Defendants Beware: Did the Sixth Circuit Just Make Prescriber Testimony Irrelevant in Failure to Warn Cases? Anand Agneshwar & Jocelyn Wiesner* I. Why It Made the List It is axiomatic that a plaintiff bears the burden of proof on each element of her claim. In pharmaceutical and medical device failure to warn claims, this [...]

Significant Digital Health and Cybersecurity Regulatory Developments, 2022 Stephanie Philbin, Steven Tjoe & Lauren Farruggia* Throughout 2022, the U.S. Food and Drug Administration (FDA or the agency) continued to refine its frameworks for oversight of the digital health and broader device industry with important regulatory updates impacting device software and cybersecurity. The Food and [...]

2022 Significant Settlements Vanessa K. Fulton* I. Introduction This chapter summarizes a selection of significant settlements (including non-litigated resolutions such as criminal plea bargains or agency consent orders) in 2022 between members of the food and drug industry and government agencies, such as the U.S. Food and Drug Administration (FDA) and the U.S. Department [...]

Food and Drug Cases to Watch in 2023* We asked our Top Cases chapter authors for their picks on which current litigations, regulatory actions, and other developments have the potential to change the food and drug landscape in the balance of 2023. Some of the cases described here are appeals or other forms of [...]