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By Peter Hayes
Dec. 7 — In a small town in southern New Hampshire sits a 60,000 square foot manufacturing facility owned by NanoComp Technologies.
Using microscopic carbon nanotubes, the company makes lightweight, flexible and strong products that have many applications including for use in armored vests and fire protection.
NanoComp is only one small story in the world of nanotechnology, which has been touted as the next industrial revolution.
Between 2009 and 2016, revenue from nanotech products in the U.S. grew more than six-fold and it’s projected to exceed $500 billion this year, according to government estimates.
While nanomaterials have an almost unending array of uses, concerns exist about unknown risks to human health and the environment.
Nanotechnology starts with nanoparticles, which are between one and 100 nanometers in size. A strand of human DNA is less than half the diameter of a nanometer.
At such a small scale, the properties of materials change, including the melting point, electrical conductivity and chemical reactivity. These changes create the potential for unexpected risks and potential injuries.
In fact, a decade ago, many attorneys predicted suits alleging injuries from nanomaterials would be the next mass tort, even likening it to asbestos, one of the longest running and deadliest toxic torts in U.S. history.
Yet, to date, no such wave of litigation has materialized.
Are nanotech tort suits still on the horizon, or were the predictions unfounded?
Some attorneys, even those on the defense side, remain convinced the new wave of personal injury suits is coming, and sooner rather than later.
While others, continuing to draw parallels with the long latency periods before asbestos injuries first started showing up, say it’s too early to tell.
Still other attorneys credit manufacturers’ careful compliance with early-round federal regulatory work and guidance as possibly averting the liability concern altogether.
Attorneys agree, however, that it’s difficult if not impossible to generalize about thousands of types of engineered nanoparticles which also are used in products like sunscreens, medical devices and even food packaging.
“It’s anybody’s guess when the tort suits will come. But I think it will be less than five years,” defense attorney William Rogers with Prince Lobel Tye LLP in Boston told Bloomberg BNA.
Rogers is chair of the firm’s multidisciplinary Nanotechnology Practice Group. He represents a broad array of clients including technology companies and manufacturers.
Many hurdles may have contributed to the delay in nanotort litigation, Rogers said.
“People who have experienced exposures to nanomaterial from nanotech products and who may ultimately sustain harm may not manifest symptoms for some time, and there is a potentially long latency period. And even if there are symptoms, there may be confusion about how to differentiate from symptoms caused by other things,” Rogers said.
But even if a nanoparticle is a cause of a symptom, that isn’t enough under traditional tort theory to trigger liability, he said. “You still need a causal relationship between exposure and manifestation of physical injury.”
And plaintiffs also need an expert, Rogers said. “It requires a significant amount of data. The plaintiffs’ bar has been unable to find qualified people to say the magic words supported by that data.”
Medical monitoring claims, however, which don’t require a showing of full blown disease to bring a case, are an early avenue of litigation to watch for in the few jurisdictions that allow them.
But Rogers cautions against generalizing.
“The reason why you cannot generalize with nanoparticles is that they can be wildly different in their physico-chemical characteristics, and in their use and applications,” he said.
Defense counsel Kevin Mayer with Crowell Moring in Los Angeles says it’s too early to tell when, or if, the litigation will take off.
“We haven’t had a sufficient latency period to hypothesize whether chronic effects will manifest,” he told Bloomberg BNA.
Mayer’s practice includes toxic tort and product liability. He recently addressed the Environmental & Emerging Claim Manager Association, an association of insurers, on nanotechnology liability issues.
“There were predictions that carbon nanotubes will behave like amphibole asbestos particles, but that’s a 25 to 50-year latency period,” he said.
“It could be 15 to 20 years before we see whether there’s sufficient evidence to bring claims,” Mayer said.
One law professor tracking the issue finds the asbestos comparison apt, saying that, at some point, toxic tort litigation involving nanomaterials could follow a course similar to those suits.
Distinguished Emeritus Professor Jean Eggen at Widener University Delaware Law School specializes in toxic torts, civil procedure, and science and the law.
“If personal injuries associated with nanomaterials include diseases that typically develop over years or decades from the time of exposure—such as cancer—then the picture of the populations in need of relief may not be clear for decades,” Eggen told Bloomberg BNA.
“I think we are in an early pre-litigation stage,” Eggen said. “This includes conducting research and amassing information on the potential hazards of nanomaterials, something that is unclear at the present time.”
Latency periods come into play as well, she said.
Just as the earliest asbestos cases involved workers compensation claims, she said, so too might nanotech tort suits.
In the asbestos world, courts allowed those claims to proceed in court only after the hazards of the materials became widely known, a development that took time even though asbestos was ubiquitous.
The gradual deterioration of the commonly used material resulted in “the potential for a broader population to be exposed,” and, after its further degradation, the potential of the “substance to contaminate the environment was high,” she said.
“Nanotechnology could follow a similar course,” Eggen said. “Because of the potential for nanotechnology to touch upon every aspect of our lives—consumer products such as sunscreens, medical treatments such as drug delivery devices inside human bodies, food packaging, etc.—the foreseeable scope of litigation is vast.”
Eggen also said nanotechnology now, like asbestos when it was first being developed as insulation, is “a situation where innovation has outpaced investigation into the potential health and safety hazards of the technologies.”
Rogers, with Prince Lobel, doesn't like the asbestos comparison.
“Science and medicine have both improved dramatically in the last 80 years, so to say nanoscience and any resulting litigation will mirror the evolution of the asbestos crisis of the 20th century is an over-simplification,” Rogers told Bloomberg BNA.
But he agrees that the investigation into nanomaterials' potential harms is only in its early stages.
“Five or six years ago, I was on a panel with a representative from the National Cancer Institute, who said they had studied only 141 nanomaterials to that point,” he said.
With thousands of types of engineered nanoparticles, he said, this represents only “a tiny fraction of the universe.”
The National Cancer Institute, based in Bethesda, Md., is part of part of the National Institutes of Health and is the federal government's principal agency for cancer research and training.
“The process for evaluating nanomaterials for safety is ongoing, and yet there are limited people at the FDA and EPA” to work on the issue, he said. “It will take time.”
But other attorneys say early work by some government regulators, including the Environmental Protection Agency and the National Institute for Occupational Safety and Health (NIOSH), may actually account for the lack of litigation so far.
“Beyond the latency period issue, I think the biggest thing is that there is no (or very little) worker exposure happening, and workers are typically the first to be exposed,” attorney John Monica with Porter Wright Morris & Arthur LLP in Washington told Bloomberg BNA.
“NIOSH has done a good job of advising companies about potential risks to their workers and providing them with tools to prevent exposure, and EPA has regulated potential workplace exposures to nanomaterials considered new chemical substances under the Toxic Substances Control Act,” he said. “These are good developments.”
“Beyond workers, I think consumers also have limited direct exposure to nanoscale materials in their native forms once they are incorporated into final products. Time will tell on this issue,” Monica said.
“The market for certain nanoscale materials that were of the most EHS [environmental, health and safety] concern has been slow to develop—carbon nanotubes are a good example,” he said.
“Although touted as miracle materials, several key players in the carbon nanotube industry have come and gone over the past decade. This is not necessarily related to the EHS issue, but rather simply a matter of economics,” Monica said.
And the jury is still out on the carcinogenicity of carbon nanotubes, David Schwartz with the scientific consulting firm Innovative Science Solutions LLC in Morristown, N.J., told Bloomberg BNA.
“There have been studies of carbon nanotubes using animals. Some showing problems, some not,” Schwartz said.
Ironically, those studies, such as a 2008 study published by Craig Poland, in Nature Nanotechnology 3, 423 - 428 (2008), could make it less likely that suits are filed over carbon nanotubes, Rogers with Prince Lobel said.
“Those articles attracted a lot of media hype and regulatory attention," he said, noting NIOSH issued recommended exposure limits for both carbon nanotubes and carbon fibers.
“When something gets a lot of scrutiny and exposure limits are established, it tends to reduce but not eliminate the risk they’ll be the subject of litigation,” Rogers said.
In fact, some attorneys are so optimistic about companies' compliance with federal regulators' efforts to date, that they say that, despite much hype, mass litigation over nanomaterials may not materialize at all.
“I have been and remain optimistic that the much talked about `nano tort’ will not make even a cameo appearance on the world stage,” attorney Lynn Bergeson with Bergeson, & Campbell P.C. in Washington told Bloomberg BNA.
Bergeson counsels corporations, trade associations, and business consortia on issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters related to conventional, bio-based, and nanoscale chemicals.
“ `Latency period’ presumes an injury has occurred and we await manifestations of harm,” she said.
Instead, she, said, we should credit the efforts of industry and NIOSH.
“I would prefer to think that innovators, manufacturers, users, and others are engaged in appropriate personal protective clothing and equipment practices, and following the plethora of NIOSH and industry-supported best practices to minimize and abate exposure, thereby ensuring that the passage of time yields no surprises,” Bergeson said.
“That no injury has manifested itself, under this interpretation, is a reflection of prudent research and business practices, and not a latency period playing itself out.”
Time, it seems, will tell whether this is merely the calm before the storm, and, if so, whether nanotech faces widespread mass tort claims or something much more limited in scope.
To contact the reporter on this story: Peter Hayes in Washington at PHayes@bna.com
To contact the editor responsible for this story: Steven Patrick at email@example.com
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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