Johnson & Johnson to pay $4.7bn in talcum powder cancer case

US Pharmaceutical giant Johnson & Johnson has been ordered to pay out a whopping $4.69 billion in damages to 22 women who alleged a talc sold by the company contained asbestos, which led to cancer. The controversial matter has seen thousands of lawsuits filed against J&J, which says multiple errors were made in the verdict. It cannot, however, be denied that J&J could have been more ethical in its marketing and labelling practices.

What has hit the company?

Johnson & Johnson was ordered on July 12 to pay $4.69 billion to 22 women and their families who had claimed that asbestos in the company’s talcum powder products caused them to develop ovarian cancer.

A jury in a Missouri circuit court awarded $4.14 billion in punitive damages and $550 million in compensatory damages to the women, who had accused the company of failing to warn them about cancer risks associated with its body powders.

After a six-week trial, the jury in St. Louis deliberated over the compensatory damages for eight hours but decided on the punitive damages in roughly 45 minutes, said Mark Lanier, a lawyer for the women. Six of the women have died; almost all of the rest, along with friends and relatives, were in the courtroom during the hearing. One of the plaintiffs is undergoing chemotherapy and was too ill to attend, Lanier said. “There were people crying, people hugging,” he added. “It’s been quite an emotional scene.”

Lanier said Johnson & Johnson had spent 40 years covering up evidence of asbestos in some of its talcum-based products and should mark those products with warning labels or focus on powders made with cornstarch. The punitive damages are among the largest ever awarded in a product liability case, he said.

Plaintiffs in talc cases have approached litigation in smaller groups instead of suing Johnson & Johnson en masse.

The risky strategy allows earlier plaintiffs to send signals about legal tactics and their award amounts to women who bring cases later. Suing in clusters also maximizes the emotional effect of the women’s stories on juries, Lanier said. “It’s easier to get justice in small groups,” he said. “In small groups, people have names, but in large groups, they’re numbers.”

The first talc trial was in 2013 in Federal District Court in South Dakota. A jury found Johnson & Johnson negligent but did not award damages to the plaintiff. Several other cases have involved sizable damages, including a $417 million verdict reached by jurors in Los Angeles County Superior Court last year. The plaintiff in the Los Angeles case has since died, and the verdict was overturned and a new trial granted.

Johnson & Johnson, which has successfully appealed a number of talc cases, said in its statement on July 12 “the multiple errors present in this trial were worse than those in the prior trials which have been reversed.”

Why is it important to understand Johnson & Johnson’s view?

Johnson & Johnson, the maker of Johnson’s Baby Powder, said it was “deeply disappointed” in the verdict and planned to appeal. The company is facing more than 9,000 plaintiffs in cases involving body powders with talc, according to a regulatory document filed this spring.

The company will appeal, Carol Goodrich, a spokeswoman, said in an email. The verdict “was the product of a fundamentally unfair process that allowed plaintiffs to present a group of 22 women, most of whom had no connection to Missouri, in a single case all alleging that they developed ovarian cancer,’’ she said. The company has said concerns about talc’s being linked to cancer are based on inconclusive research.

The result, “which awarded the exact same amounts to all plaintiffs irrespective of their individual facts, and differences in applicable law, reflects that the evidence in the case was simply overwhelmed by the prejudice of this type of proceeding,’’ Goodrich added.

The company’s products don’t contain asbestos and don’t cause ovarian cancer, she said. Goodrich predicted the verdict would be reversed. “The multiple errors present in this trial were worse than those in the prior trials which have been reversed.”

Why must J&J’s claims be taken with a pinch of talc?

“The money came from the law firm that was representing J&J, so it was indirectly from J&J,” Michael Huncharek tells Chemistry World. “The actual money came from the law firm so it is splitting hairs – in my mind, it makes no difference,” he adds. “The law firm was retained by J&J as their counsel, so most likely J&J was paying the bill.”

J&J has allegedly been involved in funding shadow research into the health effects of talc, and the allegation appears to be substantiated by Huncharek, a former academic researcher involved in the work.

Michael Lanier, the attorney for 22 women diagnosed with ovarian cancer, points to internal emails showing that J&J partly financed a particular research paper from 2008 that found no link between talc use and ovarian cancer.

During the deposition, Lanier produced and quoted from additional documents indicating that the costs of the study were split between J&J – whose baby powder still contains talc, although the company now offers an alternative product that uses cornstarch – and the French mining company Luzenac, which is described as the world’s largest producer of talc. However, the only funder acknowledged in the paper is Crowell and Mooring, the law firm that was representing J&J in its talc litigation, though that connection was not divulged.

“We have more on this and other situations where J&J polluted the literature through lack of transparency, but I will not be showing it until I begin cross-examining the company in the trial over the coming two weeks,” Lanier told Chemistry World on July 2. He said the company paid about $22,000 for the study, and even retained the right to edit the work.

But Huncharek is very adamant that neither he nor J&J committed any wrongdoing. “J&J came to me and said, “What do you think of this,” and I said, ‘I agree with you, talc is not a carcinogen,’” he recalls. “We asked them to provide funding for us to do that paper that you cite, but they were completely hands off,” Huncharek adds. “We sent it to them and they said “This looks good,” but we never got a call from them to change anything or modify anything.”

Huncharek notes that he had published research examining talc and cancer well before his involvement with J&J, and that analysis pooled existing studies in the field. “The results did not support, on epidemiological grounds, that talc is a human carcinogen,” he says.

To be fair to J&J, very few researchers have actually duplicated findings by Harvard University epidemiologist Daniel Cramer showing that there is a potential link between talc and ovarian cancer. However, in 2010 the World Health Organization’s International Agency for Research on Cancer classified perineal use of talc-based body powder as ‘possibly carcinogenic to human beings’, based on the fact that ‘many case–control studies of ovarian cancer found a modest, but unusually consistent, excess in risk.’

When do the plaintiffs seem right?

Six of the 22 plaintiffs in the latest trial have died from ovarian cancer. That itself made the case compelling and urgent. Five plaintiffs were from Missouri, with others from states that include Arizona, New York, North Dakota, California, Georgia, the Carolinas and Texas.

In February 2016, a jury determined that Johnson & Johnson should pay more than $70 million to the family of a woman who was diagnosed with advanced ovarian cancer, in 2013, at age 59. In depositions, Jacqueline Fox said she sprinkled J&J’s baby powder in her underwear every day since she was a teenager to stay “fresh and clean”; she passed away in October 2015.

One of the plaintiffs, Gail Ingham, 73, of O'Fallon, Missouri, told that she was diagnosed with stage-3 ovarian cancer in 1985 and underwent chemotherapy treatments, surgeries and drug treatments for a year before being declared cancer free in the early 1990s. Ingham, who used baby powder for decades, said she joined the lawsuit because women who use baby powder "need to know what's in there. They need to know what's going on. Women need to know because they're putting it on their babies."

Lanier made a strong case that Johnson & Johnson had covered up evidence of asbestos in their products for more than 40 years. Medical experts testified during the trial that asbestos, a known carcinogen, is intermingled with mineral talc, which is the primary ingredient in Johnson & Johnson's Baby Powder and Shower-to-Shower products. The plaintiffs' lawyers said asbestos fibers and talc particles were found in the ovarian tissues of many of the women.

"We hope this verdict will get the attention of the J&J board and that it will lead them to better inform the medical community and the public about the connection between asbestos, talc, and ovarian cancer," Lanier said. "The company should pull talc from the market before causing further anguish, harm, and death from a terrible disease."

During closing arguments, Lanier told the jurors this case was the first where jurors saw documents showing that Johnson & Johnson knew its products contained asbestos and didn't warn consumers.

The company, it has been argued in all of the more than 1,000 cases against it, knew that the talc in its Baby Powder and ‘Shower to Shower’ products was linked to ovarian cancer when used in the genital area, but didn’t warn customers.

The company marketed both products for feminine hygiene, and in the ‘80s it told The New York Times Magazine that 70 percent of baby-powder users were adults. A 1988 ad for Shower to Shower said “just a sprinkle a day keeps odor away.” Others reminded women: “Your body perspires in more places than just under your arms.”

J&J’s Baby Powder labels do advise that it’s meant for external use only, but some researchers argue that baby powder applied topically could travel up the vagina and make its way through the uterus, finally landing in the ovaries. Though research is still not clear on the link, it cannot be disputed that J&J at least had a duty to warn the customers about a possible correlation.

But whether or not talc causes cancer, it’s worth looking at the reason why some women use these products on their undercarriages in the first place: They’ve gotten subtle (or not-so-subtle) hints throughout their lives that their vaginas are ‘smelly’ and even repulsive and are in need of fragrance, douches, and other feminine hygiene products, most of which can ironically cause irritation. Women born after the ‘50s and ‘60s have witnessed a different conversation, and thanks to the internet, they can easily find out that they don’t need soap, powder, or douches and that vaginas are self-cleaning.

Where does Talc come from?

Talc is a form of magnesium silicate. Its history dates from ancient Arabic times and there was widespread European and American talc mining and processing in the 19th century.

Most people are familiar with talc as a cosmetic or hygiene product, but it has many industrial uses too. It’s used to make ceramics, paints, paper and roofing materials. It’s useful as an industrial lubricant as it can withstand very high temperatures, so it’s useful for things such as the smooth running of conveyor belts.

Safety concerns often emerge first in the workplace, where levels and lengths of exposure are usually much higher than in domestic settings. As talc deposits are often found near asbestos ore, mined talc can be contaminated with asbestos.

In the 1960s questions emerged about links between workers exposed to talc and ovarian cancer after researchers found that asbestos could cause cancer of the lungs and pleural cavity (the lining of the lungs). This triggered more detailed studies in the 1970s of talc’s mineral and chemical composition. Some of these studies looked at lung diseases in talc miners and millers.

In the 20th century, body talc became widely used as a domestic product because of its ability to absorb moisture and eliminate friction. If used as a feminine hygiene product, it has been suggested that the powder can reach the ovaries by travelling through the vagina, uterus and fallopian tubes. Despite home talc products going asbestos-free in the 1970s, there were still concerns that talc was linked to ovarian cancer and so the research focus moved to asbestos-free talc.

Who is snowed under lawsuits?

Most people use (or have used or were made to use as a baby!) Johnson & Johnson products on a regular basis, and there’s no doubt that the company has become a staple of the American – and international – health product industry. What many people don’t know, however, is that Johnson & Johnson has been named in hundreds of thousands of lawsuits – along with various subsidiaries like Janssen, Ethicon and DePuy – over the safety of its products.

Xarelto

The Drug: With more than 20,000 Xarelto lawsuits filed against Johnson & Johnson, this prescription blood thinner is one of the largest subjects of litigation in this group. As one of the first of a new generation of anticoagulants, Johnson & Johnson failed to develop an antidote for Xarelto when it was introduced, leaving patients without a way to counteract effects of the drug if something should go wrong. *The lack of an antidote has led the Institute for Safe Medication Practices to declared blood thinners like Xarelto and Pradaxa to be among the most dangerous prescription drugs available on the market today.*

The Claims: The vast majority of claims by plaintiffs in Xarelto suits are related to severe bleeding events, in some cases resulting in death by exsanguination (draining of blood). J&J’s failure to properly inform patients that no antidote was available led to pain and suffering, especially since other blood thinners with antidotes exist, such as warfarin, and could have been used instead of Xarelto. Several verdicts have gone against Johnson & Johnson, but the company is appealing those verdicts and continuing to fight against new lawsuits as they are filed.

Invokana

The Drug: This prescription drug is used to treat type-2 diabetes by blocking a specific protein in the bloodstream (SGLT2), which prevents glucose (sugar) from being reabsorbed into the body. Canagliflozin, the active ingredient in Invokana, was developed by Janssen Pharmaceuticals (a division of J&J) and the Japanese drugmaker Mitsubishi Tanabe Pharma.

The Claims: Diabetics are already at a higher risk of many health conditions, but large-scale studies have shown that taking Invokana can put them at even higher risk for some severe problems. The most common side effects of Invokana claimed in lawsuits include lower-body amputations (toe, foot, or lower leg), diabetic ketoacidosis – a potentially deadly blood acid condition – kidney failure, and pancreatitis. A host of other side effects are also associated with the drug, from dehydration and constipation to urinary problems and even greater risk of broken bones.

Ethicon Physiomesh & Gynecare TVT Abbrevo

The Device: Surgical mesh is used in a number of different ways, such as to repair hernias or repair transvaginal pelvic organ prolapse. Introduced in the 1950s, surgical mesh came pre-approved, and as a result it was not until relatively recently that enough evidence of problems has become available to change the device’s classification.

The Claims: Hernia mesh and vaginal mesh lawsuits range in claims from pain and discomfort to allergic reactions, infections, and even perforation or erosion into nearby organs and tissues. In many cases, the condition initially treated with the mesh (i.e., hernia or pelvic organ prolapse) recurs as well, requiring additional surgeries to remove the mesh and repair damage.

Risperdal

The Drug: Risperdal is a prescription drug used to treat schizophrenia in adults, but it has slowly grown in practice to treat a number of psychological disorders in people of all ages – despite not having been approved by the FDA (US drug regulator) for all of those uses. Off-label uses of Risperdal include treatment of ADHD, anxiety, and “agitation.” The U.S. Department of Justice fined Johnson & Johnson $2.2 billion because of its marketing of these and other off-label uses, making it the largest healthcare-related fine in history.

The Claims: Plaintiffs in Risperdal lawsuits claim that taking the drug can lead to a higher risk of serious health problems, including gynecomastia (enlarged breasts), heart attack, and stroke. Elderly patients with dementia are at an even higher risk of death than others, and as such the FDA now requires a black box warning on Risperdal stating that risk. Less severe side effects include headache, constipation, tiredness, and sexual problems.

DePuy Synthes Hip Replacement Implants

The Device: DePuy started as an independent business, but was purchased by Johnson & Johnson in 1998. Among other things, the company specialized in a line of hip replacement components, including the DePuy Pinnacle Acetabular Cup System, DePuy ASR Acetabular System, and DePuy ASR Hip Resurfacing System.

The Claims: Thousands of individuals have filed claims against Johnson & Johnson related to DePuy hip replacement implants, asserting that the joint components have led to severe complications like metal poisoning (metallosis), allergic reactions, dislocations, fractures, and deep-vein thrombosis, among other things.

Concerta

_The Drug: _Concerta is a prescription drug approved by the U.S. Food and Drug Administration (FDA) to treat attention-deficit/hyperactivity disorder (ADHD), and it contains methylphenidate – the same active ingredient as the more well-known Ritalin, which is made by Novartis. With more than 6 million children who have been diagnosed with ADHD, that’s a lot of prescriptions each year.

_The Claims: _The most concerning claim is that Concerta can cause severe depression and suicidal thoughts, prompting attempts to commit suicide – even in children as young as 7 or 8 years old. The drug can give rise to other mental health conditions, such as anxiety, agitation, and hallucination. Physical side effects of Concerta include seizure, priapism, gastrointestinal problems, and uncontrolled tics.

How guilty is talc really?

While the more than $4 billion punitive-damage verdict will grab the headlines, the jury’s decision that asbestos in J&J’s Baby Powder caused the women’s ovarian cancer may be a bigger, long-term concern, said Jean Eggen, a Widener University law professor who teaches about mass-tort cases. “This was a new theory and the jury lined up behind it,” Eggen said. “That may be a harbinger of things to come and there are many more ovarian cancer cases than asbestos cases tied to the powder.”

Ovarian cancer has several known risk factors. When health agencies list different risk factors they sometimes also give weight to each of these. For example the International Agency for Research on Cancer lists talc-based body powder as associated with ovarian cancer when applied between the legs, observing “modest but unusually consistent excess in risk” in many case-control studies. This marks a change from its 1987 report, which found there was inadequate evidence for talc causing cancer in humans. The American Cancer Society noted that studies produced mixed findings and considered that, if there were a risk, the risk would be very small. Still, the society thought that because talc was so widely used in many different products more research should be done to establish if the risks were “real”.

The European talc industry association considered the suggested link between talc use between the legs and ovarian cancer in US case-control studies to be highly controversial because the observed difference in risk between the talc users and the non-talc users was slight. Instead, the association cites two studies from 2005 and 2006 to back its position. One of the studies – a prospective cohort study – did not find a “substantial association” between using talc on the genitals and an increase in ovarian cancer risk. (Prospective cohort studies are considered to be a higher quality of evidence than case-control studies.)

Cancer Research UK has examined various risk factors and preventive factors for ovarian cancer including age, genetics, weight, various other diseases and hormones as well as talc use between the legs. While it rates different levels of risk for these factors, its position on talc is that the risk is not clear and if any risk is found it will be “fairly small”.

But more recent scientific studies continue to confirm a trend that links talc use and epithelial ovarian cancer (the most common type of ovarian cancer).

A 2013 analysis led by Harvard University of 8,525 ovarian cancer cases and 9,859 controls concluded that genital talc powder use is associated with a small-to-moderate increase in risk of various sub-types of ovarian cancer. It found that “genital powder use was associated with a similar increased risk of borderline and invasive ovarian cancer overall”.

They also noted that, as there are few ovarian cancer risks women can avoid, “avoidance of genital powders may be a possible strategy to reduce ovarian cancer incidence”. This would seem a wise precautionary policy.

According to the National Cancer Institute, claims that talc used for feminine hygiene purposes can be absorbed by the reproductive system and cause inflammation in the ovaries are not supported by “the weight of evidence.”

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.

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.

Note: Douching is a method to wash out the vagina, usually with a mixture of water and vinegar. Douches that are sold in drugstores and supermarkets contain antiseptics and fragrances. A douche comes in a bottle or bag and is sprayed through a tube upward into the vagina.