In a recently unsealed legal action on November 20, Pfizer and its partner Tris Pharma are accused of knowingly distributing adulterated medication to children.
The lawsuit, filed by Texas Attorney General Ken Paxton, alleges that Pfizer and Tris Pharma distributed Quillivant XR, a medication for children with attention-deficit/hyperactivity disorder (ADHD), despite being aware that it did not meet federal standards.
Although the U.S. Food and Drug Administration (FDA) approved Quillivant in 2012, subsequent quality control tests revealed its failure. Rather than addressing the root cause, as mandated by federal rules, Tris allegedly changed testing methods multiple times in an attempt to generate positive results, driven by financial pressure to rapidly increase production without adequate controls.
Quillivant, a Schedule II controlled dangerous substance, requires a black box warning about abuse, dependence, and potential side effects such as nausea, vomiting, and insomnia. Developed by Nextwave Pharmaceuticals and acquired by Pfizer in May 2012, the drug faced issues early on, with Tris attempting various unapproved testing methods to resolve them.
Despite consumer complaints dating back to 2013, Pfizer and Tris allegedly diverged on how to respond. While Tris aimed to investigate the complaints, Pfizer purportedly wanted to attribute them to poor titration. The companies' response, blaming patients and caregivers for improper handling, concealed vital information, leading to Texas authorities approving the medication for Medicaid.
Despite FDA notices in 2014 and 2015, Pfizer and Tris continued manufacturing and distributing the drug. In 2017, the FDA identified violations of federal rules, leading to a recall by Pfizer. The suit alleges that Tris advised Pfizer to halt supply until the violations were addressed, but Pfizer insisted on continuing production.
Pfizer's actions, including not notifying Texas authorities about the issues, are part of the alleged violation of the Texas Medicaid Fraud Prevention Act. The lawsuit seeks a jury trial, demanding repayment of all funds and benefits received by the companies due to the alleged illegal acts, along with additional penalties exceeding $1 million.
The suit, filed on November 8 in Harrison County court, was unsealed on November 20. Both Pfizer and Tris have not responded to requests for comment. Texas Attorney General Ken Paxton expressed his dismay at the uncovered dishonesty, emphasizing that Pfizer and Tris intentionally concealed issues with Quillivant to receive taxpayer-funded benefits, defrauding the state and putting children at risk.
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