Tuesday, November 30, 2021
The Supreme Court recently granted certiorari in two cases addressing criminal liability for doctors who prescribe controlled substances in good faith. It is also considering a similar petition from the Fourth Circuit, which includes Maryland and Virginia. The Court last addressed this issue nearly 50 years ago. United States v. Moore, 423 U.S. 122 (1975). Since then, the federal courts have drawn very different conclusions as to the level of wrongdoing required for prosecution. These cases present an opportunity for the Supreme Court to clarify whether physicians can become criminals for a simple mistake.
As two professors of health law point out, the potential for injustice goes far beyond those who are imprisoned. Fear of prosecution may inhibit other doctors from prescribing medicine, to the detriment of patients with legitimate medical needs. The easier it is to convict a medic, the more cautious one will be with medicine that many patients find necessary.
Too low a bar also risks interfering with traditional regulation of the medical profession. One of the defendants, Dr. Saheel Kahn, was twice investigated—and cleared—by the Arizona Medical Board. Nevertheless, he was found guilty of violating federal law.
Just the Facts
Saheel Kahn, who practiced in Arizona and Wyoming, failed to realize that some of his patients were selling their medication. Xiulu Ruan owned a pain clinic and pharmacy in Alabama, where he prescribed unusually large numbers of pain-killers. George Naum worked at an addiction clinic in West Virginia, where he signed prescriptions based on his nurse’s evaluations and reports. All were charged with distributing controlled substances.
Dr. Kahn, Dr. Ruan, and Dr. Naum maintained that they had their patients’ best interests at heart. The courts said, in effect, that it didn’t matter. All of the doctors were convicted. Two of them were sentenced to decades of imprisonment.
Is Legitimate Medical Purpose A Defense?
A physician violates the law when by distributing controlled substances “outside the usual course of professional practice.” Moore, 423 U.S. at 124. Thus, physicians can be prosecuted when they prescribed drugs “not for legitimate purposes” or their “conduct exceeded the bounds of ‘professional practice.’” Id. at 135, 142.
As a matter of common sense, to avoid criminalizing medical error, conviction should require a lack of legitimate purpose and treatment beyond the bounds of medical practice. The appropriate regulation arguably supports this requirement: “A prescription . . . must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). A few appellate courts have unambiguously adopted this position. U.S. v. Pellman, 668 F.3d 918, 923 (7th Cir. 2012); U.S. v. Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006).
Many circuits, however, have taken the opposite approach. In the Fourth Circuit, for example, the government must prove that a doctor’s actions “were not for legitimate medical purposes in the usual course of his professional medical practice” or that they were “beyond the bounds of medical practice.” U.S. v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995). Thus, “malicious motive or the desire to make a profit” is not required to convict a physician. Id. at 1188.
This reasoning reached its logical conclusion in Dr. Naum’s trial. Dr. Naum tried to prove that his treatment was for a legitimate medical purpose. The judge did not let him. The court of appeals affirmed his conviction: because the government wasn’t required to prove the lack of any legitimate medical purpose, it wasn’t relevant whether Dr. Naum had one. U.S. v. Naum, 832 F. App’x 137, 142 (4th Cir. 2020).
Similarly, in the Tenth Circuit, a physician may be convicted “if she prescribes the substance either outside the usual course of medical practice or without a legitimate medical purpose.” U.S. v. Nelson, 383 F.3d 1227, 1232 (10th Cir. 2004). The Court of Appeals denied Dr. Kahn’s request to reconsider this rule. U.S. v. Khan [sic], 989 F.3d 806, 822 (10th Cir. 2021). Dr. Kahn then sought certiorari on this issue.
What Is “Good Faith”?
Formally, good faith is a defense throughout the nation. Its effectiveness, however, varies greatly from circuit to circuit. Practically, in some parts of the country, it is no defense at all.
A few circuits have, with varying degrees of clarity, allowed a subjective test for good faith. That is, in some parts of the country, physicians may defend themselves by demonstrating that they were sincerely attempting to treat their patients.
By contrast, some circuits employ an objective standard. The Fourth Circuit is one of them. United States v. Hurwitz, 459 F.3d 463, 478-80 (4th Cir. 2006). Confusingly, some (non-binding) decisions arguably go further, suggesting that even an objectively reasonable belief is no defense. See United States v. Purpera, 844 F. App’x 614, 626-27 (4th Cir. 2021); United States v. Orta-Rosario, 469 F. App’x 140, 145-46 (4th Cir. 2012). In other words, it might not matter that a doctor believed he was following proper medical practice, only whether he should have believed it.
The Tenth Circuit leaves no doubt on this point: if a physician acted beyond professional boundaries, whatever her reasons, she cannot claim to have acted in good faith. Khan, 989 F.3d at 825-26. In the Eleventh Circuit, a defendant might not be entitled to a good faith instruction at all. U.S. v. Joseph, 709 F.3d 1082, 1097 (11th Cir. 2013). Effectively, there is no good faith defense within these circuits. It is on this issue that Dr. Ruan sought certiorari, as did Dr. Kahn.
These cases offer the Supreme Court an opportunity to correct the appellate courts’ error. The conflation of medical standards with legitimate purpose, and the absence of a good faith defense, mean that physicians can violate the law through a well-intentioned mistake. At best, this creates a crime out of what should be dealt with through professional discipline or malpractice lawsuits. At worst, it makes outlaws out of well-meaning doctors who trust their patients or employ unorthodox forms of treatment. In some cases, like Dr. Kahn’s, it can even lead to punishment where medical boards have investigated and found no wrongdoing.
Yet, a favorable decision alone will do little good for any individual defendant. An accused physician must understand precisely what the government will prove, how to convince the jury otherwise, and the necessary legal arguments. A small error, such as the failure to request the correct jury instructions, could ensure the conviction of even an innocent defendant. Therefore, as always, it remains important for wrongly-accused doctors to secure the representation of a skilled defense lawyer.
Tuesday, November 2, 2021
Here's the DOJ's Memorandum on the creation of a internal corporate crime advisory group - Corporate Crime Advisory Group and Initial Revisions to Corporate Criminal Enforcement Policies.
This Memo talks about the internal advisory group to reinforce the forthcoming department changes regarding corporate prosecutions.
I am also announcing, through this Memorandum, the creation of a Corporate Crime
Advisory Group within the Department that will consider and, where necessary, recommend
additional guidance concerning the three revisions set forth herein. This group will also consider
additional revisions and reforms that will strengthen our approach to corporate crime and equip
our attorneys with the tools necessary to prosecute it when it occurs.
It is hoped that this new Corporate Crime Advisory Group will consider working with the corporate sector in eradicating criminality. Colloboration can be a key to success in stopping white collar crime.