Bad to Put Baby Powder on Girls Bottoms
Johnson & Johnson Has a Baby Powder Problem
More than than 1,000 women are suing the company for covering upwardly a cancer risk.
From 
Jacqueline Fox worked in eating place kitchens and school cafeterias, cleaned people's houses, watched their kids, raised a son, and took in two foster children. She was careful about her appearance and liked to tend the garden in front of her home in Birmingham, Alabama. She had been treated for high blood pressure, arthritis, and diabetes, but, at 59, she was feeling pretty good. In the spring of 2013, her poodle, Dexter, began interim strangely. He'd jump on her, he'd weep, he'd stay close by all day. Fox happened to watch a goggle box program nigh a dog that sensed its owner was unwell. When she let Dexter sniff her, he whined even more.
A week later, Fox was diagnosed with advanced ovarian cancer. She had chemotherapy to shrink the tumors and surgery to remove her uterus, ovaries, fallopian tubes, and office of her spleen and colon. In December of that twelvemonth, she saw a commercial from an Alabama law firm, Beasley Allen, suggesting a connexion between long-term use of Johnson & Johnson's Infant Powder and ovarian cancer. Fox had been sprinkling Baby Powder made from talc on her underwear every solar day since she was a teen. "I was raised up on it," she later said in a deposition. "They was to assistance you stay fresh and clean. … We ladies have to take care of ourselves." Information technology was equally normal as using toothpaste or deodorant. "Nosotros both were a flake skeptical at first," says her son, Marvin Salter, a mortgage banker in Jacksonville, Fla. "It has to be safe. It'due south put on babies. Information technology's been around forever. Why haven't nosotros heard about whatever ill effects?"
Source: Fox Family
Fox died from the cancer in October 2015. Four months later, a jury in St. Louis concluded that talcum powder contributed to the development of the disease and that Johnson & Johnson was liable for negligence, conspiracy, and failure to warn women of the potential risk of using Baby Pulverisation in the genital area. The verdict, decided by a 10-2 vote, included $10 million in compensatory amercement and $62 million in punitive damages, more than Fox's lawyers had recommended. Salter bowed his head and wept.
"People were using something they thought was perfectly safe," he says. "And it isn't. At least give people the pick. J&J didn't give people a choice." Amidst the nigh painful revelations, he says, was that in the 1990s, fifty-fifty as the company best-selling concerns in the health community, it considered increasing its marketing efforts to black and Hispanic women, who were already buying the product in high numbers. Play tricks was black. The jury foreman, Krista Smith, says internal documents provided the virtually incriminating evidence: "It was really clear they were hiding something." She wanted to accolade the Fox family unit fifty-fifty more than. Imerys Talc America, the biggest talc supplier in the country and the sole source of the pulverization for J&J, was also named as a defendant. The company wasn't constitute liable.
"Jury verdicts should not exist confused with regulatory rulings or rigorous scientific findings," Ballad Goodrich, a spokeswoman for Johnson & Johnson Consumer, said in an eastward-mail. "The overwhelming trunk of scientific research and clinical evidence supports the safety of cosmetic talc." The visitor says it will appeal the verdict. In a statement, Imerys said it's "confident that its products are safe for use past its customers. Our confidence is supported by the consensus view of qualified scientific experts and regulatory agencies."
Johnson & Johnson has spent more than than $v billion to resolve legal claims over its drugs and medical devices since 2013. That year, information technology agreed to pay $2.2 billion to settle criminal and civil probes into claims that it illegally marketed Risperdal, an antipsychotic drug, to children and the elderly; two other medicines were included in the settlement. Information technology was one of the largest health fraud penalties in U.S. history. The company has also agreed to pay some $2.viii billion to resolve lawsuits about its artificial hips and $120 million for faulty vaginal-mesh inserts. In its 2015 annual study, J&J stated that more than 75,000 people had filed product liability claims, and that didn't include the talc pulverisation cases.
More than than 1,000 women and their families are suing J&J and Imerys, challenge the companies have known of the association with ovarian cancer for years and failed to warn them. The adjacent trial is scheduled to brainstorm on Apr eleven in a St. Louis excursion courtroom. "Whether or non the scientific discipline indicates that Baby Powder is a cause of ovarian cancer, Johnson & Johnson has a very significant breach of trust," says Julie Hennessy, a marketing professor at Northwestern'south Kellogg School of Direction. "In trying to protect this one business organization, they've put the whole J&J brand at risk."
"It has to be safe. It's put on babies. It's been around forever. Why haven't nosotros heard nearly any ill effects?"
Talc is the softest mineral on earth, able to blot odors and moisture. It's equanimous of magnesium, silicon, and oxygen and is mined, usually from deposits above ground, in more than a dozen countries. It'due south used in heart shadow and chroma and chewing gum, but by and large it's used in ceramics, pigment, paper, plastic, and condom. Cathay is the biggest source; Johnson & Johnson'due south supply comes from the southern province of Guangxi.
Johnson & Johnson began selling Baby Powder more than than 100 years agone, soon after the visitor was founded in New Brunswick, North.J. Among its beginning products were adhesives infused with hurting relievers such equally mustard seed, capsicum, quinine, and opium. When customers complained that removing the plasters left them with pare irritation, J&J's scientific managing director sent them small containers of talc to assist soothe whatever rashes. A few reported that the talc too seemed to ease diaper rash. In 1894 the company introduced Baby Powder, made of 99.8 percent talc and sold in a metal tin labeled "for toilet and nursery."
The other 0.2 percent is a mix of fragrant oils. Odour is evocative, and this item olfactory property is mingled with powerful memories—a marketer'southward dream. "It's calming, nurturing. … It doesn't grab your senses. It wafts," Fred Tewell, a J&J executive, told the Associated Printing in 2008. The visitor has said that in blind tests, the smell of Baby Pulverization is recognized more often than that of chocolate, kokosnoot, or mothballs. From the early 1900s, J&J tried to persuade women to use the powder on themselves, too. Ads in 1913 included the tag line, "All-time for Babe, Best for You." By 1965, when Fox was 12 years old, ads featured a sultry woman sprinkling talc on her bare shoulder. No infant is in sight. "Want to experience absurd, polish and dry out? Information technology'southward as easy as taking powder from a baby." Two decades afterwards, the company told the New York Times Magazine that 70 per centum of its Infant Pulverization was used by adults. Sales of J&J's talcum powder products came to virtually $374 million in 2014, according to Euromonitor. That's not essential to a $70 billion visitor that makes about of its money selling medical devices and drugs. But without Baby Powder, J&J may not have developed Baby Oil or Baby Shampoo nor have a infant division worth some $2 billion. Baby Pulverisation'due south value to the visitor extends well beyond sales.
Forty-5 years agone, British researchers analyzed 13 ovarian tumors and institute talc particles "securely embedded" in x. The study, published in 1971, was the showtime to heighten the possibility that talcum powder could pose a risk. In 1982 a study in the journal Cancer past Daniel Cramer, an epidemiologist at Brigham & Women'due south Hospital in Boston, showed the commencement statistical link between genital talc use and ovarian cancer. Soon after, Cramer received a call from Bruce Semple, an executive at J&J. The two met in Boston. "Dr. Semple spent his time trying to convince me that talc use was a harmless habit, while I spent my fourth dimension trying to persuade him to consider the possibility that my study could be correct and that women should be advised of this potential chance of talc," Cramer, a paid expert and witness for the plaintiffs, said in a 2011 court filing. "I don't think this was a question of money," he says at present. "I think it was pride of ownership. Baby Powder is a signature product for J&J."
Baby Pulverization is considered a cosmetic, which doesn't demand to exist approved by the Food and Drug Administration nether the 1938 Food, Drug, and Cosmetic Act. The constabulary is laid out in a 345-folio certificate; only ii pages are devoted to the safety of cosmetics. Congress is considering updating the constabulary to give the FDA more authority to regulate products. "It shouldn't exist up to consumer groups or jurors to try to brand decisions about toxic products," says Stacy Malkan, co-founder of the Entrada for Safe Cosmetics. J&J and many other big companies back up the changes.
J&J does have a warning on Baby Powder, cautioning confronting inhalation. And the label notes that the powder is for external use only. Under pressure from consumers, activists, and impending California rubber regulations, J&J has removed triclosan, formaldehyde, and other so-called chemicals of concern from its baby products in the past few years. In 2013, Samantha Lucas, a company spokeswoman, explained the shift to Scientific American: "Nosotros've been replying with evidence of the science that ensures safety. Now we have to go across science and exist responsive to our consumers, because it's really about their peace of mind." If J&J applies this same thinking to Baby Pulverisation, it has an alternative: Information technology already sells Infant Powder made from cornstarch for about the aforementioned price. No study shows that cornstarch poses any potential risks; the American Cancer Society has been suggesting since 1999 that women consider it if they want to use genital pulverization. Some of J&J's competitors, including Gold Bond, California Babe, and Burt'southward Bees, sell baby powder made of cornstarch only.
Since Cramer'southward commodity was published, an additional xx epidemiological studies have found that long-term perineal talc use increases the run a risk of ovarian cancer past about 33 percent. Notwithstanding other research has found no association. These mixed results have been cited by many agencies and institutions—with the exception of the International Agency for Research on Cancer (IARC) at the Globe Health Organization—when they've looked at a potential link. Roberta Ness, erstwhile dean of the University of Texas Schoolhouse of Public Health and sometime president of the American Epidemiological Society, testified at the Fox trial every bit an good witness for the family. She argued that several of the studies showing no link didn't properly mensurate women's exposure to talcum powder. Some asked women how many years they had used the powder; others asked how often they used it. Simply five measured both. "What's confused everyone in the past," she said during the trial, is that "all these studies, they looked at just frequency or but duration, and they're all over the map." She went on to explicate that "all of the studies that have actually measured frequency and duration … have all shown a statistically pregnant trend toward more exposure causing more than disease." Ness pointed out that the clan between hormone therapy and breast cancer is statistically smaller than the reported clan betwixt talc and ovarian cancer, yet hormone therapy is considered to be a existent hazard.
She also said that not beingness able to prove how talc powder could contribute to cancer doesn't relieve a visitor of the responsibility to warn women of the clan. "We at present have data that advise there's an association betwixt the Zika virus and microcephaly," she said. And even though scientists don't know how the virus causes the disease, "people aren't waiting. … People are out there saying, 'Oh my gosh, be aware, this is trouble.' "
J&J and Imerys, the talc supplier, argue that the statistical associations between use of the powder and ovarian cancer are limited, weak, and based on unreliable data. They say a causal link isn't biologically plausible, because there'southward no proof that talc particles can move up through the reproductive tract or that once there they could cause cancer. And if at that place's no causal connectedness, they say at that place's no reason to add a alarm to Baby Powder. "In that location are statistical correlations. You tin ever summate correlations," says Joshua Muscat, a professor of public wellness sciences at Penn State College of Medicine who serves every bit an expert consultant to J&J. "There hasn't been a single scientific body that has considered talc to exist a causal amanuensis. Many don't even consider talc to exist a run a risk cistron. To me, the science is black and white."
The odds of a woman in the U.S. falling ill with ovarian cancer are 1 in 70. Talc employ is associated with worse odds, one in 53, co-ordinate to those epidemiological studies. The risks seem to be higher for invasive serous cancer, which Play a joke on had. Ovarian cancer is among the most deadly cancers. Some xx,000 women are diagnosed each twelvemonth, often after the illness has spread. The symptoms are easily dismissed as menstrual or abdominal discomfort. There'south no regular screening for ovarian cancer, no known causes, but take a chance factors, and some research suggests the malignancy may begin outside the ovaries, at the terminate of the fallopian tubes. More than fourteen,000 women die from the illness every yr.
At the Fox trial, Ness did some harsh math for the jury. She claimed that Baby Powder use could contribute to some two,500 women beingness diagnosed with ovarian cancer every twelvemonth and one,500 dying. The defence counsel, with great skepticism, chosen that effigy "astonishing." Ness also noted that although blackness women generally have lower odds than white women of getting ovarian cancer, a pocket-size study recently showed they're more than at risk of developing ovarian cancer when exposed to talc.
In the last months of her life, Flim-flam answered questions from attorneys on both sides of the example. The sound of her deposition was played in the courtroom near the terminate of the three-calendar week trial. When asked why she was suing J&J, she said, "To put out there that we as women got to have intendance of ourselves. This is a disease I didn't enquire for. But who am I? I merely want to do right."
The science may exist express, and it may be ambiguous. Many of the researchers involved, including Cramer, say more written report is necessary. Just the scientific discipline wasn't on trial in St. Louis; Johnson & Johnson was. "You don't win with jurors on science. They don't understand scientific discipline, statistics, the design of studies," says Erik Gordon, a professor at the Schoolhouse of Business concern and School of Law at the University of Michigan. "They do understand there was some evidence of a connection between talc and cancer, and J&J didn't tell customers about it."
Ebony magazone advert: Gaslight Ad Archives
Lawyers for Pull a fast one on introduced documents from 1986 through 2004 that, even so selective they may be, portray a company struggling to revive interest in a symbolically important production with no proven wellness benefits and some suspected health risks. A 1992 memo outlining "major opportunities and major obstacles" acknowledged that "negative publicity from the wellness community on talc (inhalation, dust, negative doctor endorsement, cancer linkage) continues." The same memo included a recommendation to "investigate ethnic (African-American, Hispanic) opportunities to abound the franchise," noting that these women accounted for a loftier proportion of sales. An added handwritten note says the visitor planned a print advertisement entrada. Goodrich, the J&J spokeswoman, said in her eastward-mail that this was "simply function of the visitor's efforts to appropriately understand who is using its products." More than than a decade later, a job force devoted to improving sales of Shower to Shower, a mix of talc and cornstarch marketed to women, ended: "African American consumers in particular will be a good target with more than of an emotional feeling and talk about reunions among friends, etc., team up with Ebony Mag." It suggested promotions in churches, dazzler salons, and barbershops, and Patti LaBelle or Aretha Franklin equally glory endorsers. Neither became a spokeswoman for the make. It'south not clear how much of the rest of the plan was put into activity, since the company had already been advertising to blacks.
It'south standard exercise for companies to focus on their most committed customers. Airlines take care of business fliers; loyal shoppers get special deals at stores. "That'due south probably what they were doing," says Hennessy, the Kellogg marketing professor. "In today'south climate, though, that looks horrible. From the outside it looks like J&J is less concerned, not more concerned, about its virtually loyal users because of their ethnic origin."
Baby Powder is a legacy brand in the blackness customs. "Some people might say, 'What's wrong with companies recognizing women of color as important consumers?' " says Robin Means Coleman, a professor of communications studies and Afro-American Studies at the University of Michigan. "We practice want that. Just nosotros do non want companies to market potentially carcinogenic products."
Salter, Fox'southward son, hadn't been enlightened of the marketing documents until the trial. "When I heard about it, I was infuriated," he says. "So was the jury."
In the 1990s a toxicologist named Alfred Wehner worked equally an outside consultant for J&J. His official part was to help evaluate the inquiry on ovarian cancer and talc and advise the company on its response. Unofficially, he was its scold. Wehner was on J&J's side, but he was concerned that a cosmetics trade grouping (partly funded by the visitor) was mischaracterizing the scientific instance for talc. "A true friend is non he who beguiles you lot with flattery but he who discloses to you your mistakes earlier your enemies discover them," Wehner began a 1997 letter to Michael Chudkowski, J&J's manager of preclinical toxicology. Wehner described statements on talc research from the group as inept, misleading, and outright false. Referring to a statement a few years earlier, he wrote: "At that time there had been about nine studies (more by now) published in the open up literature that did prove a statistically significant clan betwixt aseptic 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 up of all evidence to the contrary." He wanted the trade group to argue that the studies' biological significance was questionable.
Cosmetic talc isn't a big part of Imerys's business organization. The company, formerly called Luzenac, primarily sells the mineral for industrial purposes. Simply until 2006, it also fought any suggestion that talc could be a potential carcinogen. In the late 1990s, according to a Luzenac memo introduced at the trial, executives visited the head of epidemiology at the University of California at Irvine for advice on how "to terminate the rumor about Ovarian cancer." 1 suggestion: Become "two or 3 experts from the gild" to make the scientific instance. "The club" could refer to contained scientists Luzenac had worked with before, but Fox's lawyers argued for a more than sinister interpretation—that these were scientists who would respond to industry pressure level. They likewise suggested that Luzenac and J&J exerted influence over a government grouping. In 2000 scientists with the National Toxicology Plan, function of the U.S. Department of Health and Man Services, voted 13-ii to listing talc, used perineally, as a possible man carcinogen, co-ordinate to Fox's lawyers, just the companies persuaded the NTP to defer an official decision on the status of talc. A Luzenac executive, Richard Zazenski, wrote to a colleague after: "Nosotros, the talc manufacture, dodged a bullet in Dec, based entirely over the defoliation of the definition issue." He was referring to ambiguity over the composition of the talc studied because, until the early on 1970s, some powder contained naturally occurring asbestos fibers. He also discussed a coming NTP review, saying, "Fourth dimension to come up with more confusion!" Imerys declined to comment on the specifics of the trial, but i witness for the defence force offered the possibility that Zazenski was joking. Goodrich, the J&J spokeswoman, said any proffer by Fox'southward lawyers of improper influence is "merely an unsubstantiated allegation."
In 2006, the IARC, the WHO cancer agency, declared that perineal employ of cosmetic-grade talc was possibly carcinogenic. It cited "a pocket-size, but unusually consistent, excess in adventure" and also noted that bias in the studies couldn't be ruled out. Publicly, Luzenac and J&J tried to diminish the significance of the designation; red meat and java are also included in this group of possible carcinogens.
Earlier the year concluded, however, Luzenac stopped backing studies to prove talc'south safety because the "equus caballus has already left the barn," wrote one executive, noting that cosmetic companies had also cut funding. One of their primary arguments for doing so, he said, was that there were already too many studies showing an association with ovarian cancer "to stem the tide of negative sentiment." More than important, Luzenac added a alarm on the safety data sail included with the 2,000-pound bags of talc it delivers to J&J: Perineal use of the powder is a possible adventure factor for ovarian cancer.
"Nosotros, the talc industry, dodged a bullet in December. ... Futurity up with more than confusion!"
Johnson & Johnson says information technology will continue to defend the safety of talc, and it does so on its website. At that place, in a section explaining its policies nigh ingredients, the company addresses concerns over formaldehyde, parabens, phthalates, and triclosan—chemicals with damaged reputations, and worse. In every case, J&J states that the chemicals haven't been proven harmful or that they were used in pocket-size enough amounts to be safe, but the company decided to remove them from its products anyhow. "We understand that from your perspective, regime regulations may non be your only consideration when it comes to the personal-care products you and your family utilise," information technology says well-nigh parabens. For phthalates, the company says it recognizes that "the best mode to keep your confidence was not to use information technology at all."
Why non apply that same standard to talc? Goodrich said the company listens when consumers raise concerns about ingredients. But "few ingredients have the same demonstrated performance, mildness and safety profile as cosmetic talc."
The first woman to sue Johnson & Johnson for non warning of the risks of talcum pulverization was Deane Berg, who was diagnosed with ovarian cancer in 2007. She says she turned down a $1.3 million out-of-court settlement considering she didn't want to sign a confidentiality clause. Her case went to trial in 2013 in a Due south Dakota federal court as she was in remission. The jury found J&J was negligent, but didn't accolade Berg whatsoever damages.
After the Fox verdict, 17,000 people contacted her attorneys at Beasley Allen; the firm is looking into ii,000 of those, in addition to 5,000 potential claims it was already investigating. Its adjacent instance will be tried in the same St. Louis excursion court as Fob'due south, which has a reputation for being sympathetic to plaintiffs. Gloria Ristesund's trial is set for April. She used Baby Powder for 40 years and was diagnosed with ovarian cancer in 2011.
Among those waiting their turn is Tenesha Farrar, who was diagnosed with Stage 3 ovarian cancer in 2013 and is represented by the Lanier Constabulary Business firm. Farrar, who's twoscore and black, says she'd used Baby Pulverisation and Shower to Shower (which J&J sold to Valeant in 2012) for the final ii decades. "My grandmother and mother used it, and I learned from them," she says. Afterward hearing about the J&J marketing document, she began crying. "I can't believe they singled us out." Farrar had chemotherapy and a total hysterectomy. She had to take off five months from her work as a clerk in a dialysis dispensary outside St. Louis. She lost her health insurance considering she exceeded the policy limits and had to skip her last chemo handling. She and her married man eventually filed for bankruptcy. She'south back at work at present. "I have v children who depend on me," she says. "I will never use another J&J product again."
(Corrects the year that the Ebony magazine J&J ad ran.)
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Source: https://www.bloomberg.com/features/2016-baby-powder-cancer-lawsuits/
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