On June 27, 2022, the United States Supreme Court issued a highly-anticipated decision for the health care community that defines what level of intent the Government must prove to convict a prescriber for the unlawful distribution of a controlled substance under the Controlled Substances Act (CSA). Now, the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.

The decision resolves a split in the Circuits as to the mens rea required to convict a prescriber under the CSA. The ruling comes at a time when federal, state, and local governments have been fighting hard against the opioid epidemic.

Fueled by national drug force initiatives, the U.S. Department of Justice has been pushing the bounds of the CSA, and what it means to be a drug dealer. In recent years, the DOJ has brought novel prosecutions of drug company executives, medical professionals, manufacturers, and pharmacists.

Examples of such prosecutions include the cases of Insys Therapeutics Inc. executives involved with the Ruan case, John Kapoor and Sunrise Lee. Another case concerns Rochester Drug Cooperative Inc. CEO Laurence Doud, III, who is being prosecuted for his leadership in an alleged conspiracy to traffic opioids.^[i]

Even non-physicians can be convicted under the CSA, as is shown by high court’s June 13, 2022 denial of certiorari in the Kapoor and Lee cases.^[ii]

The Supreme Court’s ruling in Ruan indicates there are limitations to this strategy of expansion. Below, we take a look at the impact this decision will have on our nation and the opioid crisis, and in particular what prescribers should expect regarding CSA prosecutions moving forward.

The decision makes a prescriber’s intent a necessary element of conviction under the CSA

The Ruan decision vacated and remanded the convictions of Doctors Xiulu Ruan and Shakeel Kahn.

Ruan, a doctor and joint owner of two pain management clinics in Alabama, was convicted in 2017 for running a so-called pill mill operation and taking kickbacks for prescribing opioids.

Kahn, a doctor in Arizona and Wyoming, was convicted of 18 counts under the CSA related to his issuance of prescriptions—primarily opioids—between 2011 and 2016, and related counts of possessing a firearm and money laundering.

In each case, the trial court did not allow the jury to consider whether the doctor sincerely believed he was acting as a physician should. The doctors appealed.

On June 27, 2022, the Supreme Court agreed with the doctors that they could not be convicted solely on the proof that the prescriptions were, in fact, not authorized. The Court held that once a defendant meets his or her burden of production under § 885, i.e., that he or she is entitled to the prescriber exception, the Government must prove that the prescriber knowingly or intentionally acted in an unauthorized manner by prescribing the controlled substance.^[iii]

Under the CSA, it is a crime for anyone to “knowingly or intentionally…manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substances,” with an exception for practitioners who are registered to distributed controlled substances and do so “to the extent authorized by their registration.”^[iv]

For prescribers to avoid criminal liability under the CSA, the prescription for a controlled substance must “be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”^[v] Now, a prescriber can be convicted under the CSA only if the Government proves that he or she knowingly or intentionally acted in an unauthorized manner.

The decision eliminates the gross unfairness that prescribers were facing

By resolving the Circuit split, SCOTUS has eliminated the inherent unfairness that came with holding practitioners to different standards based on where they practiced.

Previously, prosecutors were required to prove different levels of intent to convict medical professionals under the CSA. For example, in the U.S. Court of Appeals for the First and Ninth Circuits, a prescriber could only be convicted if the prosecution proved the prescriber’s subjective “intent to act as a pusher rather than a medical professional.”^[vi] The Court adopted this standard in the Ruan decision.

Other Circuits, including the U.S. Court of Appeals for the Second Circuit, previously allowed a prescriber to rely on an objectively reasonable belief that he or she was acting in the usual course of professional practice.^[vii] Meanwhile in the U.S. Court of Appeals for the Tenth and Eleventh Circuit, where Ruan and Kahn practiced, a prescriber’s subject intent was irrelevant to whether he or she violated the CSA.

The decision eliminates this unfairness. In doing so, the Court affirmed the longstanding principle underlying the mental element of crimes: that “wrongdoing must be conscious to be criminal.”^[viii]

Prescribers can focus on patients rather than fearing criminal prosecution

The decision reaffirms the Supreme Court’s 1975 decision in U.S. v. Moore, that “physicians be allowed reasonable discretion in treating patients and testing new theories.”^[ix]

As the U.S. Court of Appeals for the Fourth Circuit has stated in U.S. v. Hurwitz in 2006, “latitude must be given to doctors trying to determine the current boundaries of acceptable medical practice.”^[x] Ultimately, uncertainty in this field was hurting patients as well as prescribers. Indeed, many physicians and advocacy groups raised this concern in amicus briefs to the Court.^[xi]

The Supreme Court appeared to share the concern that providers be given some latitude in their prescribing decisions.

Under normal circumstances, the Court reasoned, it would not view dispensations of controlled substances by physicians via prescription “as inherently illegitimate; we expect, and indeed usually want, doctors to prescribe the medications that their patients need.”

The act becomes criminal when the prescriber issues an unauthorized prescription. The “authorization plays a ‘crucial’ role in separating innocent conduct—and, in the case of doctors, socially beneficial conduct—from wrongful conduct,” according to the Court in Ruan.^[xii] It also noted that “[a] strong scienter requirement helps to diminish the risk of ‘overdeterrence,’ i.e., punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line.”^[xiii]

Opioid prescribers are attempting to treat a patient’s pain, which can be inherently difficult to verify. There is always a risk that some patients will exaggerate their circumstances or take advantage of a prescriber’s trust. The knowledge or intent mens rea allows prescribers to trust that their patients are legitimately suffering when they say they are, and ensures that fewer patients suffer needlessly from pain that can be safely alleviated.

Prosecutions are unlikely to slow, but the Government will likely focus on more egregious cases

The Ruan decision continues a trend of the Court pushing back on extensions of federal power over the practice of medicine. In Moore, the Court held that a physician can be convicted for federal narcotics offenses if his or her “activities fall outside the usual course of professional practice.”

In Gonzales v. Oregon, in 2006, the Court permanently enjoined the enforcement of the U.S. Attorney General’s interpretive rule that threatened prosecutions under the CSA of physicians who assisted suicide of terminally ill patients under an Oregon law. In this case the Court state, as it often does, the “regulation of health and safety is ‘primarily, and historically, a matter of local concern.’” Gonzales, 546 U.S. at 271 (citing Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 719 (1985)).

Although the Ruan decision does not articulate this federalist principle, the Supreme Court has once against pushed back against the DOJ expanding its power over medicine.

Still, the decision should be read within the context of the federal government’s repeated pledge to address the opioid crisis. Significant resources are being spent to combat the distribution of unlawful opioid prescriptions, including by creating joint law enforcement task forces, such as the Appalachian Regional Prescription Opioid (ARPO) Strike Force, aimed at regions that are particularly afflicted by the epidemic.

President Joe Biden has created a National Drug Control Strategy and signed into law legislation to help states address the epidemic.^[xiv] Moreover, as we learned when the Supreme Court denied certiorari in the Kapoor and Lee cases, even non-prescribers can be convicted under the CSA.^[xv]

With political pressure and public opinion on its side, we should not expect the DOJ to back down from such prosecutions any time soon.

Prescribers can learn from Ruan to protect themselves in practice and in the courtroom

Health care is a regulated industry and, as noted above, prescribers face immense scrutiny in light of the country’s current concern about opioids. The Ruan decision offers many takeaways for prescribers, both in practice and should they find themselves defending a case under the CSA.

The ruling reiterates that prescribers should always avoid prescribing in a way that gives the appearance of being driven by financial motives, as prosecutors are likely to use such evidence to show that the prescriber knew or intended to act without authorization. For example, the Government presented evidence that Ruan significantly increased his prescribing of an opioid after purchasing stock in the manufacturing company.^[xvi]

Other elements that prosecutors rely on in establishing whether a professional acted within the usual course of professional practice, include the following: whether prescribers miss red flags about their patients; whether prescribers adequately warn patients before prescribing opioids and monitor the patient during the prescription period; whether prescribers keep thorough medical records without errors or missing prescriptions; and whether prescribers increase patients’ dosage too quickly.

As part of monitoring, prescribers should test their patients to ensure the prescriptions are being used and not sold on the black market, and should look out for warning signs of abuse. Hospitals and provider groups should also consider implementing policies and procedures to encourage diligent recordkeeping and adequate oversight by prescribers.

Finally, physicians should take care not to rely on their physician extenders, such as nurse practitioners, to write opioid prescriptions unless within that provider’s scope of practice under state law, or examine patients receiving opioid medication on the physician’s behalf. It is more difficult for a jury to conclude that the prescriber knew or intended to act without authorization if the prescriber was present and active during the patient’s treatment.

In addition, convictions under the CSA often come down to expert testimony. To prove that a provider’s activities fall outside the usual court of professional practice, prosecutors typically rely on expert evidence.

For example, in Ruan’s case, the Government’s experts testified that Ruan should have tried other methods to treat chronic pain. Now, the prosecution will also need to prove knowledge of a lack of authorization.

As the Court stated in the Ruan decision, “‘the more unreasonable’ a defendant’s ‘asserted beliefs or misunderstandings are,’ especially as measured against objective criteria, ‘the more likely the jury…will find that the Government has carried its burden of proving knowledge.’”^[xvii] Thus, the defense should be prepared with strong experts to convince the jury that the prescriber subjectively believed he or she was authorized.

Conclusion

At its heart, the CSA is aimed at criminal prosecution of drug dealers, not prescribers. The Supreme Court’s decision reaffirms that. The Ruan decision protects those prescribers whose cases are a closer call by requiring the Government to prove in each case that the prescriber knew or intended to act without authorization.

Still, prosecutions under the CSA remain a real possibility, with serious consequences. We will need to watch what the DOJ does to see if Ruan impacts the Government’s efforts to prosecute prescribers to combat the opioid epidemic.

[i] United States v. Laurence F. Doud, III, No. 1:19-cr-00285-GBD (S.D.N.Y.).  A Southern District of New York court declined to dismiss Mr. Doud’s indictment earlier this year.  See id., Dkt. No. 119, Memorandum Decision and Order (Jan. 5, 2022).

[ii] Kapoor v. United States, No. 21-994, 2022 WL 2111364, *1 (June 13, 2022); Lee v. United States, No. 21-6952, 2022 WL 2111365, *1 (June 13, 2022).

[iii] Ruan v. United States, No. 20-1410, 2022 WL 2295024, *5 (June 27, 2022).

[iv] See 21 U.S.C. § 841(a)(1).

[v] 21 C.F.R. § 1306.04.

[vi] United States v. Feingold, 454 F.3d 1001, 1008 (9th Cir. 2006); States v. Sabean, 885 F.3d 27, 45 (1st Cir. 2018).

[vii] United States v. Wexler, 522 F.3d 194, 206 (2d Cir. 2008).

[viii] Ruan v. United States, No. 20-1410, 2022 WL 2295024, *5 (June 27, 2022) (quoting Elonis v. United States, 575 U. S. 723, 734 (2015)).

[ix] United States v. Moore, 423 U.S. 122, 143 (1975).

[x] See United States v. Hurwitz, 459 F.3d 463, 477 (4th Cir. 2006) (holding that “a doctor should not be held criminally liable if the doctor acted in good faith when treating his patients”).

[xi] See, e.g., Brief for National Pain Advocacy Center as Amici Curiae Supporting Petitioner at 12-14, Ruan v. United States (2022) (No. 20-1410); Brief for Professors of Health Law and Policy as Amici Curiae Supporting Petitioner at 12, Ruan v. United States (2022) (No. 20-1410); Brief for Due Process Institute as Amici Curiae Supporting Petitioner at 25, Ruan v. United States (2022) (No. 20-1410);  Brief for Cato Institute Supporting Petitioner at 19, Ruan v. United States (2022) (No. 20-1410); Professors of Health Law and Policy as Amici Curiae Supporting Petitioner at 25-27, Ruan v. United States (2022) (No. 20-1410).

[xii] Ruan v. United States, No. 20-1410, 2022 WL 2295024, *5-6 (2022) (quoting United States v. X-Citement Video, Inc., 513 U. S. 64, 73 (1994)).

[xiii] Id. at *6.

[xiv] See The Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act (the SUPPORT Act), available at https://www.congress.gov/bill/115th-congress/house-bill/6.

[xv] Kapoor, No. 21-994, 2022 WL 2111364, *1; Lee, No. 21-6952, 2022 WL 2111365, *1.

[xvi] See 11^th Cir. Decision at 9-11.

[xvii] Ruan v. United States, No. 20-1410, 2022 WL 2295024, *9 (2022).