Tylenol® Lawsuit: Did taking Tylenol® during pregnancy cause Autism?

Lawsuits are filed on mounting evidence of increased autism risk from pregnant mother’s use of Tylenol® and other acetaminophen products.

After years of studies pointing to a connection between the prenatal use of Tylenol® and fetal development of autism, many health experts are calling for limiting the use of acetaminophen products by pregnant women.

“We have sufficient data from multiple populations and studies to say that acetaminophen is not as safe as it is considered.” ¹

Researchers are still struggling to understand what causes autism. While some autism spectrum disorders have been associated with specific genetic abnormalities, scientists believe that autism has a variety of potential causes. Under most circumstances, an autism diagnosis cannot be traced back to a single event, condition, or decision. However, growing evidence suggests that unborn children face an increased risk of developing autism if and when they are exposed to certain substances in the womb.

Unfortunately, in the past decade, a building body of research indicates that some substances—many common—could be to blame for the ever-growing prevalence of autism diagnoses.²

“Together, these nine studies suggest an increased risk of adverse neurodevelopmental outcomes following prenatal [acetaminophen] exposure.” ³

For example, pregnant women often depend on over-the-counter medications to manage pregnancy-related aches and pains. Tylenol® and other acetaminophens have long been advertised as safe for pregnant women. In 2021, the American College of Obstetricians and Gynecologists even reassured women that controlled Tylenol® use is unlikely to cause neurodevelopmental problems in fetuses.

Despite physicians’ reassurances, intensive studies have uncovered evidence of a connection between taking acetaminophen products like Tylenol® during pregnancy, and autism spectrum disorders.

In one comprehensive survey encompassing children from a half-dozen different countries, European scientists found that children with a history of prenatal acetaminophen exposure were more likely to have been diagnosed with autism than children whose mothers either never took acetaminophen or took acetaminophen irregularly. ⁴

While companies like Tylenol® have pushed back against claims that their medications are unsafe for pregnant women and unborn babies, struggling parents have begun to assert their rights in courts around the world. 

The Link Between Pregnancy Tylenol® Use and Autism Spectrum Disorders

The active ingredient in Tylenol® is acetaminophen, a compound that is used to manage fevers and relieve pain. First discovered in the 19^th century, acetaminophen was, at first, little more than a chemical novelty—a substance that seemed to have great promise, but routinely caused human test subjects discomfort.⁵ Nevertheless, acetaminophen—sometimes referred to by its other name, paracetamol—has been sold as an over-the-counter drug since 1955.⁶

Today, most Americans are more than aware of acetaminophen’s side effects,⁷ which include stomach pain, nausea, and even liver disease. Under most circumstances, these side-effects are temporary, short-lived, and provide little cause for concern.

Acetaminophen: not as safe as advertised. ^{8 9}

Until very recently, acetaminophen was widely heralded as an incredibly safe drug—a medication that even pregnant women and expecting mothers could take without risk to themselves or their unborn children. ¹⁰ However, a growing body of research suggests that “prenatal exposure to [acetaminophen] might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders.” ¹¹

In one large-scale study, scientists analyzed data collected from lab studies, animal research, and more than 220,000 mother-child pairs.

Ann Bauer, a postdoctoral research fellow at the Center for Autism Research & Education at the University of Massachusetts-Lowell, told CNN that studies indicate a correlation between acetaminophen exposure during pregnancy and assortment of neurodevelopmental complications.¹²

“The identified disorders were primarily attention deficit hyperactivity disorder, or ADHD, and related ADHD behavior abnormalities that also include autism spectrum disorder, language delays, decreased IQ and conduct disorders,” Bauer said.

Despite increasing evidence that acetaminophen could endanger unborn children, the use of over-the-counter painkillers is common: an estimated 65% of American women take paracetamol to mitigate pregnancy-related discomfort, with many likely believing that the risks of acetaminophen consumption are minimal. ¹³

NIH releases media advisory concerning potential dangers associated with acetaminophen.

Emerging information about the suspected casual relationship between prenatal acetaminophen exposure and autism spectrum disorders is sufficiently alarming that the National Institutes of Health recently released a media advisory underscoring the compound’s potential dangers.¹⁴

In its media release, the N.I.H. cited a JAMA Psychiatry analysis that found that children who had been exposed to acetaminophen in the womb were more than 3.5 times more likely to develop autism spectrum disorders than children whose mothers did not take paracetamol.¹⁵

How Injured Americans Are Fighting Back Against Negligent Pharmaceutical Manufacturers

Pharmaceutical companies have a legal and moral obligation to warn consumers about the potential dangers of their products. When companies fail to conduct proper safety studies, follow regulatory guidance, and respond to emerging research, they could be held liable for any resulting damages.

Current lawsuits against Johnson & Johnson for acetaminophen / autism connection

Johnson & Johnson, the makers of Tylenol®, have already faced consumer complaints about the unreported neurodevelopmental risks of acetaminophen use.

Some of these complaints have since been filed in court, alleging that Johnson & Johnson should compensate parents whose children have been diagnosed with disorders including but not limited to:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Autism spectrum disorders (ASD)
• Conduct disorders

In most of these complaints, personal injury attorneys have maintained that pharmaceutical companies and pharmaceutical manufacturers knew, or should have known, that their products carry unique risks for pregnant women and unborn children.

Retailers may be legally responsible for selling acetaminophen products like Tylenol® without warning pregnant women of the risks to their babies’ development.

Other lawsuits have targeted large retailers, alleging that they negligently sold acetaminophen products without including updated warning labels.¹⁶

These lawsuits have named defendants such as:

• Costco
• CVS
• Walgreens
• Rite Aid
• Safeway
• Target
• Rite Aid

Mass Torts Empower the Victims of Industrial Negligence

Between 2019 and 2022, many acetaminophen-related claims have been consolidated into mass torts.

Unlike conventional lawsuits, a mass tort allows an entire class of plaintiffs to combine their cases, using their collective resources to challenge large companies that could otherwise leverage their multi-billion-dollar profits¹⁷ to quash individual challenges.

The Tylenol® Autism / ADHD lawsuit: Class Action vs. Mass Tort

Mass tort lawsuits are, in some respects, similar to class action litigation, in that they represent an entire category—or class—of plaintiffs.

However, in class action proceedings, plaintiffs are effectively pooled together, with their claims encompassed by and within a single lawsuit.

In contrast, a mass tort allows individual claimants to maintain separate claims against the same defendant, empowering them to hold a wrongdoer accountable for the specific injuries they, or their loved ones, have suffered.

An Experienced Mass Tort Attorney Could Help You Recover the Resources You Need to Support a Loved One with Autism or Another Neurodevelopmental Disorder

Justinian & Associates has spent years aggressively advocating for the rights of injured Americans. Since our founding, we have helped our clients recover tens of millions of dollars in damages from reckless corporations, negligent product manufacturers, and defective device makers.

A community-oriented law firm that believes that nobody is above the rule of law, Justinian & Associates knows first-hand the struggles that parents face while raising developmentally challenged children.

The costs of treating development disorders can be high.

For many Americans, the high costs of supporting a child with an autism spectrum disorder¹⁸ are secondary to the emotional toll of knowing that their son or daughter could have had an ordinary life if a corporation had simply put people before profits.

Depending on the circumstances of your case, Justinian & Associates could help you, and your family, secure the compensation you need to not only hold a company accountable for negligence but ensure that no other family has to endure a similar tragedy.

Money Is Never an Obstacle When You Work With Us

Justinian & Associates is confident in our legal experience and knowledge, which is why we never charge our clients for our services. Instead, we work on a contingency-fee basis: if we win your case, we only take payment as a percentage of your settlement. If we cannot help secure the compensation you need and the justice you deserve, we will not charge you for our services or our expenses.

Contact Justinian & Associates Today

Please send us a message online or call us at (512) 980-0000 to schedule your free, no-cost consultation as soon as possible.

^{[1] A Systematic Review of the Link Between Autism Spectrum Disorder and Acetaminophen: A Mystery to Resolve, interpreting data from Parker SE, Collett BR, Werler MM: Maternal acetaminophen use during pregnancy and childhood behavioural problems: Discrepancies between mother- and teacher-reported outcomes. Paediatr Perinat Epidemiol. 2020, 34:299-308. 10.1111/ppe.12601).}

^{[2] “New study shows increase in global prevalence of autism”. Autism Speaks, Science News (April 29, 2022).}

^{[3] “Prenatal paracetamol exposure and child neurodevelopment: A review.” Bauer, Ann Z., et al., Hormones and behavior 101 (2018): 125-147.}

^{[4] “Prenatal and postnatal exposure to acetaminophen in relation to autism spectrum and attention-deficit and hyperactivity symptoms in childhood: Meta-analysis in six European population-based cohorts.” Alemany, Silvia, et al., European journal of epidemiology 36.10 (2021): 993-1004.}

^{[5] Drug discovery: a history. Sneader, Walter., John Wiley & Sons, 2005.}

^{[6] “Acetaminophen.” Ameer, Barbara, and David J. Greenblatt, Annals of internal Medicine 87.2 (1977): 202-209.}

^{[7] Acetaminophen. Mediline Plus website.}

^{[8] A Systematic Review of the Link Between Autism Spectrum Disorder and Acetaminophen: A Mystery to Resolve, interpreting data from Parker SE, Collett BR, Werler MM: Maternal acetaminophen use during pregnancy and childhood behavioural problems: Discrepancies between mother- and teacher-reported outcomes. Paediatr Perinat Epidemiol. 2020, 34:299-308. 10.1111/ppe.12601).}

^{[9] “Paracetamol use during pregnancy—a call for precautionary action.” Bauer, Ann Z., et al., Nature Reviews Endocrinology 17.12 (2021): 757-766.}

^{[10] “Common painkiller should be investigated for possible risks to developing fetuses, experts say.” Sandee LaMotte, CNN (September 23, 2021).}

^{[11] “Paracetamol use during pregnancy—a call for precautionary action.” Bauer, Ann Z., et al., Nature Reviews Endocrinology 17.12 (2021): 757-766.}

^{[12] “Common painkiller should be investigated for possible risks to developing fetuses, experts say.” Sandee LaMotte, CNN (September 23, 2021).}

^{[13] “A Systematic Review of the Link Between Autism Spectrum Disorder and Acetaminophen: A Mystery to Resolve.” Khan, Farhana Yaqoob, et al. Cureus 14.7 (2022).}

^{[14] “NIH-funded study suggests acetaminophen exposure in pregnancy linked to higher risk of ADHD, autism”. National Institutes of Health website, News Releases (October 30, 2019).}

^{[15] “NIH-funded study suggests acetaminophen exposure in pregnancy linked to higher risk of ADHD, autism”. National Institutes of Health website, News Releases (October 30, 2019).}

^{[16] “Mass tort launched for claims that acetaminophen caused autism, ADHD.” Brendan Pierson, Reuters, Legal (October 6, 2022).}

^{[17] “Acetaminophen Market to be worth US$ 14.07 Billion by the year 2031 – Comprehensive Research Report.” Future Market Insights Global and Consulting Pvt. Ltd., Yahoo! Finance (March 6, 2022).}

^{[18] “Coping with the high costs of raising an autistic child.”Chris Taylor, Reuters, Money (June 24, 2014).}

^{[19] A Systematic Review of the Link Between Autism Spectrum Disorder and Acetaminophen: A Mystery to Resolve, interpreting data from Parker SE, Collett BR, Werler MM: Maternal acetaminophen use during pregnancy and childhood behavioural problems: Discrepancies between mother- and teacher-reported outcomes. Paediatr Perinat Epidemiol. 2020, 34:299-308. 10.1111/ppe.12601).}

^{[20] Paracetamol use during pregnancy—a call for precautionary action, Bauer, A.Z., Swan, S.H., Kriebel, D., Liew, Z., Taylor, H.S., Bornehag, C.G., Andrade, A.M., Olsen, J., Jensen, R.H., Mitchell, R.T. and Skakkebaek, N.E., 2021. Nature Reviews Endocrinology, 17(12), pp.757-766.}

^{[21] A Systematic Review of the Link Between Autism Spectrum Disorder and Acetaminophen: A Mystery to Resolve, interpreting data from Parker SE, Collett BR, Werler MM: Maternal acetaminophen use during pregnancy and childhood behavioural problems: Discrepancies between mother- and teacher-reported outcomes. Paediatr Perinat Epidemiol. 2020, 34:299-308. 10.1111/ppe.12601).}

^{[22] Paracetamol use during pregnancy—a call for precautionary action, Bauer, A.Z., Swan, S.H., Kriebel, D., Liew, Z., Taylor, H.S., Bornehag, C.G., Andrade, A.M., Olsen, J., Jensen, R.H., Mitchell, R.T. and Skakkebaek, N.E., 2021. Nature Reviews Endocrinology, 17(12), pp.757-766.}