CaliforniaIn a June 2013 decision, the United States Supreme Court held that federal law bars states from imposing tort liability on the manufacturer of a generic drug for providing allegedly inadequate warnings relating to the potential health risks associated with use of a drug.

In Mutual Pharmaceutical Co. v. Bartlett, the United States Supreme Court repeated its 2011 ruling in Pliva, Inc. v. Mensing and held that federal law preempted the state-law failure-to-warn cause of action at issue because it conflicted with federal law, reasoning that it would be impossible for the generic drug manufacturer, Mutual, to comply with the labeling requirements imposed on it by state law while also complying with federal law. The plaintiff, Bartlett, was a New Hampshire resident who developed toxic epidermal necrosis after taking generic sulindac manufactured by Mutual. A jury awarded her $21 million in damages because it determined sulindac was defectively designed by Mutual's failure to provide adequate warnings regarding the drug's side effects.

generic-pillsWEBAccording to the Court, the primary flaw in Bartlett's theory was that the sulindac labeling was mandated by the U.S. Food and Drug Administration ("FDA"). Had Mutual altered its labeling to provide the additional warnings required by state law, it would have violated federal law, which requires a generic drug to contain the same labeling as its brand-name equivalent. As in Mensing, the Court therefore determined that the state tort action was preempted because it was impossible for Mutual to comply with both federal and state law.

The Court expressly rejected Bartlett's argument that Mutual could have complied with both federal and state law by withdrawing sulindac from the market. It noted that allowing plaintiffs to avoid preemption with a stop-selling argument would essentially overrule all of the Court's impossibility preemption decisions. However, the Court left the door slightly ajar to claims alleging a parallel violation of the FDA's misbranding prohibition. Though such a cause of action would likely only be successful in a small percentage of pharmaceutical product liability cases, we expect plaintiffs to begin asserting these claims simply to get beyond the pleading stage.

The FDA responded promptly to Bartlett by announcing plans for a new regulation whose apparent purpose is to overrule the Court's decisions. A July 2013 notice by the FDA indicated that it will soon release a proposed regulation entitled, "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products." The notice indicates that the proposed regulation would authorize generic drug companies to submit labeling changes to the FDA for approval, and then to unilaterally implement the changes while the FDA considers the submission. Under the proposed regulation, it would no longer be impossible for a generic drug manufacturer to comply with both federal and state law.

Opponents of the proposed FDA regulation argue that a straightforward reading of the Food, Drug, and Cosmetic Act ("FDCA") suggests that the FDA lacks the statutory basis for authorizing generic drug manufacturers to adopt unilateral labeling changes which expose them to liability. The FDCA provides that the Abbreviated New Drug Application ("ANDA") submitted by a generic drug company must "show that the labeling proposed for the new drug is the same as the labeling approved for" the underlying brand-name drug. It further provides that the FDA may not approve the ANDA unless the application demonstrates that the labeling "is the same." In addition, soon after the FDCA was amended to include the above provisions, the FDA adopted a regulation confirming that a generic drug manufacturer must ensure that its product's labeling is identical to its brand-name counterpart and that the "sameness" requirement prohibits a generic drug manufacturer from making unilateral labeling changes.

The the only purpose of such a new regulation would be to eliminate generic drug manufacturers' preemption defense to state tort claims and thereby to reverse the Mensing and Bartlett decisions.

The FDA's proposal for the new regulation is expected to be released in September 2013, at which time polarizing public comment is anticipated.

Lisa M. RiceKatie A. StricklinFeel free to contact the authors with any questions:  

Partner - Orange
Lisa M. Rice at
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Senior Associate - Orange
Katie A. Stricklin at
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