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Wednesday, April 1, 2020

Johnson & Johnson claims FDA's new asbestos testing based on 'faulty assumptions'

Attorneys & Judges

By Daniel Fisher | Mar 6, 2020

Babypowder

WASHINGTON (Legal Newsline) - Johnson & Johnson says a Food and Drug Administration panel charged with designing new standards for detecting asbestos in talc used “faulty assumptions” and failed to reflect scientific consensus in its draft recommendations. 

In comments following a February public meeting over the proposed talc testing rules, J&J said the Interagency Working Group on Asbestos in Consumer Products (IWGACP) incorrectly concluded that testing laboratories can’t distinguish between asbestos fibers and other mineral forms that are similarly narrow in relation to their length but haven’t been shown to cause disease. 

Trial lawyers and their expert witnesses support the IWGACP recommendations, which would make it easier for them to sue over “elongate mineral particles” in cosmetic talc and other products.

A number of participants in talc litigation filed comments with the FDA before a March 4 deadline, expressing conflicting opinions over the basic question of whether talc contains asbestos, as well as whether other EMPs cause cancer. Plaintiff lawyers, supported by favorable coverage by Reuters and the New York Times, have convinced juries in multiple trials that talcum powder contains asbestos. Johnson & Johnson and other manufacturers say jurors are being misled by clever scientific testimony designed to confuse true asbestos with particles that don’t share that substance’s dangerous qualities.

United States Pharmocopeia, a nonprofit standard-setting organization the FDA charged with developing a new method for testing talc for asbestos, said in its comment that the FDA had made a mistake about its views on using electron microscopy to detect asbestos particles. Johnson & Johnson said the IWGACP’s recommendations “may encroach” on USP’s ongoing efforts to produce a testing standard.

“Obviously, dueling methodologies could create significant confusion,” J&J said. “The IWGACP should consider working with USP to develop consensus definitions and approaches based on the science.”

Plaintiff lawyers and their experts weighed in on IWGACP’s side, saying there was no scientific basis for distinguishing asbestos from other EMPs because they all can cause disease. Chris Panatier of Simon Greenstone Panatier, a Dallas asbestos law firm, argued for a broader regulatory definition of asbestos in cosmetic products and said his firm would have recruited thousands more clients to sue over talc if lawyers had known earlier what their hired experts are now saying about asbestos in talc.

“I shudder to think how many hundreds, or thousands, of cases my firm and others turned down because we could not connect people’s mesothelioma to an asbestos exposure, when those individuals were long time users of talc,” Panatier wrote. “Had we been aware of the true extent of asbestos in talc used in cosmetics before seven or eight years ago, we would have been able to bring cases for dying victims and their families.”

In an acknowledgement of the importance of talc litigation to his firm, now that an older generation of workers who could plausibly claim industrial exposure to asbestos is dying off, he added: “Because we are taking cases where individuals have talc exposures, our clients’ average age at diagnosis has dropped.”

Several of the most important expert witnesses for plaintiff lawyers also filed comments before the deadline, in addition to speaking at the public meeting Feb. 4. Their testimony is critical to talc litigation, because J&J and other defendants deny there are any measurable quantities of talc fibers in their products. 

Laura Plunkett, a toxicologist who has testified for plaintiffs in talc cases as well as lawsuits over Xarelto and Paxil, made the legal argument that because talc products are non-essential cosmetics “without benefits to health,” warnings “do not need to be based on definitive conclusions.” Dr. David Egilman, a prolific plaintiff expert who has testified on everything from popcorn fumes to NFL player concussions, claimed without citing any scientific study that babies “have died from asphyxiation” from talc use.

Plaintiff experts say they can detect talc fibers using electron microscopy and other techniques, while defense experts say they are mistaking talc plates standing edgewise and “cleavage fragments” created when talc is milled for true asbestos fibers, which form in a unique geologic process that can be observed in their structure. Geologists say these fibers have an “asbestiform habit” and can be distinguished from other EMPs by a skilled technician.

Leigh O’Dell, a lawyer with Beasley Allen who has many talc plaintiffs as clients, said “any effort to re-insert the strict mineralogical and textural criteria of an `asbestiform habit’ should be resisted.” O’Dell also said talc causes 1,400 deaths from ovarian cancer a year, citing a single 1999 study that other experts have criticized as relying on self-reported talc use and providing no evidence of a dose-response relationship, normally a critical indication of a substance’s toxicity. 

Organizations allied with plaintiff lawyers including the American Association of Justice and the Environmental Working Group filed thousands of signed form letters from citizens concerned about talc safety. Deborah Cates of Hoover, Al. wrote: “Please help those of us who have experienced ovarian cancer due to the greed of big businesses like Johnson and Johnson.”

Most of the lawyers and their hired experts cited a critical finding by the International Agency for Research on Cancer, or IARC, linking talc contaminated with asbestos to cancers including mesothelioma, a deadly cancer of the chest lining. However that study found no evidence that inhalation of asbestos-free talc causes cancer, citing numerous studies of workers who mined and milled talc for years and showed no increased risk of mesothelioma and other cancers. 

IARC has been criticized by defense lawyers and others for linking many common products to cancer, including cellphones, fried food and glyphosate, the active ingredient in Roundup herbicide. The Environmental Protection Agency has prohibited glyphosate manufacturers from saying their product causes cancer, setting up a conflict with plaintiff lawyers and their experts who have convinced juries to award hundreds of millions of dollars in damages to consumers who claim they contracted non-Hodgkin’s lymphoma from using Roundup. 

Brooke Mossman, a retired University of Vermont pathologist who has testified as an expert witness for J&J, said she worried the FDA standard-setting process has been infected by outside influences. The draft report “frequently made conclusions that were not supported by scientific panels or recent publications in the peer-reviewed scientific literature,” Mossman wrote. 

Plaintiff experts typically claim that asbestos is found in the same deposits where talc is mined but that is only true of certain mines for industrial talc, she said. She also criticized the IWGACP report for repeating the claim of plaintiff experts that “there is no known safe level of asbestos exposure.”

“This is not a scientific statement and should be removed from this document as it engenders fear,” she wrote. “Although this statement is used in courtrooms, it is contradicted by the fact that members of the general population have millions of fibers in their lungs, yet mesotheliomas are rarely observed in nonoccupational settings.”

She also criticized the panel’s recommendation that the standard be set at fibers as short as 0.5 microns with an aspect ratio, or length-to-width ratio, of 3:1 or more. Scientific studies have established that asbestos fibers longer than 5 microns and slightly wider than the wavelength of light are responsible for disease and the shorter definition will sweep up many non-asbestos particles that the body safely digests or exhales, she said. The report excludes peer-reviewed literature supporting the longer fiber length standard, she said.

“To focus on and lump together all EMPs having lengths >0.5 microns does not support the essential tenets of fiber type differences, dimensions and durability that have been linked to disease by asbestos,” Mossman wrote.

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Organizations in this Story

Beasley AllenJohnson & JohnsonSIMON GREENSTONE