Malvern pharmaceutical company ordered to pay more than $1.5 billion after admitting it mislead doctors about a powerful opioid

Endo Health Solutions Inc., a Malvern pharmaceutical company that was once one of the country’s largest opioid manufacturers, has been ordered to pay more than $1.5 billion in criminal financial penalties after pleading guilty to falsely marketing the powerful opioid painkiller Opana ER.

The combined penalties — $1.086 billion in fines and $450 million in criminal forfeiture — make up the second-highest court-ordered penalty against a pharmaceutical company, the U.S Department of Justice said Friday in a news release.

Endo will actually pay far less than that, a company spokesperson said in an email.

Endo Health Solutions (EHSI) and its corporate affiliate, Endo International PLC, filed for bankruptcy in 2022 amid thousands of lawsuits over its role in the opioid crisis.

In emerging from bankruptcy, Endo agreed with the federal government to pay $200 million to resolve its civil and criminal claims, the company spokesperson said. The company could pay an additional $100 million over five years to resolve those matters, the spokesperson said.

The company has also paid $450 million into trusts funding state and local efforts to combat the opioid crisis, the spokesperson said, noting this covers the company’s criminal forfeiture payment.

Endo pleaded guilty in April to a misdemeanor, acknowledging its role in “introducing misbranded drugs into interstate commerce.”

The company admitted that sale representatives falsely claimed that Opana ER, their extended-release brand of the opioid painkiller oxymorphone, was manufactured to deter patients from crushing the pills to snort or inject in order to achieve a quicker and more pleasurable high.

But federal officials said they lacked “clinical data to support those claims.”

Endo called this week’s court order “an important step in our settlement with the DOJ.”

“The company has made significant changes since the historical conduct of certain former sales representatives,” a statement from the company said. “We remain committed to operating with integrity and maintaining a culture of compliance and ethics.”

Federal officials said that while EHSI’s “corporate affiliates emerged from bankruptcy” last month, EHSI itself will “cease to operate in its current form and not emerge from bankruptcy.”

Opana ER made hundreds of millions of dollars for Endo, though concerns had been raised for years about oxymorphone, which is three times more powerful than morphine. The Inquirer has reported that as early as 1970, when Endo was marketing the drug as Numorphan, researchers working with people in addiction at the Philadelphia General Hospital noted that a fifth of the 309 patients they interviewed had used Numorphan to get high at least once.

Heroin, the researchers noted, was cheaper and more readily accessible at the time. But the researchers wrote that they suspected they had stumbled upon “the first stages in the evolution of a drug abuse pattern.”

Endo, which is headquartered in Ireland but operates from Malvern, later pulled the drug from the market.

In 2006, amid a boom for prescription opioid painkiller sales, Endo resurrected its old oxymorphone pills as Opana, marketing the drug in immediate release (IR) and extended release (ER) versions. The ER pills came in higher dosages and were supposed to release into the body over time, increasing the longevity of a patient’s pain relief.

In 2011, Endo asked the FDA to approve a reformulated version of the drug, and described it as crush-resistant — a key selling point to convince physicians that their patients couldn’t use Opana to get high.

Endo proposed including a disclaimer on the reformulated drug’s label that said the company was unsure of the new crush-resistant formula’s “clinical significance” or abuse potential. The FDA eventually approved the drug but told Opana they couldn’t label it as crush-resistant, saying there wasn’t sufficient evidence to support that claim — and that labeling it as such could give customers a false sense of security.

Still, Endo later admitted in its guilty plea that some sales managers at the company knew that salespeople were telling potential customers in 2012 and 2013 that Opana ER couldn’t be crushed or tampered with. Some salespeople even smashed placebo pills with hammers to get the point across, federal officials said.

At the federal government’s request, Endo pulled Opana from the market in 2017, but it still holds a patent on the drugs.

Staff writer Jeremy Roebuck contributed.