Pennsylvania Supreme Court Holds Plaintiffs May Assert Negligent Design Claims Against Drug Companies

The Pennsylvania Supreme Court in Lance v. Wyeth (2014 Pa.LEXIS 205) recently ruled that pharmaceutical companies can be held liable for negligent design, testing, marketing, and distribution of drugs regulated by the FDA. This decision alters the landscape of Pennsylvania law because pharmaceutical companies previously succeeded in having similar claims dismissed based upon the learned intermediary doctrine. Under this doctrine, the manufacturer of prescription medications discharges its duty to warn users of the risks associated with its products by warning the prescribing physician of the proper use and risks of the product. Hence, this doctrine holds that the prescription drug manufacturer’s duty runs to the doctor. However, by limiting the application of the learned intermediary doctrine, juries may disregard FDA approval and determine a particular drug is dangerous or was too dangerous to be marketed in the first place. Consequently, pharmaceutical companies can now be sued “for lack of due care.”

This case arose from the prescription of the weight loss drug Redux to Catherine Lance in 1997, which was manufactured by Wyeth. Approximately seven years later she was diagnosed with primary pulmonary hypertension and died the following month. Her mother sued Wyeth in 2006 for negligently marketing this dangerous drug knowing there were reports that it was linked to valvular heart disease.

Wyeth filed a motion for summary judgment and argued Pennsylvania law did not extend strict liability to prescription drug manufacturers. Furthermore, Wyeth argued prescription drugs are unavoidably unsafe but not unreasonably dangerous when accompanied by appropriate warnings. The Philadelphia Court of Common Pleas granted the motion and essentially found that a plaintiff is not permitted to sue a pharmaceutical company for injuries unless there was evidence the drug was impure or had inadequate labeling.

The Pennsylvania Superior Court reversed and held negligent design claims could move forward. The Supreme Court affirmed and rejected Wyeth’s argument that manufacturing defects and inadequate warnings are the only viable product liability claims against pharmaceutical companies. Writing the majority opinion, Justice Thomas G. Saylor found a drug maker’s reliance on federal regulations and the learned intermediary doctrine was insufficient to limit a plaintiff’s access to civil recovery. Moreover, his opinion states, “Under Pennsylvania law, pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace… with actual or constructive knowledge that the drug is too harmful to be used by anyone.”

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