A federal grand jury in Ohio has indicted two Southern West Virginia pharmacists and two former executives from a pharmaceutical company — one of the largest pain pill suppliers to Appalachia — on charges of conspiring to distribute controlled substances throughout the region.
Samuel “Randy” Ballengee and Devonna Miller-West are named in the indictment handed up by the grand jury, Benjamin Glassman, U.S. Attorney for the Southern District of Ohio, said during a Thursday afternoon news conference in Cincinnati.
Ballengee and Miller-West are charged with Anthony Rattini, 71, the former president of Miami-Luken, and James Barclay, 72, the former compliance officer of the company.
All four people, along with Miami-Luken as a company, are charged with one count of conspiring to illegally distribute controlled substances, Glassman said. If convicted, each defendant could spend up to 20 years in prison. Indictments are not findings of guilt, and defendants are presumed innocent unless convicted.
Ballengee, 54, of Lovely, Kentucky, is the former owner and operator of Tug Valley Pharmacy, in Williamson. Miller-West, 49, of Oceana, is the owner and operator of Westside Pharmacy, in Oceana. She also owns Alternative Healing, in Oceana, and Coalfield Cannabis, in MacArthur, both of which claim to offer “alternative” treatments for pain by selling a wide selection of CBD products, the non-psychoactive component in marijuana.
In the indictment, the pharmacists, pharmaceutical executives and the company are accused of seeking to “enrich themselves by distributing millions of painkillers to doctors and pharmacies in rural Appalachia, where the opioid epidemic was at its peak,” Glassman said.
Between 2008 and 2015, Miami-Luken generated more than $173 million in consolidated sales per year while supplying pharmaceuticals to more than 200 pharmacies in Ohio, West Virginia, Indiana and Tennessee, Glassman said.
Glassman said Miami-Luken, based in Springboro, Ohio, and its officials are accused of continuing to distribute millions of pills to Ballengee’s and Miller-West’s pharmacies in West Virginia, as well as other, unnamed, pharmacies, even after U.S. Drug Enforcement Administration officials advised company officials of their responsibilities as a wholesaler to ensure drugs were not being diverted and to report suspicious orders.
Ballengee’s pharmacy allegedly received more than 120,000 painkillers from Miami-Luken in a single month and more than 6 million hydrocodone pills between 2008 and 2014, Glassman said.
Between 2008 and 2010, Miami-Luken, Barclay and Ballengee allegedly distributed more than 1.8 million dosage units of oxycodone to an unnamed pharmacy, referred to as PHARMACY 1 in the indictment, despite knowing that pharmacy and the physician who wrote the oxycodone prescriptions were under investigation for illegally distributing the pharmaceuticals, according to the indictment.
Miami-Luken, the fourth largest supplier of prescription opioids to West Virginia, has faced lawsuits and multiple investigations in recent years.
Between 2007 and 2012, Miami-Luken shipped 20.4 million hydrocodone doses and 8.2 million oxycodone doses to West Virginia pharmacies.
In 2017, a congressional committee started investigating Miami-Luken to turn over documents amid allegations that the firm shipped massive amounts of powerful painkillers to the state’s southern counties and failed to report “suspicious orders” from local pharmacies.
The panel targeted Miami-Luken’s painkiller shipments to four Southern West Virginia drugstores, including Westside Pharmacy and Tug Valley Pharmacy. The others were the former Sav-Rite Pharmacy, in Kermit, and Colony Drug, in Beckley.
At a congressional hearing last year, Miami-Luken board Chairman Joseph Mastandrea testified that he stripped former CEO Rattini of his duties supervising the company’s efforts to comply with federal drug regulations “as DEA inquiries increased.” Rattini has since retired.
Mastandrea was one of five drug CEOs called by Congress to testify amid the committee’s pill-dumping probe. The executives were asked if their companies contributed to the opioid epidemic. Mastandrea was the only one who answered “yes.”
The panel later issued a report that included a transcribed interview with Mastandrea, who called the shipments by his company and its competitors to small towns in Southern West Virginia an “abomination.”
“Clearly, this was drug diversion,” Mastandrea said. “No one was paying attention.
The DEA cited Miami-Luken’s questionable drug shipments in a “show-cause” order that was part of the separate ongoing investigation that led to Thursday’s charges. Miami-Luken, headquartered in Dayton, Ohio, fought the DEA’s effort to revoke the wholesaler’s license to distribute opioids and other controlled substances.
The DEA order disclosed that a Miami-Luken sales representative reported to his superiors in 2008 that Tug Valley Pharmacy’s painkiller sales were “unusually high,” noting that the pharmacy filled prescriptions from nearby pain clinics. But his superiors at the company failed to investigate whether the prescriptions were legitimate.
Miami-Luken shipped 27 orders of hydrocodone — a total of 258,000 doses of the prescription painkiller that’s better known under brand names like Lortab and Vicodin — to Tug Valley Pharmacy in just one month in 2009, according to the DEA. That’s more than 10 times what a typical retail pharmacy in rural West Virginia receives each month.
Miami-Luken also was a major supplier to the Sav-Rite Pharmacy. The DEA alleges that Miami-Luken “failed to maintain effective controls against diversion” of hydrocodone between 2008 and 2011, when the Mingo County pharmacy purchased 10.8 million doses of the painkiller.
For years, Miami-Luken did the bulk of its West Virginia business in Mingo County, which has about 27,000 people.
Between 2007 and 2012, 63 percent of the distributor’s hydrocodone shipments in West Virginia went to Mingo County, DEA records show. The company shipped 14.7 million doses of hydrocodone to Mingo over six years.
Elsewhere, Westside Pharmacy, in Wyoming County, had been limited to buying 6,000 doses of oxycodone (sold under brand names like OxyContin) per month. But Miami-Luken’s shipments exceeded that limit every month from September 2008 to December 2015. The company reported that it received only one suspicious order from Westside, according to the DEA’s order.
The DEA also cites Miami-Luken’s questionable shipments to Colony Drug, in Raleigh County. In March 2008, for instance, the company shipped 16,400 doses of oxycodone to the Beckley pharmacy. The next month, Miami-Luken sent 37,200 oxycodone doses to Colony — a 127 percent jump. The distributor never investigated the increase, according to the DEA.
The DEA also investigated Miami-Luken’s shipments to five other pharmacies, in Southern Ohio and Eastern Kentucky, according to court filings.
In February 2016, West Virginia Attorney General Patrick Morrisey ended a state lawsuit against Miami-Luken, after the company agreed to pay $2.5 million to settle allegations that it flooded the state with painkillers. Morrisey, a former lobbyist for a trade group that represents Miami-Luken and other drug distributors, inherited the lawsuit in 2013 after ousting longtime attorney general Darrell McGraw.
Miami-Luken took the DEA to court in 2016, asking a judge to force the feds to release agency documents that the company would presumably use to fight the DEA’s effort to take the firm’s license. A judge rejected the DEA’s arguments for keeping the agency’s documents under wraps and out of Miami-Luken’s hands.
The company distributes drugs in Ohio, Indiana, Kentucky, Tennessee, West Virginia, Western Pennsylvania and Southern Michigan. Most of its shipments go to independent pharmacies, not chain drug stores.
Miami-Luken has mostly flown under the radar amid growing national scrutiny over the role of prescription drug distributors in the opioid epidemic. The nation’s largest wholesalers — McKesson, AmerisourceBergen and Cardinal Health — have shouldered most of the criticism and a barrage of lawsuits filed against them by cities, counties and states. The “Big Three,” as they’re collectively known, are big targets with big pockets. Their combined revenue totaled $460 billion last year.
Ballengee opened Tug Valley Pharmacy in downtown Williamson in 2007, and sold it in 2016. The pharmacy officially closed last May, and CVS Pharmacy, in South Williamson, Kentucky, purchased the rights to manage its customers.
Last August, a federal judge in Charleston dismissed a lawsuit that Ballengee filed against CBS News, which had broadcast a series of reports on the opioid epidemic in West Virginia.
The summary judgment ruling, granted by U.S. District Judge Joseph Goodwin in West Virginia’s Southern District, tossed the pharmacist’s $15 million lawsuit. Ballengee claimed CBS’ reporting was incorrect and defamatory, and intentionally inflicted emotional distress. Goodwin ruled that Ballengee could not prove any of that, and the judge found no defamation in CBS’ reporting.
CBS had reported that Ballengee was responsible for filling massive numbers of pain pill prescriptions from one pain clinic.
Ballengee alleged that CBS’ reporting was responsible for McKesson Corp., the nation’s largest prescription drug distributor, cutting ties with Tug Valley Pharmacy and refusing to supply any more pills to it.
In 2011 and 2012, 29 Mingo County residents filed lawsuits against Tug Valley Pharmacy and three other nearby drugstores. The residents, who are being represented by Charleston lawyer Jim Cagle, allege that they became addicted to prescription painkillers or lost loved ones to overdoses after the pharmacies filled bogus prescriptions for rogue doctors and “pill mill” clinics. The lawsuits are scheduled to go to trial this fall.
Williamson Mayor Charlie Hatfield said pill-mill pharmacies like Tug Valley have disproportionately harmed people in Williamson and elsewhere in Appalachia.
“So many lives have been lost over this, and not only lost in terms of death, but destroyed,” Hatfield said. “You’ve got grandparents raising kids, hundreds in foster care, people living on the street because of these addictions.”
Hatfield runs a real estate company and owns the building next to where Tug Valley Pharmacy was located. He said he remembers, for years, watching people line up outside the pharmacy and camp in the parking lot waiting to fill their prescriptions. In his recollection, though, it wasn’t all Mingo County — or even West Virginia — residents abusing the lax pain pill prescription practices.
“You could see the license plates on their cars, and in Kentucky, the plates tell you the county. We would see people from Owsley County, from Breathitt [County],” Hatfield said. “Were there people in the area using the product? Sure. But the problem was people coming in, getting pills and leaving. That’s all they came for.”
While people in counties and cities nationwide have suffered at the hands of pharmaceutical companies like Miami-Luken, McKesson and Amerisource-Bergen, Hatfield said, it’s no surprise to him that the modern opioid epidemic started in Appalachia, and specifically in West Virginia.
“Coal mining — it was a hard, intensive job, and it brought with it a lot of pain. Here in Williamson, we had coal miners that suffered that pain, and it was an obvious place, I think, for these companies to come and sell their drugs,” Hatfield said. “We had legitimate pain practices here for legitimate reasons, but it didn’t take long — regulators turned a blind eye, and our people — people everywhere — suffered.”
From 2006 to 2016, drug wholesalers shipped 10.2 million hydrocodone pills and 10.6 million oxycodone pills to Tug Valley Pharmacy and Hurley Drug, in Williamson, according to data obtained by the U.S. House Energy and Commerce Committee and reported in 2018 by the Gazette-Mail.
In the years since, Hatfield, who also is CEO and owner of Williamson Memorial Hospital, said that prescription abuse in Williamson has declined, even though the drug epidemic still has a hold on the town.
Dr. Dino Beckett, owner and founder of the Williamson Health and Wellness Center, said more and more people in the area are abusing methamphetamines.
“Methamphetamines — It’s just a whole different type of abuse that comes with a lot of issues of its own,” Beckett said. “The most frustrating thing is that, as we do curtail the use of opioids and prescription abuses, we have to deal with this. It’s always what happens — when you take one thing away, something else will pop up to take its place.”
The drug epidemic is something Hatfield said he’s constantly working to tackle in the city, especially now that he operates the hospital. Things are improving, though, he said, and Williamson — once dubbed “Pilliamson” for its reputation of pill abuse — is not where it was 10 years ago, or even two years ago.
“We got the negativity and the bad images, and yeah, that came from the pill mills. In the court of public opinion, though, we’re doing fine today. We’re open for business, and we’re celebrating our successes as we try to move forward in dealing with this problem,” Hatfield said. “I’m proud to be mayor here, and I’ll tell you, as the mayor, under my watch, there will not ever be another pill mill in this city. We’re not going to allow that ever again.”
Earlier this week, a federal judge in Cleveland issued an order that paved the way for the release of previously confidential information that disclosed prescription opioid shipments to every state, county, town and pharmacy in America. The DEA data spans 2006 to 2012.
On Thursday, drug distributors filed an “emergency petition” with the 6th U.S. Circuit Court of Appeals, asking the court to block the release of any additional shipment numbers from the DEA database. The companies also requested that the judge keep sealed numerous documents that include allegations about their painkiller deliveries to pharmacies across the United States. The Gazette-Mail and Herald-Dispatch, along with The Washington Post, went to court to pry loose the pill data, and are fighting to unseal the court records and force the disclosure of additional prescription opioid shipments, from 2013 to 2014.
Nearly 2,000 towns, counties and cities are suing drug distributors and manufacturers, alleging that they fueled the opioid crisis by flooding communities with pain pills. The distributors said Thursday that the lawyers representing local governments are using the release of the painkiller numbers as a “bargaining chip” to prod the companies to settle the lawsuits.
In the petition, the companies said they were “blindsided” by Cleveland-based U.S. District Judge Dan Polster’s order. They complain that the release of the pill information sparked “multiple, lengthy” news reports. They allege that Polster’s ruling assisted a “public relations strategy” by the trial lawyers suing them.
Patrick McGinley, a Morgantown lawyer representing the Gazette-Mail and Herald-Dispatch, disputes those assertions.
“The disclosure of DEA data and court filings that have been withheld from the public isn’t about any public relations strategy,” McGinley said. “Disclosure honors the right of people in communities across the country to know the facts about the opioid epidemic and what is transpiring in opioid litigation.”