On April 9th, the U.S. Department of Justice (DOJ) announced that a federal grand jury returned a 28-count criminal indictment against Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.) and Indivior PLC (Indivior) for allegedly engaging in a nationwide scheme to increase prescriptions of Suboxone Film, a Schedule III controlled substance used in the treatment of opioid addiction.
The criminal indictment alleges that Indivior:
- Illegally obtained billions of dollars in revenue from Suboxone Film prescriptions by deceiving health care providers and health care benefit programs into believing that Suboxone Film is safer and less susceptible to diversion and abuse than other, similar drugs; and
- Sought to boost its profits from Suboxone Film by establishing a telephone program for patients to call to be connected with a doctor for opioid addiction/dependence treatment, which Indivior used to connect patients to doctors Indivior knew were prescribing Suboxone and/or other opioids in a careless and clinically unwarranted manner.
The allegations are supported by statements and materials, deemed to be false and fraudulent by the government, that were made by the company’s executives and employees and directed toward health care providers, health care benefit programs, patients, investors, and others throughout the country. For example, the government devotes paragraphs 33-72 of the indictment to statements and representations made by sales representatives and reported to their supervisors and fellow sales representatives to use as models for promoting Suboxone Film. The government acknowledges how the compliance committee identified “compliance risks” posed by the reports and discontinued their use, but the compliance committee failed to contact patients, physicians, pharmacists, health benefit programs, or others to correct or retract the statements and reports.
The indictment charges Indivior with one count of conspiracy to commit wire fraud, mail fraud, and health care fraud, one count of health care fraud, four counts of mail fraud, and twenty-two counts of wire fraud. In addition to criminal charges, the government seeks to impose severe penalties such as a $3 billion monetary judgement, forfeiture of business entities (including all related assets, inventory, and property) and bank accounts, and forfeiture of certain drug-related patents and trademarks.
Indivior’s Response
On the same day the DOJ announced its indictment, Indivior issued an eight-page statement in stating the charges against the company are “wholly unsupported by either the facts or the law” and that “[k]ey allegations . . . are contradicted by the government’s own scientific agencies, they are almost exclusively based on years-old events from before Indivior became an independent company in 2014, and they are wrong.” The company also made specific rebuttals to DOJ claims related to pediatric safety and on misuse and diversion.
Along with the statement, Indivior released an open letter from Howard Pien, Chairman of the Board Directors, who rebuked the government for bringing criminal charges against the company. He explained that “[t]he Indivior Board of Directors, including through a special committee of the board that [he] chaired, [] investigated the department’s allegations, and the board believes they are flat wrong.” He confidently stated how “Indivior has never deliberately diverted its product” and “[t]he federal government’s own scientific agencies have stated that Suboxone film in its unit-dose packaging reduces the risk of accidental pediatric exposure.”
Indivior intends to vigorously contest the charges.
DOJ’s Prescription Interdiction & Litigation (PIL) Task Force
It should be noted that Indivior’s prosecution is part of a coordinated effort by the DOJ’s Prescription Interdiction & Litigation (PIL) Task Force. The PIL Task Force was announced by then-Attorney General Jeff Sessions in February of 2018 and created to “combat the opioid crisis at every level of the distribution system.” In the announcement, the Department of Justice made clear that “the PIL Task Force will use all available criminal and civil remedies available under federal law to hold opioid manufacturers accountable for unlawful practices.”
Indivior’s Whistleblower Suits
In August of 2018, the Department of Justice filed a motion that it was partially intervening in a 2013 whistleblower lawsuit filed against Indivior Plc and Reckitt Benckiser Group PLC alleging the companies violated the False Claims Act and Anti-Kickback Statute concerning the improper sale and marketing of Suboxone and Subutex (see our coverage here; read the unsealaed Second Amended Complaint here). In October, the government filed a motion to consolidate the lawsuit with two other whistleblower lawsuits and stay all actions to allow the parties to negotiate a possible settlement. According to the latest filing from the government, the consolidated actions are stayed until 60 days after the conclusion of the criminal proceedings.
This indictment will be fully explored in an upcoming issue of Policy and Medicine Compliance Update