Billion Dollar Baby Powder

Johnson & Johnson Told to Pay $4.7 Billion in Baby Powder Lawsuit, reports the New York Times reports:

A jury in a Missouri circuit court awarded $4.14 billion in punitive damages and $550 million in compensatory damages to the women, who had accused the company of failing to warn them about cancer risks associated with its baby and body powders. Johnson & Johnson, the maker of Johnson’s Baby Powder, said it was “deeply disappointed” in the verdict and planned to appeal. The company is facing more than 9,000 plaintiffs in cases involving body powders with talc, according to a regulatory document filed this spring….Asbestos is a carcinogen that sometimes appears in natural talc but was stripped from commercial talc products in the 1970s, according to the American Cancer Society. And according to the National Cancer Institute, claims that talc used for feminine hygiene purposes can be absorbed by the reproductive system and cause inflammation in the ovaries are not supported by “the weight of evidence.”

[https://www.nytimes.com/2018/07/12/business/johnson-johnson-talcum-powder.html  ]

When I first read this, I was horrified, especially since I own a little Johnson and Johnson stock.  Headlines like the above are blood in the water to plaintiff’s attorneys (“ambulance chasers”).  I also failed to see any connection between baby powder and ovarian cancer.  But, indeed, there is a plausible connection.

For one, there is an association between talc, the main ingredient of body powders, and asbestos.  Of course “asbestos” does cause cancer.  But I have that word in quotes because it is really quite vague.  “Asbestos” is a commercial term that might cover six or more minerals, some with quite different chemical and physical properties.  In addition, there are many more “asbestiform minerals.”  The potential toxicity, in this case carcinogenicity, varies considerably between those minerals.  Talc, the chief ingredient in baby powder may be “asbestiform” but is different chemically from fibers known as “asbestos.”  Are asbestos minerals common in talc deposits?  The following is from IARC:

https://monographs.iarc.fr/wp-content/uploads/2018/06/mono93-8.pdf

The Tremolite and Anthophylite are indeed asbestos, but they were found in only one or two of the sources.  Thus it is possible that talc might be contaminated with asbestos.  So, there is a chance that prior to 1977, when industry started to pay attention to asbestos-related diseases, talc might have been contaminated with asbestos.  However since then baby powder manufactures have been diligent and there is no proof that since 1977 there has been asbestos contamination in baby powder.  While we are discussing dates, there is no proof, that I have heard of, of asbestos contamination in body powders prior to 1977, that is, proof that J&J used talc sources that were contaminated – although the opposite can’t be proved either.  [BTW, skipping to the lawsuit, it alleged J&J failed to warn.  So about warnings, should J&J now jump in a time machine and warn people back prior to 1977?  Or warn people in 2018 that should not have used baby powder in 1977?  I’m sure a lawyer can explain that much better than an engineer or scientist. ]

However the cancer claims did not need to relate to asbestos in talc.  IARC make it easy; they were able to identify sources of asbestos-free talc and did a monograph on the same.  They found that, unlike asbestos, inhaled talc did not cause cancer or at any rate was unclassifiable.  However, for “perineal use of talc-based body powder” they classified it, in 2010, as a group 2B, possibility carcinogenic to humans.  Now, I had to go to the font-of-all knowledge, Wikipedia, and find out what “perineal” was.  Both males and female have a perineum, but since only females practice “female hygiene” and have ovaries, us males can both breathe and power at will.

But the lawyers have a goldmine.  Ovarian cancer is not rare and feminine use of perineal powder is fairly common.  Thus, if a causal link can be proven between ovarian cancer and talc use, the manufacturers may be liable.  But liable for what misdeed exactly?  The manufactures of talc powder did not cause the cancer, nature did.  [Of course by this time in the ENVE 652 course you realize that the more scientific approach in pathology is to describe things as “risk factors” rather than “causes.”  Most people that smoke do not die of lung cancer and some die of lung cancer who never smoked – tobacco use best described as a “ risk factor” in lung cancer,  not as a “cause.” (But please don't smoke within a 100 feet of my nose.) Bur hereafter I’ll use the common term, “cause.”]

So to discuss liability, we need to look at two factors, the true likelihood that talc causes ovarian cancer and the issue of the duty that the manufactures may have owed the users of the product. Let’s start with the later.  The notion of “product liability,” the strict liability for manufacturers of “unreasonably dangerous products,” is a creature of state law and thus can vary from state to state.  In most states it is common law recognized by state courts rather than a statute law set by the legislature.  Missouri, where J&J was sued, must have had laws particularly suited to the plaintiff, but I couldn’t find any support for that idea in my cursory review.  However, Missouri law was plain that if “The product was then unreasonably dangerous when put to a reasonably anticipated use without knowledge of its characteristics, and the plaintiff was damaged as a direct result of the product being sold without an adequate warning.” The defendant would be liable.  Thus, even if the powder was “unreasonable dangerous” and that fact would be determined by the jury, if there was “adequate warning” J&J would be off the hook.  Note that what “adequate warning” might be is also a fact to be determined by the jury.  Presumably, and this is a broad presumption, if the jury determine the risk (remember – probably and severity of some harm) risk was high, more stringent warning would be required, and vice versa.  But what if the risk was uncertain? That is, there is substantial uncertainty in the science regarding the “harm or probability.”  Which brings us to the next factor, the likelihood talc causes ovarian cancer.

Starting with IARC in 2010, which presumably was composed in 2009 and based on research from 2008 and earlier, in the conclusions, IARC says that some/most of the committee felt there was no causation connection between perineal talc use and ovarian cancer, but a few of the committee felt there was, so they settled on the notion of “possible” and gave talc a 2B rating. Confounding the committee were many issues.  Although there were many studies done, only a few showed a statistical significant correlation between perineal talc use and ovarian cancer.  There have been no positive laboratory studies, which does not mean much, since the reproductive tracts of lab animals are different than humans.  So the epidemiological studies must be consulted.  But here we note that there were many confounding factors.  Here are some:

• Most studies were “case-control” studies that compared known cases with a control group matched for demographic factors.  The weakness of case-control include “selection bias” and “reporting bias.” Although the morbidity and mortality of the cases is known objectively, the factor is self-reported.  Thus, once the possibly of compensation or other media attention is focused on the factor, the self-reporting of that factor tends to rise. 
• A “prospective cohort study” is far sounder, but quite expensive.  It requires that a cohort be identified and followed through the years.  The Nurses’ Health Study did that since 1977, following up thousands of female nurses with a questionnaire ever two years. ( The thoroughness is quite impressive.)  For whatever reason, in the 1982 questionnaire, the study asked about talc use, including frequency.  Note that is not the same a “dose” but then dose for skin applications is often vague.  But, based on my quick review, the “nurses study” is about as good as epidemiology gets.  IARC used it.
• The questionnaire was limited to that time point, and did not ask how long they had been using the talc, nor did the study follow up.
• There was no dose-response relation in most of the positive studies.  Since there would be a long latency period between use and cancer diagnosis, human memory regarding usage amount was stretched, especially if talc use was discontinued later in life.  Ignoring what data was available, some researchers used the “ever” as the variable – “Have you ever used…” Note this is Toxicologically absurd, since it confabulates someone who remember using something once a long time ago, with someone who used the product daily for many year.  Again, the nurse’s study did do a dose-response, but only for that one time .
• For any credence to be placed on epidemiology, a “plausible etiology” must be established.  To my surprise, after some reading, there is such.  The presumed route of the talc fibers would be up the reproductive tract, through the endometrium (the coating of the uterus), then up the tubes into the ovaries.  While this seem far-fetched to me, there is some support, including the finding of talc fibers in excised ovaries.  But the issue is not talc fibers, but whether or not they were the cause cancer at the site.  Here there are two finding they do not.  One is that the study that found talc in the ovaries did not find a dose-response, no relation between the amount of the fibers and the cancer incidence.  The second is that there was no relation between those who nurses reported having their tubes tied and those without the ligation.  An third might be that the studies did not find any correlation with endometrial cancer.

Overall, the nurses study did not show a correlation with talc use , quoting from IARC’s report: Overall, no association between ‘ever use’ of talcum powder and total risk for epithelial ovarian cancer (relative risk, 1.1; 95% CI, 0.9–1.4) and no trend of increased risk for ovarian cancer with increasing frequency of talc use were observed.

IARC noted other issues.  For one, there was a slightly positive correlation with serous ovarian cancer – a very virulent form.  IARC did not mention, but I will, that finding would mean there was a decrease in there other forms of ovarian cancer.    Also, there was no correlation with endometrial cancer.

Here I will go somewhere I probably should not, but….The analysis of the nurses study when the authors [Gertig 2000] matched the controls to the cases, they did account for BMI, body mass index - measure of fat.  Since increase in BMI leads to increases in skin fold irritation, it likely leads to increase in powder use.  Gertig did address that, “Obesity is known to be a very strong risk factor for endometrial cancer, and obesity is also independently associated with talc use. The adjusted and unadjusted results did not differ greatly when adjusted for possible confounding variables other than BMI.”  But then goes on to say the results were not much different when they accounted for BMI.

Before we go to my suggested warning label, let’s look at some numbers from the nurses study:

So, if there was an increase in risk, it would be between 0.0002.  As it was, the author’s of the report on the nurses’ study judged it not statistically significant.  But even it if was significant, it would be minuscule.  One thing the author’s did not do, would be to compare the risk using two other variables, for example broccoli use or vitamin E use.  My guess is one or the other would be more significant than the talc.

Now to the warning label.  I would suggest a good warning label would be what IARC said:

There is limited evidence in humans for the carcinogenicity of perineal use of talc based body powder… and Perineal use of talc-based body powder is possibly carcinogenic to humans (Group 2B).  For perineal use of talc-based body powder, many case–control studies of ovarian cancer found a modest, but unusually consistent, excess in risk, although the impact of bias and potential confounding could not be ruled out. In addition, the evidence regarding exposure–response was inconsistent and the one cohort study did not provide support for an association between talc use and ovarian cancer. Concern was also expressed that exposure was defined in a variety of ways and that some substances called talc may have contained quartz and other potentially carcinogenic materials. A small number of Working Group members considered the evidence to be inadequate. Despite these reservations, the Working Group concluded that the epidemiological studies taken together provide limited evidence of an association between perineal use of talc-based body powder and an increased risk for ovarian cancer.

With that, I wish Johnson & Johnson good luck with their appeals to higher courts.

[Dear Reader. I put this together in a hurry in late November 2018. I emailed several entities who have posted information asking for references and citations, and not received them as I put this site on the web.}

Dorota M. Gertig  David J. Hunter  Daniel W. Cramer  Graham A. Colditz Frank E. Speizer  Walter C. Willett  Susan E. Hankinson.  JNCI: Journal of the National Cancer Institute, Volume 92, Issue 3, 2 February 2000, Pages 249–252, https://doi.org/10.1093/jnci/92.3.249.  Use of talcum powder and endometrial cancer risk, Cancer Causes and Control http://rd.springer.com/article/10.1007%2Fs10552-011-9894-5