Dr. Xiulu Ruan and Dr. John Patrick Couch, licensed physicians, owned and operated a medical clinic in Mobile, Alabama, along with a connected pharmacy solely engaged in the business of dispensing drugs prescribed at their clinic. In a little over four years, they wrote nearly 300,000 prescriptions for controlled substances. In fact, they were among the top prescribers nationally of transmucosal immediate-release fentanyl (TIRF), which is FDA-approved for breakthrough cancer pain. Though no more than 15% of their patients had a cancer diagnosis, they prescribed more than 475,000 doses of TIRF to over 1,000 patients, which at times was more than double the number of TIRF prescriptions written by the next highest U.S. prescriber.
Drs. Ruan and Couch invested over $1 million in the pharmaceutical company making Abstral, a particular brand of TIRF, at the same time “massively” increasing their prescriptions of the drug. They collected “substantial” speaking fees from the maker of a different TIRF drug, Subsys, and were paid to host weekly programs promoting the drug, a gig intended to influence their prescribing practices according to a drug rep. This strategy apparently worked. Their clinic ranked among the top 10 prescribers of Subsys nationally.
All of this caught the attention of the federal Drug Enforcement Agency (DEA). During an investigation, an agent was easily able to obtain prescriptions for controlled substances from the clinic without an adequate examination and from clinic personnel who were not licensed to prescribe them, using prescriptions that appeared to be pre-dated and signed by Dr. Couch.
Drs. Ruan and Couch were indicted and, after a jury trial in an Alabama federal district court, were each convicted on multiple counts, including violations of the Controlled Substances Act, health care, mail, and wire fraud, and racketeering conspiracy. Dr. Ruan was sentenced to 21 years in prison, Dr. Couch to 20 years.
Dr. Shakeel Kahn, also a licensed physician, operated a clinic in Arizona where he “routinely” prescribed controlled substances, including oxycodone and alprazolam, with a perfunctory examination or, in some case, no exam at all. He doctored medical records to show, falsely, that he had seen patients in person, completed assessments, made referrals, and collected samples for testing.
Dr. Kahn priced his services, mostly cash-based, according to the number of pills he prescribed: the more pills, the greater the charge. For patients who could not afford his services, he prescribed fewer pills or refused to write a prescription. Some patients who referred others to Dr. Khan were given discounted fees. At times, his clinic manager would meet patients in the parking lot to exchange prescriptions for cash.
When area pharmacies started refusing to fill his prescriptions, he opened a second practice in Wyoming, where his prescriptions were more easily filled, inviting his Arizona patients to follow him there. In 2015, Dr. Kahn wrote a high-dose prescription for oxycodone and other controlled substances for a young woman who paid him $1,250. After filling the prescriptions, the patient died two days later of an oxycodone overdose.
After a DEA investigation, which revealed he charged a $500 minimum for writing prescriptions, Dr. Kahn was indicted and tried before a jury in a federal district court in Wyoming. At trial, experts testified that that Dr. Kahn’s prescriptions were issued outside the usual course of medical practice and not issued for legitimate medical purposes. He was convicted of one count of conspiring to dispense and distribute controlled substances resulting in death, along with a number of other controlled substances offenses. He was sentenced to 25 years in prison.
At trial, in both cases, the defendant physicians requested that the judge instruct the jury on a subjective “good faith” defense – in essence, that they could not be convicted if they sincerely and honestly believed that that their prescriptions were for a legitimate medical purposes and within the usual course of professional practice. Their jury instruction requests were denied. They appealed and, in both cases, their convictions affirmed (save for one racketeering conspiracy count in the Alabama case, which was overturned but is not relevant here).
Dr. Ruan and Dr. Kahn each petitioned the U.S. Supreme Court for a writ of certiorari and both were granted, the Court consolidating the two cases. Oral arguments were heard on March 1.
The federal Controlled Substances Act (CSA) makes it illegal to knowingly or intentionally distribute a controlled substance “except as authorized”, such as when a physician prescribes a drug for a patient. DEA regulations promulgated pursuant to the CSA require that controlled substance prescriptions, to be legal,
must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.
As succinctly explained by health care lawyers in a Lexology post,
In 1975, the Supreme Court held that doctors could be convicted under the CSA when “their activities fall outside the usual course of professional practice.” But in the decades since, courts have interpreted that decision differently. Some have adopted a subjective good-faith standard and hold that practitioners cannot be convicted if they sincerely and honestly believe that their prescriptions were within the usual course of professional practice. Others have adopted an objective good-faith standard and hold that a practitioner cannot be convicted if they “reasonably believed” that their prescription was within the usual course of professional practice. A minority of courts have rejected any consideration of good faith and found it irrelevant to criminal liability.
Given that the [CSA] statute requires the “knowingly or intentionally” unauthorized distribution of a controlled substance, the Supreme Court is expected to permit the good-faith defense. The only question remains: To what extent? If a doctor honestly believed the prescription was for a legitimate medical purpose, should that absolve the conduct, or should the belief be judged on an objective standard?
[Footnotes omitted.]
Unsurprisingly, the defendants argue that the Court should adopt a subjective good faith defense.
Some interesting friends
The consolidated cases attracted no less than a dozen amici curiae (“friend of the court”) briefs, although some specifically stated they had no interest in the outcome of these defendants’ cases one way or another. Rather, they were participating solely to argue how the CSA should be interpreted in general.
Many amici, including a group of Professors of Health Law and Policy and the National Association of Criminal Defense Attorneys, argue that some federal appellate courts are interpreting the CSA in a manner that essentially criminalizes conduct that deviates from accepted medical standards (that is, conduct that is basically malpractice) without considering whether the practitioner acted without a legitimate medical purpose. This, according to the health law professors’ brief, will
criminalize mistaken or negligent prescribing for which there are already myriad civil [e.g., malpractice], administrative [e.g., medical board complaints], and even lesser criminal remedies.
The ask the Court to
clarify that the CSA’s reach only extends to practitioners who prescribe knowingly or intentionally (i.e., not in good faith) without a medical purpose outside the usual course of professional practice.
They also argue that the criminalization of prescribing practices usurps the states’ authority to regulate the practice of medicine.
Two patient advocacy groups filed amicus briefs: Compassion & Choices, which describes itself as “committed to improving care and expanding choice at the end of life” and advocating “for high quality end-of-life medical care and educate[ing] the public about available end-of-life options”, and the National Pain Advocacy Center, “an organization dedicated to improving the health and protecting the rights of people living with pain”. Both argue that denying a good faith defense to practitioners will have a chilling effect on the willingness of physicians to prescribe opioids to patients in pain and those who are at life’s end. (The National Pain Advocacy Center has been criticized for failing to disclose funding from opioid manufacturers, from whom it accepted over half a million dollars over a five-year period. Its chairman received $170,000 from Insys, the maker of Subsys, which featured in the convictions of Drs. Ruan and Couch.)
Of note to regular SBM readers, representing the “brave maverick doctor” faction of the medical community, the Association of American Physicians and Surgeons (AAPS, who we have met before) filed an amicus brief which, contrary to the neutral stance of some amici, most assuredly takes up the cause of Dr. Ruan, portraying him as someone who received a “21-year imprisonment for medicating pain” and describing him as having “acted in good faith”. This statement in AAPS’s brief caught my eye:
Most innovative physicians advance medical practice contrary to “generally recognized and accepted” treatments . . .
Yep, like the crank members of the AAPS, who promote antivaccine pseudoscience and HIV/AIDS denialism, blame immigrants for crime and disease, and claim that abortion causes breast cancer. Innovative indeed.
The health care lawyers, in a second Lexology post following oral arguments, opined that
the majority of the justices seemed prepared to adopt a subjective good-faith standard that would protect practitioners from criminal prosecutions if they sincerely and honestly believe their prescriptions were for a legitimate medical purpose and within the usual course of professional practice.
A decision is expected in June.
I am not sure how a physician could “seriously and honestly believe” his prescriptions “were for a legitimate medical purpose” if his belief is not objectively reasonable, that is, within acceptable medical standards. To me, this implies that the physician has no duty to inquire as to what the standard of care is when prescribing. In fact, any attempt to discern the standard of care could undermine his argument that his beliefs were “serious” and “honest”, counseling that he best avoid trying to find out, lest he undermine his own “beliefs”.
In any event, should the convictions of Drs. Ruan and Kahn be overturned and they are retried, I doubt any jury would buy into the notion that they “in good faith” believed what they were doing was legit. At least I hope not.
