Ruan and How the Courts and Prosecutors are Managing it

by | Nov 15, 2022 | Criminal Defense, Drug Crimes, Federal Crimes, Pennsylvania Criminal Law, Professional License Issues |

In every pill mill federal prosecution against physicians, the prosecution must prove the doctor knowingly and intentionally distributed and dispensed medication, outside the usual course of professional practice and for no legitimate medical purpose, a mixture and substance containing a detectable amount of the scheduled substance in violation of 21 U.S.C. § 846.  IN, Ruan v. United States, 213 L. Ed. 2d 706, 142 S. Ct. 2370 (2022), the US Supreme Court  ruled that mens rea requirement for “doctor” defendants in Pill Mill cases. Ruan does not apply to pharmacy technicians, or drug dealers.  It only applies to § 841 prosecutions.

Ruan involved two “doctors who actively practiced medicine” and “possessed licenses permitting them to prescribe controlled substances.” They challenged their § 841 Pill Mill convictions claiming they were entitled to a jury instruction that  “[a]fter a defendant produces evidence that he or she was authorized to dispense controlled substances, the Government 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.” The court states, § 841 contains a general scienter provision—“knowingly or intentionally.” And in § 841 prosecutions, authorization plays a “crucial” role in separating innocent conduct from wrongful conduct. The regulatory language defining an authorized prescription is “ambiguous” and “open to varying constructions,” meaning that prohibited conduct (issuing invalid prescriptions) is “often difficult to distinguish” from acceptable conduct (issuing valid prescriptions).”  As such, the doctor – not a pharmacists or pharmacy technician, could have received the jury charge.


The doctors argued after presenting evidence of patient history, patient objective medical diagnosis, and patient prescription medication treatments they had a good faith belief the prescriptions written were proper and medically necessary  This then shifted the burden to the government to refute that doctors’ argument they had a good faith belief the medications dispensed were reasonable and medically necessary.  The Supreme Court agreed, requiring trial court’s to now instruct juries in Pill Mill cases that they were entitled to a jury charge addressing the doctor’s state of mind only after the doctor presents objective medical evidence supporting their reasonable belief of medical appropriateness of the prescriptions dispensed,.

Translating this case into my client’s legal defense is easy.  Having handled many physician prescribing prosecutions, long-term physician patient relationships are easily documents through chart reviews.  Medically appropriate prescriptions can only be proven through clear charts, well documented and proper physical examinations, objective medical tests and diagnostic imaging.  Call me to discuss your case, your patient load, your prescribing history, any state or federal DEA investigatory subpoenas.  Lets talk about debarment, public or private health insurance audits and claw backs for care properly rendered and medically necessary.

Grand Jury subpoenas, state investigative subpoenas, IOG dispensing subpoenas are point towards these prosecutions.  Call me to discuss.