New NIH Findings on Talc and Ovarian Cancer Challenge J&J's Defense

Johnson & Johnson (J&J) ceased distributing its talc-based baby powder in the U.S. in 2021, substituting it with a cornstarch alternative. This decision came amid ongoing litigation, with more than 53,000 women in the U.S. filing injury lawsuits against the corporation, claiming the talc-based product increased their risk of developing ovarian cancer.

These claims have recently gained traction due to new findings from the National Institutes of Health (NIH), suggesting a connection between prolonged use of talcum powders and a heightened risk of ovarian cancer. The NIH study, published in the Journal of Clinical Oncology, analyzed data from the Sister Study, which involved over 50,000 U.S. women aged 35 to 74 who enrolled between 2003 and 2009 and were surveyed again between 2017 and 2019. The study indicated a "positive association between genital talc use and ovarian cancer."

According to the study, women who used talcum powder on their genitals for extended periods were more likely to develop ovarian cancer. Specifically, those who used talcum powder for 20 years or more faced nearly double the risk. Leigh O’Dell, a lawyer from Beasley Allen and co-chair of the plaintiff steering committee, highlighted the significance of these findings, noting that previous data did not show an increased risk.

Despite these findings, J&J maintains its stance that talcum powder does not cause ovarian cancer and argues that the study does not establish causality or implicate any specific cancer-causing agent. Erik Haas, J&J’s legal chief, emphasized that the study's conclusions were based on speculative assumptions rather than the actual data. The company remains confident that the claims will be dismissed following a Daubert review, which allows judges to discredit flawed testimonies in expert opinion-based hearings.

Lawyers representing the plaintiffs believe the NIH findings bolster their case. They argue the research aligns with what their experts have been asserting for years. The study's detailed analysis of the participants' lifetime use of talcum powder provided a comprehensive view, estimating that 56% of participants applied the product to their genitals.

Recently, J&J criticized the research methodology in a letter to New Jersey federal Judge John Porto, arguing that the results were based on questionable corrections and assumptions that drove the findings. J&J's efforts to resolve the talc-related lawsuits have seen multiple approaches, including creating a subsidiary to house the claims and declaring it bankrupt, both of which failed. This month, J&J announced a plan to reorganize the subsidiary, LTL Management, offering a $6.475 billion settlement to be paid to talc litigants over 25 years. This proposal is less than the $8.9 billion settlement offered in the previous bankruptcy attempt.

J&J justifies the current settlement offer by citing its 95% success rate in ovarian cancer cases that have gone to trial over the past six years. However, the company has faced significant losses, including a 2018 case in Missouri where $4.69 billion was awarded to 22 women, later reduced to $2.11 billion by an appeals court.

Last week, J&J filed a complaint against the law firm Beasley Allen, accusing them of distributing "false information" to clients to influence their voting on the settlement offer, which will occur over the next three months. O’Dell from Beasley Allen criticized J&J's actions, labeling them as not being in good faith.

J&J’s connection to baby powder spans over a century, with concerns about the product emerging at least half that time. In 1971, J&J funded a study where asbestos was injected into prisoners to compare their skin reactions to those using talc. The company apologized for this study in 2022, noting such tests were "widely accepted" at the time.

In 2019, after the FDA discovered trace amounts of asbestos in the talc-based product, J&J recalled 33,000 bottles as a precaution. Facing declining sales and rising settlements and litigation, J&J pulled the product from the U.S. market in 2021 and worldwide by 2023, replacing it with a cornstarch version.

Motions for the Daubert review are scheduled to be filed by July 23, with opposing filings due a month later. The best outcome for J&J would be a ruling akin to a 2022 verdict that freed several companies from lawsuits related to the heartburn drug Zantac, overturning previous scientific findings.