American Journal of Law & Medicine

Expert testimony: expert witnesses must be prepared to produce positive evidence to establish general causation in drug products liability actions.

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. …

Log in to your account to read this article – and millions more.