Acetaminophen MDL 3043 Officially Consolidated

By Christina Grube

(MASS TORT NEWS) – The Judicial Panel on Multidistrict Litigation (JPML) officially consolidated 18 plaintiff actions against acetaminophen producers last week to the Honorable Denise L. Cote in the Southern District of New York, creating MDL No. 3043 – IN RE: Acetaminophen – ASD/ADHD Products Liability Litigation. The JPML also approved the conditional transfer of 48 additional actions to the MDL. 

Plaintiffs continue bringing suit against acetaminophen distributors and sellers who failed to inform users of the risks of taking the popular pain-killer while pregnant. Recent studies show prenatal exposure to acetaminophen (also referred to as paracetamol, or other brand-names including Tylenol, Tactinal, Ofirmev, or Mapap) may cause issues with the child’s neurological development. The MDL currently consists of 18 plaintiff actions against 5 big-name distributors: Costco, CVS, Walgreen, Safeway and Wal-Mart.

Patrick Luff of Luff Law serves as a docket leader in the emerging tort and expressed anticipation for moving forward in court, telling Mass Tort News, “We expect an order from Judge Cote soon on the initial organization of the litigation, and we look forward to getting down to work.”

Plaintiff’s claim they only used acetaminophen because distributors specifically marked the pain medication as ‘safe’ to use while pregnant and remained the only pain-reliever on the market approved for use during pregnancy. A 2021 study showed 65% of American women use a form of acetaminophen while pregnant.

Over the last decade, multiple studies have found positive relationships between prenatal acetaminophen exposure and a child’s development of autism (ASD) or attention deficit/hyperactivity disorder (ADHD). Briefing documents quoted 26 separate studies, and specifically highlighted a 2020 study which found biomarkers in children’s umbilical cords indicating a dose-response relationship (the higher the drug dose, the higher the risk of neurological disorder.) Plaintiffs bring misconduct suits against big-name sellers and manufacturers, claiming producers either knew and chose to withhold information from consumers, or should have known the risks of using their product while pregnant.

Despite acetaminophen’s popularity, court documents also draw attention to how little the medical community actually knows about the drug. “Scientists have yet to figure out how APAP [acetaminophen] relieves pain and reduces fever,” reads the case background. 

“In the United States alone, moreover, 82,000 emergency room visits and 26,000 hospitalizations are attributed to the use of acetaminophen annually,” the briefing document continues, “Despite the drug’s unknown mechanism of action, APAP has long been marketed to pregnant women as the safest pain reliever and fever-reducing drug for use during pregnancy.”

Recent studies also show risks to mothers who use acetaminophen while pregnant. A 2021 study showed a correlation between women using acetaminophen in the third trimester and developing severe preeclampsia. Some wonder if the Federal Drug Administration should also accept liability in the public misinformation. The FDA quietly withdrew its support of pregnant women using the pain-killer in 2015, declaring the current scholarship “too limited to make any recommendations based on these studies at this time.”