OT. So FDA approves this drug, and we wait. Amazing.
Ruling says patients can sue drugmakers
Bob Egelko, Chronicle Staff Writer
Thursday, March 5, 2009
(03-04) 17:08 PST WASHINGTON -- In a resounding victory for consumers over the pharmaceutical industry, the Supreme Court ruled Wednesday that patients harmed by medication can sue the drugmaker for neglecting to list known dangers on the label even if federal regulators haven't required them to do so.
The 6-3 decision upheld $6.7 million in damages to a musician from Vermont who lost an arm to gangrene after being injected in 2000 with an anti-nausea drug manufactured by Wyeth Pharmaceuticals.
The majority rejected arguments by Wyeth and the Bush administration that the U.S. Food and Drug Administration's approval of the drug's label in 1955 barred all claims of negligence under state laws.
The label warned doctors to use extreme caution in injecting the drug but did not tell them it should never be injected. The court said the company was on notice of the danger - citing at least 20 similar reports of amputations since the 1960s - and could be sued for not adding such a warning on its own.
"Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness," Justice John Paul Stevens said in the majority opinion.
Noting that the federal agency "has limited resources to monitor the 11,000 drugs on the market," Stevens said Congress in more than 70 years of regulating pharmaceuticals has never barred damage suits against drugmakers. Despite FDA oversight, he said, "the manufacturer bears responsibility for the content of its label."
The ruling means patients who believe a more complete warning label could have prevented their illness or injury can take a pharmaceutical company to court, rather than relying on the FDA to protect them.
Dissenting view
Dissenters, led by Justice Samuel Alito, said the ruling interferes with uniform national regulation of pharmaceuticals and allows local juries to second-guess FDA decisions on what warnings are required for consumer protection.
"Juries are ill-equipped to perform the FDA's cost-benefit-balancing functions," said Alito, joined by Justice Antonin Scalia and Chief Justice John Roberts.
Bert Rein, a lawyer for Wyeth, said the company's FDA-approved label provided "clear warnings about the very risks at issue in this case" and should have precluded damages. But the court said a drugmaker can justify omitting a known danger from a label only when the FDA has considered and rejected such a warning.
Pfizer Inc. of New York, which announced in January it had agreed to purchase Wyeth, said it was disappointed with the ruling. "Pfizer believes that, due to its medical and scientific expertise, the U.S. Food and Drug Administration is the best authority to weigh the benefits and risks of prescription medicines and to ensure that those benefits and risks are being appropriately communicated in product labels," the company said in a written statement.
The ruling follows a court decision in December that allowed smokers to sue tobacco companies under state deceptive-advertising laws for the companies' promotion of "light" cigarettes, rejecting similar arguments based on federal regulation of cigarette labeling.
Drug manufacturers, however, were hoping the court would follow a precedent it set a year ago when it threw out a lawsuit in a state court by a patient injured by an FDA-approved catheter. That ruling cited a law shielding federally approved medical devices from state requirements, which the court interpreted to include suits for damages.
Precluding regulation
No such law exists for drugs. But drug companies, joined by President George W. Bush's administration and the FDA officials he appointed, argued that the existence of federal regulation should preclude suits for damages in individual states, based on the same safety concerns that federal regulators are supposed to consider.
The court's rejection of that argument has implications for other federally regulated industries and businesses covered by similar laws. San Francisco attorney Mark Savage, who filed arguments in the case on behalf of the Consumers Union of the United States, said the ruling should also help California and other states that are trying to enforce consumer-protection laws against national banks.
One such case, to be argued before the Supreme Court in April, involves New York's attempt to enforce a state predatory-lending law.
Attorney Allen Untereiner, who filed arguments on behalf of the U.S. Chamber of Commerce, said Wednesday's ruling was perplexing for businesses in light of last year's decision on medical devices. He said the court should have accepted the FDA's conclusion that allowing state suits for damages would result in excessive product warnings and would undermine the agency's regulatory authority.
But the court, which usually defers to a regulatory agency's view of the law, said it would not do so in this case because of the FDA's "dramatic change in position" after approving such lawsuits during earlier administrations.
The court ruled in favor of Diana Levine, a professional guitarist and piano player who went to a Vermont health clinic in August 2000 with a migraine headache and nausea and was given Phenergan, Wyeth's anti-nausea drug. The drug was injected into a vein but migrated into an artery, causing gangrene that required amputation of her right arm.
A Vermont jury awarded $6.7 million in damages to Levine, finding that the manufacturer knew intravenous injection of Phenergan was risky and should have warned doctors against it. The Vermont Supreme Court upheld the verdict, prompting the company's appeal to the nation's high court, which drew an outpouring of briefs from business and consumer advocates.
Levine, 63, said she learned of the ruling from a reporter Wednesday morning and collapsed in tears.
"It feels like a tremendous weight has been lifted off of me," she said in a conference call with reporters. "I feel like I did something worthwhile, which is one good thing that came out of a tragedy."
The case is Wyeth vs. Levine, 06-1249. The ruling is available at links.sfgate.com/ZGHW.
Staff writer Bernadette Tansey contributed to this report. E-mail Bob Egelko at begelko@sfchronicle.com.
This article appeared on page A - 1 of the San Francisco Chronicle
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