HARRISBURG, PA (STL.News) Pennsylvania Attorney General Josh Shapiro announced that Pennsylvania and other states have reached a $700 million settlement with pharmaceutical distributor Reckitt Benckiser Group over allegations the company improperly marketed Suboxone and defrauded state Medicaid systems. Suboxone is a drug product approved for use by individuals recovering from substance abuse disorder to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.
“Suboxone is critical for helping individuals recovering from substance abuse disorder reduce withdrawal symptoms and stay in recovery,” said Attorney General Josh Shapiro. “But this company improperly marketed it by not revealing its risks and promoting it to physicians with unsafe prescribing practices. Reckitt’s recklessness put the health and wellbeing of patients at risk and defrauded state Medicaid systems, which provide health care to low income residents. Today’s settlement holds Reckitt accountable for its misconduct and restores badly needed funds to the Medicaid programs.”
Reckitt is a public limited company headquartered in Slough, England, the United Kingdom. Until Dec. 23, 2014, Reckitt’s wholly owned subsidiary Indivior Inc. (then known as Reckitt Benckiser Pharmaceuticals Inc.) distributed, marketed, and sold Suboxone Sublingual Tablets and Suboxone Sublingual Film in the United States.
Under the terms of the settlement, Reckitt will pay $700 million to resolve various civil fraud allegations impacting Medicaid and other government healthcare programs, of which more than $400 million will go to the Medicaid programs. Pennsylvania will receive more than $53 million of the settlement.
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 and for uses that were unsafe, ineffective, medically unnecessary, and often diverted for an illegitimate medical purpose.
- Promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that it was less subject to diversion and abuse than other buprenorphine products and less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets.
- Submitted a petition to the Food and Drug Administration on Sept. 25, 2012, that fraudulently claimed it had discontinued manufacturing and selling Suboxone Sublingual Tablet “due to safety concerns” about the formulation of the drug.
- Took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone to improperly control the 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.