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Johnson & Johnson Talcum Powder Cases

California Court of Appeals, Second District, Third Division

July 9, 2019

JOHNSON & JOHNSON TALCUM POWDER CASES. ELISHA ECHEVERRIA, as Trustee, etc., Plaintiff and Appellant,
v.
JOHNSON & JOHNSON et al., Defendants and Appellants.

          APPEALS from a judgment of the Superior Court of Los Angeles County No. BC628228, JCCP No. 4872 Maren E. Nelson, Judge.

          Robinson Calcagnie, Mark P. Robinson, Kevin F. Calcagnie; Ferguson Case Orr Paterson, Wendy C. Lascher; Esner, Chang & Boyer, Stuart B. Esner and Holly N. Boyer for Plaintiff and Appellant.

          Proskauer Rose, Bart H. Williams, Manuel F. Cachán; Munger, Tolles & Olson, Mark R. Yohalem, Michael. R. Doyen; Tucker Ellis, Michael C. Zellers; Sidley Austin and David R. Carpenter for Defendants and Appellants.

          Cole Pedroza, Curtis A. Cole, Cassidy C. Davenport and Scott M. Klausner for California Medical Association, California Dental Association, and California Hospital Association as Amici Curiae on behalf of Defendants and Appellants.

          ADAMS, J. [*]

         INTRODUCTION

         This case is one of several coordinated suits in which the plaintiffs allege talcum powder products manufactured by Johnson & Johnson and Johnson & Johnson Consumer Inc. (JJCI; collectively, defendants) caused them to develop ovarian cancer. In July and August 2017, bellwether plaintiff Eva Echeverria's case was tried to a jury on a single claim of negligent failure to warn. The jury returned a verdict in Echeverria's favor against both defendants, awarding compensatory damages of $68 million against Johnson & Johnson and $2 million against JJCI. The jury awarded punitive damages of $340 million against Johnson & Johnson and $7 million against JJCI.[1] Defendants filed motions for judgment notwithstanding the verdict (JNOV) as to liability and punitive damages, as well as a joint motion for a new trial. The trial court granted the motions. Both sides have appealed.

         We affirm the JNOV in favor of Johnson & Johnson, but partially reverse as to JJCI. To establish her negligence claim, Echeverria was required to prove each defendant had a legal duty to warn consumers about hazards inherent in their talc-based products; they breached that duty; and the breach caused Echeverria's injury. The causation element required evidence that talc-based products not only cause ovarian cancer in general (general causation), but also that defendants' products caused Echeverria's ovarian cancer in particular (specific causation). We conclude there was no substantial evidence to support a finding of liability as to Johnson & Johnson, a parent company that stopped manufacturing Johnson's Baby Powder in 1967, several years before there were any investigations or studies about a link between genital talc use and ovarian cancer. The evidence also failed to support a finding of malice as required for a punitive damages award, and we affirm the JNOV in favor of JJCI on that ground. We conclude there was substantial evidence to support the jury's other findings as to JJCI. However, we must apply a different standard of review when evaluating the trial court order granting JJCI's motion for a new trial. We determine the causation evidence was in significant conflict and would have supported a defense verdict. We therefore reverse the JNOV in favor of JJCI as to liability, but affirm the trial court order granting JCCI's motion for a new trial.

         FACTUAL AND PROCEDURAL BACKGROUND

         General Background

         Plaintiff Eva Echeverria began using Johnson's Baby Powder as a feminine hygiene product in 1965, when she was 11 years old. She continued using the product two to three times each day, applying it to her genital area, underwear, and sanitary napkins, until 2016. She also briefly used the product “Shower to Shower.” In 2007, Echeverria was diagnosed with invasive, serous, high-grade ovarian cancer.

         Johnson & Johnson manufactured Johnson's Baby Powder from 1893 until 1967. In 1967, JJCI began manufacturing the product. JJCI is a wholly owned subsidiary of Johnson & Johnson.

         Investigations of a Link Between Talc and Ovarian Cancer in the Scientific, Medical, and Regulatory Communities

         According to Echeverria's evidence at trial, the first epidemiological study to investigate a link between talc and ovarian cancer was published in 1982. In the decades that followed, researchers published over 30 additional epidemiological studies exploring whether there is an association between talc use and ovarian cancer. The parties' experts offered competing trial testimony about the validity, significance, and proper interpretation of these studies.[2]

         Other scientific studies have hypothesized that talc causes ovarian cancer by creating inflammation in the ovaries. Studies have concluded talc can migrate from the vagina into the peritoneal cavity, where the ovaries are located. Experts for both sides testified talc causes inflammation. Studies have found chronic inflammation plays a role in the development of some types of cancer. Studies referenced at trial have also indicated increased inflammation may be linked to ovarian cancer. However, no published studies, regulatory agencies, or scientific organizations have concluded talc-based inflammation causes ovarian cancer.

         The World Health Organization International Agency for Research on Cancer (IARC) evaluates the carcinogenicity of different agents. In 2006, the IARC evaluated talc. The agency characterized perineal use of talc as possibly carcinogenic to humans, giving it a “2B” rating. This rating reflected a determination that there was “limited evidence” of carcinogenicity in humans and in experimental animals. The limited evidence determination meant: “A possible association has been observed between exposure to talc and ovarian cancer for which a causal interpretation is considered by the working group to be credible, but chance, bias, and confounding could not be ruled out with reasonable confidence.”

         Some medical and scientific organizations have publicly identified genital talc use to be a risk factor for ovarian cancer, while others have not. In 2014 and 2015, the National Cancer Institute identified perineal talc use as a risk factor for ovarian cancer; in 2017, it indicated the weight of the evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.

         Defendants' Response to Ongoing Questions Regarding a Link Between Talc and Ovarian Cancer

         The evidence at trial included a series of documents from defendants' files regarding talc and Johnson's Baby Powder. Several of the documents lacked identified authors or other information to distinguish whether they were generated by Johnson & Johnson or JJCI. Other documents reflected communications between or among employees of both companies.

         In 1964, W.H. Ashton, a Johnson & Johnson scientist, penned a memo to the file regarding plans for a test of a baby powder product composed of cornstarch, rather than talc. The goal was to “determine a preference rating” of Johnson's Baby Powder compared to another product. The memo suggested “Dry Flo, ” “a low substituted A1 salt of mildly treated cornstarch, ” could be used as a potential additive. Although other potential additives were identified, Ashton wrote Dry Flo “has a very appealing tone because it would open the door to a merchandising advantage which could refer to an all starch product....” The memo reported: “Since the meeting, Ashton established the largest commercial uses of Dry Flo are in Vitamin A manufacture... and as a condom lubricant where it replaced talc because it was found to be absorbed safely in the vagina whereas, of course, talc was not.”

         A 1975 letter on “Johnson & Johnson” letterhead bore the subject line “Talc in the Ovaries.” A handwritten note on the document suggested a Johnson & Johnson scientist's contact with a cancer research institute may have provided “the opening to put us on notice re: the talc/ovary problem.”

         Documents from 1986 and 1992 acknowledged genital talc use had been “implicated” or “linked” to ovarian cancer. The 1986 document expressed a continuing belief that talcum powder products were safe. It referenced a Cosmetics, Toiletries, and Fragrance Association (CTFA) sponsored animal study concluding talc does not migrate, and also cited the company's “extensive experience in use.” Still, the documents recognized that cancer concerns, risks from inhalation, and a move among health professionals to discourage use of talc-based powders on babies, all posed a potential obstacle to sales.

         Documents from 1993 to 1995 reflected defendants' awareness of epidemiological studies about talc use and ovarian cancer, their creation of a “Worldwide Talc Steering Committee, ” their monitoring of scientific studies and regulatory action on talc, and their strategies to respond to adverse press or media inquiries about talc safety issues. For example, a 1994 document prepared by a JJCI employee proposed answers to questions about a causal link between talc and cancer, and about two specific epidemiological studies. The proposed answers stated one study did not show a causal relationship between talc and ovarian cancer, while the other study found a higher incidence of ovarian cancer in women who routinely used talc, yet ultimately concluded talc was unlikely to be the cause of the majority of epithelial ovarian cancers. In response to the question of whether cosmetic talc use could lead to ovarian cancer, the document offered the answer: “Studies in animals have shown that talc does not migrate from the vagina to the ovaries. In conventional animal dosing studies, there is no evidence of ovarian cancer. Based on the available scientific data, no cause and effect relationship has been established showing that the use of talc can cause ovarian cancer.”

         A 1995 memo on “Johnson & Johnson Consumer Products Worldwide” letterhead, authored by “John Hopkins of Johnson & Johnson, ” addressed methods for responding to “adverse press and media issues around talc.” The memo laid out three potential strategies, ranging from “do nothing, ” to a more “pro-active” strategy. Hopkins reported they had been taking the first approach: “We do not cause waves and we give no further publicity to adverse comments.” Hopkins recommended a middle approach that would entail “responding to articles in the press, possibly including medical journals where we believe we can influence future behaviors and comment.” A note from a vice president of research and development suggested “it might be worthwhile to have some effort” in the “proactive” strategy as well.

         In 1997, an outside consultant wrote to a JJCI employee, offering criticisms of CTFA responses to claims of a link between talc and ovarian cancer. The consultant noted “several investigators have independently reported talc particles in ovarian tissue” and it was inaccurate to state that studies had failed to demonstrate “any real association” between hygienic talc and ovarian cancer. The letter pointed out that at least nine studies published in the open literature had shown a statistically significant association between the two. The consultant cautioned that denying the association “risks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence to the contrary. This would be a particularly tragic misperception in view of the fact that the industry does have powerful, valid arguments to support its position.” He suggested the better arguments were that the study results were “ambiguous, inconsistent, contradictory and therefore inconclusive....” He concluded the letter: “I realize that CTFA is not J&J. However, I believe that a defeat or embarrassment of CTFA also negatively affects J&J to some extent.”

         In 2002, a director of product safety at Luzenac, defendants' talc supplier in the United States, sent a document to Ashton reporting: “We've been successful thus far in fending off the [National Toxicology Program (NTP)] classification of talc as being a potential human carcinogen. But we must also keep an eye out for IARC. If they decide to re-review the status of talc because of all the ovarian epidemiology studies that have been published since 1986, IARC can surprise us all and decide to list ‘talc' as a potential human carcinogen.... Their threshold for required medical evidence is predictably quite minimal. You might want to counsel your management on this potential (and not to be too complacent about the status of talc).”

         In 2004, the same Luzenac employee forwarded Ashton a study published earlier that year. He indicated the study “offers some compelling evidence in support of the ‘migration' hypothesis. Combine this ‘evidence' with the theory that talc deposition on the ovarian epithelium initiates epithelium inflammation-which leads to epithelium carcinogenesis-and you have a potential formula for NTP classifying talc as a causative agent in ovarian cancer.” In 2006, Luzenac began including the IARC 2B classification in its talc material data safety sheets (MSDS).

         Internal documents and e-mails from 2005 and 2006 reflected discussions among several individuals, including JJCI employees in the United States and Johnson & Johnson “regulatory” and “research” employees in Europe, about NTP and IARC evaluations of talc as a potential carcinogen. The e-mails referenced a project to “defend talc” and efforts to prevent a classification of talc as a carcinogen. They revealed the correspondents' desire for certain “helpful” scientists to participate in the evaluations. The e-mails also discussed efforts to promote or develop studies or documents “that scientifically support the lack of a relationship of talc and ovarian cancer.”

         In 2016, the Food and Drug Administration (FDA) issued a request to JJCI for information on talc. The JJCI response noted that in 2014, the FDA reviewed the safety of talc and denied citizen petitions filed in 1994 and 2008. The “ ‘FDA did not find that the data submitted presented conclusive evidence of a causal association between talc use in the perineal area and ovarian cancer.' ” According to the response, the FDA also reviewed “the toxicity literature from 1980 to 2008 and did not find enough additional support at that time for the types of warning labels proposed” in the citizen petitions.

         The JJCI response summarized the company's position: “At Johnson & Johnson Consumer Inc., our confidence in using talc is based on more than 100 years of safe use and more than 30 years of research by independent researchers, scientific review boards and global regulatory authorities. Various agencies and governmental bodies have examined whether talc is a carcinogen, and none have concluded that it is. The scientific literature, post-market experience, and expert opinion do not support the association of talc and ovarian cancer.”

         The Expert Testimony at Trial

         Echeverria offered the testimony of four experts: pharmacologist and toxicologist Dr. Laura Plunkett; epidemiologist Dr. Jack Siemiatycki; pathologist Dr. John Godleski; and Echeverria's treating gynecologic oncologist, Dr. Annie Yessaian.

         There was extensive pretrial litigation on the admissibility of plaintiff's proposed expert testimony, including a hearing pursuant to Sargon Enterprises, Inc. v. University of Southern California (2012) 55 Cal.4th 747. The trial court ruled only Dr. Yessaian would be allowed to testify as to “specific causation, ” i.e., offering an opinion that talc caused Echeverria's ovarian cancer. The other experts whose testimony was not completely excluded were allowed to testify only about general causation, i.e., offering an opinion that talc in general may cause ovarian cancer. Dr. Godleski was also allowed to provide opinions based on his personal examination of Echeverria's tissues.

         Defendants offered the testimony of Dr. Alan Andersen, a biophysicist and former high-level employee at the FDA and the Cosmetic Ingredient Review (CIR); Dr. Douglas Weed, an epidemiologist and medical doctor; Dr. Juan Felix, a gynecologic pathologist; and Dr. Cheryl Saenz, a gynecologic oncologist.

         General Causation: Plaintiff's Expert Testimony

         Dr. Laura Plunkett

         Dr. Plunkett is a former assistant professor of pharmacology and toxicology at the University of Arkansas. She is currently a consultant in the areas of toxicology, pharmacology, and human health risk assessment. Dr. Plunkett opined talc is toxic, it can migrate from the vagina to the ovaries, it can cause inflammation in human tissues, and chronic inflammation can cause ovarian cancer. Plunkett's opinion that talc is toxic was based on animal studies and human and animal cell studies. Plunkett testified she cited hundreds of studies in her expert report, a few of which she highlighted in her testimony.

         For example, Plunkett described a 1984 study in which the injection of a talc solution near rat ovaries caused precancerous lesions in the rat's tissues. Plunkett also relied on a 1993 NTP study showing rats exposed to airborne talc for two years-a lifetime-developed precancerous lesions and, in some cases, tumors. She noted “dozens” of earlier studies established “talc can cause inflammation at the site.”

         Plunkett also discussed two human cell studies. According to Plunkett, a 2007 study found talc produced neoplastic transformation in human ovarian cells.[3] A 2009 study showed talc had effects in human cells, “as far as the type of genes it turns on and off, ” that are similar to the effects observed with compounds known to cause cancer. Plunkett testified these studies supported her opinion that talc initiates an inflammatory response that leads to cancer. Her opinion that talc can migrate from the vagina to the upper genital tract and to the ovaries was based on five studies dating from the early 1960's to the early 2000's, each of which she described for the jury.

         Defendants tested and challenged Plunkett's interpretation of these scientific studies on cross-examination. She acknowledged weaknesses and limitations in the studies, but still felt they provided useful information. She also admitted there were several studies that came to different conclusions about the role of chronic inflammation in the development of ovarian cancer and the effect of talc on the female genital system.

         Plunkett additionally based her opinion on her review of the epidemiological literature, including six meta-analyses showing a statistically significant increased risk between exposure to talc in the genital area and ovarian cancer. Plunkett explained that no single study could conclude talc causes cancer. Instead, she described each study as a piece of the causation puzzle.

         Having reviewed the scientific data, Plunkett opined that regular genital use of talc sets up a chronic inflammatory condition in the cells that causes them to change to precancerous cells. The precancerous cells eventually lead to tumor growth, metastasizing tumors, and “full-blown advanced stage ovarian cancer.” Plunkett also evaluated the Bradford Hill criteria, a framework for considering whether a substance causes a disease.[4] She opined she had enough information relevant to the criteria to state, to a reasonable degree of scientific and professional certainty, that genital exposure to talc causes ovarian cancer.

         Dr. Jack Siemiatycki

         Dr. Siemiatycki is an epidemiologist and professor at the University of Montreal and McGill University. He has over 200 peer-reviewed publications and numerous honors and awards for his work in epidemiology and biostatistics.

         Siemiatycki explained several epidemiological concepts to the jury. He informed the jury that “relative risk” is the risk of developing a disease among people exposed to a particular chemical agent or toxin, divided by the risk of developing the disease among those not exposed to the same agent. He offered an example: “So if the risk of cancer in the general population... is 4 percent in the general population but among a group of people with a certain environmental exposure it is 6 percent, the relative risk of cancer due to that environmental exposure would be 6 percent divided by 4 percent equals 1.5.”

         Siemiatycki then elaborated: “[W]hen the risk is exactly the same among the exposed and the unexposed, then the relative risk will be 1.... The risk among the exposed is the same.... And that means the agent, whatever the exposure is, has no effect on the risk of developing the disease If the relative risk is greater than 1, it means exposure to that agent increases the risk of developing the disease. If the relative risk is less than 1, so the risk among the exposed is less than the risk among the unexposed, it means that exposure to the agent prevents the disease.”

         Siemiatycki explained the related concepts of “confidence intervals” and “statistical significance.” Statistical significance concerns the question, “how solid is our belief that the relative risk that we observe in a study is really precise and accurate?” Statistical significance depends on a number of factors, including the size of the study. Siemiatycki provided the jury with an example in which a study estimated a relative risk of 1.2, with a 95 percent probability that the true estimate is between 1.1 and 1.3. “That's a pretty tight interval, and we call that a confidence interval. We call it a 95 percent confidence interval when we calculate it in such a way that it covers 95 percent of the underlying relative risks that are compatible with this estimate from this study.” If the results of a study have a confidence interval that includes relative risk numbers under 1-reflecting decreased risk-they are not statistically significant. In those cases, the results could be due to chance. However, Siemiatycki disagreed that a study with a nonstatistically significant result must be disregarded. Such studies still contain information that may be useful when combined with evidence from other studies.

         Siemiatycki chaired the 2006 IARC working group on talc. The group concluded the association between perineal talc use and ovarian cancer could have other possible explanations. The available evidence was not strong enough to exclude chance, bias, and confounding-the presence of another factor that may be causing the disease-as explanations for the association that had been observed between talc and ovarian cancer.

         Siemiatycki's current opinion is that it is more likely than not genital talc use can cause ovarian cancer. His change of opinion was based in part on a 2013 study which, he testified, showed a dose-response pattern-increased risk with increased exposure-that was missing in earlier studies. Siemiatycki opined the 2013 study, as well as studies published in 2015 and 2016, led him to conclude the statistical evidence associating genital talc use and ovarian cancer is now much stronger than it was 10 years earlier.

         Siemiatycki also conducted a meta-analysis using existing talc literature to develop an opinion for the litigation. His analysis of 28 or 29 studies led him to believe there is a “very, very strong statistical association between use of talc and ovarian cancer.” The analysis resulted in a relative risk of 1.28, with a confidence interval of 1.18 to 1.38, rendering the results highly statistically significant. In other words, Siemiatycki found a 28 percent greater risk of ovarian cancer among women who used talc compared to women who had not used talc.

         Siemiatycki evaluated the Hill factors and concluded they support an opinion that there is a causal relationship between genital talc use and ovarian cancer. He testified that for as many as half of the known carcinogens for which there is epidemiologic data, the data show relative risk estimates less than 2.0. Like Plunkett, Siemiatycki testified epidemiologists typically do not write articles stating “this causes that.” He explained “that sort of communication tends to come from authoritative agencies who have the capacity to integrate the viewpoints of multiple experts and, preferably, multiple experts from multiple disciplines.”

         General Causation: Defendants' Expert Testimony

         Dr. Alan Andersen

         Dr. Andersen is a former director of the CIR. He described the CIR as an independent review group, but also admitted an industry trade group is the CIR's sole funder. Andersen testified the group's mission is to review and assess the safety of ingredients in an “open, unbiased, and expert manner, ” and to publish the results in peer-reviewed scientific literature. In 2011, a CIR panel began a review of the safety of talc and concluded, in 2013, that talc is safe.

         The CIR panel determined available data “did not reliably demonstrate” talc could migrate from the perineal area into the ovaries. The panel concluded the epidemiological data did not consistently reveal statistically significant positive associations between talc use and ovarian cancer; there were uniformly small risk ratio estimates; and other plausible alternative explanations of the association had not been ruled out. The panel did not see a consistent dose-response pattern reflected in the available literature. The panel also concluded there was no plausible biological mechanism to explain how genital talc use could cause ovarian cancer. It found a “lack of credible defensible evidence of carcinogenicity from the results of epidemiological studies of occupational exposures and animal bioassays.” The panel determined the available cellular studies were “unremarkable, ” meaning there were no adverse cellular effects relating to talc.

         Dr. Douglas Weed

         Dr. Weed, medical doctor and epidemiologist, is a former chief of the office of preventive oncology at the National Cancer Institute, and currently a consultant. Based on his review of the scientific literature and the Hill criteria, Weed opined it has not been established that talc use causes ovarian cancer. In his evaluation of the epidemiological literature, he concluded the published cohort studies show no association between genital talc use and ovarian cancer. The case-control studies establish only a “weak” association reflected in a relative risk estimate of 1.3.[5] Weed opined the studies do not establish a dose-response pattern.

         Weed further testified that some studies call into question the proposed biological mechanism of migrating talc particles causing inflammation. For example, although one would expect that women who used genital talc but had tubal ligation or hysterectomies would experience a reduced risk of ovarian cancer, Weed testified studies reveal “a mix of results.” Similarly, studies show no uniformly reduced risk of ovarian cancer in women who use medications that reduce inflammation. Weed also indicated studies have not established genital talc use increases the risk of other kinds of cancer in the female genital tract.

         Pathology: Plaintiff's Expert Testimony

         Dr. John Godleski

         Dr. Godleski is a professor of pathology, recently retired from Harvard Medical School and the Harvard School of Public Health, where he continues to consult on research programs. He has close to 150 peer-reviewed publications, including a case report regarding the presence of talc particles in the lymph nodes of a woman diagnosed with ovarian cancer who had used genital talc for over 30 years.

         Godleski examined slides of Echeverria's gynecologic tissue, using electron microscopy and x-ray analysis to identify talc particles. He found 11 talc particles and fibers in the examined tissues-eight particles of talc in ovarian tissue, and three talc particles in pelvic peritoneum and omentum tissue. Godleski opined that finding 11 particles in a small sample indicated there was a “substantial burden of talc” in Echeverria's tissue. He was “convinced” the particles were present as the result of perineal talc use.

         Godleski admitted his expert reports submitted before trial did not mention that he observed inflammation in Echeverria's tissues. However, at trial Godleski testified he observed a talc particle, and other particles with characteristics of talc, near or “involved with” macrophages, which are cells that are signals of an inflammatory reaction. Godleski believed this suggested the occurrence of a chronic inflammatory process. The talc particle involved with a macrophage was from a slide of Echeverria's ovarian tissue. The other particles and cells were from a slide of Echeverria's pelvic peritoneum tissue. Godleski testified “to a reasonable degree of medical certainty that the presence of talc found in a woman's ovarian tissue can be contributory evidence for a causal link between the presence of talc and the development of a woman's ovarian cancer.”

         Pathology: ...


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