Drug company releases statement after being named in Knox Co. suit

KNOXVILLE, Tenn. (WVLT) — A company named named in a lawsuit filed the State Attorney General's Office for allegations tied to Tennessee's opioid epidemic has released a statement in response to the suit.

Prescription painkillers

The suit targets AmerisourceBergen Drug Corporation over allegations that they are generating and prolonging the ongoing opioid epidemic in Tennessee.

The company told WVLT News on October 8, "We are committed to collaborating with all stakeholders, including in Tennessee, on ways to combat opioid abuse."

The lawsuit filed in Knox County by Attorney General Herbert H. Slatery III on October 3 alleges a disproportionate amount of opioid pills were sold to the Food City located in Bearden, totaling more than 8.5 million immediate-release oxycodone 30 mg pills.

The lawsuit accuses Amerisource of shipping hundreds
of millions of prescription opioids to Tennessee pharmacies for years, even when the lawsuit claims the company knew the drugs were being abused and sold on the street. "The State's Complaint alleges that Amerisource knowingly participated in the diversion of opioids in Tennessee by continuing to supply pharmacy customers with opioids even after it knew--often from firsthand accounts--that diversion was occurring from or in those pharmacies," the complaint's memorandum said.

According to the state, on November 2, 2010, Amerisource shipped 168,000 oxycodone immediate-release 30 mg pills to Food City in Bearden, an amount almost equal to Knoxville’s population on that one day.

In the memorandum, the State listed 11 complaints against Amerisource saying that the company:

- Oversupplied Tennessee pharmacies with "opioids at astounding rates, Amerisource shipped enough opioids for every man, woman, and child to receive approximately 109 pills from Amerisource"

- Ignored "multiple red flags for abuse and diversion from suspect pharmacies, such as high percentages of patients paying for controlled substance prescriptions in cash, cars in the parking lots with out-of-state license plate tags, patients abusing or selling drugs in the pharmacy parking lot"

- "Knowingly supplying two major and clearly defined hot spots for diversion of oxycodone and buprenorphine without naloxone in the Knoxville-area and Tri-cities area"

- "Continuing to seek business from select independent pharmacies that it knew were more likely to be sources of opioid diversion and suspicious orders"

- "Helping suspect pharmacies avoid detection by the DEA"

- Implemented anti-diversion compliance programs designed to minimize the "impact on sales of opioids to high volume pharmacies and were also underfunded, fundamentally unsound, applied inconsistently, or completely ignored"

- Neglected "to provide employees with cohesive and meaningful training on basic topics related to compliance and anti-diversion measures"

- Made "broad exceptions from due diligence investigations for its most lucrative customers"

- Failed to maintain "accurate records and due diligence documents for problematic customer pharmacies despite having reasons to believe those pharmacies were involved in diversion"

- Established "extremely high thresholds for what would trigger a suspicious order review so that it could avoid identifying suspicious orders placed by certain pharmacies"

- Broke "what few protocols were in place and informally assigning different thresholds for different distribution centers based on financial considerations, among many other things"

The full complaint filed by the State is under a temporary seal, meaning it cannot be viewed by the public; however, records show the Tennessee investigators believe the full complaint should be public.

It "should be made public because the information contained in it is damning, and there is no compelling reason why any of the information contained in it should be permanently withheld from the public," the State said.

The memorandum said the complaint "seeks a permanent injunction, civil penalties of $1,000 each for each TCPA violation, disgorgement of ill-gotten gains, restitution a nuisance abatement order, equitable costs of abating the nuisance on behalf of the State...suspension or revocation of Amerisource's registration as an authorized wholesaler and distributor of controlled substances in Tennessee, and costs that the state has incurred."

The release from the State said, “Our office has conducted an extensive investigation into AmerisourceBergen’s unlawful conduct,” said General Slatery. “We believe the company actively subverted and exploited its unique position in the opioid supply chain and its market power to maximize profits. The numbers don’t lie. Amerisource made billions. On the other hand, Tennessee has to deal with the consequences of a public health crisis whose severity and destruction I find really hard to describe.”

Amerisource released a full statement to WVLT News on October 8:

AmerisourceBergen and other wholesale drug distributors are responsible for getting FDA-approved drugs from pharmaceutical manufacturers to DEA-registered pharmacies, based on prescriptions written by licensed doctors and health care providers. Our role in doing so is quite widespread across different therapies, with the distribution of opioid-based products constituting less than two percent of our sales.

We are dedicated to doing our part as a distributor to mitigate the diversion of these drugs without interfering with clinical decisions made by doctors, who interact directly with patients and decide what treatments are most appropriate for their care. Beyond our reporting and immediate halting of potentially suspicious orders, we refuse service to customers we deem as a diversion risk and provide daily reports to the DEA that detail the quantity, type, and the receiving pharmacy of every single order of these products that we distribute.

We are committed to collaborating with all stakeholders, including in Tennessee, on ways to combat opioid abuse.

Amerisource is headquartered in Chesterbrook, Pennsylvania and is one of the largest drug distributors with reported revenues of $167.9 billion in 2018.

On it's website, Amerisource says it's committed to fighting the opioid epidemic by, "Maintaining an order monitoring program with sophisticated technology that tests every controlled substance order against established governing criteria. Orders exceeding those criteria are redirected to experienced diversion control personnel for further analysis and possible cancellation."

The company said it also fights the epidemic by, "Providing daily reports to the United States Drug Enforcement Administration of all opioid-based medication orders, including the quantity, type and recipient of each shipped order."

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