Court weighs limits on drug suits

Company appeals amputee’s $6.7 million award

WASHINGTON – The Supreme Court appeared likely Monday to decide an amputee’s lawsuit against a drug maker based on how much federal regulators knew about an anti-nausea drug’s risks in the event of a botched injection.

Several justices indicated that if the U.S. Food and Drug Administration had clear information about the risks of Wyeth Pharmaceuticals’ anti-nausea drug Phenergan and approved its warning label anyway, then Wyeth probably would prevail in its court fight against Diana Levine, of Vermont.

But there was considerable skepticism among the justices – and disagreement between the opposing lawyers – that the FDA had a clear picture of the disastrous consequences of improperly giving Phenergan by an intravenous method of injection known as IV push, the fastest way to bring relief to nauseated patients.

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

Justice Ruth Bader Ginsburg chimed in, “No matter what benefit there was, how could the benefit outweigh that substantial risk?”

Levine, a guitar- and piano-playing musician, was in the courtroom for Monday’s arguments in Wyeth’s appeal of a $6.7 million verdict she won from a state jury.

The jury agreed with Levine’s claim that Wyeth failed to provide a strong and clear warning about the risks of IV push, which include that gangrene is likely if the injection accidentally hits an artery. That is precisely what happened to Levine.

The company appealed and, backed by the Bush administration, argued that once a drug’s warning label gets FDA approval, consumers cannot pursue state law claims that they were harmed.

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.

The Supreme Court has largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.

The Levine case has drawn a lot of attention because the administration and Wyeth contend that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs.

But any sort of sweeping ruling seemed unlikely after Monday’s arguments.

Chief Justice John Roberts and Justice Antonin Scalia seemed most receptive to Wyeth’s arguments, suggesting that FDA approval should protect Wyeth.

The warning label indicates gangrene can result if the injection accidentally hits an artery and also makes clear that intramuscular injection is the preferred method of delivery. It also says that the next best method is to use an IV drip and fluids and drugs can be administered.

But David Frederick, Levine’s lawyer, said there is no evidence the FDA ever considered and rejected a stronger warning against the IV push method.


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