Supreme Court Backs Patients' Right To Sue Drug Makers

(By tatar job | Tribune chitral Bureau
11:08 AM EST, March 4, 2009
citral - The Supreme Court today upheld the right of patients who are hurt by a prescription or over-the-counter drug to sue the drug maker for damages.

The 6-3 decision rejected a strong move by the Bush administration and the pharmaceutical industry to shield drug makers from lawsuits if their products were approved by the Food and Drug Administration.

At issue were suits involving the more than 11,000 drugs on the market in the United States. The outgoing Bush administration told the court last fall that federal approval of a drug "preempts," or bars, juries from deciding whether it is unduly dangerous.

But the high court, led by Justice John Paul Stevens, disagreed and said Congress had not taken away the consumer's right to sue. He said the view of the Bush administration "does not merit deference," particularly considering that the FDA prior to the Bush era had favored lawsuits as a means of protecting consumers from dangerous drugs.



Today's ruling upholds a nearly $7 million jury verdict in favor of a Vermont musician whose right arm was amputated after she was injected with an anti-nausea drug made by Wyeth.

The injection struck an artery and caused gangrene, a rare but occasional complication from directly administering Phenergan, the anti-nausea drug.

Diana Levine, the Vermont woman, settled a suit against the clinic that gave her the injection and then sued Wyeth. She contended that the drug maker had not properly warned her and other consumers of the danger.

In its defense, Wyeth said the federally approved warning label told doctors and nurses to use extreme caution when injecting the drug. Levine and her lawyers said that was not sufficient. Who would take an injection to relieve nausea, she asked, if a patient knew she could lose her arm as a result?

The jury agreed with her and awarded her $6.7 million in damages.

In its appeal in Wyeth v. Levine, the drug company argued that since the FDA had approved its warning label as adequate, a jury should not have the power to second-guess this conclusion.

"Congress has repeatedly declined to preempt state law," Stevens said today. "Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling."

Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Steven G. Breyer agreed with him.

Justice Clarence Thomas concurred in the result. Thomas has been reluctant to go along with decisions that say federal regulations trumps state law.

The dissenters were Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr.

"This case illustrates that tragic facts make bad law," Alito wrote. He called the result "a frontal assault on the FDA's regulatory regime for drug labeling."