Texas Attorney General Sues Tylenol, Citing Controversial and Debunked Claims It Causes Autism and ADHD

Texas Attorney General Ken Paxton announced Tuesday he had filed a lawsuit against Tylenol’s manufacturer, citing numerous controversial and debunked claims by Health and Human Services Secretary Robert F. Kennedy Jr. that acetaminophen, the drug’s active ingredient, causes “a significantly increased risk of autism and other disorders.”

Kennedy, who holds no science or medical degrees, has a long track record of promoting conspiracy theories and unfounded claims about vaccines and autism, including debunked research by Andrew Wakefield, who lost his medical license for fraud and “serious professional misconduct.”

In September, Kennedy held a press conference with President Donald Trump during which they made multiple false or unproven claims about a link between autism and acetaminophen, circumcision, and other factors. Trump has repeatedly made comments and written social media posts claiming pregnant women and children should not take Tylenol “for virtually any reason.”

“Completely erroneous and dangerous”

Numerous doctors, scientists, and medical organizations decried Kennedy and Trump’s claims as “completely erroneous and dangerous” and supported by “no proof whatsoever,” including Fox News senior medical analyst Dr. Marc Siegel, MSNBC medical analyst Dr. Vin Gupta, and Republican senator and licensed medical doctor Sen. Bill Cassidy (R-LA).

Dr. Steven J. Fleischman, the president of the American College of Obstetricians and Gynecologists (ACOG), said in a statement denouncing Kennedy’s press conference for presenting “irresponsible” claims that were “not backed by the full body of scientific evidence and dangerously simplif[y] the many and complex causes of neurologic challenges in children” and sending a “harmful and confusing message” to pregnant women.

“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children,” Fleischman continued, noting that “the two highest-quality studies on this subject — one of which was published in JAMA [the Journal of the American Medical Association] last year — found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability.”

That April 2024 JAMA study, which looked at health records of over 2.5 million children born in Sweden over a 25-year period, further noted that its result “suggests that associations observed in other models may have been attributable to familial confounding.”

Complaint rests on foundation of Kennedy’s false, unfounded, and misleading claims

Nonetheless, Paxton’s lawsuit presented Kennedy’s claims as providing a factual basis for the lawsuit.

Filed in Panola County, a staunchly conservative county in rural east Texas, the complaint names as defendants Johnson & Johnson, Tylenol’s manufacturer and distributor; Kenvue, Inc., a wholly-owned subsidiary of Johnson & Johnson that was created in 2022 and from which it fully divested in 2024; and Kenvue Brands LLC (formerly known as Johnson & Johnson Consumer Inc.), a wholly-owned subsidiary of Kenvue, Inc.

Paxton accuses the defendants of “willfully ignor[ing] and attempt[ing] to silence the science that prenatal and early-childhood exposure” to acetaminophen “can cause ASD and ADHD in children,” failing to include a warning label on their products that there is a risk of ASD or ADHD, and “market[ing] the drug as a completely safe pain medication for pregnant women and children.”

The complaint argues that autism is “over two times more prevalent in the United States than the global average,” and that diagnoses of ASD and ADHD have both “become more prevalent among American children over time.”

Critics of Kennedy’s autism claims have pointed out that the increasing number of cases is primarily a function of expanded diagnostic criteria for both conditions. Furthermore, American access to healthcare is greater than large parts of the developing world and that predictably results in a higher number of reported cases.

Additionally, as the complaint itself notes, “[a]cetaminophen was first discovered in the latter half of the 19th century,” and “has become one of the most widely used drugs in the world” — a fact that contradicts claims it could be causing a spike in autism in more recent years.

The complaint goes on to claim that “[f]or years, the scientific evidence has shown that acetaminophen can cause ASD and ADHD in children whose mothers ingested the drug while pregnant and that the more acetaminophen ingested, the greater the risk,” citing several studies, which — notably — did not include the April 2024 JAMA study of 2.5 million Swedish children that “found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability” and directly called into question the results of previous studies.

Risks to mother and child from untreated fevers and pain can be severe, even fatal

Other studies — not mentioned in Paxton’s complaint — show a link between fevers during pregnancy and ASD, and forgoing treatment for pain and fever during pregnancy presents multiple “long documented health risks” for both mother and child.

In the statement by Fleischman, the ACOG president, he warned against the dangers of Kennedy’s HHS needlessly scaring pregnant women from using acetaminophen, noting that it “is one of the few options” for them to treat pains and fevers:

Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it. The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus.

Specifically, pre-eclampsia and other “hypertensive crises” during pregnancy are are well-established in numerous peer-reviewed studies as one of the leading causes of maternal death due to pregnancy, due to increased risks of complications like strokes, damage to organs like the liver or kidneys, respiratory failure, depression, and anxiety. These issues also increase the risk of preterm labor, caesarean section, placental abruption, low birth weight, fetal growth restriction, and other complications that can cause miscarriages or death of newborn babies, and children whose gestation was affected by pre-eclampsia have a higher risk of problems like diabetes, coronary artery disease, obesity, certain types of cancers, osteoporosis, and psychiatric illnesses.

Dr. Peter Hotez is a pediatrician, professor, and researcher at the Texas Medical Center whose daughter, Rachel Hotez, has autism. He has long been a critic of the claims by Kennedy and other anti-vaccine activists about the causes of autism.

Reached for comment by Mediaite, Hotez shared links to multiple research studies showing that “the neurodevelopmental processes leading to autism or autism spectrum disorder occur in early fetal brain development through the action of more than 100 known autism genes.”

“There are a few known chemical exposures that can interact with autism genes and lead to autism — the best established one appears to be the anti-seizure medication valproate,” Hotez added. “In contrast, the evidence for acetaminophen or Tylenol is not strong at all,” mentioning the study of 2.5 million children in the Swedish study that found “no significant associations.”

Hotez noted “a more organized autism science initiative to look at additional environmental exposures interacting with autism genes” was needed, “but right now Tylenol is not on any autism scientist’s priority list,” and pointed to a “strong statement” released earlier this year by the Coalition of Autism Scientists on the topic.

Intriguingly, Hotez added, there were also some studies that actually “show a protective effect, meaning Tylenol may actually prevent autism,” including one of the studies that was highlighted during Kennedy’s press conference — “although they forgot to mention that part!”

Partnering with personal injury lawyer whose expert witnesses were tossed by the court in similar lawsuit

As The Texas Tribune reported Tuesday, Paxton contracted with Ashley Keller of the Chicago law firm Postman Keller to assist with this litigation.

Keller is the lead counsel for a group of plaintiffs suing Johnson & Johnson and Kenvue in personal injury lawsuits claiming that prenatal use of Tylenol caused neurodevelopmental harms like ASD and ADHD to their children; about six hundred plantiffs’ cases were consolidated into multi-district litigation that was heard in the U.S. District Court for the Southern District of New York.

In December 2023, Judge Denise L. Cote, a Clinton appointee, issued an order excluding all of five of the expert witnesses the plaintiffs had submitted to argue that there was a causal link between acetaminophen and ASD or ADHD.

One of those plaintiffs’ witnesses, Dr. Andrea Baccarelli, has also been cited by Kennedy’s HHS. Baccarelli testified that he was paid “about $150,000” for his participation in this litigation led by Keller. Baccarelli’s involvement in the study cited by Kennedy, and now this lawsuit by Paxton, was disclosed in a disclaimer that said it could present “a conflict of interest regarding the information presented in this paper on acetaminophen and neurodevelopmental outcomes.”

Early in the extensively-detailed 148-page opinion, Cote noted that the court had invited the Food and Drug Administration (FDA) and other government agencies to “submit its views” on the case, and the federal government “declined to submit a Statement of Interest but noted in its letter the FDA’s independent 2023 conclusion…that the scientific evidence on this topic is as of yet ‘unable to support a determination of causality.'”

The majority of the opinion is devoted to analyzing the claims and deposition testimony by the plaintiffs’ proffered expert witnesses. Cote finds all five of them to be so fundamentally lacking in reliability that she ruled that their testimony should be excluded.

“[T]he unstructured approach adopted by the plaintiffs’ experts permitted cherry-picking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data,” wrote Cote, finding that all of the witnesses presented by the plaintiffs “have failed to show that their methodology in [claiming a link between Tylenol and ASD or ADHD] is generally accepted by the scientific community.”

Going through each of the plaintiffs’ proposed witnesses, Cote found “fatal” and “overarching methodological flaws” in each of their proffered expert opinions, criticizing how they had “cherry-pick[ed] isolated findings,” “misrepresented study results and refused to acknowledge the role of genetics in the etiology of either ASD or ADHD,” “ignor[ed] inconsistent findings, and disregard[ed] limitations expressed by a study’s authors as well as generally accepted statistical principles,” “contain[ed] so many errors in its description of the relevant research that it is inherently unreliable,” and offered opinions were “rushed,” “too undeveloped to be otherwise admissible,” and had admitted many “limitations and inconsistencies in the data” that presented “simply too great an analytical gap between the data and the opinion proffered.”

One particular plaintiffs’ expert witness was lambasted for claiming there were seven studies that supported his opinion, but which “did not suffice to provide a scientifically sound basis” for that opinion. As Cote observed, the witness claimed that these studies found that exposure to acetaminophen for more than 28 days during pregnancy “showed a two-fold increased risk for childhood ‘ADHD and ASD diagnosis,'” but “[n]one of these studies involved an ASD diagnosis,” and regarding the study the witness claimed carried the “greatest weight,” it “did not involve even an ADHD diagnosis.”

Overall, the judge wrote about these plaintiffs’ witnesses, “[t]heir analyses have not served to enlighten but to obfuscate the weakness of the evidence on which they purport to rely and the contradictions in the research…With these rulings, the plaintiffs do not have admissible evidence to demonstrate that prenatal exposure to acetaminophen causes either ASD or ADHD in offspring.”

The plaintiffs then submitted a sixth expert witness, but Cote issued another ruling in July 2024 excluding that witness as well, finding her to have “little relevant expertise,” including a “lack of expertise in the fields most pertinent to this litigation,” and a “lack of familiarity with ADHD” that was “apparent at her deposition” when she “was frequently unable to answer even basic questions about ADHD,” and “struggled to answer during her deposition even basic questions.”

Cote assessed this witness’ proffered opinion testimony as “problematic,” “unreliable and inadmissible,” displayed “flagrant cherry-picking,” showed a “failure to confront carefully and fairly the profoundly important issue of confounding by genetics,” and was “result driven” and therefore “not an objective or rigorous application of scientific methodology.”

Accordingly, in the summer of 2024, Cote issued two rulings dismissing the plaintiffs’ cases in two batches, finding that after the plaintiffs’ expert testimony had been excluded, their legal claims could not survive without it.

Keller has appealed Cote’s orders excluding the expert witnesses and dismissing the cases to the U.S. Court of Appeals for the Second Circuit, accusing the judge of “making up rules of science” in an interview with the New York Law Journal. Oral arguments in the appeal were conducted in early October.

Johnson & Johnson and Kenvue have maintained that “[c]redible, independent scientific data continues to show no proven link between taking acetaminophen and autism,” either prenatally or when given to children. The Tylenol website advises consumers to “[t]alk to your healthcare professional before taking or administering acetaminophen” if pregnant, breast-feeding, or if giving to children, and “always follow the dosage guidelines provided on the product label or by your healthcare provider.”

This is an opinion piece. The views expressed in this article are those of just the author.

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