Part one of a two-part series

Last December, the Pennsylvania Superior Court handed a sharp blow to pharmaceutical liability plaintiffs’ lawyers in the state who have consistently argued that a “heeding presumption” should apply to their failure-to-warn claims and, in effect, relieve them of the burden of proving causation. A unanimous three-member panel upheld the decision of the trial court awarding  summary judgment to the defendant because the plaintiff “presented no evidence that a different warning would have changed [the prescribing physician’s] decision to prescribe [the drug at issue] for Appellant.” Lineberger v. Wyeth, 2006 PA Super. 35, at *24 (Pa. Super. Ct., Feb. 23, 2006). Relying on the appellate court’s 1996 decision in Demmler v. Smith Kline Beecham, 671 A.2d 1151 (Pa. Super. Ct. 1996), the panel reasoned that failure-to-warn claims in the pharmaceutical context require the plaintiff to come forward with evidence showing that the alleged inadequate warning was the proximate cause of the resultant injury in order to state a prima facie case. Id. at *12, 23-24. Evidence that the manufacturer breached its duty to warn the medical community of the risk of harm associated with its product is insufficient in and of itself to impose liability on the manufacturer, the Pennsylvania appellate court explained, because under the standard articulated in Demmler, proximate cause is not presumed. Id. at *23. Hence, traditional negligence principles prevail in drug liability cases in Pennsylvania — pharmaceutical plaintiffs cannot get their case before a jury unless they are able to make a prima facie showing as to each element of their negligence claims, including proximate cause.

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