Johnson & Johnson Has a Baby Powder Problem: More than 1,000 women are suing the company for covering up a cancer risk
By Susan Berfield, Jef Feeley, and Margaret Cronin Fisk | March 31, 2016
Photograph by Travis Rathbone
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Jacqueline Fox worked in restaurant 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 acting strangely. He’d jump on her, he’d cry, he’d stay close by all day. Fox happened to watch a television program about 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 part of her spleen and colon. In December of that year, she saw a commercial from an Alabama law firm, Beasley Allen, suggesting a connection between long-term use of Johnson & Johnson’s Baby Powder and ovarian cancer. Fox had been sprinkling Baby Powder made from talc on her underwear every day since she was a teen. “I was raised up on it,” she later said in a deposition. “They was to help you stay fresh and clean. … We ladies have to take care of ourselves.” It was as normal as using toothpaste or deodorant. “We both were a bit skeptical at first,” says her son, Marvin Salter, a mortgage banker in Jacksonville, Fla. “It has to be safe. It’s put on babies. It’s been around forever. Why haven’t we heard about any ill effects?”
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 Powder in the genital area. The verdict, decided by a 10-2 vote, included $10 million in compensatory damages 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 choice. J&J didn’t give people a choice.” Among the most painful revelations, he says, was that in the 1990s, even as the company acknowledged 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. Fox was black. The jury foreman, Krista Smith, says internal documents provided the most incriminating evidence: “It was really clear they were hiding something.” She wanted to award the Fox family even more. Imerys Talc America, the biggest talc supplier in the country and the sole source of the powder for J&J, was also named as a defendant. The company wasn’t found liable.
“Jury verdicts should not be confused with regulatory rulings or rigorous scientific findings,” Carol Goodrich, a spokeswoman for Johnson & Johnson Consumer, said in an e-mail. “The overwhelming body of scientific research and clinical evidence supports the safety of cosmetic talc.” The company says it will appeal the verdict. In a statement, Imerys said it’s “confident that its products are safe for use by its customers. Our confidence is supported by the consensus view of qualified scientific experts and regulatory agencies.”
Johnson & Johnson has spent more than $5 billion to resolve legal claims over its drugs and medical devices since 2013. That year, it 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. It was one of the largest health fraud penalties in U.S. history. The company has also agreed to pay some $2.8 billion to resolve lawsuits about its artificial hips and $120 million for faulty vaginal-mesh inserts. In its 2015 annual report, J&J stated that more than 75,000 people had filed product liability claims, and that didn’t include the talc powder cases.
More than 1,000 women and their families are suing J&J and Imerys, claiming the companies have known of the association with ovarian cancer for years and failed to warn them. The next trial is scheduled to begin on April 11 in a St. Louis circuit court. “Whether or not the science 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’s Kellogg School of Management. “In trying to protect this one business, they’ve put the whole J&J brand at risk.”
Talc is the softest mineral on earth, able to absorb odors and moisture. It’s composed of magnesium, silicon, and oxygen and is mined, usually from deposits above ground, in more than a dozen countries. It’s used in eye shadow and blush and chewing gum, but mostly it’s used in ceramics, paint, paper, plastic, and rubber. China is the biggest source; Johnson & Johnson’s supply comes from the southern province of Guangxi.
Johnson & Johnson began selling Baby Powder more than 100 years ago, soon after the company was founded in New Brunswick, N.J. Among its first products were adhesives infused with pain relievers such as mustard seed, capsicum, quinine, and opium. When customers complained that removing the plasters left them with skin irritation, J&J’s scientific director sent them small containers of talc to help soothe any rashes. A few reported that the talc also 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. Smell is evocative, and this particular scent is mingled with powerful memories—a marketer’s dream. “It’s calming, nurturing. … It doesn’t grab your senses. It wafts,” Fred Tewell, a J&J executive, told the Associated Press in 2008. The company has said that in blind tests, the scent of Baby Powder is recognized more often than that of chocolate, coconut, 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, “Best for Baby, Best for You.” By 1965, when Fox was 12 years old, ads featured a sultry woman sprinkling talc on her bare shoulder. No baby is in sight. “Want to feel cool, smooth and dry? It’s as easy as taking powder from a baby.” Two decades later, the company told the New York Times Magazine that 70 percent of its Baby Powder was used by adults. Sales of J&J’s talcum powder products came to about $374 million in 2014, according to Euromonitor. That’s not essential to a $70 billion company that makes most 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 baby division worth some $2 billion. Baby Powder’s value to the company extends well beyond sales.
Forty-five years ago, British researchers analyzed 13 ovarian tumors and found talc particles “deeply embedded” in 10. The study, published in 1971, was the first to raise the possibility that talcum powder could pose a risk. In 1982 a study in the journal Cancer by Daniel Cramer, an epidemiologist at Brigham & Women’s Hospital in Boston, showed the first 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 time trying to persuade him to consider the possibility that my study could be correct and that women should be advised of this potential risk 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 now. “I think it was pride of ownership. Baby Powder is a signature product for J&J.”
Baby Powder is considered a cosmetic, which doesn’t need to be approved by the Food and Drug Administration under the 1938 Food, Drug, and Cosmetic Act. The law is laid out in a 345-page document; only two pages are devoted to the safety of cosmetics. Congress is considering updating the law to give the FDA more authority to regulate products. “It shouldn’t be up to consumer groups or jurors to try to make decisions about toxic products,” says Stacy Malkan, co-founder of the Campaign for Safe Cosmetics. J&J and many other big companies support the changes.
J&J does have a warning on Baby Powder, cautioning against inhalation. And the label notes that the powder is for external use only. Under pressure from consumers, activists, and impending California safety 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: “We’ve been replying with evidence of the science that ensures safety. Now we have to go beyond science and be responsive to our consumers, because it’s really about their peace of mind.” If J&J applies this same thinking to Baby Powder, it has an alternative: It already sells Baby Powder made from cornstarch for about the same 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 powder. Some of J&J’s competitors, including Gold Bond, California Baby, and Burt’s Bees, sell baby powder made of cornstarch only.
Since Cramer’s article was published, an additional 20 epidemiological studies have found that long-term perineal talc use increases the risk of ovarian cancer by about 33 percent. Yet 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 World Health Organization—when they’ve looked at a potential link. Roberta Ness, former dean of the University of Texas School of Public Health and former president of the American Epidemiological Society, testified at the Fox trial as an expert witness for the family. She argued that several of the studies showing no link didn’t properly measure women’s exposure to talcum powder. Some asked women how many years they had used the powder; others asked how often they used it. Only 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 just duration, and they’re all over the map.” She went on to explain that “all of the studies that have actually measured frequency and duration … have all shown a statistically significant trend toward more exposure causing more disease.” Ness pointed out that the association between hormone therapy and breast cancer is statistically smaller than the reported association between talc and ovarian cancer, yet hormone therapy is considered to be a real risk.
She also said that not being able to prove how talc powder could contribute to cancer doesn’t relieve a company of the responsibility to warn women of the association. “We now have data that suggest there’s an association between 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’s no proof that talc particles can move up through the reproductive tract or that once there they could cause cancer. And if there’s no causal connection, they say there’s no reason to add a warning to Baby Powder. “There are statistical correlations. You can always calculate correlations,” says Joshua Muscat, a professor of public health sciences at Penn State College of Medicine who serves as an expert consultant to J&J. “There hasn’t been a single scientific body that has considered talc to be a causal agent. Many don’t even consider talc to be a risk factor. To me, the science is black and white.”
Read more:
http://www.bloomberg.com/features/2016-baby-powder-cancer-lawsuits/
