Category: Toxic Torts

Recommended Reading: Nano Developments

Posted Jun.09, 2010 under Litigation, Nanobiotechnology, Nanotoxicology, Products Liability, Regulation, Research, Toxic Torts

If you are not already familiar with Ron Wernette and his excellent blog, I recommend you add it to your nanolinks at

http://www.nanotortlaw.com/nanoblog/blog.aspx

The blog keeps track of developments and learning opportunities in the field and is a perfect complement to our blog, as the blog’s mission statement demonstrates:

“The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential – and as yet unkown – liability risks of Nanotechnologies. “

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A Digression Lesson: What Nanotechnology Can Learn from the Climate Change Litigation

Posted Jun.03, 2010 under Environment, Litigation, Toxic Torts
usalawyerstoday.com

usalawyerstoday.com

Law sometimes happens in peculiar ways.  And none so peculiar as the Fifth Circuit Court of Appeals’ recent dodging of the important issues raised by climate change litigation.  What happened (or rather, didn’t happen) is so important that it merits a digression here.  It also suggests ways that courts can make law without seeming to make law, especially when the cases involve new claims, new theories, and even new technologies.  The Fifth Circuit’s maneuver should serve as a warning – and a reminder of the clever traps of procedure – to those who attempt novel theories in the era of new technology.

 Here’s what happened.  Property owners and other residents along the Mississippi Gulf coast brought a tort action against oil companies, electrical companies, and utilities, claiming that the defendants caused massive emissions of greenhouse gases that contributed to global warming, which, among other things, added to the power of Hurricane Katrina.  They sought compensation for property damage from Katrina.  The lower court dismissed the action on a pretrial motion, and the plaintiffs appealed to the Fifth Circuit Court of Appeals.  The 3-judge Fifth Circuit panel (“the panel”) reversed and held that the action could go forward, Comer v. Murphy Oil USA, 585 F.3d 855 (5th Cir. 2009), but that decision was vacated when the Fifth Circuit accepted the case for a full-bench (“en banc”) rehearing.  A number of judges recused themselves from the rehearing, presumably because of potential conflicts of interest with the case.  Last week, the Fifth Circuit said that because the court no longer had a quorum of judges, it was not empowered to rehear the case, so it dismissed the appeal and reinstated the lower court’s dismissal of the action.

 Is it really so easy to circumvent our judicial processes?

 Why is this procedural maneuver important, and what does it have to do with nanotechnology?

The net effect was to reinstate a lower court ruling over the Fifth Circuit panel’s own decision.  That lower court ruling was a dismissal of the lawsuit.  What was unusual was that the Fifth Circuit did this without considering the issues raised on appeal.  In other words, the case was decided on a technicality.  In so ruling, the Fifth Circuit rejected a variety of measures that would have allowed the rehearing to go forward.  If the court had wanted to continue with the rehearing en banc, it could have found a way.

 Nanotechnology tort actions will arrive in the courts soon enough, raising unprecedented issues (and yes, some old issues as well).  It is important that those issues (new and old) received full consideration.  The law favors deciding cases on the merits, not dodging difficult controversial and new issues.  Moreover, nanotechnology litigation will involve many industries, enormous and small, so the notion that judges may have to recuse themselves is not far-fetched.

 Most judges have past connections with big industry in this country, whether it is oil and utility companies, pharmaceutical companies, nanomaterial firms, or anything else.  They had clients who either were those companies or who were engaged in business or litigation with or against those companies.  They had investments of their own.  Their legal practices, government service, or other pre-judicial professional obligations involved them with many law firms and attorneys.  It is important that judges recuse themselves when there is the potential for a conflict of interest or even just the appearance of a conflict of interest.  But if courts will decline to hear cases because too many of their judges must recuse themselves, then the parties, and all of us, will end up on the losing side.

 And that’s not justice.

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What Do the Studies Mean?

Posted Apr.22, 2010 under Cosmetics, Health, Litigation, Nanotoxicology, Products Liability, Regulation, Research, Toxic Torts
www.h20technologies.com

www.h20technologies.com

In the call for studies on the health and safety of nanoparticles in various uses, it is easy to overlook important questions about what the studies mean.  Does a study demonstrating what may be considered an adverse outcome provide a basis for legal action?  The complex answer is, “Sometimes yes and sometimes no,” or in the words of every law professor, “It depends.”

Let’s take a look a highly publicized study published in late 2009.  See Trouiller et al., Titanium Dioxide Nanoparticles Induce DNA Damage and Genetic Instability In vivo in Mice, CANCER RES. 2009; 69: (22), Nov. 15, 2009.  Researchers from UCLA conducted a study in vivo on mice to test the effects of the titanium dioxide nanoparticles, regularly used in many consumer products, including cosmetics (especially sunblocks), food coloring, toothpaste, and paint.  The researchers herald their study as the first in vivo study to demonstrate a connection between the particular substance and genetic harm.  Previous in vitro studies, they say, produced mixed results and by their very nature did not involve living tissue.

First, a word about how the law views in vitro and in vivo studies.  In vitro studies, such as the Ames test, test the effects of chemicals on bacteria or other cells in a laboratory dish, looking for genetic mutations.  These studies are sometimes offered in a legal setting to suggest that exposure to the substance is carcinogenic in human, on the theory that somatic cell mutations lead to uncontrolled cell reproduction and, ultimately, cancer.  In vivo studies compare laboratory animals exposed to a particular substance to a control group that was not exposed, looking for differences in outcomes between the two groups.  What both types of studies have in common is that they do not involve humans.  As a result, they also have in common the need to extrapolate from the test data to predictable results in humans, a process that is speculative.  In other words, both studies fall short of demonstrating exactly what will happen when humans are exposed to the substance.  But both are relatively fast, inexpensive, and do not involve the ethical dilemmas of testing on humans.

Courts bristle when plaintiffs seek to introduce this kind of evidence, without anything else, in personal injury litigation as proof that exposure to a particular substance caused their illnesses.  The role of courts in determining what evidence is admissible under the rules of evidence is designed to keep frivolous suits from consuming resources and from reaching juries, which might be more impressionable than the court.  Regulators are less constrained than courts, however.  The role of government regulators is circumscribed by the legislation giving them authority.

In the scheme of things, the law prefers in vivo studies to in vitro studies because in vivo studies demonstrate some action of the substance on mammalian living tissue.  But both types of studies are a distant second to epidemiological studies on human populations.  Such statistical studies of risk factors examine groups of humans to determine the strength of relationships between exposures and outcomes.  But even they do not examine the direct impact of the substance on human tissues.

All scientific and statistical studies used to demonstrate carcinogenicity serve to demonstrate the difficulty the law has with understanding and using the studies to make legal decisions.  In the important U.S. Supreme Court case of Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), in which the Court provided guidance on determining the reliability of scientific studies in the federal courts (in the context of a toxic torts case involving the prescription drug Bendectin), the Court had the following to say about the distinctions between science and litigation:

[T]here are important differences between the quest for truth in the courtroom and the quest for truth in the laboratory. Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly. The scientific project is advanced by broad and wide-ranging consideration of a multitude of hypotheses, for those that are incorrect will eventually be shown to be so, and that in itself is an advance. Conjectures that are probably wrong are of little use, however, in the project of reaching a quick, final, and binding legal judgment – often of great consequence – about a particular set of events in the past.

Id. at 596-97.

There is strength in numbers, however.  The more reliable studies that are conducted showing similar results, the more likely the substance will be regulated effectively.  And the more likely litigants will be able to assemble a package of expert scientific evidence that will support their positions.

 

An abstract of the article may be found at http://cancerres.aacrjournals.org/cgi/content/abstract/69/22/8784

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Nanotechnology in Our Food

Posted Apr.18, 2010 under Artificial Molecular Machines, Governmental Interaction, Health, Litigation, Nanotoxicology, Products Liability, Regulation, Toxic Torts
www.inoxpa.com

www.inoxpa.com

According to a recent report from the United States Government Accountability Office (GAO), the FDA is currently taking a hands-off approach to food additives that contain engineered nanoparticles.  In fact, the FDA does not require food manufacturers to report additives that are deemed generally regarded as safe (GRAS).  Who determines the GRAS status?  The food manufacturers, without oversight or approval from the FDA!  The following excerpt from the GAO report, United States Government Accountability Office, Report to Congressional Requesters, Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS) (2010), provides a realistic and chilling view at the current intersection of the American food supply and nanotechnology:

FDA’s approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA’s knowledge. While some uses of engineered nanomaterials have the potential to help ensure food safety, uncertainties remain about how to determine their safety in food. After reviewing the uncertainties associated with the safety of engineered nanomaterials, FDA has decided that it does not need additional authority to regulate products containing such materials. Rather, FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with the agency regarding whether such substances might be GRAS. Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances. In contrast to FDA’s approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.

Id. at Highlights page (emphasis added).

The application of nanotechnology to food is potentially very beneficial. Two specific examples are 1) nanotags to “improve the traceability of food products (the ability to track these products from point of origin to retail sale)” and 2) the most prolific “usage appears to be in food packaging, where applications such as antimicrobial nanofilms—thin layers of substances meant to hamper the growth of bacteria and fungi—may help bolster food safety.” Notwithstanding the current and obvious benefits, the FDA, and its foreign counterparts, realized that the potential for hidden challenges does exist.  As a result, the FDA created a taskforce in 2007 to identify some of the potential pitfalls, and to recommend possible solutions. The taskforce identified several challenges posed by utilizing nanotechnology, specifically “ensuring the adequacy of methods for evaluating the safety of these engineered nanomaterials in food.” It also made mention of how little the FDA actually knows about nanotechnology and as a result, declined to include a definition of it in its report. (GAO Report 26-27).

At this point in time, even if something were to go awry as a result of nanomaterials being utilized in the food supply, where does the blame fall? According to current administrative law, the courts take an extremely deferential stance in favor of agency decisions when it comes to science. In Baltimore Gas & Elec. Co. v. Natural Res. Def. Counsel, 462 U.S. 87, 103 (1983), the Court stated, “[a] reviewing court must remember that the [agency] is making predictions, within its area of special expertise, at the frontiers of science. When examining this kind of scientific determination, . . . , a reviewing court must generally be at its most deferential.” This case dealt with a rule adopted by the Nuclear Regulatory Commission (NRC) based on findings “that permanent storage of nuclear waste would have no significant environmental impact.” Michael Asimov & Ronald M. Levin, State and Federal Administrative Law 595 (3d ed. 2009). This leads one to believe that if the NRC received this level of deference in the early stages of nuclear energy proliferation, the courts would almost certainly provide the same to the FDA’s lackadaisical decision-making approach to nanotech and the food we eat.

I certainly do not wish to suggest that the use of nanomaterials in our food supply is going to lead us down the long road of massive tort litigation, but I do wish to assert that if we are not vigilant from the very beginning, it is anyone’s guess where it could lead.

www.gao.gov/new.items/d10246.pdf

www.foodsafetynews.com/2010/03/gao-fda-does-not-ensure-safety-of-food-additives/

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Risk and State of the Art

Posted Apr.13, 2010 under Cosmetics, Environment, Governmental Interaction, Health, Litigation, Products Liability, Safety, Toxic Torts
usalawyerstoday.com

usalawyerstoday.com

In product liability litigation, product sellers often rely on the so-called state-of-the-art defense.  By raising this defense, the seller – usually the product manufacturer – argues  that the risks or hazards of the product complained of in the current litigation were not known to it at the time the product was designed, marketed, and sold to the user or consumer.  As with everything in the law, arguments abound as to how to define the state of the art.  For example, manufacturers have argued that the state of the art should be defined as the industry standard at the time.  This was essentially the argument made by asbestos insulation products manufacturers in the seminal case of Borel v. Fibreboard  Paper Products Corp., 493 F.2d 1076 (5th Cir. 1973).  The court had a very different view, however.   Reflecting concerns that using the industry standard to define the state of the art at any point in time would encourage entire industries to be lax in conducting research on the hazards of their products and/or disseminating information about known hazards to the public, the court held the manufacturers to the standards of experts in the industry.  The court defined this as follows:

The manufacturer’s status as an expert means that at a minimum he must keep abreast of scientific knowledge, discoveries, and advances and is presumed to know what is imparted thereby.  But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.

Id. at 1089-90.

Plaintiffs, on the other hand, prefer to define the state of the art to reflect technology on the cutting edge of scientific knowledge at the relevant time.  This concept would limit use of the state-of-the-art defense to a much smaller group of cases and result in broad liability for product sellers.  This view completely ignores whether making the product safer was feasible at the time or whether the utility of the product was greater than the possibility of any dangers it might create.  At the extreme, sellers could be absolutely liable for any and all injuries from their products.  Thus, in Beshada v. Johns-Manville Products Corp., 447 A.2d 539 (N.J. 1982) – another asbestos failure-to-warn case – the court refused to recognize the state-of-the-art defense on policy grounds because the manufacturers were in a better position to bear the losses associated with their products, and spread those costs, than the injured victims.

But the prevailing view allows product sellers to rely on state of the art as a defense to claims for defective products.  The Third Restatement of Torts:  Products Liability (1998) refers to “the foreseeable risks of harm” as a basis of liability for defective design and failure to warn of the hazards of a product.  But what is foreseeable?  All lawyers know the answer to that question is unclear and very fact specific.

Which brings us to the risks of nanotechnology.  What should we demand of sellers of nanotechnology and the products making use of the technologies?   Should the burdens of research into the risks be greater or less because the technology is developing?  Whether or not regulation occurs, personal injury litigation will arise at some point.  It seems inevitable, given the course of other consumer and workplace products.

One thing is clear:  It will not suffice for defendants to argue that they were not aware of the potential hazards of their products if they did not conduct research into the health and safety impacts and apprise themselves of all other available and pertinent research results.  If concerns arise from initial research (as they have in some studies of nanoparticles), their obligation is to conduct further research and to use the information in product design decisions or to provide sufficient warnings.  The words of the Court of Appeals in Borel resonate here:  “But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.”

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Initial Thoughts on Regulation

Posted Apr.09, 2010 under Environment, Governmental Interaction, Health, Regulation, Toxic Torts
www.h20technologies.com

www.h20technologies.com

We are seeing an explosion of interest in and information about nanotechnology, its uses and its risks.  The law has yet to develop in this field.  I am pleased to start the conversation in this blog on the legal issues that are beginning to emerge about nanotechnology.  My entries will focus on efforts to determine what risks the new technologies may pose to consumers and the population in general.  My expertise in the area of toxic tort law is uniquely suited to examining the emerging health concerns from the viewpoint of anticipated litigation.  My co-blogger, Eric Laury, Widener Law ’11, will focus on the legal issues involving the development and use of the technologies, including intellectual property matters.  This blog is not intended to be a news source, though it will provide some links to stories in the news that bear upon our commentary.  Rather, we intend to analyze and question the developments as they emerge, and to place them in a legal context that will be useful for attorneys, regulators, and other legal observers.  We hope that our observations will begin the discussion and debate over the legal ramifications of nanotechnology.

Every week, numerous developments are reported in the media, but I will give my attention here to just one of them.  On March 25, 2010, the President’s Council of Advisors on Science and Technology (P-CAST) issued its report on the Third Assessment of the National Nanotechnology Initiative.  Among many other things, P-CAST calls for “clear principles” for identifying the environmental, health, and safety risks of nanotechnology.  To implement this, the report recommends further development of the existing cross-agency strategic plan to link research activities and information sharing and suggests that “member agencies increase coordinated efforts to overcome barriers to effective, sustainable, and responsible commercialization of nanotechnology.”

This is vague, suitably so for the first steps toward regulation.  One might question, however, the laissez-faire approach that it supports.  To start the discussion on examining the risks of nanotechnology, it is worthwhile to consider how the Government might regulate the products of these technologies.  What would regulation of the health and environmental impacts of nanotechnology look like?  One possibility is the current P-CAST proposal – interagency exchange of information with an individual directing interagency coordination efforts.  Another model would be the creation of an umbrella agency to manage nanotechnology, including the health, environmental, and safety risks of products using the technology.  This concept would take all nanotechnology-related matters away from other agencies – which, presumably, have at least some experience with handling new technologies – and place them within the authority of the new agency.  Another model might be creating a Department of Science and Technology along the lines of the Department of Homeland Security, though determining which agencies – or which parts of which agencies – would fall within the authority of a new Department would be problematic.  Finally, we could leave well enough alone and let existing agencies regulate individual uses of nanotechnology as they arise.  Under this incremental approach, for example, the FDA could regulate medical uses of nanotechnology on a use-by-use basis.

We need to think now about regulating nanotechnology and about what structure that regulation should take.  The history of toxic tort litigation is strewn with products that were allowed on the market with little or no health and safety regulation.  The result was massive health risks, seemingly endless litigation, and studies done too long after the fact.  Just consider the course of asbestos litigation.

www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nano-report.pdf

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