Southern District Of Florida Hands Endo Subpoena For Opioid-Related Docs

On Thursday January 11th, Endo Pharmaceuticals Inc.’s parent company, Endo International Plc, said they were issued a grand jury subpoena by federal prosecutors. The company was ordered to provide the information about products containing the opioid oxymorphone that Endo pulled from the shelves earlier this year.

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The Irish company said in a statement that the U.S. Attorney’s Office for the Southern District of Florida issued a grand jury subpoena in regards to oxymorphone, a narcotic painkiller that Endo sold under the name Opana ER until last July, when the company bowed to FDA pressure and halted sales of the drug.

In their statement, Endo said the subpoena requests documents related to product safety, overdoses, abuse, addictiveness, diversion, overprescribing, dependency, effects, and additional documents produced in past or pending lawsuits. Additionally, documents related to interactions with government agencies, distribution and third-party agreements, and sales and marketing were also requested.

Endo has faced several lawsuits over its marketing of opioids by Kentucky, Louisiana, Mississippi, Missouri, New Mexico, and Ohio. Endo and other companies that face similar lawsuits have all denied wrongdoing. They claim that all drugs carried warning labels and that the U.S. Food and Drug Administration approved their respective drugs as safe for the public.

“Endo and EPI intend to be responsive to the subpoena and cooperate with any related government investigation,” the company said in their statement. “In all circumstances, it is Endo’s policy to comply with applicable laws, rules, regulations and industry guidance governing the sale and marketing of pharmaceutical products.”

When the drug was pulled from the market in July, Endo said that it “continues to believe in the safety, efficacy and favorable benefit-risk profile of Opana” but that it would abide by the FDA’s request.

A month later, Endo removed a reformulated version of Opana, or oxymorphone hydrochloride. Users continued to liquefy and inject the drug because of its resistance to crushing and snorting. The increase of the drug’s usage was linked to  “a serious outbreak of HIV and hepatitis C,” according to the FDA. This represents a heavy financial hit for Endo, which earned $160 million from Opana sales last year, approximately 14% of their revenue.

America is facing an opioids crisis. In 2015, over 30,000 Americans suffered fatal overdoses from abuse of opioids, mostly prescription painkillers and heroin. This has sparked a wave of lawsuits against pharmaceutical companies, like Endo, that are responsible for opioid production, marketing, and distribution.

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