Johnson & Johnson says talc products have always been asbestos-free. Court documents suggest otherwise

Facing thousands of lawsuits claiming its talcum powders have caused harm, Johnson & Johnson has argued that science is on its side and that its products do not contain asbestos. But documents filed in the ongoing legal saga, provided to FiercePharma, suggest some tests found asbestos and that the company debated internally about the issue.

Meanwhile, in a proposed class action filed Thursday, a J&J investor claims the company knew for decades that its talc products contained asbestos fibers and that exposure could cause cancers.

As of its last quarterly filing, J&J faces about 5,500 lawsuits claiming its talcum body powders caused harm, with many alleging the product caused ovarian cancer. Some, such as a case brought by Tina Herford in Los Angeles, alleged the product contains asbestos and can cause mesothelioma. J&J prevailed in the Herford case last November. 

A J&J representative told FiercePharma the company is "confident that our talc products are, and always have been, free of asbestos, based on decades of monitoring, testing and regulation dating back to the 1970s."

"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," she added.

The court documents—sent by plaintiff's attorneys in the liability litigation—challenge that assertion. Two internal memos date from the 1970s, and testimony provided in the case last year concerns talc samples studied that same decade.

RELATED: J&J notches latest win in long-running talc saga as caseload grows to 5,500 

The new shareholder lawsuit—filed by plaintiff Frank Hall on behalf of investors who purchased J&J shares between February 2013 and February 2018—alleged that J&J "has known for decades that its talc products, such as its Baby Powder, include asbestos fibers and that the exposure to those fibers can cause ovarian cancer and mesothelioma."
The suit named J&J as a defendant along with CEO Alex Gorsky and CFO Dominic Caruso. J&J didn't address the lawsuit in its statement.
Two of the documents provided to FiercePharma are memos from J&J employees: one about a mine in Vermont and the other about the company's Italian talc supplier. Another document is a lab report that found "insignificant amounts of tremolite—a few isolated crystals" in two talc batches. Tremolite is a type of asbestos, according to the National Institutes of Health.
In a 1973 memo titled WINDSOR MINERALS AND TALC, a J&J employee wrote that "we believe this mine to be very clean; however, we are also confident that fiber forming or fiber type minerals could be found." The employee wrote that talcs used in packaging materials "contain widely varying amounts of tremolite or fibrous talc." 

"Our Baby Powder contains talc fragments classifiable as fiber," the memo reads. "Occasionally sub-trace quantities of tremolite or actinolite are identifiable (optical Microscope) and these might be classified as asbestos fiber." 

The employee said the company was exploring alternatives to "better protect our powder franchise," such as improvements to "better select" talc and an effort to remove a "large portion of the very fine particles presently found in talc." Replacing talc with corn starch was also suggested as one option. 

And in a 1974 memo, a J&J employee wrote that he visited the company's Italian talc supplier, SVC, to "forestall the upsetting impact which distribution of a recent SVC publication will have on the world talc market." 

He said the "business threat" with the pamphlet is that it "can raise doubts on the validity of the documentation of purity and safety of talc, which we have established both here (F&DA) and in England." 

According to the memo, the SVC publication said Italian talc is the "purest and best in the world," only containing "traces of chrysotile asbestos." The memo also said the pamphlet "calls undue attention to a host of trace metals in talcs and brands them as harmful elements, SVC talc being the least harmful." 

The J&J employee said he and others had successful talks with SVC and that the supplier agreed to "stop distribution of all English versions of the publication." SVC further allowed the J&J representative to rewrite it for English speaking countries, according to the memo.

Another document outlined April 2017 testimony from a former New York University graduate chemistry student saying he found random amounts of asbestos in "over 50 percent" of talc samples he studied in 1972 and 1973.

In the case of Lois Slemp, the $110 million verdict for which is under appeal, former NYU chemistry graduate student Aviam Elkies testified that during his research at the university under a J&J scholarship, he "did find asbestos in the baby powder of Johnson & Johnson." He said the crystals showed up "randomly" in dozens of samples.

"It might be one concentration, higher concentration, low concentration, none, of asbestos in the talc," he testified, according to the document.

In a 1972 lab report testing two batches of Johnson's Baby Powder, experts found "insignificant amounts of tremolite—a few isolated crystals." Elkies' professor from NYU conducted the work, according to the documents.

On Friday, J&J's spokesperson responded that the Baby Powder product "has been around since 1894 and it does not contain asbestos or cause mesothelioma or ovarian cancer."

"Last November, a California jury ruled in favor of Johnson & Johnson in a lawsuit by a woman who said she developed mesothelioma after using the company’s talc-based products," she added. "We will continue to defend the safety of Johnson’s Baby Powder in future trials.”

J&J has stood by its product as the caseload has grown. The company lost some early suits but has managed to get verdicts worth hundreds of millions of dollars reversed in appeals. It suffered losses in St. Louis worth $55 million, $70 million and $110 million and has pledged to appeal in each instance.  

The drugmaker additionally faces a lawsuit filed last fall alleging its talc "is not now, nor has it ever been, free from asbestos and asbestiform fiber." J&J disputed the allegation by pointing to results from the FDA and independent testing.

Editor's note: This story was updated with a statement from Johnson & Johnson.