Facts: In 1978, the Food and Drug Administration (FDA), a federal government agency, approved a nonsteroidal anti-inflammatory pain reliever called “sulindac” under the brand name Clinoril. At the time, the FDA approved the labeling of the prescription drug, which contained warnings of specific side-effects of the drug. When the Clinoril patent expired, the law permitted other pharmaceutical companies to sell generic versions of sulindac under their own brand names. Federal law requires that genetic sellers of drugs use the exact labeling as required on the originally drug, without alteration. Mutual Pharmaceutical Company, Inc. (Mutual) manufactured and sold a generic brand of sulindac. Karen L. Bartlett was prescribed sulindac for shoulder pain and the pharmacist dispensed Mutual’s generic brand of sulindac to her. Bartlett soon developed an acute case toxic epidermal necrolysis. The results were horrific. Sixty percent of the surface of her body deteriorated and burned off. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She is now severely disfigured, has a number of physical disabilities, and is nearly blind. The original patented drug’s label, and therefore Mutual’s generic brand label, did not refer to the possible side-effect toxic epidermal necrolysis. The state of New Hampshire law required stricter warnings on prescription drugs than federal laws. Bartlett sued Mutual for product liability under New Hampshire law. The jury of the U.S. district court found Mutual liable and awarded Bartlett more than $21 million in damages, and the U.S. court of appeals affirmed the award. Mutual appealed to the U.S. Supreme Court, asserting that the federal labeling law preempted New Hampshire law under the Supremacy Clause. 

Issue: Does the federal drug labeling law preempt a stricter state drug labeling law? 

Language of the U.S. Supreme Court: Under the Supremacy Clause, state laws that require a private party to violate federal law are preempted and, thus, are “without effect.” In the instant case, it was impossible for Mutual to comply with both its state-law duty to strengthen the warnings on sulindac’s label and its federal-law duty not to alter sulindac’s label. Accordingly, the state law is preempted. The dreadful injuries from which products liabilities cases arise often engender passionate responses. But sympathy for respondent does not relieve us of the responsibility of following the law. 

Decision: The U.S. Supreme Court held that federal drug labeling law preempted New Hampshire’s stricter labeling law under the Supremacy Clause of the U.S. Constitution. The Supreme Court reversed the U.S. court of appeal’s decision that was in favor of Bartlett. 

Ethics Questions: What is the public policy for having the Supremacy Clause? Do you think that pharmaceutical companies supported the passage of the federal drug labeling statute? Was it ethical for Mutual to deny liability in this case?