Manufacturers Knew They Could Not Guarantee Talc Was Free From Asbestos Decades Ago: Report

A new report warns that Johnson & Johnson has known for decades there is a risk of asbestos contaminating Johnson’s Baby Powder, Shower-to-Shower and other talc-based powders, and also knew their tests were not good enough to detect the presence of the toxic fibers.

Researchers from Columbia University published a report online this week in the American Journal of Public Health, taking a look at documents from the early 1970s which reveal what the Johnson & Johnson, the cosmetics industry and the U.S. Food and Drug Administration (FDA) knew about the link between asbestos and talc.

The report points out that recent talcum powder lawsuits filed against Johnson & Johnson and other companies raise questions about what the manufacturers knew about the talc asbestos risks, when they knew it and what they did about it.

Asbestos exposure, even at low levels, has been linked to a number of serious and often life-threatening health problems, including lung cancer and mesothelioma. As a result, use of the product has largely been banned worldwide in recent decades.

Mesothelioma is a rare form of cancer that is only known to occur as a result of exposure to asbestos. It typically has a very long latency period before it is diagnosed, and the disease is often at a very advanced stage by the time it is discovered, resulting in few treatment options.

In this new study, researchers used historical documents from the early 1970s, which indicated the FDA was already concerned about findings indicating low levels of asbestos detected in talc. The FDA wanted the industry to guarantee its talc products were 99.99% free of chrysotile and 99.9% free of amphibole asbestos. The industry, however, said it only wanted to have the capability to detect asbestos up to 99.5% through a procedure known as the J4-1 method. While that percentage seems small on its face, given the amount of talc used, it represents a significantly larger amount of potential asbestos contamination than many may realize.

“The difference in these methodologies meant that potentially billions of asbestos fibers could be released into the air when babies were powdered or adults powdered themselves,” the researchers warned. “Cosmetic talc powder manufacturers pressed for the less stringent methodology and adopted the term ‘nondetected’ asbestos, rather than ‘asbestos-free’ as a term of art.”

Researchers found suspicions that talc contained asbestos went back as far as the 1930s, when clinical reports of talc workers began to come in showing they were suffering from symptoms resembling asbestosis. A report in 1942 also showed the same condition appearing among talc millers and miners. They also found studies and warnings from the 1950s and 1960s which raised red flags about the potential for asbestos contamination of talc.

In August 1972, the National Institute for Occupational Safety and Health (NIOSH) realized there was a problem. It tested nine commercially available baby powders with electron microscopes and found the “possible asbestos fiber contamination of commercial baby powders.” Another investigator, working for the FDA, found that, out of 102 samples, more than 40 percent may have contained asbestiform minerals such as chrysotile or tremolite.

But in March 1975, industry objected to new proposed FDA rules, which sought to adopt strict standards and testing methodologies for asbestos in commercial talc. Under those more stringent testing standards, only two-thirds of commercial talc had tested as being asbestos-free, suggesting the remaining one-third was contaminated. Those rules were shelved under the weight of industry objections, and the FDA dropped the issue, leaving the testing methodology preferred by the Cosmetic, Toiletry & Fragrance Agency (CTFA), now known as the Personal Care Products Council, in place.

“By 1977, the FDA essentially gave up its efforts to regulate asbestos in talc, as the J4-1 method created by the CTFA had been adopted by the industry despite the CTFA’s own acknowledgement that its methodology was inadequate to the task,” the researchers concluded. “Despite this, the J4-1 method, one that the industry itself acknowledged is incapable of determining low-level pollution, is still the standard within the industry.”

Talcum Powder Cancer Litigation

Johnson & Johnson currently faces nearly 12,000 Johnson’s Baby Powder lawsuits and Shower-to-Shower lawsuits pending in courts nationwide, each raising similar claims that the manufacturer has known for decades about the potential link between talc powder and cancer, yet failed to warn consumers.

In addition to mesothelioma claims, many of the complaints involve allegations that particles included in the talcum powder may cause ovarian cancer, following years of regular application around the genitals for feminine hygiene, which has been marketed by the company for decades.

A number of cases have already gone to trial at the state level, with several resulting in large verdicts for plaintiffs, often including punitive damages. Last year, a Missouri jury returned a landmark $4.7 billion verdict for 22 women diagnosed with ovarian cancer.

Most of the talcum powder litigation is current pending in the federal court system, where lawsuits filed by individuals nationwide are centralized for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Freda L. Wolfson in the District of New Jersey.

Later this year, Judge Wolfson is expected to rule on Johnson & Johnson’s challenges to the admissibility of certain expert witness testimony under the federal rules. However, if the Court finds that the evidence is sufficiently reliable, Johnson & Johnson could face large numbers of individual trial dates in courts nationwide in coming years.