Controversial Diabetes Clinic Owner to Pay Doc $8M in Damages

The mastermind behind a network of controversial diabetes clinics must pay more than $8 million in damages after a federal judge decided that the treatment protocol he sold to clinic investors was not his to sell.

Gregory Ford Gilbert -- now a disbarred Sacramento attorney and a felon -- along with his companies Trina Health and Bionica Inc., are liable for damages stemming from his patent and copyright infringement, false and misleading advertising, and unfair competition, U.S. District Judge Troy L. Nunley, in the Eastern District of California, ruled this week.

His 53-page decision caps a 2011 lawsuit filed by Thomas Aoki, MD, former chief of endocrinology at the University of California Davis, and a 19-day bench trial that ended in June 2019.

Nunley also set forth a process for ordering a permanent injunction against Gilbert, which would "halt operations of illegitimately licensed clinics" still operating. It is unclear whether any clinics using Gilbert's protocols or versions of them still exist.

Nunley made no formal determination of whether the treatment has any clinical merit, while acknowledging that both Aoki and Gilbert believed that it does.

"Nonetheless," he wrote, "the evidence reflects that a lack of oversight at the clinics licensed by Trina Health resulted in negative patient outcomes in some cases, indicating the public would be better served by the grant of an injunction to halt operations of illegitimately licensed clinics."

Origins of the Dispute

The story of Gilbert's and Aoki's dispute begins more than 30 years ago, after Aoki, then at the Joslin Diabetes Center in Boston, developed a theory and protocol for treating people with diabetes via pulsed insulin infusions, and believed it worked or could work.

He moved to UC Davis in 1984 as he continued to research his diabetes strategy, then offered it through a limited population of CalPERS beneficiaries in his Sacramento lab, the Aoki Diabetes Research Clinic, (ADRC) primarily for people with type 1 diabetes.

Aoki joined up with Gilbert, who acted as his attorney to help with licensing agreements and set up the ADRC. Gilbert signed a confidentiality agreement in 1986, according to Nunley's decision.

Nunley found Gilbert liable for breach of fiduciary duty and breach of confidentiality, in that he "obtained confidential information regarding Dr. Aoki's technology" and "used his position as a fiduciary to garner access to and understanding of Dr. Aoki's technology, which ultimately allowed him to infringe the patents, demonstrating bad-faith."

According to Nunley's decision, Gilbert had in effect copied Aoki's protocol, which Aoki had called Metabolic Activation Therapy (MAT), and rebranded it as Trina's Artificial Pancreas Treatment. Gilbert claimed to investors and many others that he had changed Aoki's protocol to make it better, or that it was his own idea all along.

'Gilbert Stole It'

Aoki's attorney, Duyen Nguyen, summed up the ruling: "Mr. Gilbert stole Dr. Aoki's invention, which Dr. Aoki had been researching and refining for over 30 years, and in the process made a lot of money by falsely representing to others that the treatment would be covered by Medicare when it was not."

The $8 million, she said, will "help to get funding to do a clinical trial so that this treatment in the future would be available to the masses, to people all over the world, so that it becomes mainstream, and so that Medicare recognizes that it should be covered," she said.

As documented in a two-part MedPage Today series (partnered with inewsource.org) in 2018, Gilbert sold dozens of clinic franchises to numerous investors from California to Mississippi and from Montana to Florida on the promise that insurance companies and federal payers would pay claims for weekly Trina sessions, as much as $700 each.

But payer audits and investigations realized that back in 2009, a panel for the Centers for Medicare & Medicaid Services that studied Aoki's MAT protocol -- which it called OIVIT or outpatient IV insulin therapy -- determined it could not find sufficient evidence of benefit and refused to pay for it. Commercial insurers generally follow Medicare's rulings.

Over the last decade, Gilbert enticed clinic owners to pay him franchise fees for his protocols, and sold them infusion chairs and insulin pumps with licenses and training sessions. The clinics incurred significant expenses setting up the clinics, hiring medical staff, getting their own operational licenses, expecting to be compensated by payers after the patients came in droves. For many clinics, Gilbert and Trina Health managed claims paperwork.

Yet even as Medicare and private payers were denying payments and sometimes demanding clawbacks, which Gilbert and Trina Health knew, MedPage Today's investigation discovered that Gilbert continued to market and sell his clinic franchises and protocols to additional investors in other states without telling them the problems other clinics were having.

In the MedPage Today series, nationally renowned endocrinology experts, including some who studied Gilbert's protocol, debunked claims that outpatient pulsed insulin infusions benefited anyone because it has never been properly studied.

John Buse, MD, past president of the board of medicine and science for the American Diabetes Association, looked into the evidence behind the infusions in mid-2016 at the request of a North Carolina businessman who was considering opening a Trina clinic. After spending 10 to 15 hours analyzing about 50 articles Gilbert sent him, and after an hour-long conference call with Gilbert and his team, Buse said this:

"The advice that I gave the businessman from North Carolina ... is that he probably could make money on it, but to me it's sort of -- it was a scam. It's just not backed up by medical evidence that he would meet his objective of helping people with diabetes in North Carolina."

Judge: Gilbert 'Disingenuous'

Gilbert served time in federal prison last year after he pleaded guilty to attempting to bribe an Alabama lawmaker in a scheme to require BlueCross BlueShield of Alabama to pay for the infusions offered at several Trina clinics Gilbert had sold to franchise owners there. The insurance company had stopped paying, pointing to the 2009 Medicare decision, and Gilbert wanted BCBS's denials reversed.

Throughout his decision, Nunley was highly critical of Gilbert's credibility calling him "disingenuous" three times, saying he made "a false representation to the court," and described many of his claims as "not credible," and his testimony "generally confusing and misleading." A magistrate judge issued discovery sanctions against Gilbert totaling $10,355 because he failed to produce documents and comply with discovery orders, Nunley wrote.

"Mr. Gilbert's credibility is undermined by repeated statements he made during trial that were contradicted by his own subsequent statements, his own prior statements, or by witness testimony and other evidence the Court finds more credible than Mr. Gilbert's contradictory evidence," Nunley wrote.

Asked for his response to the decision, Gilbert wrote in an e-mail that the judge's decision "is not a decision" but "these are proposed findings, they are not final and they are in error. Motions will be made to correct errors and a judgment will be rendered in the future."

If the judgment is not in his favor, he continued, he will appeal. "Trina Health disagrees with the decision of the Court and will appeal any claim of wrongdoing," Gilbert said, insisting "there was no evidence of any wrongdoing."

Nguyen scoffed at Gilbert's contention. "This is not a proposed finding of fact," she said. "These are conclusive findings of fact and conclusions of law. They're not proposed. It's definitive."

As to whether Gilbert and his operations have $8 million on hand, Nguyen's co-counsel, Frank Sommers, said he believes that "probably" Gilbert has hidden money away, and hopes to assist Aoki in obtaining what the judge determined Aoki had lost.

Comment