the U.S. Supreme Court unanimously overturned lower court decisions in the consolidated cases of Ruan vs. United States and Kahn vs. United States. The two physicians were convicted of prescribing opioid pain medicine “outside the usual course of [medical] treatment” and were sentenced to prison.
The jury in Ruan was not instructed to consider Dr. Xiulu Ruan’s “good‐faith defense,” i.e., that he was indeed prescribing the drug “legitimately” to treat pain based upon his good‐faith assessments of his patients’ medical contexts and requirements…The Supreme Court held “the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”….There are always robust debates among clinicians regarding the proper and rational treatment of a host of conditions, from high blood pressure to diabetes to acute and chronic pain—and that patients and their clinical contexts vary—that there is no ONE RIGHT WAY to treat a wide range of medical conditions, treatment must be individualized, and clinicians must remain open to modifications and adjustments along the way. In Ruan vs. United States, the government failed to consider this.
Prescribing medications in an unusual manner, or a manner that falls outside the mainstream, might be a “standard of care” or malpractice issue, but should not be automatically considered a criminal issue. Approximately 20 percent of medications approved by the Food and Drug Administration (FDA) are legally prescribed “off‐label,” i.e., for different purposes than those for which the FDA approved them. The originators of off‐label uses fall outside the mainstream of prescribers, but they are not treated as criminals. And many off‐label uses are later approved by the FDA. This is one of the ways clinical medical science advances.
The lower court convictions of Drs. Ruan and Kahn treated what, at worst, could have been medical malpractice or standard of care violations as criminal matters. This amounted to, in effect, cops practicing medicine. Cases and convictions like these have sent chills up the spines of other health care practitioners who are trying to help their patients in pain, causing many pain patients to be under‐treated or, worse, abandoned.
Today’s Supreme Court decision was a victory for the “good faith” defense. But it was also a victory for physician autonomy, the patient‐doctor relationship, and patients in pain.
Singer filed an amicus brief in support of the doctors challenging their convictions, in a brief joined by the Association of American Physicians and Surgeons (AAPS). That brief addressed the medical issues. He also assisted in a brief addressing the legal issues, found at this link.