High Court Case Looms Large for Drugmakers

By Jerry Markon
Washington Post Staff Writer
Tuesday, November 4, 2008

Diana Levine went to a medical clinic with a severe migraine headache. She wound up with gangrene and an amputated forearm, the victim of a rare side effect from a popular anti-nausea drug.

"It's horrific when you think about it," said Levine, 63, a professional musician who needs a prosthetic arm to strum a few chords on her beloved guitar. "Either I'm not going to throw up or I'm going to lose a limb."

The Vermont woman sued the pharmaceutical company Wyeth, winning a $7.4 million judgment that triggered one of the most hotly contested cases of the Supreme Court's term. The justices yesterday debated Wyeth's contention -- which is supported by the Bush administration -- that the lawsuit should be thrown out because federal law preempts such state court claims.

The company's argument caused divisions within the conservative bloc on the court, which has sided with corporations in several recent similar cases. Justice Samuel A. Alito Jr. questioned how the Food and Drug Administration approved the anti-nausea drug, Phenergan, as "safe and effective" when "you have the risk of gangrene."

Justice Anthony M. Kennedy disputed Wyeth's contention that it could not have followed the Vermont law under which Levine sued without violating the federal law that regulates drug labeling. "As a textual matter, as a logical matter, as a semantic matter, I don't agree with you," Kennedy, often a swing vote in important cases, told a Wyeth attorney.

But Justice Antonin Scalia grilled Levine's attorney intensively, scowling at him and saying the FDA-required warning label specified that the way Levine was administered the drug was "dangerous" in certain circumstances. "Excuse me, the risks were set forth on the labeling," Scalia said. "If you're telling me the FDA has acted irresponsibly, then sue the FDA. . . . If you are simply eliminating certain drugs which the public has a real desperate need for . . . you're not benefiting the public."

The argument was the latest in an intensifying national debate over "preemption," a doctrine under which companies can be shielded under federal law from state lawsuits. Business groups strongly favor preemption, while state regulators fear it hurts consumers.

Levine's lawsuit struck a particular nerve, with both sides mounting intensive media campaigns before yesterday's argument. That's partly because of Levine's injuries -- which all sides agree are tragic -- but also because the pharmaceutical industry could face massive liability if she wins.

Courts have been flooded with product liability lawsuits in recent years, and statistics show about a third are against drug companies. More than 27,000 lawsuits are pending over Merck's painkiller Vioxx, one of several FDA-approved drugs withdrawn because of health hazards.

Without preemption, Wyeth and its supporters argue, fear of litigation could keep vital drugs off the market and excessive warning labels will scare people into skipping medications they need.

But Rep. Henry A. Waxman (D-Calif.), one of 18 members of Congress who filed a brief supporting Levine, said in an interview that the "threat of liability acts as one of the most powerful incentives for companies to be more concerned about safety." If the court rules for Wyeth, Waxman said, "Congress has an obligation to change the law if it's harmful to consumers."

Levine, a chronic migraine sufferer, went to a Vermont clinic on April 7, 2000. She was treated with Demerol and Phenergan, which was first approved in injectable form in 1955.

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