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.
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.