September 14, 2020
The pharmaceutical company Indivior Solutions agreed to pay a total of $600 million to resolve opioid fraud charges involving the marketing its drug Suboxone. Indivior’s parent company, Reckitt Benckiser Group, already agreed to pay $1.4 billion for the same fraud. The $2 billion recovery is the largest-ever resolution in an opioid fraud case brought by the U.S. Department of Justice.
Even by the standards of big pharma fraud, this case stands out. And not just because of the eye-popping numbers. Indivior knowingly used false information about child safety to market Suboxone to a State Medicaid program. But that’s just the start.
The case also involves Indivior’s secret letter writing and email campaign. That campaign featured outrageous references to giving small-pox infected blankets to native peoples and filibustering the Civil Rights Act.
The international conglomerate Reckitt Benckiser Group bankrolled the whole sordid affair. That is the same company which sells Scholl’s footpads, Clearasil acne ointment, and Durex condoms.
The national opioid epidemic caused State Medicaid programs to scramble to find treatment for patients addicted to oxycontin, fentanyl, and other opioids. And Indivior saw an opportunity to make big, big profits from its sale of Suboxone.
Doctors use Suboxone to treat recovering opioid addicts. Suboxone contains buprenorphine, which is itself a powerful opioid.
We’ve written before about State and Federal efforts to hold companies like Purdue Pharma and Insys accountable for their roles in creating the nation’s opioid epidemic. This case shows Indivior and Reckitt Benckiser were just as willing to bend the rules to cash in on the cure to that epidemic.
In 2010 the FDA approved an Indivior/Renckitt Benckiser product called Suboxone Film. The FDA approved Suboxone Film for use in the treatment of opioid addiction. Indivior then went to work pressuring state Medicaid programs to make Suboxone Film a preferred drug.
When it came to the Massachusetts MassHealth program, Indivior used false data to promote Suboxone Film. Indivior told MassHealth officials that Suboxone Film was safer than its competitors when it came to children. Indivior officials falsely told MassHealth officials the data showed children were less likely to mistakenly swallow Suboxone Film than pills or tablets sold by competitors.
As Indivior knew, the data showed children were more likely to ingest Suboxone Film than pills kept in child-proof bottles. Indivior officials simply lied about the safety of Suboxone Film. One Indivior official told colleagues that her rationale for lying about children’s safety was “don’t ask, don’t tell.”
Indivior and its paid boosters also used a letter campaign to turn up the pressure on MassHealth officials. One bogus letter to local papers claimed that MassHealth officials were “engaging in 21st biological warfare, no different than given small pox blankets to the Indians” when they declined to immediately approve Suboxone Film.
Another communication directed to MassHealth officials repeated the false claim that “there is less chance that a curious child” would swallow Suboxone Film. That email went on to compare the delay by MassHealth officials in approving Suboxone Film to the filibuster in opposition of the Civil Rights Act.
Court documents identify the author of those communications as a “purported physician.” According to the filings, the same individual demanded a $30,000 donation and a Harley-Davison Road King motorcycle from Indivior for his efforts.
How much Indivior paid to its “purported physician” is unknown. What is known is that Indivior and its parent company Renckitt Benckiser Group will pay $2 billion for their misconduct.
In July 2020 Indivior Solutions, Inc. pled guilty to criminal charges. Indivior CEO Shaun Thaxter also pled guilty to a criminal charge. Both pleas took place in the U.S. District Court for the Western District of Virginia.
A Senior Justice Department Official made clear “This resolution holds Indivior to account for placing profit above patient and community safety.”