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talc 5/11
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Of Talc, Cancer, and Chemophobia
May 11, 2016 | Undark.org
By David Ropeik
Two weeks ago, a jury decided that Johnson & Johnson’s baby powder caused a woman’s ovarian cancer, and ordered the company to pay her $55 million. Her attorney said the case against talc, the principal ingredient in the powder, was clear: “Science has been simple and consistent over the last 40 years,” he told the jury, according Bloomberg News. “There’s an increased risk of ovarian cancer from genital use of talc.” -
Jere Beasley tells Johnson & Johnson to end talc litigation
May 11, 2016 | Montgomery Advertiser
By Andrew J. Yawn
The scientific community remains split over whether or not talcum powder used by women conclusively causes ovarian cancer, but juries continue to find Johnson & Johnson liable for not warning its consumers of possible risk. -
Talcum Trouble: Where Does J&J’s Responsibility Lie
May 11, 2016 | Knowledge@Wharton
By Adetunji T. Toriola and Robert Field
Johnson & Johnson is battling claims that it has prioritized revenues over ethics after a recent court case awarded damages to a woman who was diagnosed with cancer following years of using its talcum powder. Although this was the third such case, the company maintains that the medical evidence of the links between ovarian cancer and talc is uncertain. However, despite scientific facts, its brand image could take some knocks, say experts at Wharton and Washington University.
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Of Talc, Cancer, and Chemophobia
May 11, 2016 | Undark.org
By David Ropeik
Two weeks ago, a jury decided that Johnson & Johnson’s baby powder caused a woman’s ovarian cancer, and ordered the company to pay her $55 million. Her attorney said the case against talc, the principal ingredient in the powder, was clear: “Science has been simple and consistent over the last 40 years,” he told the jury, according Bloomberg News. “There’s an increased risk of ovarian cancer from genital use of talc.”
The company, which was ordered to pay $72 million in a separate ovarian cancer case in February, responded aggressively, posting “A Message About Talc” on its website following the jury’s decision, which Johnson & Johnson says it plans to appeal. “After 30 years of studies by medical experts around the world, science, research and clinical evidence continues to support the safety of cosmetic talc,” the company noted, pointing to two recent studies – one from the Harvard School of Public Health, and another published last fall in the Journal of the National Cancer Institute — that showed no association between talc and ovarian cancer.
“We also know that some epidemiology studies have reported an association between talc and ovarian cancer,” the company conceded. “However, various governmental and non-governmental agencies as well as other expert panels have reviewed and analyzed all available data, and none have concluded that talc can cause cancer.”
The scientific truth about the carcinogenicity of talc is, well — there is no accepted black-and-white truth, and that’s the problem, with this and many industrial substances. The evidence linking talc to ovarian cancer is sketchy – the American Cancer Society notes that important research is still needed to sort out the connection, and if there is one, the risk for any given person is tiny – but there are enough hints to prompt the International Agency for Research on Cancer to rate talc as “possibly carcinogenic to humans.”
That sounds scary, but such a rating from IARC means the evidence is thin, and it puts talc in the same category as aloe vera, gingko biloba extract, and goldenseal root powder, which haven’t set off alarm bells (yet). It’s also the same category for several things that certainly have raised alarms, including chlordane (a pesticide), and perfluorooctanoic acid (PFOA), the chemical used to make Teflon.
There haven’t been a lot of lawsuits alleging that aloe vera or gingko biloba cause cancer, but there have been several making that charge about PFOA and chlordane — and now the legal focus is turning to talc, a naturally occurring mineral. But if the evidence for each suspected substance is equally equivocal, why are some of these possible toxins targeted while others aren’t? Shouldn’t they all evoke the same degree of concern?
Scientifically, perhaps. But risk perception is emotional — a combination of the facts and how those facts feel. That’s the foundation of chemophobia, an instinctive fear of chemicals — particularly those that are (or feel) human-made. It’s a potent enough fear that we often overlook important scientific details that determine whether something is a risk and how much of a risk it might be. These include the precise dose of a chemical that causes certain levels of risk, whether we are actually exposed to those doses, at what age, and whether we’re exposed just once or regularly.
These pivotal details are rarely reported by the media, and they are ignored by environmental advocates. Perflourooctanoic acid sounds scary. Gingko biloba doesn’t. Chemical and pharmaceutical companies sound scary. Organic farms don’t.
But chemophobia cannot be blamed on the media (although their incomplete risk reporting makes it worse), nor on environmentalists, who quite rightly want to protect human and environmental health from the harm that industrial chemicals certainly have done (though environmentalist chemo-alarmism makes things worse too). Fear of industrial chemicals is an inherent feature of human psychology.
Research by Paul Slovic and Baruch Fischhoff and others long-ago established that we instinctively fear human-made risks more than natural ones. Radiation from nuclear power plants is scarier than carcinogenic radiation from the sun, for example. The side effects of industrial pharmaceuticals scare us more than the side effects from natural and herbal remedies. Bacillus thuringiensis (Bt) is a naturally occurring pesticide used on organic farms. Using genetic engineering to get the Bt gene into corn or soy creates plants that don’t need to be sprayed with as much industrial pesticide — but it also suddenly makes Bt sounds scarier.
Chemophobia is also fueled our instinctive fear of risks that are imposed on us by others, as opposed to those risks we take on knowingly, and voluntarily. It doesn’t feel like nature imposes risks on us, for example, but it sure feels like DuPont and Johnson & Johnson and Monsanto do. Most of the lawsuits that target industrial chemicals blame the companies that foisted them on us for knowing about the risks and not warning us. That was the central claim in the talc case against Johnson & Johnson, and it is at the heart of the 1,200 lawsuits that the company still faces.
BUT CHEMOPHOBIA IS MORE than just a form of science ignorance that ought to be corrected with better education. It’s dangerous. It drives us to ban things that feel scary but have far more benefit than risk — like fluoridated drinking water. It drives us to ban some substances, only to end up with alternatives that are even worse: We got rid of toxic gasses used as refrigerants, like methyl chloride and sulfur dioxide, for example, and ended up with chlorinated fluorocarbons and a hole in the ozone layer. Chemophobia drives us to spend lots of money on higher-priced items that are marketed as “natural,” but which confer no demonstrable health benefit (see: organic fruits and vegetables.)
Reverse chemophobia is dangerous too. “Natural” does not automatically mean “safe,” yet we don’t regulate herbal and natural medicines nearly as much as we do industrial pharmaceuticals, though both are biologically active substances that sometimes have harmful side effects. You may recall the lawsuits against Merck’s painkiller Vioxx (Merck withdrew it and paid nearly $5 billion to settle 27,000 legal claims). But you’d be hard-pressed to find lawsuits concerning St. John’s Wort, despite evidence that it increases sun sensitivity and the risk of skin cancer, or demands from environmental groups to ban soy products, which are far more estrogenic than the bisphenol A — that chemical in plastic that was banned from baby bottles in 2012.
Talc isn’t human-made, of course. It’s a natural mineral under attack mostly because the very speculative risk of ovarian cancer it raises has been imposed on us by a big, greedy industry that we mistrust — and that attorneys can get rich suing. Yes, their lawsuits feed chemophobia too. Like the media and environmental advocates, the plaintiff’s bar is only taking advantage of an inherent facet of human nature.
Ours is an emotion-based risk perception system, and to give it its due, this system mostly gets things right. Let’s not forget, after all, that plenty of the industrial chemicals we’ve worried about over the years have been proven to do plenty of harm. But when this human reflex gets things wrong, it can become a risk all by itself, and chemophobia can end up being just as much a threat to our health as the industrial chemicals we all so readily fear.
That alarm should be raised too.
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Jere Beasley tells Johnson & Johnson to end talc litigation
May 11, 2016 | Montgomery Advertiser
By Andrew J. Yawn
The scientific community remains split over whether or not talcum powder used by women conclusively causes ovarian cancer, but juries continue to find Johnson & Johnson liable for not warning its consumers of possible risk.
For the second time in three months, a jury has found Johnson & Johnson liable for ovarian cancer potentially caused by genital use of the company’s talcum powder products. A St. Louis jury awarded ovarian cancer survivor Gloria Ristesund $55 million on May 2.
Two days after that decision, Montgomery attorney Jere Beasley, lead co-counsel on the lawsuit, offered his opponent free legal advice: End the litigation and set up a collection fund.
“I suggest we bring this thing to a close before it gets any further. Work out a settlement plan,” Beasley said, paraphrasing his May 4 email to Johnson & Johnson.
Beasley also suggested that the company either label its talcum powder products as potentially hazardous or pull them from store shelves altogether.
A week after the proposal, Johnson & Johnson hasn’t responded.
Company spokesperson Carol Goodrich declined to comment on the possibility of a settlement and only said that Johnson & Johnson will appeal the Ristesund decision. Defense attorney Gene Williams did not reply to multiple requests for comment.
If Johnson & Johnson settles, the Ristesund decision will theoretically be the end of talcum powder lawsuits making it to the courtroom.
If the health-care product giant doesn’t, it is just the beginning.
Ristesund is only one of 64 women involved in the joint lawsuit against Johnson & Johnson and is the second of the group to go to court.
In February, the family of Jacqueline Fox — a Birmingham native who died of ovarian cancer in October 2015 — was awarded $72 million. In both the cases of Fox and Ristesund, talc was found in their ovarian tissue.
The problem for Johnson & Johnson, however, is that in the Ristesund case, the jury chose to award Ristesund $55 million. In other words, Beasley and the prosecution did not ask for the amount given.
“In closing argument, you usually ask for a specific amount or a range of amount,” Beasley said. “In this case we said, ‘Jury it’s up to you. You’ve heard the evidence and seen the documents. Whatever you think.’ They actually picked that number.”
In the case of Jackie Fox, Beasley had asked for a total in the range of $12 million to $20 million. The jury far exceeded that amount, awarding Fox’s family $72 million with $62 million of that in punitive damages.
The jury’s reasoning? One million for every year the 62-year-old Fox used Johnson & Johnson talcum powder.
If it was only 64 women suing Johnson & Johnson, it can be assumed the company would have to pay about $4 billion total if juries continue awarding similar amounts. While that total seems daunting, Johnson & Johnson earned $70 billion worldwide in gross sales in 2015, according to the company’s end of year report, and appeals may lower the number they actually have to pay.
But it’s not only 64 women.
There are about 1,200 other lawsuits claiming a talc-ovarian cancer link filed against Johnson & Johnson. After the Fox decision, about 17,000 more women reached out to Beasley about filing suit.
Due to statutes of limitations, that list has been whittled down, and the Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. law firm is currently evaluating about 11,000 claims.
With the sheer volume of lawsuits pending and being evaluated, Beasley said a settlement just makes sense for both sides.
“They can’t do this for 11,000 people,” Beasley said. “They know us well enough to know we’re not bluffing. If they don’t want to do this, we’re dedicated to going that route and trying case after case after case.”
For its part, Johnson & Johnson is maintaining that its talc powder products — Johnson’s Baby Powder and Shower to Shower — are safe for women to use between their legs despite the company offering several corn-starch powders. After the latest loss, Johnson & Johnson said in a statement that “the jury’s decision goes against 30 years of studies by medical experts around the world.”
It is true that there is no conclusive link between talc and ovarian cancer at this point. In fact, the American Cancer Society only lists talc containing asbestos as a carcinogen, and the International Research Agency on Cancer lists perineal use of talc by women as a “possible carcinogen.”
A 2008 study by Penn State University’s Dr. Joshua Muscat also found that “mechanistic, pathology and animal model studies have not found evidence for a carcinogenic effect.”
However, Dr. Daniel Cramer of Brigham and Women’s Hospital in Boston has been studying the talc-ovarian cancer link for 30 years. His most recent study published this month shows that women who use talc regularly on their genitals have a 33 percent higher chance of getting ovarian cancer. Several other studies support a moderate increase in risk from genital talc use.
“Our research was the first to demonstrate an epidemiologic association between the use of talc powder in the genital area and an increased risk for ovarian cancer in 1982. Since that time, there has been more than 20 studies addressing this association,” Cramer said in a statement. “Our most recent study demonstrates a substantially greater risk in women who used the product on a daily basis for more than 20 years, particularly for serous ovarian cancer arising pre-menopausally.”
That 33 percent is higher than the 27 percent relative risk that earned hormone-replacement drug Prempro a black-box warning from the FDA in 2003 for links to breast cancer.
While the possible link between talc and ovarian cancer is bad for Johnson & Johnson, worse is evidence that the company knew about the potential connection and failed to warn its consumers.
“Let’s assume the studies were 50/50. That’s not true, but let’s assume that. You still want to warn folks that there is a (33 percent) relative risk,” Beasley said. “If you want to use it, fine. That’s a little crass, but all you have to do is warn.”
Internal correspondence obtained by Beasley shows paid company medical consultant Alfred Wehner discussing talc-related studies with then-Johnson & Johnson Preclinical Toxicology Manager Michael Chudkowski in 1997.
“At that time there had been about nine studies (more by now) published in the open literature that did show a statistically significant association between hygienic talc use and ovarian cancer,” Wehner’s memo reads. “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.”
Self-described “world’s leading talc producer” Imerys is also named as a defendant in the case. However, the talc-mining company hasn’t been found at fault in either the Fox or the Ristesund case after putting warning labels on its talc shipments in 2006, Beasley said.
“All this in combination is so devastating to Johnson & Johnson. If I were representing them I would say, ‘We need to bring this to a halt or it’s not going to get any better,’” Beasley said.
As of yet, Johnson & Johnson has not responded to Beasley’s legal advice.
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Talcum Trouble: Where Does J&J’s Responsibility Lie
May 11, 2016 | Knowledge@Wharton
By Adetunji T. Toriola and Robert Field
Johnson & Johnson is battling claims that it has prioritized revenues over ethics after a recent court case awarded damages to a woman who was diagnosed with cancer following years of using its talcum powder. Although this was the third such case, the company maintains that the medical evidence of the links between ovarian cancer and talc is uncertain. However, despite scientific facts, its brand image could take some knocks, say experts at Wharton and Washington University.
The links between ovarian cancer and talcum powder are not clear, according to Adetunji T. Toriola, assistant professor in the division of public health sciences at Washington University School of Medicine and a molecular cancer epidemiologist at its Siteman Cancer Center. “Some studies have found increased ovarian cancer with increased use of talcum powder in the genital areas, while others have not,” he said.
Toriola noted that the Lyon, France-based International Agency for Research on Cancer had in 2006 classified the use of talc-based body powder as “possibly carcinogenic to humans.” According to him, that means “there is not sufficient evidence of carcinogenicity in humans,” although the agency found sufficient evidence of that link in experiments with animals. “We need more data from prospective studies that follow women over time,” he said.
Could a case be made that J&J ignored the information or warnings from some of those studies? “It looks like they did. But there is no smoking gun at this point,” said Robert Field, Wharton lecturer in health care management and Drexel University law and health management professor. “[J&J] didn’t do what the asbestos companies did or the tobacco companies did, which was to actively suppress it. In those cases, you had billions and billions of dollars [awarded] in judgments.”
Toriola and Field discussed the ethical and business issues involved in the J&J case on the Knowledge@Wharton show on Wharton Business Radio on SiriusXM channel 111. (Listen to the podcast at the top of this page.)
Talc Damages: A Brief Account
The latest case is the third J&J has faced over its talcum powder product. On May 2, a judicial circuit court for the City of St. Louis in Missouri awarded $55 million in damages to Gloria Ristesund of South Dakota, who had used J&J’s talc-based feminine hygiene products for nearly 40 years and was diagnosed with ovarian cancer in 2011. Her cancer is now in remission. The award includes $50 million in punitive damages, which are imposed when courts want to punish a defendant over and above simple compensation ($5 million in this case). J&J faces more than a thousand such lawsuits in courts, and has been accused of ignoring warnings linking its talcum powder to ovarian cancer and failing to inform users of that potential risk.
Earlier this year, the same St. Louis court had awarded $72 million in damages to the family of another woman who had used the product and died of ovarian cancer. Three years ago, a South Dakota court had found the company to be negligent in not warning Deane Berg, the petitioner, of the risks associated with its baby talcum powder that she had used for 30 years, but it did not award any damages.
J&J will appeal the latest verdict, according to a company statement. “Multiple scientific and regulatory reviews have determined that talc is safe for use in cosmetic products and the labeling on Johnson’s Baby Powder is appropriate,” it said.
Uncertain Links, but a Damning Judgment
According to reports, J&J was aware of medical concerns over talcum use in the 1990s, but the firm ramped up promotion of its baby powder to African American and Hispanic consumers, who are heavy users of its product.
“One thing that looks very bad for J&J is that the indications from the data … that the risks are particularly heightened among African American and Hispanic women … and J&J promoted that use among this population,” Field said. “It certainly looks like they were singling out a minority group.”
According to Field, that link between J&J’s talcum powder and African American/Hispanic women has been damaging for the company. “[The company’s actions here were] not just negligent but almost intentional,” he said. “They were completely rough riding and ignoring the evidence because they saw a potentially lucrative market. It looked bad to the jury, and that is one of the reasons they tagged on these huge, punitive damages.”
But the medical evidence there is slim, according to Toriola. He said one of the risk factors for ovarian cancer is reproductive history and the use of birth control. “It is likely and possible that women of African American descent have a different reproductive history compared to Caucasian women,” he said. But he also noted that those with a family history of ovarian and breast cancer have a higher risk. “All that needs to be considered as well in this case.”
‘Drawing a Line in the Sand’
“I don’t think the issue in this case has to do with placing revenue objectives over ethical behavior,” said Wharton management professorJohn Kimberly. “It has more to do with the company drawing a line in the sand, in the belief that ultimately their approach to assuring product safety will be validated.”
According to Kimberly, J&J must have “carefully considered the reputational risks” as it decided how to proceed with the latest case. “J&J, like any other company, and particularly any consumer products company, always has to be mindful of its reputation among consumers,” he said. “They clearly have opted for an aggressive defense of their approach to product safety in this case.”
Impact on Brand Image
J&J’s baby powder was one of its earliest products and was launched in 1894, six years after the company was founded in New Brunswick, New Jersey. “In that sense, it reflects the essence and core of the brand heritage,” said Wharton marketing professor Patti Williams. “And of course, it is closely associated with the baby-focused business, where the credo itself is very important to consumers.”
J&J earned a reputation for living by its credo of putting consumers before profits in its handling of the Tylenol case in 1982, when bottles of the drug were found to contain traces of cyanide, resulting in seven deaths. The company spent more than $100 million in a nationwide recall of Tylenol, replacing bottles with new tamper-proof packaging.
That credo is “in J&J’s blood…. There is a real sense of what the credo means,” Wharton professor of legal studies and business ethicsThomas Donaldson told Knowledge@Wharton in a 2012 story. Around that time, the company faced a string of quality issues, including recalls of its Children’s Tylenol, Benadryl and hip-replacement devices, and a case involving its anti-psychotic drug Risperdal, where it agreed to pay a $158 million settlement.
According to Williams, J&J faces “a lot of risks” on the trust aspect in the fallout of the latest case. “Trust is crucial to a brand that has been built on its care and concern for babies,” she said. “To some extent the sense that the brand can be trusted to care for children is central to the essence of the J&J brand overall.”
“To the extent that consumers perceive this as the latest in a series of ways in which J&J hasn’t lived up to its credo, this could certainly be problematic for the brand.”–Patti Williams
Williams said it is not clear to what extent consumer perceptions of the J&J corporate brand — versus the individual product brands — still reflect the quality issues the company faced in earlier years. “However, I think that the centrality of [baby powder] to the J&J brand position is problematic,” she added. “To the extent that consumers perceive this as the latest in a series of ways in which J&J hasn’t lived up to its credo, this could certainly be problematic for the brand.”
Issues to Pursue
The case has brought into focus other issues that also merit attention, according to Toriola. He noted that the studies conducted thus far suggest a link to only one type of ovarian cancer, although that is the most common type. Also, only continued, long-term use of the talc could expose a person to those risks, as opposed to infrequent use, he added.
Toriola called for “a bigger investigation” into the suspected links between talcum powder use and ovarian cancer. “The most definitive evidence will come from a trial, but it is not ethical to conduct a trial,” he said. “The next step is a bigger study that just follows people over time who have used this product and compare it with others who have not used it. That is where you will find the ultimate evidence.”
Meanwhile, law firms have been actively pitching for business, promising to extract compensation for other users of the talcum powder. “The lawyers are all over the potential links between the use of the company’s talcum powder and the onset of ovarian cancer, sensing a potential gold mine,” noted Kimberly.
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