Texas Attorney General Ken Paxton has sued Pfizer and its drug manufacturer for allegedly providing medicine it knew to be ineffective.
In a lawsuit unsealed Monday, Paxton sued Pfizer, Inc., Tris Pharma, Inc. and Tris CEO Ketan Mehta, accusing both companies of defrauding the state to get children's ADHD medicine Quillivant XR added to the state’s list of preferred drugs under the Medicaid insurance program for low-income people. The drug previously failed to meet quality standards, he said.
According to Paxton, Pfizer and Tris "continually" manipulated quality-test results from 2012 to 2018 to obtain the benefit of taxpayer-funded Medicaid reimbursement for Quillivant.
"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," he claimed.
"I am horrified by the dishonesty we uncovered in this investigation," said 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."
Paxton alleged Pfizer knowingly distributed Quillivant to children despite it failing quality control tests and its flawed manufacturing practices.
"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 filing explained.
The Texas attorney general also said many Texas families complained that Quillivant was not effective.
The U.S. Food and Drug Administration previously warned Tris of manufacturing lapses in 2017, according to the filing. The complaint notes, however, "While these events are not necessarily connected, regulatory [agencies] must have confidence that they are not."
The lawsuit stems from a whistleblower complaint by Tarik Ahmed, who worked as Tris' head of technology from 2013 to 2017, Reuters reported.
Nextwave Pharmaceuticals developed Quillivant XR. The company was acquired by Pfizer in 2012.
The state of Texas is seeking monetary payments equal to any monetary or in-kind benefits Pfizer and Tris received due to the alleged violations as well as other civil penalties.
Reuters contributed to this report.