The United States Justice Department is joining other whistleblower lawsuits against Reckitt Benckiser Group Plc and Indivior Plc, makers of the opioid addiction treatment Suboxone.
In federal court filings last week, the Justice Department said it was intervening in four whistleblower lawsuits related to the marketing of Suboxone and the related drug Subutex.
The move came after Indivior, a spin-off of Reckitt, announced it was in discussions with the Justice Department to settle allegations related to its marketing practices. The company said it allocated $438 million to cover legal expenses, the majority of which relates to the investigation.
Indivior said in a statement that it had been cooperating with the “DOJ in its investigation for years” and that the company remained in “advanced discussions about a possible resolution that would render any suit by the department unnecessary.”
Reckitt has separately set aside 303 million pounds to cover costs related to the investigation.
Patty O’Hayer, spokeswoman for Reckitt, said the company would be presenting its case to the department “in the appropriate channels to defend the actions that we believe that we have taken.”
The lawsuits were filed under the False Claims Act, which permits employees to sue companies on the government’s behalf.
One lawsuit alleged that the companies were marketing unapproved dosages of the drugs Suboxone and Subutex. It also claimed that Reckitt was making misleading claims to the FDA in order to gain approval for a version of Suboxone that would come as a dissolvable film.
Reckitt claimed that the dissolvable strips were safer and less likely to be abused. The lawsuit alleges that the strips were an inferior version of the drug and would make it easier to use for improper purposes. The lawsuit also brings up concerns of children accidentally putting the strips in their mouths.
The Justice Department’s action comes after Insys Therapeutics, maker of the Fentanyl-based drug Subsys, agreed to pay $150 million to settle an opioid kickback probe.