The U.S. Department of Health and Human Services (HHS) declared that the opioid crisis was a public health emergency in 2017. According to the CDC, the total number of fatal drug overdoses has increased from 70,000 people in 2017 to 92,000 people in 2020, and opioids accounted for nearly 75% of deaths in 2020. The HHS estimated that prescription opioids were involved in 40% of opioid-related deaths in 2016, a result of over-prescriptions or misuse of prescriptions.
Ruan v. United States examined an alternative perspective of the opioid epidemic — the protections for doctors prescribing controlled drugs. Doctors prescribing these drugs outside of standard medical procedures should be held responsible, but it is unclear how far ‘standard practice’ extends. This decision helps establish whether acting in ‘good faith’ is protected within standard medical practice.
Facts of the case
The Defendants, Dr. Xiulu Ruan and his partner Dr. John Couch, operated a clinic in Alabama that focuses on the management of chronic pain, prescribing over 475,000 doses of Transmucosal Immediate-Release Fentanyl Medicines between January 2011 and May 2015. Notably, they prescribed at a faster rate than any other prescriber in the United States and to patients whom they had never met — an operation referred to as “pill mills.”
In 2016, the two doctors were tried in the United States District Court for the Southern District of Alabama for violating code § 841 of the Controlled Substances Act stipulating that it is “unlawful for any person to knowingly or intentionally… distribute” controlled substances. It was the duty of the court to decide whether the Defendants were legally responsible for violating the Controlled Substances Act by determining if the defendants had acted against standard medical procedures and if the drugs were administered for legitimate purposes.
The Defendants argued that they acted in good faith, and therefore could not be held as violating the Controlled Substances Act. The District Court and the United States Court of Appeals for the Eleventh Circuit both held that acting in good faith is only a valid defense if the defendant is acting within normal medical procedure. Both courts decided the Defendants were not in accordance with standard practice and found them guilty. The Defendants filed a petition for certiorari, requesting the Supreme Court review the guilty verdict.
Another doctor, Dr. Shakeel Kahn, faced similar charges and decisions, and filed a petition of certiorari to the Supreme Court. Due to the similarity of the two cases, they were consolidated when they were accepted by the Supreme Court on Nov. 5, 2021.
In a 9-0, decision, the Supreme Court overruled the decision made in the lower courts and found that the Defendants were all not guilty. Justice Stephen Breyer authored the majority opinion, claiming that criminal law “seeks to punish conscious wrongdoing.” The Court held that the “knowingly or intentionally” clause applies not to standard medical practice as argued by the prosecution but to the authorization of their conduct. The Court held that applying that clause to a “good-faith effort” would put the burden of proof on the defendant to prove their reasonableness, citing Elonis v. United States as a precedent for the flaws in that practice. Therefore, the United States is required to prove beyond a reasonable doubt that the doctors knowingly acted in an unauthorized manner, not whether they acted in good faith.
In a concurring opinion Justice Samuel Alito, Justices Clarence Thomas, and Amy Coney Barrett cited the predecessor to the Controlled Substances Act, Harrison Narcotics Tax Act. In Linder v. United States, the Court established that a physician acts in accordance with standard practice when they write prescriptions in good faith, and they believe that standard is met in this case.
Amidst the ongoing opioid crisis, the Supreme Court afforded more protections to physicians in prescribing drugs controlled by the Controlled Substances Act. The new standard requires the government to prove that doctors know that they are acting in an unauthorized manner when they write prescriptions, making it much more difficult to prosecute physicians for medical fraud.
Legal protections for doctors are important because they enable doctors to safely prescribe necessary treatments that might otherwise be deemed controversial. Without them, doctors may act more defensively and avoid such treatments, even if it is to the detriment of the patient. In that regard, this decision will have positive ramifications. However, making it safer to write those prescriptions might make “pill mills” more numerous and profitable. Time will tell whether the decision exacerbates the opioid crisis, or if it simply affords increased physician protection.
James Gaspar is from Oak Park, CA, studying Biology and Philosophy with a certificate in Philosophy, Politics, and Economics.