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A district judge’s decision to bar expert opinion purporting to show that a controversial anti-diabetes drug caused the death of a patient has been upheld by a federal appeals court. The 2nd U.S. Circuit Court of Appeals said Southern District of New York Judge Lewis Kaplan was right to reject the expert’s opinion on the drug Rezulin, because of the method the expert used to determine that Rezulin must have caused liver failure by cirrhosis. The decision by 2nd Circuit Judge Dennis Jacobs came in Ruggiero v. Warner-Lambert Co., 04-6674-cv, one of more than a thousand cases concerning Rezulin that have been consolidated before Kaplan. The plaintiff is Anne Ruggiero, the widow of Albert Ruggiero, who was diagnosed with Type-II diabetes in 1982 and began taking Rezulin in May 1997. Mr. Ruggiero died of liver failure in August 1998, less than two years before Warner-Lambert halted distribution of the drug at the request of the Food and Drug Administration, which had warned that Rezulin increases liver toxicity. Kaplan granted summary judgment for the company on the failure to show general causation — finding that Ms. Ruggiero had failed to present enough evidence to show that Rezulin can cause cirrhosis of the liver or make it worse. Ms. Ruggiero had submitted the expert opinion of Dr. Douglas T. Dietrich, who had concluded that Rezulin could cause or exacerbate cirrhosis. But Kaplan rejected the opinion as inadmissible, explaining that the methodology used by Dietrich failed to meet the standard set for the admissibility of expert opinion set forth by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Kaplan said Dietrich had appeared to use a methodology known as “differential diagnosis,” the process of examining a patient and ruling out potential causes of an illness until only one possible cause remains. “Dr. Dietrich was unable to point to any studies or, for that matter, anything else that suggested that cirrhosis could be caused or exacerbated by Rezulin,” Kaplan wrote. The judge went on to find that differential diagnosis is not reliable enough to support an opinion on general causation in this case. The 2nd Circuit panel included Judge Barrington D. Parker and Northern District Judge David N. Hurd, sitting by designation. Jacobs said other courts have noted that the “patient-specific process of elimination” that is differential diagnosis cannot support a finding of general causation “because, like any process of elimination, it assumes that ‘the final, suspected “cause” remaining after this process of elimination must actually be capable of causing the injury.’” Experts who use differential diagnosis to “rule out” other potential causes for an injury must also be able to “rule in” the suspected cause using valid scientific methodology, he said. “Dr. Dietrich may have used a differential diagnosis to rule out competing causes of cirrhosis without establishing that Rezulin is among them,” Jacobs said. JUDICIAL DISCRETION But Jacobs also was careful to clarify that the court was not ruling out the methodology in all circumstances. “We cannot say that a differential diagnosis may never provide a sufficient basis for an opinion as to general causation,” he said. “There may be instances where, because of the rigor of differential diagnosis performed, the expert’s training and experience, the type of illness or injury at issue, or some other case-specific circumstance, a differential diagnosis is sufficient to support an expert’s opinion in support of both general and specific causation.” And district judges have “broad discretion” in “determining whether in a given case a differential diagnosis is enough by itself to support such an opinion,” Jacobs said. Ronald R. Benjamin of Binghampton represented Anne Ruggiero. David Klingsberg of Kaye Scholer represented Warner-Lambert.

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