Pharmaceutical manufacturer liability for unreasonable marketing
On the Docket
The Supreme Court of Pennsylvania recently reversed dismissal of a lawsuit brought against a pharmaceutical manufacturer. That court accepted the argument that a manufacturer may be liable for marketing a drug that is unreasonably dangerous for any patient. This ruling has the potential to expand the liability of pharmaceutical manufacturers beyond the traditional lawsuits based on manufacturing defects and the failure to warn.
The lawsuit alleged lack of due care by the manufacturer of the appetite suppressant dexfenfluramine (Redux—Interneuron Pharmaceuticals), a drug approved by FDA in April 1996. The drug labeling included a prominent warning of an increased risk of primary pulmonary hypertension (PPH), a condition that had been associated with this class of drugs. In September 1997, the manufacturer and FDA announced that dexfenfluramine would be withdrawn from the market because the drug was associated with serious cardiac problems.
The plaintiff bringing the lawsuit was the mother of a woman who allegedly ingested dexfenfluramine for several months in 1997 and died from PPH. The plaintiff framed her central claim as “unreasonable marketing of a dangerous drug and unreasonable failure to remove the drug from the market prior to January 1997.”
The manufacturer sought to dismiss the case, contending that this type of claim cannot support the liability of a pharmaceutical manufacturer to a patient because the only permissible allegations supporting such liability are manufacturing impurities and deficient warnings. The lower court granted the motion to dismiss, based on its interpretation of prior legal precedents. The plaintiff’s appeal of this ruling eventually reached the Supreme Court of Pennsylvania.
On appeal, the court noted the manufacturer’s concerns with “the wisdom of putting judges and/or lay jurors in a position of reevaluating and ‘second-guessing’ the risk–benefit calculus of the FDA.” According to the court, the manufacturer’s analysis “ultimately circles back to its policy position that the appropriate balance between allocating responsibility for injury and safeguarding development of valuable pharmaceutical products entails recognition only of manufacturing-defect and failure-to-warn claims against drug companies.”
The court also noted the plaintiff’s contrary position that a manufacturer should be held liable for unreasonably marketing a drug with risks that far outweigh its benefits. According to the court, the plaintiff’s position “places responsibility squarely on the manufacturer to remain alert for serious drug hazards that emerge both during clinical trials and after the drug has entered the market, and creates powerful incentives for the manufacturer to act upon that emerging risk information and to promptly disclose it to the FDA.”
Citing a previous case from the U.S. Supreme Court, the Pennsylvania court observed that “FDA has only limited resources to monitor the thousands of drugs in the marketplace, as well as to assess new entrants, and [...] the tort system may be particularly helpful in redressing new risks which may emerge postmarketing.” The court then concluded that “a company which is responsible for tendering into the market a drug which it knows or should know is so dangerous that it should not be taken by anyone can be said to have violated its duty of care either in design or marketing.”
This case has not yet been decided by the lower court. Although the dismissal of the case was reversed, the plaintiffs will not necessarily succeed as the case proceeds. One of the most significant lessons of the case is the importance of postmarketing information and the shared responsibility to gather and assess this information.
Based on: Lance v Wyeth, 2014 Pa. LEXIS 205 (January 21, 2014).