Buckman Co. v. Plaintiffs' Legal Committee
- Case Date: 9/13/2000
- Project Name: Health Care Project
On September 13, 2000, WLF filed a brief with the Court, urging it to prohibit plaintiffs' lawyers from second-guessing Food and Drug Administration (FDA) product approval decisions by filing state-law suits against the product manufacturer. WLF's brief argued that federal law does not permit such challenges because they would undermine FDA's authority to regulate the pharmaceutical industry. The suits here are product liability claims against the manufacturers of orthopedic screws used in spinal surgery; the plaintiffs assert that the screws never should have been permitted on the market and that FDA approved marketing only because manufacturers defrauded the FDA in connection with their product-approval applications. WLF argues that because FDA has stood by its decision to permit marketing of the screws, federal law prohibits plaintiffs from filing state-law tort actions that in essence second-guess FDA's approval.