Monday, October 24, 2016

Drug Distribution: The Story of Miami Luken and the Temponeras Connection


For at least 10 years, the United States government fought a behind-the-scenes war against pharmaceutical companies – wholesale distributors of prescription narcotics that shipped drugs from manufacturers to consumers. The Drug Enforcement Administration targeted these middlemen to force companies to police their own drug shipments. This would keep millions of pills out of the hands of abusers and dealers, and it would be much more effective than taking the fight against diversion to each drug store and pain clinic.

Many companies complied and held back drugs. Some did not. 13 companies identified by The Washington Post knew or should have known that hundreds of millions of pills were ending up on the black market, according to court records, DEA documents and legal settlements in administrative cases. Even when they were alerted to suspicious pain clinics or pharmacies by the DEA and their own employees, some distributors ignored the warnings and continued to send drugs.

The 13 companies – large and small distibutors – included Fortune 25 giants McKesson, Cardinal Health and AmerisourceBergen (which together control about 85 percent of all pharmaceutical distribution in the United States) and regional wholesalers such as Miami-Luken and KeySource Medical, both based in Ohio, as well as Walgreens, the nation’s largest retail drugstore chain.

I am using the article from the Post written by Lenny Bernstein, David S. Fallis, and Scott Higham to relate details of a report with significant local interest. I know I am taking content from the original source. My purpose is to inform readers about the tragic events of what has become known as the Scioto County Pill Mill Era.

I beg all readers to read The Washington Post article in its entirety for the best perspective. I pray the reporters will understand my significant plagiarism. I condensed content and copied material for distribution purposes. I thank them for writing the account.

The Story of Miami-Luken and the Temponeras Connection

Starting in 2011, the DEA had repeatedly warned Miami-Luken, an Ohio-based distributor, about suspicious sales of opioids, according to Jim Geldhof, then the agency’s program manager in Detroit. The DEA spoke to the management of the company and warned them they had to look at their sales.

Yet investigators couldn’t persuade lawyers at the DEA headquarters to allow them to take action.
Geldhof said orders to show “cause” that he requested in 2013 were not even issued until November 2015. The matter sat there for two years while Geldhof, who was unsure of the cause for delay, told officials, “You tell us what you want and we’ll give it to you.”

Even employees of Miami-Luken, the drug wholesaler, reported seeing troubling signs. Two of them reported “up the chain” – Cindy Willet, a pharmaceutical buyer, and a customer-service representative were concerned about large oxycodone orders by a particular southern Ohio pain clinic.Their warnings reached senior company officials, including then-chief executive Anthony Rattini. But little changed.

Frustrated about the inaction, Willet told investigators in 2015 that she eventually “stopped talking to (Rattini) about her concerns because he wasn’t doing anything about it. It was as if it was falling on deaf ears. Tony never stopped an order.”

The pain clinic in question was no other than Unique Pain Management, based in Wheelersburg, Ohio, in the epicenter of the opioid epidemic.

The clinic was run by a father-daughter team of physicians, John and Margaret (Margy) Temponeras. Between December 2009 and June 2010, the clinic’s monthly orders of oxycodone rose from 67,800 doses to 104,400.

Despite signs that something was wrong, Miami-Luken did not investigate the dramatic increase, according to the DEA. “Miami-Luken not only continued to ship Dr. (Margy) Temponeras oxycodone, but also shipped increased amounts,” the DEA alleged.

However, Margy Temponeras ordered so much OxyContin from Miami-Luken that in August 2010 she drew the attention of Purdue Pharma, the drug’s manufacturer. Purdue cut Miami-Luken’s OxyContin supply by 20 percent, prompting Miami-Luken to halt drug shipments to Temponeras, records show.

Last year, a federal grand jury indicted the Temponerases and a pharmacist on charges that they conspired to illegally sell medication, alleging that at least eight people had died of overdoses connected to the drugs.

Three of those people died while the clinic was receiving drugs from Miami-Luken between November 2008 and August 2010, according to the indictment and DEA records. It is unclear whether Margy Temponeras also purchased drugs from other distributors, or whether any of those who died consumed drugs distributed by Miami-Luken.

The Temponerases are scheduled to stand trial early next year (2017). Their attorneys declined to comment to the Washington Post. An attorney for the pharmacist, Raymond Fankell, who is also scheduled to stand trial next year, said Fankell’s involvement was limited to helping Margy Temponeras set up the dispensary in her office and to filling her prescriptions at his drugstore.

During one of their interviews with Rattini, DEA investigators asked how the company documented suspicious orders. Rattini pointed to his compliance officer, who put a finger to his head. “It’s all just up here,” he said.

The agency is now attempting to revoke Miami-Luken’s license. The company has asked for a hearing before a DEA administrative law judge and is battling the DEA in federal court over a subpoena for agency records.

(Lenny Bernstein, David S. Fallis, and Scott Higham. “How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job.'” The Washington Post. October 22, 2016.)

Please read the entire article by clicking here: 

Margaret Temponeras, John Temponeras, and Raymond Fankell were charged with illegally running a pain clinic and distributing pain killers not for a legitimate purpose and outside the scope of medical practice.

Their office was raided by the FBI and DEA in 2011. At the time Margaret Temponeras' license was suspended in 2013, she was referred to as "one of the largest dispensers of controlled substances in the United States."

WSAZ News said investigators reported that Margaret and John Temponeras would "examine" more than 20 customers per day and would provide large amounts of prescription medications to the customers who they likely knew where drug addicts who were diverting or selling the medication.

Investigators said the Temponeras' would charged at least $200 per office visit, only accepted cash, and would not accept insurance payments.

The Temponeras' would allegedly refer patients to Fankell to fill the prescriptions.

The indictment alleges that once local pharmacies refused to fill prescriptions ordered by the Temponeras, the Temponeras had Fankell train a pharmacy technician to work at a dispensary at the pain management clinic. The dispensary was called Unique Relief LLC. They only accepted cash payment and a limited number of insurance payments for filling prescriptions.

The indictment lists the following as those whose deaths have been linked to the Temponeras:

Thomas Austin: September 26, 2008
James Smith: October 3, 2008
Monte Loop, Jr: October 8, 2008
Troy Dummitt: January 15, 2009
William Stapleton: April 29, 2009
Ira Marsh: Ocyober 29, 2009
James Tolliver: November 6, 2010
William Darby: March 1, 2011

The three are charged with two counts of illegally distributing medication, which each carry a maximum penalty of 20 years in prison and a million dollar fine, these charges also carry an enhanced penalty of 20 years to life in prison if death resulted. John Temponeras and Raymond Fankell were charged with one count and Margaret Temponeras with two counts of maintaining a place for the purpose of distributing controlled substance, a crime punishable by up to 20 years in prison and a fine of up to $500,000. 

(“UPDATE: Three Face Federal Indictment for Wheelersburg Pill Mill.” WSAZ 3 News. 
June 18, 2015.)

No comments: