MICHAEL DOWELL ESQ., RPh: DISCUSSES IMPACT ON PHARMACIES U.S. SUPREME COURT RULING THAT DEA MUST PROVE “KNOWING AND INTENTIONAL VIOLATIONS OF THE CSA”

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NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., IN THE SPIRIT OF ERLIN CLEMENT SR.,  JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., LEROY BAYLOR,   JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

(article published from independent research of this blog)

December 8, 2022

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.

MICHAEL DOWEL ESQ @10MDowell

Education

• Indiana University Maurer School of LawIndiana University Maurer School of LawJuris Doctor, LawJuris Doctor, Law1980 – 19831980 – 1983
  • Activities and societies: BALSAActivities and societies: BALSA
  • • Accelerated GraduateAccelerated Graduate
• Purdue UniversityPurdue UniversityBachelor of Science, PharmacyBachelor of Science, Pharmacy1975 – 19801975 – 1980
  • Activities and societies: Alpha Phi Alpha,
  • 
    SNPhA

Hinshaw & Culbertson LLP is a U.S.-based law firm with offices nationwide. The firm’s national reputation spans the insurance industry, the financial services sector, and other highly regulated industries. Hinshaw also serves as counsel to the professional services sector and provides business advisory and transactional services to clients of all sizes.

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