The seemingly never-ending products liability case in Pennsylvania’s Supreme Court Lance v. Wyeth has finally drawn to a close after more than three years of arguments and appeals. This case involves Catherine Ruth Lance, whose family argues that Wyeth (a pharmaceutical company) was negligent in allowing an “unreasonably dangerous prescription drug on the market and failing to withdraw it upon discovering that it was unsuitable for public consumption.” Lance took a Wyeth diet drug called Redux (also known as Phen Fen) for several months in 1997, which her family claimed led to her death from primary pulmonary hypertension in 2004. The trial court ultimately concluded that Lance’s family had “failed to present a cognizable claim,” and the family later appealed.
Asserting that Wyeth was negligent in its testing, labeling, marketing, and manufacturing Redux, the family enlisted both the American and Pennsylvania Associations for Justice for help, and these groups wrote a brief arguing, “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.” This passage concludes by invoking the power of the tort system as it provides recourse to consumers who are injured “when a drug manufacturer disregards these responsibilities.”
After many years of argument and counterargument, the Pennsylvania Supreme Court recently published a decision reversing much of the initial trial court’s decision. A summary of the decision in the case reads, “[P]rimary responsibility for drug safety rests with the manufacturer, which has ‘superior access to information about [its] drugs; especially in the post-marketing phase as new risks emerge.’ […] 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 a lack of due care resulting in personal injury or death. […] Neither [Congress nor the legislature] has conferred such immunity […].”
This is far from the first time that the FDA has come under fire for its failure to test and regulate drugs after they have made their way to the marketplace. In the spring of 2012, the independent non-governmental Institute of Medicine released a report claiming that the FDA’s post-market oversight is not systematic or thorough enough, and suggesting that the administration standardize its practices in this respect in a way that will make it “more predictable, transparent, and proactive.”
The Pennsylvania Supreme Court decision last week is a small step toward safer drugs for citizens, but real change will only be possible when the government stops trusting drug companies themselves to report problems with their products. They have proven time and time again that they value their profits over the safety of their customers.