Film depicts dangers of preemption
The Missouri Association of Trial Attorneys has issued the following press release and i believe everyone should watch this film. The issue of preemption is one in which most injured parties have never thought of until it negatively effects them. Basically, preemption is a doctrine of law that removes a parties rights under state law and gives federal law controlling authority. Given that many, including those formally with the FDA have stated that the agency is severally underfunded, the idea of preemption is one which will become more relevant as aging baby boomer are subjected to more and more prescription drug treatment (and advertising).
The Alliance for Justice has been partnering with AAJ on the issue of preemption, primarily in the new Campaign to Stop Corporate Immunity. As such, they are promoting the film Access Denied?: The Fight for Corporate Accountability, featuring Diana Levine, the plaintiff in the Wyeth v. Levine case currently pending before the U.S. Supreme Court. Please take some time to watch the film online.
Some background: Levine, a lifelong musician and guitar player, went to the hospital with a migraine. She left with injuries that led quickly and irreversibly to the loss of her right hand. Levine was administered the anti-nausea drug Phenergan via the "IV push" method, resulting in an inadvertent introduction of the drug into an artery, which ultimately caused gangrene.
Levine filed suit in state court against Wyeth, the manufacturer of Phenergan, asserting that the drug's labeling provided an inadequate warning of the known dangers of the "IV push" method. Wyeth argued that because the label had gone through FDA approval and included some indication of potential dangers, they were not subject to liability based on a failure to warn. A jury nevertheless ruled in Levine's favor, and she was awarded $7.4 million in damages. Wyeth appealed to the Vermont Supreme Court, which also rejected Wyeth's argument. The majority held that the "federal labeling requirements create a floor, not a ceiling, for state regulation." Finding that there was "no conflict between federal objectives and Vermont common law," Levine's state law claims were not preempted. Wyeth then appealed to the United States Supreme Court.
Wyeth may become the latest in a series of cases that have substantially altered consumer protection law in the United States. Last term, in a significant anti-consumer decision, the Court held that persons injured by a negligently manufactured medical device cannot bring state law claims against the manufacturer for damages if the device received pre-market approval from the federal Food and Drug Administration ("FDA"). In Wyeth, the Court will address the same preemption issues as it relates to labeling of prescription drugs.