In a Northern California trial to determine if Johnson & Johnson baby powder caused a man’s rare and fatal cancer it seemed on Tuesday to come down to the question---is a low amount of asbestos in the powder a risk?
“Our talc is safe and does not contain asbestos,” Dr. Edwin Kuffner told a jury. “It does not cause cancer.”
The trial is being streamed live courtesy of Courtroom View Network.
The plaintiff Anthony Valadez is suing Johnson & Johnson and other corporations including retailers Safeway, Walmart and Target stores plus LTL Management Company, claiming exposure to talc powder for 23 years between 1998 and 2022 caused his mesothelioma, a rare cancer of the linings of the lungs.
Valadez has pericardial mesothelioma, the rarest of three types of the disease. The other two are pleural and peritoneal mesothelioma.
Doctors have given him probably a few months to live.
The company through its subsidiary LTL filed for bankruptcy in 2022 and later offered to settle the lawsuits for $9 billion after a federal appeals court rejected an earlier attempt to settle the claims.
Bankruptcy stopped legal actions against the company. Plaintiffs nationwide want the bankruptcy protective status removed.
A U.S. bankruptcy court allowed the Alameda trial to proceed only because Valadez is not expected to live beyond a few more months. Even if he wins a judgment any monetary award would be delayed until the bankruptcy process is resolved.
Safeway, Walmart and Target stores are accused along with J&J of selling tainted baby powder to Valadez’s mother who then used it on the plaintiff.
Kuffner is a Pennsylvania toxicologist and J&J’s chief medical officer, a person responsible for baby powder safety. He told attorneys defending the company there was no asbestos found in the powder after numerous tests conducted by J&J.
This after the U.S. Food and Drug Administration (FDA) in 2019 found trace amounts of chrysotile, one of several types of asbestos, in two out of three samples of the powder.
Kuffner said he was responsible for the safety of the product and described the FDA 2019 finding as “very serious.” He said based on it the company did 155 of their own tests and no asbestos was found. Even so, bottles put on the market from the same lot of powder tested by the FDA were recalled, 38,000 bottles in all.
“What was your conclusion after re-testing?” Allison Brown, the attorney for J&J asked.
“It (FDA finding) was likely due to some (lab) contamination that happened,” Kuffner said. “It was safe to continue selling it. The asbestos levels (in the FDA report) were extremely low, but we took it seriously and recalled it.”
The amount the FDA said it had found Kuffner referred to as a “sub-trace” amount. He said he would have ordered the powder taken off the market if there had been a safety issue.
“I would have made that decision,” Kuffner said.
The company has been hit with 40,000 lawsuits nationally over its baby powder and earlier this year stopped selling it with talc in the powder opting for corn starch instead.
Kuffner said that decision was not reached because of safety issues.
Historically, the FDA in its testing had reported no asbestos in the powder. Neither had other world regulatory agencies like Health Canada, a government agency in that country responsible for public health.
Both plaintiff and defense lawyers have agreed there is no known safe level of asbestos exposure.
The amount of chrysotile found by the FDA was reportedly 0.00002%, lower than a background level of 0.1%, for example from breathing air and considered safe.
Five different principal types of testing of powder samples are done by labs. Through the heavy liquid separation method, TEM or transmission electron microscope, the SEM scanning electron microscope, PLM or polarized light microscopy and XRD or X-ray diffraction method.
Plaintiff expert witnesses have testified that heavy liquid and TEM were the best methods, XRD the least sensitive.
Heavy liquid involves using a spinning tube in which liquid is placed to separate heavier materials including asbestos fibers which settle at the bottom of the tube.
In past trials plaintiff attorneys have accused company officials of avoiding the liquid separation method because they were afraid it would turn up asbestos fibers and opted instead for the XRD testing.
The evolving argument seems to be that if small amounts of asbestos in the powder by new methods such as liquid separation have been found, is it enough to cause cancer? Is J&J liable even though the small amounts found are below the minimum levels set by regulatory agencies?
Joseph Satterley, Valadez’s attorney, got agreement from Kuffner that he wasn’t a micro biologist, a microscope researcher, a pathologist, a cell biologist or had done analysis of tissue samples.
Kuffner said a J&J safety team under his supervision did such analysis. He added that his opinion the product was safe was arrived at after detailed review of findings from scientists and regulators.
“It is a safe product,” he reiterated.
Kuffner also said that if he had determined that a warning on the bottle was necessary he would have ordered it. In 1986, a citizens’ petition called for warning labels to be installed on baby powder bottles. The FDA rejected it as unnecessary.
According to Salon.com, the FDA responded to the petition by saying, “The petition has not persuaded us that cosmetic talc that is presently being produced contains significant amounts of asbestos form minerals.”
That leaves open the question about lower amounts of asbestos found with new technology (higher-powered microscopes and liquid separation).
Defense attorneys' arguments are that given the rarity of Valadez’s disease, only 15 or so cases per year nationally, and the fact that millions of people use the baby powder, it isn’t logical that the powder caused the illness. In addition they have attempted to place the blame for the disease on other possible exposures to asbestos. Valadez’s father worked at construction sites as a handyman they said where asbestos could have been used (Valadez’s mother said he was a gardener). Valadez attended school in an old building.
The attorneys also contend that given his young age, 24, it makes it unlikely Valadez contracted mesothelioma from baby powder but more likely from a family history of cancer.
Plaintiff attorneys maintain that even a small amount of asbestos is dangerous. It has a latency period from first exposure to the onset of illness that can take decades.