On March 4, 2009, the U.S. Supreme Court ruled 6-3 on the side of the consumer in a landmark pharmaceutical liability case against drug manufacturer Wyeth. The ruling may be the death knell in the argument for preemption – an effort to protect corporations from state tort litigation.
The case, Wyeth v. Levine, involved Vermont musician Diana Levine, who sued Wyeth when she lost her forearm in 2000 to gangrene because of improper administration of Phenergan. The labeling on the Wyeth-produced anti-nausea drug, she claimed, had failed to adequately warn medical personnel that the method used to give her the drug, an “IV-push,” was dangerous and could lead to gangrene.
The basis of the preemption argument, as put forth by drug and medical device manufacturers, is that if their product is approved by the U.S. Food & Drug Administration (FDA), they are protected from any future claims of harm from consumers. They say that because their product is approved by the federal government, they should be immune from any claims at the state level. Federal approval trumps state law, they said.
The U.S. Supreme Court disagreed.
Drug manufacturers are required to get approval from the FDA in order to sell their products, so if FDA approval implies preemption, the drug manufacturer would basically have built-in protection against any future legal actions. But, as is evident from the many stories in the news about defective drugs and products, FDA approval doesn’t guarantee safety or effectiveness. It only sets a minimum standard.
Many drugs are approved after only minimal testing on limited numbers of people. If, once they enter the general population, it turns out they have previously unknown serious side effects, there must be a factor to motivate the manufacturer to fix the problem. Litigation provides that motivation, and an additional safeguard, holding the manufacturer ultimately responsible for the safety of its product.
In their ruling, the U.S. Supreme Court justices noted that “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”
In other words, when consumers are allowed to hold drug manufacturers liable for the harm caused by their products, they motivate the drug companies to provide safe, reliable and well-tested products, and to quickly remove from the market or fix products identified as dangerous.