Healthy Skepticism Library item: 15194

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Publication type: news

Stohr G.
Wyeth, Drugmakers Lose as Top U.S. Court Allows Suits
Bloomberg.com 2009 Mar 4
http://www.bloomberg.com/apps/news?pid=20601202&refer=&sid=aJHVUGV0Aw4U

Full text:

The U.S. Supreme Court said patients can sue drugmakers for failing to provide adequate safety warnings, upholding a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.

The justices, voting 6-3, said pharmaceutical companies aren’t shielded from suit by the Food and Drug Administration’s approval of a treatment and its packaging information.

“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” Justice John Paul Stevens wrote for the court.

Injured patients and their families are pressing thousands of suits around the country, seeking billions of dollars in damages from drug companies. Today’s decision might help former users of Wyeth’s Prempro and Premarin menopause drugs and consumers of AstraZeneca Plc’s antipsychotic drug Seroquel.

The impact isn’t clear for allegations that Pfizer Inc. and GlaxoSmithKline Plc should have done more to warn that their anti-depressants might cause suicidal tendencies. The FDA for many years said warnings weren’t necessary for adult patients. The justices have deferred action on a pending patient appeal in an anti-depressant case while they considered the Wyeth case.

In his opinion for the court, Stevens left open the possibility that suits might be barred in cases where the FDA explicitly considered and rejected a requirement for stronger warnings.

‘Some Turf’ Still Open

“It’s still leaves open some turf for industry, but it narrows the playing field,” said Mark Herrmann, a Chicago product-liability lawyer who represents companies and co-writes a blog on drug and medical-device law.

Stevens pointed to the FDA’s “limited resources” and said that suits “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” He said that “manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.” The decision upholds a ruling by the Vermont Supreme Court.

The ruling is a victory for Diana Levine, 63, a former bass guitar player who specialized in children’s music. She said Wyeth should have warned against the injection method that caused gangrene in her right arm.

Levine said she “collapsed into tears for quite a while and that turned into jumping up and down” when a reporter called her at her Vermont home and told her about the decision.

“It’s not my arm, but it’s just going to help so much in terms of my economic stress level,” she said.

Wyeth Reaction

Bert Rein, a lawyer who represented Wyeth, called the ruling a “disappointment” and said it will create uncertainty about when and how to use prescription drugs. “We don’t think this really serves the best interest of patients or the medical community,” Rein said.

Wyeth rose 45 cents to $40.72 at 4 p.m. in New York Stock Exchange trading. The company, based in Madison, New Jersey, agreed in January to be taken over by Pfizer.

The decision marks the second time during its current term that the high court has said federal law doesn’t preempt consumer lawsuits. The justices in December said smokers can sue tobacco companies over the marketing of “light” cigarettes.

“We’re ecstatic about the results, and on a personal note I am so pleased that Diana Levine has at least obtained a measure of justice and redemption,” Levine’s Supreme Court lawyer, David Frederick, said in an interview.

Thomas Opinion

Justices Anthony Kennedy, David Souter, Stephen Breyer, Ruth Bader Ginsburg and Clarence Thomas joined Stevens in the majority. Thomas wrote separately to say the court should have been even more deferential to state laws.

Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito dissented. Alito, writing for the three, said state- law product liability suits would interfere with the federal drug-approval system.

“The FDA told Wyeth that Phenergan’s label renders its use ‘safe,’” Alito wrote. “But the state of Vermont, through its tort law, said, ‘Not so.’”

Levine received two injections of Phenergan in 2002 to treat nausea associated with a migraine headache. The second injection was administered using an intravenous or “IV push” method, which uses a syringe to push the medication directly into the patient’s vein.

The drug penetrated Levine’s artery, destroying it and eventually killing much of the tissue in her arm and hand. She underwent two amputations, first losing her right hand and then her arm up to her elbow.

Push Technique

Although Phenergan’s two-page label at the time included a warning about injection into an artery, it didn’t advise not to use the IV push technique.

Stevens pointed to evidence that Phenergan injections had caused gangrene and an amputation in at least 20 cases prior to Levine’s.

“As amputations continued to occur, Wyeth could have analyzed the accumulating data and added a stronger warning about IV-push administration of the drug,” he wrote.

Former President George W. Bush’s administration backed the industry, pointing to a 2006 FDA regulation that included language opposing state-law suits.

Stevens said that position wasn’t entitled to the deference the court normally affords the government. Stevens said the Bush stance “represents a dramatic change” from the FDA’s longstanding approach toward the issue.

Product Liability

U.S. drug-approval law bars state rules that create a “direct and positive conflict” with federal requirements.

The decision means that product liability cases that had been delayed while judges waited for the Supreme Court decision can now go forward, said Tobi Millrood, who represents women suing over Wyeth’s Premarin and Prempro menopause drugs.

“The decision makes clear that victims injured by these products are entitled to their day in court,” said Millrood, who said a Florida judge delayed one of his cases while awaiting the Supreme Court ruling.

The case is Wyeth v. Levine, 06-1249.