Case details

Makers of talc failed to warn of potential ovarian cancer: plaintiff

SUMMARY

$417000000

Amount

Verdict-Plaintiff

Result type

Not present

Ruling
KEYWORDS
emotional distress, mental, psychological
FACTS
In April 2007, plaintiff Eva Echeverria, 53, was diagnosed with ovarian cancer. She claimed that her cancer was caused by her decades-long application of talc-based body powder to her genital (perineal) area. Echeverria alleged that the powder she used was produced, marketed and sold by Johnson & Johnson. Echeverria and six other plaintiffs (Charmaine Lloyd, Osalase Adelabu, Doris Beaver, Melanie Berry, Anita Delguidice, and Maria Engelmann) sued Johnson & Johnson, Johnson & Johnson Consumer Cos. Inc., and talcum powder supplier Imerys Talc America Inc. Echeverria’s complaint was coordinated with hundreds of other cases that were pending in different counties that shared common questions of fact or law regarding direct and indirect exposure, and involved many of the same defendants. The cases were joined in one court, the Los Angeles County Superior Court, but many of those cases were put on hold while awaiting a decision regarding an appellate case involving indirect exposure. Lloyd, Adelabu, Beaver, Berry, Delguidice and Engelmann were ultimately dismissed from the case. In addition, Imerys’ counsel moved for summary judgment based upon the bulk supplier doctrine, which provides, among other things, that raw materials suppliers, like Imerys, are not liable to ultimate consumers when the goods or materials they supply are not inherently dangerous and are sold in bulk to a sophisticated buyer rather than the end consumer. The motion was granted. Thus, only Echeverria’s complaint proceeded to trial against Johnson & Johnson Consumer Cos. and its parent company, Johnson & Johnson. Echeverria claimed that she used Johnson & Johnson’s talc-based body powder products two times per day from 1964 until 2016. Echeverria’s counsel contended that Johnson & Johnson was aware that its talc was dangerous since the 1960s and that perineal use of talc-based body powder is capable of causing ovarian cancer. Thus, counsel argued that Johnson & Johnson was negligent in its failure to warn Echeverria and other customers of the risk of ovarian cancer. Plaintiff’s counsel contended that talc can travel upward (or “migrate”) from the exterior genital area, up the vagina, cervix, uterus, and fallopian tubes, to the ovaries, and elicit unspecified chronic inflammation that, over time, causes neoplastic changes that can ultimately result in ovarian cancer. Counsel also contended that in 1971, a peer-reviewed study reported finding talc fibers in ovarian cancer tissue and that a number of retrospective epidemiologic studies published since 1982 have reported risks that women who apply talc-based powder to their vaginal area have a 70 percent increased risk of developing ovarian cancer. Plaintiff’s counsel also cited language from a 2014 letter from the U.S. Food and Drug Administration, which was sent in response to a Citizen’s Petition seeking that the FDA require a warning against perineal talc use on cosmetic talc products, stating, “While there exists no direct proof of talc and ovarian carcinogenesis, the potential for particles to migrate from the perineum and vagina to the peritoneal cavity is indisputable.” The letter further stated, “The best evidence for an association or causal relationship between genital talc exposure and ovarian cancer comes from epidemiologic data, which show a statistically significant, but modest, increased risk of epithelial ovarian cancer, especially with serous histology, among women with a history of genital dusting with talcum powder. While the growing body of evidence to support a possible association between genital talc exposure and serous ovarian cancer is difficult to dismiss, the evidence is insufficient for FDA to require as definitive a warning as you are seeking.” Plaintiff’s counsel also cited a 2006 decision from the International Agency for Research on Cancer (IARC) classifying perineal use of talc as a 2B “possible carcinogen.” Thus, Echeverria’s counsel argued that talc is toxic, that the Canadian government classifies talc as ‘very toxic’ and that it has been known to be toxic since the 1960s. Counsel also argued that internal documents showed that Johnson & Johnson was aware of a causal relationship between talc and ovarian cancer as early as the 1960s, but chose not to warn consumers. Echeverria’s counsel further argued that a 1964 memo noted that Johnson & Johnson knew that cornstarch had replaced talc as a condom lubricant “because it was found to be absorbed safely in the vagina, whereas, of course, talc was not.” Counsel also noted that on a 1975 memo, reporting a donation to a cancer research institute made by a lower level Johnson & Johnson employee, a senior Johnson & Johnson scientist handwrote a note worrying the donation had given the cancer research institute the opening to “put us on notice re: the talc/ovary problem.” In 1997, Johnson & Johnson’s outside toxicology consultant sent Johnson & Johnson a letter stating that “several investigators have independently reported talc particles in ovarian tissue…The workshop concluded that, although some of these studies suggested a weak association might exist, when taken together, the results of the studies are insufficient to demonstrate any real association.” However, plaintiff’s counsel argued that the memo was inaccurate because, at that time, there had been nine studies published in open literature that showed a statistically significant association between hygienic talc use and ovarian cancer. Plaintiff’s counsel argued that Imerys put the IARC talc classification on its Material Safety Data Sheet, but that Johnson & Johnson did not put the IARC classification on its product labels. In addition, counsel introduced two baby powder products purchased at Dollar Tree and Walmart that contained warnings that use of talcum powder may increase the risk of ovarian cancer, but the warnings on both products post-dated the initiation of lawsuits against Johnson & Johnson. The plaintiff’s expert pathologist testified that he identified eight particles of talc in Echeverria’s ovarian cancer tissue and three others nearby. He also opined that the presence of talc in Echeverria’s ovarian cancer tissue was, to a reasonable degree of medical certainty, contributory evidence for a causal link in the development of ovarian cancer. He further testified that he was convinced the talc particles that he found got there as a result of the perineal use of talc, based on the response of the tissue to the particles and the steps he took to avoid contamination during the testing he performed. Echeverria’s treating gynecological oncologist testified that, to a reasonable degree of medical certainty, talc was a substantial contributing factor in Echeverria’s development of ovarian cancer. The expert also testified that Echeverria had applied talc-based baby powder more than 30,000 times during her lifetime. The plaintiff’s experts further testified that talc causes chronic inflammation and a series of non-genotoxic insults to cells that lead to neoplastic changes and ovarian carcinoma. Johnson & Johnson’s counsel contended that Johnson & Johnson firmly believes in the safety of talc and that talc is not capable of, and does not, cause ovarian cancer. In support of their position, defense counsel argued that the better type of epidemiologic studies–cohort studies that follow thousands of women throughout their lives–have shown no overall increased risk of ovarian cancer from the perineal use of talc. Counsel also argued that the association between talc products and ovarian cancer is weak and inconsistent and that the increased risk found in some case control studies was likely the result of chance, bias, or confounding, and did not show that talc causes cancer. Defense counsel also argued that there is no plausible, biologic mechanism through which talcum powder could cause ovarian cancer. Defense counsel relied on the decisions of cancer watchdog agencies, such as the National Cancer Institute, the National Toxicology Program, the Centers for Disease Control, and the FDA, none of which have found that talcum powder causes ovarian cancer, or is even a risk factor for the development of ovarian cancer. Defense counsel contended that the same letter from the FDA that plaintiff’s counsel relied on for the proposition that talc can migrate to the ovaries, rejected a request that the agency require a warning about ovarian cancer on talcum powder because the agency “did not find that the data submitted presented conclusive evidence of a causal association between talc use in the perineal area and ovarian cancer.” The defense’s expert pathologist testified that he believed that the talc found in Echeverria’s ovarian cancer tissue was due to contamination in the lab at the time the tissue was embedded. The defense’s expert gynecological oncologist testified that there is no known cause of ovarian cancer and that no one can say what caused Echeverria’s cancer. The expert also testified that even if a woman has the BRCA (breast cancer 1) gene, she would still not be able to conclude that BRCA caused that woman’s breast cancer because there are many variables that can cause cancer. Thus, defense counsel argued that there is no conclusive proof or evidence that talc causes ovarian cancer and that epidemiological studies report an association, but do not conclude or prove a causal relationship. Counsel also argued that no governmental agency has ever declared that talc causes ovarian cancer and that Johnson & Johnson’s internal documents only show that the company was aware of the association, but never believed that talc causes ovarian cancer. Specifically, counsel argued that Johnson & Johnson’s internal documents showed that the company was aware of the public scientific literature that reported an association between talc and ovarian cancer and that the company analyzed that literature carefully and concluded that it supported the safety of talcum powder. With respect to Echeverria’s cancer specifically, defense counsel argued that the plaintiff’s experts failed to demonstrate that talcum powder was more likely than not the cause of her cancer, as the cause of most ovarian cancers is unknown. In addition, defense counsel argued that the plaintiff’s treating physician failed to account for the possibility that Echeverria’s disease was idiopathic in origin, or due to Echeverria’s obesity and family history. Thus, counsel argued that Echeverria’s ovarian cancer could have been caused by genetics yet to be discovered, her family history, or her obesity and that Echeverria’s treating gynecologic oncologist was biased in her testimony because of her years of treating Echeverria., Echeverria was diagnosed with a 13 centimeter tumor on her left ovary and stage III-C, high-grade, invasive ovarian cancer in April 2007, at the age of 53. The cancer metastasized to her spleen, liver, kidneys, intestine, pancreas and thoracic spine. As a result, over the next 10 years, she underwent approximately 110 cycles of chemotherapy. Echeverria testified that she suffered from constant, severe pain in her pelvis, abdomen and kidneys, as well as leg pain due to movement of the mass in her pelvis. She claimed that her pain caused a hindrance in her ability to sleep. She further claimed that the cancer caused severe emotional distress due to her attachment to her family, and especially her 5-year-old grandson. Thus, Echeverria sought recovery of an unspecified amount of non-economic, compensatory damages as well as punitive damages.
COURT
Superior Court of Los Angeles County, Los Angeles, CA

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