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The FDA's Role in Product Liability Litigation
Aside from promulgating regulations, imposing rigorous standards on myriad product manufacturers, and conducting research and studies on all such products, the FDA also takes an active role in participating in an array of product liability litigations both on the state and federal levels. Often, the FDA's position and “expertise” on an issue carry great weight with the courts and consequently can affect the outcome of litigation. Thus, defense counsel involved in product liability matters in which the FDA historically has had an interest should keep abreast of the FDA's positions on the relevant issues.
Three areas of product liability litigation in which the FDA has involved itself are cases in which 1) the question was presented whether the Food, Drug, and Cosmetic Act, 21 U.S.C. '' 301 to 399 (2003), (FDCA) broadly preempts state common law tort claims; 2) there was an issue as to what deference courts should accord to the FDA's “expertise” in matters of drug labeling and advertising; and 3) the FDA brought matters regarding a party's compliance with federal law, or lack thereof, to the courts' attention. (These areas of the FDA's involvement in product liability litigation are by no means exhaustive. Therefore, the reader is encouraged to investigate further the FDA's evolving positions on other relevant issues.)
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.