Litigation over the cancer risks of Johnson & Johnson’s talc powder products is heating back up after juries delivered two historic multi-million verdicts earlier this year, with trials slated for September in Missouri and October in New Jersey. Courtroom View Network hopes to webcast both trials, and as a lead up we are featuring a guest column by Dr. David Schwartz, Ph.D. of Innovative Science Solutions, breaking down some of the key scientific studies and expert testimony backing up the legal arguments in these high-stakes cases. (Become a CVN subscriber to watch previously recorded and upcoming talcum powder trials for as little as $99/month)
Video Analysis: Don’t Let Plaintiff (Or Defense) Experts Play Fast And Loose With The Science
by David Schwartz, Ph.D.
Johnson and Johnson has recently litigated two cases involving allegations that genital use of its cosmetic talcum powder product causes ovarian cancer. In February 2016, they lost a $72 million verdict to a St. Louis woman who died of ovarian cancer, and more recently they lost a $55 million verdict to a South Dakota woman who blamed her ovarian cancer on genital talc use. In this post we discuss some of the epidemiological studies related to talc and ovarian cancer and then provide some analysis of a short piece of plaintiff expert testimony in a recent talc case. To illustrate, we have embedded video testimony of Dr. Daniel Cramer in the Gloria Ristesund v. Johnson & Johnson case.
TALC EPIDEMIOLOGICAL STUDIES ARE KEY PIECES OF EVIDENCE IN PLAINTIFF CASE
As the cornerstone to their cases, plaintiffs have used the epidemiology purporting to show associations between talc use and cases of ovarian cancer. Scientists have conducted both case control and cohort epidemiological studies evaluating the alleged association.1
To date, only case control studies have reported statistically significant associations. The Ovarian Cancer Association Consortium pooled eight case control studies and reported a summary OR of 1.24 (CI = 1.15 – 1.33). The cohort studies that have been conducted (e.g., The Nurse’s Health Study and the Women’s Health Initiative) hare reported slightly elevated, but statistically non-significant elevated risk ratios.
TALC EPIDEMIOLOGICAL STUDIES SUFFER FROM BIAS
There are very real methodological concerns with case control studies assessing the risk of ovarian cancer with talc exposure. Even the American Cancer Society states “these types of studies [case control epidemiological studies] can be biased because they often rely on a person’s memory of talc use many years earlier.” Nevertheless, these elevated ORs will be referred to by plaintiff experts as evidence that talc causes ovarian cancer.
In confronting the use of epidemiological studies (especially case control studies) in this type of case, the devil is always in the details. Experts (both plaintiff and defense) often play fast and loose with the data and fail to mention fatal inconsistencies in an individual study that he or she relies upon.
Dr. Cramer Relies on “The Wu Study”
Below we demonstrate how, Dr. Daniel Cramer – an epidemiologist testifying for plaintiffs in the talc litigation – fails to address or account for critically inconsistent data within a study that he cites as part of his testimony. Specifically, the study asserts that inflammation increases the risk of talc-induced ovarian cancer; but Cramer fails to explain why anti-inflammatory drugs (e.g., non-steroidal anti-inflammatory drugs or NSAIDs) also increase the risk for talc-induced ovarian cancer.
In the video clip below, Cramer relies on a study by Wu and colleagues in his direct examination in the Ristesund case.
Dr. Cramer refers to Table 3 from the Wu paper in which the authors purport to show that the risk ratio for ovarian cancer increases if women had a history of endometriosis and talc use.
Cramer sets up the importance of the Wu study – i.e., specifically the importance of endometriosis in talc’s ability to cause ovarian cancer - with the following testimony: “There are two important interactions here: one, the interaction of the talc use and the BMI, and the second, the possible interaction between the talc use and the endometriosis.”
THE WU STUDY SUFFERS FROM MAJOR INCONSISTENCIES
The importance of this finding to the Ristesund case is that the plaintiff, Ms. Ristesund, had endometriosis. The clear implication by Dr. Cramer is that plaintiff’s endometriosis – an inflammatory condition – enhanced her susceptibility to ovarian cancer in the presence of talc. In fact, the title of the article is “Markers of inflammation and risk of ovarian cancer in Los Angeles County.” (emphasis added)
To test the core hypothesis of the paper, it would be critical to know what effect anti-inflammatory drugs had on the risk of ovarian cancer. According to Cramer’s theory, cosmetic talcum powder use is an event that increases the risk of ovarian cancer, and is associated with chronic inflammation. Based on this premise, anti-inflammatory drugs such as NSAIDs would be expected to decreasethe risk for ovarian cancer.
But in the Wu study that Cramer relies on, NSAIDs actually increased the risk for ovarian cancer. As the authors state:
“However, contrary to the study hypothesis that NSAIDs may have chemopreventive effects by decreasing inflammation,6 we found that risk of ovarian cancer increased significantly with increasing frequency and duration of NSAIDs use.” (emphasis added)
Dr. Cramer was never asked about the findings related to NSAIDs or how these findings differed dramatically from the very hypothesis offered up in the paper. Or how the findings differed from other well established findings in the literature, and actually contradict Cramer’s own chronic inflammation hypothesis.
This case highlights the need to develop an intimate familiarity with all of the scientific literature related to your adversary’s case and to be prepared to counter these arguments by pointing out fatal inconsistencies in the findings.
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1. Case Control Study: A study that compares patients who have a disease or outcome of interest (cases) with patients who do not have the disease or outcome (controls), and looks back retrospectively to compare how frequently the exposure to a risk factor is present in each group to determine the relationship between the risk factor and the disease.
Cohort Study: A study design where one or more samples (called cohorts) are followed prospectively and subsequent status evaluations with respect to a disease or outcome are conducted to determine which initial participants exposure characteristics (risk factors) are associated with it. As the study is conducted, outcome from participants in each cohort is measured and relationships with specific characteristics determined.
https://himmelfarb.gwu.edu/tutorials/studydesign101/cohorts.html