Pennsylvania Court Recognizes New Cause of Action in Pharmaceutical Products Liability Case

In Lance v. Wyeth, the Pennsylvania Superior Court held that a plaintiff may properly maintain a cause of action for negligent design defect under Pennsylvania law in a pharmaceutical products liability case. In Lance, the plaintiff alleged that her daughter took Redux to treat her obesity from January 1997 through April 1997. Redux, which was manufactured by Wyeth, had been approved by FDA as safe and effective in April 1996. Wyeth ultimately withdrew the drug from the market in September 1997. More than seven years after plaintiff’s daughter had ingested Redux, she was diagnosed with primary pulmonary hypertension (PPH). One month after being diagnosed with PPH, plaintiff’s daughter was dead.

Wyeth filed a motion for summary judgment and argued that the plaintiff had failed to assert a cognizable cause of action as a matter of law. Wyeth argued that a plaintiff can only recover from a drug manufacturer by proving either a manufacturing defect or an inadequate warning. Plaintiff had not alleged either.   Instead, plaintiff had alleged that Redux was “unreasonably dangerous” and that Redux’s “risks outweighed it benefits as to all possible classes of users” of the medication.  The Court of Common Pleas granted Wyeth’s motion for summary judgment and this appeal followed.

Acknowledging that, under Pennsylvania law, a plaintiff may not state a cause of action for strict liability arising out of a design defect, so long as the drug is manufactured properly and contains adequate warnings, the court held that plaintiff properly stated a cause of action for negligent design defect. Citing Philips v. Cricket Lighters, the court stressed the difference between a cause of action for strict liability arising from design defect, which examines the product itself, and negligent design defect, which examines the conduct of the pharmaceutical manufacturer.

The court’s analysis centered around Comment k of the Restatement (Second) of Torts, § 402A, which was adopted by the Pennsylvania Supreme Court in Hahn v. Richter, and which provides:

k.            Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous . . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their sue, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

The court found that nothing in comment k proscribes a plaintiff from stating a cause of action for negligent design defect. To the contrary, by its very terms, comment k expressly bars only claims for strict liability arising from design defect, insofar as they allege that a product’s design was defective and unreasonably dangerous.

Turning to the plaintiff’s claim that Wyeth acted negligently by failing to recall the product, the court refused to impose a common law duty to recall on the manufacturer, particularly where FDA has not withdrawn approval of the drug in question. 

Manufacturers should take note that the Wyeth did not argue that the plaintiff had failed to adduce sufficient evidence to withstand summary judgment, but, rather, that the plaintiff’s claim failed as a matter of law. Following Lance, manufacturers facing a negligent design defect may be more successful in attacking the plaintiff’s argument on the former grounds. Manufacturers should also take note that Lance expressly holds that negligent failure to withdraw claims are barred as a matter of law.

 

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