Roughly $2.6 million is headed to Michigan as part of a multi-million-dollar settlement agreement Michigan and 32 other states reached with opioid addiction treatment drug manufacturer Reckitt Benckiser Group (Reckitt) in July, Michigan Attorney General Dana Nessel announced last week. The settlement resolves allegations that Reckitt improperly marketed and promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds
Suboxone contains a combination of buprenorphine (an opioid) and naloxone (blocks the effects of opioid medication, including pain relief and feelings of euphoria that can lead to opioid abuse). The drug was approved to suppress opioid withdrawal symptoms as part of a complete withdrawal treatment plan that would include counseling and psychosocial support.
The settlement resolved allegations that Reckitt directly or, through its subsidiaries, knowingly:
—Promoted the sale and use of Suboxone to physicians who wrote prescriptions (1) to patients without any counseling or psychosocial support, such that the prescriptions were not for a medically accepted indication; and (2) for uses that were unsafe, ineffective and medically unnecessary and that were often diverted for uses that lacked a legitimate medical purpose. Such prescriptions lacking a legitimate medical purpose are also not for a medically accepted indication.
—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. Physicians relied on these false and misleading claims in prescribing Suboxone Sublingual Film, and state Medicaid agencies relied on these false and misleading claims to their detriment in making formulary and prior authorization decisions.
—Submitted a petition to the Food and Drug Administration on September 25, 2012, fraudulently claiming that Suboxone Sublingual Tablets had been discontinued “due to safety concerns” about the tablet formulation of the drug and 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 health care programs.
“The opioid crisis has ravaged Michigan communities across our state, and instead of helping combat it with life-saving medication, Reckitt appears to have exploited the crisis in an effort to bolster its bottom line,” Nessel said. “To any company that seeks to exploit a crisis for personal gain, know this: Putting profits over people will not stand in our state.”
Nessel said most of Michigan’s settlement proceeds will be used to reimburse the state’s Medicaid programs.
The investigation resulted from a number of Medicare and Medicaid fraud actions, three of which were originally filed in the United States District Court for the Western District of Virginia.
The Attorney General’s Health Care Fraud Division is a member of the National Association of Medicaid Fraud Control Units. A NAMFCU Team participated in the investigation and in the settlement negotiations.
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