U.S. Joins Lawsuits Against Buprenorphine Manufacturers

The U.S. Department of Justice (DOJ) has joined four whistleblower lawsuits against Indivior PLC and Reckitt Benckiser Group PLC over allegations that the manufacturers improperly marketed their opioid-addiction treatment buprenorphine. DOJ intervention in these lawsuits, initially filed on the government’s behalf, strengthens the cases against the two pharmaceutical manufacturers.

Plaintiffs in the lawsuits argue that Indivior and Reckitt marketed products they knew to be inferior. One complaint, filed by former Reckitt employee Ann Marie Williams, alleges that, as Reckitt’s period of marketing exclusivity for a tablet form of buprenorphine was coming to an end, the company sought to market a dissolvable film version of the drug.

According to Ms. Williams, this form of the drug was marketed as safer for patients and children, even though it could be more easily diverted for illegal purposes and posed an increased risk to children. The lawsuit further alleges that Reckitt made misleading claims to the U.S. Food and Drug Administration in order to obtain approval for this version of buprenorphine.

Both companies expressed optimism that the matter would be settled out of court. “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,” representatives from Indivior said in a statement.

Reckitt spokeswoman Patty O’Hayer went further, saying 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.”

Source: Reuters, August 8, 2018.