Have you ever entered a dark room without a flashlight or other source of illumination and discovered that the light switch was on the other side of the room? Perhaps you were lucky enough to walk through an empty room and thus left whole, or perhaps a box or chair invisible in the dark tripped you up, causing you injury before your path was illuminated.
October 03, 2019 Feature
Nanotechnology Liability Outlook 2019—Still in the Dark?
By Edward R. Glady, Jr.
The liability outlook for nanotechnology in 2019 differs little from this suggested scenario. Predictions of potential dire legal consequences for nanotechnology use made ten or more years ago have yet to come to fruition, but the walk through the dark room is nowhere near complete. Given that we still have no flashlight to show us the way ahead, how does one navigate any liability hazards still before us?
This article will not present a comprehensive overview of the multitude of liability issues and potentials that remain in place for nanotechnology. In an industry involving trillions of dollars and thousands of ideas, innovations, research and development efforts, and ultimately products, such an effort would tax both author and reader beyond endurance. Instead, this article will take a more general approach to examining the liability landscape for a still-emerging technology that promises many wonderous things, but at an unknown cost.
A Short History of Liability for “New Technology”
With rare exception, the law lags technological development. Innovators seeking financial gain create new markets, new products, and new uses for scientific and medical discoveries and technological advancements as quickly as possible. Prior to the advent of regulatory efforts, little concern was given to the harm such innovations could or would cause to the workers involved in the manufacturing process, to the consumers who interacted with them during their use, or to the environment that received the waste or other effects produced by the innovations. The law sought to compensate some of those harmed by these innovations, but legal efforts were often slow and not always adequate. In all cases, the remedy was effected after the fact of injury.
The advent of governmental regulation of the marketplace, originating with concerns based on food safety, brought about the first efforts to seek to address potential harm before a product was introduced to consumers.1 Worker safety concerns also began to be addressed in limited ways.2 (The environment would not get due attention arising from the effects of innovation for years to come.)
In these early efforts at regulating commerce for the health and safety of workers and consumers, most of the effort was aimed at immediate or acute risks: Food should not immediately poison those who consume it; railroad work should not maim or kill industry workers. No effort was made to examine or regulate long-term effects of innovations put into the stream of commerce. Indeed, science and medicine were ill-equipped at the time to do so. Relying on both for its efforts at redressing wrongs, the legal system also had few tools to suspect or address potential long-term harm.
Into this mix of marketplace reward and primal regulation and legal redress for acute injury entered a “wonder” technology that promised to address numerous needs and situations: asbestos. It is difficult today to imagine the excitement and wonder that greeted a product that promised protection against fire, a ubiquitous source of damage to structures and possessions, as well as injury to persons.3 Moreover, the ability of asbestos to absorb heat without igniting made it a perfect choice for brake linings, insulation, building materials, and a multitude of other industrial applications and uses involving heat, including fire retardant coatings for military warships. Innovators looked for new opportunities to use asbestos at every turn. Indeed, the future for asbestos seemed to face no limit.
But after a length of time, people who worked around or otherwise were in proximity with asbestos began to exhibit pulmonary issues, often leading to death.4 Medical studies ensued, building a new understanding of toxicity, epidemiology, and long-term causation not only for asbestos but in the fields themselves. Yet, the legal system was still slow in responding to this newly emerging knowledge, and it took a number of years for civil litigation to process claims and provide compensation for those who claimed to have been injured by asbestos.5
The asbestos “circle of life” fairly represents how innovation and new technology thrived under the laissez-faire worldview existing in the mid-twentieth century. Innovation and capitalism were for the most part given a free hand to develop technology and products with little concern or regard for any harm or ill-effects other than those of an immediate or acute nature. It is also fair to say that asbestos dramatically changed this same worldview when its long-term harm came to light, a development that occurred parallel to a general awakening that substances and products might have both short-term and long-term harmful effects and that such harms should be better understood before they are unleashed onto an unsuspecting public. The result of this new worldview is a modern marketplace that still rewards innovation and entrepreneurship, but now holds such efforts liable for any harms they cause, even if such harms are not known for years to come. And part of this marketplace is a more mature legal system that seeks to regulate harm before it happens, as well as compensate those affected by the harm. The key for all these efforts, however, is knowledge. Regulators cannot govern how technological innovation is unleashed into the marketplace without knowledge of possible consequences, nor can the civil litigation system fairly compensate those injured by the new technology without knowledge of the cause and effect involved. Indeed, it is this bedrock need for knowledge that darkens our vision when discussing potential nanotechnology liability. Yet, darkness or not, the marketplace wants, encourages, welcomes, and rewards nanotechnology innovation. But by entering this marketplace with its continuing darkness regarding potential liability, is the nano industry whistling in the dark?
Treading in the Darkened Room
The nanotech industry is huge and covers a broad landscape of products and services, including medical, consumer goods, and industry applications. Like asbestos in its day, nanotechnology is seen as an answer to a thousand different needs and uses, upgrading life in some instances (thick, white “ugly” suntan lotion becomes clear and “unobtrusive” with nano-sized active ingredients) and hopefully saving lives in other instances (nano-imaging improves treatment and diagnosis of asbestos-caused mesothelioma6). Innovators are daily trying to uncover new properties and new uses for nanotechnology, with trillions of dollars at stake. As with asbestos, the future of nanotechnology seems to contain no limits.7
But, because of asbestos, we no longer just think of a technology’s potential for good; we also now think of its potential cost in terms of harms to worker, user, and the environment. And, unlike asbestos, we now have a strong regulatory framework in place that is designed to frontload safety concerns so that harm is detected and regulated before products are distributed to a consuming public.
Given this new reality, we’re now in a better place to measure and calculate potential harm and liabilities of nanotechnology before entrepreneurs, investors, innovators, and business entities risk capital and develop and launch their nano products and services into the marketplace, right? Maybe not.
Even though we have developed a much more sophisticated appreciation of the potential harm new substances and products might cause, and even though we have developed new understanding and procedures to probe for such harm in both animal and human populations, the uncomfortable truth is that we have not advanced much past the days of asbestos when clear knowledge of harm comes only from long-term exposure of a human population and actual harm manifests. Without this real-world experience, we can at best only take an educated guess at what harms might result from exposure to various nano components and uses.
Some of these educated guesses come from animal testing, where a large population of test animals are exposed to a nano element or compound to see what harmful effects arise.8 In addition, scientific or medical literature might report an individual’s physical reaction to a possible nano exposure.9 Regardless whether from animal testing or isolated human experience, suggested connections between nano exposure and resulting harm from such studies must be replicated many times over in similar situations before a scientifically justifiable connection can be made for a cause-and-effect determination that supports legal causation conclusions. In this setting, a great deal of time and experience must accrue before there is a sufficient body of scientific and medical knowledge to understand how nano components might or do cause harm to humans.
Regulators are charged with the obligation to minimize risk to the public from the multitude of harms potentially confronted in daily life, including something as seemingly innocuous as drinking a glass of water. U.S. regulators in this regard come in two forms: those that govern the things the public consumes or comes in direct contact with, such as food, cosmetics, and consumer goods, and those that govern the environment encompassing the public and the environs in which the public dwells, such as air, soil, or water contamination or work conditions. These regulators use scientific and medical knowledge to set “safe” limits of exposure to identified harms, often using very conservative standards such as an exposure level thought to cause no more than one death related to the exposure out of a population of a million. Regulators often rely heavily on animal studies or on existing human studies regarding suspected harm to determine toxicity and perceived “safe” dosage levels for exposure.
As of 2019, there remains a paucity even of animal studies for regulators to determine if and how to set “safe” standards for those nano products within their regulatory jurisdiction.10 Without this body of science and medicine, regulators are moving slowly in how they deal with nano products. To the extent nano innovators—and the public—rely on regulators to provide them with a cloak of protection based on scientific and medical knowledge, they must wait for another day. So how does a nano innovator operate without the light of knowledge?
Living in Darkness
Current scientific and medical knowledge and accompanying regulatory actions shed little light on liabilities nanotechnology innovators, entrepreneurs, and producers potentially face with the interaction of their products on workers, consumers, or the environment. Eerily like asbestos, any long-term ill effects will manifest only after a period of extended human exposure. Given the ultimate price tag arising from the eventually revealed long-term harm caused by asbestos (lives ruined, companies destroyed, insurers decimated), no reasonable person or entity wants to create or be part of another such industry Armageddon. Yet, without sufficient scientific or medical knowledge about the potential short-term or long-term harmful effects of nano products, how do nano producers or their financial backers move ahead in the marketplace with any sense of security? And how does a legal system charged with compensating victims of defective products do its work when precious little medical or scientific knowledge exists to inform its decisions?
Like the problem, potential solutions are neither simple nor surefire. But several areas offer some rays of light.
As a starting point, anyone who is involved in releasing new nano products into the stream of commerce must understand that legal responsibility flows from that action.11 No product is immune from attack or allegations that it caused harm. This basic premise is crucial as it informs how those involved in the innovation, production, and distribution process must see that process as not only one to transform an idea into a product, but also to question from the beginning how that product might cause harm and be modified as a result or reasonable warnings given to users so that they understand the risks of using the product.12 This suggestion might at first seem counterproductive: Why should we look for trouble? Shouldn’t it instead come looking for us? Unfortunately, such a question ignores the reality of our judicial system: If your product is harmful, you will be called to account for it someday. And actual ignorance of the harm will provide you no shield against legal liability for if by reasonable effort you could have known of its harmful potential, but sought to take no steps that might gain that information, you could still face product liability exposure.13
Indeed, some in the nanotechnology industry have sought to establish standards for determining a risk management process for nano materials and products. One process, developed jointly by DuPont and the Environmental Defense Fund, establishes a disciplined process for evaluating and addressing nanotechnology risks.14 Others exist as well. 15 By conducting such efforts, a nano product producer can analyze the nano component materials for a potential risk of harm based on current knowledge. It may not totally shield the nano producer from legal claims but provides a powerful defense that reasonable efforts were made to make the product as safe as possible based on knowledge available at the time of its design and manufacture.
Likewise, participation in industry groups and compliance with any voluntary standards and codes that might exist provide the nano producer with the ability to follow current state-of-the-art practices, another important plank in any legal defense raised in response to legal claims.16
Obviously, if a nano producer in doing its due diligence acquires actionable knowledge that its product or nano components are in fact or reasonably could be harmful, it absolutely must take immediate steps to address the potential harm, including warning others of the potential harm.17 Any notion that such knowledge can be concealed while production and distribution continue unabated should be greeted with an invitation to study the repercussions from similar decisions by the asbestos and tobacco industries.
Of course, part of the risk management process is risk allocation. Specifically, nanotech innovators might look to insurers to share some of the risk inherent in launching nano products into the marketplace. As the nanotech industry began to blossom, a number of insurers entered the nano marketplace to offer coverage to nanotechnology producers. As the nano industry exploded, however, insurers became less enthused as risk calculations became more complicated and less clear.18 Insurers like liability risk “darkness” even less than those involved in the nanotech industry, so until there is clearer loss experience and more certainty as to liability risks faced by the nano industry, insurance coverage may offer only limited options for risk management efforts.
Is There a Light Ahead?
As noted at the outset, despite predictions starting many years ago that the nano industry soon would be deluged with lawsuits claiming an untold number of injuries and bankruptcy-inducing-sized damages, the nanotech civil litigation battlefront is still very quiet. Is this good news and a sign that we are near the light switch with its promised illumination of our way? Or, like the asbestos life cycle, are we still too early to see the whirlwind headed our way?
As cliché as it may sound, only time will tell. Some nanotech products have seemingly passed the “no acute harm test,”19 but for many others, the jury may still be out.20 More importantly, what can we know about long-term harm liability issues with a form of technology barely into its teenage years?
Like it or not, our legal system is informed by experience and is still, for the most part, reactionary to harms caused. It is a system that requires knowledge, experience, and reasoned scientific and medical conclusions to act, to remedy, and to compensate. An inescapable corollary to such a truth is that people must suffer actual harm for knowledge to be gained and remedies provided. If a nanotech material, component, product, or technology results in harm from long-term exposure or use, it will fall on future generations to use that acquired knowledge to adjudge who will bear the brunt of the now-revealed harm. This is not an entirely satisfactory result or process for all stakeholders involved, including those facing harm—workers, consumers, and those living in an affected environment. But perhaps past experience will educate us to be more effective in how we seek and analyze experiential data, be more responsive and responsible in how we apply new knowledge, and be more attuned to the hard-learned lesson of the past that human lives are inexorably linked—for better or worse—to the technology we devise and employ.
Nanotechnology potential liability exists, and perhaps that risk can be partially managed by the nano industry and regulators, at least based on current knowledge, but in the end, this potential liability will depend on information gained through future experience and the understanding it will bring. Such a reality should not stop nanotech innovation, investment, or implementation but should bring a sober realization that what is done for good purposes or intentions today may bring unforeseen or unwanted consequences tomorrow. As we reach for the light switch, we must be ready to accept what is illuminated when the darkness fades.
Endnotes
1. The first such legislation, the 1906 Food and Drug Act, was enacted in response to claims of unhealthy food, a claim famously illustrated in Upton Sinclair’s novel The Jungle.
2. See, e.g., the Safety Appliance Act of 1893, requiring basic safety equipment for the protection of railroad workers.
3. A 1942 newsreel shows cheerful workers without safety equipment assembling many useful devices utilizing asbestos: British Pathé, Newsreel of the Week: The “Wonderful” Uses of Asbestos (1942), YouTube (Aug. 27, 2015), https://www.youtube.com/watch?v=HxfZSEboVM4.
4. British medical researcher Dr. Edward Merewether began linking asbestos to pulmonary issues starting in the 1930s. Other studies showing the same links followed.
5. Claimants argue that this delay was caused by intentional efforts on the part of the asbestos industry to keep hidden facts regarding the toxicity of asbestos.
6. Alexander De Ridder, Mesothelioma Treatment and Diagnosis Improved by Nanotechnology, Edgy (Dec. 23, 2016), https://edgy.app/mesothelioma-treatment-nanotechnology.
7. “This tiny science [nanotechnology] has limitless potential to revolutionize our daily lives and solve the daunting challenges of our future[.]” Press Release, Senators John Kerry & Olympia Snowe, Kerry-Snowe Bill Strengthens Safety in Nanotech Research (July 17, 2008) (statement by Senator Snowe).
8. See, e.g., C.A. Poland & R. Duffin, Carbon Nanotubes Introduced into the Abdominal Cavity of Mice Show Asbestos-like Pathogenicity in a Pilot Study, 3 Nature Nanotechnology 423 (2008).
9.See, e.g., W. Journeay & R. Goldman, Occupational Handling of Nickel Nanoparticles: A Case Report, 57 Am. J. Indus. Med. 1073 (2014).
10. Professor Marchant’s 2014 observation still rings true today: “. . . we still know relatively little about the hazards of . . . nanomaterials, never mind being able to perform quantitative risk assessments.” G.E. Marchant, “Soft Law” Mechanisms for Nanotechnology: Liability and Insurance Drivers, 17 J. Risk Res. 709 (2014).
11. Restatement (Third) of Torts: Product Liability § 1.
12. This process must be well documented and include efforts to involve outside expertise regarding the safety analysis, if practicable. Juries may someday be asked to judge these actions and decisions, and the more complete the record of the decision process that is kept, the better the chance of convincing a jury of the reasonableness of the product design and warnings.
13. “Dangers that a seller ‘should know’ include those that are reasonably foreseeable or scientifically discoverable at the time the product is sold.” Wood v. Phillips Petroleum Co., 119 S.W.3d 870, 873 (Tex. App. 2003) (citations omitted).
14. For more information, go to http://www.nanoriskframework.com/.
15. For a nice summary of risk management options for nanotech innovators and “soft” incentives for using them, see Professor Marchant’s previously cited article, supra note 10.
16. Restatement (Third) of Torts: Product Liability § 4(b) affords a defense based on compliance with an applicable safety statute or administrative regulation. In the absence of such statutes or regulations, compliance with voluntary codes—if shown to be reasonable—may also offer the nano product defendant some protection in a product liability lawsuit.
17. Restatement (Third) of Torts: Product Liability § 10.
18. “[I]nsurance industry leaders agree that the industry will n ot be able to quantify potential losses related to nanotechnology risks, and that it is too soon to tailor policy forms to nanotechnology risks.” T.F. Segalla & T.S. Flascher, Perspectives: How to Evaluate Emerging Risks of Nanotechnology, Bus. Ins. (Feb. 24, 2013), https://www.businessinsurance.com/article/20130224/story/302249974/perspectives-how-to-evaluate-the-emerging-risks-of-nanotechnology.
19. Nanoparticles in Sunscreens, Envtl. Working Grp.: 2019 Guide to Sunscreens, https://www.ewg.org/sunscreen/report/nanoparticles-in-sunscreen (“we believe [nano ingredients] zinc oxide and titanium dioxide lotions are among the best choices on the American market”).
20. T. Chernova et al., Long-Fiber Carbon Nanotubes Replicate Asbestos-Induced Mesothelioma with Disruption of the Tumor Suppressor Gene Cdkn2a (Ink4a/Arf), 27 Current Biology 3302 (2017).