Texas sues Pfizer, Tris Pharma for alleged Medicaid fraud

The Attorney General’s Office said the lawsuits were filed Nov. 8 under seal but were unsealed at the attorney general’s request.

The lawsuits, Cause Numbers 23-1031 for New York-based Pfizer and 23-2030 for New Jersey-based Tris Pharma are in the Harris County 71st District Court. They allege Pfizer and the manufacturer it contracted with for production of Quillivant, a drug to treat attention deficit hyperactivity disorder, defrauded the Texas Medicaid program by providing an adulterated drug to children in violation of the Texas Medicaid Fraud Prevention Act.

‘No Merit’

Pfizer responded, stating, “Pfizer is deeply committed to the safety and well-being of the patients it serves and takes any allegations about the quality of its products very seriously. Pfizer examined the historic allegations detailed in the complaint on multiple occasions, and did not find any impact on the safety of the product.”

“Pfizer believes that the state’s case has no merit, and will move to dismiss the case in due course. Tris Pharma served as the contract manufacturer for Quillivant during the period at issue in the complaint and purchased the product line from Pfizer in 2018,” Pfizer said.

‘Issues Affecting Its Efficacy’

The attorney general alleges in the complaints that, “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 problems, Pfizer allegedly 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, the attorney general claims.

As a result of these alleged misrepresentations and concealments, Pfizer and Tris obtained the benefit of taxpayer-funded Medicaid reimbursement for Quillivant, the complaints assert, adding that from 2012 to 2018 Pfizer and Tris continually manipulated testing to hide poor manufacturing processes, even as many parents complained the medication failed to work.

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

The complaints were prepared by assistant attorney generals Jonathan D. Bonilla, Jessica L. Weltge, and Jordan Underhill.

Tris and its chief executive officer Tarik Ahmed are represented by E. Glenn Thames Jr. of Potter Minton in Tyler, and by Jason T. Brown of Jersey City, New Jersey.

None of the attorneys responded to a request for comment.