Tylenol Autism Lawsuit

December 18, 2023

Today, Judge Denise Cote issued a lengthy ruling finding that the plaintiffs’ scientific experts failed to provide credible evidence linking Tylenol to autism or ADHD. Although this was a setback for the federal MDL, there are still options for appeal as well as the potential to pursue Tylenol autism cases in state courts.

December 1, 2023

Both sides are preparing for the upcoming Daubert hearing next week. The sole focus of this hearing is to determine the admissibility of plaintiff’s expert testimony evidence.

The Managing Attorney for The Lanier Law Firm’s New York Office, Evan M. Janush, was also named to the MDL Plaintiffs’ Executive Committee for the Tylenol autism MDL. 

There are now a total of 441 cases in the MDL.

November 11, 2023

Judge Cote scheduled the Daubert hearing for December 7, 2023. While both sides will present oral arguments, the judge will not be hearing testimony from the plaintiffs’ expert witnesses. A ruling on the matter is not expected until early 2024.

Meanwhile, other Tylenol autism lawsuits have been filed in state courts, including one in Illinois. The state lawsuits are still in their early stages.

October 18, 2023
Both the Plaintiffs and Defendants have filed briefs stating their objections to the other side’s experts. In federal court, those briefs are called Daubert challenges, and losing a Daubert challenge can be the end of a case. Each side will have the opportunity to respond to the other side’s Daubert briefing. Plaintiffs are expecting to hear rulings on the Daubert challenges by the beginning of 2024.

October 17, 2023
In a little less than a month, 118 cases were added, bringing the total number of cases in the Tylenol autism MDL to 383.

October 9, 2023
Judge Cote has asked both parties to submit their proposals for the upcoming Daubert hearings. The proposals were submitted last week to determine the logistics of the hearings.

The defendants have requested an extensive week-long hearing process to contest the scientific evidence provided. In contrast, the plaintiffs are advocating for a shorter process and have suggested that Judge Cote identify in advance which experts she needs to hear from, thereby narrowing down the scope of the hearings.

October 5, 2023
A recent study has found that taking paracetamol (acetaminophen) during pregnancy may affect a baby’s brain development. The study used stem cells that were turning into brain cells and exposed them to paracetamol.

The researchers discovered that the drug can affect certain genes important in brain development, including those controlling communication between brain cells and the type of cells they become. These findings align with previous discoveries in cord blood samples from babies exposed to paracetamol during pregnancy.

The plaintiffs in the case wanted to strengthen their medical experts’ testimony by submitting supplemental expert reports based on information from this study. The defendants objected, claiming the supplemental expert reports based on the new study are untimely.

October 2, 2023
The parties informed Judge Cote through a letter this morning that they have completed the newly revised versions of the Plaintiff Fact Sheets and uploaded them into the case administration system. Additionally, the parties agreed on new health record authorization forms to be completed and signed by incoming plaintiffs to make it easier to collect certain medical records.

September 20, 2023
There are currently 265 cases pending in the MDL.

September 11, 2023
In light of the FDA’s decision not to submit a statement of interest, the defendants submitted a letter to the court requesting a status conference. Judge Cote swiftly declined the request, upholding the scheduling order issued in February.

September 8, 2023
In a letter from the U.S. Attorney for the Southern District of New York, the FDA responded to Judge Cote’s request for a statement of interest regarding whether warning labels, as suggested by the plaintiffs, should be included on Tylenol and other acetaminophen products.

The FDA letter stated:
“The United States respectfully declines the Court’s invitation to submit a statement of interest in this matter, but attaches a copy of FDA’s literature review, dated March 10, 2023, providing FDA’s most recent review of available epidemiological evidence.”

August 21, 2023
Judge Cote has granted the defendants permission to submit a consolidated brief on the Daubert challenges regarding the admissibility of scientific expert evidence presented by the plaintiffs. The plaintiffs had requested Judge Cote to deny the request, arguing that separate briefs for each expert were necessary to ensure a fair outcome.

August 3, 2023
In Manhattan, U.S. District Judge Cote denied Kenvue’s request to immediately appeal an earlier decision to deny the defendant’s motion to dismiss based on a lack of scientific evidence. Kenvue is Johnson & Johnson’s consumer health spinoff.

The judge stated that Kenvue “has not pointed to any authority to suggest that there is any ground for a difference of opinion” and that the appeal could not proceed to the 2nd U.S. Circuit Court of Appeals.

July 17, 2023
There are currently 188 cases in the MDL. The litigation is still in the discovery process.

June 15, 2023
As of this date, 136 cases are pending in the MDL.

May 15, 2023
Judge Denise L. Cote ruled on two motions to dismiss claims against retailers.

In the first ruling, Judge Cote granted the motion to dismiss a lawsuit based in Texas due to a state statute giving drug manufacturers and retailers a safe harbor when drugs are labeled in accordance with federal regulations. This dismissal is significant because it impacts all Texas cases in the acetaminophen autism litigation.

The California case involved plaintiff Makesha Anderson, whose case against Johnson & Johnson was previously dismissed. The retailers argued that the plaintiffs’ case against them should also be dismissed because California law provides that compliance with federal law is a defense for not adding warnings to package labeling. The court disagreed and denied the motion.

In light of the previous dismissal of this plaintiff’s lawsuit against Johnson & Johnson, this ruling is good news for California residents because it means they still have a cause of action in the acetaminophen litigation.

May 15, 2023
There are currently 118 pending cases in the MDL.

April 28, 2023
Judge Cote dismissed a California claim against Johnson & Johnson filed by plaintiff Makesha Anderson because California product liability law requires a plaintiff to prove a manufacturer misrepresented facts rather than only omitting facts.

The court denied Johnson & Johnson’s motion to dismiss a Nevada claim because Nevada’s laws allow defendants to be held liable based on an omission.

April 20, 2023
The court denies Johnson & Johnson’s motion to dismiss all of the claims in the MDL.

April 17, 2023
To date, 108 cases are pending in the MDL.

April 12, 2023
Judge Cote reviewed the suggested label change submitted by the defendants and invited the Food and Drug Administration to submit its own opinion on the following questions:

• Should the plaintiffs’ proposed warning be added to acetaminophen labels?
• Does the science warrant adding such a warning to the labels?

The judge requested an answer from the FDA by July 28, 2023, or as soon as possible afterward. The FDA’s answer could weigh heavily on the case.

April 7, 2023
Plaintiffs submitted to the court their version of the new warning that should be included on acetaminophen packaging, which reads as follows:

“Autism/ADHD: Some studies show that frequent use of this product during pregnancy may increase your child’s risk of autism and attention deficit hyperactivity disorder. If you use this product during pregnancy to treat your pain and/or fever, use the lowest effective dose for the shortest possible time and at the lowest possible frequency.”

March 15, 2023
No new cases have been added to the MDL since last month, but this is likely a temporary pause as the case works through the inevitable barrage of motions to dismiss by defendants. Once there is a greater degree of certainty that these complaints will be allowed to move forward, the number of lawsuits is expected to grow significantly.

February 16, 2023
There are currently 107 cases pending in the MDL.

February 10, 2023
Johnson & Johnson filed a motion to dismiss all of the short-form (individual) complaints against it on the grounds that federal law pre-empted state laws requiring them to update the label.

January 27, 2023
Judge Cote issued an order directing how the discovery process will proceed in the case. All parties in the case will have access to documentation uncovered during the discovery process.

The parties are ordered to avoid duplicating discovery efforts. Individual plaintiffs are prohibited from obtaining written discovery separately that duplicates discovery obtained in the coordinated effort. The parties are ordered to avoid subjecting non-experts to more than one deposition.

The parties are ordered to confer about disputes and attempt to reach an agreement outside of court. If this is not possible, the parties may file a motion up to two pages long, which states that the dispute could not be resolved in conference.

These terms and conditions are common in MDL cases.

January 17, 2023
To date, 104 cases have been transferred to the MDL.