Alerts and Updates

Supreme Court Holds FDCA Preempts Common Law Design-Defect Claim Against Generic Drugs

July 2, 2013

The Supreme Court reversed the First Circuit and, in an opinion authored by Justice Alito, concluded that the FDCA preempted the respondent's common law design-defect claim.

On June 24, 2013, the U.S. Supreme Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that the Federal Food, Drug, and Cosmetic Act (FDCA) preempted the respondent's common law claim for damages arising from the alleged defective design of a generic pharmaceutical. The Supreme Court had previously held in PLIVA, Inc. v. Mensing, 564 U.S. __, 131 S.Ct. 2567 (June 23, 2011), that the FDCA preempted failure-to-warn claims against manufacturers of generic drugs. Bartlett extends the holding in Mensing to design-defect claims, providing greater protection to generic drug manufacturers, who are prevented by the FDCA from modifying either the label or the design of a generic pharmaceutical.

The respondent in Bartlett was prescribed sulindac, a generic version of Clinoril, for shoulder pain. Sulindac is a nonsteroidal anti-inflammatory drug (NSAID). Shortly after taking the sulindac, the respondent developed acute toxic epidermal necrolysis, a rare but recognized side effect of sulindac. She suffered severe and debilitating injuries, which resulted in her spending months in a medically induced coma, undergoing 12 eye surgeries and requiring tube-feeding for a year.

The respondent sued Mutual Pharmaceutical ("Mutual"), the manufacturer of the sulindac she took, and asserted both design-defect and failure-to-warn claims. Her failure-to-warn claims were dismissed because her doctor admitted to not reading the drug's package insert. The respondent's design-defect claim proceeded to trial, and a jury awarded her more than $21 million in damages. The First Circuit affirmed.

The Supreme Court reversed the First Circuit and, in an opinion authored by Justice Alito, concluded that the FDCA preempted the respondent's common law design-defect claim. Under the FDCA—as amended by the Hatch-Waxman Act—a generic pharmaceutical may be approved without the same level of scrutiny required of a new brand name drug, as long as the generic drug is chemically equivalent and bioequivalent to the brand name drug, and provided that the generic drug has identical labeling to the brand name drug.

The Court held that New Hampshire's strict products liability cause of action imposes an affirmative duty on drug manufacturers to ensure that their products are not "unreasonably dangerous." Manufacturers can satisfy that duty, the Court observed, either by changing a drug's design, or by changing its labeling. However, the FDCA precludes generic drug manufacturers from changing the design of a generic drug. The only other option available to a generic manufacturer under state law would be to change the drug's warning, but the Court's previous decision in Mensing foreclosed that option. Therefore, the Court reasoned that it would have been impossible for Mutual to satisfy its state common law duties while also obeying the FDCA. Thus, even though the FDCA does not contain an express preemption clause, it preempted by implication the directly conflicting requirements of New Hampshire common law.

The majority rejected two arguments raised by Justice Sotomayor, who wrote one of two dissenting opinions. First, the majority rejected as "incompatible with [its] pre-emption jurisprudence" the argument that a manufacturer can obey the FDCA as well as state law, even where they are in direct conflict, by simply not marketing a product. Second, the majority held that a state common law cause of action imposes affirmative obligations on manufacturers and does not merely create an incentive to improve a product's safety.

Finally, the majority and dissenting opinions appear to suggest that the Court would welcome guidance from Congress and the U.S. Food and Drug Administration (FDA). Justice Breyer, writing in dissent, concluded that he could not "give special weight to the FDA's views" because it had not developed them through hearings and had not expressed them except through briefing. The majority opinion invited "Congress' 'explicit' resolution of the difficult pre-emption questions that arise in the prescription drug context." Thus, although the Bartlett decision appears to provide protection to drug manufacturers who are obligated to follow the FDCA, it also indicates that there may be future changes in this area of law.

For Further Information

If you have any questions about this Alert, please contact Sharon L. Caffrey, Alan Klein, Andrew R. Sperl, any member of the Products Liability and Toxic Torts Practice Group, any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy & Food group or the attorney in the firm with whom you are regularly in contact.

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