Health Industry Online


Michael A. Walsh
Michael A. Walsh

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Federal Preemption of Failure to Warn Claims against Generic Drug Manufacturers

On June 23, 2011 in Mensing v Pliva and Demahy v Actavis the United States Supreme Court held that because under federal law a generic manufacturer can not change its label, a generic manufacturer may not be sued for failing to meet the requirements of state law.  Under the current federal law and regulations, generic manufacturers must copy, verbatim, the branded drug label and may not change their label unless the branded label is first changed.  Lawsuits claiming failure to warn against innovators/branded drug manufacturers, are not preempted because the Court held that those manufacturers can change the label to meet the requirements of state law before getting FDA approval. 

Prior to 1984, before marketing any medication, all manufacturers were required to establish that a medication was both safe and efficacious.  But in 1984, the Hatch Waxman Amendments to the FDCA achieved what was touted as an important societal goal of reducing price and increasing availability of important prescription medications to patients who may otherwise go untreated.  Congress accomplished this goal, in part, by permitting generic manufacturers to market a generic “equivalent” to a branded medication without undertaking the time and expense of proving it safe or effective.
Mensing v Pliva and Demahy v Actavis concerned the generic drug, metoclopramide, a generic version of the branded drug Reglan.  Reglan was put on the market in 1980 to treat digestive problems, including reflux and diabetic gastroparesis.  The label for the medication stated that it is to be used short term for up to 12 weeks and warned of the potential development of a neurological disorder known as tardive dyskinesia.  The lawsuits alleged that the generic manufacturers knew the drug was being prescribed longer than 12 weeks and that the number of patients developing tardive dyskinesia was higher than warned of in the label.  Plaintiffs claimed the generic manufacturers should have (1) changed the labels immediately, (2) sent letters to physicians warning of this alleged increased risk, and (3) asked FDA to approve a change in the label warning of the increased risk of developing TD. 

While the decision was 5-4 along ideological lines, the entire Court agreed that a generic manufacturer’s label must be identical to the branded drug label and it is not permitted to unilaterally change its label or send “Dear Doctor” letters advising physicians of risks that differ from those in the label without first obtaining FDA approval.  The Court did not agree on a more complex issue concerning whether the generic manufacturers could be liable for failing to ask FDA to approve a change to the label for the branded drug, which would require a change to their own generic label.

The majority of the Court found the state law claims preempted holding that it was “impossible” for the generic manufacturers to comply with federal law and have the additional warnings that plaintiffs claim were required under state tort law.  According to the Court, “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.”   

In its briefing to the Court, the FDA recognized a duty for generic manufacturers to propose stronger labeling when the product is “misbranded,” under 21 USC §352(f)(2), where there is a reasonable association of a known hazard 21 CFR 201.57(e).  The court stated that, “[a]ccording to the FDA, the Manufacturers could have proposed – indeed, were required to propose – stronger warning labels to the agency if they believed such warnings were needed.”  On this point the Court assumed that such a “duty” existed and stated “[b]ecause we ultimately find preemption even assuming such a duty existed, we do not resolve the matter.”  Nonetheless, the Court reasoned that asking the FDA for a label change would not satisfy the state law duty for a different warning and recognized that the plaintiffs admitted their claims were not based on the generic manufacturer failing to ask FDA for a label change. Citing Buckman Co. v. Plaintiffs Legal Comm. 531 US 341 (2001) (rejecting a private cause of action for fraud on the FDA).  The Court recognized a “novel question” of “whether conflict preemption should take into account these possible actions by FDA and the brand-name manufacturer” in taking steps necessary to change labeling.

The dissenting justices found differently on the preemption issue.  According to the dissenting justices, the generic manufacturer could have asked the FDA for a label change and it was therefore “possible” the change could have been in place before the plaintiffs in these cases ingested metoclopramide. 

This is a long awaited decision that will impact hundreds if not thousands of currently pending cases alleging generic manufacturer liability based on alleged inadequate labeling, and significantly limit the claims that may be asserted against a generic manufacturer.  While the Court recognized that the outcome was “unfortunate” for those with claims against a generic manufacturer based on inadequate labeling, it was not prepared to rewrite the law or regulations stating “[a]s always, Congress and the FDA retain the authority to change the law if they so desire.”

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