On the same day that President Trump told pregnant women not to take Tylenol based an unproven link to autism, a legal ally of Health Secretary Robert F. Kennedy Jr.’s also took a swing at the issue.
The ally, Aaron Siri, a plaintiff’s lawyer who for years joined with Mr. Kennedy in court battles over vaccines, filed a 12-page petition to the Food and Drug Administration demanding that it strengthen warnings on the painkiller’s label.
The issue is familiar to Mr. Siri, whose law firm encouraged people in 2023 to file claims about Tylenol and autism as lawsuits were pending across the country.
An official F.D.A. warning related to pregnancy would likely bolster any litigation against the manufacturers of acetaminophen, including Kenvue, the maker of Tylenol. Kenvue has long maintained that Tylenol is safe for pregnant women.
The petition was the latest salvo in a series of actions by lawyers and activists who are applying pressure in ways that align with Mr. Kennedy’s efforts to undermine vaccine policies and challenge product safety. Mr. Siri, who was Mr. Kennedy’s campaign lawyer, is at the forefront now of furthering their shared interests, inside government circles and outside through the courts.
Their relationship seems mutually beneficial. The authority Mr. Kennedy wields over health policy is already proving advantageous for Mr. Siri and others who have been pursuing far-reaching changes that Mr. Kennedy also sought for years.
Mr. Siri is leading a legal effort to enforce a religious exemption to vaccines that Mr. Kennedy officially supports. He has played a role in vetting candidates for departmental jobs and for an influential vaccine committee. In addition, Mr. Siri has filed a flurry of lawsuits against children’s toothpaste makers over fluoride, an additive that Mr. Kennedy also opposes.
Mr. Siri said he did not know whether his firm was involved in Tylenol cases. Nor did he work with Mr. Kennedy’s office or with the White House on the acetaminophen matter, he said. His law firm sometimes refers clients to other lawyers and splits the fees.
Legal ethics experts said Mr. Siri’s efforts were troubling because of their potential effect on public policy in ways that might benefit his clients.
“I think the concern is always just whether there is some sort of insider influence, or whether decisions being made by the government are backed by hard science and research,” said Elizabeth Chamblee Burch, a University of Georgia law professor
Late last year as Mr. Kennedy became the president’s choice to run the Department of Health and Human Services, Mr. Siri was leading interviews with candidates for key departmental jobs.Mr. Trump. In public, Mr. Siri’s role seemed to recede after news of his effort in 2022 to halt the use of the stand-alone polio vaccine caused an uproar.
But he has remained influential. Just last month, Susan Monarez, the fired director of the Centers for Disease Control and Prevention, told senators that Mr. Kennedy had instructed her to meet with Mr. Siri.
Dr. Monarez did not meet with Mr. Siri. But her public comments hinted at Mr. Kennedy’s willingness to include him in departmental matters.
Mr. Siri told The Times that he was continuing his longstanding work, much of which, including the Tylenol petition, was for the Informed Consent Action Network, or ICAN, a nonprofit run by Del Bigtree, Mr. Kennedy’s former campaign communications director and an anti-vaccine activist.
“Our push, on behalf of our clients, for transparency and positive change within the federal government over the last six months is no different than that push over the past decade,” Mr. Siri said.
But Mr. Siri has suggested elsewhere that this was a distinct era for their advocacy efforts.
“It is also the time where we probably, and hopefully, can get the most accomplished,” Mr. Siri said in a conversation on Mr. Bigtree’s webcast in April. “So let’s press our advantage, to the extent that we have one.”
Vaccine mandates and exemptions
Early in September, Mr. Kennedy’s department issued a reminder to states to respect the rights of people seeking religious exemptions from vaccines.
At the same time, Mr. Siri was at the forefront of a legal effort alongside West Virginia’s governor to permit those exemptions. Mr. Siri shared a stage with Gov. Patrick Morrisey in June to announce a lawsuit against the state’s Board of Education on behalf of a mother seeking a religious exemption for her child.
Though the governor had issued an executive order allowing the exemption, the education board voted to honor the state’s vaccine requirement for school entry.
Mr. Kennedy expressed support for the governor’s position in a post on X. The federal health department also sent a letter to West Virginia, suggesting that because it receives $1.4 billion in federal Vaccines for Children funds to cover inoculations for low-income children, it is obligated to honor religious exemptions.
Mr. Siri won an early injunction in the case. The American Civil Liberties Union entered the fray in August to block the religious exemption. The litigation is pending.
Mr. Bigtree and Mr. Siri have said the case in West Virginia is part of a broader effort to seek religious exemptions from inoculation requirements in states that don’t have them, which include California and New York.
Lawsuits on fluoride and Tylenol
Mr. Siri enjoys the support of conservative lawmakers who distrust vaccines and regularly call him to testify before Congress.
He has argued frequently that liability protections for vaccine makers should be lifted, which would enable more lawsuits. He has said that his law firm has about 90 lawsuits pending on behalf of ICAN.
On another shared concern with Mr. Kennedy, Mr. Siri sued several makers of children’s toothpaste, seeking class-action status and claiming that images on the packaging induce children to consume excessive amounts of fluoride.
The companies defend their products, in one case saying that the “reasonable consumer is not a dimwit” and noting that the products include clear warnings.
Mr. Kennedy had asked the C.D.C. to review appropriate fluoride levels in drinking water and has called on states to remove it. Fluoride has historically been added to water to prevent dental decay.
On the Tylenol issue, Mr. Siri’s office appeared to have been preparing its petition to strengthen the warning about two weeks before Mr. Trump’s address on Sept. 22; a staff member of Mr. Siri’s law firm had uploaded documents to the Internet Archive website that were later cited as footnotes in the petition. The records included F.D.A.’s internal review records on Tylenol that had been unearthed in lawsuits.
That petition for a stronger warning on Tylenol landed at the F.D.A. the same day that Dr. Marty Makary, the agency’s commissioner, announced a plan to add a Tylenol warning.
Mr. Siri said he and his team had no knowledge of H.H.S. or White House officials’ “intent to connect this drug with autism when we started” on the petition. “Those happened entirely independent of one another.”
Studies have not proved a causal link between acetaminophen and autism.
An official F.D.A. warning on pregnancy and Tylenol would likely benefit plaintiffs and their lawyers in court cases alleging a failure to warn of the autism risk.
“It is, of course, going to be easier and more intuitive for us to explain to a jury that that warning should have been given, if the warning is now actually on the bottle of Tylenol,” said Ashley Keller, a lead lawyer suing Tylenol makers.
Spotlight returns to polio vaccines
When The New York Times reported in December on Mr. Siri’s petition to withdraw or suspend use of the stand-alone polio vaccine, Mr. Kennedy was still facing Senate confirmation. An uproar ensued, and Mitch McConnell, the former Senate majority leader, and a polio survivor warned Mr. Kennedy to “steer clear’’ of associating with such an effort.
Mr. Siri went on a media tour clarifying his critiques of the vaccine’s safety. But in recent months, both Mr. Siri and Mr. Bigtree — as well as Mr. Kennedy — have broadened or repeated criticism of polio vaccines used in the United States.
In a social media post in June, Mr. Siri suggested that the C.D.C.’s vaccine panel change its recommendation that parents routinely vaccinate their children with the inactivated polio vaccine and other shots to “shared clinical decision-making,” which could limit vaccine use.
Asked about the post, Mr. Siri said that vaccines that did not stop transmission of a virus “provide personal protection at best.” Public health experts view that as sufficient, since the shots are effective in reducing suffering, death and health care spending.
In written testimony submitted to Congress on May 19, Mr. Siri repeated some points from his polio petition, noting that the U.S. polio vaccine is a “different product” than the one developed by Jonas Salk in the 1950s, with the newer version grown in “monkey kidney cells.”
Though there were problems in the 1950s with cells taken from a variety of monkeys, scientists agree that newer inoculations eliminated the problem by using a thoroughly tested line of cells.
In a lengthy post on X in June, Mr. Kennedy echoed Mr. Siri’s language and concerns. A spokesman for H.H.S. did not respond to questions about it.
Mr. Siri said that he and Mr. Kennedy “have long discussed” the inactivated polio vaccine, “but I don’t recall doing so after he has taken office.”
On a podcast in July, Mr. Bigtree described his views.
Mr. Bigtree’s nonprofit heavily funds Mr. Siri’s legal work, providing $6 million to the firm in 2023, according to its most recent tax filing, and about $13 million in additional funds since 2018.
Mr. Bigtree said that getting polio was “like having a cold,” a notion that public health experts say is false and dangerous. He said that infection with the disease could offer strong immunity. “Polio is not the epidemic that we believe that it is,” Mr. Bigtree said.
Weeks later, Mr. Bigtree appeared at the White House to give an unrelated interview about vaccine policy on Lindell TV, a far-right broadcaster. A White House spokesman did not respond to questions about the visit. Mr. Bigtree did not respond to requests for comment.
Dr. Walter Orenstein, associate director of the Emory University vaccine center, said that in 2000, the inactivated polio vaccine replaced a live-virus vaccine that caused about eight to 10 people to develop paralytic polio each year. The current vaccine eliminated the problem.
“I would hate to have to need a polio resurgence in order to get people to realize they should be getting their children vaccinated against polio,” he said. “It’s an absolutely terrible disease.”
Reshaping vaccine recommendations
For his part, Mr. Kennedy has presided over a series of actions that have upended standard vaccine policies. He purged an influential C.D.C. committee, replacing members with several vaccine skeptics.
Diana Zuckerman, president of the National Center for Health Research, said she was interviewed as a potential committee member by Mr. Siri’s firm, but never heard back.
Dr. Zuckerman said a senior partner in Mr. Siri’s law office asked if she would be comfortable saying that decisions on vaccines should be entirely between parents and doctors. She interpreted that as seeking her position on doing away with mandates on childhood inoculations. She told the interviewer that view would be harmful.
She said she was surprised that Mr. Siri had been given so much influence after the polio controversy. “I guess that R.F.K. Jr. thinks he’s untouchable,” she said.
The health department declined to comment on the law firm’s role with the committee.
Mr. Siri said in an email that the White House screens and selects the members. “We have no ability to make those choices, but we certainly would be open to having the White House let us choose,” he said.
Still pending is a legal effort Mr. Siri launched in May against Mr. Kennedy’s department that seeks to make public a vaccine safety database. The following month, Mr. Kennedy said in an interview with Tucker Carlson that he planned to make the same database “available for independent scientists so everybody can look at it.”
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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