If you are following opioid litigation across the nation, you probably wouldn’t be surprised by another billion dollar settlement. But this latest case against Endo Health Solutions Inc. (Endo) is different. It is a criminal fine (not a settlement) with criminal forfeiture. The degree of culpability and burden of proof is very different from the previous settlements with opioid manufacturers and distributors.

On April 18, 2024, Endo pleaded guilty to one misdemeanor count of introducing misbranded drugs into interstate commerce. According to the U.S. Department of Justice press release, Endo admitted that from April 2012 through May 2013, certain Endo sales representatives marketed Opana ER to prescribers by touting the drug’s purported abuse deterrence, tamper resistance and/or crush resistance, despite a lack of clinical data supporting those claims. The company also admitted that it marketed the drug with a label that failed to include adequate directions for its claimed abuse deterrence use, in violation of the Federal Food, Drug and Cosmetic Act.

Endo withdrew Opana ER from the market in 2017 and filed for bankruptcy. The now-reorganized Endo has agreed to pay $1.086 billion in criminal fines and $450 million in criminal forfeiture. Going forward, Endo and its affiliates are prohibited from selling or marketing opioids.

A similar trajectory was followed in the case against Reckitt Benckiser Group PLC (Reckitt) that resulted in the largest criminal penalty relating to opioid distribution. Back in 2019, Reckitt agreed to pay $1.4 billion for its role in marketing of the opioid addiction treatment drug Suboxone.

In terms of settlements, the largest one in opioid litigation was against the three largest pharmaceutical distributors: McKesson, Cardan Health, and AmerisourceBergen and manufacturer Janssen Pharmaceuticals, Inc (including its parent Johnson & Johnson). In 2021, these companies settled collectively with states and local governments for $26 billion.

Some other large settlements with opioid manufacturers and distributors:

  • Teva: $3.34 billion
  • Allergan:  $2.02 billion
  • CVS: $4.90 billion
  • Walgreens: $5.52 billion;
  • Walmart: $2.74 billion.

These numbers are simply mind-blowing and make one wonder (again and again) how much money is involved in opioid and drug industry. Due to these large settlements, many pharmacy chains and distributors implemented drastic changes in how they distribute and dispense opioids, often resulting in patient hardship and drug shortages. The pendulum is swinging in a completely different direction now. The current trend set by these settlements and criminal fines is to err on the side of caution and minimize any government scrutiny