TX AG Paxton Sues Drug Manufacturer Tris Pharma for Fraud

The Texas Office of the Attorney General’s Civil Medicaid Fraud Division has sued Tris Pharma, Inc. and Tris CEO Ketan Mehta for defrauding the Texas Medicaid program by making false statements in violation of the Texas Medicaid Fraud Prevention Act, now known as the Texas Health Care Program Fraud Prevention Act (“THFPA”).

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.

Tris Pharma also manufactured the drug Quillivant XR, which Pfizer distributed to Texas children on Medicaid.

Another suit, filed in Harrison County in East Texas, alleged Tris Pharma altered testing methods of Quillivant to hide that it often failed to dissolve properly in a liquid mixture, resulting in a reduction in effectiveness.

Pfizer continued to distribute the drug to children and concealed from Medicaid decision-makers that the drug had altered testing methods to pass quality control tests, according to the lawsuit.

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.”  

The lawsuit was initially filed under seal, but the judge has since unsealed the petition at the Attorney General’s request.

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