Drugmakers could win lawsuit limits at top US court

The U.S. Supreme Court hears arguments on Monday in a closely watched case that could limit liability claims against drugmakers if one of their medicines causes harm.

The case pits drug giant Wyeth against a musician who lost part of an arm after she was improperly injected with an anti-nausea drug made by the company.

A Vermont jury awarded the woman, Diana Levine, $7 million in damages. Her attorneys argued that Wyeth should have given stronger warnings about the dangers of administering the drug in the way she received it.

Wyeth says it acted properly by including the U.S. Food and Drug Administration’s approved warnings on the label for the drug, Phenergan.

“We were under federal command to put out the label exactly as FDA approved it,” Bert Rein, an outside lawyer for Wyeth, said in an interview.

“We were doing something we thought was consistent with the public health, and so did FDA,” he added.

The key legal question is whether the FDA-approved label preempts state product safety laws, as Wyeth and other drug companies argue. They say state juries looking at the experience of one patient do not have the expertise to determine if a drug has proper warnings.

Federal preemption has been a goal of the pharmaceutical industry for years, and the position has been supported by the Republican George W. Bush administration. The Supreme Court’s decision could limit patients’ ability to sue, and save drugmakers billions of dollars.

MILLIONS OF BUSINESSES

The case also could affect millions of other businesses outside the pharmaceutical industry that face liability claims, the U.S. Chamber of Commerce says.

Preemption opponents say the FDA does not always make the right judgment, and therefore companies should not be fully protected by the agency’s backing.

By providing a legal shield with the FDA label, “it decreases manufacturers’ incentives to improve safety and to inform FDA of risks,” Levine’s lawyers said in a brief for the Supreme Court.

In her case, the drug accidentally hit an artery when it was injected, leading to gangrene that required amputation of her left forearm.

Wyeth could have added a stronger warning against the injection method that was used, her attorneys said.

The Supreme Court already ruled in favor of federal preemption earlier this year. In February, the justices sided 8-1 with medical device maker Medtronic Inc after it was sued by a man harmed by a catheter during an artery-clearing procedure.

If the court again rules strongly in favor of preemption, Democrats in Congress have pledged to push legislation to preserve a patient’s right to sue under state law.

“I think we could see the backlash come through very quickly in Congress,” said Kim Monk, a health-care industry analyst with Capital Alpha Partners.

The case at the Supreme Court is Wyeth v. Levine.

By Lisa Richwine
WASHINGTON (Reuters)