‘Mass tort launched for claims that acetaminophen caused autism, ADHD’- Reports Reuters
Do you know what is acetaminophen?
When down with a fever or a toothache, most of us would obviously go for the usual medicine in your home, without waiting for a physician’s advice.
In this blog, we will focus on one such drugs relied by majority of the people in the U.S, Tylenol or acetaminophen and the booming Tylenol class action lawsuits.
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Tylenol
One of the most well-known and often used over-the-counter painkillers is Tylenol, which is the brand name for acetaminophen. In pharmacology and medicine, acetaminophen occupies a singularly dominant position.
McNeil Laboratories established the brand in 1955. They packaged it like a red fire engine with the motto, “for little hotheads,” and promoted it as a medication to lower fever in children. Using the drug’s chemical name, N-acetyl-para-aminophenol, McNeil created the brand name Tylenol.
The first aspirin-free pain medication for children, Tylenol Elixer, was introduced by McNeil in 1955. After Johnson & Johnson acquired McNeil in 1959, the medication was sold over the counter the following year.
Tylenol is used by millions of people both as painkiller and a fever reducer. The drug is also widely used to treat minor discomfort and fevers brought on by illnesses like the flu, headaches, muscle pains, arthritis, and menstrual cramps. Tylenol is advised by the World Health Organization as first-line treatment for pain problems. This medication was first authorized by the American Food and Drug Administration in 1951.
In the United States, acetaminophen is available over-the-counter (OTC) in a variety of dosage forms, including regular (325 mg) and extra-strength (500 mg) oral tablets or capsules, oral liquids with quick release, chewable or orally disintegrating tablets, and rectal suppositories. In the United States, acetaminophen (Ofirmev) is also available by prescription in an intravenous (IV) form.
Around 50 million American consumers in the United States use products containing acetaminophen each week, with more than 25 billion doses being used annually.
Acetaminophen is found in over 600 prescription and OTC products in the U.S. like antihistamines, decongestants, cough suppressants, and diphenhydramine.
Common over-the-counter (OTC) drugs in the US that contain acetaminophen are as follows.
- Delsym NightTime Multi-Symptom used for cough, runny nose, congestions, headache, cold and flu
- Excedrin used for migraine headache pain relief
- Robitussin Flu used for headache, runny nose, cough, congestion and flu
- Sudafed PE Sinus Headache used for sinus headache
- Theraflu Sinus and Cold used for sinus headache, congestion, cold, flu symptoms
- Tylenol PM used for mild pain relief combined with an antihistamine OTC sleep aid
Mechanism of Action of Tylenol
The mechanism of action of Tylenol is not fully understood and it is still under research.
The available research findings indicate that the drug interferes with the prostaglandin synthesis which is responsible for pain sensation in our body. Two isoforms of cyclooxygenase, COX-1 and COX-2 is involved in prostaglandin synthesis, which is blocked by Tylenol. Acetaminophen has no peripheral anti-inflammatory benefits because it does not inhibit cyclooxygenase in peripheral tissues.
The direct impact of acetaminophen on the brain’s heat-regulating areas is presumably what causes its antipyretic effects, which include peripheral vasodilation, sweating, and a loss of body heat.
Tylenol, Pregnancy and Autism
The National Institutes of Health and the Agency for Health Care Research and Quality conducted its own study in October 2019 under the direction of Xiaobing Wang, M.D., and colleagues from the Baltimore-based Johns Hopkins Bloomberg School of Public Health.
The study came to the same conclusion that acetaminophen use during pregnancy was associated with an increased risk of autism and ADHD.
In September 2021, issue of the journal Nature Reviews Endocrinology, reported the shocking truths about Tylenol and pregnancy. New scientific evidence suggests that Tylenol or generic acetaminophen while pregnant may raise the risk of autism in the baby, which is the basis for the acetaminophen lawsuits. The reports of the research studies triggered the parents of autistic children to file lawsuits, suing Tylenol manufacturing companies.
In September 2021, the United States Food and Drug Administration released a statement regarding Tylenol during pregnancy, and concluded that the studies were “too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. We urge pregnant women to always discuss all medicines with their health care professionals before using them.”
Animal studies show that acetaminophen exposure during pregnancy can affect foetal development and raise the likelihood of neurodevelopmental disorders including autism. One of the suggestions from the studies is to add a notice against acetaminophen usage during pregnancy to all products containing the drug.
Consistent exposure or Tylenol during pregnancy is also reported to have other issues like
- ADHD (Attention Deficit Hyperactivity Disorder)
- Undescended testicles
- Neurodevelopmental issues
- IQ level deficits
- Behavioral issues
- Sleep issue
- Early puberty in girls
- Male fertility problems
Tylenol Autism Class Action Lawsuit
Tylenol autism class action lawsuit was certified in New York on October 5, 2022 by the JPML. It will accommodate all the Tylenol lawsuits filed in any federal court in the U.S.
A motion for MDL consolidation was submitted by a number of plaintiffs, which was opposed by all of the defendants including Walmart, Walgreens, CVS, and other companies involved in the manufacturing and distribution of the drug. They argued that an MDL cannot be initiated without the participation of all of the case’s significant defendants.
J&J has not been listed as a defendant in any of the claims that attorneys are attempting to combine into a Tylenol class action lawsuit for tactical reasons.
Twenty Tylenol autism claims are currently underway in various federal districts, according to the motion submitted to the JPML.
The plaintiffs claim that the increased risk of autism and Attention Deficit Disorder in the infants was not disclosed to the consumers by the product’s manufacturers and distributors.
Tylenol Class Action Lawsuits MDL Update 2024
Tylenol lawsuits MDL titled In Re: Acetaminophen – ASD/ADHD MDL No. 3043 – consolidated under Judge Denise L. Cote in the Southern District of New York has 58 active lawsuits pending as of August 2, 2024.
Tylenol MDL Status Update 2024
Judge Cote dismissed all the pending Tylenol autism lawsuits in the MDL, on August 20, 2024. The plaintiffs had filed an appeal to review the decision. Earlier, on July 10, 2024, she had grantedthe defendant’s motion to exclude the plaintiffs’ expert witness Dr. Roberta Ness. she opined that the expert testmony could not establish the link between Tylenol intake and prenatal injuries.
November Update
The appeal challenges Judge Cote’s decision to exclude testimony from plaintiffs’ experts on the potential link between prenatal Tylenol use and autism or ADHD, arguing that the judge misapplied the Daubert standard. The Daubert standard ensures that technical evidence presented in court is reliable and based on sound scientific principles. Plaintiffs’ attorneys argue that the judge went beyond her role as a gatekeeper by dismissing reputable scientific testimony and taking a definitive stance on the scientific validity of the evidence. They also claim she prioritized public policy concerns over scientific evaluation, which they assert should not factor into a Daubert ruling. A decision on the appeal is expected early next year, with updates to follow as the case progresses.
What are the damages covered in Tylenol Class Action lawsuits?
Autism spectrum disorder has no known cause or treatment that works for everyone. The aim of treatment is to improve the child’s functioning by minimizing the symptoms of autism spectrum disorder and fostering growth and learning. The child’s requirements may change over time, and the variety of home- and school-based therapies and interventions for autism spectrum condition can be bewildering.
A child with ASD may require therapy, medication, and additional tutoring. In some cases, they may require life-long care. Parents may be forced to miss work to take their children for treatment, forfeit job opportunities to care for their children, or substantially reduce their standard of living to afford treatment.
All these factors would be considered while analyzing the damages to be covered under Tylenol autism lawsuit.
The following are the damages that will be covered under the lawsuit.
- Medical expenses for treating autism
- Future medical expenses for the treatment of autism
- Permanent autism disability
- Autism-related anguish and pain
- Earnings lost by parents who have to stay home to take care of a disabled child
Expert lawyers foresee Tylenol lawsuits to become the largest consolidated lawsuit in the United States. When the lawsuit moves ahead with a greater number of plaintiffs joining the battle and the defendant coming to the picture, the true race will begin.
As of now we cannot come to a conclusion regarding Tylenol class action settlement, as the lawsuits are still in the budding stage.
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Is this the first lawsuit against Tylenol manufacturers?
No. Tylenol is involved in numerous lawsuits associated with liver damage. A claimant sued McNeil Consumer Healthcare, in 1993 on the grounds that it neglected to warn that combining alcohol with the drug’s key ingredient, acetaminophen, could harm the liver.
Benedi, the claimant received $8.8 million from a federal court jury, which was divided into $7.855 million in compensatory damages and $1 million in punitive damages.
Numerous complaints have been made since 1994, claiming that taking Tylenol damaged their livers. By the end of June 2013, 187 people had filed lawsuits across the nation, with at least 14 of those claims being filed in New Jersey, the state where Johnson & Johnson is based, and 74 of those cases being filed in federal court. 13 federal MDL litigation out the 233 plaintiff-filed federal lawsuits are still pending as of April 2019.
Know How to File a Tylenol Autism Class Action Lawsuit
Are you the parent of a child with Autism Spectrum Disorder or ADHD? Do you suspect Tylenol intake, the culprit?
Consult a Tylenol lawsuit lawyer and proceed with a case evaluation.
If the mother was seeing a doctor or ob-gyn while pregnant, the mother’s medical records are a typical technique to prove it.
If the plaintiffs can demonstrate that they used Tylenol or acetaminophen products over an extended period of time while pregnant, their cases will be stronger.
Potential evidences in Tylenol class action lawsuits could be the following
- Acetaminophen purchase receipts
- Records from the child’s doctor stating that the exposure to acetaminophen caused a neurological issue
- Records from the child’s therapist or psychiatrist
- Any documentation from medical practitioners regarding the use of Tylenol during pregnancy
The claim should not have any evidence of a family history of autism, pregnancy problems, or other known risk factors for autism and neurological disorders.
Despite all the increasing evidence against Tylenol and acetaminophen, there is currently no black box warning label on these medications alerting consumers and physicians to any potential connection between Tylenol usage during pregnancy and Autism or ADHD.
Furthermore, there is no guidance regarding the levels that may or may not be deemed safe for expectant mothers. The only way to be safe is to seek medical advice before taking Tylenol during pregnancy.
Stay glued with LezDo TechMed, the finest medical record review company in the U.S for more updates on Tylenol class action lawsuits update 2025.
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5/5 Expert lawyers foresee Tylenol lawsuits to become the largest consolidated lawsuit in the U.S.
The true race will begin when more plaintiffs join the lawsuit and the legal proceedings commence.
Read more here https://t.co/2QNEE35HCO— LezDo MedLegal (@LezDoMedLegal) October 29, 2022
