THE TRUMP FDA GIVES HOPE AND A PATHWAY TO PARENTS OF AUTISTIC AND ADHD CHILDREN—THE MAJORITY OF DEMOCRATS STILL ENJOY BIG PHARMA MONEY—FOLLOW IT HERE
INTRODUCTION
Recently, and ignoring the cries of “junk science,” President Trump and his HHS and FDA team of Robert F. Kennedy Jr. and Marty Makary publicly announced that the prenatal use of Acetaminophen may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The FDA also issued a letter alerting physicians nationwide to this. While stating that a causal relationship has not yet been established, the Trump FDA has pointed out that multiple large-scale studies HAVE found such an association, and the FDA has begun the long overdue process of mandating label changes for Tylenol and similar products. The goal is to utilize the regulatory power of the FDA to instill a culture of caution in mothers and to continue to monitor epidemiological studies to hopefully isolate the factors that have caused an alarming increase in the diagnosis of autism spectrum disorder (ASD) and ADHD (attention deficit hyperactivity disorder) in children. The FDA was clear to state, however, that there are studies with contrary conclusions and that in some instances it is reasonable to use Acetaminophen for certain scenarios since Aspirin and Ibuprofen have well-documented adverse effects on fetal development.
This is a significant shift from the Biden FDA, as feckless and corrupted as he is and was. There is no question that this bold and pragmatic statement is more in line with “real” and not “junk” science and may well change the course of years of litigation wherein suffering parents have sought redress for what they allege is a general causal relationship between chronic use of Acetaminophen and the conditions of ASD and ADHD in their beloved children. It may well be in response to a recent ruling by a United States District Judge in the Southern District of New York in the Acetaminophen ASD-ADHD Multi-District Litigation, who ruled, in consolidated cases brought by scores of the best plaintiff attorneys in the country, that the parents could NOT use the expert testimony and studies interpreted by such experts to prove causation, essentially dismissing the cases unless the ruling is overturned on appeal. Acting as an amateur scientist and epidemiologist, this lay judge, acting arbitrarily, held that ALL FIVE of the parent’s experts, including an incoming Dean of the Harvard School of Public Health, could NOT testify. The evidence was deemed “unreliable” by the court without the opportunity for a jury to consider the evidence. Biden’s FDA was invited by the court to weigh in on the effectiveness of current warnings and simply replied, “There is no current evidence of causality,” and stayed out of the fray. Bought and paid for cowardice. The Court considered this statement persuasive in trashing the plaintiffs erudite list of proffered experts.
This “gatekeeper” role for federal judges considering proposed expert testimony was the result of a disgruntled Big Pharma buying off Congress in the year 2000. I trace herein the steps that have kept meritorious litigants from ever seeing a jury. The stranglehold that Big Pharma has on both Congress and previously corruptible FDA Commissioners is undeniable. Read on.
A LOSS IN THE SUPREME COURT IN 1993 PUT BIG PHARMA ON THE WARPATH, AND CONGRESS GAVE THEM THEIR WAY IN 2000 WITH A SIGNIFICANT AMENDMENT TO THE FEDERAL RULES OF EVIDENCE PERTAINING TO EXPERT TESTIMONY
In the years that the prenatal anti-nausea drug BENDECTIN was irresponsibly marketed to pregnant women, several hundred children were born with severe birth defects. Merrill-Dow Pharmaceuticals pulled the drug from the market in 1980 due to studies showing a causal relationship between use of the drug and these life-altering defects but defended cases brought against it by paying for experts and studies that refuted such claims. Jason Daubert and Eric Shuller, minor children who had such defects, sued for redress from these injuries in a California court. Merrill-Dow predictably used its power over the medical community and its flush coffers to win at the trial and appeal levels by excluding the plaintiffs proffered expert testimony. However, the Supreme Court saw the need to resolve some confusion that was filtering its way through the federal courts involving the implementation and interpretation of Federal Rule of Evidence 702. This Rule, enacted in 1975, established the criteria under which an expert witness may be utilized to assist the jury in understanding evidence beyond their usual lay expertise in simply living life and assessing witness credibility. In 1993, in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, the Supreme Court reversed Merrell Dow’s wins below and remanded the matter for reconsideration of the experts’ opinions previously excluded. Big Pharma filed amicus briefs urging courts to rigorously screen plaintiff’s experts to ensure “reliability.” Even though Merrell Dow ultimately won, the die was cast to be sure that Rule 702 would be tightened to create potential barriers for plaintiffs to seeking a jury trial in cases where experts would be needed. This is absolutely true in drug litigation.In practice, Big Pharma controls the science of epidemiology—namely the study of the causes, incidence, and distribution of diseases. It has the money and resources to create and influence data through various means. The medical community, in my view, has parroted statements from drug manufacturers and falls in lockstep even though their training is quite remote from that distinct science. The mutually beneficial association need not be belabored.
In the wake of Daubert, Big Pharma sought to have the Federal Rules of Evidence 702 amended so that they could have an advantage in the costly and high-stakes litigation involving pharmaceutical safety. Follow the money.
IN 2000 BIG PHARMA AND THEIR LAWYERS GOT THEIR WAY, AND ALL EXPERTS IN ALL FIELDS WOULD HAVE TO BE SUBJECT TO COURTS ACTING AS AMATEUR SCIENTISTS IN ASSESSING SCIENTIFIC RELIABILITY. CONGRESS SERVED ITS MASTERS.
In 1997, in another case dealing with expert testimony, the Supreme Court held that for ALL disciplines, whether scientific or technical, a judge considering the application of Rule 702 should perform a gatekeeping role to ensure that such testimony is “reliable” and represents the “scientific method.” It urged a flexible role, however. Still, quite a task for a lay judge. The Rule states as now amended from its original form:
“A witness who is qualified as an expert by knowledge, skill. Experience, training or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:
- (a) The expert’s scientific, technical or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
- (b) The testimony is based on sufficient facts or data;
- (c) The testimony is the product of reliable principles and methods; and
- (d) The expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.”
This amendment not only made it more difficult to get an expert to speak to a jury, but it also created much more expense for plaintiffs to get a case to trial. Big Pharma, the greatest beneficiary of this Rule change, held the keys to the courthouse and could, with the right mix of studies and paid liars, persuade the amateur scientists that now added this credential to their law degrees when they were made federal judges to exclude an expert while destroying any hope of a plaintiff’s success in court. It chills litigation that is meritorious, at least presumptively.
TRUMP’S FDA WILL LIKELY PROVIDE THE VERY WARNING REQUIREMENTS REJECTED BY THE ACETAMINOPHEN TRIAL JUDGE’S RULING, AND THE FDA WILL ALSO VALIDATE SOME OF THOSE STUDIES THAT THE JUDGE ARBITRARILY RULED UNRELIABLE ALONG WITH THE PREEMINENT EXPERTS WHO INTERPRETED THEM
It is well settled in the legal community, based upon empirical studies, that juries have the capability to judge the reliability and relevancy of conflicting and often complex expert witness testimony. Ideally, studies and experts’ consideration of them would be tested on cross-examination in the crucible of a trial, and counsel for both sides would be tasked with pointing out the vulnerabilities in these opinions and the data underlying such opinions. The jury would be the voice of what is “good science.” What Big Pharma was able to buy into Congress’s rule change in 2000 was that juries are “easily swayed” by experts and that the court must ensure that they don’t get the chance to be captivated by an expert using “flawed” methods. Exclude and let’s not take the chance. It is that simple. Now courts can limit expert testimony in an arbitrary and inconsistent manner and usurp the time-honored role of the jury to determine the intellectual rigor employed by experts in arriving at their conclusions.
The plaintiff’s proposed warnings on all Acetaminophen products were part of the record in the litigation cited herein in the Southern District of New York. The plaintiff’s counsel proposed:
“AUTISM/ADHD: Some studies show that frequent use of this product during pregnancy may increase your child’s risk of autism and attention deficit hyperactivity disorder. If you use this product during pregnancy to treat your pain and/or fever, use the lowest effective dose for the shortest possible time and at the lowest possible frequency.”
The Court asked Biden’s FDA to comment on the proposal. Crickets. He was reviewing classified documents in his garage in Delaware. Considering the court’s de facto dismissal of the claims of thousands of children by excluding all of the plaintiff’s experts, this warning may never have been mandated. Now RFK Jr. and Marty Makary, who know all too well what is going on, neither of whom is nor was beholden to Big Pharma, may bring some hope to the struggle of parents denied access to a jury on one of the most important scientific and medical issues in human history. I suspect this is the warning, in large part, that we will see the new FDA mandate on all Acetaminophen products. Expect Big Pharma to call in the big guns in Congress whom they purchased to push back on what is a noble and responsible act of public education. I think of the strength and resolve of the parents whose lives and relationships are strained by what they deal with every day. If Acetaminophen is a contributing cause, let the jury decide—not a lone judge.
CONCLUSION
Immanuel Kant was quoted as stating:
“…..Science is organized knowledge; wisdom is organized life….”
It is the jury that can wield such wisdom to determine whether expert testimony and studies used in certain types of litigation are indeed reliable. What happened to the parents of emotionally and physically disabled children as the result of the court’s rulings in the Acetaminophen Multi District Litigation was the predictable result of the pressure that Big Pharma has exerted on Congress, and indirectly, the courts, for decades. We can only hope that the change of the guard at Health and Human Services and the FDA will herald a new era of transparency and hope in this tawdry arena. The fact that Trump Derangement Syndrome has caused the Left to support corrupt Big Pharma is the ultimate hypocrisy. It is Trump and his team that are trying to bring hope to thousands, maybe millions. Didn’t we learn during the Covid years that neither “mainstream scientists” nor “mainstream medicine” are deserving of any trust or moral authority?
Mike Imprevento
September 28th, 2025
