Business Law 9th Edition by Henry Cheeseman

تمرين 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
"But sympathy for respondent does not relieve us of the responsibility of following the law."
-Alito, Justice
Facts
In 1978, the Food and Drug Administration (FDA), a federal government agency, approved a nonsteroidal anti-inflammatory pain reliever called sulin-dac 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 generic sellers of drugs use the exact labeling as required on the original 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 a pharmacist dispensed Mutual's generic brand of sulinac to her. Bartlett soon developed an acute case of 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 of toxic epidermal necrolysis.
The law in the state of New Hampshire required stricter warnings on prescription drugs than did 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 pre-empted 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 pre-empted. The dreadful injuries from which products liabilities cases arise often engender passionate responses. But sympathy for respondent does not relieve us of the responsibility offollowing 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.
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?