“Negligent Design Defect” • Pharmaceuticals
Lance v. Wyeth, PICS No. _______ (Pa. Jan. 21, 2014), Saylor J. (56 pages).
Pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace, or continue a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone. Affirmed in part and reversed in part.
Plaintiff’s daughter died of pulmonary hypertension after ingesting “fen-phen” weight loss products. Plaintiff brought an action against Wyeth, the manufacturer and/or supplier of the drugs. The complaint alleged “Negligence – Unreasonable Marketing of a Dangerous Drug and Unreasonable Failure to Remove the Drug from the Market . . . “, and asserted that Wyeth owed a duty not to introduce onto the market a drug that was unreasonably dangerous for any person to use.
Wyeth moved for summary judgment. It argued that plaintiff failed to assert a cognizable cause of action because impurities or deficient warnings are the only allegations which would support liability against a pharmaceutical company based upon adverse effects from the use of a prescription drug. The common pleas court granted the motion.
A three-judge panel of the Superior Court reversed, finding that plaintiff had asserted a cognizable claim of “negligent design defect” against Wyeth. However, it rejected plaintiff’s allegation that Wyeth negligently failed to withdraw the drug from the market.
Both parties filed cross-appeals. Wyeth challenged the Superior Court’s holding that pharmaceutical companies are not immune from claims of negligent drug design, i.e., that Pennsylvania law recognizes only two liability theories based on adverse effects of prescription drugs, namely, manufacturing defects and inadequate warnings. Plaintiff challenged its finding that claims of negligent marketing, testing and failure to withdraw drugs are unviable.
The Pennsylvania Supreme Court affirmed in part and reversed in part.
As to Wyeth, the court refused to invoke policy justifications to scale back the existing duty of pharmaceutical companies to independently and vigilantly protect against unreasonable health risks which may be posed by products intended for human consumption, because Wyeth failed to present a full and balanced record covering the range of relevant policy matters.
As to plaintiff, the court held that under Pennsylvania law, pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace, or continue a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone.