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Acetaminophen ASD

OpenACTIVE
MDL 3043Pharma
3,025+
Total Cases

Causation

Plaintiffs allege that acetaminophen exposure during pregnancy disrupts fetal neurodevelopment, increasing the risk of autism spectrum disorder and ADHD. A 2021 consensus statement in Nature Reviews Endocrinology signed by 91 scientists called for precautionary action based on epidemiological evidence. However, Judge Cote excluded plaintiffs' general causation expert in October 2023, finding the epidemiological evidence insufficient under Daubert to establish that prenatal acetaminophen causes ASD/ADHD. The ruling is a major obstacle, though plaintiffs argue the science is evolving and additional studies support the association through endocrine-disrupting pathways and oxidative stress mechanisms.

Defendants

EntityRoleNote
Walmart Inc.Retailer/DistributorEquate brand acetaminophen — largest retail defendant
CVS HealthRetailer/DistributorCVS Health brand acetaminophen
Walgreens Boots AllianceRetailer/DistributorWalgreens brand acetaminophen
Costco WholesaleRetailer/DistributorKirkland Signature brand acetaminophen
Target CorporationRetailer/DistributorUp & Up brand acetaminophen
Rite AidRetailer/DistributorRite Aid brand acetaminophen

Litigation Timeline

Oct 2023
Judge Cote excludes plaintiffs' general causation expert (Daubert ruling)
Dec 2023
Plaintiffs seek reconsideration and interlocutory appeal
2025
Continued filing despite Daubert setback. New expert reports submitted
2026
~3,025 cases pending. Appeal and re-evaluation of causation evidence ongoing

Intelligence Signals

Federal RegisterregulatoryAcetaminophen ASD
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-Qualified DeferredCompensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation

This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). In addition it will establish new requirements and revise exist

44mo ago
Federal RegisterregulatoryAcetaminophen ASD
CDC Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), announces the availability of the CDC Clinical Practice Guideline for Prescribing Opioids for Pain--United States, 2022 (2022 Clinical Practice Guideline). The 2022 Clinical Practice Guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016 (2016 Guideline) and provides evidence-based recommendations for clinicians who provide pain car

41mo ago
Federal RegisterregulatoryAcetaminophen ASD
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID-19

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2023 based on our continuing experience with these systems. We describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates and refines the requirements for the

41mo ago
Federal RegisterregulatoryAcetaminophen ASD
Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications

This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, identification of overpayments, formulary changes, and other programmatic area

40mo ago
Federal RegisterregulatoryAcetaminophen ASD
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Auth

This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2025 based on our continuing experience with these systems. We describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates the requirements for the Hospital Outpatie

16mo ago
PubMedpubmedAcetaminophen ASD
Safety of acetaminophen use in pregnancy: review of existing evidence.

Smith R, Zipursky JS. American journal of obstetrics & gynecology MFM. 2026 Mar 2.

1mo ago
PubMedpubmedAcetaminophen ASD
Maternal Acetaminophen Use and Child Neurodevelopment.

Lee PC et al.. JAMA pediatrics. 2026 Mar 9.

1mo ago
PubMedpubmedAcetaminophen ASD
Emerging Discussions on Folinic Acid and Acetaminophen in Autism.

Balkanas M, Durcan G, Doğangün B. Journal of autism and developmental disorders. 2026 Mar 19.

23d ago
PubMedpubmedAcetaminophen ASD
Familial confounding and causal inference in child and adolescent neurodevelopment and mental health.

Mataix-Cols D et al.. The Lancet. Child & adolescent health. 2026 Mar 24.

18d ago
Courtcourt
McCoy v. Johnson & Johnson Consumer, Inc.
Courtcourt
Morehart v. Openloop Health, Inc.
Courtcourt
Allen v. Openloop Health, Inc.
Courtcourt
SANCHEZ v. JOHNSON & JOHNSON

Key Facts

Status
active

Geographic Exposure

·S.D.N.Y. (MDL 3043, Judge Cote)
·Nationwide filing — all 50 states
·Parallel state court proceedings

Eligibility Criteria

  • Mother used acetaminophen during pregnancy
  • Child diagnosed with autism spectrum disorder (ASD) or ADHD
  • Acetaminophen use was regular or frequent during pregnancy
  • Used store-brand or retailer-labeled acetaminophen product