United States Supreme Court Weighs in On Defending Doctors Who Prescribe Opioid Medications

07.08.22

On June 27, 2022, the Supreme Court issued its opinion in Ruan v. United States, overturning the separate convictions of two doctors under the Federal Controlled Substances Act, 21 U.S.C. 841 (the “Act”). The Act provides that it is a federal crime for any person “knowingly or intentionally” to dispense a controlled substance such as opioids, except as authorized under 21 CFR Section 1306.04(a), which permits registered doctors to dispense prescribed controlled substances issued for a “legitimate medical purpose.”

At trial, lawyers for the doctors had argued that the defendants should not have been convicted since they were registered and authorized to prescribe such drugs, and that they should have been able to make a good faith defense, i.e., that they were prescribing within professional norms in an effort to meet the needs of their patients.

The Department of Justice argued in its prosecution that the doctors could not make this defense since their prescribing patterns were so far out of bounds as to clearly not be for a legitimate medical purpose, and that the claim of the prescribers as to intent was irrelevant. The government’s position was that there was no necessity to prove intent as a separate element because the prescribing habits were outside the bounds of what it found to be legitimate. The trial court rejected the doctors’ proffered defense, accepting the DOJ’s argument that intent was irrelevant and did not have to be proven as an element of the prosecution, resulting in conviction of each doctor in separate trials.

Both convictions were upheld on appeal prior to seeking relief from the U.S. Supreme Court, with the central issue being the intent of the doctors to violate the Act through their prescribing practices.

Justice Breyer, writing for the Court, overruled the earlier decisions and sided with the doctors, finding that intent to violate objective standards of practice had to be proven beyond a reasonable doubt; that the DOJ had to prove that the doctors acted “knowingly and intentionally” to violate the statute and the norms of medical practice, and that the doctors should have been able to make their defense regarding good faith and lack of intent to violate the statute.

Writing for the Court, which was 9-0 as to the result, he stated,

“After a defendant produces evidence that he or she was authorized . . . the Government must prove beyond a reasonable doubt that the Defendant knew that he or she was acting in an unauthorized manner, or intended to do so. “

The good faith of the doctors was an appropriate defense to the prosecution.

The Ruan opinion has significant ramifications for physicians who practice both in internal medicine and as pain specialists. Many internists/family practice doctors are fearful to prescribe opioids to their patients in the current prosecutorial environment and only refer patients to pain specialists, who are likewise fearful that their prescribing standards might be questioned and result in an adverse licensure action or even a criminal prosecution. The Supreme Court’s ruling provides guidance to physicians who appropriately prescribe opioid medications as well as to attorneys who defend allegations of improper distribution of these drugs.

The Health Care attorneys at Aronberg Goldgehn have significant experience in the defense of doctors regarding appropriate opioid prescriptions, as well as other issues before the Illinois Department of Financial and Professional Regulation, and have also defended state and federal investigations into such matters. This Supreme Court opinion provides attorneys new and additional tools for internal investigations into prescribing practices (to ensure proper and appropriate prescribing norms are being followed), as well as for responding to investigation initiated by state and federal regulators.