Discovery of Medical Study Participants' Names in Trade Libel Lawsuit Against Scientists/Expert Witnesses
From Pecos River Talc LLC v. Emory, decided Tuesday by Magistrate Judge Robert Krask (E.D. Va.):
Pecos River Talc LLC … sued defendants, Drs. Theresa Emory, John Maddox, and Richard Kradin, alleging that certain statements they made in an article published in a scientific journal about cosmetic talc, asbestos, and malignant mesothelioma were false. The Court granted in part and denied in part defendants' motion to dismiss [see here -EV], allowing the case to proceed on the trade libel claim (count one).
Pending before the Court is Pecos River's motion to compel the identities of the article's subjects…. [T]he Court … [concludes that] the names of the subjects in the article are within the scope of discovery….
Pecos River was formed as part of Johnson & Johnson's effort to resolve talc-related claims through bankruptcy. Defendants … serve as plaintiff-side expert witnesses in litigation between individuals with mesothelioma and manufacturers of cosmetic talc. In March 2020, defendants published an article titled "Malignant mesothelioma following repeated exposures to cosmetic talc: A case series of 75 patients" in the American Journal of Industrial Medicine (the "article"). The article stated that it "present[s] 75 … subjects, with malignant mesothelioma, whose only known exposure to asbestos was cosmetic talc[,]" who were "additional" to the 33 subjects reported in an earlier study by Dr. Jacqueline Moline ….
Defendants identified and selected the 75 subjects "from medical-legal consultation practice." To determine asbestos exposures, defendants relied on records obtained when they served as expert witnesses for asbestos plaintiffs—many times in cases against Pecos River—and examined "sworn deposition testimonies and answers to sworn interrogatories provided from subjects, parents, and spouses." Tissue samples were tested for the presence of asbestiform fibers in nine subjects.
The article does not include the subjects' names but refers to them by an assigned case number and presents information about each subject in two tables. The first provides for each subject: their sex, the year they were diagnosed with mesothelioma, their age at diagnosis, the mesothelioma site, histology, the estimated number of years they used talcum powder, and the estimated number of years of the latency period. The second details the results of the tissue examination for nine subjects, including the mesothelioma site, the type of asbestos, the tissues examined, the concentration of fibers detected in the tissue, the limit of detection, and the tissue digest weight….
Because the Court concludes that the names [of the study subjects] are relevant, proportional to the needs of the case, and are not privileged, the names are discoverable, and defendants must produce them to Pecos River subject to the protective order discussed here.
Relevance[:] Pecos River seeks the names of the article's subjects so that it can prove that two statements—that the 75 subjects' "only known exposure to asbestos was cosmetic talc" and the 75 subjects are "additional" to the subjects of the Moline study—are false and defendants made those statements knowing that they were false or with reckless disregard of their falsity (that is, with actual malice). Pecos River maintains that the names will allow it to investigate "three critical sources of information" not in defendants' possession: (a) defendants' deposition testimony, trial testimony, and expert reports for the subjects' underlying cases; (b) evidence of the subjects' non-talc exposures to asbestos "in plain sight"; and (c) "to demonstrate that individuals were subjects of both [d]efendants' [a]rticle and Dr. Moline's paper[.]"
Pecos River compared the contents of its asbestos litigation files from cases where it was a defendant to the information reported in the article. From that comparison, Pecos River alleges that "at least six individuals in the [a]rticle are plaintiffs with documented alternative exposures to asbestos." As one example, Pecos River alleges that I.B. is a "possible match" for the subject identified as "case eight," as its records from I.B.'s asbestos case show information nearly identical to that reported in the article. Moreover, in the section of defendant Kradin's 2017 expert report from I.B.'s case titled "Exposure History," he stated that I.B. was exposed to asbestos by "smoking as much as a package a day" of Kent cigarettes in the 1950s and 1960s. And defendant Kradin concluded that I.B.'s "cumulative exposures to asbestos from cosmetic talc and the inhalation of crocidolite asbestos in Kent cigarettes[ ]" caused her malignant mesothelioma. [Other examples omitted. -EV] …
Similarly, Pecos River alleges that at least one subject was included in both the Moline study and defendants' article, and therefore, the "additional" statement is also false. Because the identities of the subjects of the Moline study are public, their names are relevant to determining whether there is overlap and whether defendants acted with actual malice when they claimed there is none. Again, Pecos River has been able to make educated guesses. But the Rules of Civil Procedure authorize discovery—subject to proportionality and privilege—on "any matter that bears on, or that reasonably could lead to other matter that could bear on, any issue that is or may be in the case." …
Proportionality[:] … Discovery of the names must also be "proportional to the needs of the case[.]" In deciding whether they are, the Court must consider, among other things, "whether the burden or expense of the proposed discovery outweighs its likely benefit." … According to defendants, … [a]s medical researchers, they "must minimize the risks of research, including those related to privacy and confidentiality, and endeavor to safeguard the subjects of their work." And defendants contend that information from the subjects' litigation files is not public, and the subjects' identities are confidential regardless of their status as plaintiffs in other litigation. According to defendants, the burden of disclosing the subjects' names outweighs the likely benefit, as doing so would violate research ethics and chill medical research. The Court disagrees….
Each subject retained at least one of the defendants as an expert witness in a lawsuit relating to asbestos and mesothelioma. Defendants received substantial information from the subjects, including their name, medical records, and personal history, not in aid of scientific research, but to opine on what caused the subjects' mesothelioma. And each subject arguably had every expectation that the expert witnesses would write a report documenting the bases of that opinion and publicly testify, if necessary, at the subject's trial about the same. Against this backdrop, it is safe to conclude that the subjects did not provide confidential information to defendants, expecting it to remain confidential for all purposes. See Expert Report of Lisa S. Lehmann, M.D., Ph.D. ¶ 11, ECF No. 46-22 ("Lehmann Report") ("Since the individuals in the case series published by [defendants] in their article were plaintiffs in publicly discoverable legal cases, the individuals in the case series should not have any expectation of medical confidentiality."). Thus, the manner defendants received and intended to use the subjects' personal information diminishes any concern that disclosing their names would be so violative of research ethics as to preclude discovery.
The context of the study is also important. Defendants did not obtain the names of the subjects (or information about them) in the context of a patient-physician relationship or a medical research study. They learned of information relevant to the study through "medical-legal consultation practice," relying on a subject's "sworn deposition testimonies and answers to sworn interrogatories"—which they had received as an expert in the asbestos case—to identify the pool of potential subjects for the study. Dr. Lehman states in her expert report that the subjects' "identities as individuals with mesothelioma constitute information that was generated for a legal purpose and not for the provision of health care or for research purposes."
Defendants did not solicit the subjects to participate in a medical research study, obtain written consent from them, or even notify them that they were included in the study. This may very well be the usual course for "archival" disease studies, as defendants contend. And the Court does not question that the confidentiality concerns are "particularly weighty in the context of rare diseases like mesothelioma, which is challenging to research because it is difficult to identify a sufficient sample of cases to study." However, these considerations also diminish any burden caused by disclosing the names, especially when weighed against the benefits to the needs of this case.
Further, the underlying principles of the Health Insurance Portability and Accountability Act ("HIPAA") strongly support the Court assigning minimal weight to the burden that defendants claim disclosing the names will place on them. Defendants themselves concede that HIPAA does not prevent them from disclosing the names of subjects to Pecos River in discovery. And for good reasons. First, defendants are not covered entities, meaning that HIPAA protections do not apply to them. Second, even if they were covered entities, defendants would incur no burden by disclosing the names because HIPAA allows them to disclose protected health information in a judicial proceeding (such as this) in response to a court order compelling them to do so….
Risks of Chilling Medical Research[:] Defendants also make much of the risk that disclosing "confidential source material underlying a peer-reviewed medical publication" would have on "chilling critical scientific research." This, too, is insufficient to show that the burden of disclosing the names outweighs the likely benefit.
As discussed above, defendants conducted the study, which has concluded, through "medical legal consultation practice." Defendants did not publicly solicit participation. The subjects did not volunteer to participate in the study or consent to be participants. They consented to sue a talc manufacturer. Therefore, disclosure of the names of the subjects would not upend any expectations that a subject may have had from knowing and voluntary participation in a research study because those expectations never existed. These factors minimize any potential chilling effect on the willingness of people to participate in future medical research should the names here be disclosed.
Defendants also argue that researchers might be chilled, opting not to venture into this type of research out of fear that the data underlying their conclusions would be dug up in litigation. The Court is not insensitive to the optics of this case and the potential chilling effect that may result. Pecos River—closely associated with a large multinational corporation—has sued defendants to delve into their research to discredit their conclusions about the potential harmful effects of cosmetic talc. But the Court found in denying defendants' motion to dismiss that Pecos River has plausibly alleged trade libel, and it is entitled to discovery to prove that claim….
A protective order is appropriate[:] Disclosure of the names of subjects of a medical research study, along with highly sensitive personal records, is, however, of great concern. As discussed above, the Court will mitigate the risks to the subjects posed by such a disclosure and concludes that defendants have shown good cause for a protective order under Rule 26(c)…. The Court agrees with defendants that the subjects' names—including those whose names are alleged in the complaint (if they are subjects)—and their medical records should be protected. [I assume that the protective order would limit disclosure of the names outside court, but will allow some such disclosure in court filings, for instance, if plaintiffs use the information to argue that particular people listed in the study as having no other risk factors were actually named plaintiffs in other cases where they were found to have such risk factors. -EV]
Benjamin L. Hatch, Sylvia Macon Kastens, and Samuel L. Tarry, Jr. (McGuireWoods LLP), and Kristen Fournier and Matthew Bush (King & Spalding LLP) represent plaintiffs.