Life Sciences

Pre-emption bill could impact Supreme Court case

Pharma Compliance Alert, July 2, 2008

A bill introduced in the House of Representatives could have a negative impact on pharmaceutical companies, even though the legislation is aimed at medical device companies.
 
As expected, Representatives Frank Pallone (D-NJ) and Henry Waxman (D-CA) introduced Medical Device Safety Act that would overturn the Supreme Court’s decision in Riegel v. Medtronic by explicitly allowing consumers to sue medical device makers under state law.
 
In February, the court ruled 8–1 that the federal Food, Drug, and Cosmetic Act preempts state product liability lawsuits seeking damages for injuries caused by FDA-approved devices.
 
Waxman sent a letter to FDA Commissioner Andrew von Eschenbach requesting all:
  • Documents related to communication about preemption with representatives of drug or medical device companies, government officials, and internal FDA staff
  • Briefs filed by the FDA in product liability cases
  • Drafts of the final drug labeling rule
  • Documents relating to FDA's proposed rule modifying the “changes being effected” regulation
Senators Ted Kennedy (D-MA) and Patrick Leahy (D-VT) plan to introduce a companion bill in the Senate.
 
The legislation does not directly affect pharmaceutical companies because they are not covered under the statute that implies preemption. However, the legislation could affect the Supreme Court’s decision in the upcoming Wyeth v. Levine case. The case centers on Wyeth’s challenge to a judgment awarded to a Vermont woman over an anti-nausea drug approved by the FDA.
 

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