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What effect (if any) would not having a Supremacy Clause have on court decisions like Mutual Pharmaceutical Company, Inc. Bartlett , 133 S. Ct. 2466,

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What effect (if any) would not having a Supremacy Clause have on court decisions likeMutual Pharmaceutical Company, Inc. Bartlett, 133 S. Ct. 2466, 2013 U.S. Lexis 4702 (2013)

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CASE 4.1 U.S. SUPREME COURT CASE Supremacy Clause Mutual Pharmaceutical Company, Inc. v. Bartlett 133 S.Ct. 2466, 2013 U.S. Lexis 4702 (2013) Supreme Court of the United States "Sympathy for respondent does not relieve us of the Federal law requires that sellers of sulindac use responsibility of following the law." exact federally required wording on the labeling of -Alito, Justice the side effects of the drug. This required label does not provide for warning of the possible side effect of toxic epidermal necrolysis that may result from use Facts of sulindac. The Food and Drug Administration (FDA), a federal Karen L. Bartlett was prescribed sulindac manu- government agency, approved the use of a nonsteroi factured by Mutual Pharmaceutical Company, Inc. dal anti-inflammatory pain reliever called sulindac. (Mutual). After use of the drug, Bartlett suffered (continued)toxic epidermal necrolysis, which resulted in horrific are preempted and, thus, are "without effect." injuries requiring 6 months of a medically induced In the instant case, it was impossible for coma, 12 surgeries, and tube feeding for 1 year. She Mutual to comply with both its state-law duty is now severely disfigured, has physical disabilities, to strengthen the warnings on sulindac's label and is nearly blind. and its federal-law duty not to alter sulindac's Bartlett sued Mutual in U.S. district court for label. Accordingly, the state law is preempted. violating a broader New Hampshire labeling law for Sympathy for respondent does not relieve us failing to warn her against the possible side effect of the responsibility of following the law. of toxic epidermal necrolysis. The jury awarded Bartlett $21 million in damages, and the U.S. court of appeals affirmed the award. Mutual appealed to Decision the U.S. Supreme Court, asserting that the federal The U.S. Supreme Court held that federal drug label- labeling law preempted New Hampshire law under ing law preempted New Hampshire's stricter labeling the Supremacy Clause. law under the Supremacy Clause of the U.S. Consti- tution. The Supreme Court reversed the U.S. court of appeal's decision. Issue Does the federal drug labeling law preempt the 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

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