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 On Tuesday, 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 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 defense 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 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.
Saldivar declined to comment.
NO SAFE LEVELS
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.
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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.
‘JUST NOT CORRECT’
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.
In an Oct. 3 deposition in a New York lawsuit, J&J Chief Executive
Alex Gorsky dismissed the findings of asbestos over the years,
saying “they were later shown to be inaccurate, incomplete and just
not correct.”
Attacking Saldivar’s finding, some legal experts told Reuters, could
hurt the company’s ability to use him as a witness in lawsuits and
undercut its broader message to jurors and consumers. That message
boils down to: Trust our experts.
But a product liability defense lawyer who helped organize a recent
talc litigation symposium said the impact on pending cases could be
limited because asbestos-related cancers are known to take decades
to develop. The FDA’s new finding “would be difficult to tie” to
cancers allegedly caused by long-ago exposures, said Edward Ulloa, a
Los Angeles-based lawyer who does not represent J&J.
The FDA findings are “essentially anecdotal,” Ulloa said, “specific
to that product and that particular sample.”
In its Tuesday announcement, J&J said that one of the labs it hired
initially found asbestos in three samples of Baby Powder, but the
lab determined that a portable air conditioner running when the
samples were prepared was contaminated with asbestos. Subsequent
tests in a different room found no asbestos, the company said.
NO EXPERIENCE, NO ASBESTOS
In 2010, when the AMA lab tested 34 talc products for the FDA,
including Johnson’s Baby Powder, the lab had no experience looking
for asbestos fibers in talc milled for powders and cosmetics.
Saldivar testified in several depositions that the lab’s work had
previously focused on determining the amount of asbestos in old
building products, such as vinyl flooring.
AMA made fast work of the 2010 FDA job, lab records reviewed by
Reuters show. His lab examined 102 samples, three from each product,
in a single day, using a method called transmission electron
microscopy (TEM). That works out to less than five minutes per
sample, assuming an eight-hour shift with no breaks.
Experts who have found asbestos in milled talc powders told Reuters
they require anywhere from a half hour to a day per sample using
TEM, and litigation records show they often look at more talc per
sample than Saldivar has testified is the practice at AMA.
In a deposition earlier this year, Saldivar acknowledged that he
looked at less talc per sample than others in the field and that
looking at more talc "would raise your analytical sensitivity" - the
ability to find any contamination. But he said he believed that his
methods were sufficient.
After the AMA lab found no asbestos in 2010, the FDA cautioned
against reading too much into the results - not because of the
sensitivity of the test but because so few products were tested.
Though the agency has described the testing as using the “most
sensitive techniques available,” it said the results “do not prove
that most or all talc or talc-containing cosmetic products currently
marketed in the United States are likely to be free of asbestos
contamination.”
When J&J’s lawyers approached Saldivar a few years ago about serving
as an expert and testing Baby Powder, they “wanted me to follow my
protocols that I used on my FDA testing” in 2010, Saldivar testified
in May 2018. In June, he testified that his lab had never found any
asbestos in talc samples, including Baby Powder, that it had tested
for J&J and other manufacturer defendants.
The testing by Saldivar’s lab for the FDA this year was a different
story.
“This positive test turns up the heat on J&J,” said Nora Freeman
Engstrom, a Stanford University law professor who studies complex
litigation. “And their expert lit the match.”
(Editing by Julie Marquis and Mike Williams)
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