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Horn v. Thoratec: FDA's Bold New Position on the Pre-emptive Effect of Product Approvals
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.”).
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The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.