Will the Supreme Court’s latest decision on mens rea leave the prosecution of medical professionals empty? | Epstein Becker & Green

Last June, the U.S. Supreme Court issued a landmark decision clarifying the mental state the government must establish to convict a licensed health care professional of illegally distributing drugs under the federal Controlled Substances Act ( “THAT’S IT”). ). A physician can no longer be convicted of such a crime solely on the basis of objectively unreasonable prescribing practices. The government must now demonstrate that the health professional subjectively, knowingly and intentionally prescribed a controlled substance without a legitimate medical purpose. While unlikely to have a significant impact on the number of DOJ opioid prosecutions, the case will undoubtedly inform charging decisions in marginal cases and support important defense arguments during of the trial.

In Ruan v. United StatesThe Supreme Court overturned the convictions of two physicians for violating the CSA, holding that to convict a licensed physician of illegally distributing a controlled substance, the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally prescribed a substance regulated by the Controlled Substances Act that was not for a legitimate medical purpose.

Roan concerned the consolidated appeal of the criminal convictions of physicians Ziulu Ruan and Shakeel Kahn, who were convicted of distributing drugs in violation of 21 USC § 841, and each sentenced to more than 20 years in prison. Section 841 criminalizes “[e]except as permitted. . . knowingly and intentionally. . . distribute, or dispense. . . a controlled substance. Federal regulations permit prescriptions for controlled substances that are “issued for legitimate medical purposes by an individual practitioner acting in the ordinary course of their professional practice.” 21 CFR s 1306.04(a).

During the trials of Drs. Ruan and Kahn, jury instructions on the meaning of the “except leave” clause of Section 841 were challenged. Both juries were told they should not be convicted if the doctor was acting in “good faith”. Dr. Ruan’s jury was told that “good faith” meant providing treatment “in accordance with the generally recognized and accepted standard of medical practice in the United States”. Dr. Kahn’s jury was told that “good faith” meant “an attempt to act in accordance with what a reasonable physician should believe to be proper medical practice”. In upholding Dr. Ruan’s conviction, the Eleventh Circuit found that a physician’s subjective belief that he was meeting the patient’s needs was not a “complete defense,” and whether he adhered to the “usual course of his/her professional practice” is assessed using an objective. Standard. As for Dr. Kahn, the Tenth Circuit also ruled that a conviction could stand despite the “permitted” clause if the government proved that the “prescription was objectively not within the ordinary course of professional practice.” No circuit imposed a mental state – or mens rea– requirement on the “except as authorized” clause of Section 841. Instead, both circuits approved a rule that would allow a conviction when a statute of limitations was In fact unauthorized, even if the prescribing doctor believed that it was for a legitimate medical purpose.

The Supreme Court found that the trial court wrongly failed to apply a mens rea the requirement of the “except as authorized” clause. Citing the fundamental purpose of criminal laws to punish only conscious wrongdoing, the “general intent” mens rea set out in Section 841, the “ambiguous” terms of the federal regulations and the severe penalties that flow from violating the law, the Supreme Court chose to impose a “strong scientific requirement” on this clause. In doing so, the Court rejected the government’s argument that the “unless authorized” clause was more like an exception to the rule and, pursuant to another provision of Title 21 governing standards of pleading, the government did not need to refute each of these “exemptions or exceptions”. ”

The government also proposed a hybrid “objectively reasonable good faith effort” standard for assessing whether a doctor’s prescribing behavior was “authorized”. While appealing to the dissent written by Justice Samuel Alito and joined by Justices Clarence Thomas and Amy Coney Barrett, who advocated a “good faith” standard without further specification, the Supreme Court majority also rejected that argument.

The dissent also argued that the “except leave” clause was not part of the statute at all, but rather an “affirmative defence” not deserving of the presumption that mens rea even applies. Unconvinced, the majority concluded that the “unless authorized” clause was “sufficiently elemental” to “warrant similar legal treatment” and concluded that a display of mental state “knowingly and intentionally” was necessary to satisfy the conviction under the clause. .

The court’s decision directly overruled decisions of the Tenth and Eleventh Circuits and indirectly overruled other courts that had been convicted of prescribing controlled substances that were In fact not authorized under federal regulations, even if the physician subjectively believed the prescription was authorized or for a legitimate medical purpose.

Today, DOJ prosecutors, especially those prosecuting opioid cases, must do more than show that no reasonable physician would have written the prescriptions at issue. Below Roanthe DOJ must now prove that the defendant doctors wrote the prescriptions knowledge that they had no legitimate medical purpose. In opioid lawsuits, which have grown and will continue to grow with the media surrounding physician and opioid manufacturing cases, expert testimony that a defendant physician’s prescribing practice was within the realm of healthcare Reasonable medical procedures will present a significant hurdle for the DOJ. But prosecutors will still rely on the same proven circumstantial evidence to prove that a medical professional subjective intent in opioid cases, such as quantities prescribed, patient characteristics, length of examination, medical records (or lack thereof), medical necessity, compliance with distribution agreements, non- compliance with patient “red flags” and prescriber financial practices.

As for Drs. Ruan and Kahn, the Tenth and Eleventh Homers will now decide whether the result under the new standard would have been the same; that is, whether the error in jury instruction was “harmless”.

Although it is not clear if the Roan the case will have a significant impact on DOJ charging decisions in the future, the DOJ’s enforcement efforts in the area of ​​opioids are not expected to falter anytime soon. At most, the Roan decision will influence the DOJ’s declinations in marginal cases. Roan will bolster the defense’s case where prescribing or dispensing practices, particularly those that were arguably consistent with a reasonable medical purpose, and leave the onus on the government to establish, not only that the defendant’s prescribing practices did not were not up to professional standards, but which the defendant intended to prescribe without a legitimate medical purpose.

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