A jury recently awarded $70 million to a California woman who used Johnson & Johnson's talc-based baby powder and claimed that it caused her ovarian cancer. Two lawsuits from earlier this year awarded a combined $127 million, and thousands of other women have filed suits against Johnson & Johnson. Meanwhile, two other lawsuits in New Jersey were thrown out by a judge who said the scientific evidence wasn't reliable enough to establish a clear cancer link. All these cases follow on an original 2013 jury finding for physician's assistant Deane Berg, which paradoxically found that baby powder could have been a factor in her cancer yet awarded her zero damages.
While these real-world juries have been forced to make decisions on whether a substance causes cancer, the metaphorical scientific "jury is still out." The American Cancer Society's review of the evidence notes:
Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase. Many case-control studies have found a small increase in risk. But these types of studies can be biased because they often rely on a person's memory of talc use many years earlier. Two prospective cohort studies, which would not have the same type of potential bias, have not found an increased risk.
The ACS concludes that "if there is an increased risk, the overall increase is likely to be very small." Most other cancer researchers seem to take a similarly measured approach in characterizing the current state of the evidence, such as these guidelines from the Dana-Farber Cancer Institute:
"All of these studies suffer from incomplete data on patients' family history of ovarian or breast cancer, as well as the duration and frequency of powder use, says Panos Konstantinopoulos, MD, PhD, of the Gynecologic Oncology Program in the Susan F. Smith Center for Women's Cancers at Dana-Farber. "In general, population-based studies have shown a statistically significant association with ovarian cancer risk, while hospital-based studies showed that this association is not statistically significant," he says. In addition, none of the studies found that risk rose with increased exposure to the powder, and there is no evidence that talcum powder use on other parts of the body affects ovarian cancer risk.
[Continues...]
On the other side of this argument is Daniel Cramer, an epidemiologist at Brigham and Women's Hospital, also with appointments at Dana-Farber and the Harvard Cancer Center, who was the first to publish research connecting talc to ovarian cancer in the 1980s and who has devoted significant time to further studies on the issue. (He is also a paid consultant for plaintiff's lawyers in many of these cases.) Cramer thoroughly believes the data is incontrovertible, and he has mentioned particular strategies for convincing juries of this: "Juries are very persuaded by the forensic evidence. [...] If you put up a picture of a lymphatic channel with a talc particle in it, that's pretty convincing."
But legal experts don't always think the science is even relevant. A Bloomberg feature story earlier this year quoted University of Michigan law professor Erik Gordon: "You don't win with jurors on science. They don't understand science, statistics, the design of studies. [...] They do understand there was some evidence of a connection between talc and cancer, and J&J didn't tell customers about it."
This final claim -- that J&J "didn't tell customers about it" -- is the rationale behind the inflated punitive awards in the verdicts so far. Rather than merely claiming Johnson & Johnson was negligent, plaintiffs have alleged that the company's actions were knowing and deliberate, thereby justifying hundreds of millions of dollars in punitive damages. Most of these claims seem based on two internal memos (archived by Bloomberg here and here). The first, a 1992 marketing memo, notes various obstacles to successful marketing, including "negative publicity from the health community on talc." While the memo primarily appears to be recognizing that there was a publicity problem with health claims, rather than admitting an actual health problem, plaintiffs have used this as evidence that J&J was aware of the issue decades ago and tried to downplay it. But the plaintiffs have also gone far beyond this in claiming a racial bias, since one of the marketing "opportunities" in the memo is to "investigate ethnic (African American, Hispanic) opportunities to grow the franchise," groups that now appear to have higher rates of ovarian cancer.
Like the tobacco trials a couple decades ago, the plaintiffs have thus alleged that J&J not only knew about risks, but specifically targeted people with what they knew was a dangerous product. Ironically, the second memo was essentially a warning that this could happen if J&J wasn't careful. This 1997 memo from a toxicologist consultant has been widely quoted in media reports:
At [the time of a previous scientific review panel] there had been about 9 studies (more by now) published in the open literature that did show a statistically significant association between hygienic talc use and ovarian cancer. Anybody who denies this risks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence to the contrary.
Taken out of context, this quote surely sounds like a "smoking gun" of a scientist sounding the alarm. Unfortunately, media reports (and the plaintiffs in court, presumably) don't quote the memo sentences immediately following, which make the context clear:
This would be a particularly tragic misperception in view of the fact that the [talc] industry does have powerful, valid arguments to support its position. [...] What the workshop panel did conclude was that (1) the results of the studies were ambiguous, inconsistent, contradictory and therefore inconclusive, (2) therefore hygienic use of cosmetic talc does not present a risk to the consumer. So why not use these powerful and irrefutable arguments [...] instead of questionable mush that leaves one vulnerable to counterattack?
In other words, we have a scientist here who was arguing for nuance: He isn't saying there's proven research and the talc industry is "denying the obvious" like Big Tobacco. He's saying if you make sweeping claims that there's no creditable scientific evidence out there, you'll be portrayed like Big Tobacco, i.e., denying reality. Instead, it should be noted that there are studies out there (some of which seem statistically valid), but expert review panels have found them contradictory and inconclusive. In effect, here's a scientist trying to help an industry avoid a future "Big Tobacco-like" lawsuit by presenting a more nuanced scientific perspective, and his words have been taken out of context in that very future lawsuit to make it look like the industry was acting just like Big Tobacco.
Whether or not talc is associated with cancer seems unclear, at least from a science standpoint. But the law professor quoted above may be right -- there really is no room for scientific nuance in the courtroom.
Related Stories
Johnson & Johnson has been ordered to pay $70 million in compensatory damages and $347 million in punitive damages to a woman who claimed to have developed ovarian cancer as a result of using J&J powder products. Baby/talcum powder contains talc, a clay mineral:
Johnson & Johnson has been ordered to pay $417m (£323.4m) to a woman who says she developed ovarian cancer after using products such as baby powder. The California jury's decision marks the largest award yet in a string of lawsuits that claim the firm did not adequately warn about cancer risks from talc-based products.
A spokeswoman for Johnson & Johnson defended the products' safety. The firm plans to appeal, as it has in previous cases. "We will appeal today's verdict because we are guided by the science," Carol Goodrich, spokesperson for Johnson & Johnson Consumer Inc, said in a statement.
The evidence around any link between talc use and cancer is inconclusive. Johnson & Johnson, headquartered in New Jersey, faces thousands of claims from women who say they developed cancer due to using the firm's products to address concerns about vaginal odour and moisture. Johnson & Johnson has lost four of five previous cases tried before juries in Missouri, which have led to more than $300m in penalties.
Previously: The Baby Powder Trials: How Courts Deal with Inconclusive Science
A California judge has thrown out a $417 million verdict against Johnson & Johnson. The plaintiff claimed that she developed ovarian cancer after using J&J's talc-based products:
The ruling by Los Angeles Superior Court Judge Maren Nelson marked the latest setback facing women and family members who accuse J&J of not adequately warning consumers about the cancer risks of its talc-based products. The decision followed a jury's decision in August to hit J&J with the largest verdict to date in the litigation, awarding California resident Eva Echeverria $70 million in compensatory damages and $347 million in punitive damages.
Nelson on Friday reversed the jury verdict and granted J&J's request for a new trial. Nelson said the August trial was underpinned by errors and insufficient evidence on both sides, culminating in excessive damages.
Mark Robinson, who represented the woman in her lawsuit, in a statement said he would file an appeal immediately. "We will continue to fight on behalf of all women who have been impacted by this dangerous product," he said.
Previously: The Baby Powder Trials: How Courts Deal with Inconclusive Science
Johnson & Johnson Ordered to Pay $417m in Latest Talc Cancer Case
Johnson & Johnson's baby powder has been linked to mesothelioma for the first time in court, with the plaintiffs being awarded at least $37 million (70% to be paid by J&J, and 30% by Imerys SA):
A New Jersey man who sued Johnson & Johnson and other companies after getting cancer he says was caused by asbestos in baby powder has been awarded $30 million by a jury.
A jury of seven women sitting in New Brunswick also decided Thursday that Kendra Lanzo, the wife of Stephen Lanzo III, must be paid an additional $7 million as a result of the mesothelioma contracted by her husband. The jury will decide next week whether to also award punitive damages to the Lanzos.
[...] Johnson & Johnson is responsible for 70 percent of the damages, while France-based Imerys SA must pick up the rest of the tab. Imerys supplied the talc used to manufacture the baby powder.
Previously: The Baby Powder Trials: How Courts Deal with Inconclusive Science
Johnson & Johnson Ordered to Pay $417m in Latest Talc Cancer Case
$417 Million Talc Cancer Verdict Against Johnson & Johnson Tossed Out
Johnson & Johnson's stock slammed after report it knew of asbestos in baby powder
Shares of Johnson & Johnson tumbled Friday, after a Reuters report that the drug and consumer-products company knew for decades that its baby talcum powder was contaminated with asbestos, a known carcinogen, that is alleged to have caused cancer in thousands of its customers.
The stock ended 10% lower on Friday, marking its largest one-day percentage decline in 16 years and lowest close in nearly four months, according to FactSet data. It led decliners on the Dow Jones Industrial Average and the S&P 500 on the day, and accounted for about 101 points of the Dow's 497-point loss.
[...] Reuters said an examination of internal company memos and other documents found the New Jersey–based company was aware of the presence of small amounts of asbestos in its products from as early as 1971 but failed to disclose that fact to regulators or to the general public.
Reuters stands by J&J report, says it was based 'entirely' on Johnson & Johnson documents
Reuters reporter Lisa Girion stands by her report that Johnson & Johnson knew for decades that asbestos was in its baby powder. "Our report on the fact that J&J was aware of small amounts of asbestos in its talc, in its baby power, in the ore that it mined in Vermont to make baby power, is based entirely on their documents," Girion told CNBC's "Power Lunch" on Friday.
The Reuters story sent J&J shares down 9 percent on Friday and prompted a response from the health-care company that called the article "one-sided, false and inflammatory." "Simply put, the Reuters story is an absurd conspiracy theory, in that it apparently has spanned over 40 years, orchestrated among generations of global regulators, the world's foremost scientists and universities, leading independent labs, and J&J employees themselves," the company said in a statement.
See also: Asbestos Opens New Legal Front in Battle Over Johnson's Baby Powder
Those J&J Baby-Powder Lawsuits Aren't Going Away
Johnson & Johnson loses $39.8 billion in market value in one day after report claims it knew about asbestos in its baby powder
Previously: The Baby Powder Trials: How Courts Deal with Inconclusive Science
Johnson & Johnson Ordered to Pay $417m in Latest Talc Cancer Case
$417 Million Talc Cancer Verdict Against Johnson & Johnson Tossed Out
Johnson & Johnson Loses New Jersey Talc Cancer Case
(Score: 5, Interesting) by VLM on Monday October 31 2016, @03:54PM
Following the money is interesting. If you click enough you'll eventually find
http://www.cir-safety.org/sites/default/files/talc032013rep.pdf [cir-safety.org]
which implies its a ridiculously inefficient way to kill people, compared to big tobacco. So male miners who practically swim in the stuff never get cancer and its very hard to give cancer to animals in general using talc. The report does indicate its pretty easy to contaminate the female system with talc and in fact most probably are to some extent or another contaminated. And the specific cancer is ridiculously uncommon compared to the near universal contamination level.
https://en.wikipedia.org/wiki/Cosmetic_Ingredient_Review [wikipedia.org]
There is a similarity that the organization is entirely industry funded and apparently never finds anything the industry likes to be dangerous, in comparison to real regulators in Europe who actually do their job. On the other hand the corruption seems to be in deciding what to report and what to emphasize not that the studies in the report are outright faked.
A contrast with big tobacco is half the population seems immune to talc cancer, and most women are somewhat contaminated with the stuff, yet cancer is extremely rare. It would be like if only one, very small, genetic line of people could get cancer from smoking. Whereas tobacco is fairly effective at killing all humans.
Another interesting contrast is tobacco smoke contains random tarry organic chemistry substances, and its a given truth that random o-chem tarry substances have long been proven to cause cancer. On the other hand talc is ridiculously refined and is a basically pure product of a given and known chemical formula that has been proven unlikely to cause illness or cancer everywhere but, supposedly, when applied externally to the female repro system. Which is fascinating. For example, something like benzene is a known carcinogen and it doesn't matter much if I stick my wiener in a beaker of benzene or a finger, its just not going to turn out well WRT cancer. Yet talc is apparently incredibly dependent on tissue. Its not entirely unheard of, kind of like radioactive iodine kills one gland intensely not just skin in general, but it is very rare and very weird and very unusual which makes talc very interesting assuming there is any link at all.
It might be topological like inserting any powder of certain dimensions into a reproductive system kills women just as effectively as talc. Supposedly asbestos is like that in lung tissue, the problem is the needle like shape somehow pissing off the tissue into responding with what eventually turns into a tumor. In that way banning talc will accomplish nothing if its replaced with limestone dust of identical dimensional specifications.
Scientifically its not another tobacco, thats for sure, maybe marketing and political/legally it'll be the same, sure, I mean you got a winning strategy, keep applying it. Someone's going to apply the "big tobacco money machine" to some industry, if it ain't these guys applying it to talc it'll be someone else going after some other industry. Of course it doesn't have to be binary, this or that.
(Score: 2) by zocalo on Monday October 31 2016, @05:23PM
Even though the talc is (presumably) only being applied topically, it's reasonable to expect that at least some of it is going to get inside the vagina as a matter of course, but that's not likely to be enough, is it? It's presumably also going to have to get from there, all the way up the vagina, traverse the cervix and uterus, get into *and* along one of the fallopian tubes, before it gets into close enough proximity to the ovaries that it can (maybe) trigger a cancerous reaction. And all of that has to be achieved inside a system that has multiple natural mechanisms that are going to try and flush out any particulate matter on a regular basis, over and above any additional vaginal hygiene the woman may be doing. That's a pretty big ask even for sperm, and that has both an initial head start and a method of propelling itself the rest of the way. Not impossible, but it does seem highly unlikely and more likely to be a statistical blip that any genuine issue.
UNIX? They're not even circumcised! Savages!
(Score: 1) by khallow on Monday October 31 2016, @05:52PM
There is a similarity that the organization is entirely industry funded and apparently never finds anything the industry likes to be dangerous, in comparison to real regulators in Europe who actually do their job.
Not relevant when those European regulators don't find talc to be dangerous either.
(Score: 2) by JoeMerchant on Monday October 31 2016, @08:29PM
Like nanoparticles, it might not matter so much what they are made of chemically, if they are the right (/wrong) size, they can gum up the works in new and devious ways.
🌻🌻 [google.com]
(Score: 2) by Reziac on Tuesday November 01 2016, @07:19AM
In that case, ordinary dirt should be more of a problem. Especially if you live in a region of dry clay soils and dust that gets into everything, including your underwear. Not a problem?? Hmmm.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 2) by JoeMerchant on Tuesday November 01 2016, @12:43PM
Diversity of particle size in the dirt would be rather tremendous as compared to industrial scale produced nanoparticles (though, some of those processes are still quite uncontrolled themselves and not yielding quite the uniformity they are trying for.)
So, I suppose if you do a study of female mammals that bathe their parts in mud and dirt, you might find some adaptations that deal with tiny particles better than California women do.
With a population of 7 billion, there's going to be small subsets of people who are vulnerable to all kinds of things - any big uniform process you roll out is at risk of harming some people, the question is: how do you deal with that? Are we satisfied that controlled testing on 1000 "representative" people is sufficient (0.000014% sample size)? The current regulatory thinking includes post-market surveillance, but that's only just been getting going for the last 5-10 years.
🌻🌻 [google.com]
(Score: 2) by Reziac on Tuesday November 01 2016, @02:21PM
Allowing for discussion that she has some genetic predisposition to hypersensitivity to what's okay for everyone else, or perhaps abused the product by packing her nethers solid with it, how is that the product's problem?? Cuz if it's the product's problem, then makers of just about everything that can be ingested deliberately or accidentally are in deep trouble. You can always find someone who reacts badly to just about every possible product, if you look long enough. Given 7 billion subjects, there's likely a chance intersection with someone who has an unrelated but concurrent issue... for any combination of product and issue you care to pick.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 2) by JoeMerchant on Tuesday November 01 2016, @08:49PM
And this is where post-market surveillance comes in. Reported problems should be investigated, recorded and trended. If the problem really does only show up in 0.01% of the population (350,000 women world-wide) and this is a world-wide marketed product, I would think it only basic human decency to at least inform women of the potential probability of the problem.
At some threshold (do you have to kill 1,000,000 people at least 10 years early to be a significant problem?) stronger steps need to be taken to keep the product from doing harm - or, at least prove that the product is doing more good than harm (see: anti-microbial hand soaps in the US recently.)
I don't think that products should be kept off the market until they're "proven 99.999% safe" (which still means potential harm for 70,000 people)... I do think that the effects of products on people need to be tracked, analyzed and trended - preferably by an organization independent of the one that profits from the products' manufacture and sale, and it would only seem fair that the company profiting from the manufacture and sale of the product foot the bill for this activity (yes, evil taxes and wasteful government programs), otherwise you get things like "perfectly harmless cigarettes" in broad commercial distribution, complete with mis-information campaigns backing up their marketing departments, for decades, costing trillions of dollars in extra medical care, lost productivity, etc.
Whatever system we are moving toward for product regulation, I hope it also protects manufacturers against $70M+ random lawsuits - if that's the best we've got for checks and balances in the marketplace, we need to take a few hundred lawyers, fit them with concrete shoes and make them take a long walk on a short pier.
🌻🌻 [google.com]
(Score: 4, Funny) by RamiK on Monday October 31 2016, @04:05PM
But I'm kinda digging this whole newt life style so I'm willing to settle for $40 million.
compiling...
(Score: 1, Interesting) by Anonymous Coward on Monday October 31 2016, @04:14PM
Cell division causes cancer, nothing else. Tobacco etc damages tissue which causes a need for cell division to maintain it. But also the smokers in the original studies had much lower mortality rates than the population at large and the non smokers were uber healhy (these were studies of veterans and doctors), so who knows how big a deal that even is for a typical person? You haven't heard that because medical research is so messed up, and has been for a long time. They always miss the interesting stuff in the data to focus on spinning towards whatever preconceived notions they had.
The crazy tying is I will sound like a crackpot to you when this is the position of people like Bruce Ames, Ronald Fisher, etc. Meanwhile you will get advice from a bunch of people who use stats without knowing wtf a p value is.
(Score: 0) by Anonymous Coward on Monday October 31 2016, @04:17PM
Erroneous and thing.
(Score: 1, Insightful) by Anonymous Coward on Monday October 31 2016, @05:09PM
Cell division is what cancer is. Cancer is not CAUSED by cell division. Something damages the DNA or otherwise causes cells to divide out of control. Medical research doesn't hide or ignore these facts, so what are you smoking?
(Score: 2) by ledow on Monday October 31 2016, @05:19PM
"Original studies" is your error.
The follow-up studies confirmed, without bias or excuses.
It's a medical, and scientific, fact that smoking increases your risk of cancer. It doesn't matter who you are.
It is NOT a medical, or scientific, fact that talc does. Nobody has established that beyond the usual margins of error. And it's had 1/100th the testing of things like tobacco, which took decades to establish the science behind.
So to make a legal judgement on talc is - at this point - nonsense.
But to say you should stop smoking, to ban things likely to lead to passive smoking (e.g. public-places smoking bans, etc.), and so on - that's NOT nonsense. It is, indeed, sense. Even if there are a few crackpots studying the field and doing bad science.
The carrying out of bad science does not negate the findings of proper science in the same areas.
(Score: 2) by curunir_wolf on Monday October 31 2016, @06:39PM
On the other hand, the tobacco control community is now spreading the misinformation that vaping is just as dangerous as smoking, to such a degree that three times as many people believe that than did several years ago. Complete misinformation campaign. And new FDA deeming regulations that classify all kinds of completely non-tobacco projects (batteries, glass tubes, atomizers, etc.) as actual "tobacco products", even though over 30% of users of those products don't use nicotine in them at all.
These regulations are so onerous and the misinformation campaign at such a fevered pitch that vaping products are going to get a lot more expensive or disappear altogether. Completely irresponsible behavior on the part of the CDC and the FDA that's encouraging more people to smoke combustibles and not try vapes, protecting the profits of big tobacco and possibly even costing A Billion Lives [abillionlives.com].
I am a crackpot
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @01:38AM
A local vape shop had to jack prices recently and reduce their service because of this nonsense. So I bought a pipe and I'm back to burning tobacco for my nicotine fix. :(
(Have tried to quit nicotine several times now, but there's too much drama horseshit at the day job to do without it.)
(Score: 0) by Anonymous Coward on Monday October 31 2016, @05:47PM
Cell division causes cancer, nothing else.
That is incorrect. Viral DNA insertions can cause cancer. Uncontrolled cell proliferation is a property of cancer and every time a cell divides there is an increased chance for mutation, but this is not a strict cause of cancer.
There is plenty of evidence about how smoking tobacco increases the risk for particular types of cancer. This has been found despite preconceived notions that it wasn't a problem and a large amount of industry pressure to find no link.
If you have some other evidence or know of another correlative factor that fits the increases and decreases of lung cancer as well as tobacco smoking does, then feel free to stack it up against the current evidence and see if it does better.
(Score: 0) by Anonymous Coward on Monday October 31 2016, @06:30PM
"Viral DNA insertions can cause cancer."
Source? Perhaps the insertions make the cells divide more often.
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @12:53AM
HTLV is the first virus that comes to mind. IIRC EBV and HPV have also been found to be integrated upstream oncogenes, but they also use viral proteins to force cell proliferation.
Perhaps the insertions make the cells divide more often.
Yes, cancer demonstrates the property of uncontrolled cell proliferation.
https://en.wikipedia.org/wiki/Human_T-lymphotropic_virus [wikipedia.org]
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @05:37AM
Which reference do you say includes what you say and vouch for from that summary?
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @01:26PM
I'm not sure if you're disingenuous, so how about a trade?
Provide a primary reference for your claim:
Cell division causes cancer, nothing else.
and I'll provide a primary reference for mine.
(Score: 0) by Anonymous Coward on Wednesday November 02 2016, @05:19AM
Great to see we are operating at the same level.
(Score: 2) by sjames on Monday October 31 2016, @05:31PM
Erik Gordon sure said a mouthfull. If he's correct (and I find that likely), he is essentially claiming that any blather about the courts reaching the truth is simple fraud. Very simply, if science doesn't win in court than the truth is truly orthogonal to the courts' process.
(Score: 3, Insightful) by HiThere on Monday October 31 2016, @06:36PM
Look at the rules of evidence, what is allowed to be said, etc., you will quickly decide that the effectiveness of scientific evidence is both limited and biased. How do we know that fingerprints are a reasonable identifier? What double blind studies have been performed?
Usually the police have some suspicions of who might have done it, and in that case fingerprints are quite good at winnowing the suspects, and even sometimes eliminating all of them. They aren't good at selecting people from a database without external evidence. Similarly for DNA. Even when the DNA is correctly identified (often it isn't) that still doesn't say how it got there. One guy was claimed to be committing a crime while he was actually strapped in a hospital bed with his leg elevated. That was one fortunate broken leg.
The court procedures seem to often find the correct guilty party, but the scientific evidence is used poorly when it's used at all. And this was a jury trial, so the verdict was mainly about convincing the jury. Which means that the lawyers didn't concentrate on any pieces of science which might have made the jurors mad at them. A jury trial before people selected for ignorance is a lousy place to conduct an investigation of unsettled science.
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 3, Interesting) by sjames on Monday October 31 2016, @08:08PM
Yes, police and prosecutors routinely try to blind the jury with science and the courts routinely let them do it. Their entire process is designed around producing confirmation bias. It's fraud to call it science.
It's one thing for the jury to have a limited understanding of the science (perhaps a bit sad, but not their responsibility), but it's quite another for detectives, judges, and prosecutors. It's their job to understand these things and to apply them to get at the truth of the matter. It is definitely not their job to pick someone they like for the crime and cook the books until they look guilty.