BOSTON – A pharmaceutical distributor based in the United Kingdom will pay nearly $19 million to Massachusetts as part of a multistate settlement to resolve allegations that it improperly marketed a film version of Suboxone, a drug used for the treatment of opioid use disorder by suppressing withdrawal and cravings, Attorney General Maura Healey announced today.
The settlement with Reckitt Benckiser Group resolves allegations that, from 2010 through 2014, the distributor – directly or through its subsidiaries – knowingly promoted the sale and use of Suboxone Sublingual Film based on false and misleading claims that it was less subject to diversion and abuse than Suboxone Sublingual Tablets, despite not having evidence to support such claims. The distributor also falsely claimed that the film was less susceptible to accidental pediatric exposure than the tablets.
The settlement further resolves allegations that Reckitt Benckiser fraudulently claimed to the Food and Drug Administration that it had discontinued manufacturing and selling Suboxone Tablets “due to safety concerns” about the formulation of the drug in an attempt to delay the entry of generic competition and improperly control Suboxone pricing. The AG’s antitrust litigation against Indivior, Inc., a separate corporation that was spun off from Reckitt Benckiser in 2014, involving similar allegations, is ongoing.
“This drug distributor actively and illegally profited from the opioid epidemic and put people’s health at risk,” said AG Healey. “As we fight the opioid epidemic, our office will hold drug companies accountable for the harm they cause.”
The investigation that led to today’s settlement stemmed from six qui tam actions brought by whistleblowers in the United States District Court for the Western District of Virginia and the District of New Jersey.
The AG’s Office has been active in bringing enforcement actions against individuals and companies who take advantage of those seeking substance use disorder treatment. In November 2017, AG Healey sent a letter alerting doctors who provide substance use disorder treatment that the office will take action against those who unlawfully require cash payments from MassHealth members for covered treatments and has since prosecuted several doctors and medical practices that have violated state laws and regulations.
The Massachusetts settlement was handled by Assistant Attorney General Philip Schreiber and Investigator Will Welsh, of AG Healey’s Medicaid Fraud Division, with substantial assistance from MassHealth. A National Association of Medicaid Fraud Control Units (“NAMFCU”) Team participated in the national investigation and settlement negotiations. The NAMFCU Team included representatives from the Offices of the Attorneys General for the states of California, Indiana, New York, Ohio, Virginia, and Washington.