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Manufacturing
12 min read
Areas of Expertise :
Analytical Chemistry, Toxicology, Regulatory Compliance, Food And Drug Administration (FDA), Labels And Warnings
Published Date:
Last Modified Date:
Jurisdiction:
Federal. Southern District of California
In 2024, a peer-reviewed study by University of California, Berkeley researchers, published in Environment International, reported measurable concentrations of 16 metals and metalloids (including lead, arsenic, and cadmium) in tested tampon samples from multiple brands, with lead detected in every sample tested. The researchers were careful to note that the study did not determine whether those metals leach out during use or are absorbed into the body, but it raised legitimate questions about product safety, labeling transparency, and manufacturer disclosure obligations.
Shortly after the study's publication, proposed class action lawsuits were filed against Procter & Gamble (maker of Tampax) and Kimberly-Clark (maker of U by Kotex). On July 29, 2024, Barton v. The Procter & Gamble Company (No. 3:24-cv-01332, S.D. Cal.) was filed in the U.S. District Court for the Southern District of California, alleging that certain Tampax products contained lead and that Procter & Gamble failed to disclose this while marketing the products as safe. A parallel proposed class action against Kimberly-Clark followed the next day in the same court. As of 2025, both cases remain active. Courts have denied most dismissal challenges and the litigation has moved from initial pleadings into substantive judicial review.
This article provides attorneys, plaintiffs, and litigation professionals with an updated guide to the tampon toxic metal lawsuits: where the litigation stands in 2025, what plaintiffs must prove, what the FDA has said, and which expert witnesses are critical to building or defending these cases.
As the FDA has confirmed and the study authors themselves acknowledged, detection of metals in tampon samples is not the same as demonstrated exposure or injury. These cases will turn on whether expert witnesses can bridge that causation gap from detection to leaching to absorption to harm with methodology that survives Daubert scrutiny.
The tampon toxic metal litigation has moved through several significant procedural stages since the initial filings. Every event below is sourced to an available court document, regulatory filing, or verified legal record.
Researchers at the University of California, Berkeley published a peer-reviewed study in Environment International reporting detectable concentrations of 16 metals and metalloids (including lead in every sample tested) across tampon samples from multiple brands and product lines. The researchers stated that the study did not determine whether those metals are released during use or absorbed through vaginal tissue. That distinction between detection and demonstrated exposure became the defining legal issue in all litigation that followed.
Barton v. The Procter & Gamble Company (No. 3:24-cv-01332) was filed in the U.S. District Court for the Southern District of California. The complaint alleged that certain Tampax products contained lead and that Procter & Gamble failed to disclose this while marketing the products as safe for intimate use. The case was pleaded as a consumer-protection and economic-loss matter under California law, not as a personal injury or proven toxic-exposure claim. The central theory was that consumers were denied material information that would have affected their purchasing decisions.
The following day, a similar proposed class action was filed against Kimberly-Clark in the same federal district over U by Kotex Click compact tampons. That complaint also focused on alleged lead content and argued that the company's labeling and packaging created a misleading impression of product safety. Like the action against Procter & Gamble, it was framed as a consumer-protection and economic-loss case rather than a personal-injury claim.
By late 2024, the FDA publicly stated that in September 2024 it had commissioned an independent literature review and initiated internal laboratory work to evaluate metals in tampon materials. The agency explained that the published study did not examine whether metals are released during use or absorbed into vaginal tissue or the bloodstream. The FDA later stated that the literature it reviewed did not identify safety concerns associated with tampon use and contaminant exposure, while also recognizing that scientific questions about metal release and absorption remained unresolved. The FDA did not issue a recall or make a final safety determination based on the study.
On February 13, 2025, the court granted in part and denied in part motions to dismiss in both the Procter & Gamble and Kimberly-Clark cases, while allowing plaintiffs leave to amend. The rulings did not end either case. Instead, they narrowed certain pleadings while confirming that the core consumer-protection and omission theories stated legally sufficient claims under California law.
In both the Procter & Gamble and Kimberly-Clark cases, courts rejected most renewed dismissal arguments following amended pleadings. In both matters, the unfair-prong theory under California's Unfair Competition Law was dismissed with prejudice, while the remaining consumer-protection, omission, and deceptive-labeling claims were allowed to proceed.
On December 11, 2025, the court denied Procter & Gamble's motion to transfer the case to the Southern District of Ohio. The order also referenced related later-filed cases in other jurisdictions, confirming that the litigation had spread beyond the original California filing. The ruling kept the lead case in the Southern District of California.
Court:
United States District Court for the Southern District of California
Case Name:
Barton v. The Procter & Gamble Company
Arsenic
Causation Analysis
Chemical Analysis
Chemical Exposures
Consumer Products
Consumer Protection
Heavy metals
Lead
Mislabeling
Product Safety
In 2024, a peer-reviewed study by University of California, Berkeley researchers, published in Environment International, reported measurable concentrations of 16 metals and metalloids (including lead, arsenic, and cadmium) in tested tampon samples from multiple brands, with lead detected in every sample tested. The researchers were careful to note that the study did not determine whether those metals leach out during use or are absorbed into the body, but it raised legitimate questions about product safety, labeling transparency, and manufacturer disclosure obligations.
Shortly after the study's publication, proposed class action lawsuits were filed against Procter & Gamble (maker of Tampax) and Kimberly-Clark (maker of U by Kotex). On July 29, 2024, Barton v. The Procter & Gamble Company (No. 3:24-cv-01332, S.D. Cal.) was filed in the U.S. District Court for the Southern District of California, alleging that certain Tampax products contained lead and that Procter & Gamble failed to disclose this while marketing the products as safe. A parallel proposed class action against Kimberly-Clark followed the next day in the same court. As of 2025, both cases remain active. Courts have denied most dismissal challenges and the litigation has moved from initial pleadings into substantive judicial review.
This article provides attorneys, plaintiffs, and litigation professionals with an updated guide to the tampon toxic metal lawsuits: where the litigation stands in 2025, what plaintiffs must prove, what the FDA has said, and which expert witnesses are critical to building or defending these cases.
As the FDA has confirmed and the study authors themselves acknowledged, detection of metals in tampon samples is not the same as demonstrated exposure or injury. These cases will turn on whether expert witnesses can bridge that causation gap from detection to leaching to absorption to harm with methodology that survives Daubert scrutiny.
The tampon toxic metal litigation has moved through several significant procedural stages since the initial filings. Every event below is sourced to an available court document, regulatory filing, or verified legal record.
Researchers at the University of California, Berkeley published a peer-reviewed study in Environment International reporting detectable concentrations of 16 metals and metalloids (including lead in every sample tested) across tampon samples from multiple brands and product lines. The researchers stated that the study did not determine whether those metals are released during use or absorbed through vaginal tissue. That distinction between detection and demonstrated exposure became the defining legal issue in all litigation that followed.
Barton v. The Procter & Gamble Company (No. 3:24-cv-01332) was filed in the U.S. District Court for the Southern District of California. The complaint alleged that certain Tampax products contained lead and that Procter & Gamble failed to disclose this while marketing the products as safe for intimate use. The case was pleaded as a consumer-protection and economic-loss matter under California law, not as a personal injury or proven toxic-exposure claim. The central theory was that consumers were denied material information that would have affected their purchasing decisions.
The following day, a similar proposed class action was filed against Kimberly-Clark in the same federal district over U by Kotex Click compact tampons. That complaint also focused on alleged lead content and argued that the company's labeling and packaging created a misleading impression of product safety. Like the action against Procter & Gamble, it was framed as a consumer-protection and economic-loss case rather than a personal-injury claim.
By late 2024, the FDA publicly stated that in September 2024 it had commissioned an independent literature review and initiated internal laboratory work to evaluate metals in tampon materials. The agency explained that the published study did not examine whether metals are released during use or absorbed into vaginal tissue or the bloodstream. The FDA later stated that the literature it reviewed did not identify safety concerns associated with tampon use and contaminant exposure, while also recognizing that scientific questions about metal release and absorption remained unresolved. The FDA did not issue a recall or make a final safety determination based on the study.
On February 13, 2025, the court granted in part and denied in part motions to dismiss in both the Procter & Gamble and Kimberly-Clark cases, while allowing plaintiffs leave to amend. The rulings did not end either case. Instead, they narrowed certain pleadings while confirming that the core consumer-protection and omission theories stated legally sufficient claims under California law.
In both the Procter & Gamble and Kimberly-Clark cases, courts rejected most renewed dismissal arguments following amended pleadings. In both matters, the unfair-prong theory under California's Unfair Competition Law was dismissed with prejudice, while the remaining consumer-protection, omission, and deceptive-labeling claims were allowed to proceed.
On December 11, 2025, the court denied Procter & Gamble's motion to transfer the case to the Southern District of Ohio. The order also referenced related later-filed cases in other jurisdictions, confirming that the litigation had spread beyond the original California filing. The ruling kept the lead case in the Southern District of California.
One of the most important things attorneys must understand about tampon toxic metal litigation is the gap between what the science shows and what the law requires plaintiffs to prove. The 2024 study established that metals were present in tested tampon samples. It did not establish that those metals were released during use, absorbed into the body, or caused identifiable harm, a point the FDA also confirmed in its own review. Courts will require plaintiffs to fill every gap in that chain with reliable, case-specific expert evidence.
Consumer Protection and Omission (theory at issue in both current cases)
Plaintiffs must show that the product contained concerning substances, that material information was omitted from labeling, that a reasonable consumer would have purchased differently, and that economic loss resulted. The key expert witnesses for this claim type are consumer behavior experts, analytical chemistry experts, and regulatory compliance experts.
Deceptive Labeling (theory at issue in both current cases)
Plaintiffs must show that labeling or marketing created a false or misleading impression of safety and that the misrepresentation was material to reasonable consumers. The key expert witnesses for this claim type are consumer behavior and marketing experts, and regulatory compliance experts.
Personal Injury and Toxic Tort (not established in the current cases; the scientific causation chain remains open)
Plaintiffs must prove that metals were released from the product during use, that those metals were absorbed into the body at harmful concentrations, and that the absorption caused a specific, medically documented injury. Each link must be independently proved. The key expert witnesses for this claim type are toxicology experts, analytical chemistry experts, and gynecologists or internal medicine physicians.
The Critical Gap: Detection ≠ Causation
The FDA's literature review did not identify safety concerns associated with tampon use and contaminant exposure, and the original study did not test whether metals leach or are absorbed. Expert witnesses who assume rather than demonstrate each link in the causation chain will face Daubert challenges on these exact grounds.
Because the core scientific questions (whether metals leach during use, whether they are absorbed at harmful levels, and whether that absorption causes injury) remain unresolved in the published literature and have not been resolved by the FDA's own review, both sides will depend heavily on expert witnesses to frame the science within legal standards of proof.
Role: In tampon toxic metal litigation, a toxicology expert analyzes dose, leaching potential, absorption pathways through vaginal tissue, systemic exposure levels, and whether the reported metal concentrations could plausibly cause harm under realistic conditions of use.
Why this matters here: The 2024 study left open the central question of whether metals detected in tampon materials are released and absorbed during use. The FDA's own literature review similarly did not resolve it. A toxicologist must bridge that gap with case-specific methodology that survives Daubert scrutiny. Courts will ask whether dose-response assumptions are grounded in reliable, peer-reviewed science and match the actual facts of use.
For the defense: Defense-side toxicologists will challenge plaintiffs' exposure assumptions and point to the FDA's finding that its literature review did not identify safety concerns associated with tampon use and contaminant exposure.
Role: Analytical chemists evaluate the reliability, methodology, and interpretation of laboratory testing, including sampling protocols, contamination controls, instrumentation calibration, detection limits, and reproducibility of findings.
Why this matters here: The original study reported its methodology and findings in Environment International. In trace-metals litigation, even small differences in testing methodology (how samples were prepared, what contamination controls were used, what instrumentation was applied) can substantially affect how much evidentiary weight a court assigns. Analytical chemistry experts are essential for both supporting and challenging the scientific foundation of each side's claims.
Role: Gynecologists and internal medicine physicians address absorption dynamics through vaginal tissue, whether claimed symptoms are medically consistent with the alleged exposure, and whether alternative causes are more likely explanations.
Why this matters here: The FDA acknowledged that the published study did not test whether metals are absorbed through vaginal tissue or enter the bloodstream. Medical experts must address this gap directly. Any medical expert who overstates the science relative to what the FDA and the study authors themselves acknowledged will be vulnerable on cross-examination and on Daubert motions.
Role: Regulatory compliance experts explain the framework governing tampon manufacturing, safety testing, and labeling requirements, including what manufacturers were required to disclose under applicable FDA regulations at the relevant time.
Why this matters here: The FDA commissioned an independent literature review and internal laboratory testing in September 2024, creating a regulatory record both sides will want to characterize. A regulatory compliance expert can contextualize what the FDA said, specify what disclosure obligations existed under existing law at the time of sale, and address whether the labeling met or fell short of applicable standards. Both sides need this testimony to frame the regulatory record advantageously.
Role: Consumer behavior experts analyze how ordinary consumers interpret product safety messaging and whether the alleged omissions would have affected purchasing decisions.
Why this matters here: The complaints in both cases (against Procter & Gamble and Kimberly-Clark) were framed primarily as omission and deceptive-labeling matters, meaning plaintiffs must establish that the alleged omissions were material to reasonable consumers and that they would have acted differently with full information. Consumer behavior expert witnesses address precisely these questions and their opinions are central to class certification arguments on materiality and classwide reliance.
The Early Cases Are Narrower Than Public Coverage Suggests
Public attention centered broadly on metals in tampons, but the earliest complaints against Procter & Gamble and Kimberly-Clark were framed specifically around alleged lead content, omissions in labeling, and California consumer-protection violations. Attorneys should analyze the actual pleadings, not the media narrative, because the legal theories in play differ meaningfully from the broader public discussion.
Scientific Detection Is Not Legal Causation
The study reported measurable metals but did not establish that metals leach during use, that they are absorbed into the bloodstream, or that they caused any specific health outcome. The FDA's own review confirmed these questions remain scientifically open. Expert witnesses who skip steps in the causation analysis, assuming rather than demonstrating each link, will face Daubert challenges on exactly these grounds.
Consumer-Protection Theories Can Proceed Without Proven Medical Causation
The early complaints survived multiple rounds of dismissal because they were built on omission and economic-loss theories, not on proven bodily injury. Consumer-protection claims require showing that a reasonable consumer was denied material information and suffered economic harm. Medical causation is not required for these theories, which shapes class certification strategy, discovery priorities, and expert sequencing throughout the litigation.
The FDA Record Is Double-Edged
The FDA's review helps and hurts both sides. For the defense: the FDA's literature review did not identify safety concerns associated with tampon use and contaminant exposure, and no recall was issued. For plaintiffs: the FDA acknowledged that questions about leaching and absorption remain scientifically unresolved, supporting the argument that manufacturers had reason to investigate and disclose those uncertainties to consumers. Neither side gets a clean win from the regulatory record.
The tampon toxic metal lawsuits that followed the 2024 study represent a significant and still-evolving area of consumer product liability litigation. They began not with proven bodily injury, but with a peer-reviewed study that detected metals in tampon samples and raised legitimate questions about product labeling and manufacturer disclosure obligations. By 2025, both the Procter & Gamble and Kimberly-Clark cases had survived substantial dismissal challenges and entered active judicial review, establishing this as litigation that will require serious expert witness investment from both sides.
For attorneys on either side, the central challenge is the same: bridging the gap between what the science currently shows (metals were detected) and what the law requires through reliable expert testimony. The FDA has confirmed that the questions about leaching, absorption, and health effects remain unresolved. The experts who can credibly address each link in the causation chain, in a manner that satisfies Daubert and withstands cross-examination, will have an outsized influence on how these cases are ultimately resolved.
Is Tampax still being sued over toxic metals in 2025?
Yes. Barton v. The Procter & Gamble Company (No. 3:24-cv-01332, S.D. Cal.), filed July 29, 2024, remains active as of 2025. Courts have denied most dismissal challenges in both the Procter & Gamble and Kimberly-Clark cases, and the litigation has moved into substantive judicial review.
What triggered the tampon lawsuits?
A peer-reviewed study by University of California, Berkeley researchers, published in Environment International, reported measurable concentrations of 16 metals and metalloids (including lead in every sample tested) across tampon samples from multiple brands. Although the study did not determine whether those metals are released during use or absorbed into the body, it prompted consumer lawsuits alleging misleading labeling and omissions of material product safety information.
What do plaintiffs need to prove?
It depends on the claim type. For the consumer-protection and omission theories at issue in the current cases, plaintiffs must show that material safety information was withheld and that a reasonable consumer would have made a different purchase decision, with economic loss as the primary remedy. For any future personal injury claims, plaintiffs would need to prove the full causation chain: metals were released during use, absorbed at harmful levels, and caused a specific, documented injury, a chain the study itself and the FDA both confirm remains scientifically unresolved.
What did the FDA say about metals in tampons?
By late 2024, the FDA confirmed it had commissioned an independent literature review and initiated internal laboratory testing of tampon materials. The agency stated that the original study did not test whether metals are released during use or absorbed into vaginal tissue or the bloodstream. The FDA's literature review did not identify safety concerns associated with tampon use and contaminant exposure, while acknowledging that scientific questions about leaching and absorption remain open. The FDA did not issue a recall or make a final safety determination.
One of the most important things attorneys must understand about tampon toxic metal litigation is the gap between what the science shows and what the law requires plaintiffs to prove. The 2024 study established that metals were present in tested tampon samples. It did not establish that those metals were released during use, absorbed into the body, or caused identifiable harm, a point the FDA also confirmed in its own review. Courts will require plaintiffs to fill every gap in that chain with reliable, case-specific expert evidence.
Consumer Protection and Omission (theory at issue in both current cases)
Plaintiffs must show that the product contained concerning substances, that material information was omitted from labeling, that a reasonable consumer would have purchased differently, and that economic loss resulted. The key expert witnesses for this claim type are consumer behavior experts, analytical chemistry experts, and regulatory compliance experts.
Deceptive Labeling (theory at issue in both current cases)
Plaintiffs must show that labeling or marketing created a false or misleading impression of safety and that the misrepresentation was material to reasonable consumers. The key expert witnesses for this claim type are consumer behavior and marketing experts, and regulatory compliance experts.
Personal Injury and Toxic Tort (not established in the current cases; the scientific causation chain remains open)
Plaintiffs must prove that metals were released from the product during use, that those metals were absorbed into the body at harmful concentrations, and that the absorption caused a specific, medically documented injury. Each link must be independently proved. The key expert witnesses for this claim type are toxicology experts, analytical chemistry experts, and gynecologists or internal medicine physicians.
The Critical Gap: Detection ≠ Causation
The FDA's literature review did not identify safety concerns associated with tampon use and contaminant exposure, and the original study did not test whether metals leach or are absorbed. Expert witnesses who assume rather than demonstrate each link in the causation chain will face Daubert challenges on these exact grounds.
Because the core scientific questions (whether metals leach during use, whether they are absorbed at harmful levels, and whether that absorption causes injury) remain unresolved in the published literature and have not been resolved by the FDA's own review, both sides will depend heavily on expert witnesses to frame the science within legal standards of proof.
Role: In tampon toxic metal litigation, a toxicology expert analyzes dose, leaching potential, absorption pathways through vaginal tissue, systemic exposure levels, and whether the reported metal concentrations could plausibly cause harm under realistic conditions of use.
Why this matters here: The 2024 study left open the central question of whether metals detected in tampon materials are released and absorbed during use. The FDA's own literature review similarly did not resolve it. A toxicologist must bridge that gap with case-specific methodology that survives Daubert scrutiny. Courts will ask whether dose-response assumptions are grounded in reliable, peer-reviewed science and match the actual facts of use.
For the defense: Defense-side toxicologists will challenge plaintiffs' exposure assumptions and point to the FDA's finding that its literature review did not identify safety concerns associated with tampon use and contaminant exposure.
Role: Analytical chemists evaluate the reliability, methodology, and interpretation of laboratory testing, including sampling protocols, contamination controls, instrumentation calibration, detection limits, and reproducibility of findings.
Why this matters here: The original study reported its methodology and findings in Environment International. In trace-metals litigation, even small differences in testing methodology (how samples were prepared, what contamination controls were used, what instrumentation was applied) can substantially affect how much evidentiary weight a court assigns. Analytical chemistry experts are essential for both supporting and challenging the scientific foundation of each side's claims.
Role: Gynecologists and internal medicine physicians address absorption dynamics through vaginal tissue, whether claimed symptoms are medically consistent with the alleged exposure, and whether alternative causes are more likely explanations.
Why this matters here: The FDA acknowledged that the published study did not test whether metals are absorbed through vaginal tissue or enter the bloodstream. Medical experts must address this gap directly. Any medical expert who overstates the science relative to what the FDA and the study authors themselves acknowledged will be vulnerable on cross-examination and on Daubert motions.
Role: Regulatory compliance experts explain the framework governing tampon manufacturing, safety testing, and labeling requirements, including what manufacturers were required to disclose under applicable FDA regulations at the relevant time.
Why this matters here: The FDA commissioned an independent literature review and internal laboratory testing in September 2024, creating a regulatory record both sides will want to characterize. A regulatory compliance expert can contextualize what the FDA said, specify what disclosure obligations existed under existing law at the time of sale, and address whether the labeling met or fell short of applicable standards. Both sides need this testimony to frame the regulatory record advantageously.
Role: Consumer behavior experts analyze how ordinary consumers interpret product safety messaging and whether the alleged omissions would have affected purchasing decisions.
Why this matters here: The complaints in both cases (against Procter & Gamble and Kimberly-Clark) were framed primarily as omission and deceptive-labeling matters, meaning plaintiffs must establish that the alleged omissions were material to reasonable consumers and that they would have acted differently with full information. Consumer behavior expert witnesses address precisely these questions and their opinions are central to class certification arguments on materiality and classwide reliance.
The Early Cases Are Narrower Than Public Coverage Suggests
Public attention centered broadly on metals in tampons, but the earliest complaints against Procter & Gamble and Kimberly-Clark were framed specifically around alleged lead content, omissions in labeling, and California consumer-protection violations. Attorneys should analyze the actual pleadings, not the media narrative, because the legal theories in play differ meaningfully from the broader public discussion.
Scientific Detection Is Not Legal Causation
The study reported measurable metals but did not establish that metals leach during use, that they are absorbed into the bloodstream, or that they caused any specific health outcome. The FDA's own review confirmed these questions remain scientifically open. Expert witnesses who skip steps in the causation analysis, assuming rather than demonstrating each link, will face Daubert challenges on exactly these grounds.
Consumer-Protection Theories Can Proceed Without Proven Medical Causation
The early complaints survived multiple rounds of dismissal because they were built on omission and economic-loss theories, not on proven bodily injury. Consumer-protection claims require showing that a reasonable consumer was denied material information and suffered economic harm. Medical causation is not required for these theories, which shapes class certification strategy, discovery priorities, and expert sequencing throughout the litigation.
The FDA Record Is Double-Edged
The FDA's review helps and hurts both sides. For the defense: the FDA's literature review did not identify safety concerns associated with tampon use and contaminant exposure, and no recall was issued. For plaintiffs: the FDA acknowledged that questions about leaching and absorption remain scientifically unresolved, supporting the argument that manufacturers had reason to investigate and disclose those uncertainties to consumers. Neither side gets a clean win from the regulatory record.
The tampon toxic metal lawsuits that followed the 2024 study represent a significant and still-evolving area of consumer product liability litigation. They began not with proven bodily injury, but with a peer-reviewed study that detected metals in tampon samples and raised legitimate questions about product labeling and manufacturer disclosure obligations. By 2025, both the Procter & Gamble and Kimberly-Clark cases had survived substantial dismissal challenges and entered active judicial review, establishing this as litigation that will require serious expert witness investment from both sides.
For attorneys on either side, the central challenge is the same: bridging the gap between what the science currently shows (metals were detected) and what the law requires through reliable expert testimony. The FDA has confirmed that the questions about leaching, absorption, and health effects remain unresolved. The experts who can credibly address each link in the causation chain, in a manner that satisfies Daubert and withstands cross-examination, will have an outsized influence on how these cases are ultimately resolved.
Is Tampax still being sued over toxic metals in 2025?
Yes. Barton v. The Procter & Gamble Company (No. 3:24-cv-01332, S.D. Cal.), filed July 29, 2024, remains active as of 2025. Courts have denied most dismissal challenges in both the Procter & Gamble and Kimberly-Clark cases, and the litigation has moved into substantive judicial review.
What triggered the tampon lawsuits?
A peer-reviewed study by University of California, Berkeley researchers, published in Environment International, reported measurable concentrations of 16 metals and metalloids (including lead in every sample tested) across tampon samples from multiple brands. Although the study did not determine whether those metals are released during use or absorbed into the body, it prompted consumer lawsuits alleging misleading labeling and omissions of material product safety information.
What do plaintiffs need to prove?
It depends on the claim type. For the consumer-protection and omission theories at issue in the current cases, plaintiffs must show that material safety information was withheld and that a reasonable consumer would have made a different purchase decision, with economic loss as the primary remedy. For any future personal injury claims, plaintiffs would need to prove the full causation chain: metals were released during use, absorbed at harmful levels, and caused a specific, documented injury, a chain the study itself and the FDA both confirm remains scientifically unresolved.
What did the FDA say about metals in tampons?
By late 2024, the FDA confirmed it had commissioned an independent literature review and initiated internal laboratory testing of tampon materials. The agency stated that the original study did not test whether metals are released during use or absorbed into vaginal tissue or the bloodstream. The FDA's literature review did not identify safety concerns associated with tampon use and contaminant exposure, while acknowledging that scientific questions about leaching and absorption remain open. The FDA did not issue a recall or make a final safety determination.
Why did lead become the central focus in the early complaints?
Although the study discussed 16 metals and metalloids, the complaints against Procter & Gamble and Kimberly-Clark were framed more narrowly around alleged lead content and the failure to disclose it. Lead was detected in every sample tested in the study, making it the most specific and legally focused substance to allege in initial pleadings.
Did the tampon lawsuits survive motions to dismiss?
Yes, in substantial part. On February 13, 2025, the court granted in part and denied in part motions to dismiss in both cases, granting plaintiffs leave to amend. In later 2025 rulings, courts rejected most renewed dismissal arguments. The unfair-prong theory under California's Unfair Competition Law was dismissed with prejudice in both cases, while consumer-protection, omission, and deceptive-labeling claims continued.
What expert witnesses are most important in these cases?
Given that the study did not determine whether metals leach or are absorbed and the FDA has not resolved those questions, the most critical experts are toxicologists (dose and exposure analysis), analytical chemists (reliability of the underlying testing), regulatory compliance experts (FDA standards and manufacturer disclosure obligations), and consumer behavior experts (materiality and class certification in the omission and labeling cases currently before the courts).
Arsenic
Causation Analysis
Chemical Analysis
Chemical Exposures
Consumer Products
Consumer Protection
Heavy metals
Lead
Mislabeling
Product Safety
Manufacturing
Metallurgy, +4
Manufacturing
Manufacturing, +4
Manufacturing
Why did lead become the central focus in the early complaints?
Although the study discussed 16 metals and metalloids, the complaints against Procter & Gamble and Kimberly-Clark were framed more narrowly around alleged lead content and the failure to disclose it. Lead was detected in every sample tested in the study, making it the most specific and legally focused substance to allege in initial pleadings.
Did the tampon lawsuits survive motions to dismiss?
Yes, in substantial part. On February 13, 2025, the court granted in part and denied in part motions to dismiss in both cases, granting plaintiffs leave to amend. In later 2025 rulings, courts rejected most renewed dismissal arguments. The unfair-prong theory under California's Unfair Competition Law was dismissed with prejudice in both cases, while consumer-protection, omission, and deceptive-labeling claims continued.
What expert witnesses are most important in these cases?
Given that the study did not determine whether metals leach or are absorbed and the FDA has not resolved those questions, the most critical experts are toxicologists (dose and exposure analysis), analytical chemists (reliability of the underlying testing), regulatory compliance experts (FDA standards and manufacturer disclosure obligations), and consumer behavior experts (materiality and class certification in the omission and labeling cases currently before the courts).