Thinking Aloud: The Ruan Case

First, SCOTUS found that the trial judge had erred in not instructing the jury that the prosecutor had to show evidence of intent to “knowingly or intentionally” dispense controlled substances. Last bit of law,  

“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.  An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. § 829) and the person knowingly filling such a  purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” [emphasis added]

I agree with SCOTUS that in the case of criminal prosecution, it was essential to demonstrate intent. My real problem, as in the quote’s emphasis, is the question of professional conduct. While physicians should be glad prosecutors must demonstrate unlawful intent in a criminal charge, these doctors are not to be held up as paragons of care. I am at a loss to see how they provided professional treatment, which is a civil matter and would be a case brought by a state’s medical board.

Consider a few facts from the prosecutorial brief submitted to the Supreme Court. All of these are direct quotations.

• [Dr. Ruan and his partner, Dr. Couch] jointly owned and operated a medical clinic and a connected pharmacy... The pharmacy’s sole business was dispensing drugs prescribed at petitioners’ clinic. …Between January 2011 and May 2015, each petitioner made more than $3.7 million from the clinic and more than $550,000 in prescription service fees from the pharmacy.
• Over that same four-year period, [Dr. Ruan and Dr. Couch] wrote nearly 300,000 prescriptions for controlled substances, the majority of which were Schedule II drugs … the clinic’s pharmacy, was the top purchaser in the State of Alabama of oxycodone from 2011-2015; of morphine from 2011-2015; and of fentanyl from 2012-2014). In particular, [Dr. Ruan and Dr. Couch] were among the top prescribers nationwide of a potent and expensive version of fentanyl called transmucosal immediate-release fentanyl (TIRF)
• … between November 2013 and January 2014, petitioners purchased more than $1.3 million of stock in Galena Biopharma, the owner and manufacturer of a TIRF drug marketed as “Abstral.”  …Around the same time, petitioners massively increased their prescriptions of Abstral, … Petitioners became so important to Galena’s bottom line that the company fired its CEO at their request, and the new CEO made a trip to Mobile to meet with petitioners in person. …“national Abstral sales dropped significantly” when petitioners’ clinic was shuttered in May 2015.
• Petitioners’ prescription practices also put them in position to collect substantial speaking fees from Insys, the manufacturer of a different TIRF drug marketed as “Subsys.” … Petitioners were paid to host weekly programs promoting Subsys, even though no new prospective prescribers attended those programs. … [Dr. Ruan and Dr. Couch] clinic ranked among the top ten prescribers of Subsys
• …the Drug Enforcement Administration (DEA) launched an investigation in 2014.  …  As part of that investigation, an undercover DEA agent acted as a patient seeking controlled substances from petitioners’ clinic. … Clinic staff did not ask the undercover agent about his pain levels, and the agent told clinic employees that he had previously been self- medicating with oxycodone that he had purchased on the street. …Nevertheless, petitioner Couch signed a 90-pill prescription for Roxicodone, a Schedule II controlled substance, after appearing for less than one minute of the agent’s initial office visit. ...  On several subsequent occasions, the under-cover agent obtained additional prescriptions for oxycodone, sometimes with an increased number of pills, without seeing either [Dr. Ruan and Dr. Couch] …Those prescriptions appeared to have been pre-dated and signed by petitioner Couch.  Although the undercover agent was seen by other medical practitioners at the clinic during those visits, none of those practitioners was authorized to prescribe Schedule II controlled substances like oxycodone.

Perhaps I am wrong, I have certainly been wrong in the past, but this doesn’t seem like entirely ethical practice. It appears that there is any number of financial conflicts of interest, including this from the DOJ’s statement at the end of the original trial.

“…the defendants also had a worker’s compensation dispensary, from which they directly dispensed Controlled Substances.  The jury heard evidence that Dr. Ruan and Dr. Couch received guaranteed monthly kickbacks from a dispensary management company — Industrial Pharmaceuticals Management (“IPM”) and later Comprehensive Rx (“CRX”) — in exchange for the defendants dispensing certain drugs with high reimbursement rates.   These guaranteed amounts reached $80,000.00 per month for Dr. Ruan and $20,000.00 per month for Dr. Couch.  The millions paid in kickbacks to the defendants associated with the worker’s compensation dispensary went into private bank accounts set up by the defendants.”

And the care may have left something to be desired. Again, from the DOJ statement:

“While there were some patients who received legitimate medical care at PPSA, the jury heard evidence that many patients rarely saw either of the doctors, and that the nurse practitioners who treated Dr. Couch’s patients were abusing drugs at the work place and then seeing patients.   In addition, the jury heard evidence that Dr. Couch knowingly permitted one of his nurse practitioners, Justin Palmer, to forge Dr. Couch’s name on prescriptions for Controlled Substances.  Palmer testified that he forged Dr. Couch’s name approximately 25,000 times while working at PPSA.”

It seems clear to me, and evidently to the Supreme Court that there was prosecutorial overreach in this case – a criminal case may well be made if any of the bullet points and quotations I have presented are signs of intent to violate the law. It seems equally clear to me that these are not standard medical practices, certainly not ones I was taught. There should be no victory lap for these physicians. In my view, they should have their licenses pulled, not because they prescribe opioids outside some guidelines, but because they are not ethical members of the physician community.