The Office of Texas Attorney General Ken Paxton announced a lawsuit against Pfizer, Tris Pharma, 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,” a press release read.

“Today, I have filed suit against Pfizer and Tris Pharma for defrauding Texas Medicaid and providing adulterating pharmaceuticals to children. I am horrified by the dishonesty we uncovered in this investigation,” Texas Attorney General Ken Paxton said Monday.

“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,” he added.

Cont. from the press release:


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.

“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,” the filing explained.

“As a result, thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance,” it added.

In a separate press release, Paxton’s office announced the Office of the Attorney General’s Civil Medicaid Fraud Division sued Tris Pharma, Inc. and Tris CEO Ketan Mehta for defrauding the Texas Medicaid program by making false statements.

The press release read:

Tris manufactured a potent attention-deficit/hyperactivity disorder (“ADHD”) drug for children called Dyanavel XR and targeted Texas Medicaid with a fraudulent marketing scheme for the purpose of receiving taxpayer reimbursements through the program. In 2015, Tris launched Dyanavel into a saturated ADHD medication market and sought to differentiate the drug from competitors. To do so, Mehta and Tris pushed false claims that overstated Dyanavel’s efficacy.

Tris directed their sales representatives to deliver false and misleading messages about Dyanavel to doctors in Texas, including Medicaid doctors. Sales representatives falsely told doctors that Dyanavel worked significantly faster than other drugs and provided other unproven benefits to pediatric patients.

The filing explains that Tris’s “false and/or misleading messages regarding the efficacy of Dyanavel XR were disseminated repeatedly on thousands of sales calls to Texas Medicaid providers and decision makers.”

“The lengths to which this company and their leadership went to defraud our state and the patients taking this medication are shocking,” said Attorney General Paxton. “Pharmaceutical companies who violate the public’s trust and hurt the people of Texas will be brought to justice to the fullest extent of the law.”

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