The Office of the Attorney General’s Civil Medicaid Fraud Division has sued Pfizer, Inc., Tris Pharma, Inc. and Tris CEO Ketan Mehta for defrauding the Texas Medicaid program by providing adulterated pharmaceutical drugs to Texas children in violation of the Texas Medicaid Fraud Prevention Act, now known as the Texas Health Care Program Fraud Prevention Act (“THFPA”).
Pfizer contracted with Tris, a drug manufacturer, to produce a pediatric attention-deficit/hyperactivity disorder medication (“ADHD”), Quillivant XR. Pfizer knowingly distributed Quillivant to children on Medicaid despite the drug’s pattern of failing quality control tests due to flawed manufacturing practices. For years, Tris altered the drug’s testing method in violation of federal and state laws to ensure Quillivant passed regulatory hurdles and could continue to be sold.
Despite knowing about these serious problems, Pfizer misrepresented to the Medicaid program that Quillivant was in compliance with federal and state law, and concealed from Medicaid decision-makers the fact that Quillivant was an adulterated drug. As a result of these misrepresentations and concealments, Pfizer and Tris obtained the benefit of taxpayer-funded Medicaid reimbursement for Quillivant.
From 2012 to 2018, Pfizer and Tris continually manipulated Quillivant testing to hide poor manufacturing practices and defraud the Texas Medicaid program. During this time, many families complained that the medication failed to work.
“I am horrified by the dishonesty we uncovered in this investigation,” said Attorney General Paxton. “Pfizer and Tris intentionally concealed and failed to disclose the issues with Quillivant to receive taxpayer funded benefits through Texas Medicaid, defrauding the state and endangering children. Our Civil Medicaid Fraud Division has done an outstanding job holding these pharmaceutical companies accountable.”
The filing explains: “At no point did Defendants warn Texas Medicaid providers or decision-makers that Quillivant had known manufacturing issues affecting its efficacy, thereby depriving the Medicaid program of the crucial information it relies on.… As a result, thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance.”
The lawsuit was initially filed under seal, but the judge has since unsealed the petition at the Attorney General's request. To read the unsealed petition, click here.