Michael Dowell Discusses Impact on Pharmacies of U.S. Supreme Court Ruling that DEA Must Prove Knowing and Intentional Violations of the CSA

In a legal column published by U.S. Pharmacist, Hinshaw partner Michael Dowell discussed the impact of the U.S. Supreme Court's decision in the consolidated case Ruan v. United States and Kahn v. United States. The Ruan decision ruled that the Drug Enforcement Administration (DEA) must prove beyond a reasonable doubt that a prescriber knowingly or intentionally issued a prescription that they knew or intended was not for a legitimate medical purpose in order to subject that physician to criminal penalties under the Controlled Substances Act (CSA). 

Dowell provides a thorough outline of the case, which he describes as having "significant implications for all persons and entities subject to the CSA, including pharmacists and pharmacies who are subject to a 'corresponding responsibility' to only fill lawful prescriptions issued for a legitimate medical purpose."

Dowell addressed the decision's impact on pharmacies and DEA enforcement actions:

With the added mens rea element to prove, DEA enforcement actions against physicians, pharmacies, pharmacists, drug wholesale distributors, pharmaceutical manufacturers, and other controlled-substances prescribers for wrongfully distributing or dispensing opioids and other controlled substances under various fact patterns may be less likely to occur and/or less likely to result in convictions.

He added that the decision increases the DEA’s elements-of-proof threshold for CSA violation convictions, but is not expected to be a significant obstacle for future DEA enforcement actions.

Read the full article on the U.S. Pharmacist website

"DEA Must Prove “Knowing and Intentional” Violations of the Controlled Substances Act" was published by U.S. Pharmacist on November 18, 2022.