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Industry Liability At Issue

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The Washington Post

Published: November 4, 2008

WASHINGTON - 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, Phenergan.

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

The Vermont woman sued pharmaceutical giant Wyeth, winning a $7.4 million judgment that has triggered one of the most hotly contested cases of the Supreme Court's term. The justices Monday 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 argument in Wyeth v. Levine 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 favor preemption, while state regulators fear it hurts consumers who are injured by harmful products.

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

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 More than 27,000 lawsuits alone are pending over Merck & Co.'s painkiller Vioxx, one of several FDA-approved drugs withdrawn because of health hazards.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

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