Generic Drug Preemption

In 2009, the U.S. Supreme Court in Wyeth v. Levine held that brand-name drug manufacturers are responsible for their warning labels and may be liable for not adding additional warnings when new risks are discovered. However, in 2011, the Supreme Court held that failure-to-warn claims brought against generic drug makers conflict with and is preempted by federal law in Pliva, Inc. v. Mensing. In Mensing, the Court found that generic drug makers could not be held liable for failing to warn about a drug’s dangers because they must use the same safety label as the brand-name drug manufacturers.

The Supreme Court recently held that design defect claims that are based on the adequacy of a generic drug’s warnings are preempted under Mensing, allowing generic drug companies to escape liability in Mutual Pharmaceutical, Inc. v. Barlett. The decision is a significant victory for the generic drug industry, but further restricts the recourse for people who are injured by such drugs. This decision further limits the legal avenues for people who take generic drugs, which now account for more than 80 percent of all prescriptions.

This 5-to-4 decision overturned the verdict of a New Hampshire jury, which in 2010, awarded $21 million to a woman who developed a debilitating skin disease after taking a generic version of pain medication.

Justice Alito

Writing for the majority, Justice Samuel A. Alito Jr. acknowledged the horrific injuries sustained by Karen Bartlett, who lost nearly two-thirds of her skin, was placed in a medically induced coma and is legally blind after suffering a reaction to the medication she took for a sore shoulder.

However, the Court extended Mensing which held that FDA regulations bar failure-to-warn suits against generic drug makers to design defect claims. Justice Alito, writing for the majority, ruled that it is impossible for sulindac’s maker, Mutual Pharmaceutical Co., Inc., to comply with its duty under federal law not to alter the drug’s label or composition and its duty under state law to either strengthen the warning label or change the drug’s design. Currently, generic drug makers cannot change their labels unless the brand-name equivalent does.

Justice Sotomayor

In a dissenting opinion, Justice Sonia Sotomayor said a decision by the FDA to approve a drug should not absolve a company of its responsibility to sell a safe product. Therefore, Justice Sotomayor asserted that Mensing should not have applied and stated: “The most troubling aspect of the majority’s decision to once again expand the scope of this Court’s traditionally narrow impossibility preemption doctrine is what it implies about the relationship between federal premarket review and the state common law remedies.” Sotomayor also asserted “The Court appears to justify its revision of respondent Karen Bartlett’s state-law claim through an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability.”

The FDA has recently proposed a new rule on generic drug labeling that would effectively overturn the Mensing decision by allowing generic drug manufacturers to update their labels with new safety information without prior FDA approval. The FDA’s proposed rule would prospectively restore accountability for generic manufacturers and put them on equal footing with brand-name companies.