fiercepharmaJuly 20, 2019
Tag: DOJ , illegally pushing pills , Warning Signs
With federal scrutiny mounting on claims it profiteered from the nation’s opioid epidemic, Ohio-based Miami-Luken shuttered its doors for good last year. But if the former company’s leaders thought that was the end of their problems, they were sorely mistaken.
On Thursday, Department of Justice (DOJ) prosecutors charged Miami-Luken’s former president, Anthony Rattini—along with a former compliance officer and two pharmacists—with illegally distributing opioids at the height of the nation’s addiction crisis. The charges come with a maximum penalty of 20 years in prison.
Miami-Luken is now the second wholesale opioid distributor that has faced criminal charges for its role in the opioid epidemic after two former executives from Rochester Drug Co-Operative (RDC) were indicted by the DOJ in April. According to the Dayton Daily News, Miami-Luken shut down in October amid congressional inquiries, multiple lawsuits and a $2.5 million settlement with the state of West Virginia.
According to a statement from federal prosecutors, Rattini and compliance officer James Barclay "sought to enrich themselves by distributing millions of painkillers to doctors and pharmacies in rural Appalachia, where the opioid epidemic was at its peak" between 2008 and 2015.
Prosecutors said the two executives drove distribution to rural pharmacies despite being aware of high levels of drug diversion and suspicious orders from local pharmacies.
Two of the recipients of those opioid pills were Devonna Miller-West, owner and operator of Westside Pharmacy in Oceana, West Virginia, and Samuel "Randy" Ballengee, owner and operator of Tug Valley Pharmacy in Williamson, West Virginia.
According to prosecutors, Miller-West’s pharmacy received 2.3 million oxycodone pills and 2.6 hydrocodone pills in a seven-year span despite operating in a town of just 1,394 people. In Ballengee’s case, Tug Valley Pharmacy received more than 120,000 painkiller pills from Miami-Luken in one month and more than 6 million hydrocodone pills between 2008 and 2014.
Miami-Luken, which provided wholesale distribution to 200 pharmacies in four states, was also accused of sending 2.2 million pills to another pharmacy that had been cut off from other wholesalers and distributing 3.7 million hydrocodone pills to a pharmacy in Kermit, West Virginia, a town of 400 people.
The newest charges against Miami-Luken come as federal scrutiny focuses on drugmakers, distributors and manufacturers for their role in fueling a nationwide opioid epidemic that claimed nearly 100,000 lives between 2006 and 2012.
In April, RDC and two former execs were charged with illegal distribution, a move Drug Enforcement Administration Special Agent in Charge Ray Donovan said "should send shock waves throughout the pharmaceutical industry." RDC agreed to pay a $20 million penalty and admit guilt in exchange for five years of deferred prosecution.
The two former RDC execs, former CEO Laurence Doud III and former Chief Compliance Officer William Pietruszewski, both face 15 years in prison.
Although Miami-Luken and RDC are the only distributors that have faced criminal charges for their role in the nation’s opioid epidemic, McKesson agreed to pay a record $150 civil penalty in early 2017 for not reporting suspicious sales of controlled drugs from its distribution centers in Colorado, Ohio, Michigan and Florida. The distributor had previously paid a $13.25 million penalty on similar charges.
The DOJ also knocked distributor Cardinal Health for $44 million on similar violations of the Controlled Substances Act, and both Cardinal and AmeriSourceBergen reached settlements with the state of West Virginia for a combined $36 million.
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