J&J’s own expert, working for US regulator, found asbestos in Baby Powder3 min read . Updated: 30 Oct 2019, 11:34 PM IST
- J&J says other labs it hired had found no asbestos in the same bottle of Baby Powder tested by Andreas Saldivar for FDA
- In challenging the FDA’s finding, the healthcare giant is casting doubt on one of its own experts
Ever since Johnson & Johnson disclosed this month that a government test had turned up asbestos in its Baby Powder, the company has attacked the validity of the result.
On Tuesday, for example, J&J announced that other labs it hired ultimately found no asbestos in samples from the bottle tested by the US 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 defence 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 on Tuesday, 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 on Tuesday, 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 defence in court. The company faces lawsuits from more than 16,000 people alleging that asbestos in its powders caused cancer.
The impact was immediate in one courtroom.
Hours after J&J disclosed the FDA’s asbestos finding on 18 October, 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. It declined to comment on Saldivar’s role in the FDA testing, or on how it might affect the company’s legal strategy going forward. Saldivar declined to comment.reuters