- with readers working within the Advertising & Public Relations industries
- within Compliance topic(s)
On October 28, 2025, the State of Texas filed a complaint against Johnson & Johnson and Kenvue, Inc. ("Kenvue")—formerly the consumer health division of Johnson & Johnson, and now in the process of being acquired by Kimberly-Clark—alleging deceptive marketing and fraudulent financial moves related to Tylenol (acetaminophen) (the "Lawsuit").1 Texas claims these companies hid the drug's risks to unborn and young children—especially links to autism and Attention-Deficit/Hyperactivity Disorder ("ADHD")—while promoting Tylenol as safe.
The Lawsuit emerges during a surge of heightened scrutiny surrounding acetaminophen, following national attention earlier this year. In September 2025, President Trump and the Secretary of Health and Human Services, Robert F. Kennedy Jr., publicly raised concerns about possible associations between acetaminophen use during pregnancy and neurological disorders in children, particularly autism and ADHD.
While the Lawsuit is still in its early stages, its implications for both the prescription and non-prescription pharmaceutical industry could be profound. Not only does it challenge the marketing practices around acetaminophen, but it also intersects with key Federal Food and Drug Administration ("FDA") priorities. In recent months, the FDA has sharpened its focus on drug promotion efforts and introduced new rules affecting over-the-counter ("OTC") medications. This intersection of regulatory action and legal scrutiny signals an important moment for how non-prescription drugs are marketed, labeled, and accessed by consumers.
Background
At the heart of this case is the allegation that Johnson & Johnson and its consumer health subsidiaries systematically marketed Tylenol as a safe option for pregnant women and children, allegedly ignoring and suppressing contrary evidence over recent years. The State's complaint is rooted in two main claims:
- Deceptive Trade Practices: Under the Texas Deceptive Trade Practices-Consumer Protection Act ("DTPA"), defendants allegedly failed to warn about known or emerging risks related to Tylenol use during pregnancy and early childhood, including possible links to autism and ADHD. The lawsuit alleges misrepresentation of safety information and points to internal company actions to undermine unfavorable scientific studies and regulatory warnings.
- Fraudulent Transfers: Invoking the Texas Uniform Fraudulent Transfer Act ("UFTA"), the suit claims Johnson & Johnson transferred Tylenol-related liabilities to its spinoff, Kenvue, without accompanying asset transfers, intending to insulate itself from future damages claims that may amount to tens of billions of dollars.
Texas' petition cites scientific research, referencing studies that demonstrate associations between prenatal acetaminophen exposure and increased risk of neurodevelopmental disorders. Despite this, Tylenol labeling has allegedly not been updated to reflect these risks, even as the FDA and Department of Health and Human Services have recently taken steps to initiate safety label changes and alert physicians nationwide.
Further allegations include misstatements of Tylenol's pregnancy risk category, the selective funding of research aimed at defending existing labeling, and a history of corporate maneuvers to limit exposure to product liability, such as the transfer of consumer health operations to Kenvue. The State seeks sweeping remedies—including injunctive relief, civil penalties, asset disgorgement, and a jury trial.
Takeaways
Use of Scientific Evidence
A major issue expected to be debated in this Lawsuit is whether the evidence associating Tylenol with neurological deficits warrants changes to the labeling and promotion of one of the world's most widely consumed OTC drugs.
Following a citizen petition seeking new pregnancy warnings for acetaminophen—which built on remarks made by President Trump and RFK Jr.—Kenvue responded unequivocally on October 17, 2025, stating the request was unsupported by scientific evidence. Kenvue pointed out that the FDA has fully evaluated the research, repeatedly concluding that the data does not support a causal connection between acetaminophen use during pregnancy and neurodevelopmental disorders such as autism. Furthermore, FDA Commissioner Makary, in a letter to doctors, emphasized that a causal relationship has not been established. Despite this, Texas presented contrary evidence suggesting that a link does in fact exist.
This debate reflects a broader theme in federal regulatory oversight over drug promotion and parallel state enforcement. The FDA is both compelled and bound by regulation to ensure that medical product labeling appropriately reflects safety concerns—especially in clinically controlled settings demonstrating causality. But here, the clinical evidence is associative at best—even the authors of studies relied upon by the administration have backtracked and caveated the findings.2 Moreover, Dr. Makary rightly acknowledges this point, pitting association and causality against each other, thereby putting FDA in a very difficult position vis-à-vis the rest of the press coming out of the administration about acetaminophen use.
Further, FDA faces significant constraints in its enforcement of drug labeling and promotion, particularly in two key areas: First Amendment free speech protections and the new regulatory paradigm set forth in Loper Bright.3 These issues arise because the FDA, in regulating drug labeling and promotion, is either requiring manufacturers to make certain statements or prohibiting them from making others. If challenged, courts will scrutinize these actions more closely, meaning the agency must provide strong statutory and constitutional justifications for its enforcement decisions.4 So, while the FDA may face challenges enforcing requirements—such as mandating a pregnancy warning on acetaminophen labels—states like Texas have a window to step in and pursue enforcement at their leisure.
From an industry perspective, the Lawsuit will likely provide a roadmap for other states to take their pound of flesh through civil actions against manufacturers, simply based on characterizations of scientific evidence, even when the strength of that evidence has been questioned.
FDA Labeling Change?
A remaining question is whether the FDA can and will require manufacturers to update acetaminophen labels to include a pregnancy warning. This issue underscores the agency's current limitations discussed above. We have seen the FDA mandate labeling changes for opioids to better warn the public about their long-term and serious risks, including addiction and overdose.5 However, there was broad consensus about the opioid crisis and clear supporting evidence, whereas the link between Tylenol use during pregnancy and neurological disorders in children is far less established and lacks consensus. If the FDA were to require a labeling change for acetaminophen, the likelihood of that decision withstanding ultimate legal challenges is low, especially if the warning is written broadly. The likely way through would be something more narrow and benign.
Nevertheless, this case remains notable for its potential to set precedent. If Texas is successful, it could encourage other states to pursue similar actions, leading to a patchwork of decisions that manufacturers may need to navigate, frustrating FDA's authority and confusing its role. This evolving situation is certainly one to watch, as its outcomes could significantly impact both industry practices and public health policy surrounding acetaminophen.
Footnotes
1. Lawsuit available here: https://www.texasattorneygeneral.gov/sites/default/files/images/press/Lawsuit.pdf
2. Coverage available here: Using acetaminophen during pregnancy may increase children's autism and ADHD risk | Harvard T.H. Chan School of Public Health
3. In Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), the Supreme Court held that courts must exercise their own independent judgment in deciding whether an agency has acted within its statutory authority, and may not defer to an agency interpretation of a statute.
4. In American Clinical Laboratory Association (ACLA) v. FDA and Association for Molecular Pathology (AMP) v. FDA, No. 4:24-CV-00479 (E.D. Tex. Mar. 31, 2025), the Court ruled that FDA lacks statutory authority under the Federal Food, Drug and Cosmetic Act (FD&C Act) to regulate laboratory developed tests.
5. Press Release from Health and Human Services available here: FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks | HHS.gov
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
