Supreme Court Issues Ruling on Opioid Prescriptions

State of mind is a factor in examining how physicians dispense prescription drugs, according to a new ruling by the U.S. Supreme Court.

On June 27, the court ruled in favor of two physicians serving prison sentences after government prosecution for allegedly overprescribing opioids.

The decision came in the case known as Xiulu Ruan v United States, named for a physician sentenced to 21 years in federal prison “for running a massive pill mill,” according to the U.S. Department of Justice (DOJ). Ruan’s appeal was joined with that Shakeel Khan, who was sentenced to 25 years in prison “for counts including drug distribution resulting in death,” according to DOJ.

Starting in 2017, federal investigators touted the cases as examples of a strong stance against doctors wrongly providing prescriptions, as addiction and deaths spiked due to the continuing opioid epidemic. The Supreme Court ruling did not address that issue, but examined the legality of the physicians’ convictions from separate jury trials.

Ruan and Khan were “both doctors who actively practiced medicine,” with licenses permitting them to prescribe controlled substances. In court, the doctors argued they acted in good faith prescribing the medications, the Supreme Court ruling said.

“In particular, the question concerns the defendant’s state of mind,” the ruling said. “To prove that a doctor’s dispensation of drugs via prescription falls within the statute’s prohibition and outside the authorization exception, is it sufficient for the government to prove that a prescription was in factnot authorized, or must the government prove that the doctor knew or intended that the prescription was unauthorized?”

The justices reviewed court precedents and the legal concept of “mens rea,” translated as “guilty mind,” or the consciousness of wrongdoing.

The court ruling answered: “After a defendant produces evidence that he or she was authorized to dispense controlled substances, 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 justices voted 9-0 on the decision, with Justice Stephen G. Breyer authoring the opinion for Chief Justice John G. Roberts Jr. and Justices Sonia Sotomayor, Elena Kagan, Neil M. Gorsuch and Brett M. Kavanaugh. Justice Samuel A. Alito Jr. filed a concurring opinion with Justices Clarence Thomas and Amy Coney Barrett joining parts of that.

The court vacated earlier appeals court rulings and returned the cases to them for further proceedings.

Advocates respond

The case gained attention for its potential effects on physicians and patients living with chronic pain, according to briefs filed by advocacy groups and published on the Supreme Court’s online docket.

The government has a legitimate interest in deterring misuse of controlled substances, especially in a drug overdose crisis, said the brief filed by the National Pain Advocacy Center (NPAC).

“But a standard for criminal liability that overly deters may cause medical professionals to act against their best medical judgment due to fear of oversight, have a chilling effect on their willingness to care for patients in pain, and even encourage them to engage in self-protective practices that risk the safety and endanger the lives of those in their care,” the NPAC brief said. “Each of these predictable negative outcomes is occurring in pain care today.”

The Association of American Physicians and Surgeons defended Ruan.

“Lengthy incarceration without proving criminal intent is tyrannical,” the AAPS brief said. “A 21-year imprisonment for medicating pain deters all physicians against fully treating patients who suffer.”

The group Physicians Against Abuse blasted government prosecution that it claimed has made the United States the world leader in incarcerating doctors.

Nearly 99% of convictions “boiled down to … a prosecutor with a hunch hiring an expert using the deep pockets of the government, often not even in the same field as the accused physician, to criminalize behavior of the accused physician,” the organization said in its brief. “While this may be acceptable in the context of medical malpractice litigation, it is not acceptable where the consequences are loss of freedom for the accused physician.”

Government details

DOJ announced Ruan’s sentence in May 2017 with that of John Patrick Couch, a physician partner sentenced to 20 years in the alleged scheme that made them some of the nation’s leading prescribers of Subsys and Abstral, two instant-release fentanyl drugs. A judge found Ruan and Couch prescribed illegal opioids equal to 90,000 kilograms of marijuana, that the doctors perjured themselves, and they used “special skills to carry out their criminal enterprise,” in Mobile, Alabama.

They were ordered to repay more than $11.61 million to Medicare and insurance companies, according to DOJ. “Following their convictions, the defendants agreed to forfeit to the United States several houses, beach condos, and bank accounts, as well as 23 luxury cars, including multiple Bentleys, Lamborghinis, Mercedes, and Ferraris,” and each agreed to an additional $5 million judgment, according to DOJ.

Khan, based in Casper, Wyoming, “purported to be a pain management physician,” but “targeted vulnerable addicts as customers” that paid as much as $4,000 a month for their prescription opioids, according to the DOJ announcement of August 2019.

“The patients who received the medications often had no visible source of income that would allow them to afford the prescriptions – other than what they were earning re-selling the drugs on the street,” the DOJ announcement said. “Tragically, at least one patient, Jessica Burch, died as a result of an overdose of medications received from Shakeel Kahn’s practice.”

Originally published on our sister brand, Medical Economics.