INNsight article by Andrew R. Sperl, August 2013

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 and barred all claims by patients for damages arising from the alleged defective design of generic pharmaceuticals. The Supreme Court had previously held in PLIVA, Inc. v. Mensing (June 23, 2011) that the FDCA preempted claims that generic drug companies neglected to warn consumers or their physicians of adverse health risks. Bartlett now extends the holding in Mensing to design defect claims, providing greater protection from lawsuits to generic drug manufacturers, who are prevented by the FDCA from modifying either the label or the design of a generic pharmaceutical, which needs to remain the same as the brand drug which it replicates.

A Serious Adverse Event in Bartlett Sustained by the Patient

The plaintiff 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 severe allergic side effect of sulindac. She suffered debilitating injuries, which resulted in her spending months in a medically induced coma, undergoing 12 eye surgeries and requiring tube-feeding for a year.  She remains partially blind.
The patient sued Mutual Pharmaceutical, the manufacturer of the sulindac she took, alleging state law claims of  design defect and failure-to-warn. Her failure-to-warn claims were dismissed because her doctor admitted to not reading the drug's package insert, but the design-defect claim proceeded to trial, and a jury awarded her more than $21 million in damages. The federal Court of Appeals for the First Circuit affirmed the award, and Mutual Pharmaceuticals then appealed the case to the United States Supreme Court.

The Supreme Court Reverses, Setting Another Barrier to Claims against Generics

After full briefing by numerous interested parties, and oral argument, the Supreme Court reversed the First Circuit, and, in a 5-4 decision, concluded that the FDCA and the U.S. Constitution’s Supremacy Clause preempts design defect claims involving generic drugs. 
Looking at the Hatch-Waxman Amendments to the FDCA, signed into law by President Ronald Reagan in 1984, the Court found that generic drugs are intended to be, and are intended to remain at all times the bioequivalent of the brand or reference listed drug which they duplicate both in its chemical composition and therapeutic effects.  The Court held that  insofar as state laws seek to  impose an affirmative duty on generic drug manufacturers to change a drug's design or its labeling, such state laws are inconsistent with the requirements of federal law requiring “sameness” of generic drug products in relation to the brand name drug.  Because it is impossible for a generic drug manufacturer to comply with both federal and state legal obligations on these issues, under the Supremacy Clause, which requires federal law to take precedence over inconsistent state law, state law must yield.

Dissenting Justices of the Supreme Court suggested that a generic drug manufacturer could simply stop marketing its product if it concluded that its drug’s labeling was deficient. Since federal regulations do not permit the generic manufacturer to change a drug’s labeling, they contended, the company could simply pull its product from the marketplace.  The majority of the Court, however, disagreed, ruling that this outcome would be inconsistent with Hatch-Waxman, which allows all FDA-approved generics to enter the marketplace to provide low-cost pharmaceutical options to consumers.

What Lies Ahead for Generics After Bartlett?

Both the majority and dissenting opinions appear to suggest that the Court would welcome guidance on these issues from Congress and the U.S. Food and Drug Administration (FDA).  The majority opinion invited "Congress' explicit resolution of the difficult pre-emption questions that arise in the prescription drug context."  Within days of the decision, the FDA announced that it was considering changes in its regulations to place brand and generic manufacturers on an equal footing in their ability to request label changes to strengthen drug warnings.  It is anticipated that these regulations will be proposed in September and issued then for comment by industry, consumer groups and others.  Members of Congress, also, have weighed in on these preemption issues and have threatened the introduction of legislation to achieve changes in the law to accomplish the same objective.  This solution, however, is not as simple or easy as some observers suggest, as the proposed changes may entail a restructuring of  generic drug reporting and post-market surveillance activities as well as access to confidential data of the brand manufacturer not previously available to the generic drug industry.