How Do I Talk to My Pregnant Patients About Tylenol?

President Trump didn’t do physicians, advanced practice providers (APPs) and their patients any favors when he made off-the-cuff comments at a press conference linking Tylenol to autism and instructing pregnant women to “tough it out.” Subsequent news stories report that already overloaded clinicians nationwide are now tasked with calming anxious patients worried that they caused their child’s autism with Tylenol. Going forward, patients who saw press conference clips or heard the buzz on social media may doubt or question clinicians when the recommended treatment plan includes Tylenol.

One MICA-insured physician reached out to the MICA Risk Team seeking guidance about how to minimize liability exposure in the face of President Trump’s comments and HHS and FDA communications. Part of the physician’s dilemma was whether and how he should warn pregnant or potentially pregnant patients about a risk that, he believes, does not exist based on credible, reliable research. His questions included:

• • How can I disclose a risk based on medically unsubstantiated statements from the FDA and the White House that conflict with scientifically accepted conclusions?
    
    
  • If I recommend Tylenol for a pregnant or potentially pregnant patient whose child is later diagnosed with autism, will I face claims asserting that Tylenol use caused the autism?
    
    
  • Alternatively, will I face claims that I failed to disclose and document the risks of using Tylenol?

Because many clinicians are likely asking the same questions, below we share the Risk Team’s response to this physician’s valid concerns. The response hinges on an assessment of:

• • what potential malpractice claims could arise and
    
    
  • how a clinician would defend those claims in an Arizona state court.

Armed with this information, physicians and APPs can take steps now to optimize practice processes and conversations with patients to minimize the risk that patients will file these claims and strengthen the defense of any claims filed.

What are the Potential Claims?

There are two types of medical negligence claims that patients might assert.

Negligent prescribing: Negligent prescribing allegations might read like this:

• • The defendant clinician directed me, a pregnant patient, to take acetaminophen for my complaints.
    
    
  • Defendant fell below the applicable standard of care in recommending that I take a certain amount of acetaminophen for a specific length of time.
    
    
  • But for taking that amount for that long, my unborn child would not have developed a certain condition.

Lack of informed consent: Lack of informed consent allegations could look like this:

• • Defendant clinician directed me, a pregnant patient, to take acetaminophen for my complaints.
    
    
  • I took it as she directed.
    
    
  • Later, my child developed a certain medical condition which I believe was caused by taking acetaminophen.
    
    
  • Had Defendant told me that acetaminophen could cause that, I would not have taken it, and my child would be healthy.

What Must a Plaintiff Must Prove?

To get to a jury, a plaintiff in Arizona must offer sufficient evidence to establish:

• • The defendant clinician fell below the applicable standard of care – i.e., a reasonable and prudent physician or APP of the same specialty, providing care to a similar patient, would not have prescribed acetaminophen at all or in that amount/for that length of time
    
    
  • To a reasonable degree of medical probability, the patient’s acetaminophen use while the child was in utero caused the child’s injury and
    
    
  • Damages with reasonable specificity

OR

• • The Defendant health care professional fell below the standard of care by failing to share with the patient information material to the patient’s decision about whether to take acetaminophen as recommended
    
    
  • Had the clinician told a prudent person in the patient’s position about research and/or HHS and FDA publications that caution about an association between acetaminophen use during pregnancy and autism or ADHD, a prudent person would have declined to take acetaminophen
    
    
  • To a reasonable degree of medical probability, the patient’s acetaminophen use while the child was in utero caused the child to develop autism or ADHD; and
    
    
  • Damages with reasonable specificity.

What Evidence Must the Plaintiff Present in Support of These Allegations?

Plaintiff must present an expert witness who will tell the jury what the standard of care requires. In Arizona, the plaintiff’s standard of care expert must be the same specialty as the defendant clinician. For plaintiff to get to the jury, the expert would need to testify that a reasonable and prudent physician or APP in the same specialty as the Defendant would have:

• • Not prescribed acetaminophen in that amount or for that long to a similar patient or
    
    
  • Disclosed certain additional information to the patient during the informed consent discussion – this might include the cautions published by HHS and/or the FDA in September 2025.

Would These Claims Have Merit? What Potential Hurdles Do Plaintiffs Face?

Simply filing a lawsuit is far easier than presenting sufficient evidence to get to a jury. Many malpractice cases are dismissed without payment.

Some of the hurdles Plaintiffs might face when trying to link Tylenol use during pregnancy to a child’s neurodevelopmental disorder diagnosis include the following.

Standard of Care

Plaintiffs may have a hard time finding credible expert witnesses to testify that the clinician fell below the standard of care. In contrast, it would likely be relatively easy for physicians and APPs to find a standard of care witness to defend reasonable care. Why?

 

• • Science is on your side. President Trump’s comments were off-the-cuff, too broad, not medically supported, and likely would not be admitted as evidence of the standard of care. In addition, physician professional organizations and other health-related organizations worldwide have uniformly criticized HHS and FDA communications as unsupported by science. Such organizations include ACOG, Society for Maternal-Fetal Medicine, the WHO and the European Medicines Agency.
    
    
  • The HHS fact sheet is also relatively mild. Like the FDA, HHS avoids claiming that clinicians should not prescribe acetaminophen to pregnant patients. According to HHS, “Chronic acetaminophen use in pregnant women, especially late in pregnancy, may cause long-term neurological effects in their children.”
    
    
  • The FDA letter is mild and does not say acetaminophen should not be used in pregnant patients. It says, “clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers. This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics” and “To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established.”
    
    
  • HHS continues: “Acetaminophen is the only over-the-counter medication considered safe for treating fever during pregnancy. Maternal fever itself carries risks, including neural tube defects and preterm birth.”
    
    
  • HHS also says: “When used short-term and at appropriate dosages, acetaminophen remains widely regarded as safe. However, unresolved questions remain regarding chronic or late-pregnancy exposure.”
    
    
  • In Arizona, whether a physician or APP met the standard of care in an informed consent conversation depends on the “usual practices” of others in their profession.¹ Expert testimony from a physician or APP practicing in the same specialty as the defendant is necessary to establish what information a reasonable and prudent clinician would share with a patient about the risks, benefits, and alternatives of Tylenol during pregnancy. Arizona courts have said “the precise parameters of the required disclosure” for any particular informed consent conversation must be established by expert testimony.² Physician organizations have widely criticized the Trump administration’s communications on this issue as lacking scientific support. Therefore, physicians and APPs would likely be able to identify a standard of care expert to defend their care and explain to jurors how physicians rely on scientifically accepted research to inform their consent discussions with patients.

Causation

Proving causation would also be a potential roadblock for plaintiffs. Finding an expert witness who would testify to a reasonable degree of medical probability that acetaminophen use caused autism or some other neurodevelopmental injury would likely be a challenge. No study has yet pinpointed the cause of autism, and even HHS and FDA concede that no causal relationship has been established between acetaminophen use during pregnancy and later development of autism.

One caveat to this causation point is that most attorneys prefer not to rely on causation defenses at trial, because jurors may have a hard time following complex scientific explanations.

How Can Clinicians Mitigate the Risk of Such Claims?

Although the weight of scientific research likely undercuts the merit of these types of claims, risk mitigation is always a sound idea. Here are some suggestions for how you might modify your daily operations to reduce the likelihood or strengthen the defense of such claims:

• • Consider incorporating a frank discussion of this topic into your informed consent discussions when recommending acetaminophen to pregnant patients. Most of the time, many patients likely have little idea what the FDA or HHS is up to, but this situation is different. President’s Trump’s comments were widely broadcast and even spoofed. It has become a topic of discussion on social media. Therefore, many patients may be thinking about it.
    
    You may be able to strengthen your relationships and foster trust with patients (and bolster the defense of future lawsuits) by simply acknowledging and discussing the gap between medical science and President Trump’s comments. You can also point out that the federal agencies’ recommendations are not in line with the President’s comments. The agencies’ statements are much milder and do not say “no Tylenol use.”
    
    

    Consider taking the opportunity to explain in layperson’s terms that there is research demonstrating the lack of any causal connection. You may also wish to explain how the research you find credible differs from points raised in the Consensus Statement cited in the HHS Fact Sheet. Since the patient decides whether to pursue any treatment you recommend following an adequate discussion of risks/benefits/alternatives, you can strengthen the defense of future claims by erring on the side of presenting more information that could be material to the patient’s decision.
    
    

  • Document your discussions thoroughly. You may consider developing a handout for patients on this topic. If so, make sure you save a copy in each patient’s record.
    
    
  • Keep copies of the FDA’s letter and the HHS fact sheet. Also keep copies of future communications that government agencies or professional organizations issue on this subject. We have seen that, at least in the current administration, some webpage content disappears. You will want these communications as part of your defense to any future claims. The MICA Risk Team recommends saving them in a file you keep on this topic.

<sup>[1] Riedisser v. Nelson, 111 Ariz. 542, 544 (1975)

[2] Hales v. Pittman, 118 Ariz. 305, 311 n.4 (1978)</sup>