Generic drug preemption ruling a blow to plaintiffs

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The U.S. Supreme Court’s decision barring state-law design-defect claims against generic drug makers that mirror failure-to-warn actions served a major setback to plaintiffs seeking damages for drug injuries.

The decision in Mutual Pharmaceutical Co. v. Bartlett “struck another blow against granting recourse for plaintiffs injured by generic drugs,” said Lou Bograd, senior litigation counsel at the Center for Constitutional Litigation PC in Washington.

But supporters of the ruling said that determinations about drug safety rest with the Food and Drug Administration, and allowing state-law standards would impose different and often conflicting rules that drug makers cannot meet.

“Congress intended to preempt suits that allege that a drug is unreasonably dangerous and thus defectively designed,” said Richard Samp, chief counsel for the Washington Legal Foundation, who filed an amicus brief supporting the drug maker. “Federal law impliedly preempts such common law causes of action because Congress has made clear that it looks solely to FDA to make those sorts of determinations.”

The decision is the latest in a series of preemption rulings involving drug and device claims in which the court has come down on opposite sides, sometimes finding in favor of plaintiffs seeking to bring state-law claims, and other times ruling that federal law barred them.

Bartlett sought to settle an issue that fell within the gray area between the court’s 2009 ruling in Wyeth v. Levine, which said that state-law failure-to-warn drug claims are not automatically preempted by federal law, and its 2011 ruling in PLIVA Inc. v. Mensing, which said that federal regulations governing the generic forms of drugs directly conflict with, and thus preempt, those claims.

In its 5-4 ruling in Bartlett, the court held that “state-law design defect claims that turn on the adequacy of the drug’s warnings are pre-empted by federal law under PLIVA.”

In his majority opinion, Justice Samuel A. Alito Jr. acknowledged the “tragic circumstances” surrounding the plaintiff, Karen L. Bartlett, who developed a degenerative skin disease after being given the generic version of the pain reliever Clinoril called sulindac. She went on to win a $21 million verdict, which was affirmed by the 1st U.S. Circuit Court of Appeals.

But despite her terrible circumstances, Alito said, federal law prevented the relief she sought.

“Respondent’s situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed,” Alito ruled.

Bograd said the ruling may not foreclose all generic drug design-defect claims. As the court noted in Footnote 4, “We do not address state design-defect claims that parallel the federal misbranding statute. The misbranding statute requires a manufacturer to pull even an FDA-approved drug from the market when it is “dangerous to health” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.”

The footnote might make this ruling very narrow, Bograd said.

Allison Zieve, director of Public Citizen’s litigation group in Washington, said the ruling was particularly troublesome based on a report by the organization released on the same day as the June 24 opinion. The report said that because generic drug makers are hamstrung by federal regulations that prevent them from warning doctors and patients about newly discovered information about drug risks, patients are placed in danger. The notion that the FDA is in the best position to protect the rights of patients is wrong, Zieve said.

“A lot of safety information about drugs comes to light only after they have been on the market for years,” Zieve said.