Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families.
The complaint, which was unsealed on Monday, claims that the companies knew that deficient manufacturing processes reduced the effectiveness of Quillivant XR. The lawsuit also claims the companies manipulated quality-control testing from 2012 to 2018 to ensure samples received passing grades.
During that time, many families complained that Quillivant XR did not work, the suit alleges. Properly executed tests showed that the drug did not dissolve as it was designed, preventing it from being released in the body, Texas' lawsuit claims.
“Pfizer examined the historic allegations detailed in the complaint on multiple occasions and did not find any impact on the safety of the product,” the company said in an emailed statement. “Pfizer believes that the state’s case has no merit and will move to dismiss the case in due course.”
The lawsuit is the result of a whistleblower complaint from Tarik Ahmed, who served as Tris’ technology chief from 2013 to 2017.
Tris Pharma did not respond immediately to a request for comment.
In 2018, the FDA hit Tris with a warning letter from a 2017 inspection that turned up numerous production issues. The regulator said that Tris “lacked thorough investigations into root causes and failed to implement prompt and effective corrective actions and preventative actions.”
Quillivant was developed by NextWave Pharmaceuticals, which Pfizer acquired in 2012 for $680 million. Sales of Quillivant reached $193 million in 2017. In 2018, a shortage issue caused Quillivant to lose its small portion of market share, according to an SEC filing. Pfizer sold the product line to Tris in 2018.