Federal preemption is controversial because it diminishes the autonomy of a state’s power to regulate given policy areas. However, having a coherent national policy for a given area prevents conflicting federal and state laws and regulations. In the U.S. Supreme Court case Wyeth v. Levine, the conflict between federal and state laws was evident. The Wyeth pharmaceutical company appealed a Vermont court decision which determined that Wyeth should have had better safety warnings in its drug labeling. In its appeal to the Supreme Court, Wyeth claimed that it had met federal standards in its drug safety labeling and that these federal standards preempted any state regulations in this area. The Supreme Court, in its decision, determined that Congress had not preempted the field in this case, and that Wyeth was obliged to follow state regulations on drug labeling.
It is more beneficial to an injured party if federal preemption does not come into play. If injured persons are able to sue in state court, the outcomes often are favorable because the jury consists of people from their state and who may be more sympathetic by association. The outcome of Wyeth v. Levine had immediate consequences on the rights of the injured party in this case. Had federal preemption been determined by the Supreme Court, it would have eliminated, for the most part, the possibility of Levine’s lawsuit success. This Supreme Court’s decision also had public policy reverberations that impacted and influenced the way that federal and state governments approach the crucial issue of drug labeling.
To prepare for this assignment:
- Review the U.S. Supreme Court case Wyeth v. Levine in the LexisNexis Academic database. Consider the majority and dissenting opinions in the case.
- Review the articles “FDA Preemption and Patient Welfare in Wyeth v. Levine” and “Justices Weigh Effect of F.D.A. Approval of Drug Labels on Suits in State Courts.” Consider both sides of the legal and policy debates about drug liability preemption.
- Think about the consequences of the majority and dissenting opinions on public policy.
- Consider the consequences of the majority and dissenting opinions on the rights of injured persons who argue for damages against a company whose product caused harm but whose actions were within the scope of the government regulations.
- Reflect on whether you agree or disagree with the rationale of the majority opinion in the Wyeth v. Levine case and consider why.
The assignment: (2–3 pages)
- Briefly synthesize the majority and dissenting opinions in the Wyeth v. Levine case. In your synthesis, be sure to include brief descriptions of policy arguments made in the majority and dissenting opinions.
- Explain at least one consequence of the majority opinion and one potential consequence of the dissenting opinion on public policy.
- Explain at least one consequence of the majority opinion and one potential consequence of the dissenting opinion on the rights of injured persons who argue for damages against a company whose product caused harm but whose actions were within the scope of the government regulations.
- Explain whether you agree or disagree with the rationale of the majority opinion in this case, and why. Be specific.
Support your Application Assignment with specific references to all resources used in its preparation. You are asked to provide a reference list only for those resources not included in the Learning Resources for this course.