Opioid Pill Peddling Case Threatens Future of Pain Treatment

March 29, 2022, 9:15 AM UTC

Doctors are increasingly reluctant to prescribe opioids for pain treatment amid soaring addiction rates and fear of liability as two physicians face allegations of pill peddling in a case before the Supreme Court, policy experts say.

Xiulu Ruan and Shakeel Kahn are facing over two decades of prison time for allegedly operating like drug dealers with opioid prescriptions. Their fate hinges on how far the justices believe the government should go in proving a doctor’s criminal intent—a thorny issue at the divide between substance use disorder and the need to treat pain.

A Supreme Court decision is expected in the next several months. Nearly a dozen physician, treatment, and legal advocacy groups have filed briefs backing at least one of the doctors, warning the justices of a medical climate where doctors neglect appropriate pain treatment in fear of incarceration and other severe punishment.

Lawyers and medical experts likewise say the case contributes to a years-long unease around opioid pain treatment in the medical community, where strict policies around record keeping and dosage paint both doctor and patient as potentially untrustworthy.

That mood could exacerbate addiction and other issues attached to drug use, and the outcome at the Supreme Court could impact whether people desperate for pain treatment turn to doctors or drug dealers.

“If we are closing our doors to patients who have been on long-term opioids or need opioids for their pain, then we’re essentially asking our patients to find pain relief outside of the medical system,” said Pooja Lagisetty, a physician investigator at the University of Michigan. “We’re essentially asking them to go into an unregulated system that could be more harmful.”

Even if incarceration only threatens “a small minority of egregious pill pushers, the fear of it happening to somebody that is appropriately prescribing is still there,” she added.

Doctors on Alert

Ruan’s legal woes stem back to a 2016, when a grand jury indicted the Alabama physician on charges that included the unlawful distribution of controlled substances.

From there, prosecutors teed up a conviction “based on mere negligence,” Ruan’s legal team told the Supreme Court, an outcome largely upheld by the U.S. Court of Appeals for the Eleventh Circuit.

That outcome was “truly outrageous,” said Jane Orient, a physician and executive director of the Association of American Physicians and Surgeons.

“Any doctors aware of what happened to Dr. Ruan will say, ‘hey, I’m not touching these controlled substances,” Orient told Bloomberg Law. AAPS also filed a Supreme Court brief calling Ruan’s 21-year sentence “tyrannical.”

Meanwhile, the U.S. government told the justices that Ruan and another doctor “enriched themselves through a long-running scheme of unlawfully issuing prescriptions for addictive and potent controlled substances, in response to their own financial incentives rather than the legitimate medical needs of their patients.”

Kahn, the other physician whose case is with the Supreme Court, was previously cleared after two investigations by the Arizona Medical board before his prescription practices spurred a lawsuit.

In February 2021, the U.S. Court of Appeals for the Tenth Circuit affirmed Kahn’s conviction over prescriptions filled for cash or “personal property, including firearms” and priced along the lines of street drugs.

Kahn’s legal team, however, argued that the physician was unaware patients were selling or abusing their medication, and that he was unaware he’d written prescriptions beyond the scope of professional norms.

But the government argued that the doctor “performed only a perfunctory examination—or no examination at all—before prescribing controlled substances” and “falsified notes in medical charts.”

‘Scapegoats’

For the past 20 years, health-care attorney Harry Nelson has represented numerous doctors prosecuted by their state medical boards for pain treatment.

During that time, he said he’s witnessed physicians being “bullied for prescribing,” due to “constantly changing standard of care for opioid prescriptions, and more aggressive prosecution of doctors,” a group that “became an easy scapegoat for the opioid crisis.”

There’s “inherent suspicion of any doctor prescribing above minimum levels,” despite patient need and the severity of their pain, or prescribing fentanyl, an opioid increasingly found in overdoses from street drugs, he said.

Overdoses as a whole have been climbing in recent years, particularly during the Covid-19 pandemic. Estimated annual overdose deaths topped 100,000 in the 12-month period ending in April 2021, the Centers for Disease Control and Prevention said. That’s up from about 48,000 in the 12-month period ending in January 2015.

In 2008 and 2009, Nelson said there was “a huge uptick in the severity of enforcement” against alleged actors in America’s addiction crisis, noting that the same happened in 2012. However, “it’s never been worse than it is today.”

Registered professionals are exempt from the Controlled Substances Act if they prescribe drugs for legitimate medical purposes in the regular course of practice.

For the Supreme Court, Ruan and Kahn’s cases, consolidated before the high court, provide the opportunity to address what the government needs to prove to show criminal intent. In the Justice Department’s view, it should be an objective standard rather than an individual doctor’s whim.

As of now, “the number of doctors prescribing has gone down dramatically, and the kind of patients they’ll prescribe for” like those suffering long-term or catastrophic pain and workplace injuries has “reallly shrunk,” Nelson said.

“The vast majority of doctors have opted out entirely,” while others prescribe “very limited doses,” he said. And for some pain patients, when it comes to treating pain, There’s really no great alternative.”

Tough Balance

A declining willingness among doctors to work in opioids bears out in research.

In a 2019 report published in JAMA Network, researchers found that around 40% of Michigan primary care clinics contacted said their practitioners wouldn’t take new patients getting opioid therapy for pain purposes. Findings suggest that the drop in access to care could push patients to illicit substances.

Lagisetty is one of those researchers. A specialist in addiction medicine and care, she said that many of “her colleagues hesitate” to prescribe opioids, some from fear of sanctions, while others are wary of actions from the U.S. Drug Enforcement Administration.

Ryan Hampton, an advocate and author, attributes being “abruptly cut off by a doctor” as driving his own battle with addiction.

“Within 10 minutes literally, I was using heroin,” Hampton said.

A self-described “victim of pill mills for many years,” Hampton lays the blame for threatened doctors and lower access to treatment with the government for ever-changing federal prescription guidelines, which ignore that while “some people need little to no opioids, others need more, and doctors need to have the ability to make the determinations of what’s best.”

“It’s a delicate balance—the courts need to find the right medium between holding unscrupulous doctors accountable while not harming patients who rely on opioids for chronic pain management,” Hampton said.

And while health and policy experts note that Ruan and Kahn’s cases are one among a trend that complicate matters, they note the justices’ decision will have an impact.

“It’s incredibly important that they get us right,” Hampton said. “What they determine in this case will be a standard to be used for decades to come.”

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

To contact the editors responsible for this story: Karl Hardy at khardy@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com

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