Endo Pharmaceuticals (NSDQ:ENDP) was hit by a grand jury subpoena yesterday from the U.S. Attorney’s Office for the Southern District of Florida over its oxymorphone products.
The subpoena requests an array of documents, including those derived from past or pending lawsuits, product safety and efficacy, overdoses, diversion, theft, abuse and misuse, withdrawal and addictiveness.
The attorney’s office also asked for information relating to distribution and third-party deals that Endo has made, as well as data for sales, marketing and other corporate practices.
Endo International and its subsidiary said it intends to be responsive to the subpoena and any government investigation.
“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,” the company wrote in a statement.
Last year, Endo removed its opioid painkiller, Opana ER, from the market after the FDA asked it to pull the plug on the opioid product.
The request from the FDA to remove Opana from the market marked the first time the federal agency urged a company to remove an opioid due to concerns about abuse.
Six years after Endo won FDA approval for Opana ER as a pain-management therapy, the company reformulated the drug with the intent to make it harder for people to snort or inject it.
But a review of post-marketing data revealed that the reformulation may have encouraged users to evolve from snorting Opana to injecting the drug by mixing it with large volumes of solvent.
The product was even linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana.
