WASHINGTON (Legal Newsline) -- The U.S. Supreme Court ruled this week that state law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law.

The Federal Food, Drug and Cosmetic Act, or FDCA, 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 also are prohibited from making any unilateral changes to a drug's label.

In 2004, Karen L. Bartlett was prescribed Clinoril, the brand-name version of the nonsteroidal anti-inflammatory drug, or NSAID, sulindac, for shoulder pain.

Her pharmacist dispensed a generic form of sulindac manufactured by Mutual Pharmaceutical Company Inc.

Bartlett soon developed an acute case of toxic epidermal necrolysis. She is now severely disfigured, has physical disabilities and is nearly blind.

At the time of the prescription, sulindac's label did not specifically refer to toxic epidermal necrolysis. By 2005, however, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning.

Bartlett sued Mutual in a New Hampshire state court. Mutual removed the case to federal court.

A jury later found Mutual liable on Bartlett's design-defect claim and awarded her more than $21 million. The U.S. Court of Appeals for the First Circuit affirmed.

The First Circuit, in its ruling, found that neither the FDCA nor the FDA's regulations pre-empted Bartlett's design-defect claim.

It distinguished PLIVA Inc. v. Mensing -- in which the Supreme Court held that failure-to-warn claims against generic manufacturers are pre-empted by the FDCA's prohibition on changes to generic drug labels -- by arguing that generic manufacturers facing design-defect claims could comply with both federal and state law simply by choosing not to make the drug at all.

The Supreme Court rejected that argument, holding that such a "stop-selling" theory is "incompatible" with its pre-emption jurisprudence.

"Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability," Justice Samuel Alito wrote for the 5-4 majority.

"Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be 'all but meaningless.'"

DRI: The Voice of the Defense Bar, which represents more than 20,000 defense attorneys, commercial trial attorneys and corporate counsel, filed an amicus brief in the case.

DRI sided with Mutual, arguing that the First Circuit's decision upholding the jury verdict should be reversed.

In its brief, filed in January, DRI argued that experience with pharmaceutical-liability cases and trials across the country reveals that prescription drug cases are "invariably" about the warnings in the overwhelming majority of American jurisdictions.

DRI also argued that a straightforward application of the Mensing decision to the Bartlett record results in pre-emption.

"Design-defect cases regularly come down to whether state law requires more and different warnings," said William Jay, one of the DRI brief's co-authors.

"The Supreme Court reaffirmed (Monday) that when federal law specifies the exact warnings a manufacturer must give, state juries can't penalize businesses for selling their product in compliance with that federal law."

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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