Supreme Court Rejects Limits on Drug-Injury Lawsuits

Mar. 5 -- WEDNESDAY, March 4 (HealthDay News) -- In a long-awaited legal decision, the U.S. Supreme Court ruled Wednesday that patients who are injured by a drug can sue the drug's manufacturer for damages, even if the drug has been granted FDA approval.

The decision, in the lawsuit Wyeth v. Levine, upheld $6.7 million in damages to a Vermont musician named Diana Levine who had to have her arm amputated after Wyeth's Phenergan anti-nausea drug hit an artery and caused gangrene.

The complication is a rare one but is acknowledged on the drug's labeling. Wyeth had argued that the U.S. Food and Drug Administration warning carried on the drug was sufficient.

At a press conference after the decision was announced, Levine, who was injured in April 2000, said: "I'm on the ceiling, I'm just so high about this, I'm so glad, it's such a good decision and, next to getting my hand, it's the best they could do, and it's the least they could do. I'm in a state of almost shock and almost unrestrained joy."

The court decision was hailed as a triumph by Public Citizen, a consumer watchdog group.

"It's a terrific decision, because it understands both the importance of compensation for people who are harmed by defective or mislabeled drugs and also understands that the tort system is a complement to the federal regulatory system, that it is not an obstacle to that system," said Brian Wolfman, director of the litigation group at Public Citizen in Washington, D.C.

Wolfman served as one of Levine's attorneys.

Bert Rein, an attorney for Wyeth, said the company "fully complied with federal law" in its labeling, and that the FDA "is in the best position to weigh the risks and benefits of a medicine," The New York Times reported.

In a news release, the Pharmaceutical Research and Manufacturers of America (PhRMA), said the group "is still reviewing the various opinions in the Wyeth v. Levine case. We continue to believe that the expert scientists and medical professionals at the Food and Drug Administration are in the best position to evaluate voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label."