Should Drug Companies Be Shielded From Lawsuits?

March 4, 2009
Supreme Court Rejects Limits on Drug Lawsuits
By THE ASSOCIATED PRESS

WASHINGTON (AP) -- The Supreme Court on Wednesday upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea for limiting lawsuits against drug makers. In a 6-3 decision, the court rejected Wyeth (NYSE:WYE) Pharmaceuticals' claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont. Levine, 63, struggled with her emotions when told of the ruling in a phone call from an Associated Press reporter Wednesday: "Oh, my God. I'm so, so happy. I can't believe this phone call," she said. "I've been waiting for so long, and I had no idea of what the chances were," Levine said. "I'm just ecstatic. I'm going to have to sit down."

Wyeth had no immediate comment on the ruling. The company is in the process of being bought by rival Pfizer, Inc. (NYSE:PFE) , in a $68 billion deal that is expected to close later this year. The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law. A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein, a method called IV push. Gangrene is likely if the injection accidentally hits an artery -- precisely what happened to Levine. The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the Food and Drug Administration, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.

Justice John Paul Stevens, writing the majority opinion, said Wyeth could "unilaterally strengthen its warning." Stevens said he was persuaded that until a recent change by the FDA, the agency "traditionally regarded state law as a complementary form of drug regulation" because it monitors 11,000 drugs.

Justice Clarence Thomas agreed with the outcome of the case, but did not join Stevens' opinion. Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia. "This case illustrates that tragic facts make bad law," Alito said. "The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs." The FDA has approved the use of Phenergan by injection, including the method at issue in Levine's case. The drug has been available for decades to treat nausea and when used properly, both sides agree it is safe and effective. The Bush administration and business groups aggressively pushed limits on lawsuits through the doctrine of pre-emption -- asserting the primacy of federal regulation over rules that might differ from state to state. The Supreme Court had largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.

The Levine case drew a lot of attention because the administration and Wyeth contended that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs. Stevens said there could be circumstances where consumer lawsuits would not be allowed, including if the FDA had considered and rejected a stronger warning label.

But that was not the case with Phenergan, he said. "As we have discussed, the FDA did not consider and reject a stronger warning against IV-push injection of Phenergan," Stevens said. Justice Stephen Breyer agreed in a brief, separate opinion. "It is also possible that state tort law will sometimes interfere with the FDA's desire to create a drug label containing a specific set of cautions and instructions," Breyer said.

The case is Wyeth v. Levine, 06-1249.