By and large, the FDA has confined its participation to cases where it had specifically considered – and rejected – the plaintiffs’ claims that a product’s labeling or advertising should have included different language from that which was used. See Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, Update: Food & Drug. L., Reg. & Educ. (Food & Drug Law Inst., Wash., D.C.), Jan./Feb. 2003, at 1. In 2004, however, the FDA submitted a brief in a state products liability action that signals the agency’s willingness to be much more aggressive in protecting its jurisdiction from lay judge and jury determinations concerning a product’s risk-benefit balance that conflict with the FDA’s own determination of where that balance lies. See Br. of Amicus Curiae U.S. Dep’t of Justice, Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004) (No. 02-4597) (“FDA Br.”).
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Not a Bloomberg Law Subscriber?
LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.
For questions call 1-877-256-2472 or contact us at [email protected]