Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers
In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the Supreme Court of Pennsylvania rejected arguments by Wyeth Ltd. that pharmaceutical companies could only be held liable in Pennsylvania for manufacturing defects and inadequate warnings. The decision is available, click here.
Writing for the majority, Justice Thomas Saylor stated:
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. … There has been no supported presentation here which would persuade us to immunize companies from the responsibility to respond in damages for such lack of due care resulting in personal injury or death.
In 1997, Catherine Lance took Redux-brand dexfenfluramine for weight loss. In 2004, she was diagnosed with pulmonary hypertension and died only a short time later. In 2006, Lance’s mother, Patsy Lance, sued Redux brand manufacturer Wyeth (formerly American Home Products Corp., now Pfizer Inc.) in the Philadelphia County Court of Common Pleas. Lance sued Wyeth for negligence based upon claims of unreasonable marketing of dangerous drug and for unreasonable failure to remove Redux from the market before January 1997. Lance argued that by mid-1997, there were reports of an association between Redux and valvular heart disease, but Wyeth did not withdraw Redux until September 1997. Wyeth’s motion for summary judgment was granted by the trial court, which held that because Redux was approved as reasonably safe by the FDA, a plaintiff could not sue for injuries unless they could prove that the drug was impure or the label inadequate. On direct appeal, the Superior Court found that Lance’s negligent design defect claim should have been allowed to proceed, but agreed with Wyeth that the only grounds supporting a strict liability claim were claims for manufacturing defect or failure to warn.
In its majority opinion, the Pennsylvania Supreme Court also rejected Wyeth’s argument that tort liability impinges on the development of new drugs, citing the significant research and development costs associated with the launch of a new product. The majority opinion responded that Wyeth failed to address the advantages of the federal patent system, which grant exclusivity for up to 20 years.
The decision in Lance vs. Wyeth represents a significant departure from long-established precedent in Pennsylvania. While the precise issue of a pharmaceutical company’s alleged lack of care in the design and testing of a marketed drug had not been resolved, drug manufacturers had generally succeeded in obtaining dismissal of such claims by reliance upon the learned intermediary doctrine and the FDA approval process. The decision once again emphasizes the scientific and medical dilemma which drug manufacturers face, where appropriate, even extensive pre-market testing and FDA approval may not be sufficient to protect the company from claims for unexpected complications arising years after the product’s initial release date. Also noteworthy is the relatively short period of time at issue in here, where the manufacturer was criticized for not taking actions for a period of less than one year (pre-January 1997 until September 1997) at a time when the potential complications were certainly far from established. As is often the case, once the harm is known, the speed of a manufacturer’s response will most likely not prevent future liability verdicts, but may be an important factor where punitive damage claims are presented.