Long Island Newsday Examines Recent FDA Intervention in Product Liability Lawsuits
Long Island Newsday on Wednesday examined the Bush administration's efforts since 2001 to block liability lawsuits against medical device manufacturers and drug makers. FDA has claimed in legal briefs that suits against FDA-approved products would "sabotage the agency's authority"; critics call the agency's position a "back-door approach to tort reform" (Kerr, Long Island Newsday, 8/11).
FDA chief counsel Daniel Troy has argued in legal briefs that only FDA has the authority to determine when and how pharmaceutical companies should issue product warnings and that state court decisions could undermine the agency's authority over product labels. Rep. Maurice Hinchey (D-N.Y.), a member of the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, last month said that Troy has violated an FDA tradition to avoid intervention in lawsuits against pharmaceutical companies unless asked by the courts. Hinchey also said that the briefs pose a conflict of interest because Troy represented Pfizer in his previous position as a partner in the law firm of Wiley, Rein & Fielding. The House last month passed a Hinchey-sponsored budget amendment that would reallocate $500,000 from Troy's office to improve FDA enforcement of misleading advertisements sponsored by pharmaceutical companies (California Healthline, 7/14).
A Justice Department "statement of interest" filed in one recent case states that if juries were to determine the regulatory pathway for medical devices, "it would result in an unworkable, chaotic system that Congress sought to avoid by charging FDA with the responsibility for regulating medical devices." FDA Acting Commissioner Lester Crawford added in a prepared statement, "When state courts call into question the FDA's global gold-standard determinations, FDA has an obligation to act." Five former FDA counsels have written to Congress in defense of Troy's actions.
However, Margaret Jane Porter, FDA chief counsel during the Clinton administration, who did not sign the letter, in 1997 wrote, "FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection." According to Jim O'Reilly, a visiting law professor at the University of Cincinnati, "It is a dramatic change of policy for the current Bush administration to take the pre-emption issue as a weapon against private plaintiffs" (Long Island Newsday, 8/11).