Guest Commentator

Kelly Savage Day, Sedgwick, Detert, Moran & Arnold LLP

 In a 5-4 decision, the United States Supreme Court recently held in PLIVA, Inc. v. Mensing, No. 09-993   that the Hatch-Waxman Amendments to the federal Food, Drug and Cosmetic Act (FDCA) categorically preempt state-law failure-to-warn claims brought against manufacturers of generic drugs.1  Justice Thomas, writing for the majority, concluded that federal law prohibits manufacturers of generic drugs from unilaterally changing the safety warnings contained in a product’s labeling making it is “impossible” for generic manufacturers “to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”  As a result, generic drug manufacturers cannot be held liable for failing to request a label change on their products when they obtain information on new risks.

The Majority Opinion

Plaintiffs Gladys Mensing and Julie Demahy claimed they developed tardive dyskinesia, an irreversible neurological condition, after long-term use of metoclopramide, a generic version of Wyeth’s drug Reglan, to treat acid reflux.  They sued the generic manufacturers claiming that the generic drug’s warnings were inadequate under state law.  Both argued that the generic manufacturers should be held liable because the companies: (1) failed to warn of the serious risks associated with long-term use of the drug; (2) failed to request a labeling change revision with the Food and Drug Administration (FDA) under the “Changes Being Effected” (CBE) provisions of the FDCA; and (3) failed to report safety information directly to the medical community.

In response, generic drug manufacturers argued plaintiffs’ claims were preempted for two reasons.  First, it was impossible to add the warnings required by plaintiffs without violating federal law because the FDA prohibits generic companies from unilaterally adding any additional warning to its generic labeling that differs from the brand-name labeling.  Second, plaintiffs’ claims created an impermissible conflict with, and posed an obstacle to, congressional objectives applicable to generic drug manufacturers under the FDCA.

The Eighth Circuit in Mensing and the Fifth Circuit in DeMahy disagreed.  Both courts concluded generic manufacturers failed to show it was impossible to add warnings regarding the risks of developing tardive dyskinesia and comply with federal law because generic manufacturers could have (1) proposed a label change for both brand-name and generic drugs through the prior approval process; or, alternatively, (2) requested that the FDA send out a warning letter to health care professionals.2  Both Court also rejected defendants’ argument that plaintiffs’ claims created an impermissible conflict with, and posed an obstacle to, congressional objectives applicable to generic drug manufacturers under the FDCA.

On appeal, the Supreme Court rejected plaintiffs’ argument that generic manufacturers could have unilaterally revised their product label under the CBE process. In its amicus brief to the Court, FDA explained that generic manufacturers may only use the CBE process when the generic changes its label to match an updated brand-name label or to follow FDA’s instruction.  The Supreme Court, in deferring to FDA’s interpretations regarding the CBE provisions, concluded that the CBE process was not available to generic drug manufacturers.

The Court also rejected plaintiffs’ argument that generic manufacturers could have issued “Dear Doctor’ letters to provide additional warnings to health care providers.  In its amicus brief to the Court, FDA explained that “Dear Doctor” letters constitute product labeling.  As a result, warnings provided in a Dear Doctor letter must be consistent with, and not contrary to, a product’s FDA-approved labeling.  For this reason, the Supreme Court, again deferring to FDA’s interpretation, concluded that generic manufacturers were also not permitted to provide additional warnings to the public through ”Dear Doctor” letters.

The Court also rejected any argument that the generic drug manufacturers could and therefore should have proposed stronger warning labels to FDA if they believed additional warnings were necessary.  As the Supreme Court explained:

Whether a private party can act sufficiently independently under federal law to do what state law requires may sometimes be difficult to determine.  But this is not such a case.  Before the [generic manufacturers] could satisfy state law, the FDA – a federal agency – had to undertake special effort permitting them to do so.  To decide these cases, it is enough to hold that 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.

Here, state law imposed a duty on the [generic manufacturers] to take certain action, and federal law barred them from taking that action.  The only action the Manufacturers could independently take – asking for the FDA’s help – is not a matter of state-law concern. [Thus plaintiffs’] tort claims are preempted.

The Supreme Court, in holding that state failure-to-warn claims are preempted in the context of generic drugs after holding that similar claims in the context of brand-name drugs are permitted (see Wyeth v. Levine), acknowledged the unfortunate results that might arise based solely on a physician’s or pharmacist’s selection of a generic drug, but simply could not distort the Supremacy Clause to remedy the dissimilar statutory schemes applicable to brand-name and generic drugs.

Future Implications

This decision has a number of broad ramifications for both generic manufacturers and the public.  Ultimately, Congress may seek to amend federal laws to nullify the Supreme Court’s decision.  For the time being, however, the Mensing decision all but effectively ends the ability for users of a generic drug product to file a state-law suit premised on the generic manufacturer’s alleged failure to warn.  At the same time, the decision ensures the continuing availability of affordable generic medications in the United States.


1. The Court addressed the issue together with the cases of Actavis Elizabeth, LLC v. Mensing, 09-1039 and Actavis, Inc. v. DeMahy, 09-1501.

2. In addition to submitting a supplemental application and requesting that the FDA send out warning letters to physicians, the Fifth Circuit maintained that generic manufacturers could make unilateral changes through the CBE process.