SCOTUS Sides with Doctors Convicted of Running “Pill Mills”
Legal Intelligencer article by Lamb McErlane PC Health Law attorney Vasilios J. Kalogredis.
On June 27, 2022, the Unites States Supreme Court (SCOTUS) unanimously ruled that doctors who act in subjective good faith in prescribing controlled substances to their patients cannot be convicted under the federal Controlled Substance Act (“CSA”). The Court’s decision, which was handed down in Ruan v. United States, is an important decision for doctors who have been convicted of, or who may be at risk of being convicted of, violating the CSA in connection with the nation’s opioid crisis.
Under federal law, licensed physicians are permitted to dispense controlled substances for “legitimate medical purpose” as part of their professional practice. Consequently, the justices were faced with deciding how to distinguish valid medical conduct from illegal overprescription of highly addictive drugs like opioids.
The ruling stemmed from the convictions of Dr. Xiulu Ruan and Dr. Shakeel Kahn for unlawfully prescribing opioid painkillers and being sentenced to more than 20 years in prison.
Ruan operated a medical clinic in Alabama and a pharmacy, which made more than $4 million during a four-year period and dispensed nearly 300,000 prescriptions, including many for opioids. Kahn practiced in Arizona and Wyoming, operating mostly on a cash-only basis and accepting property as payment, including firearms. Their cases were consolidated for the Supreme Court.
At their trials, counsel for the doctors argued that physicians should not be convicted under the CSA if they reasonably believed their prescribing patterns fit within professional norms, and that the doctors were trying to meet the individual needs of their patients; thus, the doctors indeed could make a good faith defense.
The government, however, maintained that some prescribing patterns were so far out of the bounds and so clearly did not have legitimate medical purposes that it amounted to a dangerous crime, no matter what the prescriber claimed their intent was.
The district courts rejected any consideration of good faith and instructed the members of the jury that the doctors could be convicted if they prescribed opioids outside the recognized standards of medical practice. The Tenth and Eleventh Circuits affirmed the instructions.
The question before the Supreme Court concerned the state of mind that the government must prove to convict a doctor of violating the CSA. Justice Stephen Breyer framed the issue: “To prove that a doctor’s dispensation of drugs via prescription falls within the statute’s prohibition and outside the authorization exception, is it sufficient for the government to prove that a prescription was in fact not authorized, or must the government prove that the doctor knew or intended that the prescription was unauthorized?”
The doctors urged the Supreme Court to adopt a subjective good-faith standard that would protect practitioners from criminal prosecution if they sincerely and honestly believed their prescriptions were within the usual course of professional practice. The government argued for an objective, good-faith standard based on the hypothetical “reasonable” doctor.
The Supreme Court sent the case back to the appeals courts to consider whether the juries in the two cases had been properly instructed and, if not, whether the errors were harmless.
The court ruling for the doctors was unanimous, but the justices differed 6-3 on the legal rationale.
Justice Breyer, writing for the majority, said that for purposes of a criminal conviction under the CSA, “the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.” To hold otherwise “would turn a defendant’s criminal liability on the mental state of a hypothetical ‘reasonable’ doctor” and “reduce culpability on the all-important element of the crime to negligence,” he explained. The Court has “long been reluctant to infer that a negligence standard was intended in criminal statutes,” wrote Justice Breyer.
Justice Samuel A. Alito Jr., writing for three members of the court, agreed with Justice Breyer’s bottom line but not his reasoning. “A doctor who makes negligent or even reckless mistakes in prescribing drugs is still ‘acting as a doctor’ — he or she is simply acting as a bad doctor,” Justice Alito wrote. “The same cannot be said, however, when a doctor knowingly or purposefully issues a prescription to facilitate ‘addiction and recreational abuse,’” he wrote, quoting an earlier decision.
The court’s alternate approach, Alito wrote, does not answer the question of whether there is a “good-faith defense” in the prosecutions of physicians. “How many other affirmative defenses might warrant similar treatment, the Court does not say. It leaves prosecutors, defense attorneys, and the lower courts in the dark. I cannot accept this cavalier treatment of an important question,” wrote Alito, who was joined by Justices Clarence Thomas and Amy Coney Barrett.
The Justice Department has declined to comment on the ruling. Former prosecutors said the decision would change the way the government assesses health-care fraud cases by requiring the Justice Department to prove beyond a reasonable doubt that a doctor knew what he or she was doing was wrong at the time the prescription was issued.
“This will have a chilling effect on how the DOJ assesses what cases to prosecute,” a former federal prosecutor with health-care fraud experience said in a statement. “The DOJ has aggressively pursued health care fraud in a post-pandemic world and each of these investigations will have to be re-evaluated to determine if the DOJ has enough evidence to meet” the Court’s new standard.
The Court’s decision will protect patient access to prescriptions written in good faith. However, for the government, the Court’s decision means prosecutors face an uphill battle in charging, much less convicting, physicians under the CSA.
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Vasilios J. (Bill) Kalogredis, Esq. has been advising physicians, dentists, and other health care professionals and their businesses as to contractual, regulatory and transactional matters for over 45 years. He is Chairman of Lamb McErlane PC’s Health Law Department. bkalogredis@lambmcerlane.com. 610-701-4402.