Big pharma has been waiting for this. The Supreme Court earlier today requested the federal government’s view of a $6.8 million judgment awarded against Wyeth to a Vermont woman, who lost part of her arm after being injected with the company’s Phernegan, an antinausea drug.

The justices, in a brief order, signaled their interest in the case by requesting a brief from the U.S. solicitor general’s office. After the legal brief is filed later this year, the court will reconsider the appeal for inclusion in its next term.

Wyeth’s appeal centers on Phenergan label info and whether the drugmaker can be sued under the state’s product-liability laws, even though Wyeth argues that it met federal labeling requirements by the FDA. The agency has a rule saying its jurisdiction trumps state courts.

The concept is called pre-emption, and essentially this gives companies some immunity against product liability claims, because the FDA has already deemed a product to be safe. An exception would occur when, say, a company knowingly hid or falsified info that would have led the FDA to make a different decision about approving a drug.

A Texas state court judge recently caused a furor when he dismissed a Vioxx lawsuit, citing the pre-emption rule, effectively putting nearly 1,000 Vioxx cases on hold. That move prompted legal experts to predict the issue would soon make its way to the Supreme Court.

In the Wyeth case, Diana Levine lost a hand and forearm in 2000 to gangrene after Phenergan was inadvertently injected into an artery during a so-called push IV injection, which is more potent and puts injected drugs into the body faster than a normal injection. Ms. Levine had gone to a medical facility in central Vermont for treatment of nausea.

The drug’s labeling, approved by the FDA, included the injection method as an option but warned of risks like gangrene if the drug were injected into an artery. Levine sued, arguing Phenergan’s labeling was unsafe, and a Vermont jury awarded her $6.8 million in damages. On appeal, the Vermont Supreme Court upheld the award, ruling that FDA drug regulations don’t prevent a company from being sued under state law over drug labeling.

Wyeth’s high-court appeal urged the justices to review the case and rule the FDA’s authority bars lawsuits alleging problems with drug labeling. “This conflict is currently at issue in tens of thousands of cases in our nation’s courts, in which plaintiffs claim that manufacturers should have modified FDA-approved prescription drug labeling,” Wyeth said in the appeal.

The Public Citizen Litigation Group, which reps Levine, argued the lawsuit wasn’t restricted by the FDA’s regulation of drugs. “The circumstances under which FDA regulation could conflict with a state-law damages action are very narrow, if not non-existent,” Public Citizen said.

Further reading…
The Wall Street Journal (subscription required);
A pre-emption primer from The Drug & Device Law blog.[tags]Pre-emption, Wyeth[/tags]