The Tylenol Lawsuit: Legal Challenges, Health Risks, And Ongoing Litigation

Tylenol is a popular painkiller used across the world. Initially, a possible link between acetaminophen, Tylenol’s active ingredient, and increased autism risk was suggested by an NIH study. But, an April 2024 study by the National Institutes of Health found zero connection for that link.

Still, concerns about acetaminophen causing autism in children have led multiple parents to file lawsuits against drug manufacturers and dealers who sold the drug. This article explains the status of the Tylenol lawsuit and all the health risks associated with it.

Serious Side Effects Of Tylenol

Acetaminophen, the main ingredient in Tylenol, is generally considered a pain reliever and medication for reducing fever. Tylenol is usually taken for conditions such as

• Cough
• Cold or flu
• Headaches
• Muscle pain
• Arthritis
• Menstrual cramps

Despite its usefulness, Tylenol is said to cause side effects for some people. Some develop allergic reactions as well, although they are rare. Given below is a list of possible side effects of acetaminophen.

• Bloody or black, tarry stools
• Bloody or cloudy urine
• Fever with or without chillness
• Pain in the lower back
• Skin rash, hives, or itching
• Instant decrease in the amount of urine
• Jaundice (yellow eyes or skin)

The Tylenol Lawsuit and Key Issues

The Tylenol autism lawsuit typically addresses various legal actions related to the use of Tylenol (acetaminophen) and its side effects.

Some of the claims in the Tylenol lawsuit are mentioned below.

• Liver Damage Claims: Acetaminophen, the active ingredient in Tylenol, is known to cause liver damage, particularly when taken in huge amounts. The Tylenol lawsuit alleges that the manufacturers did not warn users whether there were any problems behind the drug related to liver damage. The Tylenol lawsuit claims that the manufacturer's labeling and warnings were insufficient and that users suffered severe health issues as a result.
• Acetaminophen and pregnancy: Research has suggested potential links between acetaminophen use during pregnancy and developmental issues in children, such as attention deficit hyperactivity disorder (ADHD) and autism. Many parents have filed a Tylenol autism lawsuit, claiming that the manufacturers did not provide proper warnings about these potential risks. A few legitimate actions have centered around claims that the problems connected with Tylenol use during pregnancy were not adequately disclosed to customers.

The Birth of the Tylenol Autism Lawsuit

Class action lawsuits have been filed in which groups of people collectively seek damages for similar claims related to Tylenol’s safety and effectiveness. These cases often focus on alleged deceptive practices or inadequate labeling.

Legal and Regulatory Aspects

The U.S. Food and Drug Administration (FDA) regulates the labeling and marketing of medications like Tylenol. The agency has issued warnings and guidance related to acetaminophen use, especially concerning dosage limits and risks of liver damage.

Tylenol manufacturers, such as Johnson & Johnson, have faced legal challenges and have updated labels and warnings in response to legal and regulatory pressures.

The Tylenol Autism Lawsuit

Tylenol autism lawsuits are now being brought against major players, Johnson & Johnson, and acetaminophen manufacturers, stating that they failed to warn that using the painkiller during pregnancy could lead to autism. The Tylenol autism lawsuit was authorized as an MDL in late 2022. This pretty much answers those who’re searching in Google for phrases like, “Does taking Tylenol when pregnant cause autism?” or “Is it safe to take Tylenol when pregnant.”

As of July 2024, 56 Tylenol autism and ADHD lawsuits are pending in New York Federal Court as part of multidistrict litigation (MDL) No. 3043. The sections below discuss the timeline of the Tylenol lawsuit.

Tylenol Autism Lawsuit Timeline

2022

June 10, 2022: Plaintiff Aujenai Thompson files a motion to transfer 19 cases across seven jurisdictions against dealers who sold acetaminophen. The motion justifies the transfer, stating that the cases involve the same facts and allegations. The allegations are listed below.

• Failure to publish warnings about the risk of autism or ADHD
• Breach of warranty
• Unofficial claims during the marketing and sales of acetaminophen

September 6, 2022: Walmart filed two motions to dismiss the Tylenol lawsuit on the grounds that the FDA generates drug labeling, which prevents any state law that requires a dealer to add warnings to the products it sells.

September 29, 2022: The judge panel of MDL hears arguments on the motion to transfer the Tylenol autism lawsuit to the MDL. More than 30 additional lawsuits have been filed since the motion to transfer was first filed, bringing the total number of cases to 49. The defendants in the Tylenol lawsuit are listed below.

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

October 5, 2022: The MDL judge panel permits the motion to transfer the Tylenol autism cases to the MDL. The case was allotted to Honorable Denise L. Cote in New York’s southern district. Since the motion to transfer was primarily filed, the court has noted 47 related cases, bringing the total to 66 lawsuits.

November 14, 2022: Judge Cote refuses Walmart’s motions to dismiss the acetaminophen lawsuits.

November 15, 2022: As of this date, 91 Tylenol lawsuits are pending in the MDL.

November 16, 2022: Mark Lanier is appointed to be one of the three co-lead counsels in the MDL. This important role allows him to act on behalf of all plaintiffs in the MDL. He was chosen because of his broad experience in pharmaceutical liability lawsuits overall and his distinct experience in lawsuits against Johnson & Johnson and the other defendants in this case.

November 17, 2022: The initial pre-trial status conference was held on 17th November, during which lawyers started to present the arguments with the procedures and guidelines related to the discovery process, court disputes, and bellwether trial selection. A schedule was set for the filing of the 2 primary complaints in the Tylenol lawsuit, one against Johnson & Johnson Consumer, Inc., and one against those who sold the drug. A long-form master complaint will be needed for the MDL, and individual plaintiffs of the Tylenol autism lawsuit are made to file short-form complaints. A major complaint is a detailed argument against the defendants, presenting the information of the case and allegations the same to all the plaintiffs.

December 2, 2022: Judge Cote says that individual Tylenol lawsuits could be shifted to the MDL and filed directly to reduce delays. Judge Cote also makes the plaintiffs file two primary cases in the MDL. One is to be filed against Johnson & Johnson Consumer, Inc., and the other against those who sold Tylenol.

December 15, 2022: 101 cases are transferred to the MDL.

December 16, 2022: The primary complaint against the dealers and Johnson & Johnson is filed.

2023

Autism/ADHD: Some women take Tylenol when pregnant to treat the pain and/or fever. Research shows that frequent use of Tylenol during pregnancy may increase the child’s risk of autism and attention deficit hyperactivity disorder. It is recommended to use the lowest effective dose for the short-term period and at the lowest possible frequency.

January 17, 2023: As of this date, 104 Tylenol autism cases have been shifted to the MDL.

January 27, 2023: Judge Cote provided an order directing how the progress will be explored in the case. All parties in the Tylenol lawsuit will have access to documentation uncovered during the discovery process.

February 10, 2023: Johnson & Johnson files a motion to refuse all the individual cases against it on the grounds that case conflicted with FDA labeling laws.

February 16, 2023: There were 107 cases pending in the MDL till date.

March 15, 2023: None of the new cases have been included in the multidistrict litigation since last month, but this is likely a short-term pause as the case works through the certain barrage of defendant’s motions to dismiss. Once there is a higher degree of certainty that these complaints will be approved to move forward, the number of Tylenol lawsuits is expected to grow specifically.

April 7, 2023: The plaintiffs in the Tylenol autism lawsuit submitted their version of the new warning that should be added to acetaminophen packaging.

April 12, 2023: Judge Cote examined the suggested label change provided by the defendants and invited the FDA to submit its own opinion on the following questions:

• Should the plaintiff’s proposed warning be added to acetaminophen labels?
• Does the science warrant including such a warning on the labels?

April 17, 2023: To date, the MDL has 108 pending cases.

April 20, 2023: The court refuses Johnson & Johnson’s motion to drop all of the Tylenol lawsuits in the MDL.

May 15, 2023: In the MDL, the number of pending cases becomes 118.

May 15, 2023: Judge Denise L. Cote led two motions to remove the claims against dealers. In the first ruling, Judge Cote approved the motion to refuse litigation based in Texas due to a state statute giving medication manufacturers and dealers a safe harbor when drugs are sealed in accordance with federal regulations. This removal is unique as it impacts all Tylenol autism lawsuits in Texas. A Californian plaintiff named Makesha Anderson’s case against Johnson & Johnson was previously dropped. The dealers argued that the plaintiff's case against them should also be dropped. The court discarded and refused the motion.

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

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

August 21, 2023: Judge Cote has approved the defendant’s permission to provide a consolidated brief on the Daubert challenges regarding the right of scientific expert witness presented by the plaintiffs. The plaintiffs had asked Judge Cote to deny the request, arguing that separate briefs for each expert were mandatory to confirm a fair result.

September 8, 2023: In a letter from the U.S. Attorney for the Southern District of New York, the FDA replied to Judge Cote’s request for a report of concern regarding whether caution labels, as suggested by the plaintiffs of the Tylenol lawsuit, should be added to Tylenol and other products related to acetaminophen.

September 20, 2023: The number of pending cases stands at 265.

October 5, 2023: A study has found that taking acetaminophen during pregnancy may affect a baby’s brain growth. The study used stem cells that were transforming into brain cells and exposed them to acetaminophen. The researchers explored that the medication can affect several genetic operations necessary for brain growth, including those guiding communication between brain cells and the type of cells they become.

October 9, 2023: Judge Cote of the Tylenol autism lawsuit has asked both parties to provide their proposals for the upcoming Daubert hearings. The defendants wanted a broad, week-long hearing process to contest the scientific witness issued.

October 17, 2023: An additional 118 cases have been added, bringing the total number of lawsuits in the MDL to 383.

November 11, 2023: Judge Cote planned the Daubert hearing for December 7, 2023. While both sides will present oral explanations, the judge will not hear declarations from the plaintiff’s expert witnesses. A ruling on the matter is not expected until early 2024. Other Tylenol autism lawsuits have been filed in state courts, including one in Illinois. The state lawsuits are still in their initial stages.

December 1, 2023: Both sides are planning for the upcoming Daubert hearing. The main focus of this hearing is to determine the admissibility of the plaintiff’s expert testimony evidence. There are now 441 cases in the MDL.

December 18, 2023: Today, Judge Denise Cote provided an extended ruling finding that the plaintiffs’ scientific experts failed to issue credible witnesses connecting Tylenol to autism or ADHD. While this was a setback for the federal MDL, still few options are present for appeal and the potential to pursue Tylenol autism cases in state courts.

2024

February 14, 2024: California is considered a starting point. New suits are also expected in Delaware, Pennsylvania, and New Jersey.

February 17, 2024: Judge Cote exposes a need to review new expert evidence put forward in the Tylenol lawsuit involving allegations that exposure to acetaminophen during pregnancy causes ADHD. There is a belief in the Tylenol lawsuit that the ADHD case is easier to make than the autism case.

July 31, 2024: The Tylenol autism lawsuits are ongoing, with multiple lawsuits connected into a MDL for efficiency. Discovery and pre-trial motions are active, and scientific research continues to explore potential links between acetaminophen use during pregnancy and autism. Regulatory bodies like the FDA maintain that acetaminophen is generally safe when used as directed but advise caution. Settlement talks may be underway, and trial dates for specific cases are being set.

Current Status

• Settlements: There are rumors of alleged settlement amounts. Still, there has been no finalized settlement in the Tylenol autism lawsuit. The financial outcomes will depend on the resolution of these cases.
• Ongoing Research: Ongoing research continues to explore the safety profile of acetaminophen, particularly regarding its use during pregnancy and the potential long-term effects. Research into acetaminophen and autism includes huge-scale epidemiological studies, biological mechanism investigations, and meta-analyses of existing data.

Conclusion

The Tylenol autism lawsuit is still ongoing, and many cases have been mixed into a single legal process to maintain them more efficiently. As new research and legal developments continue, it is important to stay updated on how these issues might impact consumers and future legal cases.