Opinion
No. 00 Civ. 2843 (LAK).
December 9, 2004
Maria C. Young, LAW OFFICE OF RONALD R. BENJAMIN, Attorneys for Plaintiff.
David Klingsberg, Bert L. Slonim, Maris Veidemanis, KAYE SCHOLER LLP, Attorneys for Defendant Warner-Lambert LLC.
MEMORANDUM OPINION
Plaintiff's decedent in this product liability case, Albert Ruggiero, died on August 24, 1998. It is undisputed that the cause of death was hepatic failure caused by cirrhosis. Plaintiff attributes this to Mr. Ruggiero's ingestion of Rezulin. Defendant moves for summary judgment dismissing the complaint on the ground, inter alia, that plaintiff cannot adduce evidence sufficient to raise a genuine issue of material fact as to whether Rezulin was capable of causing the cirrhosis that resulted in Mr. Ruggiero's death. In other words, they challenge plaintiff's ability to get to the jury on the issue of general causation.
Womack Decl. ¶ 10; compare Def. 56.1 St. ¶ 10 with Pl. 56.1 St. passim.
Facts
Plaintiff relies upon the declaration of Douglas T. Dieterich, M.D., a highly qualified physician who is board certified in internal medicine and gastroenterology and who has expressed the opinion "with reasonable medical certainty that Albert Ruggerio's [ sic] liver disease was caused by his taking Rezulin." His declaration, however, gives no basis for this assertion save the conclusory statement that "Rezulin has been reported in many published incidences [ sic] to cause liver failure and death." Even this statement was undermined by his deposition testimony:
Dieterich Decl. ¶ 2; see id. ¶ 10.
Id. ¶ 8.
"Q. And Dr. Dieterich, can you cite any studies published in any medical or scientific literature which conclude that Rezulin causes cirrhosis? A. I certainly have seen that Rezulin causes liver failure and death.
* * *
"Q. Sitting her today, Dr. Dieterich, as a plaintiff's expert in this matter, you're not able to cite any studies published in the medical or scientific literature which conclude that Rezulin can cause cirrhosis, correct? A. No.
"Q. And, Dr. Dieterich, can you cite any studies published in the medical or scientific literature that concludes that Rezulin can exacerbate or accelerate a pre-existing liver disease? A. I can't cite medical references, but it's my opinion that that's the case.
"Q. But sitting here today as plaintiff's expert in this matter, you're not able to cite any studies, apart from your own personal opinion, but any scientific studies published in the literature that concludes that Rezulin can exacerbate or accelerate pre-existing liver disease; is that correct? A. That's correct."
Def. Reply Mem. Ex. A (Dieterich Dep.) 77-78.
There is no other basis given for Dr. Dieterich's opinion in his declaration or deposition.
Discussion
Summary judgment is appropriate if there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Where the burden of proof at trial would fall on the nonmoving party, it ordinarily is sufficient for the movant to point to a lack of evidence to go to the trier of fact on an essential element of the nonmovant's claim. In that event, the nonmoving party must come forward with admissible evidence sufficient to raise a genuine issue of fact for trial in order to avoid summary judgment.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); White v. ABCO Eng'g Corp., 221 F.3d 293, 300 (2d Cir. 2000); see also Fed.R.Civ.P. 56(c).
Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Virgin At. Airways Ltd. v. British Airways PLC, 257 F.3d 256, 273 (2d Cir. 2001).
See, e.g., Nora Beverages, Inc. v. Perrier Group of Am., Inc., 269 F.3d 114, 123-24 (2d Cir. 2001); id., 164 F.3d 736, 746 (2d Cir. 1998); Raskin v. Wyatt Co., 125 F.3d 55, 65-66 (2d Cir. 1997).
E.g., Nebraska v. Wyoming, 507 U.S. 584, 590 (1993) (when nonmoving party bears burden of proof at trial, moving party is entitled to summary judgment if nonmovant fails to make showing on essential element of its claim); Goenaga v. March of Dimes Birth Defects Found., 51 F.3d 14, 18 (2d Cir. 1995) ("In moving for summary judgment against a party who will bear the ultimate burden of proof at trial, the movant's burden will be satisfied if he can point to an absence of evidence to support an essential element of the nonmoving party's claim.") (citing Celotex, 477 U.S. at 322-23).
Causation in toxic tort cases has two components: general and specific. "General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury." As explained in the Federal Judicial Center's Reference Guide on Medical Testimony:
See, e.g., Raynor v. Merrell Pharms., Inc., 104 F.3d 1371, 1376 (D.C. Cir. 1997).
In re Breast Implant Litig., 11 F. Supp.2d 1217, 1224 (D. Colo. 1998).
"General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease (e.g., that smoking cigarettes can cause lung cancer). Specific, or individual, causation, however, is established by demonstrating that a given exposure is the cause of an individual's disease (e.g., that a specific plaintiff's lung cancer was caused by his smoking)."
Mary Sue Henifin, Howard M. Kipen Susan R. Poulter, Reference Guide on Medical Testimony, in REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 444 (Federal Judicial Center, 2d ed. 2000).
A plaintiff must establish both in order to prevail. In consequence, plaintiff can defeat the motion only if she has admissible evidence sufficient to go to the jury on the issue of general causation. Defendant argues that Dr. Dieterich's opinion is not admissible because it does not pass muster under Daubert v. Merrell Dow Pharmaceuticals and that plaintiff's case therefore must be dismissed.
509 U.S. 579 (1993).
The standard governing a district court's determination whether to admit scientific or other expert testimony is familiar. Federal Rule of Evidence 702 provides:
"If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if(1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case."
Rule 702 incorporates principles established in Daubert, in which the Court charged trial courts with a gatekeeping role to "ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable." Daubert set forth the criteria a trial court is to apply in ruling on expert testimony. The trial court must determine "whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue." The Court explained further that this requires "a preliminary assessment of whether the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue" — in essence, whether it is reliable.
Id. at 589.
Id. at 592.
Id. at 592-93.
The Daubert Court stressed that the reliability inquiry required by Rule 702 is "a flexible one" and articulated four relevant factors while leaving open the possibility of other pertinent considerations: (1) whether the expert's theory "can be (and has been) tested;" (2) whether the theory "has been subjected to peer review and publication;" (3) the "known or potential rate of error;" and (4) whether the theory has "`general acceptance.'" The proponent of expert testimony must demonstrate admissibility by a preponderance of proof.
Id. at 593-94.
Id. at 592 n. 10.
In undertaking this inquiry, a district court must focus on the "principles and methodology" employed by the expert, not on the conclusions reached. Nevertheless, "nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered."
Id. at 594-95.
General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997).
The 2000 amendment to Rule 702 added three standards that proffered testimony must meet to be admissible: "(1) the testimony [must be] based upon sufficient facts or data, (2) the testimony [must be] the product of reliable principles and methods, and (3) the witness [must have] applied the principles and methods reliably to the facts of the case." The Advisory Committee Notes explain that the amendment was intended to affirm Daubert's designation of the trial court as gatekeeper and "provide some general standards that the trial court must use to assess the reliability and helpfulness of proffered expert testimony." The standards set forth in Rule 702, however, were not intended to displace the factors identified in Daubert.
FED.R.EVID. 702 Advisory Committee Note (2000).
Measured against these standards, Dr. Dieterich's declaration and testimony fall far short. The only basis he offered for his opinion was the generalization that he had seen unspecified studies that, in his view, supported the proposition that Rezulin causes liver failure and death. But it is undisputed that the cause of death here was liver failure caused by cirrhosis. Dr. Dieterich was unable to point to any studies or, for that matter, anything else that suggested that cirrhosis could be caused or exacerbated by Rezulin.
Plaintiff suggests that Dr. Dieterich's opinion properly rested on his review of Mr. Ruggiero's medical records. Although she does not say so in as many words, she seems to suggest that the opinion is admissible on the basis that it is the result of a differential diagnosis.
Pl.Mem. 4.
"Differential diagnosis is a patient-specific process of elimination that medical practitioners use to identify the `most likely' cause of a set of signs and symptoms from a list of possible causes." "In performing a differential diagnosis, a physician begins by `ruling in' all scientifically plausible causes of the plaintiff's injury. The physician then `rules out' the least plausible causes of injury until the most likely cause remains." As one court has written:
Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1413 (D. Or. 1996).
Glastetter v. Novartis Pharms Corp., 252 F.3d 986, 989 (8th Cir. 2001).
"The process of differential diagnosis is undoubtedly important to the question of `specific causation.' If other possible causes of an injury cannot be ruled out, or at least the possibility of their contribution to causation minimized, then the `more likely than not' threshold for proving causation may not be met. But, it is also important to recognize that a fundamental assumption underlying this method is that the final, suspected `cause' remaining after this process of elimination must actually be capable of causing the injury. That is, the expert must `rule in' the suspected cause as well as `rule out' other possible causes. And, of course, expert opinion on this issue of `general causation' must be derived from scientifically valid methodology." Thus, differential diagnosis does not "speak to the issue of general causation. [It] assumes that general causation has been proven for the list of possible causes" that it rules in and out in coming to a conclusion.
Cavallo v. Star Enter., 892 F. Supp. 756, 771 (E.D. Va. 1995), aff'd on this ground, rev'd on other grounds, 100 F.3d 1150 (4th Cir. 1996).
Hall, 947 F. Supp. at 1413 (emphasis added). See also, e.g., Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 992 (8th Cir. 2001) (affirming district court's exclusion of plaintiff's experts because they lacked a proper basis for "ruling in" drug in question as a potential cause of alleged injury); Black v. Food Lion, Inc., 171 F.3d 308, 313-14 (5th Cir. 1999) ("Dr. Reyna's use of a general methodology cannot vindicate a conclusion for which there is no underlying medical support."); Hollander v. Sandoz Pharmaceuticals Corp., 289 F.3d 1193 (10th Cir. 2002) (affirming exclusion of opinion based on differential diagnosis offered to prove general causation); Soldo v. Sandoz Pharmaceuticals Corp., 244 F. Supp.2d 434, 516 (W.D.Pa. 2003) ("differential diagnosis is not a reliable methodology for determining general causation"); In re Breast Implant Litig., 11 F. Supp.2d at 1230 (differential diagnosis not reliable as to general causation; "expert opinion on . . . issue of "general causation" must be derived from a scientifically valid methodology"); Cavallo, 892 F. Supp. at 771 (differential diagnosis not usable in toxic tort case to prove general causation because "a fundamental assumption underlying this method is that the final, suspected `cause' remaining after this process of elimination must actually be capable of causing the injury"), aff'd in relevant part, rev'd in part, 100 F.3d 1150, 1159 (4th Cir. 1996), cert. denied, 522 U.S. 1044 (1998); Philip Cole, Causality in Epidemiology, Health Policy, and Law, 27 ENVTL. L. REP. 10279, 10284 (June 1997) ("[A]n agent cannot be considered to cause the illness of a specific person unless it is recognized as a cause of that disease in general.").
The Court is mindful that another district judge in this circuit seems to have come to a different view, stating that "[d]ifferential diagnosis is a reliable basis to prove general causation in this circuit," relying principally on McCullock v. H.B. Fuller Co. But the view that differential diagnosis may be sufficient to establish general causation is not borne out by McCullock. The circuit there merely registered its approval of the expert's reliance on a variety of sources to arrive at an opinion as to both general and specific causation. It is not at all clear that the Court regarded differential diagnosis as probative of general causation, let alone that a district court lacks discretion to conclude in an individual case that an expert's opinion as to general causation based on an unreliable differential diagnosis must be received in evidence.
Perkins v. Origin Medsystems, Inc., 299 F. Supp.2d 45, 57 (D. Conn. 2004) (citing McCullock v. H.B. Fuller Co., 61 F.3d 1038 (2d Cir. 1995)).
This case illustrates the fundamental problem with differential diagnosis even assuming that Dr. Dieterich relied upon it, which is not really clear. The doctor has not offered any reliable basis for concluding that Rezulin is capable of causing the cirrhosis that caused the liver failure that resulted in Mr. Ruggiero's death. In other words, he has offered no reliable ground upon which Rezulin may be "ruled in" as a plausible cause of the cirrhosis.
No one questions Dr. Dieterich's qualifications or good faith. It is possible, moreover, that time and medical research will prove him right. But Daubert requires much more — it requires that his opinion be shown to rest on sufficient facts and data and that it be the product of reliable principles and methods properly applied to the facts of the case.
None of these criteria has been satisfied here. There has been no specification of the facts and data upon which Dr. Dieterich relied. There has been no showing that he applied reliable principles and methods in reaching his conclusion. In consequence, his opinion is not admissible in evidence.
Conclusion
As plaintiff has offered no admissible evidence of general causation, which is an essential element of her case, defendant's motion for summary judgment dismissing the complaint is granted.SO ORDERED.