The False Claims Act has been a particularly effective tool in combatting the opioid crisis when wielded with the right whistleblower law firm and couching the epidemic as an issue of Medicare Fraud and Medicaid Fraud. Indivior Solutions, along with its parent companies, Indivior Inc. and Indivior plc has agreed to pay $600 million to resolve civil and criminal liabilities to resolve allegations under the False Claims Act. It has also entered into a $1.4 billion resolution with its former parent company, Reckitt Benckiser Group PLC (RB Group). This is the largest resolution in any case brought by the Department of Justice involving an opioid drug. The former CEO of Indivior plc’s, Shaun Thaxter, on June 30, 2020, pleaded guilty to a one-count misdemeanor information for false and misleading representations made by the company. Subsequently, on July 24, 2020, the company not only pleaded guilty, but also agreed to pay a total of $2 billion whistleblower settlement.
Six lawsuits in the federal courts in the Western District of Virginia and the District of New Jersey were filed through the qui tam or whistleblower provisions of the False Claims Act. The whistleblowers or realtors will be eligible to receive 10 to 30% of the total recovery made by the government. Mathematically, most whistleblower awards settle in around 20% or less for an intervention, but using that as a benchmark, the individuals who blew the whistle stand to gain almost $400 million dollars as a whistleblower award. The Act, via the whistleblower or qui tam provisions empowers private individuals and entities to report companies that seek to enrich themselves by wrongfully billing public funds. A qui tam complaint through the False Claims Act (“FCA”) must be filed with the use of a whistleblower law firm, under seal, the proper way or else one risks blowing the case before blowing the whistle.
False Claims Act Allegations against Indivior
Indivior Solutions was facing civil and criminal charges for marketing Suboxone, a drug approved for use by opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment for opioid-use disorders. Indivior Solutions pleaded guilty to a one-count felony criminal information for charging false statements related to matters of healthcare. The Company admitted to making false statements to the Massachusetts Medicaid program (MassHealth) relating to the safety of Suboxone as in its film version, even for children.
This statement was made notwithstanding the presence of buprenorphine, a powerful opioid in Suboxone. During the nationwide opioid epidemic, Indivior Solutions, in October 2012, attempted to convince MassHealth to expand the Medicaid coverage of Suboxone Film in Massachusetts by sending them false information indicating that the film had the lowest rate of accidental pediatric exposure amongst all buprenorphine drugs in the State. This lead MassHealth to announce that the access to the Suboxone Film would be given to patients with children below the age of six. Indivior Solutions aimed at increasing the prescriptions of Suboxone.
Civil & Criminal Settlement
While the criminal settlement amount it over $289 million, under the civil settlement, Indivior Inc. and Indivior plc agreed to pay $300 million for the resolution of false claims submitted to the government healthcare programs. This settlement aims to resolve allegations from 2010 through 2015 against Indivior companies for promoting the sale and use of Suboxone, without legitimate medical purpose, in an unsafe, ineffective and unethical manner, to physicians and state Medicaid agencies, including the use of false claims of the drug being less susceptible to accidental pediatric exposure in comparison to other buprenorphine products. The company had also submitted a petition to the Food and Drug Administration in September, 2012 to delay the generic competition for Suboxone and become a market monopoly and control the prices of the drug, including the pricing to federal healthcare programs.
Novel Settlement Clauses under the Agreement with the Department of Justice
In addition to the financial settlement of $600 million, Indivior Inc. also had to clear out its Suboxone sales, without reinstating it. The CEO of Indivior Inc. was required to personally certify on an annual basis that during the previous year, Indivior was in compliance with the Food Drug and Cosmetic Act and did not commit any health care fraud. Indivior Inc. has been prohibited from using any data obtained from public health care providers for marketing, sales or promotion and was required to remove any such providers who are at a high risk of inappropriately prescribing the drug. Indivior Inc. shall also be subject to contempt proceedings and reinstatement of the dismissed charges should any of the aforementioned terms be violated.
Corporate Integrity Agreement
Notwithstanding the monetary settlement for the resolution of civil and criminal liabilities, Indivior also executed a Corporate Integrity Agreement (“CIA”) with the Department of Health and Human Services Office of Inspector General (“HHS-OIG”) which requires them to implement provisions with respect to accountability and auditing, by carrying out annual risk assessments and independent reviews for multi-faceted audits. Indivior is also required to ensure that its top executives and Board of Directors certify its compliance.Indivior also entered into a separate agreement with the Federal Trade Commission (“FTC”), where they have agreed to pay $10 million to resolve claims of having engaged in unfair methods of competition and acting in violation of the Federal Trade Commission Act, 15 U.S.C. § 53(b). The agreement also requires Indivior to notify FTC if it files a Citizen Petition with the FDA for any drug-related product and disclose all the information it has to both the bodies. Indivior is also now bound to ensure that it does not withdraw a drug from the market or negatively affect the availability of a drug in the market after obtaining approval for another drug containing the same active ingredient.
It is critical for individuals aware of Medicare or Medicaid Fraud to speak with a whistleblower law firm. Some of the best whistleblower law firms dedicate a portion of their practice to litigating whistleblower claims, like Brown, LLC, led by a former FBI Special Agent, Jason T. Brown. If you know about system Medicare Fraud or Medicaid Fraud you should speak with a whistleblower lawyer right away to educate yourself about your rights and responsibilities.