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Pfizer and Tris Pharma reached a $41.5 million settlement with Texas after the state accused them of knowingly pushing a defective attention-deficit/hyperactivity disorder (ADHD) drug on thousands of Medicaid children for years, even as warnings mounted that the medicine didn’t work.
“I will never back down from taking on the biggest corporations in the world that deceive and take advantage of Texans,” Texas Attorney General Ken Paxton said in a press release on Wednesday.
The settlement resolves the state’s 2023 claims, which accused Pfizer and Tris of violating multiple federal and state laws.
The lawsuit said both companies “knowingly distributed” Quillivant XR, a liquid medication for children, despite internal and federal warnings that the drug was compromised. Tris manufactured the medication for Pfizer.
Both companies denied “any and all liability and wrongdoing” as part of the settlement, STAT reported.
Pfizer said the deal covers “historic allegations” about a product it stopped marketing in 2018. Both companies insist their own reviews found no safety issues. A Tris spokesperson said the company “fully stand[s] by the quality of our Quillivant.”
Children’s Health Defense General Counsel Kim Mack Rosenberg called the settlement “a substantial one.” She said:
“While use of ADHD medication is sometimes a controversial issue, for those who do take these medications, they should be able to have assurance that the products have met standards. Sadly, this lawsuit arose out of the defendants’ failure to meet standards — impacting some of the most vulnerable children, Medicaid recipients.”
‘Thousands of Texas children’ took adulterated drug
According to the lawsuit, the companies ignored clear warnings that the drug was defective. Tris repeatedly altered its testing methods between 2012 and 2018 to ensure the drug met regulatory requirements, while Pfizer — which marketed the Quillivant — misled Texas Medicaid officials by insisting the drug was properly manufactured.
“I am horrified by the dishonesty we uncovered in this investigation,” Paxton said in a 2023 press release announcing the lawsuit.
During those years, families across Texas reported that the medicine failed to control their children’s ADHD symptoms. Yet, according to the lawsuit, the companies never disclosed known manufacturing issues that could affect the drug’s efficacy.
In 2018, the U.S. Food and Drug Administration told Pfizer that Quillivant had been “adulterated starting in 2012 and continuing into 2018,” citing deficient manufacturing practices that affected how the medication dissolved in the body.
Despite that “clear and unequivocal assessment,” the complaint said, neither company alerted Texas Medicaid, which continued to reimburse for the drug. Quillivant’s status with Texas Medicaid even “became a selling point.”
“As a result, thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance,” the complaint said.
The case traces back to a whistleblower, Tarik Ahmed, Tris Pharma’s head of technology from 2013 to 2017.
In 2012, Pfizer agreed to buy Quillivant’s developer, NextWave Pharmaceuticals, for up to $700 million. In 2017, Quillivant grossed roughly $193.3 million in U.S. sales. Tris manufactured the drug for Pfizer until 2018, when the company bought the product outright.
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Paxton has history of targeting major drugmakers
In October, Paxton sued Johnson & Johnson and Kenvue, alleging they misled pregnant women by marketing Tylenol as safe despite studies raising concerns about links to autism and other disorders.
In August, he sued Eli Lilly, alleging the company bribed doctors to prescribe its most lucrative drugs, including the GLP-1 medications Mounjaro and Zepbound.
And in November 2023, Paxton sued Pfizer, accusing the company of making false and deceptive claims about its COVID-19 vaccine and trying to silence critics who challenged those claims.
Related articles in The Defender
- Texas Sues Pfizer for ‘Endangering Children’ by Selling Ineffective ADHD Drug
- Texas AG Sues Tylenol Makers for Hiding Autism Risks, Misleading Pregnant Women
- Texas AG Sues Eli Lilly for ‘Bribing’ Doctors to Prescribe High-Profit Drugs
- Texas Sues Pfizer for ‘False’ and ‘Deceptive’ Marketing of COVID Vaccines
