- The Washington Times - Tuesday, November 4, 2008

The Bush administration and a drugmaker urged the Supreme Court on Monday to throw out a multimillion-dollar verdict to a Vermont musician who lost an arm because of a botched injection to relieve nausea.

The case is being watched closely by the pharmaceutical industry and consumer groups because of its potential for broad limits on lawsuits by people, such as Diana Levine, who were harmed by prescription drugs.

But the justices seemed more likely Monday to be headed toward a narrow ruling that might be confined to the facts of Miss Levine’s case.

A Vermont jury awarded Miss Levine $6.7 million after the improper injection of Phenergan, an anti-nausea drug made by Wyeth Pharmaceuticals, caused gangrene that led to the amputation of her right arm.

The jury agreed with Miss Levine that Wyeth should have included a stronger warning about the risks of a method of intravenous injection known as IV push.

But lawyers for Wyeth and the government said Miss Levine’s case should have been thrown out of court because Phenergan has been approved by the federal Food and Drug Administration (FDA) and its label adequately warned about its risks.

FDA approval serves as a shield against liability lawsuits under state law in such cases, they said.

“The labeling plainly comprehended and warned about the specific risks of IV administration,” Seth Waxman, representing Wyeth, told the justices.

In recent years, the administration and business groups have 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.

But Justice Samuel A. Alito Jr., among others, had a more basic question for Mr. Waxman.

“How could the FDA have concluded that IV push was safe and effective,” Justice Alito asked, given that Phenergan is not a lifesaving drug and gangrene can result from improper administration

Justice Ruth Bader Ginsburg chimed in, “How could the benefit outweigh the substantial risk?”

Mr. Waxman responded that testimony in this case was clear that there are circumstances in which IV push is “medically warranted.”

David Frederick, representing Miss Levine, argued that Wyeth never made clear to the FDA how dangerous IV push could be. He noted that Pfizer Inc. stopped making IV push an acceptable method of injecting its anti-nausea drug after two amputations were reported.

A ruling probably will not come before early next year.



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