Attorney General Ken Paxton announced on Monday that he is suing Pfizer and the drug manufacturer Tris Pharma for allegedly committing fraud by providing adulterated pharmaceutical drugs to children.
A press release from the Office of the Attorney General (OAG) states that Pfizer contracted with Tris to produce a pediatric attention-deficit/hyperactivity disorder medication called Quillivant XR.
“Pfizer knowingly distributed Quillivant to children on Medicaid despite the drug’s pattern of failing quality control tests due to flawed manufacturing practices. 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,” claims the OAG press release.
The OAG alleges that Pfizer and Tris manipulated these results for a six-year period between 2012 and 2018, as many families reported that the medication was failing to work.
Paxton and his office hold that Tris and Pfizer knowingly misled the Medicaid program by claiming that Quillivant was in compliance with all federal and state requirements.
“At no point did Defendants warn Texas Medicaid providers or decision-makers that Quillivant had known manufacturing issues affecting its efficacy, thereby depriving the Medicaid program of the crucial information it relies on,” states the OAG filing.
The filing adds that this misrepresentation resulted in thousands of children in Texas receiving an “adulterated Schedule II Controlled Dangerous Substance.”
Due to this alleged misrepresentation, the two companies were reimbursed using taxpayer funds for the drug, thus defrauding the Texas Medicaid program, Paxton claims.
In the press release, Paxton said he is “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.”
Pfizer said in a statement reported by Reuters that it had previously investigated the allegations that led to the lawsuit but “did not find any impact on the safety of the product,” claiming the suit is without merit and that it would be moving to get the case dismissed.
Meanwhile, Tris wrote in an email to Reuters, “We categorically deny and intend to rigorously defend these allegations in the court of law.”
This lawsuit was initially filed under seal, but a judge granted the OAG’s request to remove the seal.