Vanda Pharmaceuticals, Inc. v. Food and Drug Administration Brigid DeCoursey Bondoc & Keunbong Do* I. Why It Made the List The Freedom of Information Act (FOIA) has allowed public to access government-held information upon request, while providing exemptions to protect certain information from disclosure. Over time, however, concerns that some agencies are overusing these [...]

United States v. California Stem Cell Treatment Center Anne K. Walsh* I. Why It Made the List Any case that FDA loses is significant. But this case is extra special because it tees up a potential circuit split that could jeopardize FDA’s regulatory authority over regenerative medicines. FDA has appealed this decision, so next [...]

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC Sara W. Koblitz* I. Why This Case Made the List Patents listed in FDA’s List of Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) play a critical role in maintaining the balance between access and innovation that underscores the Drug Price Competition and Patent [...]

(Alleged) False Statements to FDA Do Not Necessarily a False Claim Make Lynn C. Tyler* In connection with an FDA pre-approval inspection of a pharmaceutical manufacturing facility, a company makes false statements and provides false records to FDA inspectors. The company passes the inspection, which allows it to manufacture and sell the product, including [...]

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 [...]