Practice Tip: Product Liability Considerations of Nanomaterials

The proliferation of nanomaterials, along with a near-absence of clear science and controlling regulations, raises important liability concerns. As a major
insurer succinctly stated: “Never before have the risks and opportunities of a new technology been as closely linked as they are in nanotechnology. It is precisely those characteristics which make nanoparticles so valuable that give rise to concern regarding hazards to human beings and the environment alike.”

This article is intended to be a primer, not of the wonders or dangers of nanotechnology, but of the legal issues following closely on the heels of the nanotechnology revolution. These legal issues are still in their infancy, but in light of the growing prominence of nanotechnology, they are certain to continue to develop.

Nanomaterials: What They Are and Why They Are Different

Nanomaterials, however exotic they may seem, typically are composed of common substances. When reduced to nanoparticle size, they can take on entirely different physical and chemical characteristics.

To qualify as a nanomaterial, a substance must contain particles with one dimension less than 100 billionths of a meter (approximately four millionths of an inch), and must “[p]ossess[] a special property, provide[] a special function, or produce[] a special effect that is uniquely attributable to the structure's nanoscale physical size.” See U.S. Patent Office Classification Definitions, Class 977, Nanotechnology, available at www.uspto.gov/web/patents/classification/uspc977/defs977.htm (last accessed Oct. 19, 2012).

These “special properties” have several sources. First, because of their minute size, nanomaterials possess extraordinary surface area by volume. Because of their extreme surface area, nanoparticles can have unique or significantly enhanced chemical activity. Second, the electrical, magnetic, and optical properties of a base material can be radically changed at the “nanometer level.” Carbon becomes stronger than steel. Aluminum become explosive. Titanium oxide, when reduced to “nano-size,” becomes an effective sunscreen that rubs on smoothly, while remaining clear to the eye.

What We Know ' and What We Don't

The unique characteristics of nanomaterials can have extraordinary utility, permitting known materials to be used in radically different ways. However, there is a corollary: at the nanoscale, materials can present previously unknown risks, particularly in the case of “free” nanotech particles found in cosmetics, sunscreens and food.

This binary issue is evident in many nanomaterials. Carbon, one of the most plentiful materials on earth, comes in many forms, from graphite to diamonds, but its behavior when formed into minute rolled “nanotubes” just one or two molecules thick is unique. Nanotubes can bind together in a way that makes the resulting material many times stronger than high-carbon steel. Some carbon nanotube configurations have unique conductive properties, making them valuable for use in electronics, while still others have unique utility as thermal conductors, radar absorbers, and low-weight strengtheners of sports rackets.

Some of the unique aspects of nanotubes may also have safety implications. Unless they are encased in a matrix, they are easily airborne. They can be easily inhaled deep into the lungs, just like another notoriously tiny industrial fiber, asbestos, and there are some indications that, like asbestos, nanotubes can become lodged in lung tissue. Whether carbon tubes could duplicate the health effects of asbestos and cause mesothelioma or other lung disease is currently unknown.

The duality of unique utility with unknown risk appears over and over. Sunscreen containing nanoparticles of titanium or zinc oxide spreads smoothly and dries clearly. However, some nanoparticles can pass through the skin and into the blood and organs and remain in the body for extended periods, with largely unknown effects. Eye shadow containing nanoparticles of reflective metal create a deep sparkly hue, but little is known about the effects of metallic nanoparticles absorbed through the skin, mucus membranes and eyes.

In some cases, the ability of nanoparticles to pass throughout the body without triggering an immune response can be a positive trait: “Nanoworms,” strings of iron oxide particles coated with polymer and peptide molecules, seek out and bind to tumor surfaces in order to assist in radio imaging, and remain in the bloodstream for far longer than other “tracers.” The delivery of drugs directly to tumors by way of nanoworms is on the horizon. The other side of the coin is that the ability of some nanoparticles to evade the immune system and remain in the body may create new risks of toxicity and injury.

Law and Regulation to Date

To date, there is disagreement on whether there is a need to address the risks of nanomaterials through regulation or special laws. The federal Food and Drug Administration (FDA), which has jurisdiction over a large portion of the nanomaterials on the market today, including the ubiquitous sunscreens and cosmetics, recently issued several draft guidance documents addressing nanotech particles in food and cosmetics.

The FDA's nonbinding guidance documents do not adopt any particular standards for the use of nanomaterials in food and cosmetics. However, the FDA acknowledges that the presence of nanomaterials may change the characteristics of a product, which may require additional safety tests, and, in some cases, may require additional approvals. See Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives, U.S. Food and Drug Administration, available www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredintsandPackaging/ucm300661.htmGuidanceDocuments/FoodIngredintsandPackaging/ucm300661.htm

(last accessed Oct. 19, 2012).

Nevertheless, the FDA maintains that it regulates “products, not technology,” and declines to place nanomaterials into any separate regulatory category. Rather, the FDA continues to maintain that “the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we will regulate,” and that only the discovery of new toxicological risks would require new or different tests. See FDA Regulation of Nanotechnology Products, U.S. Food and Drug Administration, available at www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForce/ucm115441.htm (last accessed Nov. 6, 2012). Indeed, in issuing the new draft guidance documents, FDA Commissioner Margaret Hamburg took pains to state that the FDA is “taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”

The U.S. Environmental Protection Agency (EPA) also seems to be conflicted: while it claims the authority to regulate “many” nanomaterials under the Toxic Substances Control Act (TSCA), and claims to be pursuing a “comprehensive regulatory approach” to nanotechnology, it has taken little direct action on nanotechnology issues.

In contrast, various advisory bodies have proposed that the risks involved in the use of nanomaterials be carefully studied. The National Research Council recently found that there is “insufficient understanding” about the environmental, health, and safety aspects of nanotechnology, and strongly urged the development of strategies to address nanotechnology related human and environmental effects.

The National Nanotechnology Initiative, a federal advisory group under the National Science and Technology Council composed of representatives of 25 federal agencies including the FDA, EPA and the Consumer Product Safety Commission (CPSC), argued in its 2011 Environmental, Health, and Safety Research Strategy that current research is insufficient to predict human response to nanomaterial exposure, creating a “critical gap” in our understanding of nanotechnology. In the wake of such conflicting views, particularly on the part of U.S. regulatory agencies, there has been little comprehensive nanotechnology regulation.

What's a Legal System to Do?

Product liability law, which typically follows several steps behind the development of new technologies, is currently an uncertain tool to apply to the commercial uses of nanomaterials. There have been some claims of injuries arising from the alleged use of nanomaterials, for example, allegations of personal injury by welders who inhaled fumes from welding rods, but these claims have generally not focused specifically on the nanotechnology involved. In December 2011, however, a collection of citizens' groups filed one of the first broad-based nanotechnology lawsuits, seeking an FDA rulemaking on the use of nanotechnology in food and cosmetics. See International Center for Technology Assessment v. Hamburg, No. 11-6592 (N.D. Cal. filed Dec. 21, 2011). This case was closely followed by a lawsuit filed by the National Resources Defense Council seeking to overturn the EPA's conditional approval of a pesticide product containing nanosilver particles. See National Resources Defense Council, Inc. v. U. S. Environmental Protection Agency, No. 12-70268 (9th Cir. filed Jan. 26, 2012). Though the Hamburg suit was dismissed following the FDA's April 2012 issuance of its nonbinding guidance documents regarding nanotechnology, both cases are informative regarding the likely structure of future nanotechnology product liability claims.

The Anatomy of a Nanotechnology Claim

In Hamburg, a consortium of health, environmental and technology groups challenged the FDA's inaction on a 2006 rulemaking petition seeking FDA regulation of nanomaterials under the federal Food Drug and Cosmetic Act (FDCA) and environmental impact analyses under the National Environmental Policy Act (NEPA). The Hamburg plaintiffs alleged that the unique properties of nanomaterials create health and environmental risks requiring specialized regulation by FDA.

The gravamen of the Hamburg complaint was the plaintiffs' claim that free nanoparticles in FDA-regulated products, particularly sunscreens, create “increased potential for toxicity, resulting in DNA mutation, structural damage within the cell, and cell death.” According to the plaintiffs, nanomaterials “present[] new challenges to the normal defense mechanisms of the body's immune and inflammatory response systems,” as nanomaterials “readily enter the body by inhalation and ingestion” and move through the bloodstream, accumulating in organs and tissues, including the brain.

The plaintiffs challenged the FDA's 2006 determination that existing pharmacotoxicity tests should suffice for particles of any size, citing the “consensus view” of the scientific community that adverse effects of nanomaterials cannot be predicted from toxicity standards derived from their base materials. Rather, according to the plaintiffs, particle size, surface area, surface charge, solubility, shape or physical dimensions, surface coatings, chemical composition and aggregation properties create unique health and environmental considerations.

For evidence of health effects, plaintiffs focused on sunscreens, pointing to a number of studies purporting to indicate that nanoparticles of zinc oxide can be toxic to human colon cells and can damage brain stem cells in mice. They claimed titanium dioxide nanoparticles can inhibit bacterial action, and may affect fetal development in mice. To support their vague environmental claims, plaintiffs cited studies purporting to show that nanomaterials can move from simple organisms up the food chain, and claimed that available products (again citing sunscreen) transmit man-made nanomaterials “into the larger environment,” creating environmental risks.

Similarly, in the NRDC action, plaintiffs attacked the EPA's decision to give conditional approval for the use of nanosilver in a pesticide, arguing that until more is known about the risks of nanosilver in the environment, the EPA cannot lawfully approve the product. Though Hamburg has been dismissed by stipulation, and NRDC is just beginning, both suits are useful blueprints for potential future claims against nanomaterial manufacturers.

The Future of Nanotechnology Product Liability

The Hamburg and NRDC cases both attack administrative action (or inaction), rather than seek damages. However, they are useful in considering what the elements of future nanotechnology-related product liability claims are likely to be. Both cases raise as central issues elements and themes that would necessarily be raised in any product liability claim against a nanomaterial manufacturer.

These elements are:

• A claim that nanomaterials have unique risks, not only because of their size, but because their reactivity and behavior (color, conductivity, reaction speed/intensity, thermal properties, magnetism, etc.);
• An allegation that: 1) the defendant (your name here) negligently failed to warn of the risks of nanomaterials which she knew or should have known; and/or 2) that the product containing nanomaterials was so inherently dangerous that the presence of nanomaterials constituted a design defect;
• Injuries alleged to be the result of: 1) the small size of the nanoparticles (for example, because of skin or mucous membrane absorption, ingestion or inhalation); and/or 2) the unique properties of the nanoparticles, which caused toxicity, allergic reaction, soft tissue injury, blood contamination, lung, liver or immune system injury; and
• Damages arising from the failure to warn or design defect.

Whether these claims would be couched as strict liability, negligence, breach of warranty or consumer protection claims is likely to vary depending on the court, the state and the plaintiffs' attorney. It also is likely that manufacturing defect claims will sneak in from time-to-time. However, these elements are likely to describe most claims.

If these suppositions are correct, within the next few years we should expect to see a product liability claim against a manufacturer of sunscreen. A plaintiff will allege she used sunscreen on her young child, not knowing it contained nanoparticles of titanium dioxide. Because the product was an aerosol, the child also allegedly inhaled nanoparticles. As a consequence of these exposures (the lawsuit will continue), the child absorbed allegedly toxic titanium dioxide through his skin, through inhalation and through ingestion when some of the sunscreen found its way from the child's fingers to his mouth. As a direct consequence of the child's exposure to the allegedly dangerous nanoparticles, combined with the manufacturer's alleged negligent failure to warn of the toxicity of nanoparticles of titanium dioxide, his immune system was suppressed, which caused him to develop severe juvenile rheumatoid arthritis, limiting his ability to walk and play.

The plaintiff will claim that she would not have used the sunscreen on her child if the manufacturer had disclosed that it contained nanoparticles, and certainly would never have used it had the defendant warned of the (allegedly) unacceptable risks of titanium dioxide nanoparticles. Alternatively, or additionally, rather than claiming negligence, the mother would claim that the sunscreen's design was unreasonably unsafe, since it contained nanoparticles of titanium dioxide of allegedly unproven safety.

A review of the elements of future claims does not lead to Nirvana, but rather to consideration of the current significant lack of reliable information about the effects of nanomaterials. Today, it probably is most accurate to say that the state of science has moved us from ignorance to uncertainty. It is of course quite clear that many nanomaterials have unusual aspects (which is why we use them). We also know that in some cases nanoparticles can enter the body through skin or through inhalation because of their size. There are also animal and cell studies with provocative findings, but there is little reliable information on what nanoparticles do when they enter the body, how long they remain, or what their long-term effects might be. We certainly do not have any information that would justify heavily restricting or ending the use of a new, potentially transformative technology.

Difficult Questions

What should we know? Is it better for manufacturers to conduct research on the potential health effects of hundreds or thousands of different types of nanoparticles, knowing that such an effort can't even begin to recreate the real world, or is “watchful waiting” the best strategy? Are there any general rules about nanotechnology that we can discern, or is each particle sui generis? Can a manufacturer even develop a coherent strategy, or is it best to know nothing until we know everything?

These are difficult questions, particularly since we have to strategize in a significant regulatory void. However, there are a few useful guiding principles. First, intentional ignorance is not a positive trait in defending product liability lawsuits. At the very least, manufacturers should stay up-to-speed on the responsible scientific research as it develops, even if they do not conduct basic research themselves. In some special cases, warnings might be appropriate, particularly in the industrial context (i.e., avoid using raw materials containing “free” nanotubes absent ventilation).

Second, broad causation arguments in the context of nanotechnology are likely to be very challenging for plaintiffs, since a basic law of nanotechnology is that “size matters.” In a world where three different nanoparticles of gold or carbon can have three entirely different risk profiles, scientists, attorneys and juries are going to have to look at differently sized nanoparticles as entirely different substances. Extrapolating the results of a review of one nanoparticle to any other particle may be uninformative or even misleading: good science will be hard to find.

In the uncomfortable situation in which scientific answers are truly not known, plaintiffs, who after all have the burden of proof, are likely to be at the larger disadvantage. In the near future, it will be difficult to find admissible evidence of the general or specific causes of an alleged injury. Broad statements that titanium dioxide or silver can be toxic (or cause cell or immune system damage) will not be persuasive, as defense experts point out that the characteristics of nanomaterials can vary dramatically according to particle size, shape and surface. Evidence that this or that material is “generally” toxic will likely fail, particularly when challenged by a Daubert motion to strike all causation evidence unsupported by reliable science. This is particularly true when claimed injuries, such as the immune system suppression in the hypothetical above, are likely to have many alternative causes supported by better, more established science.

Given these challenges in proving causation, plaintiffs making claims against nanotechnology manufacturers may, until much more good science is available, find failure-to-warn and negligent design cases difficult to win. Of course, there is also the possibility of the less favorable situation in which regular defense verdicts are punctuated by random large jury awards ' a development that would make liability claims difficult to value.

Conclusion

In the future, science will resolve many issues of nanomaterial exposure, toxicity and injury causation. We may learn that the enormous majority of nanoparticles are benign, or that many substances do not in the end have enhanced toxicity at “nano” size. On the other hand, we also may learn of “signature injuries” arising from exposure to certain nanoparticles, with causation being widely proven (or disproven) by science. Carbon nanotubes may be shown to affect human health, or science may wholly disprove predictions that nanotubes and other nanoparticles would be the “next asbestos.”

Manufacturers, regulators, consumers and plaintiffs' attorneys all will adjust as the science of nanomaterials continues to progress. For now, we know nanomaterials are certain to continue to play a larger role in our lives, and that more and more products and a broader array of nanoparticles are likely to be commercialized, with science and regulation following behind.

Product liability concerns, which go hand-in-hand with any large developments in science or new products, will adjust and refocus as nanotechnology claims arise and are litigated. By staying up-to-speed on the health and environmental aspects of nanotechnology science and regulation, manufacturers (and their counsel) will be able to assess risks, provide good counsel, and ultimately make the tremendous utility of nanotechnology available to consumers, while minimizing the risk and impact of commercial product liability claims.

Ray Aragon is a litigation partner at McKenna Long & Aldridge LLP, where he focuses on the defense of product liability claims.

Over the last decade, nanotechnology ' the production and use of materials in tiny particles measured in billionths of a meter ' has exploded. The Project on Emerging Nanotechnologies estimates that over 1,300 products containing nanomaterials are now on the market, with several new products being added each week.

While the thought of using products containing particles with axes less than 1/60,000 the width of a human hair might seem esoteric, the reality is that nanomaterials commonly appear in sunscreens, makeup, cleaning products, air sanitizers, medical supplies, computers and even clothing and cookware.

As the commercial uses of nanotechnology continue to broaden, basic research and reliable science regarding the potential health and environmental risks of nanomaterials have fallen far behind. To date, there is little regulation of nanomaterials, and in most cases products are sold with no indication that they contain nanoparticles.

The proliferation of nanomaterials, along with a near-absence of clear science and controlling regulations, raises important liability concerns. As a major
insurer succinctly stated: “Never before have the risks and opportunities of a new technology been as closely linked as they are in nanotechnology. It is precisely those characteristics which make nanoparticles so valuable that give rise to concern regarding hazards to human beings and the environment alike.”

This article is intended to be a primer, not of the wonders or dangers of nanotechnology, but of the legal issues following closely on the heels of the nanotechnology revolution. These legal issues are still in their infancy, but in light of the growing prominence of nanotechnology, they are certain to continue to develop.

Nanomaterials: What They Are and Why They Are Different

Nanomaterials, however exotic they may seem, typically are composed of common substances. When reduced to nanoparticle size, they can take on entirely different physical and chemical characteristics.

To qualify as a nanomaterial, a substance must contain particles with one dimension less than 100 billionths of a meter (approximately four millionths of an inch), and must “[p]ossess[] a special property, provide[] a special function, or produce[] a special effect that is uniquely attributable to the structure's nanoscale physical size.” See U.S. Patent Office Classification Definitions, Class 977, Nanotechnology, available at www.uspto.gov/web/patents/classification/uspc977/defs977.htm (last accessed Oct. 19, 2012).

These “special properties” have several sources. First, because of their minute size, nanomaterials possess extraordinary surface area by volume. Because of their extreme surface area, nanoparticles can have unique or significantly enhanced chemical activity. Second, the electrical, magnetic, and optical properties of a base material can be radically changed at the “nanometer level.” Carbon becomes stronger than steel. Aluminum become explosive. Titanium oxide, when reduced to “nano-size,” becomes an effective sunscreen that rubs on smoothly, while remaining clear to the eye.

What We Know ' and What We Don't

The unique characteristics of nanomaterials can have extraordinary utility, permitting known materials to be used in radically different ways. However, there is a corollary: at the nanoscale, materials can present previously unknown risks, particularly in the case of “free” nanotech particles found in cosmetics, sunscreens and food.

This binary issue is evident in many nanomaterials. Carbon, one of the most plentiful materials on earth, comes in many forms, from graphite to diamonds, but its behavior when formed into minute rolled “nanotubes” just one or two molecules thick is unique. Nanotubes can bind together in a way that makes the resulting material many times stronger than high-carbon steel. Some carbon nanotube configurations have unique conductive properties, making them valuable for use in electronics, while still others have unique utility as thermal conductors, radar absorbers, and low-weight strengtheners of sports rackets.

Some of the unique aspects of nanotubes may also have safety implications. Unless they are encased in a matrix, they are easily airborne. They can be easily inhaled deep into the lungs, just like another notoriously tiny industrial fiber, asbestos, and there are some indications that, like asbestos, nanotubes can become lodged in lung tissue. Whether carbon tubes could duplicate the health effects of asbestos and cause mesothelioma or other lung disease is currently unknown.

The duality of unique utility with unknown risk appears over and over. Sunscreen containing nanoparticles of titanium or zinc oxide spreads smoothly and dries clearly. However, some nanoparticles can pass through the skin and into the blood and organs and remain in the body for extended periods, with largely unknown effects. Eye shadow containing nanoparticles of reflective metal create a deep sparkly hue, but little is known about the effects of metallic nanoparticles absorbed through the skin, mucus membranes and eyes.

In some cases, the ability of nanoparticles to pass throughout the body without triggering an immune response can be a positive trait: “Nanoworms,” strings of iron oxide particles coated with polymer and peptide molecules, seek out and bind to tumor surfaces in order to assist in radio imaging, and remain in the bloodstream for far longer than other “tracers.” The delivery of drugs directly to tumors by way of nanoworms is on the horizon. The other side of the coin is that the ability of some nanoparticles to evade the immune system and remain in the body may create new risks of toxicity and injury.

Law and Regulation to Date

To date, there is disagreement on whether there is a need to address the risks of nanomaterials through regulation or special laws. The federal Food and Drug Administration (FDA), which has jurisdiction over a large portion of the nanomaterials on the market today, including the ubiquitous sunscreens and cosmetics, recently issued several draft guidance documents addressing nanotech particles in food and cosmetics.

The FDA's nonbinding guidance documents do not adopt any particular standards for the use of nanomaterials in food and cosmetics. However, the FDA acknowledges that the presence of nanomaterials may change the characteristics of a product, which may require additional safety tests, and, in some cases, may require additional approvals. See Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives, U.S. Food and Drug Administration, available www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredintsandPackaging/ucm300661.htmGuidanceDocuments/FoodIngredintsandPackaging/ucm300661.htm

(last accessed Oct. 19, 2012).

Nevertheless, the FDA maintains that it regulates “products, not technology,” and declines to place nanomaterials into any separate regulatory category. Rather, the FDA continues to maintain that “the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we will regulate,” and that only the discovery of new toxicological risks would require new or different tests. See FDA Regulation of Nanotechnology Products, U.S. Food and Drug Administration, available at www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForce/ucm115441.htm (last accessed Nov. 6, 2012). Indeed, in issuing the new draft guidance documents, FDA Commissioner Margaret Hamburg took pains to state that the FDA is “taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”

The U.S. Environmental Protection Agency (EPA) also seems to be conflicted: while it claims the authority to regulate “many” nanomaterials under the Toxic Substances Control Act (TSCA), and claims to be pursuing a “comprehensive regulatory approach” to nanotechnology, it has taken little direct action on nanotechnology issues.

In contrast, various advisory bodies have proposed that the risks involved in the use of nanomaterials be carefully studied. The National Research Council recently found that there is “insufficient understanding” about the environmental, health, and safety aspects of nanotechnology, and strongly urged the development of strategies to address nanotechnology related human and environmental effects.

The National Nanotechnology Initiative, a federal advisory group under the National Science and Technology Council composed of representatives of 25 federal agencies including the FDA, EPA and the Consumer Product Safety Commission (CPSC), argued in its 2011 Environmental, Health, and Safety Research Strategy that current research is insufficient to predict human response to nanomaterial exposure, creating a “critical gap” in our understanding of nanotechnology. In the wake of such conflicting views, particularly on the part of U.S. regulatory agencies, there has been little comprehensive nanotechnology regulation.

What's a Legal System to Do?

Product liability law, which typically follows several steps behind the development of new technologies, is currently an uncertain tool to apply to the commercial uses of nanomaterials. There have been some claims of injuries arising from the alleged use of nanomaterials, for example, allegations of personal injury by welders who inhaled fumes from welding rods, but these claims have generally not focused specifically on the nanotechnology involved. In December 2011, however, a collection of citizens' groups filed one of the first broad-based nanotechnology lawsuits, seeking an FDA rulemaking on the use of nanotechnology in food and cosmetics. See International Center for Technology Assessment v. Hamburg, No. 11-6592 (N.D. Cal. filed Dec. 21, 2011). This case was closely followed by a lawsuit filed by the National Resources Defense Council seeking to overturn the EPA's conditional approval of a pesticide product containing nanosilver particles. See National Resources Defense Council, Inc. v. U. S. Environmental Protection Agency, No. 12-70268 (9th Cir. filed Jan. 26, 2012). Though the Hamburg suit was dismissed following the FDA's April 2012 issuance of its nonbinding guidance documents regarding nanotechnology, both cases are informative regarding the likely structure of future nanotechnology product liability claims.

The Anatomy of a Nanotechnology Claim

In Hamburg, a consortium of health, environmental and technology groups challenged the FDA's inaction on a 2006 rulemaking petition seeking FDA regulation of nanomaterials under the federal Food Drug and Cosmetic Act (FDCA) and environmental impact analyses under the National Environmental Policy Act (NEPA). The Hamburg plaintiffs alleged that the unique properties of nanomaterials create health and environmental risks requiring specialized regulation by FDA.

The gravamen of the Hamburg complaint was the plaintiffs' claim that free nanoparticles in FDA-regulated products, particularly sunscreens, create “increased potential for toxicity, resulting in DNA mutation, structural damage within the cell, and cell death.” According to the plaintiffs, nanomaterials “present[] new challenges to the normal defense mechanisms of the body's immune and inflammatory response systems,” as nanomaterials “readily enter the body by inhalation and ingestion” and move through the bloodstream, accumulating in organs and tissues, including the brain.

The plaintiffs challenged the FDA's 2006 determination that existing pharmacotoxicity tests should suffice for particles of any size, citing the “consensus view” of the scientific community that adverse effects of nanomaterials cannot be predicted from toxicity standards derived from their base materials. Rather, according to the plaintiffs, particle size, surface area, surface charge, solubility, shape or physical dimensions, surface coatings, chemical composition and aggregation properties create unique health and environmental considerations.

For evidence of health effects, plaintiffs focused on sunscreens, pointing to a number of studies purporting to indicate that nanoparticles of zinc oxide can be toxic to human colon cells and can damage brain stem cells in mice. They claimed titanium dioxide nanoparticles can inhibit bacterial action, and may affect fetal development in mice. To support their vague environmental claims, plaintiffs cited studies purporting to show that nanomaterials can move from simple organisms up the food chain, and claimed that available products (again citing sunscreen) transmit man-made nanomaterials “into the larger environment,” creating environmental risks.

Similarly, in the NRDC action, plaintiffs attacked the EPA's decision to give conditional approval for the use of nanosilver in a pesticide, arguing that until more is known about the risks of nanosilver in the environment, the EPA cannot lawfully approve the product. Though Hamburg has been dismissed by stipulation, and NRDC is just beginning, both suits are useful blueprints for potential future claims against nanomaterial manufacturers.

The Future of Nanotechnology Product Liability

The Hamburg and NRDC cases both attack administrative action (or inaction), rather than seek damages. However, they are useful in considering what the elements of future nanotechnology-related product liability claims are likely to be. Both cases raise as central issues elements and themes that would necessarily be raised in any product liability claim against a nanomaterial manufacturer.

These elements are:

• A claim that nanomaterials have unique risks, not only because of their size, but because their reactivity and behavior (color, conductivity, reaction speed/intensity, thermal properties, magnetism, etc.);
• An allegation that: 1) the defendant (your name here) negligently failed to warn of the risks of nanomaterials which she knew or should have known; and/or 2) that the product containing nanomaterials was so inherently dangerous that the presence of nanomaterials constituted a design defect;
• Injuries alleged to be the result of: 1) the small size of the nanoparticles (for example, because of skin or mucous membrane absorption, ingestion or inhalation); and/or 2) the unique properties of the nanoparticles, which caused toxicity, allergic reaction, soft tissue injury, blood contamination, lung, liver or immune system injury; and
• Damages arising from the failure to warn or design defect.

Whether these claims would be couched as strict liability, negligence, breach of warranty or consumer protection claims is likely to vary depending on the court, the state and the plaintiffs' attorney. It also is likely that manufacturing defect claims will sneak in from time-to-time. However, these elements are likely to describe most claims.

If these suppositions are correct, within the next few years we should expect to see a product liability claim against a manufacturer of sunscreen. A plaintiff will allege she used sunscreen on her young child, not knowing it contained nanoparticles of titanium dioxide. Because the product was an aerosol, the child also allegedly inhaled nanoparticles. As a consequence of these exposures (the lawsuit will continue), the child absorbed allegedly toxic titanium dioxide through his skin, through inhalation and through ingestion when some of the sunscreen found its way from the child's fingers to his mouth. As a direct consequence of the child's exposure to the allegedly dangerous nanoparticles, combined with the manufacturer's alleged negligent failure to warn of the toxicity of nanoparticles of titanium dioxide, his immune system was suppressed, which caused him to develop severe juvenile rheumatoid arthritis, limiting his ability to walk and play.

The plaintiff will claim that she would not have used the sunscreen on her child if the manufacturer had disclosed that it contained nanoparticles, and certainly would never have used it had the defendant warned of the (allegedly) unacceptable risks of titanium dioxide nanoparticles. Alternatively, or additionally, rather than claiming negligence, the mother would claim that the sunscreen's design was unreasonably unsafe, since it contained nanoparticles of titanium dioxide of allegedly unproven safety.

A review of the elements of future claims does not lead to Nirvana, but rather to consideration of the current significant lack of reliable information about the effects of nanomaterials. Today, it probably is most accurate to say that the state of science has moved us from ignorance to uncertainty. It is of course quite clear that many nanomaterials have unusual aspects (which is why we use them). We also know that in some cases nanoparticles can enter the body through skin or through inhalation because of their size. There are also animal and cell studies with provocative findings, but there is little reliable information on what nanoparticles do when they enter the body, how long they remain, or what their long-term effects might be. We certainly do not have any information that would justify heavily restricting or ending the use of a new, potentially transformative technology.

Difficult Questions

What should we know? Is it better for manufacturers to conduct research on the potential health effects of hundreds or thousands of different types of nanoparticles, knowing that such an effort can't even begin to recreate the real world, or is “watchful waiting” the best strategy? Are there any general rules about nanotechnology that we can discern, or is each particle sui generis? Can a manufacturer even develop a coherent strategy, or is it best to know nothing until we know everything?

These are difficult questions, particularly since we have to strategize in a significant regulatory void. However, there are a few useful guiding principles. First, intentional ignorance is not a positive trait in defending product liability lawsuits. At the very least, manufacturers should stay up-to-speed on the responsible scientific research as it develops, even if they do not conduct basic research themselves. In some special cases, warnings might be appropriate, particularly in the industrial context (i.e., avoid using raw materials containing “free” nanotubes absent ventilation).

Second, broad causation arguments in the context of nanotechnology are likely to be very challenging for plaintiffs, since a basic law of nanotechnology is that “size matters.” In a world where three different nanoparticles of gold or carbon can have three entirely different risk profiles, scientists, attorneys and juries are going to have to look at differently sized nanoparticles as entirely different substances. Extrapolating the results of a review of one nanoparticle to any other particle may be uninformative or even misleading: good science will be hard to find.

In the uncomfortable situation in which scientific answers are truly not known, plaintiffs, who after all have the burden of proof, are likely to be at the larger disadvantage. In the near future, it will be difficult to find admissible evidence of the general or specific causes of an alleged injury. Broad statements that titanium dioxide or silver can be toxic (or cause cell or immune system damage) will not be persuasive, as defense experts point out that the characteristics of nanomaterials can vary dramatically according to particle size, shape and surface. Evidence that this or that material is “generally” toxic will likely fail, particularly when challenged by a Daubert motion to strike all causation evidence unsupported by reliable science. This is particularly true when claimed injuries, such as the immune system suppression in the hypothetical above, are likely to have many alternative causes supported by better, more established science.

Given these challenges in proving causation, plaintiffs making claims against nanotechnology manufacturers may, until much more good science is available, find failure-to-warn and negligent design cases difficult to win. Of course, there is also the possibility of the less favorable situation in which regular defense verdicts are punctuated by random large jury awards ' a development that would make liability claims difficult to value.

Conclusion

In the future, science will resolve many issues of nanomaterial exposure, toxicity and injury causation. We may learn that the enormous majority of nanoparticles are benign, or that many substances do not in the end have enhanced toxicity at “nano” size. On the other hand, we also may learn of “signature injuries” arising from exposure to certain nanoparticles, with causation being widely proven (or disproven) by science. Carbon nanotubes may be shown to affect human health, or science may wholly disprove predictions that nanotubes and other nanoparticles would be the “next asbestos.”

Manufacturers, regulators, consumers and plaintiffs' attorneys all will adjust as the science of nanomaterials continues to progress. For now, we know nanomaterials are certain to continue to play a larger role in our lives, and that more and more products and a broader array of nanoparticles are likely to be commercialized, with science and regulation following behind.

Product liability concerns, which go hand-in-hand with any large developments in science or new products, will adjust and refocus as nanotechnology claims arise and are litigated. By staying up-to-speed on the health and environmental aspects of nanotechnology science and regulation, manufacturers (and their counsel) will be able to assess risks, provide good counsel, and ultimately make the tremendous utility of nanotechnology available to consumers, while minimizing the risk and impact of commercial product liability claims.

Ray Aragon is a litigation partner at McKenna Long & Aldridge LLP, where he focuses on the defense of product liability claims.