Health Editor’s Note:  When I had my first baby, back in 1977, the pediatrician recommended that I not use powder on the baby, since the baby would be breathing in the powder, much of what would be floating in the air while application.  That made sense to me so I never used it….glad I did not….Carol

Milton Packer says the $4.69-billion verdict is about anger, not medicine

by Milton Packer, M.D.

You probably heard that Johnson & Johnson lost a major court battle last year. The company was sued by a group of 22 women who claimed that they developed ovarian cancer as a result of exposure to talcum powder, sold in the form of J&J’s iconic Johnson’s Baby Powder. A jury ordered the company to pay a record $4.69 billion.

It was not the first time that J&J had lost a verdict in a lawsuit claiming that their talcum powder causes ovarian cancer. Over the past few years, the company has been on the losing side of several similar legal proceedings, resulting in awards totaling hundreds of millions of dollars. Thousands of women are additionally poised to sue J&J based on a similar set of legal arguments; lawyers’ TV ads soliciting potential plaintiffs run night and day.

There are two forms of the Baby Powder product. The original version is made of talc, and a more recent formula uses cornstarch. Many pediatricians have long preferred the cornstarch product because it is less likely to be inhaled. In 1985, in a letter published in the New England Journal of Medicine, two physicians warned that baby powder made of talc could cause breathing problems and pulmonary injury. They wrote: “Its absorptive capability is small, its lubricating properties are minimal and its perfume aspects are short-lived.” J&J disagreed, stating that the “product is safe when used as it is intended.”

Starting in the 1970s, the company started promoting its talcum powder to families, not just babies. Within several years, 70% of the sales of Johnson’s Baby Powder was for adult use. By 2001, surveys suggested 40%-50% of U.S. women had used talc powder on the perineum.

Concerns about the safety of the baby powder in adults began to emerge. Some researchers proposed that talc particulates following perineal application could migrate to the ovaries and lead to an inflammatory response that might predispose to malignancy. Several epidemiological studies reported an increased likelihood of ovarian cancer among perineal powder users versus non-users. But these studies utilized a case-control methodology, which is limited in its ability to reliably assess exposure. Cohort studies (a more reliable, albeit still limited, methodology) failed to demonstrate an association of perineal powder use and ovarian cancer. In 2006, the International Agency for Research on Cancer concluded that it had insufficient information to know whether talc alone could cause cancer.

Given this level of uncertainty, why did a jury deliver a $4.69-billion verdict against Johnson & Johnson?

The women who used talcum powder and developed ovarian cancer were suing J&J — not because of the possibility that talc might cause cancer — but because of the possibility that the talc in Johnson’s Baby Powder could be contaminated with asbestos, which is an established carcinogen.


Talc and asbestos are silicates that occur together in nature, and talc can be contaminated with asbestos due to the proximity of asbestos ore in underground talc deposits. Recognizing the possibility of contamination, in the mid-1970s, the trade association representing the cosmetic and personal care products industry issued voluntary guidelines stating that all talc used in cosmetic products in the U.S. should be free from detectable amounts of asbestos.

But what exactly does that mean?

Laboratory tests vary in their ability to determine the presence of small quantities of asbestos. Some tests are extremely sensitive and can detect incredibly minute amounts. According to court records, tests performed by J&J were typically negative, but yielded positive results for asbestos on occasion. Were these tiny amounts injurious to human health? Could these tiny amounts applied to the perineum cause ovarian cancer? It is not clear that anyone knows the answers to these questions with any acceptable degree of certainty.

Given this lack of scientific confidence, why did a jury deliver a $4.69-billion verdict against Johnson & Johnson?

Answer: The verdict had little to do with whether asbestos in talc causes ovarian cancer.

If scientists cannot determine if minute quantities of asbestos potentially present in talc and applied to the skin are harmful, a jury composed of laypeople cannot possibly decide if the tiny amounts of asbestos — if they are present in talcum powder — might cause ovarian cancer.

But they could determine whether J&J knew about the possibility of minute quantities of asbestos and decided not to inform the public.

According to a Reuters investigation in December 2018, J&J knew for decades that its baby powder could contain bits of asbestos. From at least 1971 to the early 2000s, the company’s talc powders “sometimes tested positive for small amounts of asbestos,” according to the news organization, “and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public.”

If the Reuters report is true, the public trust in J&J would have been broken. If years of public trust are based on a fiction, people predictably and justifiably respond with anger.

Did the plaintiffs raise the possibility of betrayal in their presentation to the jury? I do not know, but if they did, the argument could have been compelling.

For the record, J&J disputes the validity of the tests that indicated the possibility of asbestos contamination. They deny that they withheld evidence from regulatory agencies. But, sadly, they add: if their baby powder contained asbestos, it was too tiny to cause any health problems.

This statement, regardless of its validity, misses the point. The lay public does not want to decide what level of asbestos might be safe. People simply want to feel secure that large corporations are not deceiving the public in an effort to bolster profits.

So why did a jury deliver a $4.69-billion verdict against J&J?

I think the members wanted to send a clear message: If trusted corporations deceive the American people, they need to be punished — not because their products cause cancer — but because they must be held accountable if people believe that they have violated the public trust.

The multi-billion verdict is not about medicine or science. It is about betrayal and anger. It is high time that large corporations understood that.

Packer recently consulted for Actavis, Akcea, Amgen, AstraZeneca, Boehringer Ingelheim, Cardiorentis, Daiichi Sankyo, Gilead, J&J, Novo Nordisk, Pfizer, Sanofi, Synthetic Biologics, and Takeda. He chairs the EMPEROR Executive Committee for trials of empagliflozin for the treatment of heart failure. He was previously the co-PI of the PARADIGM-HF trial and serves on the Steering Committee of the PARAGON-HF trial, but has no financial relationship with Novartis.


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Biography
Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master's of Nursing Science Degree as an Educator.

She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen - two daughters-in-law; Suzy and Katie - two granddaughters; Isabella Marianna and Zoe Olivia - and one grandson, Alexander Paul. She also shares her life with husband Gordon Duff, many cats, two rescue pups, and two guinea pigs.

Carol's Archives 2009-2013

4 COMMENTS

  1. Talc powder is probably the least probable cause of ovarian cancer compared to radiation and everything else. However, if it did cause cancer, Johnson and Johnson could probable give a rats ass.

  2. https://www.businesswire.com/news/home/20111215005094/en/Cancer-Prevention-Coalition-Multiple-Carcinogens-Johnson-Johnson%E2%80%99s Quote:
    December 15, 2011 09:00 AM Eastern Standard Time
    CHICAGO–(BUSINESS WIRE)–The following is an opinion editorial provided by Samuel S. Epstein, M.D., Chairman of Cancer Prevention Coalition:
    “tests that incorporate the mechanistic underpinnings of disease.”
    Tweet this
    “The Campaign for Safe Cosmetics must be congratulated for securing a 11/15/11 agreement with Johnson & Johnson “for reducing or gradually phasing out – – trace amounts of potentially cancer-causing chemicals” from Baby Shampoo, “one of its signature products.” However, this agreement is limited and restricted to the U.S. market.
    There are two carcinogenic ingredients in Johnson & Johnson’s Baby Shampoo, dioxane and quaternium 15. Dioxane is a well-recognized contaminant in alcohol ethoxylates, a group of four ingredients, laureths, oleths, polyethylene glycol and polysorbates. Quaternium 15 is a precursor of two carcinogens, formaldehyde and nitrosamine. Johnson & Johnson has committed to “reducing or gradual phasing out” dioxane and quaternium-15 in their U.S., but not in their international products.
    However limited, Johnson & Johnson’s response is in sharp and disturbing contrast to the silence of the Food and Drug Administration (FDA). This federal agency has still failed to enforce the explicit requirements of the 1938 Federal Food Drug and Cosmetic Act. This directs..

    • “This directs the FDA to require that “the label of a cosmetic product shall bear a warning statement to prevent a health hazard that may be associated with the product.””
      “Samuel S. Epstein, M.D. is professor emeritus of Environmental and Occupational Medicine at the University of Illinois at Chicago School of Public Health; Chairman of the Cancer Prevention Coalition; and former President of the Rachel Carson Trust. His awards include the 1998 Right Livelihood Award and the 2005 Albert Schweitzer Golden Grand Medal for International Contributions to Cancer Prevention. He is the author of over 270 scientific articles and 20 books on the causes and prevention of cancer, including the Unreasonable Risk Book: How To Avoid Cancer from Cosmetics and Personal Care Products, The Neways Story (2001, Environmental Toxicology), the groundbreaking The Politics of Cancer (1979, Doubleday Books), Healthy Beauty (2010, BenBella Books), and National Cancer Institute And American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest (2011, Xlibris Publishing).”
      Professor Samuel S. Epstein, M.D. died last year at age 91. Unfortunately all that remains of the Cancer Prevention Coalition rests with Shelly Kramer in Los Angeles at this link:
      Cancer Prevention Coalition Information
      Information, Articles and Books by Dr. Samuel S. Epstein
      Shelley R. Kramer, Director of Los Angeles Cancer Prevention Coalition
      Contact: 310 457-5176 ..

    • Shelley R. Kramer, Director of Los Angeles Cancer Prevention Coalition
      Contact: 310 457-5176 [email protected]
      Unfortunately if you put Cancer Prevention Coalition into a search engine you get a totally different site Prevent Cancer Foundation which has nothing to do with the work of Professor Samuel S. Epstein, M.D.

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