• Wed. Sep 28th, 2022

Chester County drugmaker Endo blamed for Tennessee opioid crisis

ByRandall B. Phelps

Sep 16, 2022

Knoxville, a city of about 190,000 on the Tennessee River with a state university and downtown entertainment district, was a huge market for Endo International’s addictive opioid painkillers.

Nearly one million more Opana ER tablets from Endo were sold in the Knoxville area between 2007 and 2014 than in New York, Los Angeles and Chicago combined.

“Endo has probably inflicted more harm on Tennessee than any other state,” Attorney General Herbert H. Slatery III said in a 2019 lawsuit, adding that the Malvern Pharmaceutical Company “is largely responsible for the outbreak of ‘Opioids in Tennessee’.

Last month, Endo filed for bankruptcy, overwhelmed by 3,100 opioid lawsuits, other legal issues and billions in debt. It is the third opioid maker to file for bankruptcy. Purdue Pharma, the Sackler family-owned distributor of OxyContin, and opioid pill giant Mallinckrodt Inc. have already filed for protection.

Endo paid CEO Blaise Coleman and three other executives $55.5 million in pre-bankruptcy bonuses in two installments as part of a plan to keep the company going – bonuses that are no longer suitable for the former Appalachian Opanaland in eastern Tennessee.

“They shouldn’t get anything. Filing for bankruptcy should be as if they were bankrupt. I think all of this money should go to rehabilitation and prevention and the victims they harmed,” said Jessica Akhrass, 42, whose younger brother Addison Sharp, a student at the University of Tennessee and former captain of his high school bowling team, overdosed on oxymorphone. , the opioid at Opana, early 2012.

“We were like Opana,” Akhrass recalls. “What is that?”

Grieving and desperate to do something, Akhrass and her mother, Vicki, staked out pain clinics in the Knoxville area to gather information on in-state and out-of-state cars and on people looking for pills until a police chief tells them to stop. David Rausch, the former Knoxville police chief who now heads the state’s Bureau of Investigation, confirmed that he called Akhrass and his mother for their personal safety.

Endo withdrew the very powerful Opana from the market in 2017 after the The Food and Drug Administration asked him to due to the potential for abuse. Endo says in court documents that Opana accounted for less than 1% of the opioid market. The Washington Post reported in 2019 that Endo manufactured 297 million opioid pills between 2006 and 2012. Nationally, pharmaceutical companies manufactured 76 billion opioid pills during that time, Post reported. In addition to Opana, Endo also manufactured and sold cheaper unbranded generic opioid pills through a subsidiary.

Endo is headquartered in Ireland for tax purposes, but manages the US operations from Malvern. The company’s employment is concentrated in the United States and India, where it has manufacturing and research facilities.

» READ MORE: The maker of Percocet Endo explains how it manages the risks of selling opioids

Endo has not commented on this story. For an August 24 Inquirer article on executive bonuses, an Endo spokesperson said, “Recent incentive and retention payments are critical to Endo’s continued business during the Chapter 11 process and have been approved by the independent members of Endo’s Board of Directors”.

“It is important to note that up to the full amount of the performance-based component must be reimbursed if certain pre-established financial and operational objectives are not achieved in 2022 and 2023,” the statement said. “In addition, payments are subject to the recipient’s continued employment with Endo for several years.”

Knoxville is a hub city in Appalachia where two major highways converge – I-40 and I-75 – within a day’s drive of tens of millions of people and convenient for drug addicts and pain clinics.

Initially, pain clinics and opioid-dispensing pill-making physicians clustered together in Florida due to lax prescription drug laws. An administrative law judge, in a case involving a national drug distributor, cited a Drug Enforcement Agency official describing Florida as “the pill capital of the world” because of unscrupulous doctors and pharmacists. But Florida cracked down in 2010 and 2011, leading night clinics to move to Tennessee, which still had weak regulations on such businesses.

Also around this time, Purdue Pharma had reformulated OxyContin so that it was harder to abuse, driving addicts to other opioid medications. One was Opana.

“Opana has become what we called the holy trinity” in Knoxville — a cocktail of soma and alprazolam, said Rausch, Knoxville’s former police chief. This trinity combined the powerful opioid, muscle relaxant and benzodiazepine for a high high.

Oxymorphone, the addictive ingredient in Opana, ranked fifth in drug-related deaths in the region in 2010, according to data from the Knox County Regional Forensic Center. Higher on the list that year was oxycodone (the active ingredient in OxyContin), followed by alprazolam, morphine and methadone.

In 2011, oxymorphone rose to number two on the list of drug-related deaths and held number two in 2014, 2015, and 2016.

“They don’t deserve to exist as a going concern,” said Gerard Stranch IV, managing partner of the Nashville law firm Branstetter, Stranch & Jennings. “It’s a dirty business.”

A person who illegally distributes drugs or participates in illegal trafficking can be held liable in court. In June 2017, Stranch sued Endo and other opioid companies under Tennessee’s Drug Traffickers Liability Act, representing nine counties, 18 municipalities and Baby Doe, who was exposed to opioids in utero.

Chancellor EG Moody of the Sullivan County Circuit Court ordered Endo to provide information to Stranch in the case — such as emails and notes from a Tennessee sales rep — during the fact-finding portion. of the trial. Endo did not comply. According to court documents, Endo only produced 400,000 documents after being ordered by the judge.

The lawsuit was settled for $35 million in July 2021. Endo did not admit wrongdoing, wrongdoing or liability.

» READ MORE: Endo files for bankruptcy with billions in debt

Stranch said he was concerned at the time of settlement that Endo would have to file for bankruptcy given his liability.

“It is offensive that the people who oversaw Endo’s repeated violations of court orders and discovery obligations are being rewarded with $55 million in bonuses to encourage them to continue to stay and lead Endo,” he said. he declares. “I doubt that legitimate competitors will break down their doors to hire these people.”

The lawsuit by Tennessee AG Slatery says 916,513 more Opana ER pills were sold in Knoxville between 2007 and 2014 than in the nation’s three largest cities, with 82 times the population of Knoxville.

“Endo ramped up marketing to Tennessee pill factories to switch OxyContin suppliers from Purdue to Opana ER following a 2010 change in OxyContin’s formulation that reportedly made OxyContin more resistant to certain forms of abuse,” the Tennessee lawsuit said.

Last month, Slatery agreed to settle a multi-state investigation in Endo for $450 million before Endo filed for bankruptcy on August 16.

From a legal point of view, bankruptcy puts an end to the lawsuits against the company. Cities, counties, states, health care groups and individuals who sued Endo are now considered creditors in bankruptcy court. A hearing on Endo’s bankruptcy is scheduled for September 28 in New York.

Samantha H. Fisher, a spokeswoman for the Tennessee attorney general’s office, said the law enforcement agency was “unaware of the [Endo] pre-bankruptcy bonuses and are currently exploring options. She added that “we would prefer to continue to aggressively pursue Endo, but we are bound by the constraints that come with a bankruptcy filing.”

Pennsylvania and New Jersey also agreed to the $450 million nationwide deal with Endo that must be cleared through bankruptcy. “Our office has not approved any bounty,” said a spokeswoman for Pennsylvania Attorney General Josh Shapiro.

Addison Sharp’s phone contained 40 drug contacts, her sister said. He called seven o’clock the night he returned from a family vacation in the Bahamas.

When his mother went to his bedroom to wake him the next morning, January 2, 2012, Addison, 22, had died of an overdose. The medical examiner’s report identified the culprit: oxymorphone.

When Sharp died, Akhrass realized he was the fourth of his friends to succumb to opioids in just a few years.

“Something is seriously wrong,” she thought at the time.

“When I was at [the University of Tennessee], my friends weren’t dying,” said Akhrass, who was 10 years older than his brother. “I had no idea what was going on around us. We lived in a bubble. We didn’t know about these pain clinics.

Akhrass reached out to State Senator Becky Massey to push for tighter regulations on pain clinics and opioid prescriptions. The Addison Sharp Prescription Regulation Act of 2013 limits opioid prescriptions to 30 days and ends cash payments for opioids and other pills, Akhrass said.

Since the law was passed, the number of pain clinics in Tennessee has grown from 330 to 115, said Karen Pershing, executive director of the nonprofit Metro Drug Coalition in Knoxville.

Sharp’s mother, Vicki, died in 2015. The medical cause was cardiac arrest after an asthma attack, but Akhrass, 42, believes their mother “just about grieved herself to death.” She couldn’t go back” after the death of her son. “She couldn’t find a reason to get up anymore,” Akhrass said.

In 2020 Akhrass published a book, Sincerely, Addison’s sisterwhich is partly a story of his brother’s addiction and overdose, and partly about lobbying to pass the law.

She thinks the executives of Endo and those of other opioid companies must have known what was going on.

“Maybe they didn’t know until it got ugly. But there was a time when they had to know what was going on,” she said. “Greed got into this, and it was unforgivable. You can’t believe companies were so blind or stupid. They knew.”