Mut. Pharm. Co. v. Bartlett
570 U.S. 472, 2013 D.A.R. 8086, 186 L. Ed. 2d 607 (2013)
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Rule of Law:
Federal law pre-empts state-law design-defect claims against generic drug manufacturers when those claims, in contexts where product redesign is infeasible, effectively require the manufacturer to unilaterally change a drug's label or composition, because federal law prohibits generic drug manufacturers from independently altering their FDA-approved labels or active ingredients.
Facts:
- In 1978, the FDA approved sulindac, a nonsteroidal anti-inflammatory drug (NSAID), under the brand name Clinoril.
- After Clinoril's patent expired, the FDA approved several generic forms of sulindac, including one manufactured by Mutual Pharmaceutical.
- In December 2004, Karen L. Bartlett was prescribed Clinoril for shoulder pain, and her pharmacist dispensed Mutual Pharmaceutical's generic sulindac.
- Bartlett subsequently developed toxic epidermal necrolysis, a severe hypersensitivity skin reaction, which caused 60-65% of her body surface to deteriorate and led to severe disfigurement, physical disabilities, and near blindness.
- At the time Bartlett was prescribed sulindac, its label warned of 'severe skin reactions' and '[f]atalities,' and Stevens-Johnson Syndrome and toxic epidermal necrolysis were listed as potential adverse reactions on the package insert.
- In 2005, after Bartlett's injuries, the FDA completed a comprehensive review of NSAID products and recommended changes to the labeling of all NSAIDs, including sulindac, to more explicitly warn against toxic epidermal necrolysis.
Procedural Posture:
- Karen Bartlett sued Mutual Pharmaceutical in New Hampshire state court, asserting both failure-to-warn and design-defect claims regarding sulindac.
- Mutual Pharmaceutical removed the case to the United States District Court for the District of New Hampshire.
- The District Court granted summary judgment to Mutual on Bartlett's failure-to-warn claim, but allowed the design-defect claim to proceed.
- A jury in the District Court found Mutual Pharmaceutical liable for the design-defect claim and awarded Bartlett over $21 million in damages.
- The Court of Appeals for the First Circuit affirmed the District Court's judgment, rejecting Mutual's argument that federal law pre-empted Bartlett's design-defect claim.
- The Supreme Court of the United States granted certiorari to review the First Circuit's decision.
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Issue:
Does federal law, specifically the Federal Food, Drug, and Cosmetic Act (FDCA) and its amendments, pre-empt a state-law design-defect claim against a generic drug manufacturer when compliance with state law would require the manufacturer to unilaterally change the drug's label or its chemical composition, both of which are prohibited by federal law?
Opinions:
Majority - Justice Alito
Yes, federal law pre-empts the state-law design-defect claim against Mutual Pharmaceutical because it was impossible for Mutual to comply with both state and federal law. New Hampshire's design-defect cause of action imposes an affirmative duty on manufacturers to ensure their products are not 'unreasonably dangerous.' In the context of generic drugs like sulindac, where chemical redesign is impossible due to both the drug's simple composition and federal law's requirement that generics be identical to brand-name drugs, this state-law duty effectively requires strengthening the drug's warnings to improve its risk-utility profile. However, federal law, as established in PLIVA, Inc. v. Mensing, prohibits generic drug manufacturers from unilaterally changing their drugs' labels. Therefore, state law imposed a duty on Mutual to take an action—changing its label—that federal law forbade, creating an 'impossibility' pre-emption under the Supremacy Clause. The Court rejected the argument that Mutual could have simply chosen to 'stop selling' sulindac to avoid the conflict, explaining that this 'stop-selling' rationale would render impossibility pre-emption 'all but meaningless' and contradict prior pre-emption jurisprudence.
Dissenting - Justice Breyer
No, federal law does not pre-empt the state-law design-defect claim. It is not 'literally impossible' for a generic drug company to comply with both state and federal law, as a company could either choose to stop selling the drug in the relevant State or pay the state penalty (damages) for failing to meet a state-law tort standard. While state law creating such an incentive could potentially be pre-empted if it stands as an obstacle to federal objectives, the FDA's views on pre-emption have been conflicting and are given less weight in this context. Historically, the FDA has often viewed state tort litigation as supplementary to federal regulation. Absent a clear pre-emption command in the FDCA or convincing evidence that removing the drug from the market or requiring damage payments would seriously undercut federal purposes, pre-emption should not apply.
Dissenting - Justice Sotomayor
No, federal law does not pre-empt New Hampshire's design-defect law. The majority incorrectly expands impossibility pre-emption and operates under an undefended assumption that federal law grants pharmaceutical companies a right to sell an approved drug free from common-law liability. New Hampshire's design-defect law makes a manufacturer liable for unreasonably dangerous products but does not require any specific action, such as changing the label or redesigning the drug, that is forbidden by federal law. Instead, it creates an incentive for manufacturers to either modify their product (if legally permissible), remove it from the market, or pay compensation for injuries. This exposure to liability is not equivalent to a legal mandate that directly conflicts with federal law. The trial record also shows Mutual was not held liable for inadequate warnings. Congress intended state common law to complement federal drug regulation, and implied pre-emption should only apply when there's an 'irreconcilable conflict' or a clear obstacle to congressional objectives, neither of which exists here. The majority's holding undermines Congress' explicit efforts to preserve state common-law liability and potentially leaves seriously injured consumers without a remedy.
Analysis:
This case significantly expands the scope of impossibility pre-emption, particularly for generic drug manufacturers. By holding that state design-defect claims that implicitly require label changes are pre-empted, the Court further limits generic drug manufacturers' liability for injuries caused by their products, reinforcing the precedent set in PLIVA v. Mensing. This decision shields generic drug manufacturers from a wide range of state tort claims, placing greater reliance on federal regulatory oversight for drug safety and potentially reducing avenues for consumer recourse and compensation for injuries caused by defective generic drugs. The rejection of the 'stop-selling' rationale solidifies that manufacturers are not expected to exit the market to avoid impossibility pre-emption.
