FDA Declines Court Request to Comment on Proposed Warning Label in Tylenol Autism Litigation

FDA Declines Court Request to Comment on Proposed Warning Label in Tylenol Autism Litigation

Although the U.S. Food and Drug Administration approved acetaminophen (name brand, Tylenol) for prescription in 1950 and over-the-counter consumption in 1955, recent reports suggest that prenatal use of Tylenol may be linked to serious developmental disorders. As the scientific community investigates this alarming discovery, a variety of families whose children developed attention deficit / hyperactivity disorder (ADHD) and autism are mounting a legal challenge against the manufacturers and distributors of the popular pain relief medication. 

On September 8, the FDA responded to an official court request to comment on the accuracy and aptness of an updated label plaintiffs proposed in April 2023 that would sufficiently warn pregnant women of the risks associated with prenatal acetaminophen use. The agency “decline[d] to comment” and, instead, mentioned the inconclusive findings of its March 2023 literature review. 

What Does the FDA’s Tylenol Lawsuit Response to the Court Say? 

The 34-page court filing, which represents the FDA’s response to Judge Denise L. Cote’s request for comment, “respectfully” refrains from answering two questions which she posed to the administration in April about the accuracy of a proposed disclosure for OTC acetaminophen. Written by Jacob Lillywhite, an Assistant United States Attorney, the brief reply also contains a copy of the FDA’s March 2023 literature review of “the safety of acetaminophen (APAP) use during pregnancy” to supplement the page-long declination. 

Overall, the FDA Tylenol literature review concludes that “the limitations and inconsistent findings” of observational research are insufficient to establish a causal connection between prenatal acetaminophen use and subsequent developmental disorders. 

This critical moment in the Tylenol autism lawsuit will likely prove consequential for the way in which litigants employ expert testimonies to bolster their claims. Establishing itself as a neutral player, the FDA’s conservative move also illustrates the administration’s reticence to intrude in the lawsuits surrounding medications it has approved. 

Why Did the District Court for the Southern District of New York Request FDA Comment in Tylenol Litigation?

In April 2023, the plaintiffs of the consolidated Tylenol multidistrict litigation (MDL) proposed a new warning label for name brand and generic acetaminophen. The disclosure informs users that authoritative scientific reports indicate a probable connection between prenatal Tylenol use and developmental disorders. It then advises pregnant women to take as little acetaminophen for as short a period of time and “at the lowest possible frequency”, if they decide to take it at all. 

One of the key legal complications in the Tylenol autism and ADHD litigation is the relationship between state statutes requiring thorough side effects disclosures and federal law, including FDA regulatory oversight. On a number of occasions, high-profile defendants in the acetaminophen developmental disorder lawsuits have sought, at times successfully, to get select challenges dismissed on the basis that their adherence to federal regulations overrides their noncompliance with state law. The use of the Supremacy Clause in Tylenol autism lawsuits has undermined state-specific challenges certain plaintiffs have introduced since mid-2022. 

The court’s invitation for a statement of interest from the FDA underlines the general deference to the medical and institutional expertise of the administration and the authority which it exercises in the context of Tylenol lawsuits. At the time of the request, observers argued that the FDA’s response to the Tylenol ADHD and autism spectrum disorder (ASD) inquiry would have a large impact on the trajectory of the acetaminophen lawsuits as Judge Cote prepares to host hearings later this year and, potentially, to select bellwether cases. 

How Did the Plaintiffs Respond to the FDA Tylenol Letter? 

The day after the submission of the FDA’s acetaminophen response to the court, Ashley C. Keller, Mikal C. Watts, and W. Mark Lanier, the court-appointed co-lead counsel in the Tylenol autism litigation, filed a reply. As co-lead counsel, they collectively speak and act on behalf of the nearly 200 active plaintiffs whose cases have been consolidated into the Tylenol autism MDL. 

The letter points to an abundance of authoritative scientific research which confirms the probable connection between developmental disorders and prenatal Tylenol use. It also criticizes the FDA for a failure to scrutinize the overwhelming clinical reports that outline and confirm the risks of prenatal Tylenol consumption. It concludes with a reiteration of the necessity of ensuring that pregnant women are thoroughly informed of the risks of using Tylenol during critical gestational phases. 

In 2021, a group of 101 transatlantic physicians and researchers published a Tylenol consensus statement explicitly addressing the connection between prenatal paracetamol (acetaminophen) use and “neurodevelopmental, reproductive and urogenital disorders.” The Nature Reviews Endocrinology open address reflects the concern scientists, medical experts, and public health officials have after “witnessing disturbing increases in the number of children with cognitive, learning and/or behavioral problems” after maternal use of acetaminophen during gestation. 

Citing the alarming estimate that 65% of pregnant women in the United States use acetaminophen during pregnancy, the letter goes on to advise that such users avoid prenatal APAP consumption without medical counsel. In a revealing parallel with the April 2023 proposed proviso from the Tylenol litigation, the experts also state that prenatal use of acetaminophen should be kept at the lowest dose for the shortest period of time possible. 

Medical Research Indicates Potential Connection Between Acetaminophen and ADHD, Autism Spectrum Disorder (ASD)

Over the past decade, there has been an increased interest in the medical community about the correlation between prenatal APAP use and autism and/or ADHD. The goal of subsequent research has been to establish causation. 

In 2015, the Danish Epidemiology Science Centre published a Tylenol autism study it conducted by observing, for an average period of 12.7 years, children whose mothers ingested acetaminophen during pregnancy. It discovered that “longer duration of [prenatal] use increased” the risk of a child developing ASD or infantile autism with hyperkinetic symptoms “almost twofold”. 

Relying upon diagnoses from the Norwegian Patient Registry, another research study sought to determine the correlation between prenatal acetaminophen use and ADHD in 112,973 children. In much the same way that the 2015 Danish Epidemiology Science Centre Tylenol study concluded that dosage and time likely proved determinative, the American Academy of Pediatrics investigation discovered that prenatal APAP use was “substantially associated with ADHD”. 

The Argument of the Tylenol Autism and ADHD Litigation

Fundamentally, plaintiffs in the Tylenol autism litigation are claiming that the major manufacturers – including Johnson & Johnson – and distributors failed to warn users of the risks associated with prenatal acetaminophen use. As in most defective drug mass tort litigation, the Tylenol autism lawyers must successfully argue that the retailers and producers of acetaminophen breached a “duty of care” they owed to the consumers of their pain relief medications. 

The plaintiffs are seeking compensation for an array of damages they sustained on account of their uninformed prenatal Tylenol use, including:

  • All eligible medical expenses
  • Lost wages and/or income
  • Decreased quality of life
  • Pain and suffering
  • Emotional distress

Tylenol Autism Lawyers Can Help

There is nothing more precious to a parent than their child, and nothing more concerning than a child’s health and wellbeing. We believe that the failure of major acetaminophen manufacturers and distributors to inform expecting mothers of the risks they incurred while ingesting Tylenol constituted a massive breach of trust between pharmaceutical companies, suppliers, and the public. 

That is why we intend to hold these corporations accountable for their irresponsible business practices. Our experienced Tylenol autism mass tort lawyers and acetaminophen attorneys are intimately familiar with the inner workings of Johnson & Johnson, Walmart, and other named defendants in the Tylenol MDL. 

Offering free consultations for prospective clients and working around the clock to ensure the highest quality care, our Tylenol ADHD lawyers will protect your rights as you tend to your child’s needs. If you have questions about your eligibility to join the New York Tylenol MDL, it is best to seek the advice and assistance of a qualified acetaminophen attorney near you as soon as possible. 


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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