The doctors behind the Drug Opiate & Recovery Networksay they thought they were doing everything right.
The operators of the Carmel-based clinic had regular conversations with the Drug Enforcement Administration.
They monitored the addicted patients they treatedto ensure that they did not misuse the legal medication the clinic prescribed to curb their cravings for drugs.
But in July 2014, Carmelpolice and DEA agents arrested all the doctors and staffin a high-profile raid of the clinic.
Authorities characterized the clinic as a “pill mill” doling out Suboxone, a medicine used to treat patients addicted to opiates such asprescription pain pills and heroin. At a news conference the same day, the Carmel Drug Task Force head called the clinic’s owner “the Pablo Escobar of Suboxone.”
Two years later, however, the drug-dealing charges against the doctors and staff have been dropped. Now,the clinic doctors and staff are suing the city of Carmel, the DEA and two individuals involved with the investigation, saying false accusations besmirched theirreputations. The lawsuit asks for compensatory and punitive damages and requests a jury trial.
“For reasons unknown to us, they destroyed the lives of 12 people that were actively trying to fight this disease, and they threw all the patients who were actively fighting addiction to the curb,” said clinic founder Dr. Larry Leyin an interview with IndyStarin his attorney’s office.
Ley was cleared of all charges in August after an eight-day bench trial in Hamilton County Superior Court. All other charges against him in other counties where he ran clinicswere recently dropped.
Another doctor who worked at the facility said he, too, cannot fathom why the clinic became the target of an investigation.
“That has been the most frustrating — not knowing what we did wrong. … We were helping people,” Dr. George Agapios said. “It doesn’t make any sense. The only thing I can think about it was that it was a political decision. This was not a rogue clinic.”
The city, the lawsuitfiled in U.S District Courtcontends, wanted to avoid a visible marker of drug addiction in affluent Carmel.
Carmel City officials declined to comment on the lawsuit, saying their policy is to not speak about pending litigation.
Officials with the U.S. Drug Enforcement Administration did not respond to requests for comment.
The 91-page probable cause affidavit released in July 2014 painted a lurid picture of operations in the Carmel clinic at23 E.Main St.and four satellite offices that Ley ran. The affidavit described long lines of patients coming to the sites who would just be handed prescriptions, often without ever seeing a doctor.
Two pain specialists quoted in the affidavit said that several aspects of the operation raised concern.The clinics, for instance, did not take insurance andsawlarge numbers of patients in short windows of time. The affidavit also quoted anonymous patient reviews found on Internet sites that accused Ley of being a legal drug dealerwho doled out prescriptions without proper evaluations.
Citingthe state's prescription monitoring database,the affidavit said Ley had prescribed Suboxone for many more than 100 patients. At the time, doctors could only treat 100 patients for addiction with Suboxone.
In a recent interview, Ley defended his practice, saying his approach all fell within the bounds of proper addiction medicine. First, he defended the drug in question, a medicine that isbecoming increasingly popular as a treatment for addiction.
Unlike methadone, which like other opiates is considered to have a high potential for abuse, Suboxone belongs to a category of drugs that have a moderate to low risk of dependence, such as Tylenol with codeine and testosterone. And, unlike methadone, Suboxone does not have to be taken under a health care provider’s watchful eye but can be prescribed for at-home use.
While Suboxone is approved only to treat opioid dependency, it is often used off-label to help manage pain and depression. Ley said that he was using Suboxone for many patients to help manage their pain and treat their addiction simultaneously.
Clinic patients had to adhere to strict rules, Ley said. Over four monthsthey would be required to undergo two random drug screens to ensure thatthey were not using other drugs illicitly. The clinic also regularly checked the state's electronic database of opioid and other prescriptionsto ensure patients were not receiving any of these medications elsewhere and requiredpatients to go to counseling, he said.
The lawsuit describes how seven undercover agents sought treatment fromthe clinic as part of the investigation. Two of those were selected for random testing. One refused to comply while the other was tested and no Suboxone found in the sample. Both were immediately dismissed as clinic patients.
Overall, the clinic dismissed about 40 percent of those who started the program because of noncompliance issues, Ley said. For those who followed rules and stayed with the program, Ley would taper their Suboxone dose by 30 percent every two months in an effort to eventually wean them off the drug altogether.
Patients paid $300 for the initial evaluation and a flat program fee of $40 a week.
Ley said he made a conscious decision not to accept insurance because of the variability that existed in whether insurers would cover treatment for addiction. In addition, he thought out-of-pocket payment could improve results.
“I also felt it was important that the patient put something on the line themselves,” he said.
Some problems surfaced before the raid, according to the probable cause affidavit. In 2008, the DEA conducted an inspection of Ley's clinic, then in Noblesville,and found several violations, such as failing to maintain proper records and failing to properly obtain and maintain stocks of Suboxone to give to patients.The agency issued a letter of admonition to Ley, who moved his main office to Carmel the following year. Since 2010, the probable cause affidavit noted, Ley's Carmel clinic had received no controlled substances from DEA-registered distributors.
In June 2012, the lawsuit said, the DEA conducted an inspection that found no evidence of any illegal activities.
The clinic’s neighbors did not always welcome its presence. After one neighboring business complained about clinic patients smoking in the parking lot, Ley hired security and warned his patients not to loiter there, he said.
Ley's lawsuit says biases among city leaders led to the investigation and arrests.
“The presence of a clinic specializing in the treatment of opioid dependency in Carmel, Indiana was in visible contrast to the political position of the Carmel city administration that there was no significant opioid drug addiction problem in Carmel, Indiana that would require such a facility,” the suit says.
Shedding such stigma has proved difficult for the clinic’s doctors and staff since the arrests, said Ley and Agapios’attorney James Fisher, which is why they decided to take legal action. The clinic closed in 2014.
One former staffer, Ley’s son Eric Ley, has applied for 112 jobs and is still unemployed. Even though his record has been expunged, prospective employers can easily find news stories on the internet that talk about the arrests.
The seniorLey spent four weeks in Hamilton and Howard County jails and lost everything, he said.
Distraught after the arrest, he was arrested twice for drunken driving in the spring of 2015.
“I was emotionally at my endpoint. I was in a mental state that was undescribable,” he said.
The probable cause affidavit notes that Ley surrenderedhis medical license in 1995 because of alcohol dependency. His medical license was reinstated in 2002.
Before a trial exonerated Ley from the drug-dealing charges, Agapios was called before the Indiana Board of Pharmacy, which ruled he cannot prescribe Suboxone for two years. In the wake of that decision, he received a letter of reprimand from the state’s Medical Licensing Board.
Agapios still can legally prescribe Schedule II opiates, the type of drugs that can lead to the addiction Suboxone treats.
Call IndyStar reporter Shari Rudavsky at (317) 444-6354. Follow her on Twitter: @srudavsky.
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