In June of 2025, retired U.S. District Judge Freda Wolfson was appointed as a limited-purpose Special Master to address the Rule 702 Motions in the J&J Ovarian Cancer MDL. On January 20^th, Judge Wolfson issued a comprehensive Report and Recommendation to U.S. District Judge Michael Shipp. The purpose of Judge Wolfson’s review was to determine whether any of her prior 2020 rulings required reconsideration, either because the previous opinions demonstrably failed to adhere to Rule 702 as clarified by the 2023 amendments or because new science is shown to directly contradict or challenge the previous findings.

Background and Past 2020 Rulings

Judge Wolfson previously oversaw the J&J Ovarian Cancer MDL from its inception in 2016 until her retirement from the bench in 2023. During her time overseeing the MDL, Judge Wolfson reviewed the scientific evidence through Daubert motions in 2020. The results of the 2020 motions were as follows:

• Plaintiffs’ expert Dr. Ghassan Saed was barred from testifying that his study demonstrated a link between the use of talcum powder and ovarian cancer, but Dr. Saed was permitted to testify that talc may cause inflammation and oxidative stress. (Dr. Saed was not offered as an expert in the second round of Daubert motions.)
• Plaintiffs’ expert Dr. William Longo was qualified to testify regarding whether talc products contained asbestos using his TEM analysis and the presence of ultra-trace asbestos in talc products, but he was not permitted to testify regarding his findings of amphibole asbestos through his PLM analysis or that females who used talcum powder products were exposed to asbestos.
• Plaintiffs’ general causation experts Dr. Anne McTiernan, Dr. Daniel Clarke-Pearson, and Dr. Arch Carson were qualified to testify regarding their respective fields of epidemiology, gynecologic-oncology, and toxicology based on their Bradford Hill analyses.
• Defense expert Dr. Gregory Diette was permitted to opine on the epidemiological evidence regarding the existence of a causal connection between perineal use of talcum powder products and ovarian cancer.
• Defense expert Cheryl Saenz was permitted to opine that perineal application of talcum powder does not cause ovarian cancer based on epidemiological literature and her experience as a gynecologic oncologist.
• Defense expert Dr. Benjamin Neel was permitted to offer opinions regarding general causation and as a rebuttal to Dr. Saed’s testimony concerning cellular inflammation.

In 2023, well after Judge Wolfson’s expert rulings in the MDL, Rule 702 was amended in an attempt to clarify and emphasize that expert testimony may not be admitted unless the proponent demonstrates that it is more likely than not that the testimony meets the admissibility standards set forth in Rule 702. The amendments were intended to ensure that courts do not mistake critical questions of sufficiency for questions of weight rather than admissibility. Further, the amendments also emphasized that each opinion must remain within the bounds of the expert’s methodology.

Based on these amendments and arguments that the relevant science had evolved from what was considered in 2020, Judge Shipp ordered a reevaluation of the experts in the MDL. Judge Shipp appointed Judge Wolfson as a Special Master to assist in the evaluation of the expert testimony. Her rulings are recommendations to Judge Shipp, who can consider objections from both sides before deciding whether to adopt them.

Judge Wolfson’s Current Review

The seventeen pending motions were evaluated by Judge Wolfson for recommendations to address the following:

• Whether the proffered experts are qualified to testify,
• Whether the proffered experts’ opinions are based on a reliable methodology, and
• Whether the proffered experts’ testimony fits within the case.

Judge Wolfson emphasized that her role was to determine whether an expert’s methodology was reliable enough to present to a jury, and not to evaluate any expert’s conclusions. Overall, the most significant outcome was Judge Wolfson’s finding that Plaintiffs’ causation experts met the standards of Rule 702 and may testify at trial. Judge Wolfson wrote that “[she found], by a preponderance of the evidence, that the Plaintiffs’ experts have applied reliable methodologies to arrive at their opinions that the pre- and post-2020 epidemiologic studies, taken as a whole, demonstrate a positive, statistically significant association between genital talc powder use and ovarian cancer.”

Similarly, Judge Wolfson recommended J&J’s experts be permitted to testify that talc cannot cause ovarian cancer. This will lead to a battle of the experts to convince the jury at the time of trial.

Judge Wolfson also recommended that the Court grant J&J’s motion to exclude any expert testimony linking heavy metals and fragrance chemicals in the talc products at issue to cancer. Additionally, Judge Wolfson recommended the exclusion of the theory that talc can migrate to the ovaries if it is inhaled.

Judge Wolfson reserved ruling on Dr. William Longo’s PLM-chrysotile testing opinions, as well as the specific causation opinions of Dr. Daniel Clarke-Pearson and Dr. Judith Wolf until the pending hearings scheduled for late January and early February are completed.

A full chart of the recommended decisions, as provided by Judge Wolfson in her report, can be found below.