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May 26, 2023 Big Pharma News

Big Pharma

J&J Uses ‘Rare’ Legal Challenge in Bid to Delay Lawsuits Alleging Tylenol Caused Autism

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.

tylenol autism lawsuit feature

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.

J&J earlier this month filed a motion for 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 bid for a preemption order to dismiss a series of lawsuits filed by parents against the company and other pharmaceutical companies and 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.”

The Tylenol lawsuits allege that 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.

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

These products have been marketed as safe for 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 the Centers for Disease Control and Prevention reveal that 1 in 36 children have been diagnosed with ASD, while a JAMA Pediatrics research letter stated 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.

Thousands of lawsuits pending reports that 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.”

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 were consolidated into the MDL thus far. The remaining lawsuits are pending the outcome of Daubert challenges in the MDL — legal cases testing the admissibility of scientific evidence.

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

According to an analysis published Monday by attorney Ronald 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 a Tylenol autism case in Texas, based on a state “safe harbor” law that 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 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, the FDA issued an acetaminophen pregnancy warning, stating expectant mothers should be cautious when using such products. The 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 studies identified links between acetaminophen use by pregnant women and the onset of ASD and ADHD, and other developmental problems, in their children.

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

A July 2022 study of acetaminophen published in Minerva Pediatrics “offers 17 lines of evidence that the commonly used remedy for pain and fever may be contributing 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 that acetaminophen use in infants and children has never been shown to be safe for their neurodevelopment.

And a 2021 meta-analysis in the European Journal of Epidemiology concluded: “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 to treat fevers and pain in children in the early 1980s after aspirin became associated with Reye’s syndrome. An increase in ASD has been documented as having begun during this time period.

J&J is no stranger to lawsuits concerning 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 and mesothelioma, a type of cancer that occurs in the thin layer of tissue that covers most internal organs.

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