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Supreme Court Finds State Failure-to-Warn Claims Against Generic Drug Manufacturers Preempted

Generic Drug News Flash

June 2011
By: Martin Healy, Marina McGuire

In a 5-to-4 decision, the U.S. Supreme Court held yesterday in Pliva v. Mensing, No. 09-993, that state law claims premised on a generic drug manufacturer's alleged failure to provide adequate warnings are preempted by federal law.  Justice Clarence Thomas, writing for the majority in a sharply divided opinion, explained that federal law prohibits manufacturers of generic drugs from unilaterally changing the safety warnings contained in a product's labeling, making it "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, the Supreme Court held that the plaintiffs' claims were preempted and remanded the matters for further proceedings consistent with its decision.    

Pliva, Inc., et al. v. Mensing – Majority Opinion

In the matter before the Court, plaintiffs Gladys Mensing and Julie Demahy alleged that they developed tardive dyskinesia – a severe neurological disorder – as a result of their use of the generic drug metoclopramide. The plaintiffs filed suit against the generic manufacturers of metoclopramide alleging that its warnings were inadequate under state law.  The generic manufacturers, relying on a preemption defense, sought to dismiss the claims arguing that it was impossible for them to comply with both state law requiring enhanced product warnings and federal law mandating that generic drug manufacturers use the brand-name drug's FDA-approved labeling. 

In its opinion, the Supreme Court addressed three of the arguments made against preemption.  First, as in Wyeth v. Levine, 555 U.S. 555 (2009), the plaintiffs argued that the generic manufacturers could have revised the product label under the "changes-being-effected" (CBE) process afforded brand-name manufacturers. This position, however, was  rejected by the U.S. Food and Drug Administration (FDA) in an amicus brief submitted to the Court for consideration.  In its brief, FDA articulated its position that a generic manufacturer may only utilize the CBE process when it changes its label to match an updated brand-name label or to follow FDA's instruction.  In fact, FDA indicated that any unilateral CBE change made to strengthen a generic drug's product label would violate federal law mandating that its label match its brand-name counterpart.  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. 

Second, the plaintiffs argued that the generic manufacturers could have issued  "Dear Doctor" letters to provide additional warnings to health care providers.  Again, this position was rejected by FDA.  It explained in its brief that, under federal law, "Dear Doctor" letters are treated as 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 enhance warnings through "Dear Doctor" letters. 

Third, FDA argued that the generic drug manufacturers could have – and perhaps should have – proposed stronger warning labels to FDA if they believed additional warnings were necessary.  FDA argued that drug manufacturers (generic and brand-name alike) are obligated to revise their product labels "to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug." 21 CFR § 201.57(e).  While conceding a generic manufacturer could not implement this change on its own, FDA suggested that, once a generic manufacturer becomes aware of a safety issue pertaining to a specific product, it must ask the agency to work toward strengthening the label that applies to both its product and the brand-name drug. The Supreme Court, however, found this argument non-consequential because the generic manufacturers could not act independently of FDA. 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.  Justice Thomas, in closing, reminded Congress and FDA that they retain the authority to change the laws and regulations should they so desire – placing the matter back in their hands should they believe this result unjust.     

The Dissent

Justice Sonia Sotomayor, writing for the dissent, sharply criticized the majority for finding preemption based on the argued impossibility to satisfy both federal and state law when the generic manufacturers merely established that they might have been unable to comply – not that it was impossible.  The dissent noted that  the majority opinion "makes little sense" – noting that "[i]t effectively rewrites the Court's decision in Wyeth v. Levine which holds that federal law does not pre-empt failure-to-warn claims against brand name manufacturers . . . tosses aside our repeated admonition that courts should hesitate to conclude that Congress intended to pre-empt state laws governing health and safety . . . . [and as] a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand name or generic drug." 

In essence, the dissenting justices contend that to prevail on the preemption defense, the generic drug manufacturers were obligated to demonstrate that compliance with both federal and state law was a physical impossibility.  Considering the available mechanism of proposing labeling changes to the FDA, the generic manufacturers may well have been able to change their labels in sufficient time to warn the plaintiffs.  Having failed to take any such steps, however, the generic manufacturers cannot meet their burden to establish "physical impossibility."  At most, they established a possibility of impossibility and therefore are not entitled to preemption.          

Future Implications

This decision has broad ramifications for generic and brand-name manufacturers as well as the public.  Ultimately, Congress may seek to amend federal laws to nullify the Supreme Court's decision.  For the time being, however, the Pliva v. Mensing decision effectively ends a generic drug user's ability to prosecute claims based on an alleged failure to warn against generic manufacturers.

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Related People

Healy, Martin J.
McGuire, Marina
Vickery, Alan R.

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