Tylenol Autism Settlement Conference Scheduled To Discuss Resolution for Claims Brought By Families Nationwide

Parties involved in the federal Tylenol autism lawsuits will begin meeting early next month with a U.S. Magistrate Judge, to discuss potential settlements for claims brought over the drug makers’ failure to warn that prenatal exposure to acetaminophen may cause autism, attention hyperactivity disorder (ADHD) and other developmental delays among children.

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the belief that it is safe for unborn children. However, a growing number of lawsuits are now being pursued by families nationwide, each raising similar allegations that children were left with life-long disabilities after exposure to the active ingredient in the pain medication before birth.

Given common questions of fact and law over the adequacy of the Tylenol pregnancy warnings, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings last year, centralizing all claims brought throughout the federal court system before U.S. District Judge Denise Cote in the Southern District of New York, as part of a federal multidistrict litigation (MDL).

There are currently about 500 product liability claims pending before Judge Cote, with thousands of additional claims under active investigation by Tylenol autism lawyers, and it is widely expected that the size and scope of the litigation will increase dramatically in the coming months and years.

As part of the coordinated management of the litigation, Judge Cote has prioritized discovery into the link between Tylenol and autism, as well as ADHD and other developmental problems. The Court is also considering a series of early challenges raised by the drug makers to the sufficiency and reliability of expert witness testimony prosed by plaintiffs. However, while those issues are being addressed, the parties have been directed to engage in Tylenol autism settlement negotiations to explore potential resolutions for the claims.

Tylenol Autism Lawsuit Settlement Talks Scheduled

On December 1, U.S. Magistrate Judge Katherine Parker issued an order (PDF), indicating that a settlement conference will be held January 4, 2024.

It is not expected that the settlement negotiations will result in the resolution of any specific cases, but the discussions may form the framework for settling claims that meet certain criteria without the need for lengthy and protracted litigation.

If early negotiations are not productive, Judge Cote will likely establish a “bellwether” process, where a small group of representative cases will be selected for trial, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Although the outcome of such bellwether trials will not be binding on other families pursuing Tylenol autism and ADHD lawsuits, the average payouts awarded by juries may play a key role in future settlement discussions, influencing the amount of any Tylenol settlements Johnson & Johnson and other drug makers may offer children injured by Tylenol.

Evidence Linking Tylenol and Autism, ADHD

The settlement negotiations will get underway as Judge Cote continues to evaluate oral arguments presented on December 7, over the admissibility of opinions and testimony provided by certain plaintiffs’ expert witnesses. The Court is determining whether the opinions are sufficiently reliable to present to a jury at trial, which are known as Daubert challenges.

If plaintiffs’ expert witnesses are approved to testify at trial after the Daubert hearings, the litigation over the manufacturers’ failure to warn about the risk of ADHD and autism from Tylenol will be cleared to move forward.

Plaintiffs’ experts rely on a number of reports published in recent years, which have examined the association between Tylenol use during pregnancy and the risk of autism through observational studies and epidemiological research, since it would be unethical and illegal to conduct studies in which pregnant women are given acetaminophen to investigate whether it causes autism.

Many of the findings published in recent years have identified strong links between acetaminophen use during pregnancy and increased risks of autism or ADHD diagnosis in children.

In a study published in the European Journal of Epidemiology in May 2021, researchers analyzed data from 73,881 children and found a clear link between prenatal acetaminophen exposure and an increased risk for autism and ADHD diagnoses. An earlier study was published in the International Society of for Autism Research in 2015, finding that prenatal use of acetaminophen was associated with an increased risk of autism spectrum disorder, accompanied by hyperactivity symptoms

With such studies going back years, plaintiffs’ expert witnesses will likely argue that the manufacturers knew, or should have known, about the link between Tylenol prenatal use, autism and ADHD, but failed to provide adequate warnings to alert pregnant mothers of the risk.