1 of 4 | Registered nurse Karleen DeGroodt took Tylenol regularly during her pregnancy with son Devyn, now 14, after being told the medication was safe. Devyn was diagnosed with autism at age 2 1/2. Photo courtesy of the DeGroodt family
WASHINGTON, Oct. 28 (UPI) -- Debate over the growing scientific evidence that links women who took acetaminophen during pregnancy with giving birth to a child with autism is heading to the courtroom.
Backed by studies that tie use of the common pain reliever with autism in offspring, lawyers for thousands of affected families plan to take on some of the biggest drug retailers in America -- alleging they failed to warn of potential dangers when selling their products that contain acetaminophen.
Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation ordered that 65 individual cases on the purported autism-acetaminophen link be consolidated into mass tort litigation to reduce the burden on individual courts and produce a consistent outcome.
Pending cases were assigned to Judge Denise L. Cote, of the U.S. District Court for the Southern District of New York, for pretrial hearings.
Instead of one mega-trial, mass tort cases like this have the parties agree to try a small number of "bellwether" cases to gauge jury reaction. Sometimes the matter is settled before those bellwether cases go to trial.
Currently, the complex litigation involves nine defendants -- CVS, Costco, Family Dollar, Rite Aid, Safeway, Sam's Warehouse, Target, Walgreens and Walmart.
Active ingredient the same
Although the companies sell different brands of acetaminophen products sourced from different suppliers, the court said the active ingredient at issue is the same.
Alicia O'Neill, a lawyer involved in the litigation, said her Texas-based law firm, Watts Guerra, "likely will file against many manufacturers" as the mass tort lawsuit picks up steam.
Such litigation may take three to five years, as a conservative estimate, O'Neill said, "but they can go much more quickly or take longer. Our goal is to always move forward quickly and get justice for our clients as soon as we can."
At the heart of the dispute is a drug that tops $1 billion in annual U.S. sales.
Acetaminophen -- the most widely sold brand of which is Tylenol -- is estimated to be used by nearly two-thirds of pregnant women at some point during pregnancy.
In fact, as the most common drug ingredient in the United States, acetaminophen is found in 600-plus medicines, including prescription and over-the-counter pain relievers, fever reducers and sleep aids, as well as cough, cold and allergy medicines under brand names that include NyQuil, Excedrin, Alka-Seltzer and Robitussin.
Health professionals routinely tell women that acetaminophen is safe to take during pregnancy, especially to reduce high fever and severe pain that, if left untreated, may harm them or the developing fetus.
But women may be less well-advised when it comes to limiting acetaminophen use.
At her first prenatal visit, registered nurse Karleen DeGroodt, 43, of Orange County, Calif., recalls receiving a gift bag that contained prenatal vitamins and a list of approved over-the-counter medications to use during her pregnancy with son Devyn. Tylenol was on the list.
DeGroodt, who was on 24-hour call and constantly on her feet, said she took Tylenol after "long, grueling days" of hospital work.
"You're pregnant. You're sore," she said, estimating that she took the drug at least once a week during her pregnancy.
Devyn, now 14, was diagnosed with autism at age 2 1/2. He is essentially nonverbal, communicating with his iPad, and has "moderate leaning into severe" autism, DeGroodt said in a phone interview.
He is "still the sweetest boy," who loves the beach and symphony music, his mother said, though puberty is hitting hard since Devyn cannot express his emotions and feelings.
"We're walking on eggshells," DeGroodt said, explaining there are "moments of meltdown" when her son is screaming and hitting himself and others. And the family put a special lock on the front door after Devyn once left without telling anyone and ended up at his grandparents' house down the block.
No family history
DeGroodt said her family has no history of autism, and Devyn has received a battery of tests, including full DNA genome testing last year, looking for a genetic link.
"Everything comes back to not contributing to autism," she said of the tests. "The most reasonable [explanation], with the most signs pointing to it, is Tylenol."
One in 44, or 2.3%, of 8-year-old children in this country were identified with autism spectrum disorder in 2018, according to an analysis of the latest available data by the Centers for Disease Control and Prevention. That's up from 1 in 54, or 1.9%, of 8-year-olds in 2017.
The Food and Drug Administration, some medical groups, and Johnson & Johnson, which makes Tylenol, say further research is needed to firmly establish whether a link exists between neurobehavioral conditions and acetaminophen.
"We will always evaluate new data. At this time, we are not aware of conclusive evidence to support a causal link between acetaminophen use during pregnancy and the risk of adverse fetal outcomes," spokeswoman Meghan Harding of Johnson & Johnson Consumer Healthcare said in a statement to UPI.
According to Harding, the label on Johnson & Johnson's adult Tylenol products, in which acetaminophen is the active ingredient, states, "If pregnant or breast-feeding, ask a health professional before use."
The warning was was placed there per labeling requirements for over-the-counter drugs first set forth in the FDA Code of Federal Regulations in December 1982.
Studies too limited
In 2015, the FDA said studies that explored a possible link between acetaminophen use during pregnancy and ADHD were too limited for the agency to make any recommendations.
Seven years later, the FDA "continues to monitor and evaluate the use of acetaminophen during pregnancy and will update the public as new safety information becomes available," agency spokeswoman Lauren-Jei McCarthy told UPI in an emailed statement.
Scientific experts also cite the need for more studies -- but on such matters as the dose and frequency at which acetaminophen might become risky for pregnant people, and what alternative pain relief therapies could work safely for them.
Meanwhile, they worry about "the potential for harm from continued inaction"-- as highlighted in a consensus statement by 91 scientists, clinicians and public health professionals, published in the journal Nature Reviews Endocrinology in September 2021.
"In my opinion, given what we now know, the burden of proof should not be on researchers to prove without a doubt that acetaminophen is harmful, but rather for the manufacturers to prove it is safe," epidemiologist Ann Z. Bauer, the statement's primary author and a researcher in the University of Massachusetts Lowell's Department of Public Health, told UPI in an email.
The takeaway for the public "is to know that many scientists and doctors are concerned about the emerging research and that pregnant women should be cautious and try to avoid the use of acetaminophen for mild discomfort and nuisance pain," Bauer said.
She added, "It is important to know that the FDA last reviewed the acetaminophen research in 2015. Much of the research was done after that."
According to Bauer, scientists know acetaminophen crosses the placenta and the blood-brain barrier.
"We now have consistent signals from numerous human epidemiologic and experimental in vivo and in vitro studies suggesting acetaminophen exposure during pregnancy increases the risk of the child having adverse neurodevelopmental conditions, to include ADHD and autism," she said.
As research methods have improved, the identified risks have gotten stronger, Bauer said.
Overall, earlier epidemiologic studies, which relied on maternal reporting of acetaminophen use, reported a 20% to 30% increased risk of autism and ADHD from taking the medication, she said.
Three recent studies that used biomarkers to assess acetaminophen exposure -- measuring its levels in umbilical cord plasma, maternal blood and meconium, a newborn's first feces -- identified risks about 10 times higher, Bauer said.
Moreover, "the majority of human observational studies that were able to investigate whether there was a dose-response relationship found one," she said.
What this suggests is that one-time use of acetaminophen is likely of minimal risk, and pregnant women should primarily be concerned about its prolonged use, Bauer said, adding that animal studies found similar neurobehavioral abnormalities.
Bernard L. Harlow, professor at Boston University's School of Public Health, told UPI in a phone interview he was asked by a consortium of fellow epidemiologists to examine the scientific evidence as an independent researcher -- likely because of his focus on women's reproductive health issues and his previous work on talcum powder's association with ovarian cancer.
His review included 29 observational studies of 220,000-plus mother-child pairs from around the world, two meta-analyses and research on biological markers. A meta-analysis examines data from independent studies on the same subject to determine trends.
Harlow said he was "quite astonished" at "the consistently strong association" between acetaminophen use during pregnancy and autism spectrum disorder.
Harlow now serves on lawyer-sponsored Autism Justice's team of experts, as does consumer advocate Erin Brockovich -- who helped build a successful case against Pacific Gas & Electric Co. involving groundwater contamination in California that became the subject of the Oscar-winning 2000 film that starred Julia Roberts.
O'Neill, managing attorney at Watts Guerra, which runs Autism Justice to provide information on the mass tort litigation, told UPI that 26,000 people, including DeGroodt, have signed as clients with the firm, "and we're working up their cases so we can file them."
According to O'Neill, Watts Guerra filed roughly half of the 65 initial federal cases.
"We decided to move forward after speaking with trusted scientists, and started accepting cases and speaking with women taking all kinds of branded acetaminophen [who] had children who are autistic" and have no family histories of autism, O'Neill said in a phone interview.
She added: "I've learned one of the best ways to effect change is [via] plaintiff lawsuits, seeking justice. I find that government action follows lawsuits quite often in these situations."