Product Liability Risks | Business Litigation | Society

Introduction: Scientific Uncertainty, Legal Hurdles, and Risk for Kenvue

On September 22, 2025, President Donald Trump made public remarks suggesting that acetaminophen use (commonly Tylenol) during pregnancy may increase the risk of autism in children. He advised pregnant individuals and caregivers to avoid Tylenol unless medically necessary. These claims were widely criticized by medical experts as lacking sufficient scientific evidence. (Reuters)

At the same time, the FDA is reportedly preparing to update warning labels and issue guidance that acetaminophen “can be associated” with increased risk — even as the company that makes Tylenol, Kenvue, publicly stated it “strongly disagrees” with linking its product to autism. (PBS)

These statements come against a backdrop of existing litigation: in previous federal lawsuits, numerous plaintiffs alleged that prenatal use of Tylenol causes autism or ADHD. Many of those cases were consolidated into a multidistrict litigation (MDL) in New York. But in December 2023, Judge Denise Cote excluded expert testimony linking Tylenol to autism and ADHD, finding that plaintiffs’ scientific evidence was insufficient. This led to dismissal of many federal cases unless reversed on appeal. (Investing.com)

Why Trump’s Warning Could Open the Door to New or Revived Lawsuits

Though many federal claims were dismissed, the President’s remarks and the FDA’s potential labeling changes could shift several legal and factual levers:

1. Changed Regulatory Landscape & Warning Labels
   If federal agencies move toward a label update acknowledging potential risk, this could support new failure‑to‑warn claims (i.e. that the manufacturer should have disclosed the risk). A warning label can help establish what information ought to have been known or disclosed, potentially strengthening plaintiffs’ arguments. (Axios)
2. Public Awareness and Causation Debate
   Statements from high-profile public figures can raise awareness and potentially bring forward more plaintiffs. They may also encourage more research, expert studies, and epidemiological reports, which could be used in litigation. Even if courts have previously found evidence lacking, new studies or regulatory findings might change the evidentiary record. (Financial Times)
3. State Court Suits
   Many earlier cases were in federal court—and many failed due to strict admissibility standards for expert evidence (e.g. under the Daubert standard). State courts sometimes have different rules or lower thresholds, potentially giving new lawsuits a more favorable venue. Also, plaintiffs who were dismissed may try again under state law. (Lawsuit Legal News)
4. Appeals and Reversal Potential
   Since the federal MDL dismissal rested heavily on exclusion of expert testimony, an appellate decision in favor of plaintiffs could reopen the federal litigation path. New causal evidence or re‑framed expert testimony might clear prior admissibility hurdles. (Lawsuit Legal News)
5. Brand and Stock Risk
   Even without legal liability, public statements and media attention may affect the company’s reputation, regulatory scrutiny, investor confidence, possibly prompting defensive litigation or settlements. (MarketWatch)

Legal Hurdles & Defenses

However, there are significant obstacles for plaintiffs, many of which led to dismissals in the earlier MDL cases:

• Causation Standard: Courts require not just correlation but reliable, scientifically supported causation. Judge Cote found that the expert testimony did not meet that standard: problems included cherry‑picking, unstructured methodology, and inadequate control of confounding factors. (Investing.com)
• Admissibility of Expert Testimony: Daubert (federal) or equivalent standards in state courts are strict. Plaintiffs must show that their experts are using valid, peer‑reviewed methods, have sufficient data, and that their conclusions are not speculative. Past rulings found their experts failed on these grounds. (Investing.com)
• Preemption Issues: Manufacturers often argue that their labeling is governed by federal law (by FDA regulatory regime), which can preempt or limit state law claims about labeling. Prior cases saw arguments that labeling changes are regulated, limiting liability for failure to warn. (Forbes)
• Scientific Consensus & Regulatory Review: Regulatory bodies and major medical organizations have so far found insufficient evidence for strong causal claims. Courts tend to defer to this when weighing reliability. Because much of the evidence is still mixed or inconclusive, plaintiffs may find it difficult to overcome summary judgment. (Johnson // Becker)
• Statute of Limitations & Notice: Some earlier cases were filed years after exposure. Plaintiffs may face barriers if their claims are out of time or if the harm was anticipated (i.e. they should have known) but not disclosed. Also, failure to show that the manufacturer had actual or constructive knowledge of risk could be fatal.

Potential Impacts & What to Watch

• Labeling Changes: If FDA or other agencies require warning labels, this could reset the baseline for what manufacturers know or should know, affecting future liability.
• Expert Research & Epidemiological Studies: New large well‑designed studies may emerge, possibly changing what expert testimony courts find admissible.
• Court Decisions on Appeal: The Second Circuit’s decision in the federal Tylenol MDL appeal will be closely watched. If it reverses or loosens Daubert exclusions, it could revive some federal claims. (Lawsuit Legal News)
• Lawyer Activity: We can expect renewed interest from plaintiffs’ counsel in filing state court cases or reactivating federal suits, leveraging Trump’s remarks and any regulatory shifts.
• Prejudice & Replication Risk: Courts will also consider whether the political or public pressure influences scientific research or litigation, and whether there is risk of “labeling / scare” causing harm (e.g. pregnant individuals avoiding needed medication) if warnings are overbroad.

Conclusion

President Trump’s recent public warning linking Tylenol use during pregnancy to autism, though not backed by strong scientific consensus, could serve as a fuse for renewed litigation. Already dismissed federal cases may be revived or new ones filed in state courts, especially if labeling changes or new scientific data emerge. That said, the threshold for product‑liability cases is high: plaintiffs will need reliable causation evidence, admissible expert testimony, and to overcome significant procedural and regulatory defenses.

For Kenvue (and its predecessors), the company now faces not only precedent courts but also public and regulatory scrutiny. Even if litigation ultimately fails, the indirect costs — reputational, financial, and regulatory — could be substantial.