On February 28, 2024, opioid manufacturer, Endo Health Solutions Inc. (“Endo”), agreed to pay $475 million to settle U.S. v. Endo Int’l plc, Case No. 19-cv-80574, a qui tam action brought by an anonymous whistleblower, who Young Law Group represented, on behalf of the United States. The complaint alleged that the company had violated the False Claims Act by illegally marketing a dangerous opioid called Opana ER with INTAC. Endo’s misconduct allegedly included fraudulent billing of federal healthcare programs, including Medicare, Medicaid, and TRICARE, which contributed to the opioid crisis.
YLG’s 2019 qui tam complaint specifically alleged that Endo focused marketing campaigns for Opana ER with INTAC on the opioid’s crush resistance, falsely claiming that this property made the drug less susceptible to abuse compared to other opioids. On the basis that Opana ER was less dangerous than other opioids, Endo’s marketing efforts were allegedly intended to prompt physicians to prescribe Opana ER with INTAC to more patients.
Although this qui tam action was filed four years ago, in 2019, the anonymous whistleblower and Young Law Group’s work on this issue started far before then. Specifically, in 2013, the same whistleblower, represented by Young Law Group, filed a qui tam action against Endo in the Eastern District of Pennsylvania on a similar basis. The government declined to intervene in the 2013 case. However, the anonymous whistleblower and Young Law Group persevered, continuing on in their efforts to hold Endo accountable. Thus, Young Law Group decided to file another qui tam case in 2019 in the Southern District of Florida.
The case filed in 2019 that led to this $475 million civil settlement, despite detailing similar alleged violations and misconduct, was distinct from the 2013 case as it was accompanied by a criminal investigation on the matter. As a result, Young Law Group and the anonymous whistleblower that brought forth the civil action worked in tandem with the Federal Bureau of Investigation (FBI). The whistleblower was instrumental in the criminal investigation, providing the FBI with significant pieces of evidence that were difficult to obtain given the time elapsed between Endo’s alleged unlawful behavior and the criminal investigation.
“The working relationship with FBI agents in the field, if I compare it to all of the other whistleblower cases I’ve filed, was extremely collaborative. It was clear that the anonymous whistleblower was viewed as a critical witness,” said Eric L. Young of Young Law Group, “Among various pieces of evidence provided by the anonymous whistleblower, perhaps the most notable, was the demonstration pellet used by Endo marketing reps to emphasize the crush-resistant quality of Opana ER with INTAC and support false claims of the opioid’s comparative resistance to abuse. The FBI communicated that, due to the amount of time that had gone by, they were not able to find this piece of evidence anywhere else and expressed gratitude for the whistleblower’s help.”
In addition to the criminal investigation, and resulting collaborative effort with the FBI, this civil action coincided with Endo’s bankruptcy proceedings. As a result, Eric L. Young from Young Law Group and the anonymous whistleblower worked diligently to ensure that an appropriate settlement was obtained. Specifically, YLG and the whistleblower supported the Department of Justice in presenting comprehensive evidence of Endo’s misconduct in the case filed to secure a proper civil settlement amount that was not affected by bankruptcy proceedings.
“We were able to overcome bankruptcy, which is something difficult to achieve in cases like these,” Eric L. Young noted. “Due to the severity of Endo’s misconduct and the strong evidence we presented of said misconduct, in addition to the fact that individuals were being seriously injured by this opioid, in some cases dying, the Department of Justice, with our assistance, was able to secure a significant financial recovery for the taxpayers.”
This ten-plus year fight to hold a pharmaceutical company accountable speaks to the importance of whistleblowers’ dedication and determination in cases like these.