In a bold move to address corporate malpractice in drug manufacturing, Texas Attorney General Ken Paxton has announced the filing of a lawsuit against pharmaceutical giants Pfizer, Inc., Tris Pharma, Inc., and Tris Pharma CEO Ketan Mehta.
The companies are accused of engaging in deceitful practices that resulted in defrauding the Texas Medicaid program by providing adulterated pharmaceutical drugs specifically designed for children.
The lawsuit, brought forth by the Attorney General’s Civil Medicaid Fraud Division, leverages the provisions of the Texas Health Care Program Fraud Prevention Act (THFPA).
Paxton’s office stated that Pfizer and Tris Pharma collaborated to produce and distribute Quillivant XR, a medication developed for pediatric attention-deficit/hyperactivity disorder (ADHD), despite recurring failure in quality control assessments.
“Though Quillivant is approved by the FDA as acceptably safe and effective for ADHD when taken as directed, it still has risks associated with normal use. According to the FDA, the most common adverse reactions include insomnia, nausea, vomiting, anxiety, and tachycardia.
The filing states, “There is also a chance for patients to experience severe side effects, including serious cardiovascular reactions (which can cause sudden death), psychiatric adverse reactions (including mania), and long-term suppression of growth. Additionally, when Quillivant is not taken at the correct dose, patients could experience an overdose requiring emergency medical intervention.”
According to investigations, for several years, Tris Pharma actively manipulated the drug’s testing procedures to sidestep federal and state regulations, ensuring Quillivant XR remained in the market. During this period, Pfizer was fully aware of the malpractices but continued to supply the medication for Medicaid-covered children, falsely assuring that it conformed to legal standards.
The deceit not only compromised the integrity of the Texas Medicaid program but also risked the well-being of the children who received Quillivant XR. Family reports indicate that the drug was often ineffective, aligning with the periods when Tris Pharma reportedly tampered with the quality tests.
“Under the FDCA, it is illegal to adulterate a drug, or to introduce into interstate commerce any drug that is adulterated. A drug becomes adulterated if “the methods used in, or the facilities or controls used for, its manufacture … do not conform to or are not operated or administered in conformity with current good manufacturing practice,” the filing stated.
“I am horrified by the dishonesty we uncovered in this investigation. 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,” said Attorney General Paxton in a statement.
In an X post, Paxton wrote: “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. 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. Our Civil Medicaid Fraud Division has done an outstanding job holding these pharmaceutical companies accountable.”