Patients can sue drug companies, Supreme Court rules

[RandyW]

Patients can sue drug companies, Supreme Court rules

Patients have the right to sue drug companies when they've been harmed by medications whose risks aren't adequately disclosed, the Supreme Court ruled today in an important 6-3 decision.

The much-watched case is a significant defeat for the drug industry and could open to door to thousands of lawsuits against pharmaceutical firms.

It was brought by a Vermont musician, Diana Levine, who lost her arm in 2000 after being given an injection of an anti-nausea drug at a health clinic. Gangrene set in immediately, leading to the loss of the limb.

Levine sued Wyeth, the drugmaker, alleging that it failed to sufficiently warn of serious risks associated with intraveous injection of the medication. A Vermont jury awarded the woman $6.7 million and the Vermont Supreme Court reaffirmed the verdict in 2006.

In its defense, Wyeth argued the drug’s label, which had been approved by the Food and Drug Administration, advised extreme caution when the drug was injected, the Tribune’s Washington bureau reported today. The FDA is responsible for regulating drug safety across the U.S.

The pharmaceutical industry maintained that federal regulation by the FDA should pre-empt product liability actions brought in state courts, but the Supreme Court rejected that argument.

Writing for five justices in the majority, Justice John Paul Stevens noted “Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight.

“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” he wrote in the decision.

Justice Clarence Thomas joined the majority but cited different legal justifications.

When the court agreed to hear the case, the Bush administration stepped in voicing strong support for the principle of pre-emption. Today’s ruling counters that position.

“We’re ecstatic about the results,” Levine’s Supreme Court lawyer, David Frederick, told Bloomberg News.

Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito disagreed with the majority decision. In the dissenting opinion, Alito called the decision “a frontal assault on the FDA’s regulatory regime for drug labeling.”

Wyeth’s lawyer told the Wall Street Journal: “We believed that federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed. The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product’s label.”

Ironically, a year ago the Supreme Court affirmed that medical devices approved by the FDA were largely shielded from product liability suits in state courts. But the laws governing medical devices are different from those governing the drug industry.