The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to obtain FDA approval before marketing any brand-name or generic drug in interstate commerce. Once a drug is approved, a manufacturer is prohibited from making any major changes to the formulation of the drug product, including active ingredients, or in the specifications provided in the approved application. Generic manufacturers are also prohibited from making any unilateral changes to a drug's label.
Under New Hampshire law, a person who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his or her property is subject to liability for physical harm caused by the product, even though the seller has exercised all possible care in the preparation and sale of the product. To determine whether a product is unreasonably dangerous, New Hampshire courts employ a risk-utility approach, under which a product is defective as designed if the magnitude of danger outweighs the utility of the product. This risk-utility approach requires a multifaceted balancing process involving the evaluation of conflicting factors. Three factors germane to this risk-utility inquiry are: (1) usefulness and desirability of the product to the public as whole; (2) whether the risk of danger could have been reduced without significantly affecting either the product's effectiveness or manufacturing cost; and (3) the presence and efficacy of the warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses. A drug manufacturer's obligation under New Hampshire law is to ensure that drugs that it designs, manufactures, and sells are not unreasonably dangerous. This duty may be satisfied either by changing a drug's design or by changing its labeling.
In a very small number of patients, nonsteroidal anti-inflammatory drugs (NSAIDs)—including both sulindac and popular NSAIDs such as ibuprofen, naproxen, and Cox2–inhibitors—have the serious side effect of causing two hypersensitivity skin reactions characterized by necrosis of the skin and of the mucous membranes: toxic epidermal necrolysis, and its less severe cousin, Stevens–Johnson Syndrome.
In December 2004, a woman was prescribed Clinoril, the brand-name version of the NSAID sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac, which was manufactured by Mutual Pharmaceutical. The woman soon developed an acute case of toxic epidermal necrolysis. Sixty to sixty-five percent of the surface of the woman's body deteriorated, was burned off, or turned into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. As a result, she was severely disfigured, had a number of physical disabilities, and was nearly blind.
At the time the woman was prescribed sulindac, the drug's label did not specifically refer to Stevens–Johnson Syndrome or toxic epidermal necrolysis, but did warn that the drug could cause severe skin reactions and fatalities. However, Stevens–Johnson Syndrome and toxic epidermal necrolysis were listed as potential adverse reactions on the drug's package insert. In 2005—after the woman was already suffering from toxic epidermal necrolysis—the FDA completed a comprehensive review of the risks and benefits, including the risk of toxic epidermal necrolysis, of all approved NSAID products. As a result of that review, the FDA recommended changes to the labeling of all NSAIDs, including sulindac, to more explicitly warn against toxic epidermal necrolysis.
The woman brought a design defect claim against Mutual in New Hampshire state court. Mutual removed the case to the United States District Court for the District of New Hampshire. After a two-week trial, a jury found Mutual liable and awarded the woman over $21 million in damages. Mutual moved for judgment as a matter of law and for a new trial. The district court denied the motions, and Mutual appealed. The United States Court of Appeals for the First Circuit affirmed. The Court of Appeals found that neither the FDCA nor the FDA's regulations preempted the woman's design-defect claim. The First Circuit reasoned that generic manufacturers facing design-defect claims could comply with both federal and New Hampshire law simply by choosing not to make the drug at all.
The Supreme Court of the United States reversed. The Court held that the woman’s warning-based design defect claim under New Hampshire law was preempted by federal law. In the absence of an express preemption provision, a state law may be impliedly preempted where it is impossible for a private party to comply with both state and federal requirements. The Court found that it was impossible for Mutual to comply with both New Hampshire and federal requirements.
The Court reasoned that under New Hampshire’s risk-utility analysis, increasing a drug's usefulness or reducing its risk of danger would require redesigning the drug, since those factors are direct results of a drug's chemical design and active ingredients. The Court found that Mutual could not redesign sulindac for two reasons. First, the FDCA required a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent. Second, because of sulindac's simple composition, the drug was chemically incapable of being redesigned.
The Court reasoned that because redesign was impossible, Mutual could only ameliorate sulindac's risk-utility profile by strengthening its warnings. Thus, New Hampshire's law ultimately required Mutual to change sulindac's labeling. The Court concluded that it was impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its duty under New Hampshire law to either strengthen the warnings on sulindac's label or change sulindac's design.
The court held that state-law design-defect claims that turn on the adequacy of a drug's warnings are preempted by federal law under PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which held that federal law prohibits generic drug manufacturers from independently changing their drugs' labels. Mutual was prohibited, under PLIVA, from taking the remedial action required to avoid liability under New Hampshire law.
The Court found the First Circuit's rationale—that Mutual could escape the impossibility of complying with both its federal- and state-law duties by choosing to stop selling sulindac—was incompatible with the Supreme Court's preemption cases, which have presumed that an actor seeking to satisfy both federal- and state-law obligations is not required to cease acting altogether.
See: Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466 (U.S., June 24, 2013).
See also, Medical Law Perspectives May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication