Nanoparticles: The New Frontier For Product Liability Mass Tort and Class Action Claims

Several articles have been published in recent years concerning the potential health, environmental, and safety risks posed by exposure to nanoparticles, and with guidance for risk mitigation and reducing exposure to potential future nanotort claims. ¹See, e.g., Wernette/Morgan, Reducing the Risk of Nanotechnology Personal Injury Litigation, ABA–TIPS, Products, General Liability and Consumer Law Committee (Summer 2010); Wernette, 8 Steps to Reducing Nanotorts in Your Nanofuture, Product Liability Law360 and Environmental Law360 (July 2010); DeVries/Gotting/Leibfarth, Guarding against Nanotort Liabilities, Environmental Claims Journal, Vol. 22, No. 2 (April 2010); DeVries/Jehl, Nanotechnology: The Next Battleground for Mass Torts?, BNA Toxics Law Reporter, Vol. 24, No. 47 (Dec 2009); Wernette, The Dawn of the Age of Nanotorts, BNA Product Safety & Liability Reporter, Vol. 37, No. 16 (April 2009) (also published in BNA Toxics Law Reporter, Vol. 24, No. 3 (Jan 2009), and BNA Class Action Litigation Report, Vol. 10, No. 1 (Jan 2009)); Wernette, The Coming Age of Nanotorts, Product Liability Law & Strategy Vol. 28, No. 9 (March 2009); Moellenberg/Juni, A Practical Guide to Reduce Product Liability Risk for Nanotechnology, BNA Toxics Law Reporter, Vol. 24, No. 10 (March 2009); Wernette/Nilsen, The Legal Risks of Nanotechnologies, For The Defense (Nov 2008). This article discusses in more detail the prospect of nanoparticle mass tort/class action litigation, and the likely claims and defenses given the state of science and the law in late 2010.

Is Mass Nanotort and Class Action
Litigation Drawing Nigh?

“The Rise of Nanotech Litigation” reads the cover of the Winter 2010 issue of Litigation News, the magazine of the American Bar Association Section of Litigation.

“Nanotechnology: Brave New World for Civil Tort Plaintiffs” reads the title of a recent article in The SciTech Lawyer, the magazine of the ABA Section of Science & Technology Law.

It is not just lawyers who foresee a potential flood of new tort claims.

– “EU Ministers Call for Nanomaterial Ban,” Chemistry World, June 2010.

– “Nanosilver has No Place in Food, Textiles, or Cosmetics,” German Federal Institute for Risk Assessment, June 2010.

– “A mounting body of research shows nanoparticles can cause disease and death. But regulators are doing little to respond.” AOL News Special Report series, The Nanotech Gamble: Bold Science, Big Money, Growing Risks, March 2010.

– “Nanoparticles – one word: A multiplicity of different hazards,” Nanotoxicology, December 2009.

– “Nanotechnology could possibly translate into mega risks.” Tiny Objects, Big Concerns: Managing Nanotechnology Risks, Claims Magazine, December 2009.

How Concerned Should We Be?

Nanomaterials can enter living organisms through inhalation, ingestion, and absorption through the skin, and they can circulate within organisms as well. No one knows yet whether engineered nanoparticles will be shown to have harmful consequences or whether they present only phantom risk, because little is yet known about the acute or chronic toxicity of nanoparticles in general or the effects of various particle-specific characteristics.

Although only tentative, some early studies suggest that some specific nanoparticles already in widespread use may have health and environmental consequences. For instance, certain carbon nanotubes (CNTs)—the most commonly used nanomaterial in industrial applications—resemble asbestos fibers in some respects and some researchers have reported that CNTs, injected into mice, caused the type of lesions and inflammation that develop from asbestos exposure. Some early studies have suggested that nano-titanium dioxide (TiO2)—a commonly used nanomaterial in consumer products today—can damage or destroy DNA and chromosomes, potentially leading to cancer, heart disease and brain injury. And research concerning nano-silver (Au)—currently used in more consumer products than any other nano-material—has found probable ecotoxicity and biotoxicity for acquatic and plant species in the food chain. Although still a matter of hypotheses, it has been postulated that nanoparticles could aggregate and travel up the food chain, and there is a risk that they could become persistent pollutants that might remain in the environment for long periods of time, similar to DDT or PCB.

It is also unknown whether some engineered nanoparticles are simply toxicants under some dose/exposure circumstances, or whether they may also be carcinogens, teratogens, or mutagens. It will take many years for studies about exposure routes, the effects on human health, and effects on the environment to reach what may be viewed as conclusive results. Meanwhile, thousands of nanoparticle-containing products are already being manufactured, sold, and disposed of at both the industrial and consumer levels, with dramatic growth.

Not If, but When, the Claims Will Be Made.

As nanotechnology has proliferated, many interest groups and even governmental entities have sounded alarms about the potential risks it poses. These groups have already accused the industry of failing to do due care testing and failing to ensure the safety of those who may become exposed to engineered nanomaterials. ²See various posts at http://www.Nanotortlaw.com. This includes NGOs such as the Environmental Working Group (http://www.ewg.org), Friends of the Earth (http://www.foe.org), and The International Center for Technology Assessment (http://www.icta.org/nanotech/). A number of governmental agencies and inter-governmental groups, especially in Europe and Australasia, have also expressed similarly cautious views. Experience teaches that when there are concerns about possible health and safety hazards, litigation—feeding upon public and political risk perception—is never far behind. Vast amounts of “nanorisk” information is available on the internet, creating a network of information for potential plaintiffs and their counsel. The question is not so much if, but when, nanotort claims and litigation will arise.

Despite the uncertainties of health and environmental hazards, nanotorts are a virtual certainty. Why? Because a large, well-financed mass tort infrastructure is in place. That mechanism, financed initially by asbestos and tobacco litigation, has been used with some success for other target substances such as lead, benzene, beryllium, silica, welding fumes, pharmaceuticals, and ultrafine particles (such as diesel particles and carbon black). This mass tort infrastructure consists of two equally important and sophisticated parts: (1) the creation and management of public and political risk perception, and (2) the pursuit of litigation. Well-honed on other substances, both aspects are well suited to exploit the Age of Nanotechnology. Plaintiffs who already have a disease would assert that their diseases were caused by or exacerbated by their exposures to nanoparticles; those without disease would assert a need for medical monitoring.

Traditional Toxic Exposure
Class Action Claims

Class-certification decisions involving mass tort actions invoke Fed. R. Civ. P. 23(b)(3), or state rule counterparts. To qualify for certification under Rule 23(b)(3), a class must meet two requirements beyond the Rule 23(a) prerequisites: (1) common questions must “predominate over any question affecting only individual members,” and (2) class resolution must be “superior to other available methods for the fair and efficient adjudication of the controversy.”

Over the past 30 years, the clear trend has been to deny certification of classes in actions alleging toxic torts, including those seeking classwide medical monitoring, because the individual issues have predominated over the common issues. ³See In re Methyl Tertiary Butyl Ether (MTBE) Prod. Liab. Litig., 209 F.R.D. 323, 347-48 (S.D.N.Y. 2002) (“[T]he overwhelming majority of state and federal court have denied certification of environmental mass tort classes, even in single source cases.”). Establishing that common issues of fact and law predominate over individual issues of fact and law will be near impossible for nanomaterial exposure claims because the highly individualized issues of exposure, dose-response, medical history, causation (including the requirement that courts examine alternate causes on an individualized basis), and damages will predominate. ⁴Some recent decisions denying class certification in toxic tort cases on these bases include Houston County Health Care Auth. v. Williams,
961 So. 2d 795 (Ala. 2007) (breast implants); Jensen v. Bayer AG, 862 N.E.2d 1091 (Ill. App. 2007) (cholesterol-lowering drug Baycol); Engle v. Liggett Group Inc., 945 So. 2d 1246 (Fla. 2006) (cigarettes); Smith v. Illinois Central Railroad Co., 860 N.E.2d 332 (Ill. 2006) (chemical spill); Bourgeois v. A.P. Green Indus. Inc., 939 So. 2d 478 (La. App. 2006) (asbestos).

Despite the difficulty of class action certification in the toxic tort area, plaintiffs have had some pockets of success that may apply to the nanotechnology context. For example, class certification may be achieved if an action can successfully be divided into phases that allow for class-based litigation of some issues involving issues of common proof (e.g., negligence, whether product was unreasonably dangerous, failure to warn, entitlement to punitive damages), while providing for determination of individual liability and compensatory damages in separate phases. ⁵See, e.g.,7-Eleven Inc. v. Bowens,
857 N.E.2d 382 (Ind. App. 2006) (affirming class certification on issues of liability and general causation only, excluding individual issues of exposure, specific causation, and damages, in case alleging injuries from leaking underground storage tanks); Engle v. Liggett Group Inc., 945 So. 2d 1246 (Fla. 2006) (affirming class action jury findings on general liability issue—cigarettes were defective and unreasonably dangerous, defendants concealed information on risks of smoking, and defendants were negligent—but decertifying class for further proceedings due to predominance of individual issues of causation, comparative fault, and damages). Class certification has also recently been affirmed in the context of medical monitoring claims, in those jurisdictions recognizing such claims in the absence of a present physical injury. In such cases, because individual class members need not prove an actual injury, the courts have been more inclined to find that the key issues are matters of common proof. ⁶See, e.g., Meyer v Flour Corp., 220 S.W.3d 712 (Mo. 2007) (lead exposure from lead smelting plant) These are narrow exceptions to the trend against class certification in cases alleging personal injury or some adverse health impact.

Medical Monitoring Claims.

Medical monitoring claims represent an area of possible early nanoparticle exposure mass tort/class action activity, because they have the potential in some jurisdictions to avoid some of the stringent individualized exposure and causation problems described above. Medical monitoring claims—recognized in some, but not all, jurisdictions—are divided into two types: jurisdictions requiring present physical harm and those with no present physical harm requirement. ⁷For a breakdown of courts that recognize medical monitoring claims and those that do not, see Paz v. Brush Engineered Materials Inc., 949 So. 2d 1, 6-7 nn.3-5 (Miss. 2007). For those jurisdictions with a present physical injury requirement, the burdens described above for nanoexposure claims are essentially the same, making it very difficult for plaintiffs to succeed in exposure cases. ⁸See, e.g., Paz, supra, 949 So. 2d at 5 (Plaintiffs sought medical monitoring costs to detect diseases allegedly caused by beryllium exposure. Court held that common law requires an identifiable present physical injury and that recognizing the plaintiffs’ claim would be the same as “recognizing a cause of action for fear of future illness.”).

Nanoparticle class action plaintiffs will attempt to overcome or sidestep some of the current hurdles by making novel arguments about what constitutes a “physical injury” where there has been nanomaterial exposure. Nanotort claimants will argue that exposure to a hazardous substance has indeed caused them such an injury, in the form of cellular and sub-cellular changes that occur when the molecules of the hazardous substance entered their body. Arguments will be made that exposure to novel man-made nanomaterials requires fashioning of new law based on the unique biological issues presented by nanomaterials that have no precise legal analog. For example, will unwanted nanomaterial exposure be sufficient to prove an injury where it can be shown to have created subclinical, cellular, and/or subcellular changes, but without any diagnosed disease process? Will proof of bioaccumulation of nanomaterials in specific organs be sufficient?

The toxic exposure case of Parker v. Wellman
⁹230 F. App’x 878 (11th Cir. 2007) (applying Georgia law). gives a glimpse of how such novel arguments may be pursued, and previews the difficulty that will be presented by nanotort litigation when legal line drawing must take place where the line between science and the law is blurry. The Parker plaintiffs made a claim for medical monitoring due to alleged beryllium exposure. Applicable Georgia law holds that proof of a present physical injury is required for such a claim. Plaintiffs argued that subclinical, cellular, and subcellular damage existed and could satisfy the physical injury requirement. The Eleventh Circuit used science as a tool but ultimately was required to make a non-scientific judgment because “present physical injury” is a term of legal, not scientific, art in the context of tort litigation. So, while it may be scientifically true that exposure to a substance has in fact caused some biological change or damage, e.g., cellular damage or immune system response, the legal question is more ambiguous: is that level of harm or damage sufficient to constitute a present physical injury as that legal term of art is defined by evolving common law. The difficulty of such science/law decisions is reflected in the Parker case holding: the plaintiffs’ subclinical damage claims did not meet the present physical injury requirement, however, the court remanded the case for a further determination whether plaintiffs’ claim of “beryllium sensitization” might be considered a present physical impairment.

In Paz v. Brush Engineered Materials Inc.
,
¹⁰2009 WL 78374 (5th Cir. 2009). the Fifth Circuit also dealt with beryllium exposure. There, a group of employees claimed they had been injured from exposure to beryllium-containing products during their work. The court agreed that the evidence proved the plaintiffs suffered from beryllium sensitization, but concluded that those types of sub-cellular, cellular, and sub-clinical changes did not constitute a compensable injury under Mississippi law. The court held that, while there had been a “physiologic change” in the plaintiffs’ bodies, there would be no compensable “injury” until they actually developed the “predicted” disease, i.e., chronic beryllium disease (CBD).

In Dumontier v. Schlumberger Technology Corp.,
¹¹543 F.3d 567 (9th Cir. 2008). the plaintiff class claimed injury from exposure to cesium, a potentially dangerous radioactive substance. The plaintiffs presented evidence that the radiation damaged their DNA or other important cellular components. But the Ninth Circuit dismissed the claims, holding that “this damage does not establish that there is or will be pain or interference with bodily functions, and thus isn’t a [compensable] injury … .”

In Rainer v. Union Carbide Corp., ¹²402 F.3d 608 (6th Cir. 2005). uranium-enrichment plant workers sued the supplier of the uranium fuel for exposure to radioactive substances. Their injuries consisted solely of “various structural chromosomal abnormalities” within some of their cells. The Sixth Circuit held that the plaintiffs’ sub-cellular “damage” did not constitute a compensable “real, concrete bodily injury,” stating:

Accepting the plaintiffs’ claim would therefore throw open the possibility of litigation by any person experiencing even the most benign sub-cellular change. Based upon the average American’s exposure to chemically processed foods, toxic fumes, genetically modified fruits and vegetables, mercury-laden fish, and hormonally treated chicken and beef, this might encompass a very large percentage of the total population.

This line of cases would appear to erect an effective defense for nanomaterial product manufacturers whose products contain particles arguably capable of causing cellular or sub-cellular level changes. In states that have considered the issue thus far, plaintiffs will be required to prove the existence of a patent physical injury to successfully bring a cause of action. Asymptomatic cellular or sub-cellular changes will not be compensable under the current majority.

If claimant class counsel pursuing a nanoparticle case cannot base “injury” claims on subclinical, cellular, and/or subcellular changes without any diagnosed disease process, where will they go next? A discussion of novel and controversial injury theories advanced by some alternative medicine practitioners is beyond the scope of this article, but the complexities, unknowns, and fear perception raised by nanotechnologies makes nanoparticle exposure almost certain to be a target of practitioners in fields such as “environmental medicine” and so-called “complementary and alternative medicine.” Many of those practitioners staunchly advance an agenda that exposures to many common substances are toxic, and various nonspecific ailments and negative health conditions are caused by exposures, such as multiple chemical sensitivity, chronic fatigue syndrome, attention deficit disorder, muscle and joint pain, cardiovascular disease, hormone imbalance, and a variety of other syndromes and “ailments of unknown etiology.” ¹³See, e.g. Multiple Chemical Sensitivity Referral & Resources, at http://www.mcsrr.org; American Academy of Environmental Medicine, at www.aaemonline.org; National Center for Complementary and Alternative Medicine, at http://www.nccam.nih.gov. Arguments that exposure to new man-made nanoparticles triggers such disorders and ailments can be expected, which will focus much more attention on the scientific validity of those unconventional medical fields and controversial ailments than they have received so far.

For those jurisdictions that do not require proof of a present physical harm, an increased risk of harm is sufficient to justify a medical monitoring claim. ¹⁴See, e.g., Meyer v Flour Corp., 220 S.W.3d 712, 717-718 (Mo. 2007) (holding that no present injury is required but a plaintiff must demonstrate “a significantly increased risk of contracting a particular disease” and that “medical monitoring is, to a reasonable degree of medical certainty, necessary in order to diagnose the early warning signs of the disease.”) Courts are further divided as to the extent of the increased risk necessary to support a claim for medical monitoring. It is on this last point that the lack of hard science establishing a link between exposure to a specific nanomaterial and increased risk of any particular illness or disease process can prove legally fatal, even for a medical monitoring case in a “no present injury” jurisdiction. Several recent cases apply this principle. In M.G. v. A.I. DuPont Hospital for Children, 2010 WL 3310720 (3d Cir. 8/24/10), the Third Circuit dismissed the plaintiffs’ medical monitoring claim, finding that the facts of this case did not give rise to a medical monitoring claim because the plaintiff did not establish (1) significant exposure to (2) a proven toxic substance with (3) a known tendency to cause a serious latent disease.

Similarly, in Sheridan v. NGK Metals Corp.
, 609 F.3d 239 (3d Cir. 2010), and Anthony v. Small Tube Manufacturing Corp., 609 F.3d 239 (3d Cir. 2010) (the Third Circuit decided both cases in the same 56-page opinion by Chief Judge Anthony J. Scirica), the court affirmed the dismissal of two proposed medical monitoring classes made up of residents near a beryllium products plant and of workers at a plant where beryllium products are incorporated into other products. The named plaintiffs alleged that their airborne exposure to beryllium dust and particles put them at a heightened risk for developing chronic beryllium disease (CBD).

The Third Circuit tossed the proposed classes for the same reason: neither set of named plaintiffs had shown through positive medical tests that they were “sensitized” to the disease, meaning they had the genetic marker that would predispose them to developing CBD. The court drew a line along the exposure-to-disease continuum at sensitization, although it recognized that future developments in science’s understanding of the effects of beryllium exposure and its relationship with CBD may result in a different outcome. These recent cases suggest that a hurdle for nanomaterial claimants will be to identify a specific disease process caused by exposure to a particular nanomaterial, and to also establish a special predisposition to that specific disease.

In sum, existing case law is certainly helpful to potential nanomaterial-producing defendants and erects difficult barriers to a successful nanoparticle-based toxic exposure class action claim. But the law is certainly not static. The advent of tort litigation concerning nanomaterials that have no precedential risk assessment in science or the law creates the opportunity for claimant attorneys to press for new ways of assessing what constitutes “injury,” harm, and relevant risk. That legal ground is still unplowed.

`No Injury’ Consumer Class Action Claims.

For the reasons already described, although more aggressive claimant counsel can be expected to try and push the legal envelope with novel legal arguments where nanomaterial exposure is alleged, it is unlikely that nanotort cases alleging traditional toxic exposure personal injury, especially class action suits, will be successful unless and until a signature illness or condition is discovered. Meanwhile, more probable nanotort litigation is in pursuit of so-called “no injury” or “fraud light” claims. Pursued primarily as class actions, these cases have sprung up in the past decade in direct response to the increasing difficulty with proving personal injury in the mass tort and exposure context and the problems of obtaining class certification. Typically brought pursuant to state consumer protection statutes, these claims do not allege any personal injury at all; rather, they seek only economic damages in the form of a refund of the product purchase price. Seeking only an economic remedy avoids almost all of the difficult causation issues. In addition, the state consumer law statutes at issue typically do not require all the elements of common law fraud, e.g., proof of actual reliance by a particular plaintiff. The elimination of that individual issue of fact, combined with the elimination of difficult-to-prove individual personal injury causation, makes class certification and summary judgment survival more plausible.

The nanotechnology industry can learn from recent “lead in lipstick” litigation. ¹⁵See Frye v. L’Oreal USA Inc.,
583 F. Supp. 2d 954 (N.D. Ill. 2008); Koronthaly v. L’Oreal USA Inc., 2008 U.S. Dist. LEXIS 59024 (D.N.J. Jul. 29, 2008). The litigation was precipitated by an October 2007 special-interest group (Campaign for Safe Cosmetics (CFS)) “study” claiming that certain lipsticks contained dangerous amounts of lead and posed a danger to consumers. Within a few months class action plaintiffs’ counsel had filed suits against lipstick manufacturers parroting the CFS’s claims. Plaintiffs argued that they would not have purchased the lipstick had they known of its lead content and pursued causes of action like breach of implied warranty, unjust enrichment, and statutory consumer fraud. They sought narrow economic damages, including the return of the purchase price and the costs of diagnostic testing and medical monitoring. Although the individual claims were small, once aggregated they represented very significant liability.

The lesson for nanotechnology? First, the highly competitive plaintiffs’ class action bar is always ready to pounce on a perceived opportunity and multiple class-action lawsuits can quickly spring up across the country after the publication of a nonconclusive, but headline-catching, study or report. Second, there are already many internet-available special interest group “studies” and “reports” targeting nanomaterials for their alleged environmental, health, and safety dangers. ¹⁶For example, Friends of the Earth and ICTA filed a formal petition (still pending) with the Food and Drug Administration alleging dangers from silver nanoparticles in consumer products, including cosmetics, toiletries, and others, and demanding heightened monitoring and regulation of nanosilver. Another example is the “anti-nanotechnology in food” position, warning of dangers from the use of nanoparticles in food products and packaging, contained in a Friends of the Earth report, “Out of the Laboratory and On To Our Plates.” These examples and the corresponding reports, as well as others, are discussed and available at http://www.Nanotortlaw.com. Many could easily form a cut-and-paste basis for a “no injury” class action lawsuit. Manufacturers utilizing nanotechnology should prepare for such actions.

For example, such a claim may be made on behalf of all purchasers of an existing nanoconsumer product—such as a cosmetic or sunscreen using nano-titanium dioxide or nano-zinc oxide particles—claiming that the manufacturer failed to label the product as containing nanoparticles, failed to warn about possible adverse latent health risks of nanoparticles, and thus misrepresented the risk of injury from use of the product. Some courts may allow such a claim to proceed if claimants’ attorney is armed with an expert witness and a study or two that suggests an increased risk from exposure to relevant nanoparticles—including those that may be prepared more or less specifically to support litigation. The economic risk to the defendant manufacturer of potentially refunding the purchase price for thousands or tens of thousands of claimants may be unacceptable high, depending on the parameters of the scenario, and a large class settlement may be extracted.

Tactics for Defeating
Early Mass Nanotort Claims

For most nanomaterials, there is not yet a comprehensive understanding of their toxicological properties, how they can enter the human body, how the body might react to them, their interactions with other materials in the environment, or how they might age in the body or in the environment. The sophisticated toxic tort/mass tort bar understands that the current high level of scientific uncertainty about nanoparticle risk makes it near-impossible to meet the burden of proof of causation—general and specific—recognized in both federal and state courts in the context of toxic exposure personal injury and wrongful death claims. The science needed to assess hazards of nanomaterials in the fields of toxicology, epidemiology, and industrial hygiene, let alone meeting the standards for admissibility of such scientific evidence under Daubert, is likely to be many years in the making.

The legal principles and defenses developed in the context of other toxic exposure litigation, e.g., asbestos and benzene, should apply with equal force in the context of nanoparticle exposure claims – requiring product identification, proof of substantial factor in causation, etc. In this regard, nanomaterial detection is a significant practical obstacle to claims. Due to their size and “invisibility” except using sophisticated and expensive microscopy equipment not widely available, the mere detection of nanomaterials remains difficult. Thus, it is unclear how any examining physician could even identify the presence of any nanoparticles, much less then reliably attribute a health problem to a particular nanomaterial.

In many jurisdictions, the absence of an as-yet-undiscovered signature disease connected to nanoparticle exposure means that the substantial factor doctrine will apply, as it does in cases where plaintiff’s injury could have resulted from multiple exposures or underlying conditions. Under the substantial factor test, a “[d]efendant’s conduct in an action for personal injuries is considered a cause of the event if it was a material and substantial factor in bringing it about.” ¹⁷Stahl v. Metro. Dade. Dade Co.,
438 So. 2d 14, 19 (Fla. Dist. Ct. App. 1983) (quoting W. Prosser, Handbook on the Law of Torts at 236 (4th ed. 1971)); see also Lindstrom v. A-C Prods. Liab. Trust, 424 F.3d 488 (6th Cir. 2005); Jarnes v. Kerr Corp., 418 F.3d 583 (6th Cir. 2005); Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp 2d 584 (D.N.J. 2002), aff’d, 68 F. App’x 356 (3d Cir. 2003). The necessity of plaintiff providing admissible (Daubert-proof) expert testimony concerning differential etiology in order to meet the substantial factor requirement is an extremely high hurdle given the relatively nascent state of nanotoxicity science now in 2010 and for the foreseeable future.

Even supposing that a claimant could succeed in proving exposure to a particular type of nanoparticle, and that such exposure was a causative substantial factor in connection with an injury, the problem then is traceability to a specific defendant. Nanoparticle product identification is a major practical obstacle. Current technology does not allow uniquely identifying nanomaterials with reliability. With the number of nanomaterials under research and in production multiplying rapidly each year, it is virtually impossible to trace a particular offending nanomaterial back to its manufacturer. The lack of reliable traceability is normally a significant impediment to tort litigation, although the use of legal concepts like alternative liability and market-share liability will likely be argued in the nanoparticle context when certain nanomaterials are commoditized and the law searches for a basis to attach liability.

In light of the novel nature of the science underlying potential nanotechnology-related claims, and the difficulty of product and defendant identification, there are several powerful weapons that defendants should be developing to use from the outset of any nanoparticle mass tort claims.

Lone Pine Orders.

One approach is the use of a so-called Lone Pine order in jurisdictions where that is viable. The term is derived from Lore v. Lone Pine Corp., ¹⁸1986 N.J. Super. LEXIS 1626 (N.J. Super. Law. Div. Nov. 18, 1986). a toxic exposure case where, shortly after the case was filed, the court required the plaintiffs’ counsel to detail the facts of each plaintiff’s claims, including exposure to alleged toxic substances and reports of treating physicians and medical or other experts supporting causation. The order was designed to require plaintiffs to make an objective showing—early in the litigation—that there was sufficient evidentiary basis to warrant continued litigation. The Lone Pine order has been widely accepted and used in federal and state courts throughout the nation. ¹⁹See DeVries, et al., Use of Lone Pine Orders in Cost Effective Management of Mass Tort and Class Actions, 23 BNA’s Toxics Law Reporter 1003 (Nov. 2008).

`Twiqbal’ Motions to Dismiss.

Defendants in any mass nanotort litigation will also likely pursue so-called Twiqbal motions. ²⁰Applying the pleadings standards articulated by the United States Supreme Court in Ashcroft v. Iqbal, 77 U.S.L.W. 4387 (U.S. 2009), and Bell Atlantic Corp. v. Twombley , 550 U.S. 544, 75 U.S.L.W. 4337 (2007). Under the Iqbal/Twombley plausibility standard, will courts require toxic tort plaintiffs to now plead detailed facts that quantify exposure and dose, thoroughly explain causation mechanics, and identify the epidemiological associations on which that plaintiff bases a claim? In one recent case, the court did rely on the Iqbal/Twombley principles to dismiss a pharmaceutical product liability action. ²¹Frey v. Novartis Pharmecuticals Corp.,
642 F. Supp. 2d 787 (S.D. Ohio 2009). It would seem that federal courts, consistent with Iqbal/Twombley, should require toxic tort plaintiffs to present scientifically plausible bases for their claims at the outset in initial complaints.

Daubert Gatekeeping at Class Certification Stage.

Until recently, many federal judges had held that they must not evaluate the admissibility of scientific evidence in ruling on motions for class certification, because that “gatekeeping” function somehow overlaps with “merits” issues to be decided later in the case by the factfinder. But the tide has turned. The past few years have seen a line of emerging authority clarifying and expanding on the “rigorous analysis” district courts must apply to each class-certification factor under Rule 23. A district court must resolve factual disputes relevant to each class action prong, including those disputes inter-twined with the merits. ²²See, e.g., American Honda Motor Co. v. Allen, 600 F.3d 813 (7th Cir. 2010); Williams v. Mohawk Indus. Inc.,
568 F.3d 1350 (11th Cir. 2009); Vallario v. Vandehey, 554 F.3d 1259 (10th Cir. 2009); In re Hydrogen Peroxide Antitrust Litigation,
552 F.3d 305 (3d Cir. 2009); Miles v. Merrill Lynch & Co. Inc. (In re Initial Pub. Offering Secs. Litig.), 471 F.3d 24 (2d Cir. 2006).

That means a rigorous analysis, at the early class certification stage, of the factual bases of plaintiffs’ nanoparticle exposure claims. And that means a Daubert-style analysis of plaintiffs’ proposed exposure, dose, and causation expert opinions. Indeed, “weighing conflicting expert testimony at the certification stage is not only permissible, it may be integral to the rigorous analysis Rule 23 demands.” ²³In re Hydrogen Peroxide, 552 F.3d at 323.

In the most recent circuit opinion on this issue, American Honda Motor Co. v. Allen,
²⁴600 F.3d 813 (7th Cir. 2010). the Seventh Circuit rejected the notion that federal courts need not be gatekeepers at the class certification stage and held squarely that district courts must fully analyze and rule on the admissibility of expert testimony before certifying a class. There is now a clear and strong trend in the federal courts requiring close scrutiny of expert testimony at the certification stage in federal class actions to make certain that class certification decisions are based only on evidence that is admissible under the Federal Rules of Evidence and Daubert. That should present an almost insurmountable obstacle for any early nanoparticle class action claims, given the dearth of science that plaintiffs would need to meet their difficult burdens.

The federal trend is being followed at the state level, where a number of state courts have also opined during the past two years that rigorous analyses of facts at the class certification stage should include resolution of fact disputes regarding the propriety of certification, including evaluating the weight of expert opinions and resolving relevant expert disputes. ²⁵See, e.g., Whitaker v 3M Co., 764 N.W.2d 631, 638 (Minn. Ct. App. 2009); Jackson v. Unocal Corp., 2009 WL 2182603 (Colo. Ct. App. July 23, 2009); Mattson v. Montana Power Co., 352 Mont. 212 (2009); Cruz v. Unilock Chicago Inc.,
892 N.E.2d 78 (Ill. App. Ct. 2008).

Conclusion

Nanomaterials have special properties and present the promise of untold benefits to mankind, but with resultant risks that are still largely unknown and, in all likelihood, unknowable until time passes and doors unknown in 2010 are opened as part of the ongoing scientific recursion. In the absence of legislative or regulatory action not yet contemplated, the revolutionary changes expected to be brought about by nanotechnology will play out within the established framework of American tort liability law that has accommodated and addressed every emerging technology of the past. Mass tort and class-action toxic exposure lawyers have important roles to play in the realm of nano-risk perception as well as in nanotort litigation; roles that could significantly impact the degree to which the fantastic economic and societal benefits of nanotechnologies are realized.