(CNN)Visitors who walk into Deborah Giannecchini’s ranch house in Modesto, California, will notice a well-tended garden, four small dogs who greet every visitor with enthusiasm and a sign that hangs prominently displayed in her living room that reads “It’s never too late to live happily ever after.”
She got it when she was 62 years old, after she married her husband, Leland, but it could also represent her current mission: to help other women avoid the pain she’s experienced and allow them to have their own happy endings.
Giannecchini is living with what is considered terminal
ovarian cancer. “That’s what they say. I’m trying to prove that it’s not,” she said. “I don’t wish this on anyone else. And if I can save one person, then I’ve done my job.”
She and thousands of others claim that they got their ovarian cancer after using a common toiletry as a part of their daily feminine hygiene routine. They used talc-based powder, commonly referred to as talcum powder or baby powder,though some baby powder products are cornstarch-based.Cornstarch products are not believed to cause any health problems.
Some 4,800 women and their families have now sued pharmaceutical giant Johnson & Johnson, which has sold the talc-based product Johnson’s Baby Powder for
more than 100 years. Many women like Giannecchini who have sought help from the courts have said they want Johnson & Johnson to, at the very least, put a warning label on the powder.
A handful of talcum powder companies have done just that. For example, Assured’s Shower & Bath Absorbent Body Powder says that it is “intended for external use only” and adds, “Frequent application of talcum powder in the female genital area may increase the risk of ovarian cancer.”
Johnson & Johnson argues that sucha label would be confusing, because although the company regularly expresses sympathy for these women, it vehemently denies that its powder has anything to do with their ovarian cancer. A handful of scientists have backed the companyup in court. Andother scientists back the women’s claims.
The topic is agrowing debate in the scientific community. Some studies have found that women face an increased risk of ovarian cancer with use of talc in the genital area, but others do not. Most suggest that more research is needed.
At the intersection of this debate are lawyers who are putting this science under the microscope in courtrooms across the country. They’ve shown juries selective internal company memos that they say suggest Johnson & Johnson has been aware of this potential problem for decades and done nothing.
Johnson & Johnson’s lead counsel on two of the cases argues that the lawsuits are all about the money, rather than being all about the science. “My take on the talc ovarian cancer litigation is that it really is skillful and well-funded plaintiffs lawyers who are exaggerating science and taking it out of context to scare people and to frighten the public with the goal of lining their own pockets,” Bart Williams said. “I think they are wrong scientifically. I think they are wrong legally, and I think the evidence shows that the science doesn’t support using talc and ovarian cancer.”
Johnson & Johnson is not the only talc product manufacturer being sued over ovarian cancer claims
, although most includethe company because itsproducts have dominated the market the longest.Some
lawsuits mention talc makers including
Valeant Pharmaceuticals, which now owns the
Shower to Shower brand (owned by Johnson & Johnsonuntil 2012).
Valeant would not grant an interview, but it
sent a statement. “The safety of our products and the customers who use them are our company’s highest priority. Shower to Shower is a safe and effective product, and the scientific and medical consensus is that these products do not cause ovarian cancer,” said the statement from Lainie Keller, vice president of corporate communications for Valeant Pharmaceuticals International Inc. “It’s important to note that the lawsuits nearly all allege use of Shower to Shower prior to 2012 when our company acquired the product. Given our limited role and the strong legal, factual and scientific defenses, we do not believe claims will be established successfully against our company.”
Other lawsuits mention Gold Bond’s talcum powder, manufactured by
Chattem Inc., a Sanofi company, which did not respond to requests for comment.
Some lawsuits include
Imerys Talc America, which mines the talcin some of the powders. “We remain confident in the consensus of government agencies and professional scientific organizations that have reviewed the safety of talc, that talc is safe,”
Gwen Myers, a spokeswoman for Imerys Talc America, said in a statement. “Imerys Talc America sympathizes with women suffering from ovarian cancer and hopes that the scientific community’s efforts will be directed toward finding the true causes of this terrible disease.”
One related
batch of lawsuits against Johnson & Johnson argues that its Baby Powder is
contaminated with asbestos and that asbestos is causing women to develop the cancer mesothelioma. The two minerals are often mined near each other, although since the 1970s, talc used in all consumer products has been required to be asbestos-free. Johnson and Johnson says their talc does not contain asbestos. A jury ruled in Johnson & Johnson’s favor in one of those asbestos lawsuits in California
in November. The lawyers who argue that talc itself is the problem have experienced rapid success in convincing juries in South Dakota, Missouri and California that there is a cancer connection, winning hundreds of millions for their clients.
In October, judges reversed
two of those verdicts.
In one case against Johnson & Johnson involving Jacqueline Fox, who died four months after a jury awarded her $72 million, a Missouri appellate court judge ruled that the Alabama woman did not use the product in Missouri and that therefore, the case should not have been heard there. The court reversed the jury verdict due to jurisdictional issues.In the other, a California case involving Johnson & Johnson
and Eva Echeverria, who also died after her favorable jury verdict,
the judge reversed the jury decision, saying that there was “insufficiency of the evidence as to the causation as to both defendants.”
Each of the fivecases that has won a favorable verdict for the plaintiff is in various stages of appeal or soon will be. Johnson & Johnson won one of the talc cases in March, when a Missouri jury found that its baby powder did not cause a Tennessee woman’s ovarian cancer. Though legal teams are investigating thousands of other potential cases, what is less clear is where the science will lead and what the future will be for an iconic product that’s on bathroom shelves around the world.
A cosmetic love
Giannecchini has had a lifelong relationship with talcum powder. Long after she
went to court to sueJohnson & Johnson and its talc supplier
Imerys Talc America in 2016, she said, she found a few small bottles in an old suitcase she hadn’t used for a while.
She’d been using Johnson & Johnson’s Baby Powder nearly every day since high school. Sometimes, she’d alsouse the Shower to Shower product, which Johnson & Johnson used to own. She liked the powders because “both felt nice,” she said. “It was smooth and made your skin smell nice and fresh. It was just part of what I did every day.”
Her friends used it, and she
knew the company’s advertising jingle by heart. “A sprinkle a day keeps the odor away,” she shyly sang ditty when she took the stand in 2016. “Have you had your sprinkletoday?”
Health-conscious and a self-described label-reader, Giannecchini never saw anything on the powder bottle to give her pause. “If you’ve seen the ads, you know it is supposed to be a pure and innocent and harmless product that we use on babies,” she said. Like millions of others, she sprinkled away.
Talcum powder: A short history
Talc makes a great powder because it is among the softest minerals,reduces frictionand has a great ability to absorb oils, moisture and odor. It’s
mainly mined in China, India, Brazil, Mexico and the United States, according to the US Geological Survey.Most talc isn’t actually used for cosmetics; it’s found
more often in household products: the ceramics in your bathroom fixtures, the roof over your head, the paint on your wall. It’s in plastic, paper and even in the gum you chew.
Johnson & Johnson started selling talc
in 1894 after customers complained that the company’s original medicated bandages irritated their skin. To soothe it, the company’s scientific director mailed them Italian talc. It worked so well, customers also used it on their babies’ diaper rash and wrote Johnson & Johnson about it. Taking the cue, Johnson’s Toilet and Baby Powderwas born.
Johnson & Johnson has grown into a giant $338.6 billion company
offering hundreds of consumer products, medical devices and medicine, but its Baby Powder may have shaped its image the most, branding experts said, even though it doesn’t rank highest in the company’s sales.
“Because of it, Johnson & Johnson enjoys a strong brand image as being a company that cares,” said
Aimee Drolet Rossi, the UCLA Anderson School of Management marketing chairwoman. “In fact, a lot of consumers don’t understand that Johnson & Johnson is a company that makes more than Baby Powder.”
Sales of talc-based products like general-purpose talc, baby talcum powder, perfumed talc and “liquid talcs” — perfumed liquids that can be sprayed over the body to leave a powdery feel — brought Johnson & Johnson nearly $325.2 million in 2016 alone, according to market research firm Euromonitor.
Adults also use the powder as a dry shampoo, a foot powder and a general after-shower ritual. “I used it everywhere, like a lot of my friends did, from head to toe,” Giannecchini said.
Some women like Giannecchini also used it for feminine hygiene. Women who sued the company have testified that they’d sprinkle it in their underwear, on their thighs to prevent chafing, on sanitary napkins and on tampons. It’s use in this area that’s concerned some scientists.
‘My family saved my life’
Giannecchini didn’t know that there was some scientific concern about her favorite powder. In fact, she used it even after her ovarian cancer diagnosis, adiagnosis that came as a big surprise.
She had gone to the ER after her family pressured her because she wascoughing constantly.
“I didn’t come home right away from the emergency room like I thought I would,” Giannecchini said. Instead of bronchitis, like she suspected, doctors found the cancer, and it was so advanced, they had to remove her spleen and part of her stomach. The cancer spread toher colon, bowel and bladder, too. The treatment was grueling, the prognosis not good.
Ovarian cancer, though comparatively rare, is one of the
mostlethal. Withno general screening, it’s often caught late, like it was in her case.
“It was not pleasant,” Giannecchini said. “But my family likely saved my life.”
Giannecchini’s daughter Casey got her mom to quit her Baby Powder habit only after seeing a lawyer’s ad on TV. They’re frequently seen on late-night TV, saying things like “If you or a loved one have developed ovarian cancer after using talcum powder: call.”
Casey gave her mother the number, and Giannecchini sent in her information. She ended up speaking with
Ted Meadows at the Beasley Allen law firm in Montgomery, Alabama. Meadows would soon lead her on a legal journey halfway across the country.
The talc team
At the time Giannecchini called, Meadows had been working with another attorney,
R. Allen Smith, on a blitz of dozensof talc cases.
Smith and Meadows are a classic odd couple. Meadows is quiet, serious, a runner; when not consumed with work for his large firm, he roots for his alma mater, football powerhouse University of Alabama. Smith is easy to smile and quick with a story, and he looks as if he could have played for his alma mater, the Alabama rivalUniversity of Mississippi. Ole Miss memorabilia covers the walls of Smith’s small solo practitioner office in suburban Jackson, Mississippi. Where the two are in sync is on these talc cases.
Smith learned about how women use talc in their genital area, meaning in underwear and sanitary products, whilesitting at his parents’ dinner table. His father, a retired plastic surgeon, asked whether he’d ever heard about any connection between talc and cancer. When he got home that night, Smith started googling.
“I couldn’t believe what I saw,” he said after looking at the scientific studies and the scientific debate that followed. “And I wondered, ‘Am I the only lawyer to see this?’ “
The scientific debate
Smith learned that concerns about a link between talc and ovarian cancer started surfacing
around 1971, when a small group of scientists wrote about finding talc particles deeply embedded in ovarian and cervical tumor tissue. The study concluded that it is “impossible to incriminate talc as a primary cause of carcinomatous changes,” based solely on what was described in the study; however, “the possibility that talc may be related to other predisposing factors should not be disregarded.” The authors hoped more people would research the issue.
Dr. Daniel Cramer at Harvard took up the challenge in a study published
in 1982. He compared records from more than 400 women and found that women who had ovarian cancer were more likely to have used talc in their genital areas.
Cramer
conductedsubsequent studies and became the first American scientist to raise alarm bells about using talc in the genital area, but
his work was not alone. The conceptcomes up more than
100 times in PubMed, a search engine for medical studies, since 1971, and the results are mixed. Some study reviews show a
moderate risk. A few show that it “does
not appear to influence cancer risk.“Most are population-based studies and cannot prove a direct cause-and-effect relationship.
In general,
cancer causes are tricky to prove, since it takes time for cancer to develop and it can be influenced by a wide variety of factors.
“When it comes to talc and cancer, the message is not straightforward. It’s not necessarily black and white, and it’s a bit more complicated to explain to the layperson,” said
Dr. Paolo Boffetta. The professor of medicine, hematology and medical oncology at Mt. Sinai was in the room in 2006 when the
International Agency for Research in Cancer, which falls under the World Health Organization, decided to classify the use of talc in the genital area as “possibly carcinogenic to humans.”
Based on his own research, Boffetta found, “there seems to be a small increase or risk for women who are heavy users of genital talc,” he said. “However, we don’t necessarily know what causes it.”
Boffetta, who also thinks more research is necessary, believes that talc use in the genital area, while not a strong cancer risk factor like smoking, “may be a real factor in some cases.”
However, some studies have found no connection at all.
A 2014 study of more than 61,000 postmenopausal women in the
Women’s Health Initiative Observational Study suggested that talc use in the genital area “does not appear to influence ovarian cancer risk.” A study in 2016
found that douching rather than talc was associated with an increased risk of ovarian cancer after looking at more than 50,000 women enrolled in the
Sister Study, a national research study for risk factors for breast cancer.
The research that fits into the modest association category includes
a 2016 study focused on talc use in the genital area in black women. Researchers looked at nearly 600 cases of ovarian cancer and found a “modestly stronger association” with people who used talc. That risk increased more in those who used it below the belt. Author
Dr. Joellen Schildkraut, an epidemiologist at the University of Virginia in Charlottesville, also believes that more research is needed.
There are some theories that talc may
cause an inflammation that can become cancer, but that idea is still being tested. “I don’t think we have definitive evidence that this causes ovarian cancer, but I do think we have a hypothesis that there is a connection. Looking at my data, it should give people pause for concern,” Schildkraut said. “It is not a necessary item to use, so why take a chance with it?”
The most recent studies seem to suggest a small connection. A
January meta-analysis, or review of 24 case-control and three cohort studies, found “a consistent association” between talc use and ovarian cancer. “Some variation in the magnitude of the effect was found when considering study design and ovarian cancer subtype,” the study said.A
July meta-analysisof27 studies found a “weak but statistically significant association between genital use of talc and ovarian cancer, which appears to be limited to serious carcinoma with suggestion of dose-response.”
An August review and meta-analysis in Epidemiology found that “in general, there is a consistent association” between talc use and ovarian cancer.
Dr. Graham Colditz, who has been used as an expert for the plaintiffs in some of the lawsuits, thinks there is a connection.
“The evidence has really accumulated over decades and multiple studies,” said Colditz, the Niess-Gain Professor of Surgery at Washington University School of Medicine in St. Louis and deputy directorof prevention and control at the
Siteman Cancer Center. He believes the testing methods have improved since the 2014 study found no connection and scientists have gotten a better handle on understanding the duration and frequency of use of the product and how a lifetime burden of exposure may create an association.
“That evidence has really come together and built over nearly 30 years now,” Colditz said. “This kind of science takes time.”
US and international government agencies and medical associations that track what causes cancer seem to fall in the need-more-research camp. According to
Johnson & Johnson’s website, it sells its talc products around the world, but there are some restrictions on the way talc can be used in cosmetics and baby products in the
European Union and
in Canada.The
US National Toxicology Program, part of the US Department of Health and Human Services, keeps a congressionally mandated list of “agents, substances, mixtures, and exposure circumstances that are known or reasonably anticipated to cause cancer in humans.” Talc is not among the
248 listed; however, in 2010, when it was up for consideration to be included in the list,
the agency explained that
has not fully reviewed talc as a possible carcinogen.
“The NTP deferred consideration of listing talc (asbestiform and non-asbestiform talc) in the 10th RoC because its 2000 review of talc found that there has been considerable confusion over the mineral nature and consequences of exposure to talc, both containing asbestiform fibers and not containing asbestiform fibers. It has become evident that the literature on both forms of talc, with a few exceptions, provides an inadequate characterization of the actual materials under study to enable one to reach definitive conclusions concerning the specific substances responsible for the range of adverse health outcomes reported.”
The
National Cancer Institute website points to the 2014 study that doesn’t find a link and suggests that “the weight of evidence does not support an association between talc exposure and an increased risk of ovarian cancer,” although it also includes talc in a list of factors for which “it is not clear whether the following affect the risk of ovarian, fallopian tube and primary peritoneal cancer.”
The
American Cancer Society also says talc’s relation to cancer “is less clear” and “findings have been mixed.” It adds that “although there is some suggestion of a possible increase in ovarian cancerrisk,” its bottom-line advice is, “Until more information is available, people concerned about using talcum powder may want to avoid or limit their use of consumer products that contain it.”
Laying out the case
Smith spent about five more years immersed in talc research. He joined ovarian cancer associations. He’d visit experts on free nights and weekends. He read ovarian cancer blogs.
Late one night, reading a blog, Smith saw a question from
Deane Berg of South Dakota, who shared that she was a longtime talc user who had ovarian cancer. She’d read some of the talc cancer studies and wondered whether anyone knew anything about it. “So, I immediately (replied to her) and said ‘I’ve been investigating this,’ ” Smith said.
Smith asked whether he could help, and Berg sent her medical records. Smith also got tissue samples of her ovarian cancer tumors and sent those along with the records to some of the experts he had met.
One of those experts was Cramer, who had done the 1982 study. Cramer later testified that he found no family history or genetic predisposition to ovarian cancer in Berg’s records. Smith also sent the tissue sample to Harvard pathologist
Dr. John Godleski, who found talc in Berg’sovarian cancer tissue, Smith said.
“I asked them, could they come to court and state scientifically to a reasonable degree of medical certainty that talc was a contributing factor to Mrs. Berg’s ovarian cancer,” Smith said,”and they said ‘absolutely, yes.’ ”
Johnson & Johnson tried to get
Godleski excluded as an expert in court, but the court determined that he was qualified, “and the opinion is relevant and stems from reliable methodologies.” Johnson & Johnson went on to
challenge his findings in court.
The cases begin
Smith decided, even as a solo practitioner, he could take on the pharmaceutical giant. He personally sifted through hundreds of thousands of records from Johnson & Johnson. “I printed out all the documents on my computer, had them stacked all around this office, filing every space. And every day for 10 months, for 10 hours a day, I looked through the documents one by one,” Smith said. “I could not believe what I would discover.”
Godleski’s report on Berg’s cancer, which was read at trial, said that “based on the findings in this case, it can be stated to a reasonable degree of medical certainty that the talc found in this case is evidence for a causal link between the presence of talc and the development of the patient’s ovarian cancer.”
Smith won the first talc powder case in the country in 2013. The jury found that Johnson & Johnson was negligent, but it didn’t award Berg any damages. “So, it was kind of a bittersweet result,” Smith said. “But from there, I knew this was a much larger issue.”
When news of the trial spread, Smith’s eventual law partner on the case, Meadows, wrote a short article for his firm’s newsletter about Smith’s win. Legal experts say it’s incredibly difficult to prove exposure to a particular product may be linked to cancer. A win in South Dakota, even without damages, meant Smith might be on to something. Meadows thought after his article came out that he’d hear from women who might be interested in bringing their own cases.
Instead, Smith called.
A legal whirlwind
Other women with ovarian cancer had contacted Smith. More potential cases meant more work than Smith could handle. He and Meadows decided to work together and started flushing out what became a winning strategy, at least with juries.
In 18 months, half a dozen juries had ruled in their clients’favor, awarding tens orhundreds of millionsto five ofthe six plaintiffs in individual cases. One of those women was Giannecchini. She flew to St. Louis in 2016 and listened to every word of her trial.
“I learned a lot from them, although it was strange to hear about your life this way,” she said. “I’m kind of a private person, so sharing every little bit of your life wasn’t easy for me, but I just felt like it was something that I had to do.”
In court, a black cardigan wrapped around her shoulders, Giannecchini talked about how the grueling cancer treatment had left her with little energy, but she was determined to live. An attorney from her team showed a series of pictures Giannecchini would take with her grandchildren every Easter. They paused to look at one where she is surrounded by five grandkids, all dressed in robin’s egg blue. In the picture, Giannecchini wears a lavender headscarf, covering what she called her “old bald head” from chemo. “I decided to just embrace that and say ‘this is what cancer does,’ ” Giannecchini said.
In
Giannecchini’s case, and in the others, legal teams have to show general causation and specific causation. That means people with medical expertise or scientists who have peer-reviewed research on the topic have to explain how using talc in the genital area is connected to cancer and that it caused the harm in these particular cases. The strategy varies from case to case, but Giannecchini’s legal team has also regularly argued that Johnson & Johnson knew about these health concerns and ignored them. Johnson & Johnson’s legal teamhas presented experts showingthere is no link between its products and cancer.
Johnson & Johnson’s defense
Dr. Patricia Judson-Lancaster, an obstetrician-gynecologist now based in Utah, has testified on behalf of Johnson & Johnson. In Giannecchini’s case, she said that “talc has no relevance to ovarian cancer.”
“Cancer is caused by genetic mutations,” she told the jury. “We don’t know what causes those gene mutations in ovarian cancer, but we specifically know from studies that talc does not cause mutations in genes,” she said, reiterating, “talc does not cause gene mutations.
“Talc is not the cause,” she emphasized. “I almost wish it was the cause; it would be such the simple thing to do.”
Joshua Muscat, a professor of public health sciences in the college of medicine at Penn State who also has testified for Johnson & Johnson as an expert, agreesthatthere is no link. He
authored a review article looking at past studies about talc use in thegenital area.
“We conclude that the weak statistical associations observed in a number of epidemiological studies do not support a causal association,” he said. Unlike most other scientists, he said he doesn’t think more research on the topic is necessary. He thinks the issue is settled.
Williams, one of the lawyers for Johnson & Johnson, said that “hard science” studies in animals and human cells, compared with epidemiological studies that show a possible association, do not show that talc causes cancer, and that’s the key.
“The most compelling argument, I think, is trying to get juries to focus on the notion that correlations or association is not the same as causation,” Williams said. “So an example we use is bald men and hats. Just because bald men wear hats more often than men who have a full head of hair doesn’t mean that wearing the hats makes their hair fall out. There is an association, a correlation, but there isn’t a cause there. Wearing a hat has nothing to do with male pattern baldness, scientists will tell you.”
An end and a beginning
The jury in Giannecchini’s case decided that there was an association between talc and cancer. In October 2016, it awarded her $70 million. The decision is on appeal.
Hers came asone ofa string ofseparatejury verdicts against Johnson & Johnson. In February 2016, a jury awarded
Jacqueline Fox $72 million. In May 2016, a jury awarded
Gloria Ristesund $55 million. A year later, in May, a jury awarded
Louis Slemp $110 million. And in August,
Eva Echeverria got an award of $417 million. Johnson & Johnson
won one case in March of last year, and in June, there was a mistrial. In total, juries have handed out $724.5 million in separate decisions. But that is not the end of the story.
Judges have not completely agreed with these jury decisions, and two have been reversed.
The Fox case was reversed on jurisdictional issues: The plaintiff lived in Alabama, and Johnson & Johnson is based in New Jersey. The case was heard in St. Louis, which a judge determined wasn’t allowed based on
an unrelated court ruling in June.
The other, the
Echeverria case, was thrown out based on science. The judge cited”insufficiency of the evidence as to the causation as to both defendants,” Johnson & Johnson and its consumer products subsidiary.
She also ruled that there was error in law occurring at trial and misconduct of the jury, which led to excessive damages.
“That ruling may have taken the wind out of the sails of these cases, but it shouldn’t be a permanent setback,” said
Jean Eggen, the distinguished professor emerita of law at Widener University Law School in Delaware. “These are early days still.”
Litigation like this, unlike criminal law, “can take forever,” and “cancer is always very complicated to prove.” With tobacco and asbestos, it took decades before the science showed, and the courts believed that there may be a connection,” Eggen explained. “It does make you wonder what the next part of the story will be.”
As far as Johnson & Johnson is concerned, it has said it will continue to fight these cases.
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Smith and Meadows — and dozens of other attorneys involved in these cases — are determined to get their day in court. “What the future holds for this litigation, I don’t know,” Smith said. “I hope and pray at a minimum Johnson & Johnson will at least put a warning label on their product.”
Williams, one of the Johnson & Johnson lawyers, thinks that putting a label on the product would be “irresponsible.”
“I think having a cancer warning on a product that hasn’t been shown to cause cancer, it just isn’t the right thing to do,” he said. “If 40 years of animal studies and human cell studies have failed to show some causal connection in using talc anywhere on your body and ovarian cancer, and given that, putting a cancer warning on the product wouldn’t be proper.”
Giannecchini, who watches for news of the other trials and waits for a final ruling in her own case, continues her own personal battle with cancer. Her doctors monitor her condition closely.
“I’m fighting it,” Giannecchini said. She hopes to continue to be around to tell her story. “So far, so good. Here I am.”
Read more: https://www.cnn.com/2018/04/11/health/talc-ovarian-cancer-cases/index.html
