Acetaminophen & Autism/ADHD Litigation Update

 Acetaminophen, also known as paracetamol, is one of the most common over-the-counter pain relievers, next to ibuprofen and aspirin. Acetaminophen was first discovered in 1878, but it wasn’t marketed until the 1950s under the name Triagesic.

acetaminophen bottle and pills

Acetaminophen was traditionally the preferred over-the-counter pain medication for pregnant women because it was considered safer than NSAIDS like ibuprofen. However, in June, 2021, a group of scientists and doctors published a call for caution, citing numerous studies that suggested the use of acetaminophen during pregnancy “might alter fetal development, which could in turn increase the risks of certain neurodevelopmental, reproductive and urogenital disorders.”

Lawsuits have been initiated nationwide against distributors of acetaminophen. Over the past several years, research studies have linked the use of acetaminophen during pregnancy to childhood diagnoses of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD)

The plaintiffs in these lawsuits took medication containing acetaminophen during their pregnancy, and their child was subsequently diagnosed with autism, ADHD, or both. They allege the distributors of acetaminophen failed to warn them of this risk.

Defendants in these lawsuits include Costco, CVS, Family Dollar, Rite Aid, Safeway, Sam’s West (Sam’s Club), Target, Walgreens, and Walmart. As of October 2022, Johnson & Johnson, the makers of Tylenol, have not been named in a lawsuit. Additional possible defendants may include other manufacturers and distributors of acetaminophen-containing medications, such as Amazon, Bayer, Proctor & Gamble, and Publix.

For plaintiffs or attorneys preparing to litigate these cases, working with an experienced team familiar with acetaminophen autism litigation is essential. CaseWorks supports law firms referring and handling acetaminophen autism and other mass tort cases.

Acetaminophen Autism Litigation Update: Multidistrict Litigation

On October 5, 2022, a Judicial Panel on Multidistrict Litigation (JPML) certified multidistrict litigation (MDL) pursuant to 28 U.S.C. 1407. This consolidated 18 acetaminophen lawsuits nationwide in the Southern District of New York. On October 6, 2022, 48 more acetaminophen lawsuits were added to the MDL, bringing the total cases consolidated in the Southern District of New York to 66. District Judge Denise Cote will oversee the MDL.

The Judicial Panel held that these cases present common questions arising from the same allegation and will involve the same scientific research, history, and theories of causation. According to the MDL certification panel, the questions are:

There are cases filed after the MDL was established. For example, in the Central District of California, two new cases, Gonzalez vs. CVS Pharmacy and Walgreens and Gameroz vs. CVS Pharmacy and Rite Aid, were filed on October 17 and 15, respectively. These cases will most likely be added to the MDL.

If no settlement is reached, the MDL will dissolve, and the individual cases will go back to the original district court where they were filed and be litigated separately.

pretrial conference between the parties is scheduled for November 17, 2022.

Walmart’s Motion to Dismiss Denied

On September 6, 2022, Walmart moved to dismiss two cases filed against it on the grounds that federal law preempts the state law with regards to the duty to warn.  

The plaintiffs filed in Tennessee and Nevada, while Walmart’s corporate headquarters are in Arkansas. The case may be governed by the laws of Nevada or the plaintiffs’ respective states, but the laws of all three states impose essentially the same requirements on drug manufacturers to provide warnings to ensure the public is not exposed to an unreasonable risk of harm.   

The lawsuits allege that there were no autism or ADHD warnings included. The warning on the packaging only stated, “If pregnant or breast-feeding, ask a health professional before use.” Walmart argued that it did not have the authority to add a more specific warning to the label because FDA guidelines prohibited it from doing so. The court disagreed and denied the motion on November 14, 2022.

Initial Pretrial Conference Held on November 17, 2022: Short Form Complaints Order

On January 9, 2023, U.S. District Judge Denise Cote ordered and set guidelines for short-form complaints. All plaintiffs must file a short-form complaint. Plaintiffs already in the MDL should have filed theirs no later than January 20, 2023. Cases transferred to the MDL from state courts must be filed within 14 days. The short-form complaint will supersede the initial long-form complaint. 

For the purpose of the statutes of limitations and repose, each plaintiff will be deemed to have initiated his or her case on the date of the filing of the original long-form complaint. The court provided guidance on service of the summons to each of the defendants, and in all cases authorized service via email.

On January 27, 2023, Judge Cote issued guidelines for discovery and issued a discovery coordination order in response to actions being filed against the makers of acetaminophen with similar facts and allegations in various states. The purpose is to reduce the burden on the parties and maximize the efficiency of the judiciary. The judge authorized the parties outside the MDL to adopt the coordination order and participate in the discovery process under the leadership of the parties in the MDL, except in depositions of MDL experts. 

As of February 16, 2023, there were 107 actions pending in the MDL.

Primary Allegations Against Acetaminophen Distributors

Autism spectrum disorder is a developmental disability that affects an individual’s behavior, communication, and learning ability. In 2018, the CDC estimated that 1 in every 44 eight-year-old children has autism. Further, autism diagnoses increased by 50 percent in 2014 from 2010.

ADHD is a neurodevelopmental disorder in children that can last into adulthood. A child diagnosed with ADHD might have difficulty focusing or paying attention, be unable to control their behavior or be overactive. According to a CDC study from 2016-2019, 9.8% of children have been diagnosed with ADHD.

There is no cure for autism or ADHD. Treatment for autism and ADHD includes the management of symptoms. Every person requires a unique care plan and individualized treatment.

The rise in neurodevelopmental disorders prompted medical and healthcare professionals to investigate the causation.

Research studies conducted by medical professionals and healthcare institutions have shown a correlation between taking acetaminophen while pregnant and an elevated risk of the child being diagnosed with autism or ADHD. The studies include the following:

This study’s findings illustrate that prenatal exposure to acetaminophen had an increased chance of autism and ADHD symptoms. This chance had a stronger correlation in boys.

This study warned that prenatal exposure to acetaminophen could increase the risk of developing autism and ADHD later in childhood. This report is supported by 91 scientists, clinicians, and public health professionals worldwide.

This study found that acetaminophen exposure during pregnancy increases the child’s risk of receiving an ADHD diagnosis by 30% and their risk of receiving an autism diagnosis by 20%.

This study identified an increased risk of developing ADHD-like behaviors, needing ADHD medications, and being diagnosed with hyperkinetic disorders (HKD) after prenatal acetaminophen use.

Background on Acetaminophen Lawsuits

Minor aches and headaches are common ailments during pregnancy. Acetaminophen has been marketed as a safe over-the-counter drug for pain during pregnancy. An estimated 65% of women in the United States and more than 50% of women across the globe use acetaminophen while pregnant.

Complaints against the sellers of the generic brands of acetaminophen were filed this year. The complainants in these lawsuits allege that they took an acetaminophen-containing product while pregnant, and their child was subsequently diagnosed with autism or ADHD. They allege the following:

Plaintiffs maintain that had they known the risks of their children being diagnosed with autism or ADHD, they would not have used acetaminophen. They demand compensatory and punitive damages.