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.

By the mid-1960s, according to court documents and company officials, Wyeth had learned of a dangerous side effect when the drug is administered directly into a vein, a method known as IV-push. If the Phenergan mixes with blood from an artery, it can cause irreversible gangrene.

Wyeth alerted the FDA, which imposed a series of warning labels. At the time Levine was treated, the label instructed doctors to be extremely careful when using IV-push and specified gangrene as a side effect. Court documents said about 20 patients -- out of more than 200 million -- have been stricken with gangrene. The company and FDA think that risk is minimal enough to justify keeping IV-push as an option because it gets the drug into the bloodstream immediately.

After Levine received the drug intravenously, her headache was gone but her right arm hurt. Thus began a weeks-long ordeal to save the arm, which "turned all kinds of colors, purple, green, blue and black," she said.

The gangrene proved unstoppable. "The thought of losing my arm was horrible, but it was a life-or-death situation," said Levine, who woke up from the amputation in utter despair but has "since become grateful that I have an elbow. There are a lot of things you can do with an elbow."

Levine, who owns an independent record label, today uses several prosthetic arms and says her business has been "crippled." She sued Wyeth under a Vermont product liability law, and her attorneys yesterday argued that Wyeth should have warned doctors to not use IV-push because of the risk.

Wyeth maintained that its warning label was specified by the FDA, the sole regulator of the drug industry, and that the judgments of state laws and juries cannot be substituted for FDA expertise.

A Vermont jury disagreed, awarding Levine the $7.4 million, which was reduced to $6.7 million by a judge.

Levine, who attended yesterday's argument, said the experience has devastated "my whole self-image, my musical identity and my livelihood."

"The company took my arm. They need to take responsibility for that," she said.

View all comments that have been posted about this article.

© 2008 The Washington Post Company