The Rapid Dissolution of Sapienza v. Albertson’s Companies, Inc. Mital Patel & Francisco Cabrera López* I. Why It Made the List Sapienza v. Albertson’s Companies, Inc.[1] makes the list of “top food and drug cases” in 2022 because the court shut down yet another improper effort by the plaintiffs’ bar to turn an alleged [...]

Dobbs v. Jackson Women’s Health Organization James M. Beck* I. Why It Made the List The monumental fallout from the Supreme Court’s first abolition of a constitutional right in modern times places FDA squarely in the crosshairs of the ongoing American culture wars. Already we have seen state-law attempts to ban distribution, prescription, and [...]

West Virginia v. Environmental Protection Agency Justine E. Lenehan & T. Daniel Logan* I. Why It Made the List Although this case does not directly implicate the U.S. Food and Drug Administration (FDA) or its authorities, it has been included for two reasons. First, the Major Questions Doctrine (MQD) has the potential, if employed [...]

United States v. Elizabeth Holmes and Ramesh Balwani Bryant Godfrey & Tina Papagiannopoulos* I. Why This Case Made the List A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions last year against both executives for their roles [...]

Center for Inquiry Inc. v. Walmart, Inc. William M. Janssen* I. Why It Made the List “Get ready to match the stars—as we play the star-studded, big money Match Game! And here’s your host, Gene Rayburn!” Anyone born in the 1960s likely remembers this TV opening with its funky, synthesized musical theme, opening each [...]

Recent Cases on “Green” Messaging in Food and Beverage Company Advertising Rene Befurt, Anne Cai, Rebecca Kirk Fair & Helene Rowland* I. Why They Made the List Several recent lawsuits around “green” messaging in company advertising raise the question of how we can reliably evaluate “reasonable” consumers’ understanding of or reactions to sustainability or [...]

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 [...]