We were talking about bias in the Statistics class that I support, and a lively discussion was had about bias in the media. Given that many autistic people are on ADD / ADHD medications, I thought about this case and how it is being reported in various outlets.
This lawsuit alleges violations of the Texas Medicaid Fraud Prevention Act (TMFPA) by pharmaceutical companies Pfizer, Tris Pharma, and Tris CEO Ketan Mehta related to the medication Quillivant XR. From reading the filing, the key allegations are:
Tris struggled to consistently manufacture Quillivant to meet quality standards and specifications. Beginning in 2012, Quillivant repeatedly failed required quality control tests, including dissolution testing and particle size testing.
Rather than properly investigate the root causes of these failures as required by FDA regulations, Tris made unauthorized changes to its testing procedures, like adding a sonication step, to make it easier for Quillivant to pass tests. This rendered the testing unrepresentative of real-world usage.
Pfizer had oversight responsibilities over Tris but failed to ensure appropriate manufacturing practices were followed. Neither company informed regulators of Quillivant's quality issues even as they promoted and distributed the drug.
By concealing Quillivant's quality issues, the defendants were able to get Quillivant included on the Texas Medicaid formulary and Preferred Drug List, resulting in widespread prescribing to Medicaid patients and millions in improper Medicaid reimbursements.
Through these actions, the defendants violated regulations prohibiting drug adulteration and made false statements/misrepresentations to Texas Medicaid, violating the TMFPA.
The lawsuit seeks reimbursement of Medicaid funds paid for Quillivant, civil penalties, costs and fees, and injunctive relief under the TMFPA for the defendants' fraudulent and unlawful conduct.
If you read the story on the NYP, you might notice that much of what I just listed isn’t in their story. The article gets some key facts right, but also contains some inaccuracies:
True:
Lawsuit alleges Pfizer and Tris Pharma defrauded Texas Medicaid program regarding ADHD drug Quillivant XR
Lawsuit claims Quillivant failed quality control tests and was adulterated
Lawsuit alleges defendants manipulated testing and hid issues from regulators
Thousands of Texas Medicaid children received Quillivant
Texas is seeking damages, fines, and return of Medicaid funds
Inaccurate / Misleading:
No evidence Pfizer intentionally provided adulterated medications or was aware of all of Tris' issues
No mention that Tris was the manufacturer responsible for production issues
Suggests issues stemmed directly from deficient manufacturing, when root causes were more complex
Timeline condenses issues that unfolded over nearly a decade
No proof Pfizer blamed only patients / caregivers for lack of effect complaints
No evidence Pfizer intentionally concealed any info from Texas Medicaid decision-makers
So whilst the article captures the crux of the lawsuit's allegations regarding fraud and adulteration related to Quillivant XR, some details are overstated or presented without full context. The mention of an unrelated Dyanavel lawsuit seems irrelevant here.
So why would the write the article in the way that they did?
The ruling political class may have certain regulatory or legislative changes they wish to pursue to advance their interests - for example, heightened scrutiny or regulation of the pharmaceutical industry. To smooth the path for these efforts, it's helpful to have public sentiment aligned with outrage at big pharma "bad behavior."
This is where sensationalized media coverage can come in. The media outlets, often owned by corporations and elite individuals tied to the ruling political class, oblige by producing attention-grabbing headlines and coverage filled with words like "scandalous" or "horrifying dishonesty." This triggers public anger and builds consensus that "something must be done."
It can create a feedback loop - the media coverage shapes support for the priorities of politicians, and then politicians respond with promised actions, citing the now agreed-upon media narrative that wrongdoing is rampant. This allows new policies, agency funding, expanded powers, or regulations to be pushed through more easily, now that the public is demanding action against an industry portrayed as rogue.
Of course, the true calculation, motivations, and intricacies behind the issue are papered over in this consensus-building process. And the policies that emerge may ultimately benefit the ruling class more than ordinary Americans. But the media's role can be indispensable - inflaming public outrage such that the political class has an open runway to pursue its aims. This is an important illustration of how the media can align with elite interests, even if unintentionally.
In the lawsuit, how much in damages do individuals receive?
When analyzing this lawsuit under the Texas Medicaid Fraud Prevention Act, the complex legal reality is that the true beneficiaries are unlikely to be the vulnerable patient populations allegedly harmed. Rather, the plaintiffs’ lawyers and the State of Texas stand to reap the most significant gains if successful.
Whilst this lawsuit aims to hold pharmaceutical companies accountable for regulatory violations and lapses related to the ADHD drug Quillivant XR, the relief sought is centered on refunding state Medicaid expenses and extracting financial penalties. Individual patients harmed by potential side effects from this medication do not appear eligible for any direct compensation from litigation outcomes. No specific patient damages are enumerated within the pleadings.
Instead, the Texas Attorney General’s Office and affiliated outside counsel seem likely to gain the most financially. Through attorneys fees, investigation cost reimbursements, and other expense recouping mechanisms built into statutes like the TMFPA, the lawyers and their governmental clients could secure millions in payouts on top of any penalties or policy changes achieved.
Additionally, whilst state regulators may benefit from increased scrutiny and oversight powers over the pharmaceutical industry won through high-profile litigation, patients still lack personal remedies for experiences of medical harm. Their role in these lawsuits is primarily to illustrate aggregate system-wide fraud and misconduct rather than achieve patient-level restitution.
So in complex cases brought under Medicaid fraud-oriented statutes, the reality is that physicians, pharmacists, and vulnerable patient groups rarely end up financially made whole. The chosen few empowered by any judgment typically are the enterprising lawyers who litigate the case as well as governmental actors seeking to expand their legal and regulatory reach. For those truly injured by corporate malfeasance, alternative and more-victim centered legal avenues may be required for proper compensation. Class action or personal injury litigation better serve that purpose over Medicaid anti-fraud actions.
The AutSide is a reader-supported publication. To support my work, consider becoming a paid subscriber.
Texas sues Pfizer over ADHD meds
Texas sues Pfizer over ADHD meds
Texas sues Pfizer over ADHD meds
A recent article from the New York post notes that Texas’ AG has sued Pfizer over problems with ADHD meds. Here’s a copy of the filing.
We were talking about bias in the Statistics class that I support, and a lively discussion was had about bias in the media. Given that many autistic people are on ADD / ADHD medications, I thought about this case and how it is being reported in various outlets.
This lawsuit alleges violations of the Texas Medicaid Fraud Prevention Act (TMFPA) by pharmaceutical companies Pfizer, Tris Pharma, and Tris CEO Ketan Mehta related to the medication Quillivant XR. From reading the filing, the key allegations are:
Tris struggled to consistently manufacture Quillivant to meet quality standards and specifications. Beginning in 2012, Quillivant repeatedly failed required quality control tests, including dissolution testing and particle size testing.
Rather than properly investigate the root causes of these failures as required by FDA regulations, Tris made unauthorized changes to its testing procedures, like adding a sonication step, to make it easier for Quillivant to pass tests. This rendered the testing unrepresentative of real-world usage.
Pfizer had oversight responsibilities over Tris but failed to ensure appropriate manufacturing practices were followed. Neither company informed regulators of Quillivant's quality issues even as they promoted and distributed the drug.
By concealing Quillivant's quality issues, the defendants were able to get Quillivant included on the Texas Medicaid formulary and Preferred Drug List, resulting in widespread prescribing to Medicaid patients and millions in improper Medicaid reimbursements.
Through these actions, the defendants violated regulations prohibiting drug adulteration and made false statements/misrepresentations to Texas Medicaid, violating the TMFPA.
The lawsuit seeks reimbursement of Medicaid funds paid for Quillivant, civil penalties, costs and fees, and injunctive relief under the TMFPA for the defendants' fraudulent and unlawful conduct.
If you read the story on the NYP, you might notice that much of what I just listed isn’t in their story. The article gets some key facts right, but also contains some inaccuracies:
True:
Lawsuit alleges Pfizer and Tris Pharma defrauded Texas Medicaid program regarding ADHD drug Quillivant XR
Lawsuit claims Quillivant failed quality control tests and was adulterated
Lawsuit alleges defendants manipulated testing and hid issues from regulators
Thousands of Texas Medicaid children received Quillivant
Texas is seeking damages, fines, and return of Medicaid funds
Inaccurate / Misleading:
No evidence Pfizer intentionally provided adulterated medications or was aware of all of Tris' issues
No mention that Tris was the manufacturer responsible for production issues
Suggests issues stemmed directly from deficient manufacturing, when root causes were more complex
Timeline condenses issues that unfolded over nearly a decade
No proof Pfizer blamed only patients / caregivers for lack of effect complaints
No evidence Pfizer intentionally concealed any info from Texas Medicaid decision-makers
So whilst the article captures the crux of the lawsuit's allegations regarding fraud and adulteration related to Quillivant XR, some details are overstated or presented without full context. The mention of an unrelated Dyanavel lawsuit seems irrelevant here.
So why would the write the article in the way that they did?
The ruling political class may have certain regulatory or legislative changes they wish to pursue to advance their interests - for example, heightened scrutiny or regulation of the pharmaceutical industry. To smooth the path for these efforts, it's helpful to have public sentiment aligned with outrage at big pharma "bad behavior."
This is where sensationalized media coverage can come in. The media outlets, often owned by corporations and elite individuals tied to the ruling political class, oblige by producing attention-grabbing headlines and coverage filled with words like "scandalous" or "horrifying dishonesty." This triggers public anger and builds consensus that "something must be done."
It can create a feedback loop - the media coverage shapes support for the priorities of politicians, and then politicians respond with promised actions, citing the now agreed-upon media narrative that wrongdoing is rampant. This allows new policies, agency funding, expanded powers, or regulations to be pushed through more easily, now that the public is demanding action against an industry portrayed as rogue.
Of course, the true calculation, motivations, and intricacies behind the issue are papered over in this consensus-building process. And the policies that emerge may ultimately benefit the ruling class more than ordinary Americans. But the media's role can be indispensable - inflaming public outrage such that the political class has an open runway to pursue its aims. This is an important illustration of how the media can align with elite interests, even if unintentionally.
In the lawsuit, how much in damages do individuals receive?
When analyzing this lawsuit under the Texas Medicaid Fraud Prevention Act, the complex legal reality is that the true beneficiaries are unlikely to be the vulnerable patient populations allegedly harmed. Rather, the plaintiffs’ lawyers and the State of Texas stand to reap the most significant gains if successful.
Whilst this lawsuit aims to hold pharmaceutical companies accountable for regulatory violations and lapses related to the ADHD drug Quillivant XR, the relief sought is centered on refunding state Medicaid expenses and extracting financial penalties. Individual patients harmed by potential side effects from this medication do not appear eligible for any direct compensation from litigation outcomes. No specific patient damages are enumerated within the pleadings.
Instead, the Texas Attorney General’s Office and affiliated outside counsel seem likely to gain the most financially. Through attorneys fees, investigation cost reimbursements, and other expense recouping mechanisms built into statutes like the TMFPA, the lawyers and their governmental clients could secure millions in payouts on top of any penalties or policy changes achieved.
Additionally, whilst state regulators may benefit from increased scrutiny and oversight powers over the pharmaceutical industry won through high-profile litigation, patients still lack personal remedies for experiences of medical harm. Their role in these lawsuits is primarily to illustrate aggregate system-wide fraud and misconduct rather than achieve patient-level restitution.
So in complex cases brought under Medicaid fraud-oriented statutes, the reality is that physicians, pharmacists, and vulnerable patient groups rarely end up financially made whole. The chosen few empowered by any judgment typically are the enterprising lawyers who litigate the case as well as governmental actors seeking to expand their legal and regulatory reach. For those truly injured by corporate malfeasance, alternative and more-victim centered legal avenues may be required for proper compensation. Class action or personal injury litigation better serve that purpose over Medicaid anti-fraud actions.
The AutSide is a reader-supported publication. To support my work, consider becoming a paid subscriber.