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SRA
Risk Science & Law Specialty Group |
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| 1999-2000
Online Casebook (Second Edition)
Benedi v. McNeil, PPC, Inc. Must an inference of causation necessarily depend on statistical (epidemiological) evidence, or can clinical diagnostic evidence alone serve to reach a finding of causation? What about the relevance and reliability of anecdotal evidence in the form of medical case summaries or drug experience reports? Benedi, who used the painkiller acetaminophen, suffered severe liver damage claimed to result from coincidental use of alcohol. In upholding a jury verdict for the plaintiff, the U.S. Court of Appeals [66 F.3d 1378 (4th Cir. 1995)] affirmed the admissibility of expert testimony under Daubert that relied on the same methodologies used daily by clinicians in treating patients. The Daubert rule does not restrict expert testimony to opinions based solely upon epidemiological data. It merely requires that expert testimony be both relevant and reliable. The trial court did not abuse its discretion in admitting testimony where an inference of causation was drawn from clinical diagnostic methods commonly used in the medical community. In this case, these included: § Acetaminophen found in the blood upon hospital admission, liver enzyme blood levels, and the microscopic appearance of the liver removed during a transplant. § History of several days' use of Tylenol after regular alcohol consumption of several drinks per day. § Lack of evidence of other causes of liver failure (alternative causation), such as a viral infection. Further, the court determined that drug experience reports (DERs) and medical case summaries sent to the drug manufacturer supported a jury finding of causation. Sixty reports had been received by McNeil at the end of 1992. These reports documented cases of liver injury associated with combining therapeutic doses of Tylenol with alcohol. The manufacturer asserted, according to the Food and Drug Administration (FDA), case summaries and DERs do not establish that a particular drug is reasonably associated with a particular injury. However, FDA actually states these reports cannot serve as the basis for approving a drug. The agency does not say these case reports and DERs do not give rise to a duty to warn. Yet McNeil failed to warn of these dangers on Tylenol's label. There is a message here that a finding of causation based on clinical diagnostic evidence, and not necessarily on human statistical (epidemiological) evidence, can meet the Daubert criteria for relevance and reliability. While case reports and DERs that further validate the diagnostic findings are not admissible as causal evidence per se, they are evidence enough to compel a duty to warn drug consumers. [Contributed by Wayne Roth-Nelson] |
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