pdf

The Risky Business of Evaluating Risk: Product Liability Litigation Exposure from Green Chemistry Alternatives Assessments

Date: Aug 27, 2012

There are a growing number of state Green Chemistry initiatives that require reporting on the presence of certain chemicals in specified consumer products, which are often, but not always, children's products. Some laws go beyond reporting, which is burdensome enough, requiring submission of a formal Alternatives Assessment ("AA") to identify so-called "safer" substitutes. Laws mandating an AA require manufacturers, distributors, importers, and retailers (collectively referred to below as "manufacturers") of regulated products to perform detailed analyses not only of the chemicals used in their products, but also of potential alternatives that are "safer." The AA process has generated substantial concerns about regulatory burdens and compliance costs, especially since many consumer product manufacturers – the firms subject to the reporting obligations – simply do not have access to the detailed underlying data that will likely be required to do these assessments. In addition, balancing the array of potential health and environmental impacts of potential alternatives requires judgment calls. Where states have the ability to second-guess an AA and to commission a new one at the manufacturer's expense, cost burdens are magnified. Often left out of this discussion, however, are the litigation risks posed by Green Chemistry initiatives. More specifically, it will be important to consider the extent to which plaintiffs will be able to use the results of the AA process to strengthen product liability and related claims.

For manufacturers subject to AA requirements, it is imperative that they understand exactly what the AA process can and cannot do for a potential plaintiff. On the one hand, both the AA process and product liability litigation ostensibly deal with similar issues – i.e., the relative safety of a product. While arguably Green Chemistry laws create an artificial regulatory construct outside the typical product safety analysis, especially with regard to risk/utility considerations, many of the same types of information regarding a given chemical's risks or a product's design are involved in both. Because of this, potential plaintiffs can be expected to follow industry's participation in any AA program with great interest. On the other hand, it is equally important to note the significant differences between the two. While Green Chemistry programs address policy concerns regarding the general public's exposure to chemicals, product liability claims focus on individual plaintiffs. Thus, in many respects, each approach is designed to answer very different questions regarding issues of whether a chemical, in fact, poses a health risk, what exposure levels are of concern, and to what extent, if any, a manufacturer has a duty to address potential safety issues. Once manufacturers understand these litigation risks, they will be in a better position to manage them going forward.

Green Chemistry: A Brief Overview

For years, consumer and environmental public interest groups have lamented the federal government's perceived failure to regulate potentially hazardous chemicals, as evinced by their growing criticism of the federal Toxic Substances Control Act ("TSCA"). Although Congress, in 2008, enacted the Consumer Product Safety Improvement Act ("CPSIA"), intending to enhance the regulation of chemicals in children's products, many criticized the law for its focus on only lead and phthalates, and its failure to address a broader range of allegedly hazardous substances. It is against this backdrop that Green Chemistry laws have emerged. Focusing instead on state governments, various groups have successfully led efforts to enact laws that require the reporting, evaluation, and elimination of potentially hazardous chemicals in everyday consumer products.

To date, Green Chemistry programs have been adopted in California,[1] Connecticut,[2] Maine,[3] Michigan,[4] Minnesota,[5] and Washington.[6] The programs differ in terms of scope and requirements, but they share the same underlying goals of identifying and evaluating potentially hazardous chemicals and using this information to minimize or eliminate the risk of consumer harm. To these ends, the Green Chemistry programs typically require that:

• the state identify and prioritize lists of potentially toxic chemicals;

• manufacturers of regulated consumer products report the presence of listed chemicals in covered products; and

• manufacturers, at least in some states, perform AAs that evaluate potentially "safer" alternatives to listed chemicals used in the products (referred to in this article as "target" chemicals) and report their findings to the state.

In theory, Green Chemistry sounds like a good idea. The goal is to provide a rational, scientific framework to facilitate risk assessments of existing and alternative substances used in consumer products. In practice, however, recent developments suggest that Green Chemistry may simply provide an easy route to implement substance-specific bans even in the absence of conclusive evidence of substantial risks. Furthermore, the proliferation of differing requirements and obligations across states will subject industry to a confusing patchwork of regulations, increasing the cost and effort needed to ensure compliance. Worse yet, the underlying principle of these Green Chemistry laws is that the mere presence of a target chemical presents some type of risk, regardless of the potential for exposure based on use patterns, and overall functionality, safety, and cost implications. For purposes of this article, however, we focus on yet another significant issue inherent in many Green Chemistry legal frameworks: the potential for these AAs to expose manufacturers to a number of added litigation risks.

Although only a few states have adopted or proposed detailed AA requirements as part of their Green Chemistry initiatives, it is already apparent that these types of programs could have a substantial impact on product liability suits alleging exposures to a target chemical. Specifically, manufacturers will have to develop considerable amounts of information regarding target chemicals used in their products and any "safer" alternatives. Supply chain realities may make this information difficult for producers of many finished products to obtain. An "alternative" might include not only a replacement chemical that may pose fewer health or environmental risks, but also non-chemical substitutes, product redesign, new manufacturing processes, or the removal of the target chemical from the product. Manufacturers and/or state agencies will then use these data to compare the chemical and alternatives to determine whether it is possible to reduce or eliminate any hazards associated with the product. As discussed below, depending on the results of the AA process, the disclosure of such information may pose significant litigation risks to manufacturers defending against product liability claims.

The AA Requirement

There are three AA programs currently in various stages of enforcement or development. Maine's program has taken effect and currently applies to children's products containing Bisphenol A ("BPA") and nonylphenols.[7] California has proposed several versions of draft regulations, the latest issued in July 2012, that cover a broad range of consumer products.[8] Washington's law applies to children's products, but includes a greater number of chemicals than the Maine program. Washington does not currently have a mandatory AA program, but is encouraging manufacturers to voluntarily conduct AAs using guidance materials now being developed by the state.[9] While these programs differ in some respects, all three require information that will be of interest to plaintiffs in product liability cases. With regard to target chemicals, such information includes the:

• nature of the chemical and the amount used in each regulated product;

• function of the chemical in the product;

• likelihood of exposure through product use and exposure pathways; and

• human health and environmental risks posed by the chemical.

As for potential alternatives, relevant information includes the:

• availability, costs, and product performance of each identified alternative;

• present commercialization of the alternatives or barriers to marketplace entry;

• potential exposure levels to replacement chemicals and exposure pathways; and

• human health and environmental risks associated with the alternatives.

Under each program, the information is to be used by manufacturers and/or state agencies to compare the target chemical and alternatives to determine whether it is possible to reduce the human health and environmental impacts of the product. In Maine, a manufacturer must produce an AA report, but is not required to indicate as part of the AA whether it will adopt an alternative or continue using the target chemical, at least as a general principle,[10] although BPA is subject to special and different treatment.[11] California's proposed regulations take a slightly different approach, requiring the manufacturer, as part of the AA, to actually select an alternative or indicate that no changes to the product will be made.[12] Both programs, however, require that information submitted as part of the AA process, including the AA reports, be made publicly available subject to trade secret or confidentiality claims.[13] AAs submitted in Maine, for example, were the subject of Freedom of Information Act ("FOIA") requests from an environmental group that subsequently petitioned the state to commission its own AA for BPA and to broaden the ban on that substance.[14] It is important to remember that even a voluntary AA submitted to a state agency could be subject to an FOIA request, as might be the case in Washington, and in any event could be obtained in litigation through the discovery process.

Litigation Risks

As plaintiffs may have access to much, if not all, of the information that is produced during an AA process, they can be expected to rely on the AA report and other data to support product liability suits arguing that products containing target chemicals are defectively designed or that warnings should have been provided.

Perhaps the most significant impact could be seen in putative design defect claims, as the legal analysis often conducted in those types of cases closely mirrors the approach taken under AA programs. Specifically, in many states, plaintiffs often support arguments that a product's design is defective by submitting evidence that foreseeable risks of harm, such as those associated with chemical exposures, could have been reduced or avoided through a reasonable alternative design.[15] Under this "risk-utility" approach, the product and potential alternatives are compared. Various factors are typically considered, including cost, technical feasibility, functionality, and relative risks or hazards to human health.[16] This looks much like the AA process. While allegations regarding the mere presence of a target chemical in a product, without more, would hardly be the basis for a credible product liability suit, if an AA report concludes that there are safer alternatives, the plaintiff may seek to use such an assessment to establish a prima facie case of liability.

A similar litigation risk might also arise in failure to warn claims. In most states, a design defect may be established by showing that foreseeable risks of harm could have been reduced or avoided by adequate instructions or warnings.[17] In particular, courts will ask if the manufacturer knew or should have known of the hazards at the time of manufacture.[18] As we have already seen, manufacturers must disclose a considerable amount of information regarding the potential risks of a target chemical. For instance, in Maine and under California's proposed rules, the AA report must identify the human health and environmental hazards of the target chemical, including information like toxicological endpoints (e.g., skin irritation, reproductive effects, cancer) and pathways of exposure (e.g., inhalation, dermal, ingestion).[19] Plaintiffs will likely use this information to determine whether a manufacturer failed, in the past, to identify a safety hazard or adequately warn consumers, or adopt a design change. Moreover, the comparative nature of the AA process, where the target chemical and alternatives are measured against each other, could serve to further highlight potential human health risks that plaintiffs will argue should have been disclosed to consumers, particularly where an AA report demonstrates that a "safer" alternative exists.

Even where potential plaintiffs cannot demonstrate that they currently suffer from a physical manifestation of a disease (e.g., cancer) that is allegedly linked to a target chemical, information regarding potential chemical exposures may prompt plaintiffs to also focus on claims like fear of disease or medical monitoring, at least where those causes of action are recognized under state law. For example, in states that have already adopted Green Chemistry statutes, courts have allowed fear of disease claims where the plaintiff has been exposed to a chemical and the resulting fear is deemed reasonable.[20] Similarly, at least in California, medical monitoring costs may be recovered as damages in a negligence action where, through reliable expert testimony, the need for future monitoring is deemed reasonable and necessary.[21]

Finally, litigation risks arising in the area of product liability will not be limited to the manufacturer who actually prepares and submits the AA report. For example, a plaintiff could use information produced by a manufacturer in one state against another company producing the same product in another state, even where the latter state has no Green Chemistry statute. Furthermore, once an AA report concludes that safer alternatives exist, the redesigned product as envisioned during the AA process may become the alleged industry standard or state of the art by which plaintiffs urge all manufacturers should be judged. Indeed, the AA process seems designed, at least in part, to reduce the time and money spent by plaintiffs in developing product liability suits.

Causation Issues

The existence of an AA report, however, will not necessarily mean victory for the plaintiff in the courtroom. Plaintiffs will still have substantial evidentiary burdens, even if they come to court armed with an AA report that identifies various health hazards and concludes that "safer" alternatives exist. In addition to establishing a product defect or other wrongful conduct, a plaintiff must also prove that he/she was exposed to a target chemical in amounts that could have caused the plaintiff's injury. Simply showing that a product contains a target chemical is not enough. Central to any chemical exposure claim is the notion that "the dose makes the poison." Specifically, a plaintiff must demonstrate that: (1) the target chemical can cause the alleged disease and at what dose; and (2) he/she was exposed to the chemical at or above such dose so one may draw the inference that the chemical, in fact, caused the individual's disease. In other words, the plaintiff must submit evidence establishing a "dose-response" relationship.[22]

An AA report will not contain all of the information that is needed for a plaintiff to ultimately satisfy the causation requirement. The AA process, unlike a chemical exposure case, has virtually nothing to do with any scientifically supportable dose-response analysis. In Maine and under California's proposed regulations, a given chemical may be subject to AA requirements even if the product does not result in exposures at or above a certain dose-response level since reports on chemical use and AA reports are based on the presence of a chemical in a product. Courts should be particularly sensitive to this distinction, as chemicals are often used in products in only trace amounts or are encapsulated in the product thus minimizing the chance of exposure. Indeed, this is likely to be the rule, not the exception, with most AA reports. Nothing in an AA report, moreover, will speak to an individual plaintiff's actual level of exposure to a target chemical, thus leaving the plaintiff with significant proof burdens notwithstanding information gathered during the AA process. Although experience tells us that some plaintiffs will argue that any level of exposure – even to one molecule – may cause injury, courts routinely reject this approach as completely inconsistent with the dose-response principle underlying the science of toxicology.[23] In other words, the existence of a "safer" substance, should one be available, does not in any event conversely prove that a product containing a listed target chemical is "unsafe."

Even in cases involving fear of disease and medical monitoring claims, where there has been no showing of a present physical injury, more than just mere presence or even exposure to a chemical is often required. For example, in California, the plaintiff pursuing a fear of disease claim must show that it is more likely than not that the disease will manifest itself in the future.[24] Moreover, in medical monitoring claims, California courts look to various factors, including the significance and extent of the plaintiff's exposure, and the relative increase in risk to the plaintiff as a result of the exposure.[25] As with the more traditional product liability claims discussed above, this type of information specific to the individual plaintiff would not be contained in any AA report.

Conclusion

One of the unfortunate side effects of laws like the CPSIA and Green Chemistry initiatives is the notion that the mere presence of a chemical substance in a product equates to actual risk. While that premise, of course, is not supported by sound science, manufacturers must be aware that plaintiffs will be paying close attention to AA reports submitted by manufacturers in pursuit of product liability claims.

There are several ways in which manufacturers can minimize the potential adverse impact of the AA process. First, an AA report may be helpful to a manufacturer's defense. For instance, if it concludes that there are no "safer" alternatives, it may be that the product complies with industry standards and is thus not defective. Manufacturers should use AA reports to their advantage whenever possible. Second, manufacturers should protect all sensitive business information against public disclosure where permitted. Both Maine and the proposed regulations in California allow manufacturers to designate materials as trade secrets or confidential business information.[26] Third, manufacturers producing similar products should consider filing joint AA reports (perhaps through a trade association) in an effort to avoid inconsistencies among submissions and provide manufacturers with some amount of predictability. Maine and California's draft regulations allow these types of submissions in certain circumstances.[27] It is also important to examine functionality and performance issues.

Yet, claims are almost inevitable. When they do come, manufacturers should aggressively defend against any causation arguments and ensure that the court understands that the approach taken under an AA process does not satisfy the heightened evidentiary burdens that plaintiffs must meet in chemical exposure cases. In this regard, defendants should challenge, where possible, the admissibility of plaintiff's causation evidence under the federal Daubert standard or similar state principles.[28] Defendants must ensure that plaintiff's expert testimony and methodology are reliable.[29] This may also mean that industry must do a better job of educating the public about risk assessment concepts in general to assure that reports about the presence of chemicals in consumer products and AAs have a meaningful and useful context.

 

For more information on Green Chemistry issues contact Sheila A. Millar (202-434-4143 or millar@khlaw.com); Eric P. Gotting (202-434-4269 or gotting@khlaw.com); or Alissa D. Jijon (202-434-4109 or jijon@khlaw.com).


[1] Cal. Health & Safety Code § 25251 et seq.

[2] Conn. Gen. Stat. § 21a-335 et seq.

[3] Me. Rev. Stat. tit. 38, § 1691 et seq.

[4] Executive Directive No. 2006-6, "Promotion of Green Chemistry for Sustainable Economic Development and Protection of Public Health," available at: http://www.michigan.gov/granholm/0,1607,7-168-36898_40426-153806--,00.html.

[5] Minn. Stat. § 116.9401 et seq.

[6] Wash. Rev. Code § 70.240.010 et seq.

[7] 06-096 Me. Code R. ch. 880 (general), ch. 882 (BPA), ch. 883 (nonylphenols).

[8] See Proposed Cal. Code Regs. tit. 22, § 69501 et seq., available at: http://www.dtsc.ca.gov/upload/SCPProposedRegulationsNoUnderlineJuly2012.pdf.

[9] See Alternatives Assessment Guidance Document, available at: http://www.ecy.wa.gov/programs/hwtr/ChemAlternatives/altAssessment.html.

[10] See 06-096 Me. Code R. ch. 880(5).

[11] Maine has also implemented a ban on children's reusable food or beverage containers that contain intentionally-added BPA. Manufacturers of regulated products must report to Maine whether they intend to comply by discontinuing product sales or by substituting a "safer" alternative for BPA. 06-096 Me. Code R. ch. 882(5). This example highlights how seemingly innocuous AA requirements may expand to become substance-specific bans.

[12] See Proposed Cal. Code Regs. tit. 22, § 69505.4(c).

[13] See 06-096 Me. Code R. ch. 880(5)(F); Proposed Cal. Code Regs. tit. 22, § 69505.5(a)(6).

[14] See In Re: Citizen Petition to Require Safer Alternatives to Bisphenol A (BPA) in Food and Beverage Packaging for Young Children (June 21, 2012), available at: http://www.maine.gov/dep/bep/Citizen%20Petition/Chapter%20882/1%20Petition%20for%20BPA%20Rulemaking.pdf.

[15] See, e.g., Soproni v. Polygon Apt. Partners, 971 P.2d 500, 504-05 (Wash. 1999); Stanley v. Schiavi Mobile Homes, Inc., 462 A.2d 1144, 1148 (Me. 1983); Barker v. Lull Eng'g Co., 20 Cal. 3d 413, 431-32 (Cal. 1978).

[16] See, e.g., Barker, 20 Cal. 3d at 431.

[17] See, e.g., Bouchard v. Am. Orthodontics, 661 A.2d 1143, 1145 (Me. 1995); Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987, 999-1000 (Cal. 1991); Wash. Rev. Code § 7.72.030.

[18] Id.

[19] See 06-096 Me. Code R. ch. 880(5)(B); Cal. Code Regs. tit. 22, § 69505.4.

[20] See, e.g., Potter v. Firestone Tire and Rubber Co., 863 P.2d 795, 816 (Cal. 1993) (allowing California claim where plaintiff proves fear stems from knowledge that it is more likely than not that cancer will develop in the future due to toxic exposure); In re Moorenovich, 634 F. Supp. 634, 637 (D. Me. 1986) (permitting Maine claim where there is exposure and alleged anxiety is reasonable); Wilson v. Key Tronic Corp., 701 P.2d 518, 524 (Ct. App. Wash. 1985) (finding Washington claim reasonable where there was actual exposure to toxic chemicals).

[21] Potter, 863 P.2d at 824-25.

[22] Federal Judicial Center, Reference Manual on Scientific Evidence 603, 609, 638 (3d ed. 2011).

[23] See, e.g., Betz v. Pneumo Abex LLC, et al., 44 A.3d 27, 49 n.25 (Pa. 2012) (citing cases on this point).

[24] Potter, 863 P.2d at 816.

[25] Id. at 823.

[26] 06-096 Me. Code R. ch. 880(5)(F); Proposed Cal. Code Regs. tit. 22, § 69510.

[27] 06-096 Me. Code R. ch. 880(5)(E); Proposed Cal. Code Regs. tit. 22, § 69501.2(a)(2).

[28] Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993).

[29] Id. at 597.