In June 2022, the U.S. Supreme Court issued an opinion in Ruan v. United States that clarified the mens rea requirement for those who manufacture, distribute, or dispense drugs and are subsequently prosecuted under the Controlled Substances Act, specifically 21 U.S.C. § 841. The Supreme Court held that the Department of Justice “must prove beyond a reasonable doubt that the defendant knew that he or she was acting in an unauthorized manner, or intended to do so” in order to sustain a conviction under § 841. Essentially, the Supreme Court clarified that a “bad faith” finding on the part of a physician was not enough—physician liability under the CSA requires knowledge.
At the time, the legal community speculated on what effect this ruling would have on pending and future prosecutions under the CSA. Now, it seems to have affected at least one pending case. The U.S. Department of Justice has dropped charges against a defunct drug distributor, Miami-Luken, two of its executives, and two pharmacists who were charged with conspiracy to distribute a controlled substance. Miami-Luken was alleged to have sent millions of pills of both oxycodone and hydrocodone to locations in small towns in Appalachia, which were ultimately distributed by pharmacies run by two of the individual defendants, Devonna Miller-West and Samuel Ballengee.
While the DOJ did not expressly state that the reason it was dismissing the charges was due to the heightened mens rea requirement articulated by the Supreme Court in Ruan, it was discussed during a July 19 status conference in the Miami-Luken case. On August 11, 2022, U.S. District Judge Matthew W. McFarland of the Southern District of Ohio granted the government’s unopposed motion to dismiss the charges.
The attorneys at Chilivis Grubman will continue to monitor the effects of the Supreme Court’s ruling in Ruan. We represent clients of all types and sizes in connection to health care litigation and health care fraud investigations. If you need assistance with such a matter, please contact us today.