Attorney General Letitia James announced that New York and other states have reached an agreement with the pharmaceutical distributor Reckitt Benckiser Group (“Reckitt”) to settle allegations that the company improperly marketed and promoted the drug Suboxone, resulting in improper expenditure of state Medicaid funds. Reckitt will pay $700 million to the settle the allegations, including those it settled with the U.S. earlier this year. As part of the agreement, New York’s Medicaid program will receive more than $71.9 million in recoveries, with more than $39.9 million being returned to New York State.
“Pharmaceutical companies have a basic duty to ensure that they are properly disclosing and marketing powerful drugs,” said Attorney General Letitia James. “Reckitt misled the public about the real impacts of Suboxone and encouraged physicians to wrongly prescribe it, while cheating New York out of tens of millions of dollars in the process. No company is above the law and we will continue to take on anyone who takes advantage of the opioid crisis to increase their bottom line.”
Suboxone is a drug product approved for use to treat opioid addiction to avoid or reduce withdrawal symptoms while undergoing treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids. Reckitt has paid a total of $700 million to resolve various civil fraud allegations impacting Medicaid and other government healthcare programs, of which over $400 million will go to the Medicaid programs. New York’s Medicaid Program will receive $71,953,065.74 in recoveries from Reckitt with $39,941,582.30 being returned to the State. To resolve its potential criminal liability stemming from conduct alleged in the indictment of Indivior, Inc., Reckitt has entered into a separate non-prosecution agreement.
The civil settlement resolves allegations that, from 2010 through 2014, Reckitt, directly or through its subsidiaries, knowingly:
- Promoted the sale and use of Suboxone to physicians who were writing prescriptions to patients without any counseling or psychosocial support, such that the prescriptions were not for a medically accepted indication and for uses that were unsafe, ineffective, and medically unnecessary and that were often diverted for uses that lacked a legitimate medical purpose;
- Promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that Suboxone Sublingual Film was less subject to diversion and abuse than other buprenorphine products and that Suboxone Sublingual Film was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets;
- Submitted a petition to the Food and Drug Administration on September 25, 2012, fraudulently claiming that it had discontinued manufacturing and selling Suboxone Sublingual Tablet “due to safety concerns” about the tablet formulation of the drug;
- Took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control pricing of Suboxone, including pricing to federal healthcare programs.
The civil settlement resolves the claims against Reckitt brought in six qui tam lawsuits pending in federal courts in the Western District of Virginia and the District of New Jersey.
A National Association of Medicaid Fraud Control Units (NAMFCU) team participated in the investigation and in settlement negotiations. The team included representatives from the New York Attorney General’s Office, in addition to representatives from the attorneys general of California, Indiana, Ohio, Virginia, and Washington.