Businesses have much at stake in drug suit's outcome

McClatchy NewspapersNovember 3, 2008 

WASHINGTON — Supreme Court conservatives on Monday sounded sympathetic to a drug company's pleas for protection from state court lawsuits.

In the highest profile business case of the year, several justices appeared ready to declare that federal regulations preempted certain state lawsuits. That would be a major victory for the drug company, Wyeth, as well as many other businesses seeking to fend off expensive state-by-state legal challenges.

"The name of this game is balancing benefits and costs," Justice Antonin Scalia said, "and if you simply eliminate drugs which people have real desperate need for . . . you're not benefiting the public."

Chief Justice John Roberts joined Scalia in raising questions helpful to Wyeth's cause, as did, albeit less vehemently, Justice Samuel Alito. The three justices have previously combined to restrict lawsuits in other cases and could form the core of a majority favoring Wyeth in the new case.

"I envision a scheme under which manufacturers who are worried about jury liability of the magnitude that occurred in this case saying, 'Gee, why should we take chances?'" Alito said, suggesting that drug availability might suffer as a result.

The case is called Wyeth v. Levine. Wyeth is a New Jersey-based pharmaceutical company that posted $22 billion in revenues last year.

Levine is Diana Levine, a 63-year-old Vermont resident and former professional musician. Her right hand and forearm were amputated eight years ago after she contracted gangrene following an injection of a Wyeth anti-nausea drug called Phenergan.

Levine sat quietly in the courtroom during the hour-long oral argument Monday, dressed in a half-sleeved purple dress that revealed what remained of her arm. It ends right below her elbow.

"The drug manufacturer was negligent in its warning," Levine's attorney, David C. Frederick, told reporters after oral arguments, "and the results are here for all to see."

In this case, though, preemption is the issue: technical but important.

The federal Food and Drug Administration had approved Phenergan with a warning that it should not be injected into arteries, because of gangrene danger. The federal warning did not, however, rule out the specific form of injection used on Levine. Wyeth and its big-business allies, as well as the Bush administration, call the FDA's warning a ceiling, the maximum appropriate regulation of the drug.

"The FDA has to decide what information to provide clinicians," said Wyeth's attorney, Seth Waxman, a former U.S. solicitor general. "What it did here is provide ample, lavish warnings about the risk."

But Levine and her allies argue that the FDA's warnings are really just a floor, which states can elaborate on with stricter requirements. Levine won $6.7 million in Vermont court with her argument that Wyeth had violated the state's labeling requirements by permitting a certain form of injection that posed an unreasonable risk of entering an artery.

"Wyeth knew or should have known since at least the 1970s that there was a significant issue," Frederick told the justices Monday.

State regulations and lawsuits might help reinforce the FDA in keeping the industry honest, Levine's supporters think. Tellingly, Justice Ruth Bader Ginsburg noted that some 11,000 drugs have been approved by federal regulators.

"Is the FDA really monitoring every one of those?" Ginsburg asked.

Considerable questioning Monday circled around how much information Wyeth provided to FDA regulators. Waxman declared that on five separate occasions, the company presented FDA with Phenergan information and asked "for more warnings." Frederick, though, insisted the company "never took the trouble to connect the dots" with the available information."

At least 20 people have had limbs amputated following the onset of gangrene after a Phenergan injection, Frederick said.

Drug companies have the most immediate stake in the case, because it will be rooted in the specific work of the FDA, but the potential precedent could spread to any issue involving state-versus-federal regulations. Potentially, this could include auto safety, air quality and pesticide use.

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McClatchy Newspapers 2008

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