The U.S. Justice Department has joined a lawsuit alongside several whistleblowers that alleges that the companies marketed off-label and higher dosages than approved, as well as other deception. Several ex-workers are in the process of suing on behalf of the government, as whistleblower laws allow. It appears the government is now up to speed on the wrongs listed in lawsuits against Indivior Plc. and Reckitt Benckiser Group PLC, both involved in marketing the opioid addiction treatment Suboxone.
What is the Lawsuit About?
One of the complaints unsealed on Aug. 2 was filed by former Reckitt employee Ann Marie Williams, claiming that the companies marketed unapproved dosages and uses of Suboxone and Subutex. Williams Reckitt made misleading claims to the U.S. Food and Drug Administration to obtain approval for a dissolvable film version of Suboxone.
The lawsuits were filed under the False Claims Act, a law that allows whistleblowers to sue companies on the government’s behalf. Now it seems the government is willing to intervene in the cases as well, adding more power to the claims.
The Justice Department filed their cases in federal court in Abingdon, Virginia, saying they are ready and willingly are intervening in four separate whistleblower lawsuits related to the companies’ marketing of Suboxone and the related drug Subutex.
Indivior, an offshoot of Reckitt, claimed last month it was in “advanced discussions” with the Justice Department to resolve an investigation dating back to 2013 related to its marketing practices. It appears that the lawsuit is one way the Justice Department can force their hand.
What Part Was Illegal?
The lawsuit says that just as the patent to make Suboxine pills exclusively was finishing up, allowing competition and generic versions to potentially enter the market, Reckitt sought U.S. approval of a new patent-protected dissolvable strip version of the drug. The manufacturer said the film version would be safer and less susceptible to abuse.
However, the lawsuit alleges that this was not the case. The film version was inferior to the tablets and posed more of a chance of misuse. It also had other hazards, such as an increased risk to children who could be overdosed if they got ahold of the film and put it in their mouths.
Despite these issues, the companies marketed the Suboxone film as “safer” for patients and children than tablets, the lawsuit said. This also implied that the pill form of Suboxone was less safe, which could have caused some doctors to prescribe the film rather than the more-effective pill.
Losing the Lawsuits will be Costly
Indivior has set aside $438 million to cover lawsuits right now, while Reckitt has set aside $390 million in connection with the investigation. It doesn’t appear that either company believes they will win these cases.
“We have been cooperating with the DOJ in its investigation for several years, and we remain in advanced discussions about a possible resolution that would render any suit by the department unnecessary,” Indivior said in a statement.
Reckitt spokeswoman Patty O’Hayer said on Wednesday that the company “will be presenting our case to the DOJ in the appropriate channels to defend the actions that we believe that we have taken.”