The U.S. Supreme Court ruled 5-4 Monday state suits attacking the adequacy of a
generic drug's label are pre-empted by federal law.
Most drugs prescribed in the United States are generic, and the ruling gives their makers significant protection from liability suits in state courts.
Justice Samuel Alito wrote the majority opinion, and was joined by four other conservatives. The court's four liberals dissented.
The Federal Food, Drug and Cosmetic Act requires manufacturers to gain Food and Drug Administration approval before marketing any brand-name or generic drug in interstate commerce. Once a drug is approved, a manufacturer is prohibited from making any major changes to the "qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application."
Generic manufacturers are also prohibited from making any unilateral changes to a drug's label.
In 2004, Karen Bartlett was prescribed Clinoril, the brand-name version of the non-steroidal anti-inflammatory drug sulindac, for shoulder pain. Her pharmacist in New Hampshire gave her a generic form of sulindac manufactured by the Mutual Pharmaceutical Co.
Bartlett soon developed an acute case of toxic epidermal necrolysis -- the upper layer of the skin detaches from the lower. "She is now severely disfigured, has physical disabilities and is nearly blind," the Supreme Court majority said.
At the time, sulindac's label did not specifically refer to toxic epidermal necrolysis. By 2005, the FDA had recommended changing all such labeling to contain a more explicit toxic epidermal necrolysis warning.
Bartlett sued Mutual in New Hampshire state court, but Mutual removed the case to federal court. A jury found Mutual liable on Bartlett's design-defect claim and awarded her more than $21 million. A federal appeals court affirmed.
But the Supreme Court reversed, saying it was impossible to comply with both federal and state requirements. And the state requirements had to give way.
"This case arises out of tragic circumstances," Alito said. "A combination of factors combined to produce the rare and devastating injuries that [Bartlett] suffered: the FDA's decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by [her] physician to prescribe sulindac despite its known risks, and Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings. [Bartlett's] situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed."
Justice Sonia Sotomayor was among the dissenters.
"I do not doubt that members of the majority personally feel sympathy for Karen Bartlett," she said. "But the [court majority's] solemn affirmation that it merely discharges its duty to 'follo[w] the law,' ... and gives effect to Congress' policy judgment, rather than its own, is hard to accept."
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