On June 27, 2022, the Supreme Court of the United States ruled that physicians who act in subjective good faith when prescribing controlled substances to their patients are shielded from criminal liability under the Controlled Substances Act (CSA).  This decision will make it much more difficult for prosecutors to convict medical professionals under the CSA and could have wide-ranging implications in related enforcement proceedings.

As background, the CSA places all substances which were in some manner regulated under existing federal law into one of five schedules.  This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability.  The CSA also provides a mechanism for substances to be controlled (added to or transferred between schedules) or decontrolled (removed from control).  Relevant to this decision, the CSA can be used to prosecute healthcare providers, including doctors, physicians, physician’s assistants, registered nurses and pharmacists who aim to sell controlled substances to drug abusers for profit. While these so called “pill mills” do exist, oftentimes federal prosecutors end up charging legitimate doctors who are merely trying to help their patients, or doctors who engage in unconventional treatment in good faith. A common scenario is when physicians prescribe what prosecutors view as an unusually high quantities of pain medication to a patient. However, potentially unbeknownst to the prosecutors, the patient had developed a high level of tolerance to the medication, which medically warrants the physician’s prescriptions. Interestingly, the testimony of other medical professionals will play a key role in determining what is and is not accepted medical practice with respect to the CSA, considering the CSA itself leaves a lot of room for ambiguity.

In its recent decision, the Supreme Court opined that doctors who honestly and sincerely believe, even if mistakenly, that their prescriptions are within the usual course of professional practice, are not criminally liable under the CSA.  The determining factor in this decision was the Court’s consideration of what state of mind the Government must prove to obtain a conviction under the CSA. The Government argued for an objective, good-faith standard based on a hypothetical “reasonable” doctor.  The doctors argued for a subjective good-faith standard. The Court expanded significantly further and ultimately decided that the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner, and that to implement a “reasonable doctor” standard   would reduce culpability to a level of negligence, something the Court has long been reluctant to do with respect to criminal statutes. Said differently, it is much more difficult for the prosecution to prove that a defendant knowingly or intentionally acted in a certain way, as opposed to proving a physician acted negligently.

This decision will have major implications for the investigation and prosecution of medical practitioners and pain clinics as it severely reduces the level of culpability required to be convicted of such a crime. If you or your practice are being investigated in any capacity, either by the Department of Health and its respective medical boards or alternatively by federal prosecutors for a controlled substance offense, please call the highly experienced attorneys of Nicholson & Eastin, LLP. We would be happy to assist you in navigating the current and evolving state of the law.