Texas Sues Pfizer and Tris for Supplying Children With ‘Adulterated’ Drugs

A man walks past the Pfizer headquarters in New York on March 11, 2021. Kena Betancur/AFP/Getty Images

Texas Attorney General Ken Paxton filed a lawsuit against pharma firms Pfizer and Tris, claiming that they hid manufacturing defects in a children’s drug.

“Today, I have filed suit against Pfizer and Tris Pharma for defrauding Texas Medicaid and providing adulterating pharmaceuticals to children. I am horrified by the dishonesty we uncovered in this investigation,” Mr. Paxton said in an X post on Nov. 21.

“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.”

Quillivant XR is a pediatric drug for attention-deficit/hyperactivity disorder (ADHD).

Quillivant was originally developed by Nextwave Pharmaceuticals, in which Tris held a 5 percent stake. When Nextwave was acquired by Pfizer in 2012, Pfizer kept Tris as the manufacturer of Quillivant. Six years later, Tris acquired the drug in 2018.

In a Nov. 20 press release, Mr. Paxton’s office accused Pfizer of “knowingly” distributing the drug to children on Medicaid despite “the drug’s pattern of failing quality control tests due to flawed manufacturing practices.”

Between 2012 and 2018, the pharma companies allegedly “manipulated” the testing of Quillivant to hide poor manufacturing processes. During this time, many families complained that the medication did not work, the release said.

“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, and concealed from Medicaid decision-makers the fact that Quillivant was an adulterated drug.”

Due to such concealments and misrepresentations, both Pfizer and Tris were able to ensure that Medicaid reimbursement was available for Quillivant, the lawsuit said, allowing thousands of Texas children to receive “an adulterated Schedule II Controlled Dangerous Substance.”

Mr. Paxton alleges that the actions of the pharma companies violate the Texas Medicaid Fraud Prevention Act, now known as the Texas Health Care Program Fraud Prevention Act (THFPA).

A spokesperson from Tris told Reuters in an email statement, “We categorically deny and intend to rigorously defend these allegations in the court of law.”

Pfizer claimed in a statement that it had looked into the allegations on “multiple occasions” but failed to find “any impact on the safety of the product.” It insisted that the case had no merit and would move to dismiss it.

The lawsuit came as a result of a whistleblower complaint filed by Tarik Ahmed, who was the head of technology at Tris between 2013 and 2017.

Pfizer’s 2022 annual report revealed that it received a subpoena from federal prosecutors in the Southern District of New York over ties with Tris and the manufacture of Quillivant in 2018.

The Texas lawsuit alleges that "thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance.” klimkin/Pixabay

The Vendor Drug Program (VDP) under the Texas Health and Human Services Commission (HHSC) is tasked with overseeing the outpatient drug prescription portion of the state’s Medicaid program.

It is also charged with “safeguarding against fraud, waste, and abuse within the program,” said the lawsuit.

Healthcare providers can obtain Medicaid reimbursement for drugs through VDP as long as these medications are approved under the program and are listed in the VDP formulary.

‘Truthful, and Up to Date’

To get a drug listed in the VDP formulary, the manufacturer must file a “complete, truthful, and up-to-date” application with the VDP.

Manufacturers must certify that “their drug is not in violation of either state or federal law.” The program can reject an application for “false, erroneous, or incomplete information.”

According to the lawsuit, Pfizer successfully campaigned to get Quillivant added to the Texas Medicaid formulary in 2013. The company certified on its VDP application form that the drug did not violate any state and federal law and agreed to the program’s requirement of notifying VDP of any changes in “formulation, product status price, or availability.”

Just before Pfizer submitted its application to VDP, Quillivant started failing routine quality tests, the lawsuit notes. Due to financial pressure to manufacture large quantities of the drug, Tris attempted to boost production without adhering to protocols mandating acceptable standards, the suit says. This allegedly led to defects in the drug’s manufacturing process.

The lawsuit accuses Pfizer and Tris of modifying a “dissolution test” required on the drug so as to “conceal manufacturing defects,” thus violating the U.S. Food and Drug Administration’s (FDA) regulations.

Tris is accused of halting the dissolution tests under an existing method and instead “creating a new test under which its defective product could meet FDA criteria.”

The complaint also insists that the defendants failed to “properly investigate numerous complaints regarding Quillivant and lack of effect.”

Pfizer and Tris “understood the link between Quillivant’s quality control failures and the lack of effect complaints. Yet at no point did Defendants warn Texas Medicaid providers or decision-makers that Quillivant had known manufacturing issues affecting its efficacy,” the lawsuit stated.

“Defendants thereby deprived the Medicaid program of the crucial information it relies on to ensure the safety and quality of care provided to Medicaid beneficiaries.”

The lawsuit asks for civil remedies and penalties against Pfizer and Tris.

The Epoch Times reached out to Pfizer and Tris for comment.