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v Pharmaceutical Co. Inc. v. Bartlett, Case 5.1 Answer the following critical thinking questions regarding the Mutual Pharmaceutical case. What is the public policy for having the Supremacy Clause? Do you thinking that pharmaceutical companies supported the passage of the federal drug labeling statute? CHAPTER 5 Constitutional Law for Business and E-Commerce 91 CASE 5.1 U.S. SUPREME COURT CASE Supremacy Clause 99 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 Issue the responsibility of following the law." Does the federal drug labeling law preempt the state drug labeling law? -Alito, Justice Language of the U.S. Supreme Court Facts The Food and Drug Administration (FDA), a federal Under the Supremacy Clause, state laws that government agency, approved the use of a nonsteroidal require a private party to violate federal law anti-inflammatory pain reliever called sulindac. Federal are preempted and, thus, are "without effect. law requires that sellers of sulindac use exact federally In the instant case, it was impossible for required wording on the drug's label warning of the side Mutual to comply with both its state-law duty effects of the drug. This required label does not provide to strengthen the warnings on sulindac's label for warning of the possible side effect of toxic epidermal and its federal-law duty not to alter sulindac's necrolysis that may result from use of sulindac. label. Accordingly, the state law is preempted. Karen L. Bartlett was prescribed sulindac manu- Sympathy for respondent does not relieve us of factured by Mutual Pharmaceutical Company, Inc. the responsibility of following the law. (Mutual). After use of the drug, Bartlett suffered toxic epidermal necrolysis which resulted in horrific injuries Decision requiring 6 months of a medically induced coma, 12 sur- The U.S. Supreme Court held that federal drug label- geries, and tube feeding for one year. She is now severely ing law preempted New Hampshire's stricter labeling disfigured, has physical disabilities, and is nearly blind. law under the Supremacy Clause of the U.S. Consti- Bartlett sued Mutual in U.S. district court for violat- tution. The Supreme Court reversed the U.S. court of ing a broader New Hampshire labeling law for failing to appeal's decision. warn her against the possible side effect of toxic epi- dermal necrolysis. The jury awarded Bartlett S21 mil- lion in damages, and the U.S. court of appeals affirmed Critical Legal Thinking Questions the award. Mutual appealed to the U.S. Supreme Court, What is the public policy for having the Supremacy Clause? iseerting that the federal slaw nreempted New Do law under the Supreniacy Clause. passage of the federal drug labeling statute