Endo Health Solutions, a Malvern pharmaceutical company once one of the nation's largest opioid manufacturers, has pleaded guilty to fraudulently marketing the powerful opioid painkiller Opana ER, resulting in more than $1.5 billion in criminal fines. ordered to pay.
The U.S. Department of Justice announced in a news release Friday that the combined fine of $1.086 billion and criminal forfeiture of $450 million is the second-heaviest court-ordered fine against a pharmaceutical company.
A company spokesperson said in an email that the amount Endo will actually pay is much lower than that.
Endo Health Solutions (EHSI) and its affiliate Endo International PLC filed for bankruptcy in 2022 amid thousands of lawsuits over the company's role in the opioid crisis.
In emerging from bankruptcy, Endo reached a payment agreement with the federal government. A company spokesperson said the civil and criminal lawsuits will cost $200 million to resolve. The company may pay an additional $100 million over five years to resolve these issues, a spokesperson said.
The company also paid $450 million to a trust that funds state and local efforts to combat the opioid crisis, a spokesperson said, noting that this will be used to pay the company's criminal forfeiture money.
Endo pleaded guilty in April to a misdemeanor charge, admitting to his role in “bringing misbranded drugs into interstate commerce.”
The company admitted that its sales representatives falsely claimed that Opana ER, an extended-release brand of the opioid painkiller oxymorphone, was manufactured for pain relief. Patients do not have to crush, snort, or inject tablets to achieve their goals. It gives you a faster, more enjoyable high.
But federal officials said there was a lack of “clinical data to support these claims.”
Endo said this week's court order was “an important step in the settlement with the Department of Justice.”
“Since the historic actions of certain former sales representatives, the company has undergone significant changes,” the company said in a statement. “We remain committed to operating with integrity and maintaining a culture of compliance and ethics.”
Federal officials said last month that while EHSI's “affiliates have emerged from bankruptcy,” EHSI itself “has ceased operations in its current form and will not emerge from bankruptcy.”
Long-standing warning about dangerous drugs
Opana ER made Endo hundreds of millions of dollars, but concerns have long been raised about oxymorphone, which is three times more potent than morphine. According to a report in the Inquirer, in 1970, when Endo was selling the drug as numorphan, researchers working with addicted patients at Philadelphia General Hospital interviewed 309 patients. One-fifth of the respondents indicated that they had used numorphan at least once to get high.
Researchers noted that heroin was cheaper and more easily available at the time. But the researchers wrote that they suspect they have encountered “the first step in the evolution of drug abuse patterns.”
Endo, headquartered in Ireland but operating from Malvern, later pulled the drug from the market.
In 2006, during a sales boom in prescription opioid painkillers, Endo revived the old oxymorphone pill as Opana and sold the drug in immediate-release (IR) and extended-release (ER) versions. ER tablets were thought to provide patients with longer-lasting pain relief because they have a higher dose and are released into the body over time.
In 2011, Endo asked the FDA to approve a reformulated version of the drug, saying: That means it's hard to crush. This is a key selling point for convincing doctors that patients cannot use Opana to get high.
Endo suggested including a disclaimer on the reformulated drug's label stating that the company is unsure of the “clinical significance” or potential for abuse of the new crush-resistant formulation. The FDA ultimately approved the drug, but told Opana that it could not be labeled crush-resistant because there was not enough evidence to support that claim, giving customers a false sense of security by labeling it as such. He said that there is a possibility of giving a feeling.
Anyway, Mr. Endo Later, in a guilty plea, some of the company's sales managers said they knew salespeople had told potential customers in 2012 and 2013 that Opana ER could not be crushed or tampered with. he admitted. Federal officials say some salespeople smashed the placebo pills with hammers to get their point across.
Endo withdrew Opana from the market in 2017 at the request of the federal government, but he still holds the patent for the drug.
Staff writer Jeremy Roebuck also contributed.