8/6/2014

It’s the Small Things

Nanotechnology Toxicity and Future Claims

By Kathleen McDonough , Aaron Kroll

One of the more significant challenges facing insurance carriers and businesses is the widespread unpredictability of future risk. Unallocated risks can result in substantial monetary exposure, and companies encounter difficulties in efforts to “front” risks. Some risks ultimately may become the source of widespread litigation, or even the cause célèbre of the plaintiff’s bar. This is true at times when the causal relationship of the risk itself may not carry much weight in terms of scientific validity.

For instance, while asbestos toxicity is firmly supported by scientific and medical literature, the opposite was eventually learned to be the case with breast implant materials and the link to cancer. Yet, the litigation for the latter exposure lived on for many years, resulting in millions of dollars of payouts to claimants across the country.

Nanotechnology remains an unknown future toxic, environmental and exposure risk in the back of the minds of many. If nanotechnology materials are in fact carcinogenic, given their ubiquitous nature, corporate and insurance carrier exposure has the potential to be astronomical.

What Is Nanotechnology?

Nanotechnology is the manipulation of matter on a near-atomic scale to produce new structures, materials and devices. The underlying particles, or nanomaterials, are extremely small materials or systems that are man-made, or engineered. These materials, which were once known only as ultrafine particles in the area of air pollution, are less than 100 nanometers in aerodynamic equivalent diameter (AED). Interestingly, the European Commission has adopted its own definition of a nanomaterial, which has been criticized as too broad and at odds with the accepted U.S. definition.

Should We Be Concerned?

Nano-materials are currently being used in everything from makeup to sunscreen, items that we come across on a daily basis. And according to the National Institute of Environmental Health Sciences (NIEHS) nano-sized particles can enter the human body when we eat, breathe or even through skin contact.

The precise negative health effects, if any, of nanomaterials are unknown. Current toxicity studies reveal inconsistent conclusions regarding health outcomes and toxic thresholds, and are therefore difficult to assess. Moreover, a major challenge with nanomaterials is that it is difficult to find a set of adequate sampling and analytical methods for studying them. In addition, the introduction of various nanomaterial sizes and shapes in animal models have shown that such variations do have an impact on toxicity.

Common high-volume nanomaterials, considered to be the most toxic, can be carbon-based (nanotubes, grapheme, fullerenes), metal-based (gold, silver, titanium dioxide, zinc oxide), and biologic (liposomes and viruses designed for gene and drug delivery). Examples are abundant. For example, take a look at the label on a bottle of sunscreen bottle. Titanium dioxide is one of the most widely used nanomaterials in consumer products, and can be found in many, many items, including sunscreens, which ironically are designed to protect us from the carcinogenic rays of the sun. The same material is also widely used in paints and other regularly used household items that we come across daily.

The carbon nanotube, found in various medical, chemical and electronic products, is a common example of nanotechnology in prevalent use. Both have been scientifically linked to increased toxicity when compared to standard-sized particles. Nanotechnologies have been compared to amphibole asbestos fibers in structure as they are long and thin, and could similarly cause lung diseases and cancers if breathed into the lungs as with certain types of asbestos fibers. Further, a number of studies in the last 10 years have shown that carbon nanotubes cause fibrosis and systemic immune responses in mice.

And yet even with the carcinogenic evidence and models proposed thus far, there is a remarkably small amount of funds dedicated to researching the causal connection between nanomaterials and cancer. Groups such as The Woodrow Wilson Centre’s Project on Emerging Technologies have identified risk-related research and development funding shortfall of approximately 80 percent, or $50 million shy of the research target amounts.

Further, similar to asbestos, tobacco fumes and many carcinogens, dose plays a significant role in determining nanomaterial toxicity. Daily exposure to nanotubes certainly satisfies even the highest dose response relationship criteria. Other factors such as surface characteristics, charge, shape and size also greatly affect the toxicity, as well as the absorption rate. Also, nanoparticle toxicity has been shown to increase proportionally to the surface area; but not mass, as is the case in conventional toxicology.

Additional challenges with researching the true toxicity, and epidemiology regarding nanotechnology, includes the lack of standardized protocols and reagents, and the heterogeneity of each batch of nanomaterial. In the context of carbon nanotubes, toxicity measurement efforts are challenged by the vast number of carbon nanotube derivatives. This is exacerbated by the fact that nanomaterials have the potential to adversely affect the environment in both an airborne or liquid phase, if not properly contained while in use and disposed of after use.
Nanomaterials, and carbon nanotubes in particular, can be:

  • produced and/or cleaned using one of several different methods
  • produced using one of several different metal catalysts
  • single- or multi-walled
  • of various lengths
  • subjected to numerous surface modifications

Finally, given that nanoparticles may be capable of moving across cellular barriers to interact with subcellular structures (like mitochondria, organelles, and DNA), there are potential risks that we cannot fully comprehend or appreciate.

What Can Be Done?

The nanotechnology industry is rapidly developing, and thanks to companies like Amazon and even Wag.com, which delivers your pet’s food without having to set foot out the door, international and local business-to-consumer commerce products cross borders indiscriminately. Although nanotechnology offers many benefits, concerns regarding engineered nanomaterials continue to rise.

Absent unobstructed access to a research lab with a dedicated staff of technicians, pathologists and epidemiologists, predictive analysis will be impossible. One can, however, remain informed by performing standard Internet research or, by consulting outside counsel both dedicated to the endeavor, with an appreciation of toxic tort exposure and litigation. Such will undoubtedly ensue, including a barrage of claims, once the science is strong enough to support a causal link between nanomaterials and cancer or other diseases.



Kathleen McDonough is the Managing Shareholder with Segal McCambridge Singer & Mahoney.

Aaron Kroll is a Claims Manager with Starr Adjustment Services, Inc.

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