WEDNESDAY, March 4, 2009 (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."
The high court's decision is likely to unleash a torrent of similar lawsuits around the country.
"The court opinion not only declined to tell pharmaceutical companies that they could have this kind of immunity, it, in fact, pushed somewhat in the other direction," said Benjamin C. Zipursky, professor of law at Fordham Law School in New York City and visiting professor at Harvard Law School in Boston.
"Some trial lawyers who had been hesitant to bring claims against pharmaceutical companies are now going to be more willing to do so," Zipursky said. "A number of cases that were stayed in state and federal court pending this decision will now go forward and go forward with a more plaintiff-oriented posture. This is going to change the balance of incentives for lawyers who are thinking about suing pharmaceutical companies to make them more willing to sue and make trial judges and appellate courts less willing to throw out weak cases."
Wolfman added: "In general, it's going to mean that these claims are not pre-empted and that people with drug and injury claims are going to be able to sue for damages and get to a jury and, if the jury agrees, be compensated for that."
The high court's 6-3 decision essentially upended moves by the Bush administration to protect drug makers from lawsuits as long as the product was FDA-approved.
Many watchers had predicted that the court would decide the other way, Zipursky said.
"It was a surprise in two respects," he said. People had believed "that whatever the court did, it would rule narrowly and, in fact, the decision is quite broad."
More information
To learn more about the case, visit the U.S. Supreme Court.
