Purdue Pharmaceuticals Pleads Guilty in $8.3B Opioid Settlement

The Department of Justice (DOJ) recently announced an $8.3 billion settlement in which opioid manufacturer, Purdue Pharmaceuticals, agreed to plead guilty to a three-count felony.

As part of the settlement, Purdue will plead guilty to defrauding the US and violating the Anti-Kickback Satute from 2009 to 2017. 

The criminal resolutions include the largest penalties ever imposed against a pharmaceutical manufacturer, DOJ said, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture.

Purdue also agreed to a $2.8 billion civil settlement to resolve its liability under the False Claims Act by using false advertising tactics to convince doctors to unnecessarily prescribe opioids to patients.

And separately, the company’s owners, which include members of the Sackler family, have also agreed to pay $225 million in civil penalties.

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,” Deputy Attorney General Jeffrey A. Rosen, said in the announcement. 

“With criminal guilty pleas, a federal settlement of more than $8 billion, and the dissolution of a company and repurposing its assets entirely for the public’s benefit, the resolution in today’s announcement re-affirms that the Department of Justice will not relent in its multi-pronged efforts to combat the opioids crisis.”

Previously, the DOJ found that the pharmaceutical company made payments to two doctors through Purdue’s doctor speaker program to convince those doctors to write more prescriptions of Purdue’s opioid products.  

And from April 2016 through December 2016, Purdue made payments to Practice Fusion Inc. in exchange for referring and recommending its opioid products, including OxyContin, Butrans, and Hysingla, DOJ noted.

In a separate statement issued after the announcement, Steve Miller, Purdue’s board of chairman, said: “Purdue deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice in the agreed statement of facts.” 

“Resolving the DOJ investigations is an essential step in our bankruptcy process,” Miller continued. “The settlement agreement will pave the way for Purdue to submit a plan of reorganization to the bankruptcy court that will transfer all of Purdue’s assets to a public benefit company, and ultimately deliver more than $10 billion in value to claimants and communities.”

In 2018, nearly 70,000 people died from drug overdoses, CDC stated. Two out of three overdose deaths involved an opioid like prescription opioids, heroin, or synthetic opioids. 

In a Twitter statement, Massachusetts attorney general, Maura Healey, voiced that she believes DOJ failed patients and families affected by these overdose deaths. 

“Justice in this case requires exposing the truth and holding the perpetrators accountable, not rushing a settlement to beat an election. I am not done with Purdue and the Slackers, and I will never sell out the families who have been calling for justice for so long,” she said.

Experts believe that although the opioid crisis continues to be a challenge in the US, access to opioid use disorder (OUD) care is not as accessible as it should be. 

At the beginning of August, FDA announced that it is requiring label changes for opioid pain medicines and medicines used to treat OUD. 

Updated labels for prescription drugs will require that healthcare professionals discuss the availability of naloxone with patients and caregivers when beginning or renewing treatment. 

Naloxone is a medicine that can be given to individuals to help reduce opioid overdose deaths, usually within minutes.

FDA also noted that healthcare professionals should consider prescribing naloxone when they prescribe medicines to treat OUD, or to patients being prescribed opioid pain medicines that are an increased risk of opioid overdose.