Pennsylvania Supreme Court Redefines Negligence Liability of Drug Firms

A new decision by the Pennsylvania Supreme Court has broadened the scope of holding pharmaceutical companies liable for defectively designed drugs, holding that drug companies can be sued “for lack of due care” notwithstanding approval of the drug by the Food and Drug Administration.

This puts on a whole new dimension in the field of negligence for pharmaceutical companies and as the Philadelphia law firm Ballard Spahr LLP commented in an article published last week: “The decision upends years of accepted law in Pennsylvania. While the Supreme Court had not previously addressed the precise issue of a pharmaceutical company’s alleged lack of care in the design and testing of a marketed drug …. This new decision will enable juries to second-guess FDA approval by concluding that an approved medicine is, or at least was, too dangerous to be marketed in the first place. If it stands, this case will alter the terrain of pharmaceutical litigation in Pennsylvania.”

While in the instant case, the drug company Wyeth argued that defectively designed drugs and their effects including negligence liabilities should be strictly interpreted, the court rejected the company’s arguments and ruled that strict liability applies only to the product and not to the conduct of a manufacturer.

However the court did accede that it would be difficult to assert a claim based on negligent design on the premise that a drug is too dangerous to be used by anyone as long as the drug “maintained its FDA approval, it remained on the market, and U.S. doctors continued to prescribe it.”

But, where pharmaceutical companies are compelled to withdraw a drug from the market, the new decision can change the toxic torts situation significantly, and expand the liability of drug companies for defectively designed drugs in Pennsylvania.