Together, these two common words instantly create a sense of dread. And with good reason. Ovarian cancer is the fifth leading cause of cancer death among women. According to cancer.net, an estimated 22,280 women in the United States will be diagnosed with ovarian cancer this year, ultimately resulting in 14,240 deaths. Ovarian cancer is uncommon and the cause is largely unknown. Often, ovarian cancer remains undiagnosed until the later stages, when a cure is less likely.
As if these facts alone aren’t scary enough, now a new threat has emerged.
For years, the medical community has known about this threat. Some have warned their female patients, while others have remained silent about its deadly potential.
The threat? Talcum powder. Yes, the soft, sweet-smelling, talcum-based product widely known as “baby powder”…the same product manufactured by pharmaceutical giant Johnson & Johnson…the same product women have used to soften and smooth their skin for more than 120 years, and consequently used without reservation on their female children …potentially causes ovarian cancer.
Outraged women have taken notice, and are filing failure to warn lawsuits.
Today, Johnson & Johnson is the subject of multiple lawsuits claiming the company’s talcum-based products, Baby Powder and Shower to Shower, are responsible for causing ovarian cancer.
The lawsuits began to emerge after a South Dakota woman, Deane Berg, brought a failure to warn lawsuit against Johnson & Johnson. Diagnosed with ovarian cancer in 2006, Berg had used the company’s talc-based products for thirty years. Three physicians analyzed Berg’s cancer tissue, finding talc in the tissue with the aid of a scanning electron microscope. While the jury in this trial did not award damages, it did require Johnson & Johnson to warn consumers of the potential link between ovarian cancer and talc-based body powder usage in feminine areas of the body. This decision opened the door to additional product liability and failure to warn lawsuits.
A second case involved the family of a deceased woman from Alabama, whose family blamed her use of talcum powder for her fatal ovarian cancer. The family was awarded $72 million in damages.
Most recently, a St. Louis jury awarded Gloria Ristesund $55 million in damages and punitive damages for similar claims of negligence. She was a loyal user of baby powder prior to developing ovarian cancer, which is currently in remission.
Now, hundreds of women are stepping forward with similar negligence and failure to warn lawsuits against Johnson & Johnson, who claims its products are safe, despite a statement from The International Agency for Research on Cancer which concurs that applying talc to the genital area could be “possibly carcinogenic to humans.” Currently, the company is litigating more than 1,200 lawsuits.
How Did This Happen?
Talcum powder is made from talc, a mineral comprised of elements such as magnesium, silicon, and oxygen. As a powder, talc absorbs moisture well, helping to keep skin dry and prevent rashes. For more than 100 years, women have relied on talcum-based powder products to stay cool and comfortable. Dusting their private areas as well as devices such as diaphragms with these powders felt good, smelled pretty, and discouraged sweat and odors. However, using talcum powder for this purpose allowed the fine dust to enter the female reproductive tract and to be inhaled through the lungs, exposing women to the development of ovarian cancer. Additionally, unaware of the dangers of talc to the female reproductive organs, mothers used baby powder without restriction when diapering or bathing their babies, and at other times to keep their little ones cool and comfortable too. In time, emerging health concerns led some doctors to recommend against the use of talc-based powders, although The American Cancer Society website states, “There is very little evidence at this time that any other forms of cancer are linked with consumer use of talcum powder.” The Society suggests switching to cornstarch-based powders as a safe alternative.
Did Johnson & Johnson Know That Talcum Powder Could Cause Cancer?
If proof of the link between talcum powder and ovarian cancer has been known for years, why was nothing done to warn users of the product? According to Eva Chalas, chief of Gynecologic Oncology and Director of Clinical Cancer Services at Winthrop-University Hospital, “It’s hard to directly link ovarian cancer to talc. The information on talc powder came out many years ago when they saw talc incorporated in the tissue of women with ovarian cancer.” Additionally, the Associate Press reported on an internal J&J memo from 1997, written by a company medical consultant who stated “anybody who denies the risk of using hygienic talc and ovarian cancer is denying the obvious in the face of all evidence to the contrary.”
So the question remains: does talc cause ovarian cancer? Amid such conflicting information, the answer is – maybe, but more evidence is needed. Some studies on animals show that talc can cause tumors, but others do not. Mixed results are also found in studies exploring links between talcum powder and ovarian cancer. Because of the lack of irrefutable evidence, Johnson & Johnson intends to appeal the two most recent jury awards, and claims to have the science on their side. Part of their appeal may rest on the fact that it is nearly impossible to prove that one specific substance is the sole cause of a person’s cancer.
What Do Studies Show?
Science has struggled for years to find a direct correlation between ovarian cancer and talc exposure. Significantly different results were often reported, some showing increased risk and some showing no risk. Finding the truth is a quest complicated by reliance on patients’ strongly biased self-reporting (a lack of properly documented medical reports of talc use); complex quantification of talc dose exposure; and the presence of talc in products other than powders applied to the genitals (i.e., various cosmetics).
Given such varied evidence, it was not until 2006 that genital exposure to talc was classified as potentially carcinogenic by the International Agency for Research on Cancer. In 2015, the International Journal of Gynecological Cancer reported studies which found that ovarian cancer risk following talc exposure was increased by 30–60%.
The actual mechanism through which talcum powder increases the risk of cancer remains unknown, although chronic inflammation has been suggested to play a key role in carcinogenesis (the beginning of cancer cell formation). Interestingly, British researchers analyzed 13 ovarian tumors more than forty five years ago and found talc particles “deeply embedded” in ten of the tumors studied. Published in 1971, the study was the first to consider the risks related to talcum powder. This study was followed by a 1982 Cancer Journal study by Boston epidemiologist Daniel Cramer, showing the first statistical link between genital talc use and ovarian cancer.
While evidence may still be lacking after years of study, the question remains: is not even a slight risk of exposure enough to convince most women to avoid use of talc-based powder products? It should be, and recent lawsuits seem to bear out this thinking among the majority of women, especially as the lawsuits against J&J gain notoriety.
What Happens Next?
While Johnson & Johnson continues to list talc as one of its baby powder ingredients, they have spoken out in their defense against the burgeoning lawsuits. J&J Consumer spokeswoman Carol Goodrich stated, “Jury verdicts should not be confused with regulatory rulings or rigorous scientific findings. The overwhelming body of scientific research and clinical evidence supports the safety of cosmetic talc.” The company plans to appeal the recent verdicts, stating it is “confident that its products are safe for use by its customers. Our confidence is supported by the consensus view of qualified scientific experts and regulatory agencies.”
Since 2013, Johnson & Johnson has spent more than five billion dollars resolving legal claims related to its drugs and medical devices, including one of the largest health fraud penalties in the history of the United States involving Risperadal, an antipsychotic drug. The company’s 2015 annual report cited 75,000 liability claims filed, excluding talcum powder cases.
While Congress considers updating the law to provide the FDA with more authority to regulate products, J&J has placed a warning on its Baby Powder product, cautioning users against inhalation. Under pressure from various groups and from California safety regulations, J&J has removed concerning chemicals, such as triclosan and formaldehyde, from its baby products. The company also sells Baby Powder made from cornstarch for relatively the same price as its baby powder. J&J competitors, which include Gold Bond, California Baby, and Burt’s Bees, also sell baby powder made only of cornstarch. In the meantime, Johnson & Johnson continues to defend the safety of talc on its website, attempting to explain its policies regarding various product ingredients, and repeatedly claiming these chemicals are either not harmful, or used in such small amounts as to be negligibly significant. Considering some chemicals have been removed due to safety concerns, the logical next question is “Why not apply the same standard to talc?” Goodrich said that while J&J does listen to consumers when they raise concerns about ingredients, “few ingredients have the same demonstrated performance, mildness and safety profile as cosmetic talc.”
The Future of Ovarian Cancer & Talcum Powder
Consumers surprised by this information should consider that many common personal care products, such as shampoo, body lotion, and body powder, contain chemicals with known associations to various health problems, but no warnings are provided to consumers, most of whom simply trust that companies care about using the safest ingredients in their products for both adults and children. The fact is that United States companies are permitted to add ingredients to personal care products without required safety testing, and without ingredient disclosure. The non-governmental Cosmetics Ingredient Review Panel determines the safety of these ingredients but, even when warning companies against using certain ingredients, the recommendations are often ignored. Currently, Congress is considering an update to archaic 1938 cosmetics laws, which regulate cosmetics sold in the United States. A bipartisan bill has been introduced – the Personal Care Products Safety Act of 2015 – that would give the FDA increased authority to regulate the cosmetics industry.