Harris Beach Murtha attorneys Abbie Fuchs, Dan Strecker, and Alessandra Ash review and analyze key judicial holdings and legal developments in federal court and tort hot spots across the country that have affected the industry and may shape the years ahead. To assist clients and lawyers to prepare the best defense strategies in these suits, they share potential implications for future cases on these topics:
- Defending benzoyl peroxide acne product/benzene litigation
- AFFF MDL bellwether procedures extended to claims for thyroid and liver cancer caused by PFAS
- Defendants can leverage IARC statement on two PFAS compounds, PFOA and PFOS
- Discovery into your adversary’s scientific literature: lesso from talc litigation as of 2024
- Results in toxic exposure/product liability trials continue trend of irrational “nuclear” verdicts
Defending Benzoyl Peroxide Acne Product/Benzene Litigation
In 2024, a laboratory issued a report wherein it claimed to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In certain doses and circumstances, benzene can be carcinogenic. Shortly thereafter, dozens of class action lawsuits, alleging consumer-protection, misrepresentation and similar theories, were filed in federal courts in multiple states against manufacturers and suppliers of these products. More such claims can be expected, as well as personal injury lawsuits alleging these products caused cancer. In defending these personal injury lawsuits, defendants should understand the flaws in the laboratory’s findings and assumptions, appreciate the body of scientific literature that undermines causation theories, and employ the legal defenses available to them.
Claims
The laboratory, Valisure, claims to have discovered that out of 99 benzoyl peroxide acne products tested (83 over the counter), 94 contained benzene at room temperature, “many” above the 2 parts per million (“ppm”) concentration limit set by the FDA. Additionally, Valisure performed “incubation testing” on a subset of the products. After heating to 37 degrees Celsius (98.6 degrees Fahrenheit), over time the benzene levels generally increased above the 2 ppm limit, with some exceeding 40 ppm after 28 days. Valisure attributed the increase to breakdown of the benzoyl peroxide into its molecular components, including benzene. After heating to 50 degrees Celsius (122 degrees Fahrenheit), benzene levels increased much higher, with levels in some products exceeding 800 ppm after 21 days. Valisure heated some of the more “stable” products (those that showed less or no increase at lower temperatures) to 70 degrees Celsius (158 degrees Fahrenheit, the “temperature of a hot car”). These products also showed increased benzene concentrations, with some exceeding 2 ppm and two exceeding 8 ppm after 18 days. Valisure estimated that in a hot car, resulting airborne benzene levels (distinguishable from the liquid concentrations already discussed) could be 400 parts per billion (“ppb”) (0.4 ppm).
Potential Personal Injury Litigation
Valisure promptly filed a citizen petition asking the FDA to investigate and recall these benzoyl peroxide acne products. Class-action litigation, all citing Valisure’s findings, followed. In a victory for the defense, the Judicial Panel on Multidistrict Litigation has twice denied plaintiff requests to establish an MDL consolidating the class-actions which are currently pending in federal district court in California, New York, Illinois and elsewhere.
Valisure has resorted to similar tactics in the past after purporting to find benzene in antiperspirants, aerosol dry shampoo, antifungal products and sunscreen. These actions gave rise to personal injury litigation. For example, a plaintiff claimed in Georgia federal court that benzene in sunscreen tested by Valisure caused her to develop acute lymphoblastic leukemia (“ALL”). See Cascio v. Johnson & Johnson, et al., 2024 WL 693489 (N.D. Ga. Feb. 20, 2024). In August 2024, it was announced that a North Carolina District Court personal injury lawsuit, wherein a father alleged his 14-year-old son died from acute myeloid leukemia (“AML”) caused by benzene in defendant’s sunscreen, would be settled. Personal injury claims arising from Valisure’s report on benzoyl peroxide acne products can be expected.
Defenses of Benzene Litigation
It takes more than the mere presence of benzene to establish causation. It must also be established that (1) the type of cancer in question can actually be caused by benzene (general causation) and (2) the benzene exposures in question were sufficient to, and did cause, that cancer (specific causation). For example, the literature supporting the theory that benzene is capable of causing ALL, the alleged disease in Cascio, is vastly different than that supporting benzene’s ability to cause AML, the alleged disease in the North Carolina suit. Valisure’s statements espouse scientifically flawed theories advocated by the plaintiff bar and their experts (and cite at least one well-traveled plaintiff expert), claiming there is “no safe dose,” and “any” benzene exposure increases the risk of cancer. But there is overwhelming scientific evidence to the contrary. That evidence indicates that these levels, trace in the original products and arguably still trace even after exposure to abnormal temperatures for extended periods of time, do not pose a human health risk.
Indeed, peer-reviewed literature has already cast doubt on the notion that the type of benzene exposure that might result from these products is significant from a health and safety perspective. In a research letter published in the peer-reviewed Journal of Academic Dermatology, the authors observed that in general, transdermal benzene absorption is thought to be minimal. The authors analyzed blood-benzene levels in persons reporting use of these products and compared them to blood-benzene levels in persons who did not use these products. The authors found no difference in blood-benzene levels.
Other assertions that might be made by plaintiffs can be challenged. For example, Valisure estimates that in a hot car (158 degrees Fahrenheit) containing benzoyl peroxide acne products, benzene levels could reach 400 ppb (0.4 ppm), then compares that to the EPA estimate that lifetime exposure of 0.4 ppb “can lead” to one additional cancer case in 100,000 persons. Valisure states that therefore, these products could cause “1,000 times this US EPA limit.” Among other ready criticisms, Valisure’s assertion obscures the fact that virtually no person would ever experience these conditions — proximity to benzoyl peroxide acne products at an extraordinarily high, presumably fatal air temperature for 18 days — let alone for a lifetime.
Also of note, Valisure published some of its findings in a peer-reviewed journal. But not all of Valisure’s claims appear in the peer-vetted study — for example, the claims about and detail pertaining to the allegedly elevated benzene content at room temperature. Likewise, Valisure cites the plaintiff expert in its citizen petition, not the peer-reviewed study. An opinion piece published in the same dermatology journal criticized Valisure, citing published concerns about Valisure’s methodology and the opacity of Valisure’s data, and called on Valisure to release additional data to allow its claims to be adequately evaluated. The piece did not recommend clinicians stop prescribing these products.
Moreover, the Valisure findings may not be representative of the product generally, or the product at points in time prior to, or after, the Valisure study, when a given plaintiff may claim to have allegedly used it. In other words, merely finding “elevated” benzene levels in one container of a product does not indicate that other containers of that product have or had similar amounts of benzene.
The court in Cascio, the sunscreen case, used this reasoning in its opinion granting the defendant’s motion to dismiss. The court held plaintiffs failed to plausibly allege causation because they did not show the batches of sunscreen they claimed to have used actually contained benzene. The court reasoned that the mere presence of benzene in one batch of defendant’s sunscreen products did not extend to the batches plaintiffs allegedly used. The court also held that the existence of a recall does not establish a defect. Defendants in current and future lawsuits can leverage similar arguments.
Conclusion
Careful, critical reading of the laboratory’s reports, understanding the scientific literature and familiarity with causation defenses will be valuable tools in defending any personal injury litigation that may arise from the report on benzene content of benzoyl peroxide acne products. Scientifically, general and/ or specific causation may be readily disputable. Understanding the flawed assumptions made by the laboratory — and litigants relying on the laboratory — will be critical. And challenging causation theories as early as the pleading stage could lead to dismissals.
AFFF MDL Bellwether Process Extended to Claims of Thyroid and Liver Cancer Caused by PFAS
In 2024, the court in the aqueous film-forming foams (“AFFF”) multidistrict litigation established a new bellwether process to address personal injury claims alleging that polyfluoroalkyl substances (PFAS) in AFFF caused thyroid and liver cancer. The personal injury bellwether processes in the AFFF MDL now encompass claims for kidney cancer, testicular cancer, hypothyroidism/thyroid disease, ulcerative colitis, thyroid cancer and liver cancer.
Background
In December 2018, the Judicial Panel on Multidistrict Litigation centralized in the United States District Court for the District of South Carolina approximately 90 civil actions from eight U.S. District Courts involving claims that aqueous film-forming foams (“AFFF”) containing certain per- and polyfluoroalkyl substances (PFAS), including perfluorooctane sulfonate (PFOS) and/or perfluorooctanoic acid (PFOA), had contaminated local ground and drinking water. (In re Aqueous Film-Forming Foams Prods. Liab. Litig., 357 F. Supp. 3d 1391, 1394 (JPML 2018)). Since that time, thousands more cases, including personal injury claims, have been added from U.S. District Courts throughout the country.
To date, the court has approved settlements in excess of $10 billion, including with public water systems.
Personal Injury Bellwethers
The personal injury claims involve over 200 different injuries. These injuries include those addressed in Leach, a prior PFAS class action against one of the defendants in the AFFF MDL (kidney cancer, testicular cancer, ulcerative colitis, thyroid disease, pre-eclampsia and high cholesterol), and other types of cancer. The court in charge of the AFFF MDL has established two bellwether proceedings to address certain of these injuries.
The first bellwether process addresses cases known as the “Limited-Leach Injury Bellwether Cases,” in which the plaintiffs assert exposure to PFAS from an AFFF source in drinking water caused one of four diseases: kidney cancer, testicular cancer, hypothyroidism/ thyroid disease and ulcerative colitis. Expert discovery is underway, summary judgment and Daubert briefing is scheduled to be completed by July 2025, and trials are scheduled in October 2025.
In March and April 2024, the court established a second bellwether process for claims that exposure to PFAS from an AFFF source caused liver or thyroid cancer. The parties exchanged their peer-reviewed studies that dispute or allegedly support an association between AFFF/PFAS and these additional diseases. A “Science Day” to allow the parties to present a limited number of experts on causation is scheduled for June 6, 2025. After the “Science Day,” the parties will select bellwether cases and develop a process for Daubert and dispositive motions.
The result of the trials in the bellwether cases will not necessarily be binding on other cases, but the court’s decisions on common issues (Daubert and dispositive motions) will be influential, and any jury verdicts will be instructive.
Looking Ahead
The combined personal injury bellwether proceedings will not resolve all the personal injury claims allegedly arising from AFFF/PFAS exposure. For example, discovery is ongoing against defendants alleged to have manufactured PFAS-containing firefighting gear. Additionally, the terms of the orders establishing the bellwether proceedings do not address co-defendants in multi-exposed cases who are not alleged to have supplied any AFFF/PFAS products, but have been pulled into the MDL. Since claims are continually being added to the MDL, it is likely that additional bellwether proceedings or other procedures for addressing common claims will be instituted in the future.
PFAS defendants can use the International Agency for Research on Cancer’s (IARC’s) recent statement on the carcinogenicity of perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) in support of causation and notice defenses. PFOA and PFOS are part of the group of compounds known as per- and polyfluoroalkyl substances (PFAS), which have been disparagingly labeled “forever chemicals” due to their alleged capacity to remain in the environment for long periods.
IARC’s statement is limited to two of the thousands of PFAS compounds, and courts, like the Sixth Circuit in its decision in Hardwick, have rejected allegations that conflate these distinct substances. Furthermore, IARC recognized there is only “limited evidence” of PFOA’s ability to cause just two cancers in humans, testicular and kidney cancer, and the evidence it causes other cancers in humans is “inadequate.” IARC labeled as “inadequate” the evidence PFOS causes any cancer in humans.
IARC’S Classification of PFOA and PFOS
IARC is the cancer-research branch of the World Health Organization (WHO). IARC classifies substances in one of four groups: Group 1 (carcinogenic to humans), Group 2A (probably carcinogenic to humans), Group 2B (possibly carcinogenic to humans), and Group 3 (not classifiable as to its carcinogenicity to humans). In February 2025, Volume 135 of the IARC Monographs was published to include its evaluation of PFOA and PFOS.
In a 2016 Monograph, IARC concluded PFOA is “possibly carcinogenic to humans.” At its November 2023 conference, IARC changed PFOA’s classification to “carcinogenic to humans.” IARC based its decision on evidence in experimental animals and “strong mechanistic evidence” of immunosuppression and alteration of gene expression in humans.
However, IARC acknowledged the dearth of evidence PFOA causes cancer in humans. According to IARC, there is only “limited evidence” PFOA causes kidney and testicular cancer, and IARC noted that while some human studies have found an association, the same number or more studies have not. IARC called the evidence for all other human cancers “inadequate.” IARC reported an animal study published since its 2016 conclusions, but it focused on liver, pancreatic and uterine cancer and related effects in rats (i.e., neither kidney nor testicular cancer).
At its November 2023 conference, IARC classified PFOS as “possibly carcinogenic to humans” due to “strong mechanistic evidence” it is immunosuppressive and induces genetic alterations. However, IARC acknowledged the evidence that PFOS causes cancer in humans is “inadequate” because the few available studies showed only sporadic and inconsistent positive findings for breast, testicular and thyroid cancer. IARC also acknowledged the evidence that PFOS causes cancer in animals is “limited,” citing a study showing increased liver cancer and related effects in the highest exposed rats.
Conclusion
Defendants in widespread PFAS personal injury cases, consumer class actions and other litigation should be aware of IARC’s determinations and how they support the defense position that the available scientific evidence is insufficient to demonstrate causation. For example, IARC’s conclusions are restricted to two among thousands of PFAS compounds, and courts have rejected allegations that conflate these distinct substances. Furthermore, IARC acknowledges that the evidence either PFOA or PFOS cause cancer in humans is inadequate, comprising studies with inconsistent results and, insofar as associations have been found in humans, they are limited to cancers at specific sites: for PFOA, testicular and kidney cancer, for PFAS, testicular, breast and thyroid cancer. Defendants in PFAS lawsuits in which IARC’s findings are raised should distinguish which PFAS compounds and cancers are allegedly at issue, and emphasize that even for PFOA and PFOS, IARC acknowledges a lack of evidence for cancer causation in humans.
Discovery into Your Adversary’s Scientific Literature: Lessons from Talc Litigation as of 2024
In some litigation, the viability of an expert’s opinion rests on the expert’s asserted reliance on one or a handful of scientific studies. The study or studies, their quality, and their applicability to the facts at hand become critical to the question of a party’s liability, or lack thereof.
Despite how important scientific studies can be to a case, in many respects the studies are opaque. Generally, litigants have no access to the study authors, or the authors’ data files, notes and unvarnished opinions. The study authors choose what information to disclose and what to withhold, and the reader must rely on the authors’ ethics and the peer-review process to ensure the data and methods are characterized accurately, fairly and reliably.
The material underlying and collateral to a scientific study could be used to differentiate the study data from the facts at hand, or otherwise discredit the study and, thus, the other party’s position. If the material reveals gross deficiencies in a study, it could lead a court to exclude an expert’s opinion and/or grant a dispositive motion. Decisions and developments in talc litigation through 2024 provide a roadmap for how litigants can obtain this information and material in the right circumstance.
Non-party Discovery into Studies Underlying Talc Litigation
During the past 20 years, tens of thousands of plaintiffs have filed suit alleging they developed cancer from asbestos allegedly contained in talc products like cosmetics or baby powder. Many have relied on the 2020 report Mesothelioma Associated With the Use of Cosmetic Talc, by Dr. Jacqueline Moline and collaborators (“Moline 2020”). The authors assert they reviewed cases of anonymous individuals exposed to talc, but not asbestos, as part of a “medico-legal evaluation as part of tort litigation.” The authors conclude exposure to asbestos-contaminated talc caused mesothelioma in these cases. Dr. Moline and others, including Dr. Theresa Emory and Dr. John Maddox, subsequently authored additional articles building on the study (the “Mesothelioma-Talc articles”).
Information has emerged that undermines the integrity of its data. In the 2022 lawsuit Bell v. Am. Int’l Indus. (“Bell”), a mesothelioma/wrongful death-talc case in North Carolina federal district court, the plaintiff disclosed Dr. Moline as an expert witness. One defendant learned the decedent may have been one of the anonymous individuals studied in Moline Importantly, while Moline 2020 claimed none of its subjects had asbestos exposure (i.e., removing a potential alternative cause of their mesothelioma), this decedent had previously filed workers’ compensation claims alleging asbestos exposure. To confirm, defendant subpoenaed Dr. Moline’s employer seeking the identities of the anonymous study participants. The employer’s responsive production confirmed decedent was indeed one of them, undermining the reliability of all of the Mesothelioma-Talc articles.
The Bell court initially granted plaintiff’s motion for a protective order and limited the use of the information to the Bell case, but later vacated it. The court found that permitting defense challenges to the article’s premise, that none of the studied individuals had any known alternative asbestos exposures, in other talc litigation constituted good cause. The court held the information was relevant to the article’s credibility, cross-examination of Dr. Moline as a retained expert and author of the article, and potential expert exclusion.
Similarly, in 2024 the court approved the subpoena served by talc defendants in Clark and Clark v. Cyprus Amax Minerals Co. that sought the identities of study participants in Mesothelioma-Talc articles, after the order quashing it was reversed on appeal. The appellate court issued the decision in Matter of Johnson & Johnson v. Northwell Health, Inc., consolidating a proceeding initiated by Dr. Moline to quash the subpoena with a proceeding by the Clark and Clark talc defendants to enforce it. The court noted the information sought by the subpoena was relevant to the credibility of the Mesothelioma-Talc articles, which “speak to the central issues in dispute” and were relied on by experts, both current and withdrawn.
The court in the ovarian cancer-talcum powder MDL, In Re: Johnson & Johnson Talcum Powder Products Mktg., Sales Prac., and Products Liab. Litig.(“Talcum Powder MDL”), reasoned similarly, but in 2024 quashed the defense’s non-party subpoena to obtain records relating to the Mesothelioma-Talc articles. The court quashed the discovery on relevance grounds, since plaintiffs’ experts in the Talcum Powder MDL did not rely on the Mesothelioma-Talc articles, and plaintiffs went so far as to propose excluding reference to the articles at trial. But the court reasoned that if the plaintiffs’ experts had relied on the Mesothelioma-Talc articles, investigating their bases would be “fair game.”
In 2022, a court in the Eastern District of Virginia (Peninsula Pathology Associates v. Am. Int’l Indus.) ruled differently when it quashed the talc defendant’s subpoena, served in connection with Gref v. Am. Int’l Indus., on Dr. Emory and Dr. Maddox’s employer for documents relating to a Mesothelioma-Talc article. The Peninsula Pathology court weighed the defendant’s interest against the cost to the employer to comply and the burden of revealing anonymous study participants. Plaintiffs’ experts (which included Dr. Moline, but neither Dr. Emory nor Dr. Maddox) relied on the studies, but the court reasoned the reliance was relatively minor, and pointed out the already extensive publicly available information that could be used to discredit the study. Further, defendant offered no basis to conclude plaintiff might have been a study participant. Related, the talc defendant in Gref v. Am. Int’l Indus. also served a subpoena on Dr. Moline’s employer seeking the identities of participants in Moline 2020, the employer moved to block such disclosure, and in 2024 plaintiff withdrew his experts’ reliance on the article.
Talc Litigation Takeaways
Taken together, the decisions signal that courts may approve reasonable nonparty discovery to investigate the bases of scientific studies and other literature that adversaries rely on. The Peninsula and Talcum Powder MDL decisions delineate the outer boundaries of what might be permitted. These decisions suggest the studies under investigation must be relied on by the other party’s experts and must be more than incidental to the experts’ opinions. Further, if the sought-after information is otherwise available, or the party seeking the study cannot substantiate the reason for the investigation, it could weigh against allowing the discovery. For example, if the study was authored by the party’s expert, the expert relies on the study, and there is reason to believe that the discovery will reveal information the investigating party can use, the discovery is more likely to be allowed.
Even though the discovery was rejected in two cases, the parties challenging the Mesothelioma-Talc articles may have succeeded in other respects. The information developed in Bell, and the use of that information to seek non-party discovery in the cases that followed, appears to have dis-incentivized plaintiff experts from relying on the Mesothelioma-Talc articles.
Conclusion
Investigation into dubious scientific support for toxic tort litigants’ claims and defenses can help develop the record for summary judgment, expert exclusion or trial. Parties considering engaging in nonparty discovery to investigate, distinguish, and/or discredit their opponents’ scientific support should heed the lessons learned from recent decisions in talc litigation.
To avoid nonparty discovery being quashed, parties should develop their arguments and lay an evidentiary groundwork for the requests being made, and be prepared to answer: what information is sought, what is the basis to believe the information will be found and how will the information impact the case? Parties should also consider the potential ramifications of success. On the one hand, the efforts undertaken in Bell appear to have disincentivized multiple future talc plaintiffs from relying on the Mesothelioma-Talc articles or retaining Dr. Moline and have led to withdrawal of reliance on the Mesothelioma-Talc articles and proposals to exclude reference to them. But if the party’s adversary withdraws its reliance on flawed experts and science, a party may be deprived of otherwise available lines of attack and inadvertently teach their adversary how to make its theories stronger and less easily challenged.
Results in Toxic Exposure/Product Liability Trials Continue Trend of Irrational Nuclear Verdicts
“Nuclear” verdicts are awards that are exceptionally high, eclipsing what would be a rational, reasonable or expected amount based on the evidence. The May 2024 verdict in Gill, a toxic exposure/product liability benzene lawsuit in Philadelphia, Pennsylvania, is an example of this type of verdict and the cultural and sociopolitical trends that may be driving them.
The jury found against the defendant and awarded $725.5 million in compensatory damages to a former mechanic who alleged he developed leukemia as a result of his exposure to benzene in its petroleum products, including gasoline. The jury found that defendant failed to warn the plaintiff of the risk of benzene in its gasoline, which he alleged exposure to throughout his employment at a service station from 1975 to 1980.
The Philadelphia Court of Common Pleas denied the defendant’s post-trial motions, which sought either a judgment notwithstanding the verdict or a new trial. Among other arguments defendant raised, it emerged that one of the jurors posted information online suggesting misconduct in deliberations and that jurors made decisions based on anti-corporate animus, information not presented in court and settlement discussions they should not have been aware of. The juror wrote, “[Defendant] is objectively a villain;” “Early on in deliberations, we had 9 of 12 jurors willing to do 1.776B in honor of Philadelphia. Such a wild jury…Crazy experience. Don’t said [sic] I didn’t ever do anything for climate change lol;” “[T]he morning before deliberations, the plaintiff offered to settle the case for $1.2M. [Defendant] said no. They really didn’t see this coming. Honestly the best feeling ever [was] seeing their defense counsel look like they were going to puke,” and “the entire legal system is wack.” The juror also commented: “It’s not every day you get to be apart [sic] of sticking it to the man if you will. So I feel lucky to have done something.”
Nevertheless, in September 2024, the court upheld the verdict. Further, it added an additional $90.8 million in delay damages, resulting in a total award of $815.8 million, which the defendant is appealing.
Such a “nuclear” verdict is an example of unreasonably high awards in toxic exposure/product liability cases. The jury’s conduct also shows the type of sociopolitical and cultural trends that are driving such verdicts and that they may be based on improper motivations.
The ongoing trend of verdicts like this show the risk of such awards should always be accounted for in strategizing one’s defense to an alleged toxic exposure/ product liability case. Nevertheless, and underscoring the importance of risk management through defense advocacy, these verdicts may be subject to post-verdict challenges. And juries otherwise remain willing to find for the defense in product liability/toxic tort cases. Developing strong defenses on causation and other grounds, aggressively pursuing opportunities for pre¬trial dismissal such as summary judgment, educating juries with the right experts and considering settlement when strategically appropriate can reduce the potential for large pay-outs.
