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Wednesday, April 1, 2020

Plaintiff lawyers and their experts push FDA panel to expand definition of asbestos; Pills, chewing gum among products possibly affected

Attorneys & Judges

By Daniel Fisher | Mar 2, 2020


WASHINGTON (Legal Newsline) - A fierce behind-the-scenes conflict is growing as law firms that specialize in asbestos litigation urge the Food and Drug Administration to broaden the definition of mineral particles believed to cause disease while industry representatives try to make it narrower.

The fight is over “elongate mineral particles,” which an FDA-organized panel, the Interagency Working Group on Asbestos in Consumer Products, has proposed defining as any mineral with an aspect, or length-to-width ratio, of 3:1 or more. Industry groups worry that the broad definition of EMPs will trigger a new wave of litigation similar to the lawsuits plaintiff lawyers have filed against Johnson &Johnson and other companies claiming talcum powder contains asbestos. 

Many other products, from pills to chewing gum, contain talcum or other minerals that could fit the definition of EMPs.

“My concern is their broad, sweeping plan to make regulatory changes to what one would consider a particle of concern,” said Jeniffer Carson, a corporate defense lawyer with CMBG Law who submitted comments at a Feb. 4 public meeting on IWGAC’s proposed recommendations. “It is going to impact what is happening in courtroom now and it won’t actually increase safety. It could, in fact, have the opposite effect.”

Many pharmaceutical pills contain talc, for example, and the same sort of public-relations campaign that has prompted coverage in the New York Times and Reuters of the claims of plaintiff lawyers suing over talc might easily morph into similar allegations that drugs are unsafe, Carson said.

Asbestos fibers are incredibly thin, often slightly wider than the wavelength of light, and typically have aspect ratios much higher than 3:1. Lawsuits over talcum powder have featured intense arguments over how to define asbestos particles, with plaintiff experts declaring anything with the same mineral makeup as asbestos and an aspect ratio of more than 3:1 is asbestos. 

Defense experts use a much narrower definition, including absolute limits on fiber width that an aspect ratio alone does not capture.

Plaintiff lawyers and their experts dominated the public comment portion of the Feb. 4 meeting of the IWGACP organized by the FDA. Speakers included a lawyer from the prominent asbestos law firm Beasley Allen and plaintiff experts William Longo, Sean Fitzgerald and Dr. David Egilman. 

Those experts belong to a core group of highly paid professionals who are vital to talc litigation, since they provide testimony supporting allegations cosmetic talc contains asbestos and manufacturers knew it. When judges disqualify those experts from testifying, the case usually collapses, since medical experts who are prepared to connect a plaintiff’s cancer to talc no longer have the evidence of asbestos to support their opinion. Were the FDA to adopt a tighter definition of asbestos, plaintiff experts might find it harder to testify in court. 

Leigh O’Dell, a Beasley Allen principal who appeared at the Feb. 4 meeting, said “the most advanced testing” shows “talcum powder contains asbestos.” She said talc also contains particles plaintiff experts call “talc fibers,” although that term is not accepted by other experts - including those hired by defense lawyers.

“These fibers are genotoxic, causing both direct damage to cells and indirect damage through inflammation, which prompts oxidative stress, epigenetic changes, resistance to apoptosis and the stimulation of malignant cells,” O’Dell said in emailed comments.

The talc industry disagrees, saying there is no scientific evidence cosmetic talcum powder contains asbestos and scant evidence non-asbestos fibers covered by the proposed definition of EMP cause cancer. Inhaled in large enough quantities, any fiber can cause lung damage. But many of the particles that would fit IWGACP’s definition aren’t even respirable, said Carson.

Legal defenses will be complicated if the FDA reverses decisions it made more than 30 years ago, which companies appropriately relied upon when making their products, she said.

“Now the FDA is going to come back and say `We don’t think it’s sufficient and we need a broader definition,’” Carson said. 

The FDA formed IWGACP in 2018 to study the science of mineral particles and come up with recommendations for counting them in consumer products including talcum powder. The group includes representatives from eight federal agencies including the FDA, the National Institutes of Health and the U.S. Geological Survey. They issued a set of recommendations in January including the broad definition of EMPs, limited to particles in the mineral families of amphibole or chrysotile. Many forms of asbestos are also amphiboles, but amphibole is extremely common, constituting an estimated 6% of the earth’s crust. 

One major industry concern is that IWGACP is composed of scientists who aren’t considering the legal and policy implications of their recommendations. In their report, for example, they recommend testing laboratories use the broad definition of EMPs because all such particles are “suspected of having biological activity” similar to asbestos. Plaintiff experts make that claim, but other researchers dispute it, saying non-asbestos particles break down in the body before they can cause disease. 

Most experts agree asbestos fibers are extremely durable and because of their tiny width and tensile strength they can migrate through lung tissue and cause irritation that leads to cancer including mesothelioma, a fatal tumor of the chest lining.

Another concern is that IWGACP will issue its recommendations outside of the formal federal rulemaking process, which includes a notice and comment period and must adhere to federal administrative law. Without full agency involvement, industry lawyers fear the working group’s recommendations will become de facto regulations that don’t reflect the most current science.

The talc trials so far have been battles of the experts, with witnesses like Longo, who has made millions working for plaintiff lawyers, identifying a broad array of particles as “asbestos,” including chunks of mineral that defense experts say are plates of talc or “cleavage fragments” created when the substance is mined and milled. 

Defense experts say it is simple to distinguish harmful asbestos from other fibers through optical and electron microscopy and that plaintiff experts are relying upon overly broad federal regulatory definitions, designed for workplace environments where asbestos is already known to be present, to find asbestos fibers in talc. 

After receiving comments through March 4, the IWGACP will draft a final set of recommendations for industry testing for EMPs. 

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Organizations in this Story

Beasley AllenFood and Drug Administration