A class action filed in February 2022 accuses Bayer of selling One A Day prenatal vitamins that contain undisclosed toxic heavy metals, exposing pregnant women and developing fetuses to contaminants the label does not mention. The One A Day prenatal vitamins lawsuit, Kharaeva et al. v. Bayer AG et al., is pending in the U.S. District Court for the Eastern District of Pennsylvania and has not yet produced a reported ruling on class certification, summary judgment, or trial.
What the Lawsuit Alleges
The complaint (Case No. 2:22-cv-00640) was filed on February 18, 2022, with Kharaeva as the lead plaintiff and the case assigned to Judge Mia Roberts Perez.{1Law360. Kharaeva et al v. Bayer AG et al} It is styled as a product liability class action. According to the complaint, Bayer’s One A Day prenatal vitamins contain toxic heavy metals and other harmful substances that are not disclosed on the product’s labeling.{2The Legal Intelligencer. Class Action Claims Bayer’s One A Day Prenatal Vitamins Contain Toxic Heavy Metals} The plaintiffs are represented by PGMBM LLC.
What Testing Has Found in the Product
Independent laboratory testing has echoed the concern behind the case. A comparative chart published by Lead Safe Mama LLC, updated in April 2025, ranked 25 prenatal vitamin products by heavy metal content. The One A Day Prenatal Advanced Complete Multivitamin ranked 23rd out of 25, placing it among the most contaminated in the group.{3Lead Safe Mama LLC. Prenatal Vitamins Comparative Chart} Testing reported lead at 88.5 parts per billion, cadmium at 216.2 ppb, and arsenic at 33.1 ppb. Mercury was not detected above the reporting threshold. The same analysis reported that the One A Day prenatal contained more lead than 22 of the other 24 products tested.{4Tamara Rubin. One A Day PreNatal Advanced SoftGels}
Broader research on the category points in the same direction. A 2018 study in Toxicology Reports tested 26 brands of prenatal vitamins purchased from Canadian retailers and found lead in every sample; 14 of the 26 exceeded California’s Proposition 65 limit for lead exposure, and all samples also tested positive for aluminum, nickel, titanium, and thallium.{5National Library of Medicine. Heavy Metal Contamination of Prenatal Vitamins} A 2023 study in Toxicology and Applied Pharmacology analyzed six U.S. prenatal brands and found elevated levels of aluminum, arsenic, and lead, with “natural” or “organic” formulations tending to contain higher concentrations than synthetic ones.{6National Library of Medicine. Toxic Element Contaminations of Prenatal Vitamins} Neither study named One A Day, but both concluded that prenatal supplements can be a meaningful source of toxic metal exposure.
Why Prenatal Vitamins Aren’t Pre-Screened for This
Over-the-counter prenatal vitamins do not require FDA approval before they go on sale.{6National Library of Medicine. Toxic Element Contaminations of Prenatal Vitamins} The FDA classifies dietary supplements as a special category of food rather than as drugs, so products are not evaluated for safety or effectiveness before reaching consumers, and the agency has limited pre-market oversight of what these supplements actually contain.{7U.S. Government Accountability Office. Dietary Supplements: FDA Should Improve Oversight}
A Government Accountability Office study tested 12 best-selling prenatal supplements for arsenic, cadmium, lead, and mercury, and found trace amounts of lead or cadmium in half of them. The GAO concluded that none of the detected amounts were likely to pose a health concern based on FDA-used metrics.{7U.S. Government Accountability Office. Dietary Supplements: FDA Should Improve Oversight} Researchers who have published in the area have argued that regulators should be more aggressive in setting and enforcing standards specifically for supplements marketed to pregnant women and fetuses, populations especially vulnerable to low-level heavy metal exposure.{6National Library of Medicine. Toxic Element Contaminations of Prenatal Vitamins}
The Earlier One A Day Case Was About Something Different
An earlier class action against Bayer over One A Day is sometimes confused with the current suit but does not involve heavy metals or prenatal formulations. In 2014, Kaplan Fox & Kilsheimer filed Gallagher et al. v. Bayer AG et al. (No. 3:14-cv-04601-WHO) in the Northern District of California, alleging that Bayer falsely marketed certain One A Day multivitamins as supporting “heart health,” “immunity,” and “physical energy” when those claims were not supported by science.{8Kaplan Fox. Bayer One A Day Vitamin Consumer Class Action} Judge William Orrick certified statewide classes in California, New York, and Florida in November 2017 but declined to certify a nationwide class. Plaintiffs’ damages model estimated Bayer’s potential exposure at roughly $600 million.{9Reuters. Lessons From a Class Action Trial: Should Bayer’s Big Win Embolden Defendants}
The case went to a week-long trial in San Francisco federal court in February 2019. The defense called no witnesses, relying on cross-examination of the plaintiffs’ expert and the lead California plaintiff. After about an hour of deliberation, the nine-member jury returned a verdict for Bayer across the board, finding that the plaintiffs had failed to prove the marketing claims were misleading or that class members had relied on them.{9Reuters. Lessons From a Class Action Trial: Should Bayer’s Big Win Embolden Defendants} That outcome addressed advertising claims about the general One A Day line and has no bearing on the pending 2022 case over heavy metals in the prenatal product.