Reckitt Benckiser and Indivior: The Safety Pitch Behind Suboxone Sales

Reckitt Benckiser and Indivior False Claims Act settlements required Reckitt Benckiser to pay $700 million and Indivior to pay $300 million to resolve allegations that Suboxone marketing caused false claims to government health care programs. The government alleged that the companies promoted inappropriate prescribing, misrepresented the film version’s safety and used safety concerns to delay generic competition. If you worked with the sales messages, medical data or Medicaid coverage decisions, you may recognize how a claim about a drug became a reason for the government to pay for it.

Why Reckitt Benckiser and Indivior Had Separate Agreements

Reckitt Benckiser’s pharmaceutical subsidiary marketed and sold Suboxone in the United States. In December 2014, Reckitt Benckiser spun off that business, previously called Reckitt Benckiser Pharmaceuticals, and it became Indivior. The Justice Department’s account of the separation explains why the same product and much of the same alleged conduct appear in agreements with different companies.

Reckitt Benckiser’s civil agreement covered alleged conduct from 2010 through 2014. Indivior’s covered alleged conduct from 2010 through 2015, reaching beyond the separation.

Reckitt Benckiser’s deal left the government’s claims against Indivior open. Indivior had to reach its own agreement.

What the Government Alleged About Suboxone

Suboxone combines buprenorphine and naloxone. The civil agreements describe its approval to suppress opioid withdrawal symptoms as part of a complete treatment plan that included counseling and psychosocial support. The business received approval to market Suboxone tablets in 2002 and also sold a sublingual film.

Promotion to Physicians Writing Inappropriate Prescriptions

The United States alleged that Reckitt Benckiser, directly or through its subsidiaries, promoted Suboxone to physicians writing prescriptions without counseling or psychosocial support, and for unsafe, ineffective or medically unnecessary uses. It also alleged that prescriptions were often diverted to uses lacking a legitimate medical purpose. Indivior’s later agreement described the same prescribing concerns in its own covered conduct.

The criminal indictment described a way patients allegedly reached those prescribers. According to the Justice Department’s account of the indictment, Indivior promoted its “Here to Help” internet and telephone program as a resource for people with opioid addiction. The indictment alleged that Indivior used it, in part, to connect patients with doctors it knew were prescribing Suboxone and other opioids to more patients than federal law allowed, at high doses and in a careless, clinically unwarranted manner.

Film Safety Claims Aimed at Medicaid Coverage

The government alleged that both companies promoted Suboxone Film with misleading claims that it was less susceptible to diversion and abuse than other buprenorphine products, and less susceptible to accidental pediatric exposure than tablets. The alleged audience included physicians and state Medicaid agencies.

The Reckitt Benckiser civil agreement spelled out what the government said those claims influenced:

That is where the product pitch reached the payment decision. A claim about relative safety could affect which drug a physician prescribed and which drug Medicaid would cover or require approval to use. The agreement alleged reliance at both points.

For someone in medical affairs or Medicaid contracting, the comparison is concrete: the information behind a safety claim, the version presented outside the company and the coverage decision it was meant to influence.

The FDA Petition and Generic Competition

The government also alleged that the companies submitted a petition to the Food and Drug Administration on September 25, 2012, falsely claiming that Suboxone Tablet had been discontinued “due to safety concerns.” The agreements describe the petition and other steps as efforts to delay generic competition and improperly control Suboxone pricing, including pricing to federal healthcare programs.

Here, the safety claim served a different commercial purpose. The Film allegations concerned persuading physicians and Medicaid agencies to favor a product. The petition allegations concerned keeping competing products from entering the market. In both, the government alleged that a safety representation served Suboxone sales.

Reckitt Benckiser’s Civil Settlement

The Justice Department announced Reckitt Benckiser’s agreement on July 11, 2019. Its civil allocation was $500 million to the federal government and up to $200 million to states that chose to participate.

The False Claims Act settlement terms describe how the alleged marketing reached government money. They identify claims to Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program and Labor Department benefit programs, as well as purchases by the Veterans Health Administration. The allegation reached more than a single state formulary.

The government alleged that Reckitt Benckiser caused false claims or government purchases through the covered conduct. The False Claims Act reaches a company that causes a false claim even when someone else submits it. That is the payment relationship behind this agreement: a manufacturer’s promotional decisions could affect a prescription and the resulting government-funded transaction.

Indivior’s Civil Settlement

The Justice Department announced the Indivior civil resolution on July 24, 2020. Indivior Inc. and Indivior plc were the companies responsible for the civil payment. Their executed civil agreement divided the payment between the United States and participating Medicaid states.

The safety admission came from another company within the Indivior group, Indivior Solutions, in its guilty plea. Its particular conduct deserves a closer look because it shows what a misleading comparison can do inside a government coverage decision.

What Indivior Solutions Admitted About MassHealth

According to the Justice Department’s account of its guilty plea, Indivior Solutions employed marketing and sales personnel for the Indivior group. It admitted that in October 2012 it sought expanded Massachusetts Medicaid coverage for Suboxone Film and sent MassHealth false data about accidental pediatric exposure.

The data presented Film as having the lowest rate of accidental exposure among buprenorphine drugs in Massachusetts. Indivior Solutions admitted that this was false and that the communication occurred within marketing and promotional efforts overseen by top executives.

The Justice Department reported that shortly after receiving the information, MassHealth announced access to Suboxone Film for patients with children under the age of six. The sequence connects a specific safety representation, a specific government recipient and a coverage decision directed at the very families the representation concerned.

We see a particularly ugly sales pitch here: reassurance about children’s safety, delivered through data the company admitted were false.

For a pharmaceutical insider, the useful comparison is the underlying data against the claim sent to the payer. Who prepared the comparison, what it actually showed and how it was presented can explain much more than the finished marketing message alone. Here, the company’s admission identified false data at the center of that message.

Whistleblowers Behind the Civil Resolutions

The civil settlements resolved claims against the respective companies in six qui tam cases. Whistleblowers brought those cases on the government’s behalf. The government joined the whistleblowers’ cases in part.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

What the Evidence Can Show About Suboxone Promotion

We examine False Claims Act evidence to connect the promotional decision to the representation, the prescription or coverage decision, and government payment. A sales message tells part of that story. The information used to support it and the decision it influenced tell more.

We examine what the company knew when it acted alongside what it told the payer. A medical review, an internal question about the data or a decision to keep using a disputed comparison can help explain the difference.

The prescribing concern also appears in the government’s opioid-promotion allegations against Purdue Pharma. There, the government likewise alleged promotion connected to unsafe or medically unnecessary prescribing. Both cases put the manufacturer’s choice of prescribers at the center of the alleged promotion.

In the Suboxone agreements, the government identified both prescriber reliance and Medicaid agency reliance. The MassHealth admission made the latter especially concrete. It showed a safety comparison reaching officials who could change which treatment Medicaid covered. That is the connection we help an insider explain.

When You Know What the Safety Data Really Said

If you know how a pharmaceutical sales claim differed from the data behind it, speak with our whistleblower experts about the claim and the payment it influenced. We work with you to turn that knowledge into a case strategy and bring in pharmaceutical False Claims Act whistleblower lawyers who understand drug promotion and government reimbursement. We stay beside you through the decisions that follow to build your strongest pharmaceutical whistleblower case.