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IN RE REZULIN PRODUCTS LIABILITY LITIGATION

United States District Court, S.D. New York


December 9, 2004.

In re: REZULIN PRODUCTS LIABILITY LITIGATION (MDL No. 1348). This Document Relates to: No. 01 Civ. 1040.

The opinion of the court was delivered by: LEWIS KAPLAN, District Judge

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.*fn1 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.

  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."*fn2 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."*fn3 Even this statement was undermined by his deposition testimony:

"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."*fn4
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.*fn5 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.*fn6 In that event, the nonmoving party must come forward with admissible evidence*fn7 sufficient to raise a genuine issue of fact for trial in order to avoid summary judgment.*fn8 Causation in toxic tort cases has two components: general and specific.*fn9 "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."*fn10 As explained in the Federal Judicial Center's Reference Guide on Medical Testimony:

"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)."*fn11
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*fn12 and that plaintiff's case therefore must be dismissed.

  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."*fn13

  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."*fn14 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.*fn15

  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.'"*fn16 The proponent of expert testimony must demonstrate admissibility by a preponderance of proof.*fn17

  In undertaking this inquiry, a district court must focus on the "principles and methodology" employed by the expert, not on the conclusions reached.*fn18 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."*fn19

  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."*fn20 The standards set forth in Rule 702, however, were not intended to displace the factors identified in Daubert.

  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.*fn21 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.

  "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."*fn22 "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."*fn23 As one court has written:

"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."*fn24 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.*fn25
  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.*fn26 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.

  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.


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