570 U.S. 472, 492–93 (2013)
In 2004 Karen Bartlett was prescribed Clinoril, a nonsteroidal anti-inflammatory drug whose active ingredient is sulindac, and her pharmacist dispensed a generic version manufactured by Mutual Pharmaceutical Company.1 The drug caused her to develop an acute case of toxic epidermal necrolysis; she lost nearly all of her skin from her chest to her knees and 60 to 65 percent of the skin on her arms and face, suffered severe disfigurement, lost the majority of vision in her left eye and all vision in her right eye, and continues to experience significant pain.2
Bartlett sued Mutual in New Hampshire state court alleging, among other claims, that the company had violated state law by failing to provide an adequate warning of the risks posed by sulindac.3 Mutual removed the case to federal court.4
The district court dismissed the failure-to-warn claim after Bartlett's physician admitted he had not read the box label or insert, leaving only the design-defect claim for trial.5 After a two-week trial a jury found Mutual liable and awarded Bartlett more than $21 million in damages.6
The First Circuit affirmed the judgment, holding that the design-defect claim was not preempted.7 The Supreme Court granted certiorari.8
Whether the Federal Food, Drug, and Cosmetic Act preempts New Hampshire design-defect claims against generic drug manufacturers?9
Under the Supremacy Clause, state laws that conflict with federal law are without effect, and impossibility preemption occurs when it is impossible for a private party to comply with both state and federal requirements as recognized in PLIVA, Inc. v. Mensing.10
Yes. The FDCA and its implementing regulations prohibit generic drug manufacturers from independently changing the design or labeling of an approved drug without prior FDA approval.11 New Hampshire design-defect law imposes an affirmative duty on manufacturers to ensure that the products they sell are not unreasonably dangerous.12 A duty that in this case could be satisfied only by altering sulindac's design or strengthening its warnings.13 Because federal law required Mutual's generic sulindac to match the brand-name drug's active ingredient, route of administration, dosage form, strength, and labeling, and because sulindac's simple chemical composition made redesign impossible, Mutual could not comply with the state-law duty without violating federal law.14
The established facts confirm that Bartlett received the generic version in 2004, suffered catastrophic injuries from toxic epidermal necrolysis, and recovered on the design-defect claim after her failure-to-warn claim was dismissed.15
The FDCA preempts New Hampshire design-defect claims that require generic manufacturers to change a drug's design or labeling.16
Related opinions on this issue
Justice Breyer filed a concurring opinion joining the Court's holding.17 He agrees that federal law prohibits generic drug manufacturers from independently changing a drug's design or labeling in order to avoid state-law liability.18 This prohibition means that a manufacturer cannot be held liable for a design defect under state law.19
Joined by Justice Ginsburg
Justice Sotomayor dissents on the ground that the majority mischaracterizes the design-defect claim as a disguised failure-to-warn claim.20 New Hampshire law imposes no legal obligation to change the label or design.21 It creates only a duty to compensate consumers injured by an unreasonably dangerous product.22
Whether a generic drug manufacturer facing state design-defect liability can avoid preemption by withdrawing the product from the market?23
Impossibility preemption is not defeated by the theoretical possibility that the regulated actor could cease acting altogether, because that option would render the doctrine meaningless as established in prior impossibility cases including PLIVA.24
No. The First Circuit proposed that Mutual could simply stop selling sulindac to reconcile the conflicting duties. The Court rejects this stop-selling rationale because it would undermine impossibility preemption across the board. In PLIVA the manufacturers could likewise have avoided liability by withdrawing metoclopramide, yet the Court found preemption. The same logic applies here.
The established facts show that the FDA-approved generic remained on the market, was dispensed to Bartlett, and caused her injuries, but the mere option of market withdrawal does not eliminate the direct conflict between state and federal duties.25
A generic drug manufacturer cannot avoid preemption by withdrawing the product from the market.26
Related opinions on this issue
Joined by Justice Ginsburg
Justice Sotomayor argues that the majority's rejection of the stop-selling option rests on an implicit assumption.29 Federal premarket approval confers a right to sell free from common-law liability.30 This proposition is inconsistent with the FDCA's consumer-protection purpose and its preservation of state remedies.31