Kentucky Attorney General Andy Beshear has filed a lawsuitagainst opioid maker Endo Pharmaceuticals for pushinga highly addictive drug on doctors in Kentucky and contributing to the opioid crisis. In 2016, more than 190 Kentuckians overdosed on Opana ER — the extended release version of the pain medication manufactured by Endo.
“Endo put its own profits ahead of public health and patient safety,” Beshear said in a press conference on Monday. “And rather than help limit the opioid epidemic by reporting potential diversion through illicit prescribing, as it is obligated to do on under federal and state law, Endo looked the other way.”
Opana ER was three times stronger than morphine and highly addictive. It first hit the market in 2006 as a drug for cancer patients and for use in end-of-life care. But soon, reports began emerging suggesting the drug was highly addictive.
“Concerned that doctors’ prescribing would be chilled by evidence of addiction and abuse and seizing on a chance to protect its sales, Endo launched a reformulated Opana ER, which it promised would deter abuse,” writes Beshear in the lawsuit.
In 2012, Opana ER was re-launched, this time with a hard coating that was supposed to make it impossible to crush and therefore, snort or inject. While the Food and Drug Administration didn’t let the company market the drug as ‘abuse-deterrent,’ the lawsuit alleges that the company sent sales representatives to doctor’s offices to tell them it was.
Opana Prescriptions Skyrocket
Nationwide, there was a sharp spike in the prescribing of Opana ER. In 2012, only 14,800 Medicare patients were prescribed the opioid. Three years later, that number had increased tenfold to 149,000 Medicare patients. Beshear said that was partly due to Endo Pharmaceuticals switching gears. Rather than only market the drug to cancer patients, the company began advertising Opana ER for general pain to gain a wider swath of the pain management market.
“They knew they’d only be able to increase sales if Opana ER was prescribed for more common pain,” Beshear said. “We’re talking about back problems, arthritis or even headaches.”
Beshear said in addition, the Centers for Disease Control linked Opana ER to a 2015 wave of HIV and Hepatitis C cases in southern Indiana. The majority of these cases happened because people had shared needles to inject Opana ER. The CDC then issued a report of counties most risk of HIV and Hepatitis C because of injecting drugs. Of the 220 counties included in the report, 25 percent were in Kentucky.
Earlier this year, the Food and Drug Administration pulledOpana ER from the shelves permanently because of the public health consequences of the drug abuse.
But a generic version of Opana ER is still for sale. ImpaxLaboratories began manufacturing oxymorphone hydrochloride ER tablets, and in August, announced it would split the profits with Endo. Combined sales of Endo's new formulation of Opana ER and Impax's generic version were $229 million for the last twelve months that ended in March, according to Impax.
Beshear’s lawsuit follows many othersagainst Endo this year, including one filed by Scott County, Indiana, where the HIV and Hepatitis C outbreak occurred in 2015.
Endo Pharmaceuticals did not immediately return a request for comment Monday afternoon.
