Big Pharma Tries To Delay Legal Action On Tylenol And Autism (2023)

Johnson & Johnson filed a “rare type of legal challenge” that if granted, would put a temporary hold on a class action lawsuit filed against the drugmaker by parents alleging Tylenol caused autism spectrum disorder or attention-deficit/hyperactivity disorder in children.

By

Michael Nevradakis, Ph.D.

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Johnson & Johnson (J&J) filed a “rare type of legal challenge” that if granted, would put a temporary hold on a class action lawsuit filed by parents against the drugmaker alleging Tylenol, made by J&J subsidiary McNeil Consumer Healthcare, caused autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder(ADHD) in children.

Big Pharma Tries To Delay Legal Action On Tylenol And Autism (1)

J&J earlier this monthfiled a motionfor an interlocutory appeal in the U.S. District Court for the Southern District of New York after a federal judge, on April 20,denied the company’s bidfor apreemption order to dismissa series of lawsuits filed by parents against the company and otherpharmaceutical companiesand drugstore chains that make or sell Tylenol and other drugs containing acetaminophen.

The new motion, which would allow J&J to seek a federal appeals court decision on whether the failure to provide adequate warnings should be preempted by federal law, is part of an ongoing series of developments in what has become known as the “Tylenol lawsuits.”

TheTylenol lawsuits allegethat the makers of products containing acetaminophen (also known as paracetamol),including J&J, were negligent in not warning the general public — including pregnant women — about the risks posed by the drug to fetal development and in encouraging their widespread use during pregnancy.

(Video) A Victory for Plaintiffs in the Tylenol-Acetaminophen Autism Lawsuit #shorts

The lawsuits also allege that retailers, including Walmart, CVS, Walgreens and others, falsely advertised products containing acetaminophen as being safe forpregnant womenand did not warn them about the risks posed to fetal development.

These products have beenmarketed as safefor pregnant women since the 1950s, despite a significant number of peer-reviewed studies finding that acetaminophen poses serious risks to pregnant women and unborn children.

Lawsuits are being pursued on behalf of children under 15 who were diagnosed with ASD between the ages of 1 and 10, and children under 15 who were diagnosed with ADHD between the ages of 8 and 14.

Statistics from theCenters for Disease Control and Preventionreveal that1 in 36 childrenhave been diagnosed with ASD, while aJAMA Pediatrics research letterstated 1 in 30 children born in the U.S. in 2020 were diagnosed with autism — representing a 53% increase in ASD among young Americans since 2017.

Products that contain the drug include Tylenol, Alka-Seltzer Plus, DayQuil, Excedrin, Goody’s, Mucinex, NyQuil, Robitussin and some generic and store-brand equivalents.

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Thousands of lawsuits pending

Medtruth.com reportsthat J&J’s motion for an interlocutory review “would be independent of a final judgment on whether Tylenol contributed to any individual child’s diagnosis of ADHD or autism.”

(Video) What The Experts Are Saying About The Tylenol Autism Lawsuit

Big Pharma Tries To Delay Legal Action On Tylenol And Autism (4)

If J&J’s motion is denied, then the first set of lawsuits will proceed as “bellwether cases,” as part of an established multidistrict litigation (MDL), through which all of the lawsuits have been consolidated into one court, the U.S. District Court for the Southern District of New York.

Senior U.S. District Judge Denise Cote was appointed to oversee the MDL in late 2022.

Under the MDL, each of the lawsuits will proceed separately, but an initial series of bellwether cases — a group of representative cases that will help the parties gauge how juries are likely to respond to certain evidence, claims and testimony about the link between Tylenol products and conditions such as ADHD and autism — will be tried.

Although thousands of Tylenol lawsuits are pending, only 124 wereconsolidated into the MDLthus far. The remaining lawsuits are pending the outcome ofDaubert challengesin the MDL — legal cases testing the admissibility of scientific evidence.

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The outcome of these “bellwether” cases will not impact any other individual case but may have a significant impact on the average settlement amount that will be agreed upon for each claim. And if the bellwether cases do not reach a settlement, they may be remanded back to the U.S. District Courts for trial.

Interlocutory appeal unlikely to succeed, legal expert says

(Video) Erin Brockovich helps pregnant women sue Tylenol | NewsNation Prime

According to ananalysis published Mondayby attorneyRonald V. Miller Jr.of the Baltimore-based Miller & Zois law firm, “the court is unlikely to approve the interlocutory appeal, as it would halt litigation that the judge is evidently determined to expedite.”

However, that outcome is not certain and the court has set a schedule to ensure the issue is fully briefed, Miller said.

In February,J&J sought dismissal of the lawsuits. The April 20 order denying the motion to dismiss stated that “nothing in the federal rules and regulations actually prevented J&J from adding a warning to Tylenol about the risks of in utero exposure.”

A similar ruling was made last week denying preemption motions filed by Target and Walmart, while a previous motion by Walmart was denied in November 2022.

On Monday, Cote granted a motion to dismiss aTylenol autism case in Texas, based on a state“safe harbor” lawthat says a drugmaker cannot be held liable for a failure to warn the public if its warning labels complied with regulations approved by the U.S. Food and Drug Administration (FDA).

According to Miller, this could mean that all Tylenol lawsuits governed by Texas law may be dismissed.

In April, Cote asked the Useless FDA to provide an opinion regarding whether the warning label proposed by plaintiffs in the Tylenol lawsuits should be added to acetaminophen products.

In January 2015, theFDA issuedanacetaminophen pregnancy warning, stating expectant mothers should be cautious when using such products. The Useless FDA, however, claimed there is “not enough research” to confirm safety risks for unborn children from acetaminophen exposure.

Peer-reviewed studies support plaintiffs’ claims

A growing number of scientific,peer-reviewed studiesidentified links between acetaminophen use by pregnant women and the onset of ASD and ADHD, and other developmental problems, in their children.

(Video) FDA Warns Popular Nerve Pain Drugs Gabapentin, Pregabalin Linked To Serious Breathing Problems & Dea

Data from the ongoingBoston Birth Cohort Study, sponsored by the Johns Hopkins Bloomberg School of Public Health, has indicated that “exposure to acetaminophen in the wombmay increase a child’s risk for attention deficit/hyperactivity disorder and autism spectrum disorder.”

A July 2022study of acetaminophenpublished in Minerva Pediatrics “offers 17 lines of evidence that the commonly used remedy for pain and fever may becontributing to the autism epidemic,” as previously reported by The Defender. Dr. William Parker, the lead researcher on the study, told The Defender at the time that “acetaminophen would never be approved for pediatric use by today’s regulatory standards.”

A February 2022 study published in the European Journal of Pediatrics found thatacetaminophen use in infants and childrenhas never been shown to be safe for their neurodevelopment.

And a 2021 meta-analysis in theEuropean Journal of Epidemiologyconcluded: “children prenatally exposed to acetaminophen were 19% and 21% more likely to subsequently have borderline or clinical Autism Spectrum Conditions (ASC) and ADHD symptoms compared to non-exposed children.”

Acetaminophen became the preferred drug totreat fevers and pain in childrenin the early 1980s after aspirin became associated with Reye’s syndrome. Anincrease in ASDhas been documented as having begun during this time period.

J&J is no stranger to lawsuitsconcerning its pharmaceutical products. Tens of thousands of lawsuits are pending against the company concerning its talc-containing products, which have been linked to the onset of ovarian cancer andmesothelioma, a type of cancer that occurs in the thin layer of tissue that covers most internal organs.

Big Pharma Tries To Delay Legal Action On Tylenol And Autism (6)

Michael Nevradakis, Ph.D.

Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”

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FAQs

Is there really a lawsuit against Tylenol for autism? ›

Tylenol lawsuits are now being brought against major retailers, Johnson and Johnson, and generic acetaminophen makers claiming that they failed to warn that using the popular drug during pregnancy could lead to autism.

How much can you get from Tylenol autism lawsuit? ›

However, based on prior results in similar dangerous drug lawsuits, it is projected that Tylenol Autism ADHD Lawsuit Payouts could be between $50,000 and $300,000+ depending on the strength of the claim and direction of the litigation.

Is Tylenol causing the ADHD lawsuit? ›

Acetaminophen ADHD Class Action Lawsuit

The lawsuits claim that the drug companies were negligent because they failed to warn consumers or doctors about the risks of using Tylenol during pregnancy. The earliest handful of acetaminophen ADHD lawsuits was filed around the end of 2021.

Is there a lawsuit investigation for autism after Tylenol during pregnancy? ›

On November 16, 2022, Judge Cote approved Mark Lanier, Ashley Keller, and Mikal Watts to lead a team of 22 attorneys alleging that prenatal acetaminophen use caused autism and ADHD in children. The following day the first hearings against Johnson & Johnson and multiple retailers, including Walmart, were heard.

Which common painkiller is blamed for autism? ›

Citing new studies linking the drug to increased risk of developmental issues in babies, the plaintiffs blame their children's autism, attention-deficit problems or hyperactivity on significant doses of acetaminophen taken during pregnancy.

What is the age limit for the Tylenol lawsuit? ›

Tylenol ADHD lawsuits are being investigated for children currently under 15 years old who were diagnosed with severe attention deficit hyperactivity disorder (ADHD) between the ages of 8 and 14 years old.

When will the Tylenol ADHD lawsuit be settled? ›

These lawsuits may settle in 2023, and a new warning label will be added to protect unborn children. Parents and children affected by autism may be eligible to receive compensation for medical expenses, pain and suffering, and other damages related to the use of Tylenol during pregnancy.

What proof do you need for Tylenol lawsuit? ›

It must be proven that Tylenol or a generic equivalent was taken during pregnancy, and that your child was subsequently diagnosed with a neurological disorder related to documentary and scientific evidence. Evidence for a Tylenol Lawsuit may include: Medical records on Tylenol usage during pregnancy (if available)

Is autism is Hereditary? ›

Inheritance. ASD has a tendency to run in families, but the inheritance pattern is usually unknown. People with gene changes associated with ASD generally inherit an increased risk of developing the condition, rather than the condition itself.

How much is the Tylenol lawsuit worth? ›

Our lawyers estimate that a successful Tylenol lawsuit could have a settlement value range of $500,000 to $2,000,000. Certain cases with compelling facts or circumstances could have a much higher value.

What syndrome does Tylenol cause? ›

These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). These conditions are extremely painful and can lead to blindness and death. Acetaminophen can lead to acute liver failure, which may only be treated with an emergent liver transplant.

Can you sue Tylenol for side effects? ›

If you have taken a medication that contains acetaminophen and experienced any complications, you may be entitled to damages. Please contact an experienced defective products attorney who can evaluate your case and help explain the timeline of litigation.

What is compensation for autism? ›

“Compensation” is a phenomenon by which individuals with Autism Spectrum Disorder (ASD) show improvements in overt symptoms, namely their understanding of others (“theory-of-mind”, ToM), despite persisting deficits at the cognitive and neurobiological levels.

How do I start a lawsuit against Tylenol during pregnancy? ›

If you believe acetaminophen caused your child to develop autism or ADHD, call (888) 726-9160 to talk to our team and see if you qualify to file a lawsuit and be compensated for the harm and you and your child suffered.

Is ADHD a part of autism? ›

ADHD is not on the autism spectrum, but they have some of the same symptoms. And having one of these conditions increases the chances of having the other. Experts have changed the way they think about how autism and ADHD are related.

What is the most severe case of autism? ›

Level 3 is the most severe level of autism. People with level 3 autism have limited ability to speak clearly. Difficulty with both verbal and nonverbal communication makes it challenging to interact with others. This level of autism requires a higher level of support throughout life.

What is the safest medication for autism? ›

The only medications approved by the FDA for children with autism are Abilify and Risperdal. Both are antipsychotic medications that can help with irritability and aggression. Medication can also be helpful for kids who also have another diagnosis.

What medications increase risk of autism? ›

The only medications known to increase the risk of ASD are used for epilepsy or as a muscle relaxer in anesthesia. For example, the anti-seizure drug valproate increases the risk of autism from 1.9% to 4.4%.

What happens if you take Tylenol for years? ›

Taking too much acetaminophen can damage the liver, sometimes leading to a liver transplant or death. The body breaks down most of the acetaminophen in a normal dose and eliminates it in the urine. But some of the drug is converted into a byproduct that is toxic to the liver.

What is the Keller Postman Tylenol claim? ›

Keller Postman is suing makers of generic store brand acetaminophen for failing to warn pregnant women that the drug increases a child's risk for autism spectrum disorder, ADHD, & other developmental disorders related to infant exposure during pregnancy.

What ADHD medication is in a class action lawsuit? ›

The lawsuits alleged that the makers of methylphenidate (brand name Ritalin) and the American Psychiatric Association had conspired to invent and promote the disorder ADHD to create a highly profitable market for the drug.

How do you test for Tylenol toxicity? ›

A diagnosis of acetaminophen toxicity is usually confirmed through diagnostic tests, including an acetaminophen level, electrolytes, kidney function tests, amylase, lipase, liver function tests, complete blood count, and coagulation factors.

What is the FDA warning on Tylenol? ›

Anyone who develops a skin rash or reaction while taking Tylenol or any drug containing acetaminophen is advised to immediately stop taking the drug and seek medical attention.

Why would a doctor tell you not to take Tylenol? ›

You should not take Tylenol if you are allergic to acetaminophen, or if you have severe liver disease. Do not take this medicine without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take Tylenol.

Which parent mostly carries autism gene? ›

Since autism is less prevalent in females, autism was always thought to be passed down from the mother. However, research suggests that autism genes are usually inherited from the father.

Which parent carries the gene for autism? ›

Does The Father Or Mother Carry The Autism Gene? Autism was always thought to have a maternal inheritance component, however, research suggests that the rarer variants associated with the disorder are usually inherited from the father.

What are the 3 main causes of autism? ›

There are many different factors that have been identified that may make a child more likely to have ASD, including environmental, biologic, and genetic factors.

What is the Tylenol lawsuit in Louisiana? ›

Cle' Simon is responsible for the largest jury award of its kind in the history of Louisiana in a case against the manufacturer of Infant's Tylenol resulting in the award of $7.6 million to the plaintiffs for the death of a 5-month-old child resulting from an accidental overdose of Infants' Tylenol.

What is a class action lawsuit against pharmaceutical companies? ›

A pharmaceutical class action lawsuit is when a group of people affected by the same drug come together to file a lawsuit against the manufacturer. This suggests the scope of the drug's harm is far-reaching and has caused suffering in numerous people's lives.

How much are people getting from the Tylenol settlement? ›

Our lawyers estimate that a successful Tylenol lawsuit could have a settlement value range of $500,000 to $2,000,000. Certain cases with compelling facts or circumstances could have a much higher value.

How much can you get from Tylenol claim? ›

What Settlement Amounts Can Tylenol Autism Lawsuit Plaintiffs Expect? The trial value of a Tylenol autism lawsuit will drive settlement amounts. The average trial value of a successful verdict in a Tylenol autism lawsuit would likely be between $5 million and $10 million. Keep in mind a few things.

How much is the DG Infant Acetaminophen settlement? ›

DG Health Infants' Acetaminophen $1.8M Class Action Settlement - Top Class Actions.

Why was Tylenol discontinued? ›

1 status with a third of the analgesic market. Johnson & Johnson, which had already suspended Tylenol production, decided over the weekend to stop making the capsules after a consumer research and technology review indicated that there was no better way to protect consumers, Mr. Burke said.

Is there a Tylenol settlement? ›

According to the company, Infants' Tylenol is associated with safety features for infants such as a syringe for safe dosing practices. However, the company has agreed to pay into a $6.315 million settlement to resolve the claims against them.

What is the largest pharmaceutical lawsuit payout? ›

Pfizer (2009)

This settlement came out to $2.3 billion as a result of the false promotion of Bextra Valdecoxib Tablets, Geodon Capsules, Lyrica Pregabalin, and Zyvox. Pfizer faced allegations of paying kickbacks and submitting false claims to the government.

What is the largest lawsuit payout? ›

1998 – The Tobacco Master Settlement Agreement - $206 Billion. The Tobacco Master Settlement Agreement was entered in November 1998 and is still the largest lawsuit settlement in history.

Is it wise to join a class action lawsuit? ›

In most cases, there's little downside to joining these lawsuits, which combine many legal claims — often thousands — into one claim against a single defendant, reducing fees for each claimant and potentially earning a much larger payout. And there have been many opportunities to do so.

Videos

1. Tylenol - What you should know about it (Also Known As Acetaminophen)
(Six Echo)
2. When, Why, and How to Think About Medicines for Behavior in Autism
(SPARK for Autism)
3. Autism Parent to Parent Discussion about Getting and Using an Aide in the Classroom
(Autism Live)
4. Autism - The Science of Us
(The Science of Psychotherapy)
5. What I learned from parents who don't vaccinate their kids | Jennifer Reich | TEDxMileHigh
(TEDx Talks)
6. Epidurals and Autism Pediatrician Discusses the Safety | Dr. Amna Husain
(Dr. Amna Husain)

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