High Court sides with musician in ruling against drug company

In a case involving a professional guitarist who lost an arm when injected with an antinausea drug, the justices said state consumer protections can go beyond federal regulations.

from the March 5, 2009 edition

Page 2 of 2

Page 1 | 2

In February 2008, a different lineup of justices ruled that individuals injured by a defective medical device could not sue the manufacturer if the device received pre-market approval by the Food and Drug Administration.

The 8-1 ruling in the medical device case effectively insulates many corporations from potentially expensive product liability litigation. It has been cited as evidence of an emerging pro-business tilt at the high court under Chief Justice John Roberts.

In contrast, the Levine and Maine smoker decisions handed down this term suggest a tilt toward consumer protection and away from business interests.

In the Levine case, the question was whether state-based consumer lawsuits filed against FDA-regulated drug companies were preempted by federal law.

After losing her arm, Levine sued the technician who incorrectly injected the drug into her arm. She also sued the clinic where the injection took place. That case was settled out of court for about $700,000.

Levine's lawyers also filed the lawsuit against Wyeth, claiming the company's warnings on the drug label were not explicit enough to satisfy Vermont failure-to-warn laws protecting consumers.

In his majority opinion, Stevens rejects claims that Congress intended the FDA to exert exclusive control at the expense of the states.

"If Congress thought state law suits posed an obstacle to its objective, it surely would have enacted an express preemption provision at some point during the [federal drug laws's] 70-year history," Stevens wrote. "But despite its 1976 enactment of an express preemption provision for medical devices, Congress has not enacted such a provision for prescription drugs."

Stevens said that rather than thwarting federal goals, state-based lawsuits compliment FDA regulations and provide an additional layer of consumer protection. "The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge," he said.

"State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly," he said. "They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the [federal drug law's] premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times."

In his dissent, Alito said juries are ill-equipped to perform the FDA's cost-benefit balancing. The courtroom focus on victims can obscure the wider calculation of probabilities and potentialities of a drug's usefulness for others.

"In contrast, the FDA has the benefit of the long view," Alito said. "Its drug-approval determinations consider the interests of all potential users of a drug, including those who would suffer without new medical products if juries in all 50 states were free to contradict the FDA's expert determinations."

In a telephone conference with reporters, Ms. Levine said she first heard about the high court's decision from an Associated Press reporter Wednesday morning. "I collapsed into tears for quite a while and that turned into jumping up and down," she said.

She said she is grateful her case will help other injured consumers by establishing a precedent, and that she is thankful for the money judgment awarded by the Vermont jury that she can now collect. "It is not my arm," she said, "but it is just going to help so much in terms of my economic stress level."

1 | Page 2