WASHINGTON - New leaders at the Food and Drug Administration are sounding the alarm on talc, which could lead to lawsuits against the makers of candy, gum and pharmaceuticals, among other widely used products.
Current litigation over talc claims it contains asbestos that caused cancers in people who used products like talcum powder. Tens of thousands of ovarian cancer lawsuits against Johnson & Johnson are pending in a New Jersey federal court.
But during a May 20 hearing, President Trump's head of the FDA, Martin Makary, and a panel of researchers discussed the possible dangers of ingesting talc. The naturally occurring mineral is used to help the body receive swallowed medication and sometimes as a filler in capsules to increase their weight.
It also coats candy and rice, the panel noted, and is used during surgical procedures as an inflammatory agent.
"Scientists for a long time have been pointing to an urgent problem and that is the potential carcinogenic activity of talc," Makary said. "Talc has increasingly been recognized to have health concerns beyond just cancer but also with inflammation."
Studies were thrown about during the two-hour discussion, with none of the panelists defending the use of talc in these products. Instead, research is needed and substitutes for talc, like magnesium stearate, should be used, they concluded.
Previous Legal Newsline coverage has addressed the impact former trial lawyer Robert F. Kennedy Jr.'s position as head of the Department of Health and Human Services will have on litigation.
Action from the FDA on talc ingestion would certainly create a race to the courthouse for plaintiffs lawyers who wouldn't have to find physically injured clients. Instead, they could file class actions that said consumers wouldn't have paid as much for gum or cheese or pills coated in talc had they known about its alleged dangers.
The FDA brought together a panel of "top scientific experts," with Nicolas Wentzensen of the National Institutes of Health declaring, "There's a lot more that we don't know about talc than we know about talc."
His colleague at the NIH, Nicole Kleinstreuer, announced she wouldn't let her child participate in a talc study no matter the amount of candy that would be given to him.
"(F)irst of all not ethical, and second of all, it's just not needed based on the existing body of evidence and the availability of safer alternatives," she said.
Several of the panelists have had their previous research on talc cited by plaintiff lawyers pushing the idea it contains asbestos and causes cancer. J&J has said the talc used for its Baby Powder didn't contain asbestos, and Erik Haas, the worldwide vice president of litigation for J&J, told Legal Newsline the roundtable featured "cherry-picked plaintiff lawyer witnesses, prohibited questions from the audience and included no discussion on gold standard scientific epidemiology studies that establish that talc does not cause cancer."
J&J says the panel mainly relied on findings from the International Agency for Research on Cancer, which kickstarted litigation over the weedkiller Roundup. Those findings were just a review of existing studies that showed a "weak association" between talc and ovarian cancer.
"In fact, there was uniform acknowledgement by the panelists at today's roundtable that there was no evidence of any causal link between talc and cancer," Haas added. "We remain confident that a rigorous review of the best science will result in the same conclusion that health authorities around the world have reached for decades: that talc is safe and does not cause cancer."
One panelist, John Joseph Godleski, is the subject of a disqualification motion by J&J in the ovarian cancer MDL. He says he identified talc in tissue samples taken from five of six bellwether plaintiffs.
That ratio demonstrates a causal link between talc exposure and ovarian cancer, he says. J&J says his opinions are inadmissible, writing in a July 2024 motion to exclude them that they are "highly speculative, unscientific and unreliable."
"This is all the more true because Dr. Godleski ignores the foreign materials he identified in each plaintiff's tissue samples and fails to consider whether those materials could have caused each plaintiff's cancer," attorneys for the company wrote.
Godleski looked at particles from the women that had magnesium and silicon in the accepted proportions for talc. He looked for particles that exhibited birefringence, like talc does, but conceded in a deposition "lots of particles are birefringent."
Plaintiff lawyers said J&J is "desperate" to get Godleski's opinions excluded.
Other plaintiff lawyers have recently jumped on FDA action against fluoride that is ingested from children's toothpaste and mouth rinse. Makary says fluoride, which Kennedy has called "industrial waste," can kill intestinal bacteria important for a child's health.
Lawyers didn't wait until Makary's goal date of Oct. 31 for a complete safety review. The FDA announced its plans to phase out fluoride in children's oral care products on May 13, and by May 15, at least one class action had already been filed.
"The reality is that fluoride mouthrinse is considered by the U.S. Food and Drug Administration to be too dangerous for children under 6 to use," attorneys at Siri & Glimstad wrote in a proposed class action against Colgate-Palmolive filed in Chicago federal court.
The lawsuit cited the FDA's May 13 press release and quoted Makary. Because they are flavored, the products are "candy-like" drugs, it adds.
The lawsuit seeks a return of money spent on toothpaste and mouthrinse. "Plaintiff and the putative class do not seek recovery for any personal injuries," it says.
Another recent model of the announce-then-sue strategy is phenylephrine, a vasoconstrictor once commonly used in over-the-counter cold medicines. A few days after an FDA advisory panel declared oral phenylephrine ineffective in September 2023, the first class action hit federal court in Pensacola, Fla.
By December, there were more than 70 economic damages suits against everyone from Johnson & Johnson to Family Dollar stores. They didn’t claim anyone was injured by the drug, just that they paid too much.
Lawyers struck out with phenylephrine after a judge dismissed all the claims in November 2024, but that’s unusual. Typically, when faced with scores of lawsuits and potentially ruinous damages, companies settle and plaintiff lawyers collect a quarter or more of the money as fees.