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Category: Products Liability

The Bigger Picture: Thinking About Technology, Nano and Otherwise

Posted Sep.25, 2011 under Environment, Evidence, Government Agencies, Litigation, Products Liability, Supreme Court, Toxic Torts

usalawyerstoday.com

Wondering where we’ve been for the past month?

My summer was spent thinking and writing about technology – all sorts of technology. It got me thinking about how technology has changed our lives and how it is poised to change all aspects of the law. Let me share with you my summer projects, which go well beyond nanotechnology issues. I hope it will enable me to put the legal issues of nanotechnology in a broader context going forward.

1. Neuroscience and Tort Law. I and my co-author (and co-blogger) Eric Laury embarked upon a project more than a year ago to examine how the so-called “new neuroscience” will impact tort law. By “new neuroscience” we mean mostly functional neuroimaging (fMRI and SPECT), but also any other neuroscientific methods to examine the human brain, including brain wave technology. Our approach to this extensive law review article was both doctrinal (i.e. how the new neuroscience will eventually change the rules of tort doctrine) and practical (i.e. the problems of incorporating it in tort litigation, particularly under the rules of evidence). We spent a lot of time predicting the effect that the new neuroscience will eventually have in the courtroom. Professor Stephen Morse at UPenn Law School has pointed out that much of what we currently know as legal doctrine is based upon “folk psychology” – that is, what we believe causes people to act the way they do. The new neuroscience will eventually change the law by changing our understanding of human behavior.

2. Cell Phones. I also found myself writing a piece on cell phones and product liability. In particular, I looked at whether actions claiming the telecommunications industry should be marketing cell phones with headsets to protect against the hazards of radio frequency (“RF”) emissions should be allowed, or whether they are preempted by regulations granting the FCC the authority to set radiation standards for cell phones. The question, it turns out, it much more complicated than one might think and involves several federal statutes and regulations, including the two major statutes governing the wireless networks in this country. The Supreme Court will consider a petition for certiorari in Farina v. Nokia, 625 F.3d 97 (3d Cir. 2010), early in the new term. Even if cert is not granted, this topic likely will continue to make waves in the courts. My article appears on the BNA subscription service at 39 Prod. Safety & Liab. Rep. (BNA) 871 (Aug. 5, 2011) and 26 Toxics L. Rep. (BNA) 949 (Aug. 10, 2011). It also appears in U.S. Law Week at 80 U.S.L.W. 321 (Sept. 13, 2011).

3. Nanotechnology and the Environment. I also wrote a short article to be published in the “Insight” section of the upcoming Natural Resources & Environment journal, which is the journal of the ABA Environmental Law Section. My goal was to alert attorneys to some of the regulatory initiatives either in the works or in the pipeline. The piece focuses on TSCA, FIFRA, OSHA, and foreign initiatives (EU, Australia). It was interesting to look at the impact of nanomaterials exclusively from the environmental (outdoors and indoors) perspective.

So while I may not have been spending a lot of time blogging about nanotechnology and the law, I was busy getting the bigger picture on technology.

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Thinking Again about Nanoparticles and Asbestos

Posted Mar.29, 2011 under Asbestos, Environment, EPA, Governmental Interaction, Health, Litigation, Nanotubes, Products Liability, Regulation, Research, Safety, Toxic Torts, Workplace

Earlier, I wrote about some potential similarities between asbestos personal injury litigation and the litigation that is certain to come over nanoparticles and human health. I will be writing on and off about this topic going forward as well. I can’t emphasize enough the urgency of avoiding another disaster like asbestos litigation, which has clogged the courts since the 1970s.

For example, engineered nanomaterials are being placed into building materials. In the first instance, these materials are being designed and manufactured in the primary workplace environment, thus potentially exposing workers to hazards about which little or nothing is known. Another set of workers, those using the building materials in the secondary workplace, run the risk of exposure to potentially harmful substances.

The history of asbestos shows that the early studies were conducted on asbestos textile factory workers, but that meaningful studies on workers out in the field who were installing the materials lagged far behind. Then, when the studies began to raise danger signals, the industry ignored those signals until the specter of mass litigation and government regulation forced recognition. By then it was too late.

Nanomaterials present some of the same workplace issues, particularly when used in building materials. The hazards of the primary workplace may be different from those in the secondary workplace. Studies must be conducted on both types of environments.

Further, there is a third concern, which also mirrors the asbestos experience. At some point down the line (years or decades), the anticipated life of the materials will expire, just as asbestos insulation materials have done. At that point, degeneration of the materials could put nanomaterials into the environment to a degree that could endanger the safety of persons in the vicinity.

In the case of nanomaterials, do we know any of this for certain? No. But at the present time we know almost nothing about any of these safety issues. In December, the National Institute for Occupational Safety and Health (NIOSH) proposed a workplace exposure limit for carbon nanotubes and nanofibers. This is a start; but without hard data, it is really only a guess. And it is not necessarily consistent with limits for other substances.

While the industries creating and using nanomaterials will likely take seriously the lessons of asbestos, more should be done up front to ascertain the seriousness and scope of the hazards that the materials may present. Now is the time. If the hazards outrun the studies, the finish line will be litigation.

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Daubertizing Nanolitigation – Part 4

Posted Mar.22, 2011 under Chemicals, Cosmetics, Evidence, Health, Litigation, Pesticides, Products Liability, Research, Safety, Toxic Torts

nano 6 In my previous post, I indicated that I would be moving on to discuss the relevancy arm of the Daubert admissibility test. It turns out I have a few more thoughts about the reliability arm.

What does it mean for admissibility purposes when the expert testimony sought to be introduced in litigation is based on an established methodology used in a new context? This is likely to be an issue when parties seek to introduce studies of the health and safety effects of nanomaterials. Does such a new subject of a study transform an established methodology into a new and untested methodology? If so, the evidence would face a much more rigorous level of scrutiny.

Researchers acknowledge that the state of research on the health and safety aspects of nanomaterials is in its infancy. Some have noted that due to the costs of obtaining necessary quantities of nanomaterials for animal testing, that type of toxicological testing has given way to the use of more efficient in vitro laboratory tests. While both animal testing and in vitro tests have been used to test toxicity for a very long time, their reliability in testing chemicals at the nanoscale has yet to be fully assessed. This could lead to exclusion of the evidence under either the Frye or Daubert analysis, at least until such the use of the studies gains greater reliability. In other words, courts could view this as a new and untested methodology.

A related issue is the value of in vitro tests generally in litigation to show a connection between exposures and injuries. Studies conducted in laboratory containers do not receive high marks from courts generally when introduced to demonstrate causation between an exposure and a person’s injuries. Courts prefer both epidemiological studies – which determine statistical risks in human populations – and animal bioassays over in vitro studies.

All of this adds up to some thorny questions that will have to be resolved.

Daubertizing Nanolitigation – Part 3

Posted Mar.01, 2011 under Chemicals, Cosmetics, Environment, Evidence, Health, Litigation, Pesticides, Products Liability, Research, Safety, Toxic Torts

supct This post continues the discussions in earlier posts about evidentiary standards for admissibility of health and safety studies on nanomaterials under both the Frye standard and the Daubert standard. I will resume the reliability discussion here, this time focusing on the reliability standards applied in the federal courts and other Daubert jurisdictions.

Under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), reliability of expert scientific evidence is determined in relation to four factors. These four “general observations” set forth in the Daubert decision were intended to provide guidance to the trial court making a decision about admissibility of expert scientific evidence. All four need not be favorable to the party seeking admission of the evidence for the evidence to be ruled admissible. The Supreme Court has said that when it comes to scientific studies, evidentiary reliability is the equivalent of scientific validity. What makes a scientific study (and the expert testimony relying on it) valid? The Supreme Court set forth these “general observations”:

(1) Whether the scientific theory or technique on which the evidence is based has been tested (presumably by the scientific method);

(2) Whether the study has been published or has undergone another form of peer review;

(3) The known or potential rate of scientific error associated with the methodology;

(4) Whether the methodology has achieved general acceptance in its field.

Although these factors reduce the weight of general acceptance (the sole Frye criterion) in the admissibility analysis, the reality is that the Daubert test has raised the bar in litigation for plaintiffs seeking to have their scientific proof admitted. These factors are often applied strictly.

Will scientific studies on the health and safety effects of nanomaterials be treated differently under the Daubert reliability analysis than under the Frye general acceptance test? The primary difficulty under Daubert, as under Frye, is the newness of the studies.

Although the Supreme Court in Daubert said that the focus of the reliability analysis should be on the scientific methodology or technique – and not on the conclusions reached – the Court subsequently modified that statement. In General Electric Co. v. Joiner, 522 U.S. 136 (1997), the Supreme Court said that “conclusions and methodology are not entirely separate from one another,” thus inviting the trial court to consider the conclusion and whether it constitutes the kind of novel theory that may not be admissible.

It may be true generally that newer methodologies may not have been sufficiently tested, peer reviewed, or accepted in the relevant scientific community, and that they could have a potentially high (or unknown) rate of error. But one issue that will need to be sorted out in the era of nanostudies will be whether the methodologies for these studies consist of tried-and-true testing methods or, in contrast, will be viewed as novel because of their focus on materials at the nanoscale. This distinction could make a critical difference in whether such studies will be admitted in litigation in a Daubert jurisdiction. Tried-and-true carries more admissibility weight.

Perhaps one way to look at this issue – and one that is relevant to the emerging studies of nanomaterials – is the way that a federal district court analyzed the problem in Smith v. General Electric Co., 2004 WL 870832 (D. Mass. 2004). When confronted with novel and admittedly “controversial” studies, the court concluded that the experts were “serious scientists with controversial views that are in many respects on the periphery of the mainstream, but views that are not so divorced from a scientific method of investigation that they can be dismissed as quackery or armchair conjecture.” While the district court was likely correct in observing that Daubert did not require or perhaps even empower a court to “determine which of several competing scientific theories has the best provenance,” many would reject the flexible view of Daubert applied in Smith.

Reliability is only part of the admissibility analysis for scientific studies articulated by the Supreme Court in Daubert. Relevance of the evidence is equally important, and my next post on the subject will look at the relevance of scientific evidence as it has been explained by the Supreme Court in Daubert and Joiner (mentioned above).

Daubertizing Nanolitigation – Part 2

Posted Feb.01, 2011 under Chemicals, Cosmetics, Environment, Evidence, Health, Litigation, Nanotubes, Pesticides, Products Liability, Research, Safety, Toxic Torts

Lab beaker My previous post began a conversation about applying the evidentiary rules for admissibility of scientific studies and expert testimony to the emerging studies on the health and environmental effects of nanomaterials, all in the context of the toxic tort litigation that is soon to come. This post will continue that conversation by looking at the legal rules to determine the reliability and scientific validity of such studies. In particular, this post will look at the Frye rule and its continuing viability in a significant minority of jurisdictions.

Under the older Frye rule, reliability was determined solely by whether the scientific technique has achieved “general acceptance in the particular field in which it belongs.” Frye v. United States, 293 F. 1013 (D.C. Cir. 1923). States that have adopted and continue to apply the Frye test for admissibility of expert evidence have further clarified and refined the rule. Thus, the Minnesota Supreme Court stated in Goeb v. Tharaldson, 615 N.W.2d 800, 810 (Minn. 2000), that a two-pronged test would apply: “First, [the] technique must be generally accepted in the relevant scientific community, and second, the particular evidence derived from that test must have a foundation that is scientifically reliable.” In Goeb, the plaintiffs alleged that their son had suffered permanent injuries from exposure to a pesticide that had been applied in their residence. The court agreed that the trial court had properly excluded the plaintiffs’ expert scientific evidence of causation because the scientific methodology used was not generally accepted and because the expert’s analysis had no “independent validation.”

The Frye rule has frequently been criticized, however. Thus, the Alaska Supreme Court (in a case adopting the Daubert rule and the federal evidentiary standard), has criticized Frye as incorrectly favoring the conclusions of scientists over courts in matters of a legal nature, arguing that it “ ‘abdicates’ judicial responsibility for determining admissibility to scientists uneducated in the law.” See State v. Coon, 974 P.2d 386, 392, 394-95 (Alaska 1999). The Minnesota Supreme Court countered this argument by stating that “the Frye general acceptance standard ensures that the persons most qualified to assess scientific validity of a technique have the determinative voice.” Goeb, at 813. In Blackwell v. Wyeth, 971 A.2d 235 (Md. 2009), the Maryland Court of Appeals established a compromise rule. In Blackwell, the plaintiffs alleged that their child’s autism was caused by thimerosal in childhood vaccines. The court reaffirmed its adherence to the Frye doctrine, characterizing the doctrine in Maryland as requiring that “[g]enerally accepted methodology . . . must be coupled with generally accepted analysis” by the expert. This approach thus assures that the trial judge has the final word on acceptance of the evidence.

The debate continues, however, over whether the Frye doctrine relies on excessive deference to the scientific community on matters of a legal nature. This disagreement is not likely to be resolved soon and is reflected in the split in the states over the adoption of the Daubert rule, which, in contrast, is heavily dependent on judges to evaluate the scientific evidence.

What will happen to nanotechnology studies in a Frye jurisdiction?

The answer may depend on whether the studies are viewed as new and untested because they involve materials at a scale that has generally not been previously studied for health and environmental impacts. Frye does not favor new technologies. Frye admissibility is premised upon a history of the technologies that has evolved to the point of receiving general acceptance in the particular scientific community.

On the other hand, an argument could be made that such studies are simply versions of well-established and generally accepted scientific studies, whether of an epidemiological nature (statistical studies of human populations) or a toxicological nature (such as studies on mice conducted in a laboratory). It is worth noting, too, that studies of human populations generally take much longer to develop, and nanomaterials measurable in consumer products and the environment are a relatively new occurrence in the scheme of things. Thus, the studies on nanomaterials now emerging are laboratory experiments. See, for example, the studies summarized in Powell & Kanarek, Nanomaterial Health Effects – Part 1: Background and Current Knowledge, 105 Wisc. Med. J. 16 (2006).

In the next post, I will examine the Daubert reliability standard.

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Daubertizing Nanolitigation – Part 1

Posted Jan.26, 2011 under Chemicals, Cosmetics, Drugs, Environment, Evidence, Food, Health, Litigation, Pesticides, Products Liability, Safety, Toxic Torts

usalawyerstoday.com

Many of my posts have talked about the need for studies on the health, safety, and environmental effects of nanomaterials. But it has been a long time since I raised the question of what these studies may mean for toxic tort litigation. As in any litigation, the evidence, including scientific studies and the experts who interpret them, must be admissible under the relevant rules of evidence. In the United States, there are two basic approaches to the admissibility of expert evidence in the courts – (1) the federal courts’ approach, which is governed by the Federal Rules of Evidence and a trio of cases beginning with Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), and (2) the approach known as the Frye test. Regardless of the approach used by the particular court considering the evidence, early studies that may demonstrate health or environmental risks associated with nanomaterials will have an uphill battle for admissibility in the courts.

Over the next month, I intend to discuss some of these issues in a series of posts. This post will consider the first question: What is it about this evidence that will be so difficult for the courts?

To begin with, let’s briefly look at the rules for admissibility of the evidence in court:

1. Frye Test: This test derives from the case of Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), a criminal case that involved a scientific lie-detection technique that was a sort of precursor to the modern lie-detector tests. The court there said that “while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.” Thus, courts view as admissible under this test only expert evidence derived from scientific studies or techniques in general use, and usually long-standing use, in the particular field, and which most experts in the field recognize as being reliable.

2. Daubert Test: The Daubert case itself was a toxic tort, a prescription drug product liability action, so the Supreme Court had before it on the record scientific studies that resemble the kinds of studies of exposure-and-outcome that might be produced for nanomaterials. The Supreme Court held that the test for admissibility of expert evidence under the Federal Rules is broader than the Frye test and requires that the proponent of the evidence demonstrate that it be reliable – i.e. that it be scientifically valid – and that it be relevant to a particular issue in the case, not that it merely be suggestive of health problems. The Court emphasized that the trial judge is the “gatekeeper” who must make a determination at an early time in the litigation as to whether the expert evidence is admissible. If it is not admissible, often plaintiffs’ cases are dismissed prior to trial.

What evidentiary challenges will nanomaterial studies present?

● The studies will provide only probabilistic evidence. This means that the studies will only show statistical associations (probabilities) between exposure to a particular nanosubstance and a particular outcome (e.g. illness). While the extent to which probabilistic evidence differs from traditional forms of proof in tort cases (such as motor vehicle accidents) is a matter of degree, the inability of the studies to confirm the causal relationship between exposure to a substance and the illness the plaintiff suffers will be problematic for plaintiffs’ cases.

● The illnesses are likely to be “generic.” Some substances previously studied are linked to “signature diseases,” which occur very rarely in the general population, but with greater frequency among people exposed to the substance. Silicosis (silica dust), asbestosis (asbestos), and pleural mesothelioma (asbestos) are examples. But most cancers, respiratory conditions, and neurological disorders, for example, are caused by a variety of triggers, some related to exposures, others genetic or idiopathic. It is therefore difficult to differentiate those caused by a particular exposure and those arising for other reasons.

● The nanostudies will be new. Under either admissibility test, new and untested or unreplicated studies may not pass muster. In toxic torts, history has shown that early plaintiffs may have considerable difficulty with the admissibility of their evidence; even if the evidence is ruled admissible, problems of proof arise because juries may not view the early evidence as having much weight. As time goes on, these studies may gain more acceptance in the field – or, they may be proved to be aberrations.

Next up: Admissibility and scientific reliability of nanostudies.

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Will Nanoparticles Be the New Asbestos?

Posted Oct.18, 2010 under Environment, Health, Litigation, Nanobiotechnology, Nanotoxicology, Nanotubes, Products Liability, Research, Safety, Toxic Torts

http://www.techwall.org

The course of asbestos litigation is well known, as is the fact that there appears to be no end in sight. Is nanotechnology producing the next asbestos? Some groups are working to prevent nanoparticle litigation from following in the steps of asbestos litigation.

In 2009, the United Kingdom’s Institute of Occupational Medicine (IOM) issued a report asking the question whether High Aspect Ratio Nanoparticles (HARN) – most notably, carbon nanotubes – create some of the same health risks as asbestos fibers. The fiber-like features of HARN, although man-made rather than naturally occurring, may or may not interact with the human body in asbestos-like ways. The importance of determining whether HARN raise similar health risks cannot be overstated. These issues have yet to be resolved, with potential health risks lurking in the interim. As is often the case, development of new technology has flown past the scientific community’s ability to determine and assess the technology’s risks.

Looking back at the history of asbestos litigation, some burning questions need resolution sooner rather than later. For example:

● Do HARN fibers remain in vivo or do they degrade before disease processes are initiated?

● If HARN are shown to persist in the body, what is the likely impact on workers? In the asbestos context, the impact was seen in thousands of workers who developed debilitating progressive obstructive lung disease and/or malignant mesothelioma. Do HARN have the capacity to produce similar health problems?

● Even if HARN do not appear to behave directly like asbestos fibers, could HARN cause other, unknown, adverse health effects?

● What broader impact might HARN have outside the workplace, including consumer and environmental exposures?

Are we headed down the same litigation road with HARN that we traveled with asbestos?

The asbestos litigation debacle in the United States began modestly enough with workers’ compensation claims, which were first denied and eventually routinely paid. When asbestos insulation workers successfully brought actions against the manufacturers of the products they used in the workplace, the litigation expanded exponentially and has continued to challenge the court systems.

How can we avoid another asbestos? The answer begins with research, knowledge, and awareness.

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A Tale of Two Bills – Nudging Toward Nanoregulation

Posted Jul.27, 2010 under Cosmetics, Environment, Governmental Interaction, Health, Products Liability, Regulation, Research, Safety, Statutes

prod liab image It’s fair to say that the United States has not yet tiptoed into the waters of regulating nanotechnology directly. Rather, new efforts at regulation of chemicals and consumer products tend toward indirect regulation. That is, these efforts would strengthen and expand existing federal regulation. Two examples are recent bills introduced in the House of Representatives that would amend the Toxic Substances Control Act (TSCA) and the Food Drug and Cosmetic Act (FDCA) for substances and products that may or may not contain nanomaterials. As discussed in a previous entry in this blog, placing nanomaterials under the same regulatory standards as non-nano substances is a subject that requires discussion on its own.

Is the current trend toward indirect regulation a good idea? It’s certainly easier and more efficient in the short run to promulgate broad regulations that encompass a variety of substances and uses, and to amend existing statutes. And there is no doubt that these statutes needed updating to reflect scientific advancement and new risks. But there is a danger that regulators – and the public – would be left with the impression that once these statutes have been updated, all substances are sufficiently regulated. With the products of nanotechnology being so diverse, it is likely that many substances would slip through the cracks of the new legislation.

Let’s look at the two recently introduced bills. The Toxic Chemicals Safety Act of 2010 (H.R. 5820) would amend TSCA by requiring the chemical industry to provide EPA with minimum essential data on chemical characteristics, toxicity, exposure, and use, whereupon EPA would undertake an expedited process to reduce exposures to toxic substances in the population. An important feature of the bill provides for public disclosure of non-confidential and otherwise non-exempt information. The text of the bill may be found at

http://energycommerce.house.gov/documents/20100722/HR5820.pdf

The current text of TSCA is at 15 U.S.C. §§ 2601 et seq.

The other recently introduced bill is the Safe Cosmetics Act of 2010 (H.R. 5786), which contains provisions for protecting consumers from carcinogenic and other toxic ingredients in certain previously unregulated household products, such as perfumes, shaving creams, shampoos, and deodorants. Like the proposed TSCA amendment, a major purpose of this bill is to update the existing FDCA and its regulations and to disclose the information regarding hazards to the public, in this case primarily through product labels. Currently, the cosmetics industry is mostly self-regulated, and members of the industry have complained that this new bill lacks appropriate standards and would place an undue burden on the FDA. Instead, the industry has proposed its own new requirements.

H.R. 5786 also references nanoparticles, clearly indicating that nanotechnology was intended to be part of the amendment. For example, Sec. 618(a)(5) requires that cosmetic manufacturers submit various information to the FDA, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.” Sec. 618(e) goes on to authorize the Secretary of Health and Human Services to require that

“(1) minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than 1 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; and

(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.”

The text of this bill may be found at

http://www.govtrack.us/congress/billtext.xpd?bill=h111-5786

Both bills seem to be a step in the right direction. But in the context of nanotechnology, complicated questions persist. For example:

● Would these updated statutes reach the products of nanotechnology as effectively as they would reach substances and products that have no nano-contents?

● Because benign substances may behave differently at the nanolevel, would such regulation miss potential toxic effects?

● What science would be behind the decisions to disclose toxicity?

● Should nanotechnology be regulated separate from chemicals and consumer products?

● Which alternative makes the most sense?

These and others are the questions that Congress and regulators – and all those who may be potentially exposed – need fully discussed in the coming months and years.

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

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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NanoLaw Blog

Category: Products Liability

The Bigger Picture: Thinking About Technology, Nano and Otherwise

Thinking Again about Nanoparticles and Asbestos

Daubertizing Nanolitigation – Part 4

Daubertizing Nanolitigation – Part 3

Daubertizing Nanolitigation – Part 2

Daubertizing Nanolitigation – Part 1

Will Nanoparticles Be the New Asbestos?

A Tale of Two Bills – Nudging Toward Nanoregulation

Recommended Reading: Nano Developments

What Do the Studies Mean?

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