and OVARIAN CANCERTALCUM POWDER

© 2016 GoldenbergLaw, PLLC

What is talcum powder (talc)?

Talc is a mineral mainly composed of magnesium, silicon, and oxygen making it structurally similar to asbestos. Because talc and asbestos occur together in nature, the talc mining industry is highly regulated in order to avoid asbestos contamination of products containing talc.

Talc in Cosmetic Products

Talc is widely used in cosmetic products for its ability to absorb moisture without irritating the skin. Johnson & Johnson (J&J) developed its talc-based Baby Powder in 1894, growing the product in to a household staple for both mother and baby to prevent wetness, chafing, and rashes.

© 2016 GoldenbergLaw, PLLC

What is it made of?

What is the problem?

Scientists began studying the link over three decades ago after discovering an increased risk of ovarian cancer in female asbestos workers. Since that time, over 20 studies have been conducted showing a positive link between talc and ovarian cancer when used for genital dusting. Despite mounting evidence of serious health effects with genital use of talcum powder, J&J refuses to add a warning to their talc-based products.

A study published in Cancer Prevention Research suggests that the use of talcum powder for genital dusting by women leads to a 20 – 30% higher risk of developing ovarian cancer. The risk increases to 41% if talc is used on a daily basis.

Genital Dusting

When women use J&J’s talc-based products for genital dusting, talc fibers can make their way to the ovaries via the female reproductive tract. Once in the ovaries, the structure of talc fibers makes it easy for them to lodge themselves in to ovarian epithelial cells where they remain for many years. The link was made to ovarian cancer when scientists began finding talc fibers deeply embedded in ovarian tumors.

Talc and Ovarian Cancer

© 2016 GoldenbergLaw, PLLC

J&J’s Dangerous DenialJohnson & Johnson’s executives became aware of the dangers associated with talc in 1982 after meeting with Dr. Daniel Cramer, an epidemiologist at Brigham & Women’s Hospital in Boston who had published a study on the link between talc and ovarian cancer in the journal Cancer.

With full knowledge of talc’s potential link to ovarian cancer, J&J continued encouraging women to use their talc-based Baby Powder and Shower-to-Shower products for the purpose of genital dusting.

“A sprinkle a day… keeps the odor away.”

J&J has an alternative option to its talc-based Baby Powder – a pure cornstarch product. Despite the availability of this alternative, J&J refuses to pull talc-based products from shelves.

A 1988 J&J advertising jingle promoting genital use of its talc-

based Shower-to-Shower product.

© 2016 GoldenbergLaw, PLLC

Our Case Criteria

TALCUM POWDER USE

OVARIAN CANCER

DIAGNOSIS

MEDICALISSUES

1

2

3

What are our usage requirements?

What are our diagnosis requirements?

What are our additional medical requirements?

• Used for genital dusting• Johnson & Johnson brand talc-based product• Used daily for 10 years

• Must be diagnosed with ovarian cancer• Diagnosis must be confirmed through medical reports• The cancer must be serous or serous invasive NOT germ cell

• If there was a BRCA test, results MUST be negative• Absence of a BRCA test does not disqualify a lead

INCREASES RISK

• Family history of breast and/or ovarian cancer

• Hormone replacement therapy

DECREASES RISK

• Giving birth to children

• Birth control usage

OTHER MEDICALCONSIDERATIONS

© 2016 GoldenbergLaw, PLLC

We must prove that talc is a substantial contributing cause of a client’s ovarian cancer. Therefore, our case criteria is based upon supporting scientific studies.

Studies Informing Criteria

1992 Perineal Exposure to Talc and Ovarian Cancer Risk (B.L. Harlow, D.W. Cramer, and D.A. Bell)

"The greatest ovarian cancer risk associated with perineal talc use was observed in the subgroup of women estimated to have made more than 10,000 applications during years when they were ovulating and had an intact genital tract (OR 2.8, 95% Cl 1.4-5.4)."

"An 80% excess risk was associated with an estimated exposure of more than 10,000 applications (equivalent to daily use for 30 years) as compared with non-users."

"Among women with perineal exposure to talc, the risk was significantly elevated in the subgroups of women who applied it: 1) directly as a body powder (OR 1.7, 95% Cl 1.1-2.7), 2) on a daily basis (OR 1.8, 95% Cl 1.1-3.0), and 3) for more than 10 years (OR 1.6, 95% Cl 1.0-2.7)."

"Of the application modes studied, direct perineal application produced the greatest risk (OR 1.7, 95% confidence interval [Cl] 1.1-2.7)."

"[T]he risk was greatest in women who applied talc at least once per day."

"[R]elative to non-users, women who applied talc for more than 10 years were at 60% greater risk for ovarian cancer."

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Studies Informing Criteria

1998 Genital Talc Exposure and Risk of Ovarian Cancer (D.W. Cramer, R.R. Liberman, L. Titus-Ernstoff, W.R. Welch, E.R. Greenberg, J.A. Baron, and B.L. Harlow)

"[T]he association between talc and ovarian cancer was more apparent in women who used talc prior to a first live-born pregnancy compared to those who used it only after a first live- born pregnancy."

“There is evidence from several studies that the talc/ovarian cancer association is modified by closure of the female tract as a result of tubal ligation or hysterectomy.”

“[A]voidance of talc in genital hygiene might reduce the occurrence of a highly lethal form of cancer by at least 10%. Balanced against what are primarily aesthetic reasons for using talc in genital hygiene, the risk benefit decision is not complex. Appropriate warnings should be provided to women about the potential risks of regular use of talc in the genital area.”

“Our study found the greatest risk to be associated with invasive serous tumors, OR=1.70 (1.22 and 2.39).” “A summary odds ratio of 1.36 suggests that between 10 and

11% of ovarian cancers in these populations are attributable to the genital use of talc.”“The patency of the female tract and the nature of ovarian cancer as a

surface epithelial (mesothelial) lesion make the ovary a target for foreign body carcinogenesis.” “[O]ur results demonstrate a significant association between

the use of talc in genital hygiene and risk for ovarian cancer.”

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Studies Informing Criteria

2008 Talc Use, Variants of the GSTM1, GSTT1, and NAT2 Genes, and Risk of Epithelial Ovarian Cancer (M.A. Gates, S.S. Tworoger, K.L. Terry, L. Titus-Ernstoff, B. Rosner, I. De Vivo, D.W. Cramer, and S.E. Hankinson)

“Talc particles can induce an inflammatory response in vivo, which may be important in ovarian cancer risk.”

“Regular genital talc use was not significantly associated with the risk of the endometrioid (RR=1.41, 95% Cl=0.97-2.05) or mucinous (RR=1.28, 95% Cl=0.85-1.92) histologic subtypes in the pooled analysis.”

“Recent studies by Cramer and colleagues also support the possibility of an immune-mediated mechanism for an association between talc and ovarian cancer and suggest that exposure of the lower genital tract to talc may be sufficient to cause changes, such as production of heat shock proteins, accumulation of talc in pelvic lymph nodes, or decreased levels of anti-MUC1 antibodies, that could increase ovarian cancer risk.”

“In the pooled analysis, the relative risk for the association with regular genetic talc use was 1.36 (95% Cl=1.14-1.63) for total ovarian cancer and 1.60 (95% Cl=1.26-2.02) for the serous invasive sub-type.” “[T]he association between genital talc use and risk of ovarian

cancer may vary be genotype.”“[S]erous ovarian cancers morphologically resemble peritoneal malignant mesotheliomas, suggesting a possible rationale for the stronger association between talc and risk of serous or serous invasive cancers observed in some studies.”

“Exposure Assessment is critical – focus on type of use, frequency of use, age at first use, number of years used, and brand of powder used.”

© 2016 GoldenbergLaw, PLLC

Studies Informing Criteria

2016 The Association Between Talc use and Ovarian Cancer: a Retrospective Case-Control Study in two U.S. States (D.W. Cramer, A.F. Vitonis, K.L. Terry, W.R. Welch, and L.J. Titus)

“We analyzed case-control data collected over 16 years on talc use and epithelial ovarian cancer risk to address issues related to definition of the exposure, bias and confounding, effect modification, histologic heterogeneity, and dose-response. Talc used regularly in the genital area was associated with a 33% increase in ovarian cancer risk overall while no apparent risk was associated with talc used only in non-genital areas.”

“In our paper, we calculated talc-years when non-users are included, and the trend is even more apparent in premenopausal women with certain epithelial ovarian cancer subtypes.”

“Overall, there is an association between genital talc use and EOC and a significant trend with increasing “talc-years” of use.”

“Histologic subtypes of epithelial ovarian cancer more likely to be associated with talc include serous and mucinous borderline tumors and invasive serous and endometrioid tumors.”

“We believe the observations made here [in this study] present a good case for talc carcinogenicity and that re-analyses of existing data from already published studies might provide confirmatory evidence.”

© 2016 GoldenbergLaw, PLLC

Trials and Verdicts

2013In a 2013 talcum powder trial, J&J offered plaintiff Deane Berg of South Dakota an out-of-court settlement of $1.3 million for her signature on a confidentiality agreement that would prevent her from discussing her case. She refused and went to court. The jury found J&J liable, but declined to award damages. In an interview with the New York Post, Berg state, “it was never about the money.” Her heroic actions alerted the legal community to this danger.

2016In February 2016, a St. Louis jury returned a verdict of $72 million – including $62 million in punitive damages – to the family of Jackie Fox. Fox passed away from ovarian cancer at the age of 62 after using J&J’s talc-based products for genital dusting on a daily basis for much of her life.

In May 2016, another St. Louis jury returned a verdict of $55 million – including $50 million in punitive damages – to Gloria Ristesund. The case was a defense pick. During the trial a J&J marketing tool was shown to jurors. The tool resembled a monopoly game board and was used to sell J&J talc-based products to loyal consumers. Properties were labeled as different government regulatory agencies, such as the FDA and OSHA, with approval stamps above them if that agency had approved the usage of talc. On each side of the board was a skull and cross-bones warning of danger ahead for the company if litigation ensued regarding the dangers of talc—exposing their not-so-well-kept secret to government agencies and the public.

DEANEBERG

JACKIEFOX

2016 GLORIARISTESUND

Over 1,000 women and their families have filed claims against J&J across the nation.

The next trial is scheduled for September of 2016.

© 2016 GoldenbergLaw, PLLC