It’s been more than a year and half since two prominent pain doctors in Mobile were indicted in an alleged conspiracy to recklessly distribute a plethora of controlled medications, but only recently have criminal cases in other states shed light on why it’s taken that long to have their day in court.

The trial of Dr. John Patrick Couch and Dr. Xiulu Ruan began last week in the midst of a continuing nationwide pushback against opioid abuse and addiction that a number of federal agencies are calling “an epidemic.”

An opioid is any “opium-like” substance that binds to the opioid receptors in the human brain, which includes heroin but also substances like hydrocodone, oxycodone and morphine found in prescription painkillers.

In the face of a death toll that’s increased 30 percent over the past decade, federal law enforcement officials across the United States have made the prosecution of drug traffickers and medical professionals who improperly prescribe opioids a top priority.

That effort created “Operation Pillution” in 2015, a Drug Enforcement Administration effort specifically targeting prescription drug abuse in the South. When DEA agents raided two Physicians Pain Specialists of Alabama (PPSA) locations in Mobile, which Couch and Ruan co-owned, they also hit other pain clinics and pharmacies in Arkansas, Alabama, Louisiana and Mississippi.

Couch and Ruan’s indictments also followed a successful case against Dr. Joseph Mwau N’dolo of Fairhope, who was accused of writing improper prescriptions for painkillers, sometimes in exchange for sexual favors from patients. N’dolo was convicted and sentenced to two years in federal prison in late 2014.

However, one of the things that sets the accusations against Couch and Ruan apart from other alleged “pill mill” busts is the sheer amount of controlled medications the doctors are alleged to have prescribed.

“Together they wrote over 300,000 prescriptions for controlled substances between Jan. 1, 2011, and May 20, 2015,” Assistant U.S. Attorney Christopher J. Bodnar said in his opening remarks last week. “This was not a pill mill in a traditional sense. PPSA was not cash only; they required referrals from another doctor and they took insurance … This was a money mill.”

The case
In addition to the PPSA locations in Mobile, located on Springhill Avenue and Airport Boulevard, Ruan and Couch also co-owned and operated the C&R Pharmacy. In May 2015, both doctors were indicted on conspiracy charges for illegally prescribing controlled prescriptions and for alleged health care fraud. Later, 17 additional charges were added in a superseding indictment accusing the pair of engaging in mail fraud, racketeering and receiving kickbacks from pharmaceutical companies.

A second superseding indictment added what federal prosecutors refer to as “death enhancements,” which connect prescriptions the doctors wrote to the deaths of four patients, but those charges were dropped before the trial started.

“There’s two main questions you need to ask yourself: What did they do, and why did they do it?” Bodnar told the jury. “What did they do? They prescribed controlled substances with no legitimate medical purpose and outside the usual course of professional practice. Why did they do it? For money.”

Those statements were Bodnar’s attempt to simplify a fairly complex case that’s expected to result in an equally complex two-week trial. Couch and Raun wrote numerous prescriptions for Schedule II controlled substances, prescriptions that would be legal if they were written appropriately. Even Bodnar acknowledged both doctors had some legitimate patients that received treatment exactly as they should have.

“There were some patients that had very legitimate pain, and there were definitely some that were treated very appropriately, but that’s not why we’re here,” he added. “We’re here for the times they were prescribing drugs outside of that legitimate course of professional practice.”

However, in his opening statement defense attorney Jack Sharman, who is representing Couch, said his client has always served as a “doctor of last resort,” and by the very nature of his practice would have prescribed a high number of prescription painkillers.

Sharman said the case was going to boil down to three things: “medicine, judgment and decisions.” He told the jury the “government wants to turn a two-way street — a doctor’s judgment and a patient’s decision on what to do with it — into a crime.”

According to Sharman, the prosecution’s description of the volume of prescriptions Ruan and Couch wrote was taken out of context. Specifically referring to Bodnar’s 300,000 figure, Sharman said when divided by the 8,000 patients PPSA had during the time period covered by the indictment, those numbers come out to “about one prescription, per patient, per month.”

Sharman also took issue with the term “pill mill,” which he said was “a lazy term the media uses because it rhymes.” He also said it it doesn’t describe anything close to the businesses in Mobile that Couch and Ruan ran for years.

Unlike pill mills, Sharman said PPSA didn’t demand cash; they required insurance, kept patient records and performed a number of procedures before and in addition to using prescription pain medicine.

He said the defendants handled their billing in “a large, public compliance arena” because their company received reimbursements from the Veterans Administration, Medicare and Blue Cross and Blue Shield of Alabama — all of which “saw exactly what Dr. Couch was doing,” Sharman said.

Ultimately, Sharman said Couch had only “tried too hard to treat too much pain,” telling the jury that the prosecution’s case would only focus on “a few dozen” of PPSA’s “thousands of patients.”

“You’ll hear a lot about the hardships of addiction, but what you don’t hear a lot about are the hardships of living with chronic pain,” he added. “It limits what you can do. It limits productivity, if you’re even able to work. It reduces quality of life, and we also know that it stigmatizes those affected by it.”

Though both defendants have retained a number of attorneys, Ruan is primarily being represented by Dennis Knizley. Like Sharman, Knizley claimed the doctors had run a legitimate business and had gone above and beyond requirements for prescribing controlled substances.

He told jurors that PPSA patients had to be referred from other doctors and undergo an initial examination upon their first visit. Ruan and Couch also required patients receiving opioid painkillers to sign an “opioid agreement” that — among other things — required routine urine analysis to ensure patients were taking the medicine they were supposed to and not using any other drugs.

According to Knizley, Ruan himself has “dropped 238 patients for not following the agreement.”

“Pain management is a delicate balance. It’s difficult to help a patent regain his or her quality of life and keep them from becoming addicted,” Knizley said. “It all comes down to this: Was this a criminal enterprise or the practice of medicine — real doctors, practicing real medicine on real patients.”

Early evidence, testimony
At the time of this publication, Ruan and Couch’s simultaneous trial was already in its fifth day of testimony, though it could be at least another week before the jury is handed the case for deliberation.

The prosecution’s early witnesses have all been federal or state employees, including DEA diversion specialists Susannah Herkert and Michelle Penfold, FBI special agents Eric Lawson and Steve Sorrells and the Alabama Department of Public Health’s state pharmacy director, Nancy Bishop.

Herkert initially walked the jury through background information on the varying strength and regulatory status of opioid medications pertinent to the case — all of which she said were common to those practicing pain management and as well as those “seeking pills.”

During cross examination, defense attorneys asked Herkert how PPSA’s operation compared to other “supposed pill mill” cases she’s seen in her 11-year career with the DEA. In response, Herkert said she’d seen practices that were cash only as well as those that — like PPSA — accept insurance and rely on referrals from other medical professionals.

“I’ve seen somewhere you pay $200 to $600 cash regardless of what you get from a doctor and others where there’s a set price per drug,” Herkert said. “In recent pill mill cases, you have to have a referral. Pill mills have evolved, and now a lot of doctors will write another prescription with a controlled substance to make it look more legitimate.”

Asked about the patients that had been turned away and the medical procedures Couch and Ruan supposedly performed, Herkert said she’d seen both of those practices at other “pill mill cases” as well. The only exception Herkert noted was a NeuroBloc procedure she hasn’t “seen a lot of pill mills offer.”

During their time on the stand, Lawson and Sorrels focused on the physical evidence seized in the 2015 raids of both PPSA facilities. Lawson led an evidence team at the Springhill Avenue location while Sorrels focused on the Airport Boulevard office.

So far, some of the most notable pieces of evidence have been dozens of blank, signed prescriptions found at both PPSA locations showing Couch or Ruan’s signatures. Many of them were predated for days that would have fallen after the raid when they were discovered.

According to Herkert, a prescription signed at any time other than when a doctor meets with the patient receiving a controlled substance would not be considered legitimate or legal by the DEA.

During her testimony, Bishop focused on the Prescription Drug Monitoring Program (PDMP) — a computerized database maintained by the state that tracks controlled prescriptions as well as the patients who receive them and doctors who prescribe them.

Though the PDMP, Bishop helped compile data on a number of painkillers Couch and Ruan frequently prescribed. However, the data that’s most relevant to the racketeering and kickback charges are related to prescriptions for Subsys and Abstral, fentanyl-based drugs that prosecutors have described as “extremely potent” opioids.

Per Herkert’s testimony, fentanyl is the most potent opioid available on the legal market, and as such is closely monitored through a stand-alone program requiring both doctors and patients to register with the DEA. It’s only supposed to be prescribed to “cancer patients who are already on round-the-clock pain drugs,” though it isn’t technically illegal to write “off label” prescriptions for other legitimate medical purposes.

According to Bishop, Ruan and Couch prescribed 68,116 and 45,285 units of fentanyl, respectively, during the time frame of the indictment, making the doctors the number one and number two prescribers of the drug in Alabama. At other points relevant to the indictment, they were the top prescribers of Subsys and Abstral in the entire country.

“It’s like being a hunter, but instead of using a rifle you’re using a missile,” Bodnar said of off-label prescriptions for fentanyl. “They were prescribing extremely potent opioids because they were getting paid, and not in the best interest of their patients.”

Guilty pleas, corporate ties
One of the toughest tasks for the defense in this case will likely be rebutting the testimony of four alleged co-conspirators who have already pleaded guilty in federal court, including former nurse Bridgette Parker and former nurse practitioner Thomas Palmer — both of whom were employed by PPSA.

In December 2015, Parker and Palmer pleaded guilty to “knowingly and willingly” prescribing controlled substances “outside the usual course of professional practice. According to Bodnar, Palmer wrote anywhere from 15,000 to 20,000 prescriptions for controlled substances by illegally forging Couch’s signature.

“Couch rarely came into the office early in the morning or was often out of town on vacation and knew the prescriptions were being forged,” he said. “I don’t believe there was a single employee that didn’t know what was going on.”

However, both the prosecution and defense have acknowledged Palmer’s past struggles with drug abuse, with Bodnar stating that he’d used prescription drugs intravenously on the job and in some cases while seeing patients. That is something the defense has pointed to as a motivation for his forging prescriptions under Couch’s name.

“Justin Palmer forged [Couch’s] signature in large part so he could get drugs for himself,” Sharman said. “Did [Couch] hire some people he shouldn’t have? Absolutely. Were there situations where the paperwork could have been better? Yes, but none of that is evidence of a crime.”

Pharmacist Christopher Manfuso also accepted a plea deal in 2015, where he admitted to paying the doctors more than $2.5 million in kickbacks over a three-year period through his company, Comprehensive RX Management, which managed a state workers compensation dispensary with which PPSA had an exclusive contract.

Like Parker and Palmer, Manfuso is expected to testify for the prosecution later in the trial. The defense attorneys, however, have claimed those witnesses might be willing to “lie on the stand” in order to secure a lesser sentence for themselves.

Ruan and Couch are also accused of buying stock in Galena Biopharma Inc., the former producer of fentanyl-based Abstral, and then intentionally prescribing their products to drive up the value of the investment. Later the C&R Pharmacy also set up a rebate program with Galena that both doctors allegedly profited from.

However, the defense claims the doctors bought the stock in Galena Biopharma “because they thought it was a good company” and that they didn’t have any knowledge the managers of C&R Pharmacy set up a rebate program with the company.

However, the tie that may bind the the doctors to a larger, corporate conspiracy will likely rest heavily on the testimony of Natalie Perhacs, who pleaded guilty to anti-kickback violations in February 2016.

Perhacs claims she was hired as pharmaceutical sales representative by Insys Therapeutics, the makers of another fentanyl-based product, Subsys. In her plea agreement, Perhacs said she was hired as a kickback to Ruan, whom she claims was “romantically interested” in her.

The plea agreement states that nearly all of these prescriptions were written off-label to non-cancer patients and that all were filled at C&R Pharmacy, which then billed federally funded and private health insurance providers more than $572,000.

Last month, Insys saw six of its top executives, including former CEO Michael Babich, indicted for allegedly offering bribes and kickbacks to pain doctors in various states to persuade them to prescribe Subsys. Though Ruan and Couch aren’t named in that indictment, a doctor in Alabama is referred to as having become a paid speaker for Insys, as was Ruan.

Bodnar also stated both doctors were “very important” to Insys and Galena — claiming that top executives from both pharmaceutical companies had traveled from Arizona and Oregon, respectively, to meet the doctors in Mobile.

As for the defense, both lead attorneys have maintained that their clients did nothing wrong and were only tied to those corporations because of the nature of their business, though Sharman has at least briefly acknowledged the recent Insys indictments.

“That company … It’s entirely possible that they broke the law, but the evidence will show that [Dr. Couch] was not a participant in those corporate shenanigans,” Sharman added.

As was stated previously, the trial started on Jan. 5 and is expected to continue at least through the next week. Lagniappe will continue to follow the developments in the courtroom, which will be reported in this publication and daily at lagniappemobile.com.