
Q. . . . Did you consider that in these echoes, you were providing that type of professional services that would, for example, implicate professional malpractice, if there was any problem?
A. We stressed to our sonographers that they were to be as professional as possible, like they would be in a hospital or cardiology office. However, they realized it was for litigation and it was not medical treatment. The sonographers knew this.
McCulloch Dep. at 47-48 (emphasis added).
The EchoMotion principals have further testified that some of the law firm representatives at the scanning sites were "breathing down the backs" of the technicians to find "regurgitant jets" that would be PDA Positive (McCulloch Tr. 137-39); that the sites sometimes maintained tallies of the PDA Positive "hit rates" at each session; that EchoMotion told the technicians to check their machines if the PDA Positive rate was "consistently low" during any one session (McCulloch Tr. 134-36); and that EchoMotion in at least one instance capitulated to the demands of one lawyer-customer (George Fleming) and his annually-retained expert (Dr. Polukoff) that the area of the left atrium be traced in the same frame as the regurgitant jet — an improper technique that was contrary to their training and best judgment. Winans Tr. at 25-26; McCulloch Tr. at 13-14.
The record is currently unclear on all of the law firms who used EchoMotion for their clients, but it appears that Mr. Petroff s firm bought approximately 20, 000 tapes (Winans Tr. at 49), and that Fleming Associates and Baron Budd were also major clients.
The EchoMotion "science officer" testified she did not know that Dr. Polukoff was on a $400,000 per year retainer to Mr. Fleming at the time of these conversations. McCulloch Tr. at 181.
EchoMotion — founded solely to assist plaintiffs' law firms to process their claims — thus provided a cheap and efficient vehicle to obtain tens of thousands of echocardiograms with little bother (or medical supervision). Yet, in at least one instance, a plaintiffs' counsel apparently determined that it would be even more economical simply to take his echocardiogram operation "in house."
After purchasing about 20, 000 echocardiograms from EchoMotion (Winans Tr. at 49), Mr. Petroff, the attorney who heads up a consortium of firms which has submitted many thousands of Green Form claims, simply started hiring his own technicians. These technicians were selected by an attorney in Mr. Petroff s office who himself had no cardiology training. Lilley Tr. at 69. They were then given a day of "on-the-job" training by Ms. Lilley, another technician who worked exclusively for Mr. Petroff. Id. at 70-74, 76-77. Mr. Petroff paid these technicians directly at the rate of $1000 per day, and thus cut out the EchoMotion middleman. Id. at 143.
Mr. Petroff's technicians were instructed to fill out forms and follow "protocols" authored by the same attorney in Mr. Petroff's firm. Id. at 48-50, 135-38. There is no indication the technicians ever met — much less were "supervised" in their thousands of "fen-phen" echocardiograms by — a board-certified cardiologist. Id. at 75-77. In fact, Ms. Lilley testified that, to her knowledge, no cardiologist had ever spoken to or directly communicated with any of the sonographers that she had trained. Id. at 77.
As explained above, such unsupervised echocardiograms cannot qualify Class Members for Matrix benefits under the express terms of the Settlement Agreement. See discussion supra, at Part I. Indeed, the reason the Settlement Agreement imposes that requirement is made manifest in the problems with these unsupervised echo mill tapes. For example, many of the echo mill tapes reflect abnormally low Nyquist settings. For example, Ms. Lilley estimated that perhaps 20% of the tapes she scanned for Mr. Petroff were made with Nyquist settings in the 40s. Lilley Tr. at 122. As recognized in Pretrial Order No. 2640, a Nyquist setting of 50 or less will produce artifacts that can then be misinterpreted as regurgitation. PTO 2640, at 11-12. And a reviewing cardiologist confronted with an unduly low Nyquist setting or similar subtle defect in a tape often has no way to know whether the setting was perhaps justified by an extremely unusual patient or whether, as is more likely here, the setting was deliberately set too low to generate artifactual tapes.
Yet the doctors who were retained to read such unsupervised "echo mill" tapes routinely deferred to the measurements taken by the technicians that they had never met. Tai Tr. at 61; W. Miller Tr. at 26-27; Leonard Tr. at 105. The testimony of Dr. Waenerd Miller regarding the extent to which he would defer to the measurements of these unsupervised technicians is illuminating. He admitted that he deferred to the technicians' measurements so long as they were "feasible":
Q. Fair to say here that in this case, you just agreed with the technician?
A. I let me put it a little bit differently maybe. I have the measurement by the technician. I look at the tape and I make a determination, does that look feasible.
If it looks feasible, based on my experience, then I will say, okay, that is an appropriate number for — whatever it is. But I don't go and make a second measurement of each of these. I just — like you say, I kind of eyeball it to say is that a — a reasonable number for what I'm seeing on the tape.
W. Miller Tr. at 98 (emphasis added). See also id. at 105-106.
Dr. Miller thus acknowledged that he never reached his own independent determinations of the level of regurgitation shown on the thousands of echocardiogram tapes that he reviewed — and for which he submitted Green Forms that, if honored, would alone consume $1 billion in Trust assets. Even if the Settlement Agreement permitted claimants to rely on echocardiograms conducted without supervision in these "echo mill" operations (and it does not), the physician evaluating those echocardiograms cannot reach a "diagnosis" as that term is used in the Settlement Agreement without reaching his or her own determination of the level of regurgitation shown.
Other echo companies that devoted themselves almost entirely to "fen-phen" echocardiograms derived comparable volumes of business from plaintiffs' lawyers and similarly violated the requirements of the Settlement Agreement with respect to sonographer supervision. For example, Woodlawn Medical Group in Atlanta conducted somewhere between 20, 000 and 40, 000 fen-phen echocardiograms — not as part of anyone's medical treatment — but solely at the behest of plaintiffs' counsel, such as Mr. Fleming. Scruggs Tr. at 20-22. The CEO and sole owner of Woodlawn, Robert Scruggs, testified that, during 2001 and 2002, approximately 97% of Woodlawn's business was devoted to work for plaintiffs' lawyers in the diet drug litigation. Id. at 15-16, 38-39. In fact, during this time frame, Woodlawn earned $3.3 million in revenue from Mr. Fleming's firm alone. Id. at 37.
Woodlawn's senior technician, Paul Braum, who oversaw the other technicians and was responsible for implementing Woodlawn's protocol, conceded that they did not work under the direct supervision of a cardiologist. Braum Tr. at 19, 151-52. Indeed, he could not identify a single instance when a cardiologist was on site with Woodlawn's sonographers. Id. at 152. And although Woodlawn had a cardiologist acting as "medical director" of its organization, Mr. Scruggs testified that this medical director had no role whatsoever with respect to the fen-phen echocardiograms or Woodlawn's fen-phen protocol. Scruggs Tr. at 32-33. On the other hand, Woodlawn readily took technical direction from plaintiffs' lawyer Mr. Fleming (Braum Tr. at 164-66), and his retained cardiologist, Dr. Polukoff. Id. at 36-39.
The situation was much the same with an echo mill in Texas called Mobile Diagnostics. Again, the "general operations manager" for that organization admitted during a deposition conducted only last week that it had no cardiologist, board-certified or otherwise, on its payroll (Griffith Tr. at 26); that their customers were the plaintiffs' attorneys to whom they made all reports — including invoices which conveniently recorded the percentage of claimants found to be "PDA Positive" when asking for payment (id. at 43-44); and that the vast preponderance of their business was litigation driven. Id. at 13, 16.
To be sure, the Mobile Diagnostics operations manager claimed that in some fashion its technicians were supervised by Dr. Bradley Leonard, the cardiologist to whom most of its echocardiograms were sent for reading. Id. at 27. But Dr. Leonard, who is on probation from Texas medical authorities as a result of prior drug charges — and who had "taken off' the preceding few years from medicine to work at a Home Depot — himself admitted that while he talked to some of these Mobile Diagnostic technicians, he could not remember any of their namesand that his "training sessions" did not include any technical information. Leonard Tr. at 20, 59, 105-06.
There are other echo mills who have not yet been subject to any discovery in the litigation cases to date but whose very advertising suggests that they have engaged in the worst kind of over-reading. For example, a group variously known as "Diagnostic Management Services" or "The Medical Management Group" appears to be one of the principal providers of echocardiograms to claimants in Mississippi and other Gulf Coast States. In 1999, its founder (who also has no formal medical training) wrote to attorneys who had attended a fen-phen litigation conference boasting that his group had already performed over 2000 echocardiograms for attorneys in the Southeast, and that "approximately 90% of the reads are positive for abnormal heart valve functioning. . . ." Letter from Thomas Haverty, "Re: Fe-Phen Program Mobile 2-D Echocardiogram with Color Doppler," dated Mar. 23, 1999 (Exh. 22 hereto). At present, no one at the Trust or Wyeth knows just how many more thousands — more likely tens of thousands — of tapes were generated by Diagnostic Management Services. But the fact that this organization claims to have generated thousands of echocardiogram readings that were "positive for abnormal heart valve functioning" 90% of the time obviously demonstrates that further inquiry is appropriate.
Wyeth has been attempting to depose Mr. Haverty, the president and owner of Diagnostic Management Services, in an Intermediate Opt-Out case in which one its tapes is the purported basis of the plaintiffs medical eligibility to sue Wyeth. Initially, the attorney representing the entity agreed to cooperate in the scheduling of the deposition, but has since declined to accept service. Mr. Haverty has thus far evaded service of a subpoena.
Indeed, although tens of thousands of echocardiograms have been manufactured at these unsupervised echo mills, we do not yet know precisely which of these thousands of flawed scans serve as the purported bases for Matrix claims. Although sometimes echocardiogram tapes are labeled with the name of the testing company that performed the echocardigrams, often they are not. And the Green Forms submitted en masse by plaintiffs' law firms do not identify where and how they obtained the echocardiograms upon which the claims are based. Particularly under these circumstances, further inquiry is necessary to address this serious abuse.
D. The Doctors Retained By Plaintiffs' Counsel Did Not Review The Claimants' Medical Records When Completing Green Forms, But Relied On Lawyers' Representations Regarding The Claimants' Medical Histories
Many of the doctors who have testified thus far have admitted that they routinely signed Green Forms certifying tens of thousands of times that the claimants had no history of any of the nine factors that would reduce a Matrix benefit by 80% despite the fact that they neither took medical histories nor reviewed the claimants' medical records. Crouse Tr. at 102, 130-34; Bloom Tr. at 64-69; Hutcheson Tr. at 189-190; Leonard Tr. at 49, 54; W. Miller Tr. at 48-50; Tai Tr. at 28-29, 44, 50.
Like Dr. Crouse, who contended it was the law firm's responsibility to take a medical history (Crouse Tr. at 132), some of the doctors relied entirely on "questionnaires" administered by the claimants' law firm. Bloom Tr. at 65-66; W. Miller Tr. at 48-49. Others did not even do that much. Dr. Leonard, for example, admitted that he had no evidence whatever as to whether his Green Form claimants had a history of these reduction factors. In the absence of any information about the claimant's medical history at all, he was content to answer "no" because he had no information to the contrary:
Q. Question Group E [on the Green Form dealing with reduction factors], how did you fill those questions out if you didn't have any medical records?
A. Because it's clearly stated, to the best of my knowledge.
Q. Okay. But, for example, Question 7 talks about the history of daily use of other drugs. That's not anything you could possibly know from looking at the echo?
A. That is correct.
Q. Okay. And you just figured since you didn't know that, you could answer to the best of your knowledge, no?
A. That is correct
Leonard Tr. at 51 (emphasis added).
Dr. Tai took this "see no evil" approach one step further. He testified that he did not even want to know about such facts from records or questionnaires — but rather relied entirely on the verbal assurances of the lawyers:
Q. Do you know if the sonographers who were performing these echos were taking any medical history at all from the patients?
A. I did not know what sonographers were doing. I didn't want to know about it. Give me the tape. That's all.
* * *
Q. Now, there's parts of the green form that require you to rule out certain conditions, based on a patient's medical history; is that right? Like rheumatic fever, lupus, things like that.
A. That information was provided to me.
Q. Okay.
A. Or they would provide to me verbally, and they would say, none of those conditions exist, or have existed. This is a pure Fen Phen case. So I would assume that, based on that, then I would.
Q. And by "they," you mean the lawyers?
A. By the lawyers.
Tai Tr. at 44, 51 (emphasis added).
Most recently, Dr. Polukoff — who supplemented echocardiogram reading and Green Form fees totalling well in excess of $1 million by an additional $400,000 annual "retainer" that he received for generally advising Mr. Fleming on his Green Form program — testified that he too did not review medical records, but relied on the echocardiogram tape (which even Dr. Crouse admitted would not show the existence of a number of alternative causes that reduce the Matrix benefits by 80%) (Crouse Tr. at ISO-33) and a "questionnaire" that was typically completed by nurses from a "legal-medical consulting" firm retained by Mr. Fleming. It was Dr. Polukoff s understanding that the questionnaires were based on the nurses' interviews done over the phone with the claimant. Polukoff Tr. at 8-9, 17-20, 74-75. 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. Tr. of Mar. 19, 2003, at 132-138 (Exh. 23 hereto).
Although the are variations on this theme, one thing is clear — these doctors had no proper basis for certifying the absence of the vast majority of the reduction factors. And their lack of due regard for that duty — as doctors, and here also as those who were certifying under oath claims for literally billions of dollars — speaks volumes about the overall corruption of this entire process.
III. UNDER THE CIRCUMSTANCES, APPROPRIATE MEASURES SHOULD BE IMPLEMENTED TO ADDRESS THE ABUSE OF THE CLAIMS SYSTEM
When the express requirements of the Settlement Agreement are compared to the grotesque realities of what these attorneys, their echo mills, and their retained certifiers have done, it is clear that something must be done to identify the most prolific sources of abuse. Yet movants oppose any inquiry at all. They are wrong. Indeed, we respectfully submit that steps in addition to those already undertaken must be instituted to save the Trust and its limited fund from such abusive practices.
A. The Trust Is Authorized To Issue Medical Practices Questionnaires
First, there can be no doubt that the Trust is authorized by CAP No. 4 to issue Medical Practice Questionnaires and to require that those questionnaires be answered before a claim is subject to audit. Paragraph 7 of CAP No. 4 was specifically designed to confirm the Trust's broad authority — without prior Court approval on a case-by-case basis — to obtain information to ensure that claims are legitimate and do not reflect "the practices determined inappropriate by the Court in Pretrial Order No. 2640":
7. The Trust's Authority to Require Records and Other Claims Administration Procedures Before the Audit of Claims . When the Trust has reasonable grounds that a claim or group of claims for Matrix Compensation Benefits has not been submitted in accordance with the Settlement Agreement, reflects any of the practices determined inappropriate by the Court in Pretrial Order No. 2640 or any Order of the Court, contains misrepresentations of material fact, or suffers from any other circumstance questioning the legitimacy of the claim(s), before the claim(s) are sent to an Auditing Cardiologist, the Trust may require the Class Member to submit all (or some specified portion) of the General Medical Records relating to the claim, and the Verification described in Paragraph 6(b) above, and such other relevant documents or information within the Class Member's custody, possession, or control as may reasonably be requested by the Trust.
CAP No. 4, at ¶ 7 (Exh. 24 hereto). See also Settlement Agreement § VI.E.3.c. (providing that the Trust may require Class Members to provide "[s]uch other relevant documents or information within the Class Member's custody, possession, or control as may reasonably be requested by the Trustees and/or Claims Administrator(s), "and that if a Class Member unreasonably fails to provide such information "the Class Member's Claim shall be denied").
The purpose of paragraph 7 is plain. Rather than requiring the Trust to come before the Court and seek case-by-case approval of every measure it undertakes to obtain information on suspect claims, CAP No. 4 confirms that the Trust has the power to request that such information be provided before a claim is placed in audit. Especially in light of the evidence that Wyeth has presented above, the Trust's issuance of the Medical Practice Questionnaires is clearly an appropriate means of obtaining information necessary to determine whether thousands of Green Forms submitted to the Trust comport with the requirements of the Settlement Agreement.
Contrary to movants' suggestion, nothing in CAP No. 4 requires the Trust to seek prior Court approval before requesting information concerning the legitimacy of claims submitted to the Trust. The CAP requires only that the "Trust has reasonable grounds that a claim or group of claims" merits further investigation before information is requested regarding those claims. CAP No. 4, at f 7. Nowhere does the CAP require the Trust to first make a showing of those grounds to the Court prior to the issuance of the request. Even before the CAP was approved, the Trust already had the specific power under the Settlement Agreement to request "as a condition to consideration of the Claim . . . [s]uch other relevant documents or information within the Class Member's custody, possession, or control as may reasonably be requested. . . ." Settlement Agreement § VI.E.3.C. The CAP was plainly not meant to restrict the powers that the Trust already has under the Settlement Agreement to investigate suspect claims. Rather, particularly in light of the dubious practices uncovered in the Hariton/Napoli hearing that led to entry of PTO 2640, paragraph 7 of CAP No. 4 was meant to confirm that the Trust may employ those powers without the Court convening a formal hearing each time the Trust seeks to issue such a request.
Movants also argue that they should not be forced to respond to the Trust's questionnaires because the questionnaires call for the certifying physicians, rather than the Class Members themselves, to furnish the answers. But CAP No. 4 permits the Trust to request information not merely in the Class Members' possession or custody, but also within their "control." CAP No. 4, at ¶ 7. Tellingly, although movants claim in a single conclusory and generic sentence that "[i]nformation contained in a physician's mind is not in the Class Member's custody, possession, or control" (Baron Budd Br. at 7), the movants never disclaim that the they have sufficient "control" over their retained physicians to require those doctors to answer the questionnaires on behalf of the Class Members. Cf. Scott v. Arex, 124 F.R.D. 39, 41 (D. Conn. 1989) ("The word 'control' [as used in Fed.R.Civ.P. 34] is to be broadly construed. A party controls documents that it has the right, authority, or ability to obtain upon demand.").
To the contrary, Ms. Presby has acknowledged that "the attesting physicians are our expert witnesses." Letter from Ellen A. Presby to The Hon. Harvey J. Bartle III (Aug. 29, 2003) (Exh. 25 hereto). Indeed, Ms. Presby has asserted that "the Trust cannot contact Claimants' Attesting Physicians directly, and that all communications between the Trust and these physicians must be submitted through us, the Claimants' lawyers, as Counsel of Record." Letter from Ellen A. Presby to Andrew Chirls (Aug. 26, 2003) (Exh. 26 hereto). See also Letter from Mario D'Angelo to Andrew A. Chirls (Aug. 26, 2003) ("As an adversary the Trust must abide by established ethical guidelines that preclude the Trust from directly contacting an adversary's witness without notice.") (Exh. 27 hereto). The counsel for those claimants cannot credibly deny that they have control over these attesting physicians and yet simultaneously demand that the Trust direct any communications to "their witnesses" only through the counsel who retained them.
B. More Is Needed To Address The Widespread Abuse Of The Claims Process Than The Audit Of All Matrix Claims
Movants argue that, because all claims will ultimately be subject to audit, there is no need to investigate the practices of suspect physicians who have certified thousands of Green Forms. Baron Budd Br. at 2. But claims which are based on echocardiograms conducted in unsupervised for-profit echo mills and that are read only by litigation experts who never render a "diagnosis" of PDA Positive regurgitation are invalid on their face. They should not be entitled to the deferential review afforded to claims in audit; and the Trust should not be required to expend its time and resources conducting such reviews.
As noted above, the Settlement's entire Matrix claim processing system was premised on the assumption that the diagnosis of a doctor caring for a patient, based upon an echocardiogram tape acquired under proper supervision and using proper techniques, would tend to be accurate. A physician who is providing medical care to his or her patient, and whose compensation is not tied to the reading of the echocardiogram, generally has no incentive to inflate his or her reading. To the contrary, improperly diagnosing a patient with serious valvular regurgitation could lead to serious medical consequences such as unwarranted valve surgery. Hence the "diagnosis" of a qualified doctor, rendered in the course of the practice of medicine and bolstered by the certification on the Green Form, is granted considerable deference and only overturned in the audit process if it lacks a "reasonable medical basis." Settlement Agreement § VI.E.7.
Based on what we now know even through limited deposition discovery, however, it is clear that no such deference is warranted for the substantial majority of tens of thousands of Matrix claims. The readings of litigation experts who have no connection with the medical care of the patient, and which are based on unsupervised echocardiograms conducted by itinerant technicians sent to hotel rooms by ad hoc "echo mills," cannot be presumed reliable. Nor should any deference be given to readings made by certifying doctors willing to state conclusions under oath for which they have no basis.
CONCLUSION
For all the reasons set forth above, Certain Class Members' Expedited Motion for an Order Suspending the Claim Integrity Program and the Medical Practices Questionnaires Deadlines should be denied. At a minimum, the Trust clearly has had the authority to issue the questionnaires. The only issue is whether the Trust has gone far enough.Wyeth believes that by focusing on suspect doctors, the Trust has — at least thus far — not taken sufficient steps to deal with the two other parts of the problem: (1) the acquisition of echocardiograms by unsupervised echo mills; and (2) the lawyers who set up the whole system. And as the Trust proceeds with its investigations, we have no doubt that it will conclude that there are many other "suspect" sources of claims in addition to the specific doctors to whom it has so far sent questionnaires.
The problem is that in the meantime, illegitimate claims will continue to be sent to audit, and auditors will continue to give unjustified deference to the certification of doctors and their reading of echo tapes — a deference that is not justified under the terms of the Settlement Agreement. Such waste of the Trust's remaining assets cannot be permitted.