Litigation

The first lawsuit over regulation of the health and environmental risks of nanotechnology and nanomaterials has been voluntariliy dismissed.  That suit was the subject of my post, First Lawsuit on Risks of Nanotechnology in Consumer Products is Filed.

The Lawsuit's Origin

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The Lawsuit's Conclusion

The Plaintiff groups agreed to drop the lawsuit because the FDA has now formally responded to their petition, though the agency rejected some of their key proposals.  The groups had also requested that the agency subject its nanotechnology program to a comprehensive environmental review under the National Environmental Policy Act.

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You may be interested in a recent article in Product Liability Law360, February 2, 2012: "Mitigating Risk in Mass Nano Torts."

 

The article by attorneys Michael Lisak and James Mizgala (Sidley Austin LLP) suggests that consumer fraud (no-injury) class action claims are likely to be some of the first nanotechnology-related lawsuit faced by comapnaies making or selling nanomaterial-containing products. They suggest that the BPA plastic products liability class-action litigation can provide a useful framework for how similar nanoparticle claims may be pursued and defended.

Some excerpts are provided below, so you can decide whether to obtain the full article.

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The January 2012 issue of the Defense Research Institute’s For The Defense magazine features the nanotechnology article "A Litigator's Guide to Health and Environmental Issues," by attorney John Delany, a member of Delany & O'Brien, in Philadelphia.

Delany describes the potential for what is now a limited series of commercial, patent, and regulatory legal battles to become full-blown personal injury tort litigation in the near future. Here is an excerpt:

The factors that could create a toxic, nanolitigation storm are (1) ubiquitous exposure; (2) sympathetic plaintiffs; (3) sensational press (4) reactive politicians; (5) product identification capability pointing to a specific product or a specific defendant; (5) biomarker and causation evidence; (6) corporate culpability; (7) state-of-the art medical and liability; (8) the serious, objective, potentially permanent nature of a potential injury due to nanomaterial exposure compared with potentially subjective transitory injury; (9) deep pockets of recovery; (10) product benefit-cost utility; and (11) warnings and personal choices involved with exposure.

In addition, judicial and legislative factors may affect the liability picture, including potential immunities, economic caps, limitations on punitive damages, joint and several liability, the collateral source rule, venue shopping, removal to a federal court, preemption, and the framework that the judiciary uses to manage and adjudicate claims, such as multi-district litigation processes.

 

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The Natural Resources Defense Council (NRDC) filed a federal suit against the U.S. Environmental Protection Agency on January 26, 2012, seeking to overturn EPA's decision to conditionally approve nanosilver under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It marks the first time ever that EPA's approval of a nanoscale chemical has been challenged in court. The NRDC petition was filed with the 9th U.S. Circuit Court of Appeals, headquartered in San Francisco, Calif.

The NRDC petition claims that sales of the nanosilver-based pesticide should be halted because the health risks of the substance are unknown. The environmental advocacy group, which has been highlighting potential safety concerns about the use of ultra-tiny silver particles as an antimicrobial agent for several years, accused the EPA of giving the manufacturer a “four-year free pass” by allowing the pesticide to come to market before health and safety testing has been completed.

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The legal battle has finally been joined.  The first lawsuit over the health and environmental risks of nanotechnology and nanomaterials has been filed.

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The eighty-page 2006 Petition documents the groups' claimed scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility. The 2006 petition requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency. The FDA had yet to act on the 2006 petition, prompting the suit.

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You may be interested in an article published by BNA's Product Safety & Liability Reporter in November 2011: "Labeling and Warning for Products Containing Engineered Nanomaterials: Learning From the Past or We Are Doomed to Repeat It"

The article is a very good collaboration by attorneys William Rogers and Joseph Clark (Day Pitney LLP) and scientists Joyce Tsuji, David Dahlstrom, and Steven Arndt (Exponent), and provides guidance about how to approach the new world of labeling, warning, and instruction creation for products containing nanomaterials.

A few excerpts are provided below, to help you decide whether you want to get the full article.

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You may be interested in an article published by BNA's Product Safety & Liability Reporter in April 2011: "Nanotechnology Manufacturers' Duty to Warn and Potential Affirmative Defenses."

The well-written article, by attorneys James W. Mizgala and Michael L. Lisak (Sidley Austin LLP in Chicago), assesses a manufacturer's duty to warn of potential dangers posed by nanomaterials, and then offers suggestions for defenses that could be raised by nanomaterial defendants facing failure to warn claims.

A few excerpts are provided below, to help you decide whether you want to obtain the full article.

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"Potential Human Health Risks of Nanomaterials" was published in the March issue of the International Risk Management Institute (IRMI) newsletter.

The article, authored by Gradient Corp.’s Dr. Marc Nascarella and Dr. Barbara Beck, along with Attorney Joseph Clark of Day Pitney LLP, focuses on the potential human health hazards, risks, and liability issues associated with nanomaterial exposure.

The full article is available here, and is excerpted below.

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In an article published in the November 11, 2010, issue of Toxics Law Reporter -- Nanoparticles : New Frontier for Product Liability Mass Torts/Class Action Claims --I discuss the prospect of nanoparticle mass tort/class action litigation, the likely claims and defenses, and offer a preview of potential Daubert-style challenges to exposure, dose, and causation experts given the state of science and the law in late 2010.

In a two-part blog article, I have excerpted and condensed that article. In Part 1, on November 14, I discussed the likely mass tort/class action claims. In Part 2 below I discuss the tactics for defeating early mass nanotort claims.

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The existence of a large, well-financed mass tort infrastructure makes it likely that plaintiffs’ attorneys will try to exploit the Age of Nanotechnology through mass tort and class actions. Plaintiffs who already have a disease will assert that their diseases were caused by or exacerbated by their exposures to anoparticles. Those without disease will assert a need for medical monitoring.

In an article published in the November 11, 2010, issue of Toxics Law Reporter -- Nanoparticles : New Frontier for Product Liability Mass Torts/Class Action Claims --I discuss the prospect of nanoparticle mass tort/class action litigation, the likely claims and defenses, and offer a preview of potential Daubert-style challenges to exposure, dose, and causation experts given the state of science and the law in late 2010. 

In a two-part blog article, I have excerpted and condensed the article. Here is Part 1.

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I recommend that you add to your "links" or "favorites" for regular consultation a new blog on on the Daubert standard, "Daubert Uncensored."  The Daubert Uncensored blog is a free resource offering a unique and in-depth perspective that provides the claims industry and in-house counsel with up-to-date news and commentary on important Daubert cases and evolving trends across the country. 

The lead writer of Daubert Uncensored is John Sear, a Partner in the Minneapolis office of the national product liability defense firm Bowman and Brooke.  Sear has unique gravitas to command respect on this subject, having successfully tried or litigated a wide variety of cases involving medical devices and institutional chemical products.  Sear has briefed and argued Daubert motions in such far-ranging fields as orthopedics, chemistry, human factors, obstetrics, mechanical engineering, toxicology, epidemiology, biostatistics, immunology, and veterinary medicine, and defended his favorable rulings on appeal.  He frequently lectures and publishes on civil litigation practice and procedure, with an emphasis on Daubert and summary judgment issues.  Now we can all benefit from his experience and commentary - at no cost!

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This is the second in a two-part blog article that provides some practical guidance for chemical organizations, product manufacturers, and risk managers so that good planning can prevent or mitigate future personal injury litigation risk from nanotechnologies.

In Part 1, I outlined some of the basic challenges. Here, I outline some specific action plans.

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Over the past two years I have written extensively about some of the potential litigation risks posed by exposure to nanoparticles, and on the evolving response of U.S. government agencies to regulation of nanotechnologies.   

 This two-part blog article takes the next step and aims to provide some practical guidance for chemical organizations, product manufacturers, and risk managers so that good planning can prevent or mitigate future personal injury litigation risk from nanotechnologies.

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I recommend that you add to your “nanolinks” for regular reading the NanoLaw Blog, hosted by Widener University Law School.

The NanoLaw Blog Mission Statement: Nanotechnology has been around for a while, but it is becoming more pervasive as new products and applications appear. The National Nanotechnology Initiative lists developing uses as diverse as cancer treatments, nerve regeneration, efficient solar energy, and both industrial and consumer product enhancement. Notwithstanding this burst of technological ingenuity, the impact of nanotechnology on human health and the environment has been only sparsely studied, and nanotechnology is virtually unregulated in the United States. Without information regarding the impacts of nanotechnology, agencies entrusted with making regulatory decisions regarding applications that use the technology – such as OSHA, FDA, and EPA – cannot effectively regulate. As an emerging technology with unknown risks, nanotechnology is likely to follow the path of other toxic torts in the areas of both private law and public law. The purpose of this site is to raise legal questions about the impact of nanotechnology and comment upon the ways in which those questions are likely to be raised in the legal system.

With the permission of the NanoLaw Blog I have below reproduced one of the recent posts, an interesting discussion of the legal significance of early nanomaterial studies of environmental, health and safety. You will find it interesting.

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Prudent manufacturers, sellers, and employers in the nanotechnology community must maintain knowledge of all relevant standards, whether governmental, NGO, or industry-developed.  But there is frustration with the uncertainties about the regulatory definitions of chemicals, materials, and products made with nanotechnologies.

This is an area worth watching closely.  The current confusion and likely permanent lack of complete uniformity with respect to nanotechnology and nanomaterial definitions and related standards also has tremendous implications those corporate officials and lawyers with responsibility for managing and minimizing risk, including litigation risk.  Evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

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This is part four of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management. The author is Nick Dudley, a third-year law student at the University of Minnesota Law School.

Generally speaking, nanomaterials pose the same problems to products liability lawyers that macro products do. Manufacturing defect, defective design, and failure to warn are not going away. But nanomaterials do pose some unique problems within each cause of action. Part 4 is an overview of those various problems.

 

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This is part three of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management. The author is Nick Dudley, a third-year law student at the University of Minnesota Law School.

Products liability attorneys will face unique challenges from the nanotechnology industry. Part 3 suggests a broader coping strategy. Attorneys and insiders must find a balance between industry-wide security that some regulation would provide, while avoiding the choking effects of over-regulation.
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You may be interested in an article published by BNA's Toxics Law Reporter in December 2009:  "Nanotechnology: The Next Battleground for Mass Torts?" 

The article by Scott DeVries and Sarah Jehl, attorneys experienced with environmental mass torts and insurance coverage, offers some potentially useful procedural suggestions for defense attorneys faced with nanotech-focused mass torts.

In particular, the authors tout the possible benefit of so-called "Lone Pine" orders to test the viability of novel nanotechnology-based toxic exposure claims.  "Lone Pine" orders are derived from the case of Lore v. Lone Pine Corp., 1986 N.J. Super. LEXIS 1626 (N.J. Super. Law. Div. Nov. 18, 1986).   Such orders, designed to require plaintiffs to make an objective showing early in litigation that there is sufficient evidentiary basis to warrant continued litigation, have been widely accepted and used in other federal and state courts throughout the country.  To learn more, see Attorney DeVries' article on the subject: S. DeVries, et al., Use of Lone Pine Orders in Cost Effective Management of Mass Tort and Class Actions, 23 Toxics Law Reporter 1003 (Nov. 2008). 

Devries can be contacted at for more information or a copy of his prior article above.

Source: BNA Toxics Law Reporter

 

 

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This is part two of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management.  The author is Nick Dudley, a third-year law student at the University of Minnesota Law School. 

Nanotechnology promises to enhance existing technology in useful ways, and to make science fiction a reality. But, nanotech’s value must be weighed the consequences. Part 2 of this series explores the potential dangers of nanotech.

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You may be interested in the cover article from the Winter 2010 Issue of the ABA Section of Litigation magazine, Litigation News – “The Rise of Nanotech Litigation.”  

 

The article by Litigation News Associate Editor Kristine Roberts is, in my view, a substantially scaled down summary of a number of my previous articles on the subject, including "The Dawn of the Age of Nanotorts", published last year by BNA in three of its subject-matter reporters - Class Action Litigation, Toxics Law, and Product Safety & Liability.  

 I’m glad to see someone out there is reading. 

 

Roberts also includes a few comments from Section of Litigation members on likely nanotech-related product liability and exposure litigation.  Below are a few excerpts from the Roberts article. 

 

 

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Nick Dudley, a third-year law student at the University of Minnesota Law School, has prepared an interesting primer on nanotechnology and the likely effects on products liability litigation and risk management.  This is Part 1 of 4.   read more

Part 1 of the discussion examined the structural and systemic forces in the American tort system that will lead to the reality of nanotechnology-focused tort claims in the near future. In Part 2, I began to discuss some specific claims that are likely in early nanotort litigation, including medical monitoring claims.  Here, in Part 3, I continue that claim-specific discussion, with a focus on possible class action claims. read more

Part 1 of the discussion examined the structural and systemic forces in the American tort system that will lead to the reality of nanotechnology-focused tort claims in the near future. Here, in Part 2, I begin to discuss some specific claims that are likely in early nanotort litigation. read more

No one knows yet whether nanotechnologies will be shown to have harmful consequences or whether they present only phantom risk. Although only tentative, some early studies suggest that some nanoparticles may have negative health and environmental consequences. Experience teaches that when there are concerns about possible health and safety hazards, litigation – feeding on public and political risk perception – is never far behind. read more

An article by Reed D. Rubinstein of Greenberg Traurig LLP, in the new issue of Nanotechnology Law & Business (Fall 2009), discusses a “petition” filed with the United States Environmental Protection Agency (EPA) by the International Center for Technology Assessment (ICTA) and other special interest groups. The Petition claims that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” As a result, the Petition demands (among other things) that the EPA regulate all nano-silver products as pesticides, and stop the use or sale of all consumer products using nano-silver under the authority of FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act. read more

The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

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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