Johnson & Johnson to pay $417 million to a ovarian cancer patient: a blockbuster verdict by Jury

In a landmark decision, a jury has ordered Johnson & Johnson (J&J) to pay $417m (£323m) to a woman who claimed she developed ovarian cancer after using the company’s talc-based products such as Johnson’s Baby Powder for feminine hygiene.

The verdict was given in favor of California resident Eva Echeverria,who claimed that she developed terminal cancer after decades of use of J&J’s products.

This is the largest payout yet with J&J facing thousands of lawsuits (4800) for failure to warn the consumer about cancer risk of its talc based products.

“We are grateful for the jury’s verdict on this matter and that Eva Echeverria was able to have her day in court,” said Mark Robinson, her lawyer, in a statement.

Her lawyers argued that the company continued to market and encourage women to use its talc based products, despite aware of its carcinogenic potential.

Earlier, a Missouri jury has awarded $72 million to the family of an Alabama woman who died from ovarian cancer in October 2015.

Despite being named as baby powder, it is used by millions of adults in sensitive area to prevent  chafing or promote dryness.

In its natural form talc contains asbestos, a proven carcinogenic since decades.American Cancer Society states,” When talking about whether or not talcum powder is linked to cancer, it is important to distinguish between talc that contains asbestos and talc that is asbestos-free. Talc that has asbestos is generally accepted as being able to cause cancer if it is inhaled. This type of talc is not used in modern consumer products. The evidence about asbestos-free talc, which is still widely used, is less clear.”

It is postulated that if talc or a product containing talc is applied to your genital area in any way (whether it’s applied directly — what’s called perineal talc use —  or whether it makes its way there via pads, condoms, etc.), the powder particles might be able to travel from your vagina all the way up to your ovaries.

This may set off inflammation, which is believed to play an important role in etiology for ovarian cancer.

Many studies have looked into possible link between talc use and ovarian cancer, but the findings are equivocal. A 2003 meta-analysis of 16 studies (11,933 patients) found a link between talc use and ovarian cancer while a 2014 study of 61,576 women did not find the same link.

Meanwhile J&J said, “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder.”

So, the bottom line is we still do not have sufficient evidence to prove causation. FDA states that, “There is not sufficient evidence to prove a possible connection.” However, after a flurry of recent lawsuits The U.S. FDA Office of Women's Health has agreed to fund a study investigating the possible link between cosmetic talc use and ovarian cancer.

A posting on the FDA's website notes that while women are commonly known to use products containing talc for hygiene and cosmetic purposes, talc's effects on the tissues that make up the female genital system have not been adequately investigated.

Till causation is proved, the consumers are advised to play it safe and can use talc free powders. A lot of companies make talc-free baby powder out of cornstarch, including Johnson & Johnson.

Talc powder and ovarian cancer! Does evidence prove causation?

Recently a Missouri jury has awarded $72 million to the family of an Alabama woman who died from ovarian cancer in October 2015, which she said was caused by using Johnson & Johnson's baby powder and other products containing talcum powder.

The jury found Johnson & Johnson guilty of negligence, and conspiring to hide facts by not issuing a warning on the product used.

The general public has spoken in favor of the women but, does evidence linking use of the talcum powder as feminine hygiene product and development of ovarian cancer exist in studies and clinical research?

Talcum powder is made from talc, a mineral made up mainly of the elements magnesium, silicon, and oxygen. As a powder, it absorbs moisture well and helps cut down on friction, making it useful for keeping skin dry and helping to prevent rashes.

Since early 1980s, a few studies have found that women who regularly used talc powder for feminine hygiene had higher than average rates of ovarian cancer. Yet the evidence–which fell short of proving causation–was mostly confined to medical journals, and not known to general public.

According to an article published in Journal of  Toxicology and  Environmental Health 1976 Nov;2(2):255-84, researchers at Mount Sinai Hospital in New York published test results  on 20 talc-based consumer products, including baby and facial powders. All the formulations were before 1973. Of the 20 products 10 contained detectable amounts of tremolite and anthophyllite, principally asbestiform, while some also contained fragmented forms of these minerals They found two types of asbestos, tremolite and  anthophyllite, in 10 of the 20 products.

Before the 1970s, talcum powder was often contaminated with asbestos fibres which are known to cause cancer. But since then, all home products containing talcum powder are legally obliged to be asbestos-free.

J &J claims that all its talcum products are free of talc and are manufactured according to strict US pharmacopoeia standard.

Dr. Daniel Cramer, MD, ScD, an obstetrician/gynecologist at Brigham and Women's Hospital and Harvard Medical School in Boston and a prominent researcher in this field opines that talc does cause ovarian cancer. He was the first to link talc with ovarian cancer in his pilot study published in 1982.

He has recently published a paper in Epidemiology journal December 2015 issue, citing over 20 well executed case-control studies that support this association. In this article he has established a dose –response relationship with the trend increasing as number of years of talc use accrues. According to him “Subtypes of ovarian cancer more likely to be associated with talc included invasive serous and endometrioid tumors and borderline serous and mucinous tumors”.

Many other control studies have documented a 30% increase in risk of ovarian cancer, but the single cohort study done has not documented causation.

Due to this inconclusive research evidence, talcum powder is classified by the InternationalAgency for Research on Cancer (IARC) aspossibly carcinogenic (cancer causing) to humans when applied to the genital area. IARC is a part of the World Health Organisation which convenes international expert working groups to evaluate the evidence of the carcinogenicity of specific exposures.

While the American Cancer Society says “It is not clear if consumer products containing talcum powder increase cancer risk”.

Many research papers and epidemiology studies have specifically evaluated talc and perineal use and these studies have found talc to be safe. For example, the Nurses’ Health Study (2010)2 and the Women’s Health Initiative Observational Cohort (2014)3 are two large-scale prospective studies looking at talc and ovarian cancer. Both found no causal relationship between talc and ovarian cancer.” Both these studies were criticized insufficient exposure to the talc powder.

Meanwhile the J& J spokesperson Carol Goodrich said, "We sympathize with the plaintiff's family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence." The company is expected to appeal the ruling.

The possible mechanism of cancer causation by the talc is chronic inflammation. Very small particles of talc migrate from vagina to the upper genital tract. In fact, Jackie Fox, whose ovarian cancer prompted the court case in St Louis, had talc found in her surgically removed ovaries, according to news reports.

The American Cancer Society advises the consumers to use corn starch based products, until a definite answer to the role played by talcum powder in ovarian cancer causation is found.

The US National Toxicology Program (NTP) is formed from parts of several different government agencies, including the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). The NTP has not fully reviewed talc (with or without asbestos) as a possible carcinogen.

Further research is needed to determine whether and how talcum powder might increase the risk of ovarian cancer.

References:

http://www.cancerresearchuk.org/about-cancer/causes-of-cancer/cancer-controversies/cosmetics-and-toiletries#Cosmetics2

http://www.safetyandcarecommitment.com/ingredient-info/other/talc

http://www.cancercouncil.com.au/86105/cancer-information/general-information-cancer-information/cancer-questions-myths/clothing-cosmetics-tattoos/there-is-inconclusive-evidence-that-using-talcum-powder-can-cause-cancer/

http://journals.lww.com/epidem/pages/articleviewer.aspx?year=9000&issue=00000&article=99086&type=abstract

http://www.cancer.org/cancer/cancercauses/othercarcinogens/athome/talcum-powder-and-cancer