Bye Bye "Good Faith": 6th Circuit Erodes Medical Decision Making in Opioid Prosecutions
Ronald W. Chapman @RonChapmanAtty is a healthcare fraud defense attorney specializing in representing healthcare providers facing federal white collar crime allegations. He has successfully represented a significant number of physicians to acquittal on unlawful prescribing and healthcare fraud allegations and investigation dismissals. He is a highly regarded expert in the field and regularly speaks and writes nationally on the topic. What is the fate of a well intended physician who practices "in Good faith" but fails to conform to shifting standards of medical practice? This is the question posed in United States v. Godofsky, 943 F.3d 1011 (2919) wherein the 6th Circuit Court of Appeals effectively tanked the "good faith" standard for prescribing narcotics. While this decision quietly slipped into physician drug trafficking jurisprudence, it has now been frequently cited by prosecutors to support further erosion of medical judgment in favor of shifting Government narratives as to the appropriateness of prescribing narcotics. This coupled with the American Medical Association's new disgust with the CDC guidelines, a tool wielded by Federal Prosecutors to supplant medical judgment, leaves us with the feeling that the appropriate standard of conduct for a physician is "whatever the government says it is, when it says it is, subject to change without notice". The good faith standard explained In opioid prescribing cases in the 6th Circuit, physicians who have the benefit of knowledgeable criminal defense counsel avail themselves of the "good faith" defense. This defense is codified in the 6th Circuit case United States v. Volkman where the 6th Circuit upheld a jury instruction that stated: It is the theory of the defense that Dr. X treated his patients in good faith. If a physician dispenses a drug in good faith in the course of medically treating a patient, then the doctor has dispensed the drug for a legitimate medical purpose in the usual course of accepted medical practice. That is, he has dispensed the drug lawfully. This "good faith" standard has been utilized to protect the well intended physician who unknowingly prescribes to a patient who is seeking a controlled substance "for other than a legitimate medical purpose and outside the course of professional practice" . If a physician was honestly exercising his professional judgment but was mistaken or even flat wrong, he or she can escape jail and prosecution. Put another way, if a physician's conduct did not conform to the (now hotly contested) CDC guidelines but they were honestly treating a patient's legitimate pain, they could be free from conviction. In another death blow to physician judgment, the 6th Circuit has determined that the subjective intent of a physician is not relevant and that physicians' actions must conform to the "reasonable physician standard" in order to be considered lawful. United States v. Godofsky Dr. Godofsky what charged along with several other defendants of running a "pill mill" called the Central Kentucky Bariatric and Pain Management clinic located in Georgetown, Kentucky. Dr. Godofsky worked there and prescribed pain medication to patients. The 6th Circuit opinion, like most in this area of law, spilled a lot of ink on the layout of the clinic, its staff, numbers of patients, and the overall feeling of the clinic but made no mention of the quality of patient care received by patients there. The opinion claims that the clinic did not accept medical insurance, had an armed guard at the door and the manager patrolled the premises with a German Shepard. The opinion did not discuss the illnesses of the patients, imaging studies, results of diagnostic testing and compliance protocols. The 6th Circuit opinion proclaimed that during his ten months at the clinic, Godofsky worked about 120 days and wrote nearly 6,000 prescriptions for over 552,000 dosage units as if the volume and quantity of an opioid prescription had something to do with its legitimacy. Moreover, the opinion claims that Dr. Godofsky received $200,000 during the time he worked there as if the amount of money a physician makes is a relevant factor in the legitimacy of a particular prescription. Dr. Godofsky's attorney argued vehemently for the instruction quoted above but was rejected by the trial judge in favor of a simple instruction stating that a physician must knowingly and intentionally prescribe for other than a legitimate medical purpose outside the course of professional practice in order to be convicted. Dr. Godofsky was convicted of drug trafficking and sentenced, his attorney appealed the instruction as given. In rejecting his appeal the 6th Circuit rejected the Volkman instruction sought by Dr. Godofsky's attorney because it could arguably be used to support the theory that a jury must acquit a doctor if they acted with "good intentions in accordance with what he believed to be proper medical practice" even if such beliefs were in violation of the law. The 6th Circuit opines: "a licensed professional has an obligation to know and comply with the regulations associated with his field he can't just say well I did what I thought was best, he must do what he knows or believes complies with the rules and regulations". The obvious and most dangerous part of the 6th Circuit's position is that there are no common "rules and regulations" that clearly define permissible conduct for those that practice the science and art of medicine. Even the CDC guidelines, a frequent tool of prosecutors, is being walked back and distanced due to its dangerous impact on patient care. The Court now appears to hold an "objective good faith" standard requiring physicians to conform to the conduct of a "reasonable doctor under the circumstances". The Court stated: "this is more or less objective good faith: whether a reasonable doctor under the circumstances could have believed, albeit mistakenly, that he had acted within the scope of ordinary professional practice for a legitimate medical purpose." The Court's "objective good faith standard" dangerously mirrors the medical malpractice standard and appears to subject 6th Circuit physicians to criminal penalties - up to and including life in jail - for mere acts of negligence or incompetence. A standard that subjects doctors to prosecution for mere acts of negligence is a dangerous precedent that erodes the practice of medicine, patient care, and the autonomy of a physician to treat his patients limited only by his professional judgment and medical ethics.