Testifying to a Los Angeles jury about claims Johnson & Johnson’s talc products caused three women’s deadly ovarian cancer, Dr. David A. Kessler detailed an internal document showing J&J’s concern over an FDA proposal to test talc instead of relying on industry self-testing. The former U.S. Food and Drug Administration commissioner has stated that the company “misled the FDA for over the last half century.”
Former FDA Chief Has Testified at Both Mesothelioma and Ovarian Cancer Trials
Dr. Kessler, who was FDA commissioner from 1990 through 1997, has proven to be a compelling expert witness in both mesothelioma and ovarian cancer litigation involving Johnson & Johnson’s talc-based products. In the Los Angeles trial surrounding three women who died of ovarian cancer after having used J&J’s talc products for feminine hygiene, he has testified about internal J&J documents from decades ago, revealing that the company was aware of the asbestos in its product. He said internal documents showed that, in the 1970s, J&J and its consultant McCrone & Associates altered conclusions of tests finding alarming asbestos levels before results were given to the FDA. One report contained a handwritten note stating, “Do Not Use This Report: Replaced by Another Version,” with the second version substantially reducing tremolite amounts given to the FDA.
In another 1976 memo, a J&J executive called an FDA proposal to test its talc for asbestos “disturbing” because the test was “ultra sophisticated,” saying “chances are that this FDA proposal will open up new problem areas with asbestos and talc minerals.” Dr. Kessler noted that the agency opted out of testing talc in the ’70s because it ultimately trusted the company’s assurances that its self-testing was sufficient.
Former FDA Commissioner Describes J&J Efforts to Downplay Asbestos in its Talc
Dr. Kessler testified that documents show that the company knew the J4-1 test that the company convinced the FDA to accept was not accurate enough to be safe: it did not measure for the chrysotile asbestos that causes mesothelioma, and could not detect any asbestos below 0.5%, potentially missing millions of particles causing cancer. He said documents showed that upon detecting asbestos in its mined talc, J&J began using a chemical method to reduce asbestos levels but never informed the FDA. He said that during his time at the FDA, talc was not considered a problem because the agency relied on the company’s repeated assurances. He said a 2016 letter the company sent to the FDA asserted that “no asbestos-forming structures have ever been found” in its talc—a statement Kessler contended was untrue.
Under cross-examination, Kessler pushed back against suggestions that tremolite found in old documents might not be the asbestos-forming type causing mesothelioma. “So, here we go, you’re spinning the definition of asbestos,” Kessler said. “That’s what’s gone on for decades….If it’s a fiber, if it says tremolite fiber, if it’s long and can do harm,” causing mesothelioma, Kessler said. “That’s the biological activity … this isn’t just about geology, this is about biology and medicine.”
Across the country and the world, people diagnosed with mesothelioma and ovarian cancer are seeking justice for the negligence of those who exposed them to asbestos. If you or someone you love has been diagnosed with an asbestos-related disease, contact the Patient Advocates at Mesothelioma.net at 1-800-692-8608 to learn how we can help.
