Kentucky Attorney General Andy Beshear has filed a lawsuit against Endo Pharmaceuticals, alleging that the sale and marketing of Opana ER, a powerful pain killer, was a significant contributing factor to the opioid crisis in that state, resulting in drug addictions and deaths.
The Commonwealth of Kentucky and Beshear filed the complaint (PDF) in the state court system on November 6, alleging that Endo’s actions caused or contributed to at least 191 deaths related to the use of Opana ER in Kentucky during 2016, many of which were veterans.
Opana ER is Endo Pharmaceutical’s extended-release version of the opioid oxymorphone, and was just approved by the FDA in 2012, replacing the original version released in 2006. While the drug’s design was supposed to prevent the pills from being crushed and inhaled. the FDA has determined that the drug is still widely abused, especially after the reformulation was made to deter addicts from snorting it. This pushed many addicts to begin injecting the drug instead.
The addition of needles has added another dimension to Opana ER’s abuse, resulting in an outbreak of HIV and hepatitis C. The drug has also been linked to a blood disorder known as thrombotic microangiopathy.
Following a June 6 Opana recall request by the FDA, Endo agreed to remove the drug from the market. But Beshear said that by then a lot of damage had already been done, mainly due to the company’s aggressive marketing, which ignored the abuse risk and overstated the drug’s benefits and its alleged anti-abuse formulation.
“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 in a press release announcing the lawsuit. “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 FDA determined that Opana ER needs to be recalled from the market after a study of postmarketing data and recommendations by an independent advisory committee in March, which voted that the Opana ER risks outweigh its benefits.
A study by the U.S. Centers for Disease Control and Prevention indicated users must inject Opana several times a day because of its short half-life, which causes withdrawal symptoms to begin much sooner. Users melt the gel coating, which creates the extended release effect. They then crush and mix the drug with a significant amount of water. The diluted solution forces the user to inject several times a day.
Opana injections were the main cause of an HIV outbreak in Indiana in 2015. Addicts began injecting Opana to bypass the abuse-deterrent aspects. It also becomes 10 times more potent than morphine when injected. More than one user will share one quarter of a pill, leading to more needle sharing.
The Kentucky lawsuit presents claims of violations of the state’s consumer protection and medical fraud laws, as well as the commonwealth’s fraudulent insurance laws, and assistance program fraud statutes. The lawsuit also presents claims of continuing public nuisance, fraud, and unjust enrichment. The commonwealth is seeking compensatory and punitive damages.