Expert Evidence and Daubert Challenges in Talcum Powder Litigation

Berg v. Johnson & Johnson Consumer Cos. was one of the first lawsuits in which products containing talcum powder were ruled to be a “contributing factor” in a Plaintiff’s ovarian cancer, with an additional ruling that held that talc-based products are defective if their labels do not properly warn consumers of the risk. This case set the stage for a number of different actions against Johnson & Johnson, including class actions in California and Illinois, a potential MDL, and a scramble for litigators hoping to learn more about the relationship between talcum powder use and ovarian cancer.

Like any complex litigation, future suits involving the dangers of talcum powder will hinge on the expert evidence brought by both sides. In Berg, a number of experts in various specialties were tapped to provide expert evidence, many of which underwent Daubert challenges. By diving deep into how expert evidence was used in Berg, as well as the Daubert challenges that emerged, attorneys can come one step closer to understanding how experts might be deployed most effectively in future talcum powder litigation. Below, we’ve analyzed 4 areas of expertise deployed in Berg, along with their corresponding Daubert challenges.

1. Case Background
2. The Experts
3. Ob/Gyn Daubert Challenge
4. Toxicology Daubert Challenge
5. Pathology Daubert Challenge
6. Human Factors Daubert Challenge

Case Background

Plaintiff Deanne Berg was diagnosed with ovarian cancer in December of 2006. She was 49 years old at the time. Prior to her diagnosis, Berg used Johnson & Johnson products (Johnson’s Baby Powder and Shower to Shower) for feminine hygiene purposes. She applied the products on a daily basis from 1975 until 2007.

Talc is one of the main ingredients in Johnson’s Baby Powder and Shower to Shower. Talc is a naturally occurring mineral that is mined from the ground and used in various applications.

Berg alleged that her application of talc caused her ovarian cancer and thereafter brought a product liability action against defendants because their products did not include any warnings regarding the possible hazards of applying talc to a woman’s perineum.

The Experts:

Dr. Daniel Cramer – Obstetrics and Gynecology

Dr. Cramer is the Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School and is a practicing obstetrician and gynecologist. He also has a doctorate degree in epidemiology from the Harvard School of Public Health.

Dr. Cramer’s expert report relied on epidemiology to address two issues: (1) the association between use of cosmetic talc powders in the genital area and ovarian cancer with regard to the likelihood that this is cause-and-effect and (2) the possible relevance of talc use to the occurrence of ovarian cancer in the specific case of Ms. Berg. The report concluded that (1) there was a causal association between the use of talc and ovarian cancer, and (2) chronic talc use was the major cause of Berg’s ovarian cancer.

Dr. Gary Rosenthal – Toxicology

Dr. Rosenthal received his Ph.D. in environmental medicine from New York University. He has been certified as a toxicologist by the American Board of Toxicology since 1990. His research includes the study of the toxicity of various agents on the immune system, including mineral dusts. He has also studied causative and preventative measures of inflammation and cancer.

Dr. John Godleski – Pathology

Dr. Godleski is the head of Pulmonary Pathology at Brigham and Women’s Hospital, a major teaching hospital of Harvard Medical School. He also leads a research group at the Harvard School of Public Health. He earned his medical degree from the University of Pittsburgh School of Medicine where he did research using electron microscopy. Godleski has published more than 140 papers related to pulmonary pathology including a number using analytical electron microscopy. He is a recognized expert whose opinion is sought by pathologists from other hospitals in the diagnosis of foreign material in tissues throughout the body using scanning electron microscopy and energy dispersive X-ray analyses.

Dr. Godleski reviewed histopathological slides taken from Berg following her diagnosis of ovarian cancer using advanced microscopic methodologies. In his review of twenty-six slides, Dr. Godleski found three particles of talc. He asserted that his findings indicated that talc was present in Berg’s ovary tumor. Dr. Godleski also opined that the talc found in Berg’s tissues was evidence for a causal link between the presence of talc and the development of Berg’s ovarian cancer.

Dr. David R. Lenorovitz and Dr. Edward E. Karnes – Human Factors

Dr. Lenorovitz has 44 years of professional experience as a human factors engineer, ergonomist, and cognitive psychologist. He received his Ph.D. in human factors engineering from the State University of New York and is certified as a professional ergonomist by the Board of Certification in Professional Ergonomics. He had spent the last six years as a forensic human factors consultant with a special emphasis on warnings systems design, development, and warnings adequacy evaluation.

Dr. Karnes has 50 years of professional experience as a human factors professional. He received his Ph.D. in experimental psychology from Temple University and is board-certified. He has served as a human factors consultant for plaintiffs and defendants in several different legal cases. The majority of his research has concerned the development of warnings and user understanding of safety issues associated with the use of consumer and industrial products.

Dr. Lenorovitz and Dr. Karnes provided expert testimony addressing certain forensic human factors and warnings issues involving talc powder.

The Daubert Challenges

Expert 1: Dr. Daniel Cramer

Defendant Johnson & Johnson’s argument in support of its motion to exclude Dr. Cramer’s testimony went to the issue of whether his testimony was reliable. Defendants attacked Dr. Cramer’s testimony regarding both specific causation and general causation, arguing that the testimony put forth to support each was not reliable.

Defendants made two arguments in support of their motion to exclude Dr. Cramer’s testimony. First, they argued that Dr. Cramer’s report was unreliable because it failed to rule out alternative causes of Berg’s cancer. Second, they argued that Dr. Cramer’s report was inadmissible because the odds ratios established in the report and Dr. Cramer’s interpretations of those odds ratios stemmed from unreliable methods.

Alternative Causes

Defendants argued that Dr. Cramer’s methodology was not reliable because he failed to rule out alternative causes of Berg’s cancer. Defendants relied on three Eighth Circuit Court of Appeals opinions to support their argument that Dr. Cramer was required to rule out alternative causes of Berg’s cancer: Barrett, 606 F.3d 975; Bland v. Verizon Wireless, (VAW) L.L.C., 538 F.3d 893 (8th Cir. 2008); Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748 (8th Cir. 2006); and Turner v. Iowa Fire Equip. Co., 229 F.3d 1202 (8th Cir. 2000).

After a review of these cases, the court found that the appropriate legal proposition created from these opinions was that an expert witness who performs a differential diagnosis must consider all other possible causes and exclude each potential cause until only one remains, or consider which of two or more non-excluded potential causes was the more likely to have caused the condition. In this case, however, Dr. Cramer did not claim to have performed a differential diagnosis. Rather, his testimony was based on epidemiology. Moreover, Dr. Cramer’s report indicated that he did in fact consider other possible causes of Berg’s cancer. Therefore, the Court determined that Dr. Cramer’s opinion was not to be excluded on the basis that he failed to rule out all alternative causes.

Dr. Cramer’s Methodology

Defendants’ second argument went to the general methodology applied by Dr. Cramer. In his expert report, Dr. Cramer noted that, in general, there is an odds ratio of 1.33 between perineal talc use and ovarian cancer. Dr. Cramer further asserted that a woman with Berg’s characteristics has an odds ratio of 3.53. Defendants argued that the 3.53 odds ratio established in Dr. Cramer’s report came from unreliable methods. The court began its analysis by addressing defendant’s specific concerns with Dr. Cramer’s findings and then moved to a more general examination of the methodology employed by Dr. Cramer.

Defendants first claimed that Dr. Cramer’s testimony was unreliable because it conflicted with existing scientific literature that showed the appropriate odds ratio was more in line with the 1.33 figure that Dr. Cramer generated. But the Court believed that there was no requirement that published epidemiological studies supporting an expert’s opinion exist in order for the opinion to be admissible. The Court stated that Dr. Cramer’s testimony was to be admitted so long as his methodology was reliable even if his conclusions were novel, and that the district court could not exclude scientific testimony simply because the conclusion was ‘novel’ if the methodology and the application of the methodology were reliable.

Second, defendants argued that the testimony was unreliable because Dr. Cramer “cherry-picked” data in order to form an opinion solely for purposes of litigation, rather than basing his opinion on research conducted independent of the litigation. In showing that Dr. Cramer’s testimony was reliable, the Court noted his extensive past research on the topic at hand, and found that while it was true that his specific findings relevant to this case were generated during the course of litigation, the methods he employed in reaching his conclusions were very similar to the methods used in his previous research. The data he used to generate the odds ratios came mostly from his past research.

The Court concluded that Dr. Cramer’s expert testimony was reliable and admissible, while noting that the Defendants could still attack his testimony on cross-examination at trial.

Expert 2: Dr. Gary Rosenthal

Johnson & Johnson argued that Dr. Rosenthal was not qualified to offer his expert opinion and that his opinion was unreliable.

Dr. Rosenthal’s Qualifications

Dr. Rosenthal received his Ph.D. in environmental medicine from New York University. He had been certified as a toxicologist by the American Board of Toxicology since 1990. His research included the study of the toxicity of various agents on the immune system, including mineral dusts. He had also studied causative and preventative measures of inflammation and cancer.

Defendants argued that because Dr. Rosenthal had no experience specifically with talc or ovarian cancer, he was not qualified to testify in this case. However, the Court stated that such a narrow view of an expert’s qualifications is not required under Rule 702.

Rule 702 only requires that an expert possess knowledge, skill, experience, training, or education sufficient to ‘assist’ the trier of fact, which is satisfied where expert testimony advances the trier of fact’s understanding to any degree. Dr. Rosenthal had experience studying the toxicity of mineral dust on the immune system. His expert testimony addressed whether talc could be considered an immunotoxic agent. Further, Dr. Rosenthal had experience studying the causative and preventative measures of inflammation and cancer. His expert testimony also addressed the biological plausibility of talc as an agent capable of causing ovarian cancer. Thus, the court found that Dr. Rosenthal’s qualifications were sufficient to assist the trier of fact in deciding the issues in this case.

Reliability

Dr. Rosenthal’s expert report offered the following conclusions: (1) talc has immunotoxic potential; (2) it is biologically plausible that talc-mediated neoplastic events can be evoked through various mechanisms; (3) talc can translocate from the vagina, cervix, or fallopian tube to the ovary; (4) it is biologically plausible that Berg’s daily talc use for over 30 years led to chronic inflammation in target tissues; (5) neoplastic events related to chronic inflammation and/or immune modulation would likely have been elicited in Berg; and (6) the foregoing would have played a role in disease processes leading to Berg’s ovarian cancer.

Defendants argued that Dr. Rosenthal’s biologically plausible opinions were merely speculative, untested, and unreliable. An examination of Dr. Rosenthal’s methods by the court was required to determine whether defendants’ arguments had merit.

After reviewing Dr. Rosenthal’s methods, the Court determined that, in short, Dr. Rosenthal’s report essentially provided that talc particles that are applied in the perineal area can move to the ovaries where they can be problematic for immune cells by causing chronic inflammation and/or immunity suppression. Chronic inflammation and immunity suppression have been shown to play roles in disease processes that lead to cancer. Based on Berg’s thirty-plus years of perineal exposure to talc, Dr. Rosenthal found it likely that she would have experienced such chronic inflammation and/or immunity suppression in her ovaries, thus leading to her ovarian cancer. Dr. Rosenthal relied on several published scientific articles as well as his own experience in immunotoxicology to form his conclusions. Therefore, this was enough for the Court to determine that his testimony was admissible.

Defendants also attacked Dr. Rosenthal’s opinion from eleven other perspectives. These attacks mostly centered around the reliability of both the underlying facts and references that Dr. Rosenthal relied on in forming his opinions. The court found that the majority of Defendant’s challenges to Dr. Rosenthal’s expert testimony were unpersuasive. In making his ultimate conclusions, Dr. Rosenthal relied on his own expertise in the field of toxicology, his past research, and several other published scientific studies. The Court noted that any gaps or limitations in Dr. Rosenthal’s reasoning could be presented to the jury or addressed during cross-examination.

Conclusion The Court found that Dr. Cramer’s expert opinion was admissible because it was the product of reliable methodologies, and he was not required, as an epidemiologist, to rule out all alternative causes of Berg’s ovarian cancer. The majority of Dr. Rosenthal’s opinions were admissible because he was qualified to render such opinions, and he used reliable methodologies in forming his opinions.

Expert 3: Dr. John Godleski

Johnson & Johnson argued that Dr. Godleski was unqualified, and that his opinions were irrelevant and unreliable:

Dr. Godleski’s Qualifications

Defendants argued that Dr. Godleski had done limited research on the relationship between talc and ovarian cancer, that his knowledge of the causes of ovarian cancer was limited, and that he was not an epidemiologist. However, they did not dispute that Dr. Godleski was an expert at identifying foreign particles in human tissue. Because Dr. Godleski’s testimony was limited to identifying foreign particles in human tissue, the court found that he was qualified to offer his expert opinion without the need to evaluate his credentials any further.

Relevancy of Dr. Godleski’s Testimony

Defendants argued that Dr. Godleski’s opinions were irrelevant because he did not tie the talc particles found in Berg’s tissues to defendants’ products. Berg claimed that talc from defendant’s products caused her ovarian cancer. The Court stated that testimony that establishes that talc particles were found in Berg’s ovary tumor are certainly relevant to this case, since it goes directly to her claim.

Reliability of Dr. Godleski’s Testimony

The Court believed that defendants’ reliability arguments were based on a mischaracterization of Dr. Godleski’s expert opinion. Defendant’s arguments suggested that Dr. Godleski was opining that the talc particles he found caused Berg’s ovarian cancer. However, the Court found that Dr. Godleski’s opinion stopped short of such a conclusion. His report noted that “the talc found in this case is evidence for a causal link between the presence of talc and the development of Berg’s ovarian cancer.” His opinion merely stated that the talc found in Berg’s tissues was evidence in this case.

Defendants argued that Dr. Godleski was also required to rule out alternative causes. However, because Dr. Godleski was not opining that talc was the cause of Berg’s ovarian cancer through a differential diagnosis, the Court believed that he need not rule out other potential causes of her cancer. The fact that he found particles other than talc was to go to the weight of his testimony, and ultimately determined by the jury.

Experts 4 and 5: Dr. David R. Lenorovitz and Dr. Edward E. Karnes

Johnson & Johnson argued that the expert report went far beyond the boundaries applicable to human factors experts. In addition, Johnson & Johnson argued that any proposed testimony that was related to human factors was unreliable.

Dr. Lenorovitz’s and Dr. Edward’s Qualifications

The court began its evaluation by addressing the experts’ qualifications. As noted above, Dr. Lenorovitz had 44 years of professional experience as a human factors engineer, ergonomist, and cognitive psychologist. He received his Ph.D. in human factors engineering from the State University of New York and is certified as a professional ergonomist by the Board of Certification in Professional Ergonomics. Additionally, he had spent the six years preceding the case as a forensic human factors consultant with a special emphasis on warnings systems design, development, and warnings adequacy evaluation.

Dr. Karnes had 50 years of professional experience as a human factors professional. He received his Ph.D. in experimental psychology from Temple University and was board-certified. He had served as a human factors consultant for plaintiffs and defendants in several different legal cases. The majority of his research had concerned the development of warnings and user understanding of safety issues associated with the use of consumer and industrial products.

Moreover, the Court found both experts to be qualified to render an expert opinion within their field.

Defendants first took issue with attempts by the experts to offer testimony regarding defendant’s intent as well as testimony regarding defendant’s purported lobbying efforts. Both Dr. Karnes and Dr. Lenorovitz admitted that the basis for their opinions about defendant’s intent and lobbying efforts came from reading the documents that were provided. The Court found that such non-expert testimony should be excluded and left to the jury according to Rule 702. Thus, Dr. Karnes and Dr. Lenorovitz were precluded from offering an expert opinion about defendant’s intent or lobbying efforts.

Next, defendants sought to preclude Drs. Karnes and Lenorovitz from testifying about any legal conclusions, such as what duties the defendants owed to Berg. Under South Dakota law, whether a duty exists is a question of law, and therefore does not pass Rule 702’s requirement of assisting the trier of fact. Thus, Dr. Karnes and Dr. Lenorovitz were precluded from testifying about any duties or responsibilities that defendants allegedly owed to Berg.

Defendants also moved the court to preclude any testimony that Dr. Karnes and Dr. Lenorovitz may have offered outside their expertise, such as the medical risks of ovarian cancer, whether talc is hazardous, and whether there is a feasible alternative product. The Court noted that Rule 702 allows an expert to base an opinion on facts or data in the case that the expert was aware of or personally observed. Thus, it was allowed that Dr. Karnes and Dr. Lenorovitz could form their opinions based on the testimony of other experts in this case. But the court pointed out that Dr. Karnes and Dr. Lenorovitz could not make unsupported statements that were outside of their field of expertise.

Furthermore, the court noted that while an expert may rely on data or research outside of his or her expertise, he or she cannot go into detail on such matters. These matters outside of their expertise included whether talc posed a hazard to the populace, and whether there was a financially and technically reasonable alternative to talc. As to whether the hazard was open and obvious to a reasonable user was a question the court determined would be better left to a jury. Therefore, the Court limited the scope of the experts’ testimony to just the part about whether there was a feasible way to place a warning on the talc product.

The Court found that Dr. Godleski’s opinion was admissible because he was qualified, and the opinion was relevant and stemmed from reliable methodologies. The Court also found that Dr. Lenorovitz and Dr. Karnes, as human factors experts, were only allowed to testify on the limited issue of whether there was a feasible way to place a warning on defendants’ products.