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Pill Mill Ruling Raises Burden for Opioid Cases Against Doctors

June 30, 2022, 9:25 AM

Doctors prescribing controlled substances can breathe a sigh of relief thanks to a Supreme Court decision in favor of two physicians who had been charged with peddling opioids.

The justices this week upped the burden of proof for prosecutors looking to hold physicians accountable for their role in fueling America’s opioid crisis. The government now has to prove beyond a reasonable doubt that a doctor intended to or knew they were acting in an unauthorized manner when prescribing controlled substances—an outcome attorneys count as a victory for doctors treating pain.

This “completely raises the bar for the government bringing criminal charges against doctors,” said Harry Nelson, a health-care attorney who has represented numerous doctors prosecuted by state medical boards for pain treatment.

The dispute stemmed from charges brought by the Justice Department against Xiulu Ruan and Shakeel Kahn, two doctors accused of operating like drug dealers with opioid prescriptions. The lower courts upheld convictions of the doctors after finding they acted outside of professional norms, a standard legal experts say undermined doctors’ ability to adequately meet the needs of their patients by discounting their professional opinions.

Throughout the opioid crisis, doctors have increasingly faced “the idea of criminalization of physician conduct,” Nelson said, creating “a climate of fear” around prescribing.

Now, attorneys say the Supreme Court has eased constraints on doctors, allowing them to use their best judgment in filling prescriptions for patients.

This decision gives physicians “a day to celebrate,” Nelson said. As they’re “prescribing in good faith,” doctors “don’t have to be worried about criminal prosecution.”

Win for Doctors and Patients

Had the Supreme Court ruled differently, the outcome could have been “devastating,” said Kate Nicholson, executive director of the National Pain Advocacy Center.

“There’s been a chilling effect on pain treatment and pain care in which doctors were either afraid to prescribe or were refusing to see patients who were already on these medications,” Nicholson said.

In the government’s view, Alabama physician Ruan had been running a pill mill before being sentenced to 21 years in jail. Kahn was sentenced to 25 years for allegedly targeting addicts with an enterprise that eventually led to a patient’s death.

The Supreme Court grappled with what the government needs to show to prove a doctor ran afoul of the Controlled Substances Act when dispensing opioids and other drugs. Ruan’s attorneys told the Supreme Court that prosecutors secured their conviction based on negligence. Kahn’s legal team claimed the doctor was unaware patients were abusing or selling their medication.

The high court June 27 vacated the lower court decisions and sent them back for further review.

Justice Stephen Breyer wrote that “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.”

It’s a “‘major win for patients with chronic pain, and also a major win for patients with opioid use disorder as well as a whole range of conditions for which the medically appropriate care includes controlled substances,” such as ADHD and anxiety, said Kelly Dineen, director of the health law program at Creighton University, who authored a brief in the case.

“There’s a lot of government scrutiny” regarding addiction treatment medicines, Dineen said. Prior to the Supreme Court’s decision, “courts were kind of all over the place” on whether a doctor could be convicted for prescriptions.

“Doctors under this decision will be treated much more fairly, and they can be less concerned,” said Jennifer Oliva, director of the Center for Health & Pharmaceutical Law at Seton Hall Law, who co-authored the brief with Dineen.

“The nature of the medical practice and what we’ve been through here means that doctors will want to watch this play out. I think they’ll be cautious.”

Rejected View

In addition to fears of Justice Department charges for practices once considered routine, providers remained wary of prescribing guidelines from the Centers for Disease Control and Prevention that some considered an obstacle for doctors trying to treat their patients.

Prior to the ruling, in courts “doctors, health care providers, and even pharmacists weren’t allowed to argue that they made a good-faith mistake or that they mistakenly relied on the advice or orders of someone else,” said Sean O’Connell, counsel at Hunton Andrews Kurth LLP.

But now, “the Court specifically rejects the view that doctors are criminally liable if their prescribing is not in accord with current medical standards,” Nicholson said.

In O’Connell’s view, the decision won’t likely mean “a reduction in the amount of heartland prosecutions in the opioid enforcement world—just a revamping of how the DOJ tends to prosecute opioid cases.”

“The facts of a typical DOJ opioid case typically involve egregious facts—such as where a doctor exchanges an opioid prescription for sexual favors or prescribing habits that are mind-blowingly impossible,” he said. Now, the justices are “simply saying that prosecutors must explicitly connect those dots between bad acts and state of mind.”

Patients may find a win in the decision as well.

“We don’t want people to get cold turkey tapered or cut off from a drug they’re dependent on and rely on,” and when “there isn’t even a risk” of pill diversion, Oliva said.

The case is Ruan v. United States, Kahn v. United States, U.S., Nos. 20-1410, 21-5261, 6/27/22.

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com