Texas secures $41.5 million settlement from Pfizer and Tris Pharma for knowingly poisoning kids with an adulterated ADHD drug
By ljdevon // 2025-11-21
 
For the parents of a child with ADHD, the daily ritual of administering medication is often a delicate balance, a tightrope walk between managing symptoms and navigating side effects. They place their trust in a system—a doctor’s prescription, a pharmacist’s dispensation, and the fundamental integrity of the drug maker—believing that the capsule or liquid will deliver what it promises. But what if the drug maker altered the testing methods to hide the drug's flaws and skirt regulatory scrutiny? This is the case with Pfizer and Tris Pharma, two drug makers who put vulnerable children at risk while defrauding taxpayers with bogus testing methods. Key points:
  • Texas Attorney General Ken Paxton secured a $41.5 million settlement from Pfizer and Tris Pharma over the ADHD drug Quillivant XR.
  • The lawsuit alleged the companies knowingly sold an "adulterated" drug to children on Medicaid from 2012 to 2018, despite it consistently failing quality control tests.
  • The companies are accused of repeatedly altering testing methods to hide the drug's flaws and ensure it passed regulatory scrutiny.
  • Internal and federal warnings about the drug's compromised effectiveness were allegedly ignored, and the state Medicaid program was never alerted.
  • The case was initially brought by a whistleblower, a former Tris Pharma executive.
  • This is part of a broader boldness of legal action by Paxton's office against major pharmaceutical companies.

The hidden flaws in the formula

The central figure in this legal drama is Quillivant XR, a liquid stimulant medication designed to help children with ADHD manage their symptoms. For a drug like this, consistency is everything. Its formulation must ensure a controlled release of the active ingredient, methylphenidate, to provide stable symptom control throughout a school day. The lawsuit filed by Attorney General Paxton in November 2023 alleges that for six years, Quillivant XR was anything but consistent. From 2012 to 2018, the drug exhibited a pattern of failing critical quality control tests, specifically those related to its dissolution rate—a key factor in how the medication is absorbed and functions in a child's body. Rather than addressing the root cause of these failures, the complaint claims Tris Pharma, the manufacturer, and Pfizer, the marketer of the drug, engaged in a deliberate campaign of concealment. They are accused of continually manipulating the drug's testing methodology, a technical but crucial sleight of hand that ensured Quillivant would meet regulatory requirements on paper while masking its underlying deficiencies. This was not a one-time error but a sustained practice of fraud, a shadow operation running parallel to the official manufacturing process. The lawsuit portrays this as a direct violation of federal and state laws, a fraud designed to keep a flawed product on the market. The human impact of this alleged deception was profound. During these years, families and doctors across Texas reported that the medication seemed to fail in its primary purpose, leaving children struggling with symptoms they believed were being managed. All the while, the companies reportedly possessed internal data and faced federal warnings pointing directly to the manufacturing problems that could cause this very lack of efficacy.

A whistleblower's call and a system's failure

Tarik Ahmed, who served as Tris Pharma’s head of technology from 2013 to 2017, stepped into the role of whistleblower, bringing forward the allegations that would eventually form the backbone of the state’s lawsuit. His account provided a crucial window into the internal practices at the manufacturing plant, detailing how the testing protocols were allegedly altered to sidestep the drug's persistent quality issues. This act of disclosure highlights the immense pressure that can exist within industries to maintain product lines and revenue streams, even when the integrity of the product itself is in question. The regulatory landscape in this story also comes under scrutiny. In 2018, the U.S. Food and Drug Administration delivered a damning assessment to Pfizer, informing the company that Quillivant had been "adulterated starting in 2012 and continuing into 2018." The FDA cited specifically the deficient manufacturing practices that affected the drug's dissolution. Despite this clear and unequivocal warning from the nation's primary drug safety regulator, the state’s complaint asserts that neither Pfizer nor Tris Pharma alerted the Texas Medicaid program. This silence had significant consequences. Texas Medicaid, unaware of the known issues, continued to reimburse for the drug, and its approved status within the program even became a selling point for the companies. The result, as stated in the legal filing, was that "thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance." For families relying on this treatment, the system of checks and balances had failed them at multiple levels, from the factory floor to the highest echelons of corporate management and into the regulatory channels meant to be their safeguard.

The Texas Attorney General's pharmaceutical crusade

For Texas Attorney General Ken Paxton, the Quillivant settlement is not an isolated event but rather a prominent victory in a widening campaign against the pharmaceutical industry. His office has positioned itself as a persistent challenger to some of the world's largest drugmakers, alleging various forms of misconduct that impact Texas citizens. In a statement that leaves little room for ambiguity, Paxton declared, "I will never back down from taking on the biggest corporations in the world that deceive and take advantage of Texans. Pfizer and Tris Pharma provided adulterated drugs to children for years and changed test results in order to obtain the benefit of taxpayer-funded Medicaid reimbursement. Under my watch, Big Pharma will not escape justice for lying about the effectiveness of its drugs." This assertive stance is reflected in a series of high-profile lawsuits. Just months before the Pfizer-Tris settlement, Paxton’s office sued Johnson & Johnson and Kenvue, alleging they misled pregnant women about the safety of Tylenol. Prior to that, Eli Lilly was targeted with a lawsuit accusing the company of bribing doctors to prescribe its lucrative drugs, including the diabetes and weight-loss medication Mounjaro. Even Pfizer faced a separate suit from Paxton regarding its COVID-19 vaccine, accused of making deceptive claims and attempting to silence critics. This pattern of litigation signals a clear and aggressive strategy from the Texas Attorney General’s office, one that treats the pharmaceutical industry as a primary arena for legal and regulatory confrontation. The $41.5 million settlement, while allowing the companies to deny any liability, represents a tangible outcome from this approach, recouping taxpayer funds, and imposing a legal mandate on the companies to adhere to manufacturing laws. Sources include: ChildrensHealthDefense.org OAG.State.Texas.com Enoch, Brighteon.ai