I. INTRODUCTION1
In the United States, chemical risks are reappearing on the public agenda as a significant environmental law and policy challenge. This challenge is ever-increasing as global chemical production is set to expand significantly.2 As scientists research the toxicology and environmental fates of industrial chemicals, new data suggest that humans and wildlife worldwide are exposed to hundreds of chemicals, and that adverse health effects, including increases in adverse reproductive and developmental outcomes, appear to be on the rise across many populations.3 In response to this developing science and accompanying environmental advocacy campaigns, many consumers are becoming more aware of the possible risks embodied in the products they use—ranging from cosmetics to baby bottles, electronics to food packaging— and demanding safer substitutes. State governments are beginning to ban the use of a small set of individual chemicals, most notably phthalates, flame-retardants, and bisphenol-A (BPA), in products intended for use by children.
Since 1976, the Toxic Substances Control Act (TSCA)4 has provided a regulatory framework for governing industrial chemical risks. TSCA divides the universe of over 80,000 chemicals now on the market into existing and new chemicals. Whereas new chemicals (those introduced after 1977) must undergo a process of premanufacture authorization by the U.S. Environmental Protection Agency (EPA), chemicals that existed on the market as of 1977 do not face regulatory scrutiny unless the EPA can demonstrate that they meet threshold triggers for intervention. There is widespread agreement among government, industry, and advocacy group actors that the TSCA is deeply flawed in its structural design, leading to numerous deficiencies in the governance of chemicals and few incentives for industry to adopt green chemistry.5
The EPA has not yet tested the vast majority of existing chemicals for their environmental and human health toxicity. Almost all of the chemicals in highest volumetric production in the U.S. fall into this category, with voluntary industry testing having proven only moderately effective.6 Under the TSCA, chemical manufacturers are not obliged to generate toxicological data for use by the EPA in evaluating chemicals. Even the premanufacture notice process is inadequately implemented, with eighty-five percent of applications missing evaluations of health effects.7 The EPA, in turn, lacks the regulatory power to restrict or ban individual chemicals because the TSCA requires the agency to prove that a chemical presents an unreasonable harm before it can regulate or request that manufacturers produce evidence of safety. As a result, U.S. courts have imposed standards of review that are extremely difficult for the EPA to meet.
The U.S. regulates only five existing substances under the TSCA even though there is growing, if still uncertain, scientific evidence that many chemicals might pose risks to human health and ecosystems. In recent years, there have been intensifying calls for TSCA reforms, with Congress considering several bills such as the Kid-Safe Chemical Act, and the EPA announcing six principles for TSCA reform in September 2009.8 Unfortunately, Congress has yet to enact any TSCA reforms and may not prioritize this issue for some time.
In this context, toxic tort litigation has emerged as a means of controlling chemical risks. Where legislatures and governments are unable or unwilling to reform the regulatory system, plaintiffs may seek to bring tort actions directly against companies producing or using chemicals on the grounds that they are suffering from toxic chemical impacts, or are being exposed to the chemicals through contaminated drinking water, workplace pollution, or consumer products. Tort actions may impel industry to take voluntary steps to redesign chemical molecules or consumer products to be less toxic. These actions may generate new accountability among industry players for their production and use of potentially toxic chemicals. Nonetheless, the prospects of toxic torts serving as a new, nonregulatory influence on industry depend greatly on whether courts are able to apply tort theories to the scientific data used in appraising the health risks of chemicals.
As a rapidly expanding area of scientific research that assesses the presence and concentration of chemicals in humans, biomonitoring has become a critical source of evidence used in this emerging litigation. More specifically, biomonitoring measures the levels of a parent chemical, its metabolite, or its reaction product in human tissues such as blood, urine, breast milk, saliva, or hair.9 Previously restricted to logistically challenging and expensive academic research and industry worker studies, biomonitoring techniques have become less expensive and more widely used over the past decade.10 As a result, biomonitoring science, which measures the presence of chemicals in human tissues, is developing as a new source of technical evidence in toxic tort litigation because it provides a superior method of proving human exposure to industrial chemicals. Before the development of biomonitoring science, courts had to infer whether humans had inhaled or ingested substances in certain proportions from external monitoring data, which was rarely available.
In this article, we investigate the courts’ early responses to biomonitoring evidence, using a case study of perfluorooctanoic acid (PFOA) litigation to evaluate how attorneys are using biomonitoring evidence, how courts are treating such evidence, and to what extent this method of proving chemical exposure advances toxic tort claims.11 We identify a range of challenges involving the use of this evidence, focusing on medical monitoring and product liability claims, and particularly in the context of class action lawsuits centered on these claims. We also point to ways in which judges and attorneys, being relatively unfamiliar with biomonitoring science, may not yet fully acknowledge or adequately employ biomonitoring evidence in their decisionmaking and arguments. Finally, we propose changes to the toxic tort framework and make recommendations for legal strategies to increase the likelihood of recovering damages for chemical exposure victims, thus enhancing the potential of toxic tort claims to function alongside regulation as a mechanism for oversight of chemical risks.
II. HUMAN BIOMONITORING AND THE LAW
Humans unknowingly encounter chemicals from many sources, including consumer products, food, and drinking water. After entering the body, some chemicals are quickly excreted, while others can remain in tissue for far longer.12 Biomonitoring studies have confirmed human exposure to a plethora of potentially hazardous chemicals. Unfortunately, the health effects of these exposures are typically unknown or uncertain because little toxicological testing is done for most chemicals that are currently registered for commercial use.13
The Centers for Disease Control and Prevention (CDC)14 was the first entity in the U.S. to undertake a comprehensive and ongoing biomonitoring program. It began systematically tracking personal exposure levels in a representative sample of the U.S. population in 1999 and now issues reports on this project biannually.15 These reports detail the amount of up to 212 chemicals measured in blood and urine collected from about 2500 study participants.16 In addition to making the data available to the scientific community for further analysis, the CDC encouraged states to develop their own biomonitoring programs.17 In 2006, California became the first state to introduce its biomonitoring program, which is now taking form.18 Environmental advocacy groups also collect biomonitoring data, though their projects tend to be much smaller in size due to funding, laboratory, and logistical limitations.19
Biomonitoring results, such as lead levels in blood, have measured the effectiveness of actions aimed at reducing exposures20 and have generated media attention that stimulates policy change or forces an industry response. In 2000, for example, 3M Corporation announced its plans to discontinue production of PFOA, a chemical used in its Scotchgard product, after biomonitoring data of employees, the general population, and wildlife demonstrated widespread exposure to PFOA and led to health concerns.21 In 2003, California banned two types of polybrominated diphenyl ethers (PBDEs), which were widely used as flame-retardants in electronics and furniture, after biomonitoring studies revealed their presence in the general population in alarming concentrations.22
More recently, some baby bottle manufacturers eliminated BPA23 from their product lines in response to consumer concern stemming from biomonitoring and health studies.24 A bill banning BPA from plastic baby bottles passed in the California state legislature in 2011.25 Other states, such as Connecticut, Maryland, Minnesota, Vermont, and Wisconsin, have limited the use of BPA in consumer products.26 At the federal level, biomonitoring is influencing proposals to reform the TSCA.27 Biomonitoring data thus has the potential to help transform chemical policies in the U.S. by providing novel scientific evidence of widespread exposure.
Nonetheless, the meaning and significance of biomonitoring data are widely disputed. Industry groups contend that the presence of chemicals in the human body should not be interpreted as a hazard without quantifying the risk of disease.28 Conversely, environmental advocacy groups increasingly consider exposure a hazard in its own right.29 They argue for implementation of the precautionary principle, and thereby advocate reducing chemical exposures before the adverse health effects of such exposures are definitively determined. In support of their position, environmental advocates point out that the health effects of chemical exposures can be prohibitively difficult to establish, and that people are left as the unwitting victims of industrial pollution when such determinations are not made in short time.30 Despite its controversial nature, litigants have begun to use biomonitoring data as evidence to prove exposure in toxic tort claims, where the same debate occurs.
At present, there is no cause of action acknowledging chemical exposure, standing alone, as a legal injury.31 Therefore, plaintiffs armed with biomonitoring evidence have resorted to several tort claims, including product liability, negligence, nuisance, trespass, and battery, as well as the less prevalent common law claim of medical monitoring. In a series of lawsuits stemming from PFOA exposure, plaintiffs at first actively pursued only medical monitoring claims.32 Medical monitoring is a contentious tort theory under which a plaintiff who has been exposed to a hazardous substance seeks to recover the costs of future medical monitoring to detect the onset of disease resulting from that exposure.33 The remedy for a successful medical monitoring claim funds a medical monitoring program which may encompass biomonitoring, medical testing, and epidemiological studies on the plaintiff population to determine the health risks of a particular chemical exposure.34 Plaintiffs theoretically can use biomonitoring evidence to establish the first element of a medical monitoring claim: exposure to a hazardous substance.
III. USES AND LIMITATIONS OF BIOMONITORING EVIDENCE
Biomonitoring has proven to be an invaluable tool for public health and environmental policymakers. In the legal realm, biomonitoring data holds particular relevance to toxic torts, which generally involve personal injury claims where the injury stems from exposure to a toxic substance.35 Prior to the advent of biomonitoring, plaintiffs faced significant obstacles in proving human chemical exposures: they had to rely on data from monitoring of the air, water, food, or land to show that chemicals were present at the time of the alleged exposure, but the availability of these data was limited because most chemicals went unmonitored.36 Even if data existed, courts were then left to infer whether plaintiffs ingested, inhaled, or absorbed the chemicals and at what levels. Now, as detection techniques improve, biomonitoring provides empirical proof of exposure to an increasing number of chemicals and helps to establish the magnitude of that exposure.
Biomonitoring can be useful to plaintiffs in class action lawsuits as well as to plaintiffs pursuing claims individually. In the class action context, studies can demonstrate that a specific population has experienced heightened exposure relative to the general population.37 Examples here include towns supplied with contaminated drinking water, employees exposed to toxins in the workplace, and residents living close to polluting factories and hazardous waste dumps. Individual plaintiffs also can obtain personalized biomonitoring data that show heightened exposure relative to the general population.38
Despite its advantages, there are many technical limitations to demonstrating exposure through biomonitoring data.39 For example, some chemicals travel to different sites within the human body or may be predominantly found in only one type of sample (such as blood). In this case, a failure to sample appropriately may lead to missed exposure detections or inaccurate measurements. Also, humans metabolize different chemicals at varying rates: individual chemicals can break down more or less quickly into metabolites that may not be identifiable by existing analytical methods.40 BPA, for instance, quickly breaks down into metabolites that are excreted in urine—if sampling does not occur within a short time period following exposure, the BPA will not be detected accurately.41 Equally important, biomonitoring depends on the existence of scientifically validated biomarkers (signals of chemical presence, cellular effects, or both), yet the vast majority of harmful chemicals lack biomarkers.42 Thus, biomonitoring does not fully capture all the chemicals to which plaintiffs have been exposed.
Toxic tort plaintiffs face significant obstacles beyond proving exposure. Emission sources and other causes of exposure can be difficult to establish in toxic tort lawsuits, particularly for ubiquitous contaminants.43 Lack of evidence as to when and how the exposure occurred can make it difficult to determine who should be held liable, especially where the toxic substance is manufactured by many companies or is present in multiple products and media (such as air, food, and water) to which plaintiffs are exposed. Biomonitoring usually cannot indicate the sources or pathways of exposure, such as a particular company making a chemical, or a specific factory site. Plaintiffs therefore may need to gather additional information—such as histories of product use, employment, residence, and exposures to environmental chemicals—to build a full picture of the disputed exposure and its source.
If no health impact has materialized as a result of the chemical exposure, a limited number of jurisdictions allow plaintiffs to prove an injury by linking the exposure to an increased risk of disease (as in the tort of medical monitoring, discussed in detail below).44 The level of exposure that warrants health concerns is difficult to pinpoint because, as the CDC and other researchers have indicated, many contaminants are now so ubiquitous that nearly every American has some level of these chemicals present in his body.45 Additionally, chemicals can interact additively or synergistically, thereby requiring that exposure be analyzed in the aggregate, which is a tremendously difficult task.
There remains much discussion among scientists regarding how to define exposure levels that allow meaningful comparisons. One approach entails developing reference bands based on quantile distributions of chemical exposures in a representative sample. For example, the CDC uses geometric means and percentiles to identify where specific test results lie on a population distribution spread.46 As another approach, industry promotes the use of “biomonitoring equivalents” as potential regulatory benchmarks to which exposure levels can be compared.47 Unfortunately, very few chemicals have this kind of benchmark information and these approaches involve a significant degree of uncertainty regarding mechanistic pathways and mode of action in terms of potential toxic effects.48
Indeed, biomonitoring is a dynamic science. Techniques, biomarkers, analytical thresholds, interpretations, and reference levels are continually evolving to provide new insight into chemical exposures. Moreover, as toxicological, epidemiological, and other scientific studies of chemicals progress, risk evaluations of these chemicals can undergo marked change. Even within the last decade, biomonitoring science has led to discoveries of new ubiquitous contaminants. For example, phthalates were commonly thought to be fairly unimportant until CDC data showed widespread exposure and surprisingly high levels in young children. Further research pointed to a new set of exposure pathways that disproportionately affect young children, namely household dust and personal care products that they ingest.49 In Germany, which has a much longer history than the United States of conducting population-level surveys, the Biomonitoring Commission periodically updates reference levels, thereby changing the understandings of what exposure levels constitute critical health thresholds.50 Also, chemicals such as BPA are subject to rapidly changing evaluations of their risk status through emerging toxicological and exposure data, as well as regulatory risk assessments.51
Although courts are uniquely positioned to recognize value in new scientific evidence, they tend to deal poorly with the dynamic nature of biomonitoring science by demanding relatively high levels of certainty for proving causation and injury, thereby discouraging formal recognition of important new science. For instance, judges might hesitate to base rulings on limited evaluations of biomonitoring data and health risks that could turn out to be inaccurate at a later date.52 This is problematic because, while plaintiffs may be able to file new claims in the future, precedents might prevent them from doing so, and in the meantime they experience losses that are not redressed fairly.
Clearly, there are challenges in formulating legal arguments around the health effects of chemical exposures found through biomonitoring, as highlighted by the PFOA litigation discussed below. Plaintiffs often are unlikely to satisfy the burden of proving adverse health effects because toxicological data and epidemiological studies simply do not exist for many chemicals, and the research necessary to show that a chemical is toxic is prohibitively expensive and time-consuming to conduct as part of a lawsuit.53 Chemical exposure victims might obtain valuable human and toxicological data with the court-ordered funding that the medical monitoring remedy provides. Although biomonitoring has its limitations, it nonetheless helps toxic tort plaintiffs satisfy a significant evidentiary burden: proof of exposure.
IV. PROCEDURAL ISSUES WITH BIOMONITORING EVIDENCE
A. Use at the Class Certification Stage
Under traditional tort law principles, a plaintiff’s remedy is measured by the harm already suffered and does not account for prospective harms. Thus, in the absence of a manifest disease, toxic tort remedies are limited to the expenses associated with measures that a reasonable exposure victim would take—such as compensation to pay for medical testing to detect the onset of a disease known to result from the exposure. Because the toxicity of most chemicals is uncertain, chemical exposure plaintiffs are likely to recover only relatively low levels of compensation, if any. Thus, in toxic tort cases, when possible, plaintiffs often attempt to obtain class certification because the damages available to a limited number of plaintiffs are insufficient to cover the expense of litigation, whereas the damages available to a larger number of plaintiffs make the undertaking financially viable. The need to offset small remedies with large plaintiff groups is especially great where litigation costs are heightened by the expense of gathering biomonitoring data or proving the existence of an increased risk of disease through toxicological, biomonitoring, and epidemiological studies.
The importance of class action status for toxic tort lawsuits cannot be overstated because it entails significant benefits for plaintiffs. They are able to pool scarce resources and impose collective pressure on powerful corporate defendants to settle, where even a small probability of a large judgment can be an unacceptable risk. Additionally, the class amounts to a de facto population group that is more easily compared to another population to demonstrate significant exposure levels. Furthermore, under a legal framework that discourages recognition of prospective injuries, individual plaintiffs are disadvantaged in toxic exposure cases for two reasons. First, there can be a low probability that an individual will develop disease as a result of chemical exposure. Secondly, unless the chemical has a rare signature disease (such as asbestos and mesothelioma), it is difficult to know whether the disease outcome is actually linked to the exposure in question. This situation makes it difficult to define equitable relief for the individual plaintiff. On the other hand, having a class of plaintiffs makes prospective development of disease much less uncertain: if the class is sufficiently large, it is statistically likely that some number of plaintiffs will develop disease as a result of chemical exposure. In this case, a court can allow equitable relief through a court-administered fund created to benefit many individuals. This can undermine claims that plaintiffs are committing tort abuse by bringing lawsuits that consume court time and resources unjustifiably. The fund can efficiently oversee the review of requests for relief by a large number of plaintiffs.
Under federal law, class certification is a process set forth by Rule 23 of the Federal Rules of Civil Procedure. The prerequisites for class action status require that the proposed class of plaintiffs be so large that joinder of all members is impracticable, that there are questions of law or fact common to the proposed class, that the claims of the representative parties are typical of the claims of the remainder of the class, and that the representative parties will fairly and adequately protect the interests of the class.54 If these four requirements are met, then a court may grant the class action if the case falls into one of three categories. First, the case may qualify as a class action if prosecuting the separate actions of class members would create a risk of inconsistent adjudications or adjudications that would be dispositive of the interests of other members who are not a party to the adjudication or would substantially impair or impede their ability to protect their interests.55 Second, class action status may be warranted if injunctive relief respecting the class as a whole is needed because the party opposing the class has refused to act on grounds that apply generally to the class.56 Finally, class actions are appropriate where common questions of law or fact predominate over questions affecting individual class members.57
In federal court, plaintiffs have failed in their attempts for class certification specifically with respect to the biomonitoring evidence presented.58 The plaintiffs here generally acknowledged variations of exposure among members of the class, but argued that these variations should not prohibit class certification because scientific sampling methods can accurately assess the characteristics of a class while accommodating inherent variations.59 For example, if a properly representative group of one hundred class members can demonstrate a heightened level of chemical exposure, plaintiffs would argue that this sample is sufficient to show significant exposure across a class of thousands. In response, defendants have argued that biomonitoring data need to be fully individualized and cannot rely on assumptions based on population sampling because a specific injury must be shown for each plaintiff.60 Notably here, the plaintiffs’ views on the validity of sampling methodologies are well supported in science and often used in biomedical research, including the epidemiology that supports the connection between tobacco use and increased cancer risks. As one example, the CDC uses sampling to represent exposure levels for the entire U.S. population in its nationwide biomonitoring survey.61
B. Admissibility Under Daubert
A party presenting biomonitoring evidence may employ expert witnesses to explain how the data were collected and what the scientific implications are. If the opposing party challenges the expert’s testimony, the court is obliged to determine whether this testimony should be allowed at trial. The Daubert standard is a rule of evidence that requires trial judges to ensure expert witness testimony is both relevant and reliable.62 In doing so, the judge must assess whether the reasoning or methodology underlying the testimony is scientifically valid and whether that reasoning or methodology properly can be applied to the facts of the case.63
A judge’s evaluation of expert testimony under Daubert may occur at the class certification stage. For example, in Rhodes v. E.I. DuPont de Nemours & Co., a PFOA case discussed in greater detail below, the U.S. District Court for the Southern District of West Virginia found that Daubert principles apply at the class certification stage.64 Here, the court expressed its concern regarding potential tort abuse:
Given the high percentage of class actions which settle as a result of class certification, failure to conduct a Daubert analysis might invite plaintiffs to seek class status for settlement purposes, and essentially amounts to a “delegation of judicial power to the plaintiffs, who can obtain class certification just by hiring a competent expert.”65
Courts have not made an explicit reference to the status of biomonitoring as a scientific practice. While biomonitoring evidence is mentioned in all of the PFOA decisions, no court has questioned whether the data presented are accurate. This is likely the result of courts accepting the facts as pled in accordance with class certification procedure, but it also might suggest that judges are viewing the science as sufficiently well-established and trustworthy that they could not take issue with it under Daubert.66 Yet, as will be discussed below, the courts have not responded to biomonitoring evidence by lowering tort evidentiary standards and have remained generally unsympathetic to the argument that chemical exposures should lead to recovery without further scientific evidence (especially as to health effects) beyond proving the exposure. One area in which these judicial attitudes have been apparent is in PFOA litigation.
V. HISTORY OF PFOA LITIGATION
In a number of lawsuits brought against DuPont, plaintiffs have presented biomonitoring evidence in support of their claims stemming from PFOA-contaminated water.67 DuPont’s legal troubles began when a family neighboring DuPont’s Washington Works plant in Wood County, West Virginia observed their cattle herd suffering from an unknown wasting disease.68 After concluding the cattle’s ill health was due to substances originating from the neighboring chemical plant, the family filed suit against DuPont in 1999 in the U.S. District Court for the Southern District of West Virginia.69 In the summer of 2000, they obtained through discovery internal documents specifically referencing PFOA water contamination that DuPont had not disclosed to the public.70 The parties settled the case under confidential circumstances with no admissions of liability by DuPont.71 Testing confirmed PFOA in the local drinking water supply, which led to several class action lawsuits against DuPont.
At the outset of the series of PFOA lawsuits, plaintiffs found success in West Virginia state courts. The residents neighboring the Washington Works plant filed a class action lawsuit against DuPont in 2001 in the Kanawha County (later removed to Wood County) Circuit Court of West Virginia,72 asserting, among other claims, a medical monitoring claim alleging PFOA exposure through contamination of the community’s water supply.73 DuPont settled this lawsuit in 2004 for $107 million after the court certified the suit as a class action in 2002.74 DuPont appears to have agreed to this settlement because it was uncertain about its prospects in the state court and because it faced adverse publicity. Moreover, the West Virginia state court was not only in the minority of jurisdictions allowing medical monitoring lawsuits but was also known for being a plaintiff-friendly forum.
Under the settlement, funds were used to install water filters and to create an unprecedented community health study called the “C-8 Health Project”75 to collect data for use in evaluating the health effects of PFOA exposure through the participation of over 70,000 class members in the Ohio and West Virginia counties neighboring the Washington Works plant.76 Pursuant to the settlement, if a panel of jointly selected scientific experts finds any probable link(s) between PFOA exposure and disease, DuPont is then required to pay up to an additional $235 million for the administration of a medical monitoring program addressing any such link(s). In December 2011, the Panel found its first “probable link” between PFOA exposure and disease (a probable link was found with preeclampsia/pregnancy-induced hypertension), and is scheduled to release the rest of its probable link findings by the end of July 2012.77
DuPont’s PFOA troubles continued in 2005 when a University of Pennsylvania researcher presented biomonitoring evidence to residents of Little Hocking, West Virginia—another community neighboring the Washington Works plant—which showed community levels sixty to seventy-five times that of the general U.S. population.78 In response, DuPont initiated a program to supply residents of Little Hocking with bottled water.79
DuPont refused to settle future PFOA lawsuits in state court and successfully removed the cases to federal court as was newly allowed under the Class Action Fairness Act. The federal courts denied class certification of the PFOA plaintiffs’ claims for medical monitoring in three cases closely paralleling the initial case that resulted in the C-8 Health Project.80 The trend towards denying class certification for medical monitoring created an important barrier to PFOA litigation since these types of cases are financially unviable without a large number of plaintiffs.81 After failing to achieve class certification on medical monitoring claims, plaintiffs in the PFOA cases shifted their focus to property-related torts and citizen suits based on pollution standard violations.82 In parallel litigation, plaintiffs suing 3M, also alleging PFOA pollution, suffered similar fates on their personal injury claims and then resorted to property claims, including trespass83 and property damage.84
The shift in the courts’ acceptance of PFOA medical monitoring class action lawsuits is likely due to a number of factors. First, once one court denied a request for class certification, other courts might have been more resistant to certify a class on similar grounds. This effect may be more likely for jurisdictions criticized for being overly sympathetic to plaintiffs, as was the case here.85 Second, with judges taking a more skeptical approach to the claims and to requests for class certification, attorneys struggled to prove the elements of the medical monitoring claim at the class certification stage with the limited biomonitoring and toxicology data then available to them. Third, defendant companies became reluctant to settle claims after it became clear that the earlier settlement by DuPont had led to an onslaught of lawsuits that threatened their business. DuPont and 3M were further encouraged to take an aggressive litigation defense strategy by the trend against class certification for medical monitoring claims.
As the manufacturer of Teflon, a popular cookware product, DuPont has also been the subject of product liability litigation. Beginning in the mid-2000s, plaintiffs filed lawsuits against DuPont in over twenty federal court jurisdictions, claiming that the company failed to warn consumers of the risks posed by PFOA exposure from Teflon cookware usage.86 The Judicial Panel on Multidistrict Litigation ordered that the cases be consolidated in the U.S. District Court for the Southern District of Iowa, where the court denied class certification in 2008 because the plaintiffs failed to prove typicality among the class, among other reasons.87 Individual plaintiffs likely will not pursue their claims further because the potential recovery is too small to cover litigation costs.88
Despite the ongoing legal challenges, DuPont is committed to continuing its PFOA production.89 The chemical remains widely used in the U. S.
VI. PFOA LITIGATION: MEDICAL MONITORING CASE STUDY
A. The Concerns of PFOA Exposure
Also known as “C-8,” PFOA is an intermediate chemical used in the manufacture of nonstick cookware and water-resistant clothing, among other products.90 Industry denies that PFOA is released from consumer products, but this assertion is questionable since PFOA is found in the general population on a pervasive scale.91 Some scientists believe that this widespread exposure occurs through the use of consumer products such as Teflon in cookware, stain resistant fabrics in clothing, and food packaging products.92 In the past decade, toxicologists and environmental NGOs (most notably the Environmental Working Group) have alleged that heating nonstick cookware beyond a certain temperature results in PFOA emissions that harm pets and possibly humans.93 These groups also theorize that PFOA may leach into food through the use of nonstick cookware.94 Although the human health effects of PFOA exposure are uncertain, there is cause for concern: one recent animal toxicity study found that “[PFOA] can cause several types of tumors and neonatal death and may have toxic effects on the immune, liver, and endocrine systems.”95
B. The Medical Monitoring Cause of Action
In the PFOA water contamination lawsuits, plaintiffs first pursued only medical monitoring claims while opting not to pursue other tort claims such as negligence, trespass, and nuisance. Attorneys made this choice because the medical monitoring tort offered the best chance of recovery for prospective harms resulting from chemical exposure.
In the mid-1980s, a number of state courts began allowing cost recovery for future medical surveillance.96 The earliest cases involved “classic examples of traumatic impacts and physical injuries,” but the theory expanded to allow recovery in the absence of manifest physical injury.97 For example, in Ayers v. Township of Jackson, decided in 1987, the New Jersey Supreme Court held that a group of plaintiffs who were exposed to contaminated drinking water could recover reasonably necessary medical surveillance costs from their municipality, even though none of the plaintiffs had developed symptoms of exposure-related disease.98 This theory became known as the medical monitoring tort, where the remedy is a fund from which plaintiffs can draw to pay for preventative medical care. The goal of this remedy is to detect resulting diseases in their earliest stages, thereby minimizing the health effects of toxic exposures through timely treatment. The Supreme Court of Appeals of West Virginia, in support of its recognition of medical monitoring claims, reasoned that “[a]lthough the physical manifestation of an injury may not appear for years, the reality is that many of those exposed have suffered some legal detriment; the exposure itself and the concomitant need for medical testing constitute the injury.”99 Thus, through the medical monitoring tort, some courts have been willing to expand the legal definition of “injury” to include a prospective risk of disease.100
The medical monitoring tort generally consists of four elements: (1) the plaintiff has been significantly exposed to a hazardous substance; (2) as a result of this exposure, the plaintiff has suffered an increased risk of developing a serious latent disease; (3) this increased risk makes it reasonably necessary for the plaintiff to undergo periodic diagnostic medical examinations different from what would be prescribed in the absence of the exposure; and (4) monitoring methods exist that make the early detection of a disease possible.101 The requirements of a medical monitoring claim vary somewhat among the state courts that allow such claims. For example, West Virginia is the only jurisdiction that does not require the fourth element,102 whereas Florida, Pennsylvania, and Utah additionally require the defendant’s acts be negligent.103
The medical monitoring tort is controversial because it contradicts the traditional tort principle of allowing recovery only for manifest harms. The courts rejecting medical monitoring claims conclude that chemical exposure itself is not a legal injury because the development of disease remains speculative.104 Even in jurisdictions that do recognize medical monitoring claims, the outcome of these lawsuits is highly dependent on the availability of scientific evidence on the chemical’s toxicity. For example, if a chemical exposure is widely known to cause specific signature diseases, such as with lead, mercury, and asbestos, then the development of disease is hardly speculative. However, for most industrial chemicals, including PFOA, the corresponding data on toxicology, biological mechanisms of harm, and health effects are lacking under the existing regulatory system.105 Therefore, under a narrow interpretation of what constitutes a legal injury, medical monitoring claims relating to these chemicals struggle to be accepted. This is problematic because most potential medical monitoring claims are contingent on an evolving knowledge of chemical toxicity. By imposing such high standards for proving harm, courts resist remedies that allow for monitoring, early disease detection, and precautionary action in circumstances where the science may later establish solid links between exposure and harm.
Those opposing the medical monitoring tort as a stand-alone lawsuit note the probability that a successful plaintiff will undergo years of preventative testing without ever developing a disease related to her exposure.106 Some interpret this as a windfall for the plaintiff and an abuse of the tort system because industry is forced to compensate for greater harm than it actually imposed.107 This view neglects the possibility that the plaintiff might suffer years of fear and stress before learning her fate. Most of the jurisdictions that take a position on this issue require plaintiffs alleging chemical exposure to have a manifest physical injury such as disease.108 In these jurisdictions, plaintiffs must wait until a physical impact materializes and then connect the physical harm to a chemical exposure either by identifying a specific mechanism through which the chemical affects the human body or by finding epidemiological evidence linking that physical harm to the chemical. This presents a legal conundrum: because health effects for chronic diseases (such as cancer) typically have a long latency period, the statute of limitations may run out, proof of causation may disappear, or a defendant company may dissolve before a disease develops and legal action becomes viable.
Federal law does not currently recognize medical monitoring claims. In 1997, the Supreme Court, in Metro-North Commuter Railroad Co. v. Buckley, rejected a lump-sum recovery under the medical monitoring theory.109 In this case, a former railroad employee exposed to asbestos on the job sought damages for emotional distress and future medical monitoring costs.110 Regarding the request for medical monitoring, a seven-Justice majority—in an opinion by Justice Breyer—rejected the tort for four reasons.111
First, the Court determined that the plaintiff was requesting a traditional tort recovery in the form of lump sum damages, and then dismissed this request in the absence of a manifest physical injury.112 The Supreme Court did not comment directly on whether a more limited form of recovery would be acceptable.113 For example, a court-administered fund such as that of the C-8 Health Project is a nontraditional form of tort recovery that prevents a windfall for the plaintiff, but provides a means for the court to allow superintended recovery for chemical exposure victims.
Second, the Supreme Court expressed concern that the judicial system would struggle to identify medical monitoring costs associated with an increased risk of disease caused by exposure.114 However, a court could summon, as independent experts to advise it, scientists and doctors familiar with toxicology, public health, and epidemiology to provide reasonable monitoring methods and cost estimates. The C-8 Health Project undermines the Court’s conclusion, because this project is successfully using the funding to study the toxic effects of PFOA and to communicate any findings to those affected.
Third, the Supreme Court predicted that allowing medical monitoring claims would result in a flood of litigation based on chemical exposures that would lead to inconsistent outcomes.115 However, this concern is probably overstated: even if the standards for proving significant exposure and an increased risk of disease are lessened, there are still only a limited number of chemicals that would support a successful medical monitoring claim, given the high costs of obtaining minimal toxicological and biomonitoring data, and considering the technical constraints of biomonitoring science. Additionally, it ignores medical monitoring litigation’s value as a necessary means of properly holding industry accountable for the safety of its products and minimizing unintended human exposures.
Finally, the Court expressed a concern that court-awarded damages would pay for medical monitoring that “employers or other sources” would otherwise provide.116 This contention is problematic in reality because government-run worker compensation schemes do not pay out until some harm is proven, health insurance typically does not provide for the targeted medical monitoring that a medical monitoring remedy would provide, and industry contributes only minimal efforts in determining the health effects of chemical exposure, meaning that employers are unlikely to take on their own medical monitoring efforts.
The dissenting opinion in Metro-North, written by Justice Ginsburg and joined by Justice Stevens, focused on the public policies favoring medical monitoring. The dissent highlighted a problem with the majority’s reasoning, noting that medical monitoring claims “acknowledge that, in a toxic age, significant harm can be done to an individual by a tortfeasor, notwithstanding latent manifestation of that harm.”117 The dissent further reasoned that “[allowing plaintiffs to recover the cost of this care deters irresponsible discharge of toxic chemicals by defendants and encourages plaintiffs to detect and treat their injuries as soon as possible[, which] are conventional goals of the tort system.”118
Importantly, the Metro-North opinion was issued prior to the rapid growth in biomonitoring studies. Biomonitoring now provides potential plaintiffs with convincing proof that they have suffered exposure to a hazardous chemical, satisfying the first element of a medical monitoring claim. Biomonitoring has also increased the evidential power of toxicology and epidemiology, making it possible to determine the potential health risks of some chemical exposures by combining tissue tests with empirical evidence on toxicity and population effects. Even though biomonitoring has strengthened the case for the medical monitoring tort, and even though Metro-North does not disallow medical monitoring claims as state courts have formulated them, the Metro-North opinion has discouraged the majority of state and federal courts from allowing medical monitoring claims. Thus, plaintiffs may successfully assert medical monitoring claims only in a minority of receptive state courts.119
The proliferation of biomonitoring studies has prompted claims for medical monitoring from people who have acquired proof of their chemical exposure. However, plaintiffs using biomonitoring evidence have fallen short of recovery under the current medical monitoring framework. In the next Section, we highlight the unduly high burdens facing chemical exposure plaintiffs, which render the medical monitoring remedy unattainable in all but the most exceptional cases.
C. Use of Biomonitoring Evidence in Proving the Elements of a Medical Monitoring Cause of Action
The first element of a medical monitoring claim is that the plaintiff suffered significant exposure to a hazardous substance. Some courts define a “significant” exposure as anything higher than the exposure suffered by the general population, which serves as an influential benchmark.120 Adhering to this standard, courts consider regulatory thresholds (such as limits for PFOA in drinking water) irrelevant to identifying a significant exposure because they “provide no comparison between the exposure of the proposed class and the general population.”121 Therefore, a court would more likely accept, as a benchmark from which to determine significant exposure, evidence of a regulatory threshold based on the general population’s exposure rather than on an estimation of a “safe” or “de minimis risk” level of exposure.
In practice, it can be very difficult for plaintiffs to establish significant exposure on a class-wide basis, even with biomonitoring data. For example, in Rhodes v. E.I. DuPont de Nemours & Co., the plaintiff group consisted of customers served by a local water district,122 but due to lawsuit budget constraints only the six named plaintiffs were able to submit biomonitoring evidence in the form of individual tests showing elevated PFOA concentrations in their blood.123 The named plaintiffs also referred to PFOA data in a nationwide biomonitoring survey representing the U.S. population to show their exposure was markedly higher.124 The District Court for the Southern District of West Virginia found this evidence to demonstrate significant exposure, but only for the six plaintiffs that provided biomonitoring evidence.125 The court considered the evidence insufficient to meet the significant exposure standard for the larger class of plaintiffs because the plaintiffs failed to “establish a relationship between the class’s common characteristic (that is, a common source of drinking water) and the [PFOA] levels in the named plaintiffs’ blood.”126 It therefore held that to prove significant exposure across the class, the plaintiffs must establish a connection between the contaminated water source and higher than normal levels of PFOA in the class’s blood, where normalcy is defined by the general population’s PFOA levels.127
The standard set by this court may be unachievable, which would make the decision a significant victory for the chemical industry. It is unclear that any amount of biomonitoring data short of testing all plaintiffs individually would satisfy the court’s test. This is problematic because of the expense associated with individual testing. The value of the pro rata remedy from a medical monitoring claim would likely not exceed the costs of individual testing. The only way to make a medical monitoring claim based on biomonitoring evidence economically viable is to allow class certification based on testing of a representative group of class members.
In addition to limited biomonitoring data, the Rhodes plaintiffs presented a risk assessment to prove significant exposure.128 The EPA and state environmental agencies regularly employ risk assessment methodologies in setting regulatory standards. This form of regulatory science includes four elements: hazard identification, dose-response assessment, exposure assessment, and risk characterization.129 Risk assessment uses scientific data and, where necessary, applies scientific policy assumptions to address uncertainties regarding population susceptibility, high to low dose extrapolation, extrapolation from animal to human toxicity mechanisms, and application of safety factors in reaching conclusions on health risks.130
Two expert witnesses testified on this subject: Dr. Barry Levy, an Occupational and Environmental Health physician and epidemiologist, and Dr. David G. Gray, an expert toxicologist with extensive experience conducting risk assessments.131 Dr. Levy testified that he “conducted an epidemiological survey of available studies and literature concerning the human health effects of C-8” and found that the chemical caused an increased risk of liver damage, abnormal cholesterol levels, coronary artery disease, cerebrovascular disease, diabetes melitus, nonmalignant thyroid disorders, bladder cancer, and prostate cancer.132 Dr. Gray testified that a risk assessment showed that “exposure to .02 ppb of C-8 in drinking water would be significant after one year because health ‘effects would be observable at that time through clinical tests.’”133 The court found that this testimony134 did not “provide a relevant comparison between the plaintiffs’ exposure and the exposure of the general population.” 135
In a case largely similar to Rhodes, Rowe v. E.I. DuPont de Nemours & Co., the plaintiff class was again defined by a shared water supply.136 Here, the plaintiffs similarly were unable to submit sufficient evidence connecting the water source to a common level of heightened exposure across the proposed class.137 The plaintiffs employed the same expert witnesses used in Rhodes and likewise relied on a risk assessment as the means of proving significant exposure among the plaintiffs.138 The District Court for the District of New Jersey similarly rejected the risk assessment after determining it was merely an assumption of common exposure: “The risk assessment method requires the Court to assume that all class members weigh 70 kg and consume 2 liters of tap water per day.”139 The court called this assumption “undoubtedly false” because “the class contains thousands of individuals who are different sizes and have different water consumption habits.”140
When done well, risk assessments can be the most promising means for determining the health risks of chemical exposure. High-quality risk assessments often project how ranges of human characteristics, diseases, and clinical manifestations are likely to be distributed across the population in question. In the biomonitoring context, further assumptions may be necessary to allow for uncertainties in the intake, internal body distribution, and metabolism of chemicals among individuals. It remains unclear whether courts would accept a superior model of risk assessments as showing significant exposure, even though regulators and public health agencies depend extensively on such models for decisionmaking on a wide range of environmental issues, including chemical risks.
The Rowe Court suggested that “[p]laintiffs could have asked proposed class members to complete ‘a questionnaire or something looking at various individuals’ habits and weights’” in their attempt to prove significant exposure across the proposed class.141 It also recommended extensive biomonitoring of the proposed class through blood serum tests prior to filing a lawsuit.142 The plaintiffs highlighted the inequity of the court’s standard by stating that the required testing and analysis was what they were seeking through their medical monitoring claim.143 The court’s response was unsympathetic:
Although the Court recognizes that it would take significant investigative efforts to obtain information specific to each individual in the proposed class, the difficulty of this task does not excuse Plaintiffs from doing it. A class action is not intended to be an easy way around research problems.144
The courts’ suggestions for methods to prove significant exposure across a class through biomonitoring evidence require an unrealistic financial commitment from the plaintiffs. These standards present equally insurmountable technical and logistical challenges that come with generating the exposure data from thousands of plaintiffs. For comparison, the CDC conducts biomonitoring on only 2500 people as a representative national sample, and this project requires enormous resources, funding, time, and effort to contact, test, question, and obtain informed consent from the group.145 To require this data for an entire class of plaintiffs, with numbers often in the tens of thousands, is unworkable. If left unaltered, the courts’ high standards for proving significant exposure are likely to void nearly all medical monitoring claims based on chemical exposure shown through biomonitoring.
Medical monitoring claims also require that the plaintiff, because of her exposure, be at a significantly increased risk of serious disease. Courts divide this element into two parts, addressing first the seriousness of the risk and second the seriousness of the disease. As to the first part, district courts adhere to substantially similar tests when analyzing the term “significantly increased risk.” There is no bright line rule for determining a significant risk; the plaintiff is not “required to demonstrate the probable likelihood that a serious disease will result from the exposure.”146 To prove that a risk is significant, courts instead require “some indication” that the risk of disease is greater than it was prior to exposure, but showing “the general potential of a substance to cause disease is insufficient.”147 Courts consider regulatory benchmarks irrelevant to the analysis because a goal of regulation is to be particularly cautious, which courts conclude results in overstating the actual risk.148 In other words, courts reject the notion that regulatory standards based on acceptable or “de minimis risk” levels of exposure (such as maximum contaminant levels for chemicals in drinking water) are relevant in the context of the medical monitoring tort as baselines for either significant exposure or significant risk. For instance, the Rowe Court rejected the use of the New Jersey Department of Environmental Protection’s standard for PFOA levels in drinking water as a baseline for where a significantly increased risk occurs.149
The second half of this element requires that the plaintiff be at an increased risk of developing a “serious disease.” The District Court in Rhodes defined “serious disease” as “an illness that in its ordinary course may result in significant impairment or death.”150 This is problematic given that new toxicology suggests that endocrine disrupters (which PFOA is suspected of being) can cause subtle, non-life-impairing but nonetheless harmful subclinical effects such as changes in cognition, behavior, memory, child development, and reproduction.151 The Rowe Court did not define or discuss this term.152 Rather, it acknowledged that some studies correlate PFOA exposure with health effects such as liver disease, cancers, and cholesterol abnormalities, but concluded that such effects “appear to be uncertain.”153 The court did not say when it would consider the toxicological studies sufficiently certain to show a significantly increased risk of disease.
The District Court in Rhodes also refused to accept a risk assessment as proof of a significantly increased risk of disease, stating that the “risk assessment…only shows a C-8 concentration for drinking water at and below which the general population is ‘safe,’ but does not demonstrate that any extra level above the ‘safe’ level are [sic] significantly harmful.”154 The court further asserted that risk assessments are developed primarily for regulatory purposes and therefore are of “limited utility” in toxic tort cases because they establish levels below which there is no appreciable risk to the general population and not levels at which there is a “significantly increased risk.”155 However, risk assessments can be aimed at the latter level and can thus provide useful input into assessing the degree to which disease risks rise.
In addition to risk assessments, the plaintiffs presented preliminary results from the C-8 Health Project.156 The court dismissed the study’s preliminary findings as unreliable because “the aggregate evidence [only shows] that [PFOA] generally causes some human diseases; it does not show that the specific exposure in this case proximately caused a significantly increased risk of disease for each proposed class member.”157 In the court’s view, there are currently insufficient toxicological data on PFOA, but as more scientific research is done on correlations between PFOA biomonitoring data and health effects, future plaintiffs may be better equipped to argue that the increased risk of disease is “significant” if the data shows as much. Notably, the C-8 Health Project has already produced results indicating that PFOA might increase the risk for a number of diseases, and a court could decide to use a precautionary approach by lowering the standard for scientific proof showing a significantly increased risk of a serious disease.
The medical monitoring tort also requires a plaintiff to show that medical monitoring is necessary. The courts emphasize that this standard is to be interpreted broadly, requiring only that there be “some reasonable medical basis for undergoing diagnostic monitoring.”158 Notably, the District Court in Rhodes did not consider economic cost when conducting this analysis, and in some cases it would even consider “the subjective desires of a plaintiff for information concerning the state of his or her health.”159 In the future, this analysis may need to reflect the recent trend of lay people demanding a greater role in seeking medical information and deciding on their treatment vis-à-vis physicians, since much of the existing medical monitoring discussion assumes that physicians are the only relevant actors in determining whether monitoring is needed.160
As the final element of a medical monitoring claim, all jurisdictions allowing such claims except for West Virginia require that the proposed medical monitoring relief will produce some benefit in preventing or slowing disease. For many diseases thought to be caused by chemical exposures, medical treatments already exist. Thus, this final element is usually not difficult to establish if plaintiffs point to such diseases.
The primary barriers to succeeding on a medical monitoring claim are proving that a significant exposure has occurred and proving that this exposure leads to an increased risk of disease. The remaining two elements are more readily proven because, once the likelihood of a resulting disease is established, it logically follows that one needs to undergo periodic medical testing because most diseases are more easily treated if detected at the onset. Biomonitoring evidence is highly useful in proving a significant exposure; however, the courts’ current standards for proving significant exposure and an increased risk of disease across a class are so stringent as to prevent recovery under the medical monitoring tort for exposure to the vast majority of industrial chemicals.
VII. BIOMONITORING EVIDENCE IN CONSUMER PRODUCTS CLAIMS
Biomonitoring studies have also spurred product liability claims alleging chemical exposure from consumer products. These cases are emerging as a new frontier in chemical regulation and are likely to expand in the future, particularly as toxicology and health evidence for specific chemicals develop.161 While product liability claims can be aimed at trying to recover compensation for plaintiffs, they also may be designed to publicize the issue so that legislatures are more likely to intervene with regulation, or to put public pressure on industry to respond with product redesigns.
There are a number of product liability claims (such as inherent product defects, statutory consumer protections, and misrepresentations about product safety) that vary in the required degree of proof; some are tort-like, requiring fault on the part of the product maker or supplier, whereas others are strict liability. Plaintiffs can bring product liability claims against different actors in the supply chain: the manufacturer of the building-block chemicals, the final product manufacturer, or the retailer. Each actor can be the most suitable target for litigation depending on several factors including how the exposure occurred, which entity controls the use of the chemical, and which entity has the deepest pockets.
In response to biomonitoring studies that revealed pervasive PFOA exposure in the U.S. population, twenty-three product liability lawsuits were filed against DuPont in various federal court jurisdictions.162 The Judicial Panel on Multidistrict Litigation ordered that the cases be consolidated in the U.S. District Court for the Southern District of Iowa.163 The claims generally alleged that DuPont made false, deceptive representations regarding the safety of its Teflon product, and that DuPont “knew or should have known about potential risks in using cookware containing its coating, and failed to disclose this information” to consumers.164 The plaintiffs sought remedies to create a fund for independent researchers to investigate the potential for adverse health effects resulting from Teflon cookware usage and to require that DuPont cease and desist the manufacture, sale, and distribution of Teflon cookware; replace or exchange all existing Teflon cookware with nonhazardous cookware; and provide warning labels or other disclosures on Teflon cookware.165
Plaintiffs opted to name DuPont, the sole manufacturer of Teflon, as the only defendant even though there are multiple nonstick, PFOA-based cookware coatings made by other manufacturers. This is likely because Teflon is the most well known and most widely used nonstick coating and because DuPont is a wealthy corporation. By choosing to target the chemical manufacturer, the plaintiffs structured the lawsuit in a way that forces them to provide certain evidence and arguments that can make it far more difficult to benefit from biomonitoring data.
To demonstrate the potential health risks associated with PFOA exposure, the plaintiffs cited a number of biomonitoring studies conducted by scientists and industry, including CDC data showing that PFOA may have contaminated the bloodstream of fetuses throughout the U.S. and a study by researchers at Johns Hopkins University that found PFOA in the cord blood of ninety-nine percent of newborn infants.166 Plaintiffs also cited a biomonitoring study conducted by 3M which found that PFOA was present in the blood of ninety-six percent of 598 children tested, and noted that 3M has correlated PFOA exposure with vascular disease and prostate cancer.167
In addition to these external studies, plaintiffs cited DuPont’s own biomonitoring studies and its violation of the federal Toxic Substances Control Act, which regulates the marketing of industrial chemicals.168 Manufacturers are not obliged to generate new environmental and health data for chemicals that were on the market prior to 1977, including PFOA, but if they hold this data, they must report it to the EPA so that the agency can evaluate the chemical. In this case, DuPont had conducted a study of eight employees who were either pregnant or who had recently given birth.169 The study showed the presence of PFOA in the umbilical cord blood of at least one of the employees and in the blood of another employee’s baby.170 DuPont reported data to the EPA confirming the transplacental movement of PFOA in rats, but failed to disclose the transplacental movement of PFOA in humans and other information it had about the correlation of birth defects in the babies of its employees with exposure to PFOA.171 Due to these failings, the EPA investigated and determined that DuPont unlawfully concealed the biomonitoring study, thereby violating the Toxic Substances Control Act from June 1981 to March 2001. DuPont settled the EPA’s claims by paying the largest civil administrative fine the EPA has ever obtained under any federal environmental statute, at $10.25 million.172
The District Court denied class certification in 2008 after determining that the plaintiffs failed to show commonality among the class members because it was impossible to confirm who had used Teflon products and who was exposed to statements by DuPont regarding the product’s safety, if indeed these statements had been made at all.173 As with the medical monitoring claims mentioned above, individual plaintiffs likely will not pursue these claims further because the potential recovery is too small to cover litigation costs, according to their attorneys.174 The court’s reasoning for denying class certification depended on difficulties in proving the source of exposure and misleading information, and not on questions regarding whether PFOA exposure had occurred or whether it was harmful, as these substantive facts were accepted as true for the purpose of class certification. As such, it is unclear how the court would have evaluated the allegation of harmful exposure, had the case progressed to trial.
Although plaintiffs gathered some relevant biomonitoring and health studies to show that DuPont was aware of the potential for harmful health effects, they did not attempt to use biomonitoring data to show common exposure across the class. Instead, the proposed class was composed of Teflon pan users, an argument which ultimately failed. They also did not provide any integrated analysis of the scientific evidence for exposure and health effects. It is doubtful, however, that this would have been a viable strategy because the plaintiffs then would have had the burden of proving that PFOA exposure was specifically due to Teflon cookware as opposed to cookware more generally, which biomonitoring is unable to do by itself. Given the widespread use of PFOA in consumer products other than cookware, this would have posed a significant logistical and scientific challenge. The Teflon product liability case further suggests how biomonitoring has fallen short in affecting plaintiffs’ evidentiary burdens.
Biomonitoring data could be viable evidence in product liability claims where only one type of product and perhaps only a few product manufacturers are the source of the chemical exposure. Where there are no alternative sources of exposure, plaintiffs could use biomonitoring to establish commonality across a class. In this situation, plaintiffs could sue all makers of the product (or chemical, depending on the supply chain strategy) that are the purported source of exposure, could use biomonitoring to form a class around this exposure, and could argue that each maker shares joint liability, under a theory of market share determining degree of liability that has been accepted in a small number of other product liability litigations such as asbestos.175 The soundness of these legal arguments has yet to be tested, but they appear workable under existing law.
The major causation problem is that many chemical exposures involve multiple sources, many of which may not even be product-related. This challenge could be met by attempting to partition the relative contributions of different sources and product types to generate a risk assessment, which some scientists are doing experimentally for PFOA.176 Scientists, however, have only begun to consider methods to deal with multiple and cumulative chemical exposures, and policymakers and the law trail still further behind. Much further scientific development is required before this partitioning becomes viable. Even so, biomonitoring science already provides another tool for product liability plaintiffs to use in framing their arguments if used appropriately, with careful evaluation of which entity in the supply chain to target.
VIII. CONCLUSIONS AND RECOMMENDATIONS
Biomonitoring science has revolutionized chemical exposure detection, resulting in an increasing number of people gaining knowledge of their own exposures. For many, this knowledge results in anger, fear, and frustration. While the health effects of most exposures may be uncertain, such concerns are not unjustified. Lead, DDT, and asbestos are all toxins that were once thought to be safe, but now are known to be extremely hazardous to human health, with levels deemed “safe” continually diminishing. It follows that with expanding knowledge of chemical toxicity brought on in part by new biomonitoring science, we will likely someday find that many of today’s routine chemical exposures are cause for great health concern. Biomonitoring is already transforming our understanding of chemical exposures in diverse human populations and has the potential to help reshape the governance of industrial chemicals. In the absence of regulatory reforms such as modernizing TSCA, the legal system could play a vital role in accelerating the acquisition of knowledge about chemical toxicity, and creating new incentives for industry to redesign chemicals and products to be safer. Yet the current toxic tort framework instead leaves exposure victims without means to obtain legal recovery and fails to provide real incentives for generating new data on health effects.
Given this situation, we recommend changes to the toxic tort framework that allow chemical exposure victims to recover reasonable compensation where the damage awards are used to determine and guard against the health effects of chemical exposures. Our recommendations support the policy that manufacturers should take a proactive role in evaluating the hazards of their products and, where potential hazards exist, take precautionary measures to minimize unintended human and environmental exposures and associated risks to human health.
The most efficient way to provide a remedy is for state and federal legislatures to enact laws explicitly allowing plaintiffs to recover under the medical monitoring tort, thereby overcoming its ad hoc, idiosyncratic adoption at common law. Currently, plaintiffs must depend on the willingness of individual state courts to accept their claims, and are unable to pursue the tort at the federal level. These new laws could create a cause of action, define the elements required to establish the claim, and authorize courts to use appropriate biomonitoring sampling methods for larger plaintiff groups. Courts would not require personalized testing of each plaintiff, which is a major impediment to litigation at present even though sampling is scientifically robust. While state legislatures may be reluctant to create such provisions, those legislatures that are particularly interested in addressing chemical issues can achieve this reform.
Beyond the courtroom, the TSCA can be reformed to require chemical producers to generate full toxicological and health data, thereby allowing plaintiffs as well as governments to better show why and how chemical exposures cause health risks. Because most chemicals, including PFOA, lack this data, plaintiffs face difficult obstacles in linking chemicals with health outcomes. Developments in the European Union, notably the enactment of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) law in 2006, show that regulatory reform is indeed possible.177 REACH requires chemical manufacturers to generate the missing data for existing chemicals; plaintiffs may eventually be able to rely on data produced under REACH. Congress is considering various proposals to modernize TSCA along these lines; the insights into the prevalence of multiple chemical exposures in the U.S. population that biomonitoring science has generated support the need for such change. This development underscores the importance of combining legislative and courtroom changes to support the use of biomonitoring science.
Even in the absence of these statutory changes, however, courts can still do much to improve the predicament of otherwise justified plaintiffs. To adequately recognize the changing toxicological and public health knowledge about chemical effects, courts can accept, as legally actionable injuries, subtle health and developmental impacts as well as emotional concern and stress related to chemical exposure. Courts can cease rejecting medical monitoring claims on grounds that these are aimed at prospective injury because injury can take a spectrum of forms even if not within the traditional definitions of physical harm. Recovery for such injury does not contradict tort law principles, where “deter[ring] irresponsible discharge of toxic chemicals…and encourag[ing] plaintiffs to detect and treat their injuries as soon as possible…are conventional goals of the tort system.”178 Allowing plaintiffs to recover in this way would overcome the current incentives that manufacturers have to disregard the more subtle but perhaps far more prevalent forms of health effects.179
Moreover, the Metro-North decision should not be viewed as authority against all forms of medical monitoring because its reasoning is inapplicable to alternative forms of recovery such as court-administered funds. Most importantly, the Supreme Court’s decision here has no impact on any state courts’ recognition of a medical monitoring tort as a matter of state law. Moreover, the Supreme Court could be invited to revisit the issue in the light of the fast-evolving science of biomonitoring, if an appropriate series of lawsuits are run in federal courts.
The C-8 Health Project, created under West Virginia law, is an important example of how courts can contribute constructively to the generation of new knowledge of chemical hazards through ordering research and biomonitoring funds run by independent scientific experts with plaintiff input as study participants. Such projects integrate biomonitoring with the scientific study of health effects. The C-8 Health Project results have already linked PFOA to heightened cholesterol levels, delayed onset of puberty, and detrimental impacts on immune, liver and thyroid function, with further results expected to follow over the next few years.180 Courts should be empowered to order similar remedies that lead to ongoing research on chemical exposures. Such research would greatly expand knowledge of the health effects and mechanisms of chemicals for which there are currently inadequate or missing data, comparable to the ways in which scientists have gradually proven the toxicity and health effects associated with specific levels of exposure to tobacco, lead, mercury, and asbestos. Indeed, courts have often played an important role in shaping the evolving scientific knowledge regarding these substances through litigation and regulatory proceedings.181
We also propose implementation of the precautionary principle in the legal standards required to show significant exposure and increased risk of disease in the medical monitoring claim. Plaintiffs will then be on a more level litigation field for many harmful chemicals. In evaluating significant exposure across a class, for example, courts should not require personalized data for each plaintiff, but instead allow for appropriate sampling methods to account for exposure across a class. The courts’ current stance contradicts standard scientific procedure, where it is well recognized that sampling can lead to reliable assumptions about population characteristics.182 Importantly, sampling provides a reasonable standard that is affordable for plaintiffs, whereas fully individualized data is not. In evaluating an increased risk of disease, courts should be willing to recognize exposure levels that exceed regulatory benchmarks or credible risk assessments targeting population effects as significant evidence for disease risks, where they are available. Courts have not been receptive to this view in the tort law domain (as opposed to the administrative law realm when deciding whether to uphold regulatory agency decisionmaking, where courts frequently demand that such assessments be done as part of justifying rulemaking), but they can revise their principles for interpreting and applying such benchmarks for exposure limits.
To accommodate lowered standards of proof for showing a significant exposure and an increased risk of disease, courts can order independent technical experts or even special masters to advise them in determining whether biomonitoring data, sampling techniques, and risk assessments are adequate.183 Judges are rightfully wary of evolving scientific evidence such as toxicity because they are not trained as chemists or as environmental health scientists and thus cannot appraise the science for themselves. Appropriately qualified independent experts, however, could help judges to assess accurately the current state of the science, to determine whether standards are met and to evaluate the case for precautionary interpretation. Through the increased use of independent experts, courts can account for valid science that is currently unrecognized. Courts could be more willing to acknowledge their need to seek assistance rather than insisting on waiting for complete certainty and rejecting claims in the meantime.
To increase the prospects of the effective use of biomonitoring data in medical monitoring suits, we recommend better training of attorneys and judges about biomonitoring science and reference levels. Plaintiffs need to take better account of the extent to which claims are ripe; that is, able to be supported by some scientific evidence of possible harm. Plaintiffs’ attorneys, where possible, can invest more resources in providing personalized biomonitoring data to courts and in finding the appropriate expert witnesses to present the most effective biomonitoring evidence. These expert witnesses should be able to evaluate the CDC national data appropriately, and to use this as a baseline comparison with smaller populations so as to better situate samples of these latter populations. These actions would help to advance plaintiffs’ claims by helping to show commonality among members of a potential class. This would thus overcome a major hurdle for achieving class certification, which is critically important to the economic viability of these cases.
Plaintiffs should also comply with the existing legal framework by presenting exposure evidence from the plaintiff group and comparing this to the exposure level of the general population. The data representing the general population can be derived from the CDC’s biannual biomonitoring reports, supplemented with expert analysis and scientific research addressing specific questions about exposure pathways and sources. Finally, plaintiffs should collect relevant data by using questionnaires and statistical analysis to help illuminate the behavior and characteristics of the proposed class in terms of corresponding risks, such as consumer product use patterns or exposure to household dust that contains chemicals released from product use. This information will help to better contextualize the biomonitoring data.
Biomonitoring is an increasingly important source of information to assess chemical toxicity, but courts have not yet developed effective approaches for dealing with biomonitoring exposure science. As a result, litigation has not yet realized its potential to function as a tool to hold industry more accountable for its chemical design choices, alongside the flawed existing chemical regulatory framework. To enable litigation to develop as part of a multipronged approach to governing chemicals, just as it has in other areas of industrial production and product use, a combination of creative legislative and court actions can be taken. Innovative statutory changes can allow plaintiffs to finally achieve a fair outcome while increasing incentives for industry to produce safer chemicals. Even in the absence of statutory changes, courts have the ability and, we think, an obligation to empower chemical exposure victims through the common law to seek redress and, eventually, systemic change in industry.
References
- 1.The research for this article was conducted under National Science Foundation Award #0822724 and National Institute of Environmental Health Sciences Award #029746.
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- 11.The findings of this article also apply to Bisphenol A (BPA), flame-retardants, and other industrial chemicals detectable through biomonitoring.
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- 14.The CDC is a federal agency within the Department of Health and Human Services that seeks to promote public health and to prevent and control diseases, disorders, injuries, and disabilities. Preventive Health Amendments of 1992, Pub. L. No. 102–531, 106 Stat. 3469.
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- 65.Id. at *36 (citing West v. Prudential Sec., 282 F.3d 935, 938 (7th Cir. 2002)).
- 66.Notably, the Rowe court even recommended that the plaintiffs conduct biomonitoring to help prove their medical monitoring claim. Rowe v. E.I. DuPont de Nemours & Co., Nos. 06-1810 & 06-3080, 2008 U.S. Dist. LEXIS 103528, at *40 (D.N.J. Dec. 23, 2008).
- 67.Several other chemical companies also produce PFOA 2010/2015 PFOA Stewardship Program. U.S. EPA. 2010 Nov 10; http://www.epa.gov/oppt/pfoa/pubs/stewardship/index.html. Significantly, in 2000, biomonitoring studies by company scientists helped motivate 3M to discontinue manufacturing PFOA for use in its Scotchgard product line. Olsen Geary W, et al. Epidemiologic Assessment of Worker Serum Perfluorooctanesulfonate (PFOS) and Perfluorooctanoate (PFOA) Concentrations and Medical Surveillance Examinations. J. Occupational & Envtl. Med. 2003;45:260–267. doi: 10.1097/01.jom.0000052958.59271.10. Olsen Geary W, et al. Human Donor Liver and Serum Concentrations of Perfluorooctanesulfonate and Other Perfluorochemicals. Envtl. Sci. Tech. 2003;37:888–888. doi: 10.1021/es020955c. Olsen Geary W, et al. Perfluorooctanesulfonate and Other Fluorochemicals in the Serum of American Red Cross Adult Blood Donors. Envtl. Health Persp. 2003;111:1892. doi: 10.1289/ehp.6316. 1892.
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- 75.This landmark agreement is the first and to date the only occasion that such a settlement has funded such a large-scale biomonitoring program, The C-8 Health Project gathers and assesses health information through questionnaires and biomonitoring data from blood testing. Teams of scientists use this data as part of ongoing toxicological, epidemiological, and public health studies to establish health effects, disease mechanisms, and relevant biomarkers for PFOA. With this information, a panel of scientists, consisting of three epidemiologists agreed upon by both parties to the Leach settlement, conducts assessments of the health impacts of PFOA exposure and reports them to the court on a regular basis. See C8 Science Panel, http://www.c8sciencepanel.org (last visited Jan. 31, 2012).
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- 81.Notably, the trend against class certification does not affect individual plaintiffs having heightened exposures, who still may successfully sue PFOA manufacturers on an individual basis. However, these plaintiffs are likely deterred by the high cost of scientific data that must be collected.
- 82.In 2009, having had their hopes of recovering under a medical monitoring claim extinguished, the Rhodes plaintiffs then sought to add a claim under the imminent and substantial endangerment citizen suit provision of the federal Resource Conservation and Recovery Act of 1976 (RCRA). Rhodes v. E.I. DuPont de Nemours & Co., 2009 U.S. Dist. LEXIS 97909 (S.D.W. Va. Oct. 16, 2009). The court, however, denied the plaintiffs the opportunity to pursue this claim on procedural grounds without testing the theory. Id. Also in 2009, the Rowe plaintiffs similarly refocused on alternative tort claims seeking injunctive relief for clean water after it became clear that a medical monitoring claim was unviable. Rowe v. E.I. DuPont de Nemours & Co., 262 F.R.D. 451 (2009). In this case, the plaintiffs focused on property damage, alleging nuisance, trespass, negligence, and strict liability. Id. The plaintiff groups chose to assert their ownership interests in land near the Chambers Works plant and in a private well within two miles of the plant. Id. The District Court for the District of New Jersey granted class certification only for a private nuisance claim by a subclass of private well owners, a public nuisance claim by a subclass of water company customers, and class treatment of the issue of whether DuPont’s chemical manufacturing was an abnormally dangerous activity. Id.
- 83.Report on Safe Drinking Water Near 3M Plants, 3M, http://solutions.3m.com/wps/portal/3M/en_US/PFOS/PFOA/Information/Drinking-Water/ (last visited Dec. 5, 2011) (discussing several state district court cases in which the court denied class certification, rejecting plaintiffs’ personal injury claims as legally insufficient, and in which the jury verdict found that 3M had not committed a trespass on plaintiffs’ properties, and had not caused the plaintiffs to suffer any property damage).
- 84.Id. (further discussing several state district court cases in which the court dismissed the plaintiffs personal injury claims, focusing the case instead on property damage claims relating to the presence of trace levels of PFOS and PFOA in the environment associated with manufacturing operations at the company’s plant in Decatur, Alabama); see also id. (discussing an Alabama case in which property owners claimed to be affected by perfluorochemicals in sludge from the City of Decatur’s sewage treatment facility); id. (discussing a Florida case in which the water utility serving Pensacola, Florida filed against 3M and other companies, alleging that they negligently polluted farmland, grasslands, and water supplies in Franklin County and other counties in Alabama).
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- 100.Klein, supra note 33, at 10–11. Some jurisdictions have allowed recovery on claims for emotional distress resulting from toxic exposures (e.g., fear of cancer). However, “concern for imagined claims or fraudulent and frivolous lawsuits has prevented most jurisdictions from recognizing emotional distress claims without some additional corroboration.” Eggen, supra note 35, at 230.
- 101.Bower, 522 S.E.2d at 432-33. The District Court in New Jersey, a jurisdiction recognizing this tort theory, stated that “medical monitoring expenses ‘may only be awarded if a plaintiff reasonably shows that medical surveillance is required because the exposure caused a distinctive increased risk of future injury, and would require a course of medical monitoring independent of any other that the plaintiff would otherwise have to undergo.’” Rowe v. E.I. DuPont de Nemours & Co., Nos. 06-1810 & 06-3080, 2008 U.S. Dist. LEXIS 103528 at *12–13 (D.N.J. Dec. 23, 2008) (quoting Theer v. Philip Carey Co., 133 N.J. 610, 628 (1993)).
- 102.See Beck & Herrmann, supra note 44.
- 103.Id.
- 104.See, e.g., Badillo v. Am. Brands, Inc., 16 P.3d 435 (Nev. 2001); Henry v. Dow Chem. Co., 701 N.W.2d 684 (Mich. 2005); Paz v. Brush Engineered Materials, Inc., 949 So. 2d 1 (Miss. 2007).
- 105.Schwarzman & Wilson, supra note 13, at 1065.
- 106.See Schwartz Victor E, et al. Medical Monitoring—Should Tort Law Say Yes? Wake Forest L. Rev. 1999;34:1077. 1057. 1057, 1077 (1999) (noting that plaintiffs in medical monitoring cases are being compensated “for injuries which have not yet occurred and which…probably never will” (internal quotation marks omitted)).
- 107.Id. at 1075.
- 108.See Beck & Herrmann, supra note 44.
- 109.Metro-North Commuter R.R. Co. v. Buckley, 521 U.S. 424, 443-44 (1997) (rejecting the reasoning in In re Paoli R.R. Yard PCB Litig., 916 F.2d 829, 852 (3d Cir. 1990) (applying Pennsylvania law)).
- 110.Id. at 427-28.
- 111.Id. at 443-44.
- 112.Id. at 439-41.
- 113.Id. at 440-43.
- 114.Id. at 441-42.
- 115.Id. at 442.
- 116.Id. at 442-43.
- 117.Id. at 451 (citing In re Paoli R.R. Yard PCB Litig., 916 F.2d 829, 852 (3d Cir. 1990)).
- 118.Id.
- 119.Jurisdictions that may recognize medical monitoring claims include Arizona, California, Colorado, the District of Columbia, Florida, Missouri, New Jersey, Ohio, Pennsylvania, Utah, Vermont, and West Virginia. Other jurisdictions have either rejected or not yet addressed medical monitoring claims. See Beck & Herrmann, supra note 44.
- 120.Rhodes v. E.I. DuPont de Nemours & Co., 253 F.R.D. 365, 373 (S.D.W. Va. 2008) (citing Redlands Soccer Club, Inc. v. Dep’t of the Army, 55 F.3d 827, 846 (3d Cir. 1995)); see also Rowe v. E.I. DuPont de Nemours & Co., Nos. 06-1810 & 06-3080, 2008 U.S. Dist. LEXIS 103528, at *38 (D.N.J. Dec. 23, 2008).
- 121.Rhodes, 253 F.R.D. at 375.
- 122.Id. at 365.
- 123.Id. at 375.
- 124.Id.
- 125.Id.
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- 132.Rhodes, 253 F.R.D. at 370.
- 133.Id.
- 134.Notably, the opinion does not indicate that the experts submitted a technical report detailing the assessment. Rather, the analysis is focused entirely on their oral testimony before the court. Id.
- 135.Id. at 376.
- 136.Rowe v. E.I. DuPont de Nemours & Co., Nos. 06-1810 & 06-3080, 2008 U.S. Dist. LEXIS 103528, at *2 (D.N.J. Dec. 23, 2008).
- 137.Id. at *40-41.
- 138.Id. at *37-42.
- 139.Id. at *38-39.
- 140.Id. at *39.
- 141.Id. at *40.
- 142.Id.
- 143.Id. at *41 n.12.
- 144.Id. at *42.
- 145.CDC, supra note 16, at 1.
- 146.Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424, 431 (W. Va. 1999).
- 147.Rhodes v. E.I. DuPont de Nemours & Co., 253 F.R.D. 365, 379 (S.D.W. Va. 2008) (citing Bower, 522 S.E.2d at 433).
- 148.O’Neal v. Dep’t of the Army, 852 F.Supp. 327, 333 (M.D. Pa. 1994).
- 149.Rowe, 2008 U.S. Dist. LEXIS 103528, at *54-55.
- 150.Rhodes, 253 F.R.D. at 373 (citing Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979 (Utah 1993)).
- 151.See Grandjean Philippe, Landrigan Philip J. Developmental Neurotoxicity of Industrial Chemicals. Lancet. 2006;368:2167–2171. doi: 10.1016/S0140-6736(06)69665-7. Peterson Myers John, et al. A Clash of Old and New Scientific Concepts in Toxicity, with Important Implications for Public Health. Envtl. Health Persp. 2009;117:1652–1654. doi: 10.1289/ehp.0900887.
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- 153.Id. at *3.
- 154.Rhodes v. E.I. DuPont de Nemours & Co., 253 F.R.D. 365, 377 (S.D.W. Va. 2008).
- 155.Id.
- 156.Id. at 378-79.
- 157.Id. at 379.
- 158.Id. at 374 (citing Bower v. Westinghouse Elec. Corp., 206 W. Va. 133, 142 (1999)).
- 159.Id.
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- 161.Recently, lawsuits were brought against baby bottle manufacturers whose products contain BPA. This choice of defendant is strategic because there are many manufacturers of BPA, and it would be difficult to prove the source if defendants were pursued at an earlier phase in the production chain. Also, focusing on health impacts to babies likely has a stronger emotional pull on prospective jurors. See generally In re Bisphenol-A (BPA) Polycarbonate Plastic Prod. Liab. Litig., No. 08-1967-MD-W-ODS, 2009 U.S. Dist. LEXIS 104424 (W.D. Mo. Nov. 9, 2009); In re Bisphenol-A Polycarbonate Plastic Prod. Liab. Litig., No. 08-1967-MD.W.ODS, 2009 U.S. Dist. LEXIS 104451 (W.D. Mo. Nov. 9, 2009); In re Bisphenol-A (BPA) Polycarbonate Plastic Prod. Liab. Litig., No. 08-1967-MD-W-ODS, 2009 U.S. Dist. LEXIS 104439 (W.D. Mo. Nov. 9, 2009).
- 162. See Plaintiffs Seek Class Action in DuPont Teflon Lawsuit. Richmond Times Dispatch. 2006 Apr 21; at C-2; Pegg, supra note 74.
- 163.In re Teflon Prod. Liab. Litig., 254 F.R.D. 354, 357 (S.D. Iowa 2008).
- 164.Id.
- 165.Id. at 359.
- 166.Complaint at 9–10, 13, In re Teflon Prod. Liab. Litig., 254 F.R.D. 354 (S.D. Iowa 2008) (MDL No. 1733).
- 167.Id. at 7, 9.
- 168.Id. at 7–8.
- 169.Id. at 8.
- 170.Id.
- 171.Id.
- 172. EPA Settles PFOA Case Against DuPont for Largest Environmental Administrative Penalty in Agency History. U.S. EPA. 2005 Dec 14; http://yosemite.epa.gov/opa/adm press.nsf/68b5f2d54f3eefd28525701500517fbf/fdcb2f665cac66bb852570d7005d6665!ope ndocument. DuPont promised to do further analyses of the toxicology of PFOA as part of the settlement.The first SEP, valued at $5 million and to be completed in three years, is a project designed to investigate the potential of nine of DuPont’s fluorotelomer-based products to breakdown to form PFOA. This SEP will help industry, scientists, the public and EPA examine the potential sources of PFOA in the environment and potential routes of human exposure to PFOA. Id. DuPont’s progress here has been disappointing.
- 173.In re Teflon Prod. Liab. Litig., 254 F.R.D. 354, 363 (S.D. Iowa. 2008).
- 174.See Pearl, supra note 88.
- 175.See generally Rostron Allen. Beyond Market Share Liability: A Theory of Proportional Share Liability for Nonfungible Products. UCLA L. Rev. 2004;52:151.
- 176.See generally Vestergren Robin, et al. Estimating the Contribution of Precursor Compounds in Consumer Exposure to PFOS and PFOA. Chemosphere. 2008;73:1617. doi: 10.1016/j.chemosphere.2008.08.011. Trudel et al., supra note 90.
- 177.Commission Regulation 1907/2006, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), 2007 O.J. (L 396) (EC).
- 178.See Metro-North Commuter R.R. Co. v. Buckley, 521 U.S. 424, 451 (1997) (citing In re Paoli R.R. Yard PCB Litig., 916 F.2d 829, 852 (3d Cir. 1990)).
- 179.See generally Cranor, supra note 29.
- 180.See Fletcher Tony, et al. Patterns of Age of Puberty Among Children in the Mid-Ohio Valley in Relation to Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) C8 Science Panel. 2010 Sep 30;
- 181.See generally Jasanoff, supra note 52.
- 182.The courts’ stance also runs contrary to public health methodologies, where assumptions are regularly based on population sampling. Opponents to the medical monitoring tort argue that comparisons to policy methodologies are moot because policy is the responsibility of the legislature and not of the courts. However, many views exist on the role of courts as policymaking entities, and this article follows the view that courts have repeatedly made new policies in the past, notably in environmental and constitutional law. In ruling on legislative and regulatory decisions, courts are effectively playing a part in shaping policy.
- 183.Federal courts are already permitted to appoint special masters under Rule 53 of the Federal Rules of Civil Procedure in circumstances where “some exceptional condition” requires it, such as particularly complex or technical scientific issues being raised. Fed. R. Civ. P. 53(a)(1) (A) (i). Such appointments are difficult to make at present; special masters exercise decisionmaking power on behalf of a court, as in the U.S. vaccine compensation scheme. Courts also have the inherent power to seek technical assistance for “problems of unusual difficulty, sophistication, and complexity, involving something well beyond the regular questions of fact and law with which judges must routinely grapple.” Reilly v. United States, 863 F.2d 149, 157 (9th Cir. 1988). See generally Hess Robert L., II Judges Cooperating with Scientists: A Proposal for More Effective Limits on the Federal Trial Judge’s Inherent Power to Appoint Technical Advisors. Vand. L. Rev. 2001;54:547. Jackson Samuel. Technical Advisors Deserve Equal Billing with Court Appointed Experts in Novel and Complex Scientific Cases: Does the Federal Judicial Center Agree? Envtl. L. 1998;28:428.