An earlier post on this site discussed Wyeth v. Levine, the case before the US Supreme Court on whether federal law preempts state torts claims imposing liability on drug labeling that the FDA had previously approved. Today, the Court issued its decision rejecting the preemption argument made by the pharmaceutical defendant by a 6-3 vote. Justice Stevens wrote the majority opinion. Justice Alito wrote the dissent in which Chief Justice Roberts and Justice Scalia joined.
The factual background involves the plaintiff Levine, a children's guitarist in Vermont who went to a clinic for treatment of a severe migraine headache and associated nausea. She was originally treated with intramuscular injections of Demerol (for headache) and the pharmaceutical defendant Wyeth's drug, Phenergan (for nausea). Intramuscular injection was the preferred method for administering Phenergan identified in the product's labeling. When she had no relief from that treatment, Levine returned to the clinic, where she received a second dose of Phenergan by IV push injection. Unfortunately, the needle was inserted into an artery rather than a vein leading to gangrene and the amputation of Levine’s arm. Levine filed a failure-to-warn product liability case against the pharmaceutical company and obtained a jury verdict in amount of $6.7 million. The defendant Wyeth argued that Vermont's stricter regulations on administering the drug were preempted by less stringent federal regulations. The preemption doctrine has been used by drug manufacturers as a shield in lawsuits brought by injured consumers, adversely impacting consumers.
A NY Times article entitled Drug Approval Is Not a Shield From Lawsuits, Justices Rule suggests that preemption is no longer a valid defense for drug companies. While the decision appears on first reading to be a defeat for the preemption doctrine that federal-level approval stops liability suits at the state level, a closer reading suggests that the preemption doctrine is not entirely dead. At page 8 of the opinion, the Court draws a distinction between express and implied preemption. It also finds that congressional intent is the "touchstone" of implied preemption cases as well as express preemption cases, and that the presumption against preemption applies to implied preemption cases. The WSJ Law Blog has its take on the decision in its post A Big Day for State Tort Law: A Closer Look at Wyeth v. Levine suggesting that the case is really about statutory interpretation. In addition to the Wyeth case, the Court has recently addressed the preemption doctrine in its decisions in Riegel v. Medtronic, Inc. and Altria Group Inc. v. Good.