(Press release from the Kentucky Attorney General's office)
FRANKFORT, KY - In 2016, more than 190 Kentuckians died from a drug overdose caused by a powerful prescription opioid three times stronger than morphine.
Many of those victims were service members or veterans.
The drug is Opana ER (oxymorphone hydrochloride extended release), manufactured by Endo Pharmaceuticals and Endo Health Solutions, against who, Attorney General Andy Beshear today filed suit for violating state law and directly contributing to these as well as other opioid related deaths and overdoses in Kentucky.
"Today we are taking action to hold Endo responsible for unlawfully building a market for the chronic use of opioids in the name of increasing corporate profits, knowing all along the dangers of Opana ER that led to devastating effects on the Commonwealth," Beshear said. "My office refuses to sit back and watch families be torn apart while opioid manufacturers like Endo line their pockets at the expense of our communities and our future."
The potential for abuse by Kentuckians from Opana ER has been of concern to Beshear since he took office.
In February 2017, Beshear expressed his concerns to the U.S. Food and Drug Administration (FDA) during an open comment period, saying that the drug's reformulation that allegedly made it tougher to abuse "has merely been found to impede one of many means of abuse and approving labeling Opana ER as 'abuse deterrent' may mislead patients and providers."
The FDA requested June 8 that Endo remove Opana ER from the market. The company announced July 6 that it would no longer sell the drug.
Beshear said the removal of Opana ER from the market was an important step in battling the state's drug epidemic but that the damage from Endo's practices has already harmed the people of Kentucky.
Louisvillian Emily Walden lost her son, T.J., as a result of an Opana ER overdose in 2012. T.J., who was in the Kentucky National Guard, overdosed on Opana ER and died shortly before he was to deploy overseas.
Emily emailed Endo asking for help when her son became addicted to Opana ER. One month after T.J.'s death – a full year after she reached out to Endo about his addiction – the company finally responded to ask her for information so that it could file a report with the FDA.
"Oxymorphone was removed from the market in 1979, denied approval by the FDA in 2003 and ultimately approved in 2006 after Endo played a role in changing the clinical trial design," Walden said. "It's time these drug companies are held accountable for what they've done. This bunch has literally caused death and destruction in communities like Louisville all across the United States. My hope is that lawsuits like this will finally hold them accountable for their unethical marketing and promotion of these drugs, so that no other mother will have to walk through the fire they've caused me to endure."
Endo especially targeted Kentucky veterans in its promotion of Opana ER, according to the AG's complaint.
Beshear said Endo's blind eye to the abuse of its drug also led to a surge of HIV cases in Scott County, Indiana in 2015 and put more than 50 Kentucky counties at risk for a similar outbreak.
The Centers for Disease Control and Prevention tied the 2015 HIV outbreak specifically to the injection of Opana ER. In doing so, the federal health agency identified 220 counties across the country at the greatest risk for similar outbreaks. Fifty-four of those counties, roughly 25 percent, were in Kentucky – the majority being in the eastern part of the state.
Beshear's lawsuit, one of many to be filed by his office against rogue pharmaceutical companies, shows how the actions of Endo directly violate numerous Kentucky laws. It seeks civil penalties and compensatory and punitive damages for the Commonwealth.
As part of Beshear's multifaceted strategy to combat the opioid crisis, on Sept. 22, 2017, Beshear's office awarded a contract to the legal team his office will partner with in the investigation and prospective litigation against opioid drug manufacturers distributors, and retailers. Beshear plans to seek compensation on behalf of the Commonwealth where there is evidence that bad actors contributed to the opioid epidemic by illegally marketing, distributing and selling opioids to Kentuckians.
Beshear said the contract, which still has not been approved by the Kentucky Finance and Administration Cabinet, provides that the contracting law firms – and not the Commonwealth – will pay the costs of any litigation.