Pliva, Inc. v. Mensing
131 S. Ct. 2567 (2011)
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Rule of Law:
Federal law requiring generic drug manufacturers to use the exact same warning label as the corresponding brand-name manufacturer pre-empts state-law failure-to-warn claims against those generic manufacturers. It is impossible for generic manufacturers to independently change their labels to comply with state law while also complying with the federal requirement of label sameness.
Facts:
- The FDA approved the drug metoclopramide under the brand name Reglan in 1980, and generic versions became available in 1985.
- Evidence accumulated over time showing that long-term use of metoclopramide could cause tardive dyskinesia, a severe and often irreversible neurological disorder.
- Gladys Mensing was prescribed Reglan in 2001, and Julie Demahy was prescribed it in 2002.
- Pharmacists for both Mensing and Demahy substituted the prescriptions with generic metoclopramide, which was legally permitted under state law.
- Both Mensing and Demahy took the generic drug for several years as prescribed.
- Both women subsequently developed tardive dyskinesia.
- Mensing and Demahy alleged that during the time they took the drug, its warning label was inadequate regarding the risk of tardive dyskinesia from long-term use.
Procedural Posture:
- Gladys Mensing sued generic drug manufacturers in the U.S. District Court for the District of Minnesota.
- Julie Demahy sued generic drug manufacturers in Louisiana state court; the case was removed to the U.S. District Court for the Eastern District of Louisiana.
- In both cases, the manufacturers moved to dismiss, arguing the state-law failure-to-warn claims were pre-empted by federal law.
- Both federal trial courts granted the manufacturers' motions and dismissed the claims.
- Mensing, the appellant, appealed to the U.S. Court of Appeals for the Eighth Circuit, which reversed the trial court's dismissal.
- Demahy, the appellant, appealed to the U.S. Court of Appeals for the Fifth Circuit, which also reversed the trial court's dismissal.
- The generic drug manufacturers (PLIVA, Inc., et al.), as petitioners, successfully sought a writ of certiorari from the U.S. Supreme Court.
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Issue:
Do federal laws and regulations requiring a generic drug's warning label to be identical to its brand-name counterpart's label pre-empt state-law tort claims that hold the generic manufacturer liable for failing to provide a different, more adequate warning label?
Opinions:
Majority - Justice Thomas
Yes, federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims. State law required the generic Manufacturers to use a stronger warning label, but federal law required them to use a label identical to the brand-name drug's label (a 'duty of sameness'). It was therefore impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal-law duty to keep the label the same. The Court defers to the FDA's interpretation that generic manufacturers cannot unilaterally use the 'changes-being-effected' (CBE) process to strengthen warnings. The proper test for impossibility preemption is whether a private party can independently do what state law requires; the mere possibility that the FDA or a third party might take action to resolve the conflict is insufficient to defeat preemption. This differs from Wyeth v. Levine, where the brand-name manufacturer could unilaterally strengthen its label under the CBE process.
Dissenting - Justice Sotomayor
No, federal law does not immunize generic-drug manufacturers from all state-law failure-to-warn claims because impossibility was not established. Impossibility preemption is a demanding defense requiring an 'inevitable collision' between federal and state law, not just a potential conflict. While the Manufacturers could not unilaterally change their labels, federal regulations provided a mechanism for them to ask the FDA to initiate a label change for both the brand-name and generic drugs. Because the Manufacturers failed to use this available federal process, they cannot meet their burden of proving it was impossible to comply with state law. The majority's new 'independence' test for impossibility is not based on precedent and creates an absurd result where a consumer's right to compensation turns on the happenstance of whether their pharmacist filled a prescription with a brand-name or generic drug.
Analysis:
This decision creates a significant divide in pharmaceutical product liability, effectively immunizing the manufacturers of the vast majority of prescription drugs from state failure-to-warn claims. It establishes that different federal regulatory schemes can lead to different preemption outcomes for otherwise identical products, distinguishing the duties of generic manufacturers from those of brand-name manufacturers in Wyeth v. Levine. The ruling solidifies a narrow view of impossibility preemption, focusing on what a party can do independently rather than what might become possible through agency action. This has led to a liability gap that consumer advocates argue leaves many injured patients without a legal remedy and may spur calls for legislative or regulatory reform.
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