J&J talc settlement blasted by ex-FDA head over asbestos testing

A Johnson & Johnson unit working to resolve massive cancer litigation in bankruptcy court was accused by a former head of the U.S. Food and Drug Administration of making misleading claims that the company’s baby powder never contained asbestos.

David Kessler, who led the FDA for more than six years starting in 1990, took the stand at a trial in Houston on Wednesday as a paid expert witness for opponents of J&J’s $9 billion settlement plan to end cancer cases targeting its signature powder.

Kessler said his review of evidence emerging from more than 15 years of litigation after he led the FDA shows that the J&J unit’s bankruptcy disclosures mischaracterize what the company has known for decades. If the judge finds that the J&J unit was misleading in its filings, he could shoot down the plan.

Internal company documents dating back to 1971 “certainly showed” that tests by federal regulators found at least trace amounts of asbestos in some talc from a company mine that was intended for use in the powder, Kessler told the bankruptcy judge at the trial over a Chapter 11 plan for J&J’s Red River Talc subsidiary to resolve more than 60,000 lawsuits.

‘There is asbestos’

Alli Brown, a lawyer for the company, said J&J “hotly contests” any suggestion that it has been dishonest, and that it had “never wavered in the opinion that this product is safe and doesn’t contain asbestos.”

Under cross-examination later, Kessler said “your company, for 40 years, tried to convince the American public” that baby powder was asbestos-free. He said: “There is asbestos in these products. You can’t get away from it.”

Johnson & Johnson is trying to use the bankruptcy process to close out the vast baby powder litigation after two earlier efforts failed in other courts. At the trial, U.S. Bankruptcy Judge Chris Lopez is navigating the intricacies of the law to determine whether J&J’s efforts are proper.

Lopez is hearing testimony on whether J&J manipulated a vote on the settlement among 93,000 claimants and whether the company, which is profitable, is wrongly trying to benefit from Chapter 11 rules that should be reserved for financially distressed businesses. J&J says bankruptcy court is the most efficient way to process the cancer suits and that the pre-Chapter 11 vote was held fairly and impartially.

6,000 years

John Kim, an executive for J&J’s Red River unit, testified it would take 6,000 years for juries to weigh the claims in all the baby powder case pending against J&J.

Erik Haas, the company’s worldwide vice president of litigation, said in a statement Thursday that Kessler’s testimony “showed that his paid-for opinions were biased and unsubstantiated.” He said that Kessler acknowledged he has made tens of millions of dollars testifying for plaintiffs in such cases since he left the FDA.

Haas said that Kessler didn’t address “extensive documentation that refuted his assertions,” adding that the FDA “repeatedly concluded, for decades, that the company’s talc powder products did not contain asbestos.”

In court on Wednesday, Brown noted that FDA officials tested J&J’s raw talc in 2009 and 2010 and didn’t find any asbestos in those bottles, and that they tested the raw talc used as one of the main ingredients in the baby powder, which also came up clean. She pointed out that the FDA has never required J&J to put a safety warning on its baby powder products, despite several requests from advocacy groups over the years.

Limits of detection

Kessler, now a medical school professor at the University of California at San Francisco, acknowledged that the agency didn’t find asbestos during his years at the helm. But he said it was because J&J had hidden it from regulators, and that the agency responded to the threat only after finding asbestos in a 2019 check.

One reason J&J felt comfortable making claims that its powder had tested safe is that its staff used methods, with “significant limits of detection,” designed to miss asbestos in talc, Kessler said.

“The agency didn’t wake up until 2017,” when documents about J&J’s handling of the product were made public, he testified. “The FDA went back and tested and found it.” The agency then asked J&J to recall one lot of baby powder bottles, he told the court.

Kessler told the judge he was hired by objectors to the bankruptcy plan to assess the accuracy of J&J’s disclosures about the FDA’s baby powder testing. Officials of the Red River unit have said in filings that allegations the baby powder was tainted with asbestos “were investigated” by FDA officials and “found to be unsupported by fact or science.”

‘Precision and integrity’

“Is that statement true?” asked Leigh O’Dell, a lawyer for the objectors.

“No, that is not true,” Kessler responded.

Opponents of the settlement plan include the U.S. Trustee, the Justice Department’s bankruptcy watchdog. It urged the judge to follow the precedent set by a federal appeals court in Philadelphia, which blocked J&J’s two earlier talc bankruptcies.

In a report filed last month in connection with Red River’s bankruptcy case, Kessler wrote that J&J had spent decades reassuring consumers that regulators had concluded its products didn’t contain asbestos and that its safety testing was done “with a high level of precision and integrity.” Instead, he claimed, the company covered up its knowledge of the risks for half a century.

The case is Red River Talc LLC, 24-90505, U.S. Bankruptcy Court, Southern District of Texas (Houston).