Texas Attorney General Takes Legal Action Against Pfizer Over Quality-Control Concerns in Children’s ADHD Medication

Texas Attorney General Takes Legal Action Against Pfizer Over Quality-Control Concerns in Children's ADHD Medication

South Texas – November 22, 2023

In a noteworthy legal turn of events, Texas Attorney General Ken Paxton has initiated legal proceedings against Pfizer (PFE.N), a pharmaceutical behemoth, and its supplier, “Tris Pharma.” The lawsuit alleges that the companies knowingly supplied ADHD medication for children to the state’s Medicaid insurance program for low-income individuals, with the awareness that it might lack effectiveness. The lawsuit, unsealed on Monday in the Harrison County, Texas District Court, alleges that Pfizer and Tris manipulated quality-control testing for the ADHD drug Quillivant XR between 2012 and 2018, potentially putting young patients at risk.

The lawsuit contends that Pfizer and Tris engaged in deceptive practices by manipulating quality-control tests required under federal law. According to the legal filing, properly conducted tests often revealed that Quillivant XR failed to dissolve as intended, indicating that the medication might not be released in the body as expected.

The legal action also asserts that, despite being aware of the quality-control issues, Pfizer persuaded Texas’ Medicaid program to include Quillivant in its list of preferred drugs. Texas Attorney General Paxton alleges that numerous families in the state complained that Quillivant was ineffective in treating ADHD.

“I am horrified by the dishonesty we uncovered in this investigation,” stated Paxton, a Republican, emphasizing the seriousness of the allegations. The lawsuit accuses Pfizer and Tris of defrauding the state’s Medicaid program and seeks unspecified monetary damages from the companies.

Pfizer responded to the allegations in a statement, stating that it had examined the complaint on “multiple occasions” and found no impact on the safety of the product. The pharmaceutical company expressed its belief that the case had no merit and announced its intention to move for dismissal.

Tris Pharma, the supplier of Quillivant until 2018 when it acquired the product from Pfizer, vehemently denied the allegations in an email statement. The company declared its categorical denial and expressed its commitment to rigorously defending against the accusations in a court of law.

The origin of the lawsuit can be traced back to a whistleblower complaint by Tarik Ahmed, who served as Tris’ head of technology from 2013 to 2017. Quillivant XR was initially developed by Nextwave Pharmaceuticals, a company acquired by Pfizer in 2012. Tris Pharma took over the product in 2018.

Quillivant XR, like other medications for attention-deficit/hyperactivity disorder (ADHD), has faced challenges such as shortages and has not achieved a large national market share. The “U.S. Food and Drug Administration (FDA)” issued a warning to Tris in 2017 regarding manufacturing lapses.

In its 2022 annual report, Pfizer revealed that it had been served a subpoena by federal prosecutors in the Southern District of New York, situated in Manhattan. The subpoena pertained to Pfizer’s association with Tris and the manufacturing of Quillivant in 2018. However, Pfizer stated that it had not received any further communication after responding to the subpoena.

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