Recently, the Department of Justice (DOJ) filed to join whistleblower lawsuits against Indivior Plc and Reckitt Benckiser Group PLC, alleging that the drug makers improperly marketed Suboxone, an opioid addiction treatment.
Indivior, a spin-off of Reckitt, previously said it was in “advanced discussions” with the DOJ to resolve an investigation dating all the way back to 2013 related to its marketing practices. Indivior has said it has set aside $438 million to cover legal matters, most of which are related to the investigation. Reckitt has separately reserved roughly $390 million in connection with the investigation.
While not all of the complaints have been unsealed, one of the ones unsealed on August 2, 2018, was filed by former Reckitt employee Ann Williams, which alleged the companies marketed unapproved dosages and uses of Suboxone and Subutex and claimed Reckitt made misleading claims to the U.S. Food and Drug Administration to obtain approval for a dissolvable film version of Suboxone.
The lawsuit claimed that as the period of marketing exclusivity for the tablet form of Suboxone was coming to an end, Reckitt sought U.S. approval of a new patent-protected dissolvable strip version of the drug, which it claimed would be safer and less susceptible to abuse. The company marketed the strip as “safer” for patients and children than the tablets. However, the lawsuit alleges that the dissolvable strip version was inferior to the tablets as it could be more easily diverted for improper purposes and posed an increased risk to children who could put it in their mouths by accident.
“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.”