Women’s health and wellness is a billion-dollar industry. Unfortunately, we have seen greedy companies put profits ahead of the health of women consumers by neglecting to fully vet their products for health risks before putting them on shelves. They are not quick to pull products either. Now, women are paying the price in high rates of serious health complications. There are many loopholes that allow dangerous products to enter the market — and stay there.
This needs to stop. Women deserve to use products that are safe and effective.
This article highlights pending and past litigation for defective products designed for women and what we can learn from them.
Johnson & Johnson Baby Powder
Johnson & Johnson (J&J) baby powder was one of the company’s earliest and best-sold products. Its key ingredient is talcum powder. Although J&J baby powder is sold in the baby aisle, adult women have long used it between their legs to prevent chafing and on the pubic area as a feminine deodorant. J&J later released Shower to Shower body powder, also containing talc, specifically for adults. Now, many lifetime users of these products have developed ovarian and lung cancers. More than 25,000 lawsuits are pending against the corporation, including a major class action suit filed by Napoli Shkolnik PLLC and Ben Crump Law just last month.
How Baby Powder and Cancer Are Linked
Several times beginning as early as the 1970s, J&J’s raw talc and finished powders tested positive for asbestos — a known carcinogen — which happens to occur naturally in the earth near talc deposits. J&J company executives, mine managers, scientists, doctors and lawyers knew about these instances of contamination, but did not disclose them to regulators or the public. In 2006, the International Agency for Research on Cancer (IARC) classified perineal use of talc as “possibly carcinogenic”, saying available research provided “limited evidence” it caused cancer in humans. Again, J&J did not pass this information down to consumers.
Aggressive Targeted Advertising
Not only was J&J aware of the risks of talcum powder, it also amped up its advertising when sales began to decline in the 2000s. Our lawsuit cites disturbing evidence that J&J especially targeted Black women in its ad campaigns. Tactics included distributing millions of free baby powder samples in Black and Hispanic neighborhoods; advertising with Weight Watchers and other lifestyle brands favored by overweight women, and radio ads aired during the hot summer months when demand for baby powder would be highest.
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The success of the ad campaigns targeted at Black women is rooted in the historically racist and sexist notion that Black women are in some way “unclean” and must fix their natural scent through actions like douching. Brands like J&J took advantage of these hurtful stigmas to boost sales, failing to protect consumers in the process.
J&J finally issued a recall on over 30,000 bottles of baby powder in 2019 after asbestos was found. In 2020, the company announced it would discontinue selling talc-based baby powder in the US and Canada.
How Did Baby Powder Stay On Shelves for So Long?
Baby powder is classified as a cosmetic. Under the FDA’s Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients — except for colour additives — do not need FDA review or approval before they go on the market. The FD&C Act makes it the responsibility of the pharmaceutical company to test their products for safety. It is also up to the pharmaceutical company to issue voluntary recalls if hazards are discovered, as the FDA cannot order a recall unless there is reliable information indicating that the product is adulterated or misbranded to an extent that could cause serious harm or death.
Pharmaceutical companies can register with the Voluntary Cosmetic Registration Program (VCRP), a post-market reporting system that assists the FDA in regulating cosmetics marketed in the United States. The FDA website states, “Information from the VCRP database also has been used by the Cosmetic Ingredient Review (CIR), an independent, industry-funded panel of scientific experts, to assist the CIR Expert Panel in establishing their priorities for assessing ingredient safety as part of their ingredient safety review”.
But the VCRP is just that: voluntary. And the database is only as useful as the products registered. Leaving pharmaceutical companies to self-regulate their products is problematic because there is no guideline for how to test for safety; the definition of “safe” becomes subjective. In the case of Johnson & Johnson, it determined from their testing that the amount of asbestos found in earlier baby powder contaminations was not harmful enough to report — yet there is no known “safe” amount of asbestos. In this way, self-regulation makes it impossible to tell whether a pharmaceutical company is telling the whole truth about their product.
The FD&C Act makes it the responsibility of the pharmaceutical company to test their products for safety.
Medical Devices — More Regulation, But Not Enough
Medical devices are subject to more regulation than cosmetic products, but harmful medical devices still make it onto the market. Health complications from medical devices can be far more severe. Here are some of the ways the FDA regulates them, and where they fall short:
Black Box Warnings, or “boxed warnings,” are printed on the labelling of a prescription drug or medical device if there is a risk of serious injury or death associated with using the product. The FDA mandated a black box warning for the female sterilisation device Essure in 2016 amid thousands of reports of complications following placement of the device. As of 2020, there have been over 16,000 medical device reports (MDRs) of abdominal pain, ectopic pregnancy, organ perforation, and other serious adverse side effects associated with Essure.
FDA Adverse Events Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to the FDA. There is both voluntary reporting and mandatory reporting. Manufacturers, importers, and device user facilities are required to report certain device-related adverse events and product problems to the FDA, usually serious injury or death.
Similarly, the makers of the birth control device NuvaRing were also sued for failing to adequately warn consumers about the heightened risk of blood clots and other injuries associated with the product. In 2013, NuvaRing paid a $100 million settlement to Napoli Shkolnik clients harmed by the product.
Premarket Approval and Classification. FDA-approved drugs and medical devices are categorized as Class I, II, or III. Class III is the highest risk class, and as such has strict research and safety requirements for premarket approval (PMA). Transvaginal mesh, which is used to treat urinary incontinence and pelvic organ prolapse (POP), was upgraded from Class II to Class III in 2016. The FDA has since found several surgical mesh implant PMA applications to have insufficient proof of safety. Thousands of women are experiencing devastating, even fatal complications from transvaginal mesh as manufacturers shell out huge settlements. Had the product been correctly classified and tested from the beginning, irreparable harm could have been avoided.
Conclusion
As a leader in pharmaceutical litigation and a woman myself, I am heartbroken by the number of women currently suffering because of the malfeasance and negligence of money-hungry companies. We must reform the way cosmetics, drugs and medical devices get on the market, how they are marketed, and the process by which to get them recalled, or countless other people will be put at risk of serious injury or even death. It is time for us to prioritisez the health and safety of women and not lining the pockets of companies.
Marie Napoli, Founding Partner
Address: 360 Lexington Avenue, 11th floor, New York, NY 10017
Tel: +1 212 397 1000
Marie Napoli has been an attorney for over twenty-five years. She has experience handling personal injury, medical malpractice litigation, pharmaceutical litigation, employment discrimination, civil rights, and mass tort matters. Marie earned her JD from St John’s University Law School and her LLM degree from New York University (NYU) School of Law. She has worked for the New York Appellate Division, 2nd Department and has taught CLE courses on Tort and Civil Procedure at St John’s University School of Law. As a founding partner of Napoli Shkolnik PLLC, Marie is involved in many depositions and has tried multiple cases to verdict. She is also bringing her considerable skillset and experience to a collaboration with Ben Crump on numerous social injustice litigations.
Napoli Shkolnik is a national law firm based in New York City. Their personal injury attorneys represent victims across the country in litigation, mediation and arbitration across a range of practice areas, including medical malpractice, environmental litigation and civil rights. With additional offices in Long Island, New Jersey, California, Delaware, Florida, Illinois and Texas, Napoli Shkolnik’s team boasts 30+ years of experience and more than $3 billion secured for their clients through verdicts and settlements.
