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Catch of the Week - Endo Health Solutions

Posted  March 1, 2024

This week’s Department of Justice (DOJ) Catch of the Week goes to Endo Health Solutions.  Yesterday (February 29), the now-bankrupt pharmaceutical company agreed to pay up to $465 million over 10 years to settle criminal and civil charges relating to its sales and marketing of the opioid drug Opana.  Endo voluntarily withdrew the drug from the market in 2017.

This bankruptcy-negotiated payout flows from a criminal fine and forfeiture of roughly $1.5 billion for violating the Federal Food, Drug and Cosmetic Act.  It is the second-largest set of criminal financial penalties ever levied against a pharmaceutical company.  It also comes from Endo’s agreement to a civil settlement of $475.6 million to settle charges it violated the False Claims Act through its Opana sales covered by the federal healthcare programs.

As part of its criminal plea, Endo admitted its sales representatives marketed Opana to prescribers by touting the drug’s purported abuse deterrence and crush resistance without any clinical data supporting those claims.  The company also admitted the drug was misbranded with a label that failed to include adequate directions for its claimed abuse deterrence use.

On the civil side, the government alleged that Endo targeted Opana sales to healthcare providers the company knew were prescribing the drug for non-medically accepted indications. In fact, Endo apparently focused its marketing on the most prolific prescribers of opioids.  The government claimed that when Endo employees raised concerns about targeting prescribers engaged in pill-mill abuse, the company ignored them.

Going after companies contributing to the opioid epidemic has been a DOJ priority over the past few years.  In fact, it was one of the key areas of fraud enforcement the DOJ highlighted in its recently-released summary of False Claims Act enforcement results for 2023.  It is a priority the government strongly reaffirmed in announcing the Endo settlement:

Companies that profit from the opioid abuse epidemic by misrepresenting the safety of their opioid products and using reckless marketing tactics to increase sales threaten the health and safety of Americans.  With today’s announcement of a criminal guilty plea and a substantial civil settlement, the Justice Department re-affirms its commitment to holding accountable those whose illegal conduct contributed to the opioid crisis.  [DOJ Civil Division Chief Brian M. Boynton]

Today’s settlement ensures that Endo takes responsibility for its past misconduct, pays its federal debts, helps abate the nation’s opioid crisis by funding evidence-based treatment programs at the state and local level and distributes payments to individuals harmed by the opioid epidemic.  [SDNY US Attorney Damian Williams]

Combating the opioid epidemic remains a top public health priority for the Food and Drug Administration (FDA).  This case demonstrates FDA and the Justice Department’s commitment to work collaboratively to hold drug manufacturers accountable if they fail to share accurate information with health care professionals about the risks and benefits of opioids.  [FDA Director Center for Drug Evaluation and Research Director Patrizia Cavazzoni]

The opioid crisis remains a public health emergency nationwide, and those impacted are at the forefront of our work.  The HHS Office of Inspector General (HHS-OIG) is staunchly committed to protecting the millions of people served by federal healthcare programs from schemes such as this, while also striving to ensure they have access to necessary treatment.  [HHS Inspector General Christi A. Grimm]

Veterans and their families expect and deserve the highest quality health care delivered in a safe and accountable setting.  False or misleading claims about potentially dangerous drugs put veterans’ care at risk.  The VA Office of Inspector General is committed to working with our law enforcement partners to ensure the safety of those who entrust their health care to the providers and staff at VA’s 1,300 medical facilities.  [VA Inspector General Michael J. Missal]

Like the vast majority of False Claims Act cases, this one was originated by a whistleblower under the qui tam provisions of the statute which allow private parties to bring lawsuits on behalf of the government against those who commit fraud against the government.  In return, successful whistleblowers are entitled to up to 30% of the government’s recovery.  The amount the whistleblower will receive from the Endo settlement has not been disclosed.

If you would like more information on what it means to be a whistleblower or think you may have information relating to healthcare fraud or any other kind of government contract fraud, please feel free to contact us so we can connect you with a member of the Constantine Cannon whistleblower lawyer team for a free and confidential consultation.

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Tagged in: Catch of the Week, Criminal Proceedings, FCA Federal, Healthcare Fraud, Pharma Fraud,