Late last week, the U.S. District Court for the Northern District of Texas ruled that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional. Relying on the Supreme Court’s recent decision in SEC v. Jarkesy, 603 U.S. 109 …
Earlier this week, we posted on the retirement of DEA Chief Administrative Law Judge Judge John J. Mulrooney, II, and the lack of appointed DEA ALJs to hear DEA cases upon his retirement, effective August 1. On a related note, HPM wants to take a …
Last week, DEA registrants and applicants with pending actions before DEA’s Office of Administrative Law Judges (OALJ) received an order from Chief Administrative Law Judge John J. Mulrooney, II, staying the hearing proceedings in those cases. In those orders, Chief Judge Mulrooney announced that he …
At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. One notable exception has been the Administration’s targeting of certain surgical procedures and …
We published a version of this post several years back (see here), but recent updates to the law and trends in DEA enforcement merit a refresher. The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show …
Hyman, Phelps & McNamara, P.C. is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. to 1:30 p.m. (ET) (register here). Join us as HPM’s Anne Walsh moderates a panel …
Last month, we blogged on the Department of Justice’s (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were “unconstitutional” and that DOJ would no longer defend those removal restrictions in court. We opined that while the impact of …
Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. This opinion, which overrules a Fifth Circuit decision that FDA had …
Late last month, the Department of Justice filed a short statement regarding administrative law judges (ALJs). The statement, issued by the Department’s Chief of Staff Chad Mizelle, states in its entirety: Today the Department of Justice determined that multiple layers of removal restrictions shielding administrative law …
A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agency’s approach to crediting one expert’s testimony over that of another expert during an administrative hearing. The discussion of the Agency’s expectations of the form and substance of expert witness …
Over the last couple of months, DEA has issued four decisions revoking the registrations of pharmacies (recall that DEA issued only one decision in 2017 involving a pharmacy). In February 2018, the Acting Administrator revoked the registrations of Trinity Pharmacy I, 83 Fed. Reg. 7220 …
A couple of months ago, the DEA Acting Administrator issued an order revoking the registration of David A. Ruben, M.D., on the grounds of lack of state authority (the Arizona Medical Board suspended his medical license in 2017). The same doctor was the subject of …
Last September, we posted on the Fifth Circuit’s decision to uphold summary judgment and award of costs in favor of Solvay Pharmaceuticals, Inc. in a False Claims Act (FCA) case (see post here). The relators pursued an FCA theory against Solvay based on allegations of …
Last week, the Superior Court of Pennsylvania struck a blow to Appellant Joseph Caltagirone’s wrongful death and survival claims against drug manufacturers Cephalon, Inc. and Teva Pharmaceuticals, USA, Inc. The Superior Court’s non-precedential decision relied on federal preemption principles to affirm the trial court’s dismissal …
Last year, the First Circuit reversed the dismissal of a False Claim Act (FCA) case brought against DePuy Orthopaedics, Inc., holding that the district court had wrongly dismissed the relators’ complaint for failing to plead with particularity under Federal Rule of Civil Procedure 9(b) (see …
