Physician Prosecutions under the Controlled Substance Act

Facts of the Case

The petitioners in this case are Xiulu Ruan and Sjakeel Kahn, medical doctors with the authority to prescribe controlled substances. Dr. Ruan co-owned and co-operated a pain management clinic and an adjoining pharmacy, which filled the clinic's prescriptions. He faced criminal charges related to his medical practice, including racketeering, conspiring to violate the CSA by dispensing drugs outside legitimate medical purposes, and conspiracies to commit fraud. Dr. Ruan was alleged to have prescribed inappropriately for personal financial gain, and not monitored appropriately for diversion and misuse of opioid medications (Second Superseding Indictment, United States v. Couch, LEXIS 177974 (S.D. Ala. 2016)).

Dr. Kahn practiced as a pain management specialist in Wyoming and Arizona. He was alleged to have determined prescription quantities based on a patient's ability to pay, where he charged more for prescriptions with more pills; and prescribed fewer pills or even withheld prescriptions if a patient was unable to pay; and to have discussed the “street price” of drugs with patients and closely tracked his own fees to these prices. He allegedly received reimbursement on a “cash-only” basis and accepted personal property, including firearms, as payments. He was accused of requiring patients to sign a “drug addiction statement,” which stated that Dr. Kahn was not a “drug dealer” and described a liability of $100,000 if a patient's statements resulted in any civil or criminal actions against Dr. Kahn. One patient death was alleged to have directly resulted from Dr. Kahn's prescriptions (United States v. Kahn, 989 F.3d 806 (10th Cir. 2021)).

At separate trials, the two doctors testified to their clinical practices and that the medications were dispensed according to appropriate prescriptions. Additional details about the doctors' testimony can be found in their Petition for Writ of Certioraris for the 11^th Circuit and Supreme Court. Among these, Dr. Ruan testified to his good faith efforts to provide medical care. He reported limiting use of fentanyl to “severe breakthrough pain,” and that he terminated relationships if patients had “red flags” for diversion or misuse. He also outlined that most of the cases reviewed by the government represented “legitimate patient” relationships. He offered video evidence of himself declining to prescribe opioid pain medications to undercover DEA agents and suggesting to them that there were better alternatives. Similarly, the additional court documents reveal Dr. Kahn's position that he practiced with an honest intent to provide medical care and had been cleared previously of wrongdoing by the Arizona Medical Board.

Among other crimes, Drs. Ruan and Kahn were both convicted under 21 U.S.C. § 841 (2018) for writing unauthorized prescriptions. Dr. Ruan was given a 21-year sentence and Dr. Kahn a 25-year sentence. Both separately appealed in their respective circuit courts (Tenth and Eleventh) on the grounds that their respective juries were given improper instructions.

In Dr. Ruan's case, the jury was given the instruction to convict if “the doctor's actions were either not for a legitimate medical purpose or were outside the usual course of professional medical practice” (Ruan, p 2375). In Dr. Kahn's case, the jury was given the instructions to not find him guilty if the doctor acted in “good faith,” defined as “an attempt to act in accordance with what a reasonable physician should believe to be proper medical practice” (Ruan, p 2376). In Dr. Kahn's appeal to the Tenth Circuit, the court said that, to convict under 21 U.S.C 841, the government must prove that a doctor “either: (1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice” (Khan, p 825). Drs. Ruan and Kahn's appeals were both denied.

The petitioners appealed to the U.S. Supreme Court. In the writ of certiorari to the U.S. Supreme Court, the petitioners described variability across U.S. circuit courts in the prosecution of physicians under the CSA with some requiring a mens rea standard and others not. They argued that a Court opinion was needed, among other reasons described below, to provide consistent application of the law. The Court granted certiorari.

Ruling and Reasoning

In a unanimous decision, the U.S. Supreme Court remanded the circuit courts' rulings. The Court ruled that a CSA conviction must prove beyond a reasonable doubt that a physician knowingly intended to prescribe outside of the physician's authority, or outside a legitimate medical purpose. It deemed a negligence standard inappropriate on multiple grounds: the severity of the punishment in CSA convictions warrants treatment similar to criminal matters, as opposed to a civil matter; “authorized” prescription language is vague and not easily defined; and precedent consistently applies a culpable mental state standard to any critical component of a case that would distinguish guilt from innocence.

The Court also held that this opinion was consistent with prior rulings. In Liparota v. United States, 471 U.S. 419 (1985), the Court found that conviction for the illegal purchase of food stamps required knowledge that one is not authorized to buy food stamps. In United States v. X-Citement Video, Inc., 513 U.S. 64 (1994), the Court found that convictions for child pornography required one to know that minors are present in the videos. Similarly, in Rehaif v. United States, 139 S. Ct. 2191 (2019), the Court found that convictions for illegal possession of a gun required knowledge of being a member of a group disallowed from possessing guns.

The Court cited prior cases of criminal acts that required the defendant's intent to be of importance, and not what a “reasonable” hypothetical person thought. In Elonis v. United States, 575 U.S. 723 (2015), the Court ruled that threatening language was not defined by a “reasonable” third party, but instead by the intent of the speaker. Additionally, Rogers v. United States, 422 U.S. 35 (1975), re-affirmed that the Court has “long been reluctant to infer that a negligence standard was intended in criminal statutes” (Rogers, p 47).

In Justice Alito's concurrence, which Justice Thomas joined, he said that the majority erred in placing the burden of proof on the government to prove that a prescription was unauthorized in CSA prosecutions. He instead proposed that a physician must provide an affirmative defense to meet the burden of proof that the prescriptions were authorized. He acknowledged that a physician's prosecution under the CSA may warrant unique treatment when compared with a nonphysician, but he criticized the majority opinion for not specifically saying this.