J&J's own expert finds asbestos in Baby Powder

Ever since Johnson & Johnson (JNJ.N) disclosed this month that a government test had turned up asbestos in its Baby Powder, the company has attacked the validity of the result. For example, J&J announced that other labs it hired ultimately found no asbestos in samples from the bottle tested by the U.S. Food and Drug Administration or from the same production lot.

In challenging the FDA's finding, however, the healthcare giant is casting doubt on one of its own experts. The private Maryland lab that found asbestos in Baby Powder under a contract with the FDA is run by a paid expert witness for J&J.

Andreas Saldivar, laboratory director of AMA Analytical Services Inc, has served as a litigation expert on several occasions for J&J since 2017 in its defense against plaintiffs' claims that asbestos in talc caused their cancers.

He testified in a May 2018 deposition that testing he did in 2010 for the FDA showed no evidence of asbestos in Johnson's Baby Powder, helping to bolster the company's argument that its iconic brand is safe. Saldivar's lab began testing cosmetic talc products for the FDA again this year, and in September it found asbestos in an unmarked sample that the FDA later identified as Johnson's Baby Powder.

"I have never heard of anything like this," said Richard Ausness, a University of Kentucky law professor who specializes in product liability, referring to Saldivar's dual roles. "This is bad news for J&J. The plaintiffs are clearly going to say this lab director worked for J&J for years, and he found asbestos so there must be asbestos there."

J&J's challenge now is to discredit the single test result as erroneous without undermining the reputation and track record of its expert witness, Ausness said.

"J&J could try to frame it as not so much this lab director is unreliable or incompetent, but false positives do happen and additional tests are called for,"

Ausness said. The company appeared to do just that, saying testing done by other laboratories J&J hired had found no asbestos in the same bottle of Baby Powder tested by Saldivar for the FDA, nor in the lot of Baby Powder recalled as a result of Saldivar's finding.

In an interview with Reuters, FDA officials said they stood by the AMA lab and its results. They also said they were not surprised by J&J's findings because contaminants are not uniformly dispersed throughout talc and different testing methods can yield varying results.

The company "would say the product is free of asbestos based on their testing, and we would say the opposite for that sample," said Steve Musser, deputy director for scientific operations in FDA's Center for Food Safety and Applied Nutrition. Plaintiffs' attorneys said Saldivar's finding for the FDA could be detrimental to J&J's defense in court. The company faces lawsuits from more than 16,000 people alleging that asbestos in its powders caused cancer.

Hours after J&J disclosed the FDA's asbestos finding on Oct. 18, a plaintiff's lawyer, Nate Finch, asked an Indianapolis judge to let him tell the jury about it in a trial involving a 71-year-old woman who alleged that Baby Powder contributed to her cancer. J&J's lawyers opposed the request, arguing that the information could prejudice the jury against the company, but the judge granted Finch's request. Days later, Finch told the judge his client had come to a confidential resolution with J&J, a trial transcript shows. Finch told Reuters he could not comment on the resolution.

J&J did not respond to questions about the Indianapolis case. The company declined to comment on Saldivar's role in the FDA testing, or on how it might affect the company's legal strategy going forward. In a June deposition, Saldivar said J&J lawyers had retained him in 2017 as a company expert in "maybe 20 or 30" cases. His firm bills $200 to $350 an hour for his services, he testified.

Under the FDA contract, his lab found asbestos fibers in the Baby Powder sample on Sept. 7, according to the lab's report. J&J said it was notified of the finding by FDA officials on Oct. 16, prompting the company to recall 33,000 bottles "out of an abundance of caution."

In response, some major U.S. retailers have said they are removing all 22-ounce bottles of Johnson's baby powder from their shelves. At the same time, the company has expressed suspicions about the finding, saying it had launched its own investigation "to determine the integrity of the tested sample, and the validity of the test results."

On Friday, the FDA posted online Saldivar's 16-page report to the agency on the analysis of J&J Baby Powder. In samples weighing less than a gram, the lab said it found six chrysotile asbestos fibers. Given that the samples were extremely small, the asbestos could amount to millions of fibers per gram, testing experts told Reuters.

While most people exposed to asbestos never develop cancer, for some, even small amounts are enough to trigger the disease years later. Just how small hasn't been established. The World Health Organization and other health authorities recognize no safe level of exposure to asbestos, a known carcinogen.

"Since there are no known safe levels of asbestos, the FDA has asked manufacturers to voluntarily recall their products when fibers consistent with asbestos are found in them," the agency said this month.

Several juries over the past two years have concluded that Baby Powder exposures caused cancer and have awarded plaintiffs more than $5 billion. Other juries have sided with J&J, and some cases have settled.

The FDA has never before announced that government testing found asbestos in J&J's Baby Powder. Since the early 1970s, J&J has pushed back hard on reports of asbestos in its talc by outside scientists, plaintiffs' experts and, on several occasions, by its own testing labs.