New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

By Matthews, James W.; Koski, Katy E. et al. | Defense Counsel Journal, July 2014 | Go to article overview

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers


Matthews, James W., Koski, Katy E., Hinkle, Michael H., Drori, Jason L., Defense Counsel Journal


LITIGATION over the labeling of pharmaceuticals dates back to the mid-1800s.1 In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial, boundaries for lawsuits challenging the labeling for prescription drugs. In the 2009 case Wyeth v. Levine,2 the Court ruled that federal drug labeling regulations did not preempt a state-law "failure to warn" claim that a brand drug's labeling did not contain an adequate warning. Two years later, in PLLVA, Inc. v. Mensing,3 the Court reached the opposite conclusion with respect to state tort claims alleging inadequate labeling of generic medicines, holding in a 5-4 decision that such claims were preempted by the federal prohibition on changes to generic drug labels.4 Mensing turned on the difference between the ability of holders of a new drug application ("NDA") - to approve a new pharmaceutical for sale and marketing in the United States - and an abbreviated new drug application ("ANDA") - for approval of a generic drug product - to independently change product labeling. The Court has recently attributed the precarious position of ANDA holders fighting labeling claims to "Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings."5

Responding to the line drawn by Wyeth and Mensing, the U.S. Food and Drug Administration ("FDA") announced on November 8, 2013 that it would issue a proposed rule allowing manufacturers of generic medications to unilaterally update product labeling with newly-acquired safety information in the same way as brand companies.6 Such a move would do away with the legal distinction on which Wyeth and Mensing were decided and almost certainly resurrect once-dead state law failure-to-warn claims across the country, opening up generic drug makers to greater legal liability. We analyze below the legal landscape following Wyeth and Mensing and how the FDA's rule change would shift it.

I. Drug Labeling Claims after Wyeth and Mensing

Wyeth involved common-law negligence and strict-liability claims under Vermont law against the manufacturer of Phenergan, a brand-name antihistamine used to treat nausea that can be administered intravenously.7 Phenergan's labeling was alleged to have been defective because it failed to instruct clinicians to use a lower-risk method of intravenous administration ("IV-drip") instead of the higher risk method ("IV-push").8 The Supreme Court agreed to hear Wyeth to resolve "[t]he question [of) ... whether the FDA's drug labeling judgments preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use."

In a 6-3 decision, the Court's majority found no conflict between drug labeling requirements imposed under Vermont and federal law because, here, "it was physically possible for Wyeth to comply with a state-law requirement to provide stronger warnings on Phenergan about the risks of the IV-push administration method while continuing to market Phenergan in compliance with federal law."10 In particular, the FDA's "changes being effected" ("CBE") regulation,11 the Court reasoned, "permitted Wyeth to unilaterally strengthen its [IV-push administration] warning, and the mere fact that the FDA approved Phenergan's label does not establish that it would have prohibited such a change."12

Mensing involved claims under Minnesota and Louisiana law that the package insert for the generic drug metoclopramide, a drug commonly used to treat digestive tract problems, failed to adequately warn that long-term use could cause tardive dyskinesia, a severe neurological disorder.13 The Court distinguished Mensing from Wyeth based on the different federal drug labeling duties applicable to brand-name and generic drug manufacturers. …

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New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers
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