Reckitt Benckiser Pays the Biggest Opioid Settlement in History

On July 11, Reckitt Benckiser, a UK-based health products manufacturer, reached an agreement with the U.S. Department of Justice and the Federal Trade Commission to pay a settlement of $1.4 billion for its role in fueling the Opioid Epidemic. Reckitt Benckiser was the parent company of Invidior, which manufactured Suboxone Film.

As of this month, the Reckitt Benckiser settlement is the largest settlement that a pharmaceutical company has ever agreed to pay for contributing to the Opioid crisis. The amount far surpasses the $270 million that Purdue Pharmaceuticals agreed to pay the State of Oklahoma in March. It also surpasses the $85 million that Teva Pharmaceuticals agreed to pay the same state in May and the $225 million that Insys Therapeutics agreed to pay the federal government in June.

The federal government will claim most of the money from the Reckitt Benckiser settlement. It will then apportion $200 million to reimburse Medicaid for states which participated in the litigation. The Federal Trade Commission will also receive $50 million to settle its allegations that Reckitt Benckiser “engaged in unfair methods of competition” while marketing its products.

The settlement protects Reckitt Benckiser from prosecution. In a July 11 press release, the company explained that the settlement agreement is not an admission of guilt. It is rather a strategy for avoiding the “costs, uncertainty and distraction” of the federal investigations into Invidior, its former subsidiary. The company will relinquish $647 million in profits from Invidior as part of the settlement. In addition, the company will not be able to manufacture or sell controlled substances in the United States for three years. Invidior, as a separate party, is still under federal investigation.

What Is Suboxone?

Invidior was a subsidiary company of Reckitt Benckiser until it became a separate company in 2014. Invidior’s main product, Suboxone Film, is an Opioid-based medication which is supposed to treat Opioid addiction. Unlike Suboxone tablets, Suboxone Film is a strip that dissolves under the tongue.

Suboxone has two ingredients. One ingredient is Buprenorphine, an Opioid which blocks other Opioids from binding to the brain’s receptors. The other is Naloxone, a medication which reverses the effects of Opioid overdoses. Suboxone is less addictive than other Opioids and it prevents symptoms of Opioid withdrawal. It is not a cure for Opioid addiction, but it can be a helpful part of a treatment program. It also poses moderate risks for abuse, addiction, and overdose, which is why it is a Schedule III controlled substance.

Invidior’s ‘Here to Help’ Conspiracy

In April, a grand jury in Virginia indicted Invidior on Justice Department charges of fraud and conspiracy. Prosecutors allege that Invidior lied to doctors and insurance companies by suggesting that Suboxone Film is safer and poses less of a risk for abuse than generic Suboxone tablets. The prosecutors also allege that Invidior’s “Here to Help” program was a fraudulent scheme to connect Opioid-addicted patients to doctors whom the company knew were most likely to prescribe Suboxone Film. The program was ostensibly a help line. Furthermore, the Justice Department claims that Invidior discontinued its Suboxone tablet under false pretexts to try to prevent the Food and Drug Administration from approving generic Suboxone tablets, which would have threatened Suboxone Film sales.

With the nation continuing to battle the Opioid crisis, the availability of quality addiction treatment options is critical. When treatment medications are used, it is essential they be prescribed carefully, legally, and based on accurate information, to protect the health and safety of patients in federal healthcare programs.

Gary L. Cantrell, Deputy Inspector General for Investigations, US Department of Health and Human Services

Invidior’s alleged conspiracy to bolster Suboxone Film prescriptions was quite successful. In several states, Medicaid even began to cover Suboxone Film. Invidior denies all accusations of criminal activity and there will be a trial in May next year. Opioids have caused thousands of overdoses and cases of addiction. For this reason, the government has vowed to punish corporations that distribute Opioid-based medications irresponsibly.