Recently, The Pennsylvania Supreme Court ruled that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, despite the drug's approval by the Food and Drug Administration (FDA). In a ruling against Wyeth over their weight-loss medication Redux, the court 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."
The FDA approved Redux as a prescription weight-loss drug in April 1996.The product packaging contained a prominent warning of an increased risk of pulmonary hypertension ("PPH"). By mid-1997, there were also reports of an association between Redux's active ingredient dexfenfluramine and serious coronary impairments, including heart disease. In September 1997, Wyeth and the FDA announced that Redux would no longer be made available in the United States. In the aftermath, thousands of lawsuits were filed asserting that Redux caused injuries and deaths.
In the fall of 2006, Patsy Lance filed suit on behalf of her daughter, Catherine Lance, alleging that Catherine took Redux for several months in 1997. The complaint alleged that the drug caused Catherine to develop PPH, from which she died within a month after her diagnosis in 2004.
Notably, instead of suing Wyeth for inadequate labeling, Lance framed her central claim as "Negligence—Unreasonable Marketing of a Dangerous Drug and Unreasonable Failure to Remove the Drug from the Market before January 1997." She alleged that by mid-1997 there were reports of an association between Redux and valvular heart disease, but that Wyeth did not withdraw Redux until September 1997. According to the complaint, Wyeth "owed a duty to [Catherine] not to introduce onto the market a drug that was unreasonably dangerous for any person to use." Because Redux was "so unreasonably dangerous and defective in design" Lance argued, "it should never have been on the market."
At the lower court level, Wyeth filed and won a motion for summary judgment, arguing that Lance failed to assert a cognizable cause of action. After all, the FDA had declared the drug as "reasonably safe" when it granted marketing approval for the product, and the product included conspicuous risk warnings.
On appeal, the intermediate appellate court found that Lance should have been permitted to proceed with a claim of negligent design only.
PA Supreme Court
Wyeth argued that Pennsylvania law recognizes—and should recognize—only two liability theories based on adverse effects of prescription drugs: manufacturing defects and inadequate warnings. Wyeth supported this argument by (1) highlighting the role of federal regulation, including the FDA's decision to approve Redux as safe and effective for prescription use; (2) the independent decision-making of physicians who actually prescribe the drug to individuals, and (3) the Pennsylvania Supreme Court's past refusal to extend strict liability to prescription drug manufacturers. According to Wyeth, such an approach strikes the appropriate balance between compensating injured individuals and the need to have reasonable limitations on the liability of pharmaceutical companies. Wyeth stressed that good public policy would not deter the continued availability and development of beneficial medicines, with the risks conspicuously displayed.
The Wyeth brief stated:
Allowing the Superior Court's decision to stand would inevitably unleash a host of claims that, notwithstanding an FDA approval of a drug's risk-benefit profile as 'safe and effective,' its manufacturer was nevertheless 'negligent' in placing and keeping the drug on the market. The Court should not permit those claims, which are the antithesis of the deference that should be afforded to the FDA.
In opposition to Wyeth, Lance argued: "The tort of negligent design . . . threatens to hold Wyeth liable for unreasonably marketing a drug with risks that far outweigh its benefits. It 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." Lance also believes that the current remedies are inadequate. "Most importantly," she argued, "the tort of negligent design provides a critical remedy for consumers who are injured when a drug manufacturer disregards these responsibilities."
The Pennsylvania high court sided with Lance: "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."
Importantly, the court made sure to clarify (hidden in footnote 33) they "recognize that the application of Appellee's theory of liability would present more difficult questions in a circumstance in which a prescription drug maintained its FDA approval, it remained on the market, and U.S. doctors continued to prescribe it. The assertion that no reasonable physician would prescribe the drug (knowing what the manufacturer knew or should have known) is capable of gaining greater traction when, as here, the inquiry is more in the nature of a post-mortem."
Following the ruling, Pfizer, which acquired Wyeth in 2009, said it was prepared to defend itself against the plaintiff's claims when the suit returns to a lower court for further proceedings.
For now, at least facially, Pennsylvania has broadened the scope for holding pharmaceutical companies liable for defectively designed drugs.