November 2, 2023

Title: Pfizer Faces Lawsuit for Allegedly Distributing Adulterated ADHD Drug to Children

Summary:
Pfizer, in collaboration with partner Tris Pharma, is facing a lawsuit filed by Texas Attorney General Ken Paxton, accusing the pharmaceutical giants of knowingly distributing adulterated medication to children. The lawsuit alleges that Pfizer and Tris distributed Quillivant XR, a drug for attention-deficit/hyperactivity disorder (ADHD), despite being aware that it did not meet federal standards. The U.S. Food and Drug Administration (FDA) had approved Quillivant in 2012, but subsequent quality control failures prompted the lawsuit. Tris Pharma, under financial pressure to increase production, allegedly changed testing methods to generate positive results, violating federal rules. The lawsuit claims that Pfizer concealed information, leading to the drug’s approval for Medicaid use in Texas. Consumers reported issues as early as 2013, but Pfizer and Tris allegedly responded divergently, with Pfizer blaming poor titration and Tris wanting to investigate complaints. Despite FDA notices in 2014 and 2015, the companies continued manufacturing until 2017 when Pfizer recalled some lots due to testing failures. The lawsuit seeks a jury trial, payment recovery, and penalties exceeding $1 million. Pfizer and Tris have not responded to requests for comment.

[Note: The information provided here is based on the available article, and any further developments or updates may not be included.]