The suit alleges Pfizer knowingly distributed Quillivant XR, a drug used for treating attention-deficit/hyperactivity disorder, to children on Medicaid — despite the drug’s pattern of failing quality control tests.
Acting on behalf of the state of Texas, Attorney General Ken Paxton on Monday unsealed a lawsuit against Pfizer and its drug manufacturer, Tris Pharma, alleging the companies sold medication to children even though they knew the drug was ineffective and potentially unsafe.
The suit, filed in the Harrison County District Court, alleges Pfizer knowingly distributed a drug used for treating attention-deficit/hyperactivity disorder (ADHD) to children on Medicaid — despite the drug’s pattern of failing quality control tests.
The drug, Quillivant XR, is a stimulant that affects brain and nerve chemicals involved in hyperactivity and impulse control.
From 2012-2018, “Pfizer and Tris continually manipulated Quillivant testing to hide poor manufacturing practices and defraud the Texas Medicaid program,” according to a press release.
During those years, many families complained that the medication failed to work. According to the complaint:
“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. … As a result, thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance.”
In a tweet, Paxton said:
Commenting on the lawsuit, Kim Mack Rosenberg, acting general counsel for Children’s Health Defense, said, “Pfizer once again is in the spotlight for alleged unethical and fraudulent activity.”
Rosenberg told The Defender:
“I applaud the Texas AG for taking action here to protect some of Texas’s most vulnerable children, those who rely on Medicaid for healthcare. To knowingly supply adulterated medication to vulnerable children is inexplicable and unconscionable.”
“Unfortunately,” Rosenberg added, “this is not the first time questions have been raised about Pfizer’s conduct, including wrongdoing allegedly resulting in children dying in clinical trials in Nigeria in the 1990s and serious questions about Pfizer’s COVID-19 injections and its treatment medication Paxlovid.”
Defendants in the suit include Pfizer, Tris and Tris CEO Ketan Mehta.
The lawsuit stemmed from a whistleblower complaint made by Tarik Ahmed, who served as Tris’ technology chief from 2013-2017.
The lawyers are suing for more than $1 million, including civil penalty fees, and are asking the court to force Pfizer and Tris to pay back to the state of Texas all profits received from selling Quillivant in the Texas Medicaid program “as a result of Defendants’ unlawful acts” and, additionally, to pay back double that amount.
Lawyers with Paxton’s office requested a trial by jury.
In 2017, Quillivant grossed roughly $193.3 million in U.S. sales. The drug was developed by NextWave Pharmaceuticals, which Pfizer bought in 2012 for $680 million.
The lawyers charged the defendants with defrauding the Texas Medicaid program “by providing adulterated pharmaceutical drugs to Texas children in violation of the Texas Medicaid Fraud Prevention Act, now known as the Texas Health Care Program Fraud Prevention Act (‘THFPA’).”
The press release said, “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.”
According to Reuters, Pfizer said in a statement that it had examined the suit’s allegations on “multiple occasions” and “did not find any impact on the safety of the product.”
Pfizer said the case has no merit and will move to dismiss it.
A Tris spokesperson told Reuters in an email, “We categorically deny and intend to rigorously defend these allegations in the court of law.”
Drug failed quality control tests for years
Almost immediately after getting U.S. Food and Drug Administration (FDA) approval, Quillivant began failing routine quality tests. According to the complaint:
“Beginning at least as early as October 2012, Tris quality control personnel observed that sample of Quillivant tested under FDA-required dissolution specifications were not generating passing results.
“Dissolution testing is an important quality control tool used to measure whether a drug was properly manufactured, by comparing a simulated release of the drug to a standard set upon the drug’s initial approval.
“This in turn helps to predict whether the drug (as manufactured) will be released as expected in a patient’s body — which is critical for ensuring proper and consistent patient dosing.”
The Quillivant samples formed lumps during the reconstitution phase of the test.
Instead of investigating why there were lumps, Tris “retrained” its analysts to shake the water/drug mixture longer and to conduct the test only when “foaming is absent from the suspension,” the filing said.
Even with these changes, Quillivant continued to fail dissolution tests. Tris then stopped using that testing method and switched to a new method.
“Alarmingly,” the filing said, “the new test method was not representative of real-world usage by patients, and worse, went against the pharmacy reconstitution instructions contained in the FDA-approved label for Quillivant.”
When quality control issues continued to arise, the companies told the FDA a “misleading” and “convenient narrative to explain away the problem.”
Pfizer wanted to ‘fully exploit the economic potential of Texas Medicaid’
Meanwhile, Pfizer was petitioning Texas Medicaid to get Quillivant added to the program’s preferred drug list — but said nothing about the drug’s ongoing and unresolved quality control issues.
The FDA on March 26, 2018, sent a warning letter to Pfizer, informing the company that Quillivant was “adulterated starting in 2012 and continuing into 2018.”
Yet “even after receiving this clear and unequivocal assessment, neither Tris nor Pfizer alerted Texas Medicaid decision-makers to the FDA’s serious findings,” the filing said.
The suit alleges that the companies avoided telling Texas Medicaid about the issues because “Quillivant’s status with Texas Medicaid became a selling point.” The filing said:
“Tris and Pfizer both recognized that Texas Medicaid business would be crucial for Quillivant’s success.
“To fully exploit the economic potential of Texas Medicaid, Defendants needed Medicaid decision-makers to add Quillivant to the VDP [Vendor Drug Program] Formulary and the Preferred Drug List.
“These steps would effectively allow Medicaid providers to prescribe Quillivant to their Medicaid patients and would streamline the prescribing process by eliminating the need for the treating doctor to go through the burdensome process of obtaining prior authorization.”
Pfizer projected that Quillivant sales in Texas would significantly increase if the drug were added to the Texas Medicaid Preferred Drug List, as Texas was a “populous state with a disproportionately high percentage of children covered by Medicaid,” according to the complaint.
The Civil Medicaid Fraud Division of Paxton’s office undertook the investigation.
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