(Bloomberg) -- Johnson & Johnson trained its employees to reassure anyone concerned about whether the company’s talcum powder contained asbestos that the cancer-causing substance “has never been found and it never will’’ in its iconic baby powder, according to an undated memo unsealed in a lawsuit against the drugmaker.
But plaintiffs say other unsealed documents indicate that J&J has known for decades that its talc products include asbestos fibers and that the exposure to those fibers can cause ovarian cancer. The talc used by J&J to make its products “is not now, nor has it ever been, free from asbestos and asbestiform fibers,’’ according to the lawsuit filed on behalf of more than 50 women in St. Louis.
The unsealed documents add another dimension to the claims against J&J as it defends itself from more than 5,000 suits across the U.S. blaming its baby powder products for causing women to develop ovarian cancer. While five juries have ruled against J&J, the company has won one case and had some other claims thrown out.
One of the documents unsealed Sept. 6 indicates that in May 1974, an official at J&J’s Windsor mine in Vermont recommended “the use of citric acid in the depression of chrysotile asbestos’’ from talc extracted from the site.
“The use of these systems is strongly urged by this writer to provide protection against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time,’’ the mine’s director of research and development wrote then.
Documents provided by J&J show tests of its talc stretching back to at least 1972 found no traces of asbestos, though the two minerals often occur naturally near each other. In a 1983 worldwide study of its talc products, the drugmaker found “all talcs in this report were found to be free from asbestiform minerals and to conform to cosmetic talc requirements.”
FDA Requirements
“The U.S. Food and Drug Administration requires specific testing to ensure that cosmetic talcum powder is free of asbestos,” Ernie Knewitz, a spokesman for J&J, said in an emailed statement.
“We are confident that our talc products are, and always have been, free of asbestos, based on decades of monitoring, testing and regulation,” Knewitz said. “Historical testing of samples by the FDA, numerous independent laboratories, and numerous independent scientists have all confirmed the absence of asbestos in our talc products.”
J&J was little changed at $131.81 in New York Stock Market composite trading at 11:19 a.m.
Talc Verdicts
Lawyers representing the women can use the documents in court to allege the possibility of a link -- it can take decades from asbestos exposure to illness -- as well as suggest a pattern of J&J ignoring and covering up the risks of using its products. They also are claiming asbestos continued to be present in talc after the tests.
Five juries have held the drugmaker liable, including a California panel that ordered it to pay $417 million to a woman who’d been using J&J’s talc products since the 1960s. J&J is appealing the verdicts, which didn’t reflect asbestos claims.
New Brunswick, New Jersey-based J&J has said the plaintiffs’ allegations aren’t supported by valid scientific evidence, pointing to a New Jersey state court decision last year tossing
out two cases.
The unsealed files were used as part of an April pre-trial deposition given by Joanne Waldstreicher, J&J’s chief medical officer since 2013. Under questioning by plaintiffs’ lawyer Mark Lanier, Waldstreicher maintained that J&J’s baby powder products are asbestos free. We have experts that assure there’s no asbestos in our talc,” she told the lawyer.
Consumer Safety
According to the undated training memo, J&J representatives continued to reiterate at medical conferences that there wasn’t any asbestos in the company’s talc-based products.
“Though there will never be a problem with Johnson & Johnson talc, we also endeavor vigorously to keep an eye on all the sources of talc worldwide, which might be used by other powder manufacturers and sold here,’’ officials said.
In 1973, a company report about J&J’s Windsor Materials talc mine in Vermont noted that officials were working with federal officials to check for fibers that could indicate the presence of asbestos at the site.
A J&J official said in that report that the company’s baby powder “contains talc fragments classifiable as fiber. Occasionally sub-trace quantities of” two types of asbestos “are identifiable and these might be classified as asbestos fiber.’’
Concerned that asbestos may have tainted talc used in the company’s products, a J&J official suggested the company move toward using corn starch in its consumer products rather than talc, according to the report.
According to the unsealed documents, J&J also pushed to stop the distribution of a booklet revealing the discovery of trace amounts of asbestos in the talc the company bought from an Italian mine. Owners of the Val Chisone mine near Turin produced the booklet in 1974 to market the site’s talc.
“The business threat” with the Italian publication, according to a J&J research scientist, “is that it can raise doubts on the validity of the documentation of purity and safety of talc.’’
The scientist persuaded the mine’s owners to stop distributing English-language versions of the booklet until J&J officials could rewrite it, according to the unsealed documents.
Trace Amounts
J&J contends that testing at the Val Chisone mine two years before the marketing pamphlet was written showed no evidence of asbestos at the site. Dr. F.D. Pooley of University College, Cardiff, Wales, said in a 1972 report that “no chrysotile was found at the mine or in the samples taken.”
“Some tremolite was located, but was not asbestiform in character and has not been detected in talc imported into Great Britain for the past year,” Pooley said, according to documents provided by J&J, “nor in shipments dating back to 1949.’’
Even trace amounts of asbestos in talc products pose a cancer risk, said Dr. Barry Castleman, a consultant hired by government agencies and health groups to gauge the health effects of the once-commonly used insulation material. He has testified for plaintiffs in asbestos cases, not in talc cases.
“It is a problem even if it’s found in small amounts in talc, especially because it’s used by children and women,” Castleman said in an interview. He added that he wrote J&J in 1972 pointing out that asbestos in talc consumer products could cause serious health problems. “They responded that there was no asbestos in their talc,” Castleman said.
Lanier, the plaintiffs’ lawyer, asked Waldstreicher during her deposition if she’d seen the rewritten version of the mine booklet in which all references to asbestos were stricken. “I don’t see that here,” she said.
Lanier also pointed to some studies of J&J’s talc products that he said found asbestos, and questioned whether the company should have warned consumers about those findings. He asked her specifically about the Windsor mine testing, and she said “40 years ago, there could have been different types of testing that may not be as accurate as the testing we have today.”
“Would you agree that if asbestos is in the product, you all ought to be warning people?’’ Lanier asked. At first, Waldstreicher responded that it was a “hypothetical question.” Eventually, she conceded.
“I would like to be warned before I were around any cancer-causing substance,’’ she said.
The case is Ingham v. Johnson & Johnson, No. 1522-CC10417, Circuit Court, City of St. Louis, Missouri.