Expert Testimony: Expert Witnesses Must Be Prepared to Produce Positive Evidence to Establish General Causation in Drug Products Liability Actions-Ruggiero V. Warner-Lambert Co.1

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Expert Testimony: Expert Witnesses Must be Prepared to Produce Positive Evidence to Establish General Causation in Drug Products Liability Actions-Ruggiero v. Warner-Lambert Co.1-The United States Court of Appeals for the Second Circuit upheld a district judge's decision to exclude expert opinion, specifically differential diagnosis, purporting to show that a certain anti-diabetes drug caused the death of a patient.2 Plaintiff Anne Ruggiero is the widow of Albert Ruggiero who was diagnosed with Type-II diabetes in 1982.3 Mr. Ruggiero died of liver failure caused by cirrhosis in 1998, 15 months after he had started taking the diabetes medication Rezulin.4 In 2000, manufacturers and distributors of Rezulin halted its distribution in response to the Food and Drug Administration's concerns that the drug caused increased liver toxicity.5

Plaintiff Ruggiero, filed a product-liability suit in the U.S. District Court for the Southern District of New York against Warner-Lambert Co. and Parke Davis ("Defendants") who manufactured and sold Rezulin.6 She alleged that Rezulin caused her husband's death. The district court dismissed the claim against the Defendants, holding that Ruggiero produced insufficient evidence that Rezulin was indeed capable of causing or exacerbating cirrhosis of the liver ("general causation").7 Specifically, the court found that the medical expert's differential diagnosis that Rezulin led to Mr. Ruggiero's death was insufficient to support general causation without a scientifically valid methodology for establishing the drug as a possible cause.8 The second Circuit ultimately affirmed the district court's decision, granting summary judgment to the defendants.9

On appeal, Ruggiero first argued that the district court erred in ruling on the issue of general causation.10 Relying on a district court decision in the Southern District of New York, Ruggiero argued that because the Defendants first raised this argument in their summary judgment reply papers, it need not be considered by the district court.11 The Second Circuit, however, cited to its own decision in Bayway Ref. v. Oxygenated Mktg. & Trading,12 in which it determined that a district court had the discretion to rely on evidence submitted with reply papers, and concluded that the district court had discretion to consider the issue here.13 Further, the Court explained that although the Defendants' moving papers did not argue explicitly in terms of general causation, the motion did explicitly raise the broader argument that the Plaintiff could not establish causation between Mr. Ruggiero's liver failure and his use of Rezulin.14 Accordingly, Ruggiero could not raise the issue on appeal and claim surprise because she had ample opportunity to claim unfair prejudice in the district court.15 Ruggiero also tried to argue that the issue of general causation was the subject of on-going consolidated proceedings in a multi-district litigation ("MDL") of which Ruggiero's case was part, and therefore the law-of-case doctrine would apply, by reason of contrary decisions in those proceedings.16 But the Second Circuit disagreed, indicating that even if the law-of-case doctrine did apply, Ruggiero failed to point to contrary rulings in such proceedings.17 Ultimately, the Court ruled that there was no excuse for Ruggiero's failure to bring this complaint to the attention of the district court.18 The Court was especially reluctant to hear this complaint in the first instance given the expertise of Judge Lewis Kaplan, the district court judge, who has presided over the Rezulin MDL for over five years.19

Ruggiero also appealed the district court's decision that the expert opinion she relied upon was inadmissible. The district court held that the expert testimony of Dr. Douglas T. Dietrich-the sole evidence of general causation submitted by Ruggiero-failed to meet the standards required by the Supreme Court decision in Daubert v. Merrell Dow Pharmacenticals20 and the federal rules of evidence governing expert testimony. …