After six weeks of testimony and calling 81 witnesses, the fate of Dr. John Patrick Couch and Dr. Xiulu Ruan is in the hands of jury that will decide whether the Mobile pain doctors ran a legitimate medical practice or a criminal enterprise.
Co-owners of Physicians Pain Specialists of Alabama (PPSA) and C&R Pharmacy, Ruan and Couch face a combined 22 federal charges ranging from conspiracy to distribute controlled substances, health care fraud, violating anti-kickback statutes and several others.
In closing arguments last week, prosecutors accused the doctors of putting their financial interests ahead of patient care. By running their practice as a “money mill,” Assistant U.S. Attorney Deborah Griffin said the accomplished doctors had become “drug dealers with a pen,”
“This was not your standard pill mill where somebody comes in the back door and pays $100 for oxycontin. This was big time,” Assistant U.S. Attorney Chris Bodnar said. “Why try and get $150 when you can prescribe $18,000-a-month [drugs] and have someone’s insurance pay for it?”
Attorneys for Couch and Ruan said the allegations were the product of “speculation” and “cynicism,” accusing the government of inserting itself into the decisions doctors make when treating their patients. Couch’s attorney, Jeffrey Doss, said the case focused on the number of prescriptions when it should have been about the “medical judgment” behind them.
“[Dr. Couch] was cross-examined for more than an hour and never once did the government ask him about a single decision related to the prescriptions he wrote,” Doss said. “They had every opportunity to ask ask about his medical judgment, but they chose not to because there’s no evidence Dr. Couch ever intended to do anything other than help his patients.”
One undisputed fact is that Ruan and Couch prescribed a lot of controlled medications, which was evident in data from Alabama’s Prescription Drug Monitoring Program (PDMP). The duo wrote more than 300,000 prescriptions for controlled substances from 2011 to 2015, including a combined 223 grams of the powerful opiate fentanyl in drugs like Subsys (manufactured by Insys Therapeutics) and Abstral (by Galena Biopharma).
Ruan and Couch were once among the nation’s leading prescribers of Subsys and Abstral at times when prosecutors say they had financial interests in the companies making those drugs — collecting speaking fees from Insys and owning stock in Galena Biopharma.
The defense, however, called Ruan and Couch leaders in their field who used the relatively new drugs because they were “highly effective.” They also said the doctors never allowed their medical judgment to be compromised by any personal financial interest.
The prosecution has also focused on testimony from former employees who claimed PPSA routinely used improper billing practices and issued pre-signed and sometimes forged prescriptions bearing Ruan or Couch’s name. It is worth noting that at least some of those witnesses accepted plea deals requiring their cooperation in the government’s case.
When Ruan and Couch took the stand themselves, both doctors said they weren’t aware of those kind of practices and that any pre-signed prescriptions found at PPSA would have been left with a “trusted nurse practitioner” to use “in case of an emergency.”
In his closing statements, Doss put the blame on PPSA employees themselves, saying that even if Couch had shown “negligence” or “carelessness,” it would take “knowing or intentional conduct” to prove he violated the law.
“No organization, small or large, ever operates without a hiccup,” Doss continued. “Were there charting mistakes? Yes. Where there problem employees? Sure. Maybe there were even billing mistakes, but the law — and you should be thankful for this — does not demand perfection.”
In most of the charges, jurors will have to decide whether Ruan and Couch were writing unlawful prescriptions, which the law defines as any prescription written without “a legitimate medical purpose” or “outside the usual course of professional practice.”
Because that definition leaves room for interpretation, both sides have heavily relied on testimony from expert witnesses in the medical field. Attorney Dennis Knizley, who has represented Ruan, used his closing argument to attack the credibility of the prosecution’s experts and specifically the testimony of Dr. David Greenberg.
While Greenberg said some of the practices at PPSA were “way outside the practice of legitimate medicine,” Knizley claimed Greenberg’s testimony had a number of mistakes, including a claim that PPSA had never used the PDMP, when it had been accessed over 10,000 times.
“Your government cannot bring that type of person up here and ask a jury of its citizens to rely upon something like that to make the serious determination you’re going to have to make,” he said. “That’s $58,000 of your tax money, and he’s gotten $325,000 of your tax money over the years. You need your money back.”
However, the prosecution also tried to cast a shadow over some of the experts that testified for the defense, including two that testified to having a previous relationship with Ruan.
Dr. Christopher G. Gharibo, who has co-edited an industry publication with Ruan, acknowledged the two had exchanged emails on a number of topics, while another witness, Dr. Jeffrey Gudin, said he helped Ruan’s daughter get an internship. Gutin has has also received thousands of dollars from Insys, one of the drug companies accused of giving illegal kickbacks to Ruan.
“There are a lot of doctors in this country they could have brought in to give you information on whether Dr. Raun and his prescribing patterns were inside the usual course of professional practice,” Bodnard said. [The defense] had the opportunity to bring in a neutral third party like the United States did, and instead they chose to bring in two of Dr. Ruan’s buddies.”
A verdict is expected later this week, and if convicted of all or even most of the counts against them, Ruan and Couch could potentially face significant prison time, the loss of their medical licenses and large fines.
But no matter what the jury decides, it will likely have implications beyond Mobile because of the case’s ties to a number of other federal charges brought against former Insys top executives last December.