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U.S. Food and Drug Administration Declines to Claim Position on Tylenol-Autism Warning Labels

U.S. Food and Drug Administration Declines to Claim Position on Tylenol-Autism Warning Labels

Last month, the U.S. Food and Drug Administration (FDA) turned down a request to state their position on whether over-the-counter acetaminophen medications should include a pregnancy warning. Federal Judge Denise Cote, of the Southern District of New York, who is presiding over all current Tylenol autism lawsuits, invited the FDA to state a position by Sept. 15.

Despite the FDA’s actions, Tylenol-Autism cases continue to pour in; below, I’ll tell you more about how the FDA’s decision could affect Tylenol autism lawsuit outcomes, and when an attorney serving New York could potentially be useful to you.

If you aren’t certain whether you have a case, Buttafuoco & Associates can help you determine your rights during a free consultation.

Background on Tylenol Autism Cases

When a pregnant woman comes down with a fever or pain, acetaminophen has long been recommended as the drug of choice. Doctors and the public have repeatedly stated that the medication is not harmful to unborn children.

However, after several research studies found a link between acetaminophen and autism, families across the country began filing lawsuits. Lawsuits allege that drug makers neglected to sufficiently warn pregnant women about evidence that acetaminophen exposure could cause autism or attention deficit hyperactivity disorder (ADHD).

In 2022, all autism-acetaminophen lawsuits were centralized in a single court, to eventually be tried in what is known as a federal multidistrict litigation (MDL). This type of case is just what it sounds like: multiple cases where plaintiffs allege the same type of harm by a company’s actions are tried together in a single court. Individual plaintiffs still work with their own lawyers, but evidence is ultimately compiled and heard together to build a stronger case. Settlement amounts are typically tiered, and are determined by the severity of harm a victim has suffered.

The request that the FDA state a position on drug label warnings was prefaced by plaintiffs’ presentation of studies showing that pregnant women who frequently use acetaminophen have an increased risk of having children with autism and ADHD. Plaintiffs submitted proposals indicating the types of warnings that drug makers should, in their eyes, have provided consumers.

The example warnings included statements that certain studies indicated an increased risk of autism and ADHD, and that pregnant women should use the lowest effective dose of the acetaminophen for the shortest period of time.

Judge Cotes’ response to plaintiffs was to inquire about whether the FDA sees recent studies as sufficient grounds for providing such a warning. While they did not state that they see a causal relationship, they did provide a literature review conducted in March, stating that the evidence linking the drug to autism was inconsistent, and that they could not ultimately conclude a causal connection. A full version of the FDA’s response appears in this letter where they explain their decision not to offer an opinion. Plaintiffs disagreed, and provided several examples of evidence they say demonstrated a causal connection.

As you can imagine, working with a New York Tylenol-autism attorney is essential to these cases. Having an experienced team in your corner that can properly analyze your individual case and determine an appropriate settlement is key. Buttafuoco & Associates has worked on a wealth of MDL cases over the years, and we may be able to help you, too.

How Will Cases Move Forward?

Despite the FDA’s decision not to state a solid position on this issue, Judge Cotes will continue to review expert testimony submitted by plaintiffs and defendants, and hold hearings to determine the strength of the evidence.

After this, bellwether trials will likely occur. In this process, a small segment of cases that are representative of the whole group will be tried, and juries’ responses to evidence and testimony–including settlement amounts–will be evaluated. The bellwether process will potentially impact the size of settlements that acetaminophen makers offer to affected families. One goal of MDL is to prevent a huge number of individual cases from going to trial. In the end, this will save the courts and plaintiffs a significant amount of time, and speed up the settlement process.

Do You Have a Case?

If you believe your child’s autism or ADHD could have been caused by your use of acetaminophen during pregnancy, Buttafuoco & Associates may be able to help. We have represented clients in many multi-district litigation cases over the years, helping them recover necessary compensation, take care of medical expenses, and move on with their lives.

For a free case review, get in touch with our New York Tylenol autism attorneys today at 1-800-NOW-HURT.


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