The Whistleblower Practice Group at PWHD represented a whistleblower against Indivior Inc., wherein in 2020 the company agreed to pay a total of $600 million to the government to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment drug Suboxone.
$300 million of the settlement was paid to resolve the civil claims that the marketing of Suboxone caused false claims to be submitted to government health care programs. The $300 million settlement amount includes approximately $209.3 million to the federal government and $90.7 million to states that opt to participate in the agreement.
The civil settlement resolved allegations by the United States that, from 2010 through 2015, Indivior companies knowingly
(a) promoted the sale and use of Suboxone to physicians who were writing prescriptions that were not for a medically accepted indication and that lacked a legitimate medical purpose, were issued without any counseling or psychosocial support, were for uses that were unsafe, ineffective, and medically unnecessary, and were often diverted;
(b) promoted the sale or use of Suboxone Film to physicians and state Medicaid agencies using false and misleading claims that Suboxone Film was less susceptible to diversion and abuse than other buprenorphine products and that Suboxone Film was less susceptible to accidental pediatric exposure than tablets; and
(c) submitted a petition to the Food and Drug Administration on Sept. 25, 2012, claiming that Suboxone Tablet had been discontinued “due to safety concerns” about the tablet formulation of the drug and took other steps to delay the entry of generic competition for Suboxone to improperly control pricing of Suboxone, including pricing to federal healthcare programs.