IARC’s Cancer-Hazard Classification of Gasoline Will Fuel Wasteful Litigation
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What is IARC?
IARC is a branch of the World Health Organization (WHO) based in Lyon, France. Mandated by WHO to investigate potential causes of cancer, IARC conducts hazard evaluations of suspected carcinogens multiple times a year. The results of these evaluations are published in IARC “Monographs”—lengthy summary publications that discuss the existing literature and then apply a cancer classification based upon the Monograph Working Group evaluation. Under current IARC guidelines, it is impossible to classify any evaluated substance as “not carcinogenic”—the best the guidelines allow is “insufficient evidence to deem carcinogenic.” 0 Additionally, IARC Monograph Working Groups—with few exceptions—are only allowed to consider as part of their review published data in the peer-reviewed literature regarding substances or exposures they evaluate. In the case of regulated substances, where many safety studies are submitted to regulators but are not placed in the peer-reviewed literature, this can create a situation where IARC Working Groups only review a subset of the available data on a given compound or exposure, potentially leading to erroneous conclusions based on incomplete data sets.IARC and Litigation
IARC evaluations have been an issue in litigation for decades, starting first with the earlier iterations of asbestos cases in the 1980s and 1990s. In recent years, IARC evaluations of the chemical aspartame (found in Diet Coke) and perfluorinated chemicals have garnered widespread attention. 0 Earlier IARC evaluations of the active ingredient in the pesticide Roundup (glyphosate), the active ingredient in the pharmaceutical drug Actos (pioglitazone), polychlorinated biphenyls (PCBs), and benzene either spurred or rekindled personal injury litigation surrounding those compounds. In addition to inciting personal injury litigation, an IARC classification of “carcinogenic” (Group 1) or “probably carcinogenic” (Group 2A) results in automatic listing as carcinogenic under California’s Proposition 65 law. Under Proposition 65, bounties are available to private citizens or organizations who bring lawsuits claiming products contain levels of listed carcinogens that exceed the state’s safe harbor level. These Proposition 65 lawsuits have been brought alleging undisclosed carcinogens in products like coffee and French fries. 0 In holding that Proposition 65-mandated warnings violate the First Amendment, some courts have expressed a healthy skepticism of IARC classifications. 0 Despite that skepticism, IARC classifications continue to spur litigation, and most courts still allow the findings of IARC Working Groups to provide bases for claims against corporate defendants in a wide variety of cases.Was the IARC Working Group for Gasoline Independent?
IARC claims to maintain a strict conflict of interest policy; unfortunately, the organization has applied the policy inconsistently when forming its Working Groups. For instance, IARC has previously allowed expert witnesses in litigation for plaintiffs to serve on working groups examining exposures about which they’re testifying while excluding from participation individuals with ties to companies producing the exposures. 0 The makeup of IARC Working Group 138—which assessed gasoline and the additives—was arguably unbalanced in its viewpoints. For instance, the Working Group included an epidemiologist named Julia Heck. She had previously published on traffic pollution and byproducts of gasoline—arguing that exposure to those byproducts is associated with childhood leukemia and breast cancer. 0 Likewise, a scientist named Sunisa Chaiklieng was a member of the Working Group. She had previously published research claiming gasoline station workers were at an increased risk of all cancer. 0 Apparently, no researchers were included in the Working Group who had opined gasoline exposure or byproduct exposure did not lead to an increased risk of cancer. Given IARC’s disparate treatment of conflicts of interest in the past, it is unsurprising that Working Group 138 lacked a balance of viewpoints. This lack of balance often leads to classifications that do not reflect scientific consensus. Over the past decade, IARC classifications for a multitude of chemicals have been criticized by regulatory authorities as out-of-step with the scientific data. 0 In the case of gasoline and MTBE, IARC’s classification is again out of step with the scientific consensus. EPA has determined that the epidemiologic evidence to classify gasoline as carcinogenic is “inadequate” 0 and the federal Agency for Toxic Substances and Disease Registry noted at its last review that extant epidemiology studies had “inherent limitations that preclude[d] their use as evidence for an association between gasoline exposure and cancer.” 0 Likewise, the National Toxicology Program reviewed the carcinogenicity of MTBE in 1998 and determined at that time that rodent data was insufficient to classify MTBE as carcinogenic. 0What To Do Next?
Industries and parties affected by the IARC review should consider starting to educate the public and relevant regulatory and political bodies about what goes into an IARC classification. Specifically, the public and relevant bodies should be aware that IARC often relies upon incomplete data as the policies under which Working Groups operate do not allow for the review of data not in the peer-reviewed literature or publicly released by regulatory agencies. Thus, in many cases, IARC Working Groups do not consider many of the regulatory guideline studies necessary for product registration and use in the U.S. and elsewhere.
Additionally, interested parties should be aware than an IARC evaluation is a “closed” analysis—no peer review or public comment is permitted, and no transcript is kept of the meeting or its deliberations. Because IARC is shrouded in secrecy, exposing flaws in its process can be difficult after-the-fact. The public and relevant bodies should be informed that an IARC evaluation is a hazard assessment—in other words, it is a determination that a substance might be carcinogenic at some dose, but it does not address whether the dose to which people are exposed in their daily lives could cause cancer.
Finally, affected parties should prepare for litigation—both of the Proposition 65 and personal injury variety. IARC Working Group assessments have been used by the plaintiffs’ bar to prop up litigation for decades and for a product as ubiquitous as gasoline, it is expected that some litigation will result from the classification.
Notes
Authors
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John Kalas is a Partner at Nelson Mullins Riley & Scarborough LLP practicing in the firm’s Washington, DC office. He focuses on complex products liability, toxic torts, mass torts, and pharmaceutical and medical device litigation, serving as both trial counsel and lead science counsel for major chemical and pharmaceutical manufacturers in cases involving alleged chemical exposures, agricultural chemicals, and drug-related injuries across jurisdictions nationwide. He has taken and defended hundreds of expert and fact witness depositions, participated in multi-day Daubert hearings, and his deposition work contributed to a seminal Ninth Circuit decision resetting Rule 702 jurisprudence.
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Craig is the Office Managing Partner for the Houston office and is heavily involved in the firm’s Oil & Gas and litigation practice groups. He focuses on complex commercial litigation, employment disputes, including trade secret litigation and non-compete claims, intellectual property litigation, catastrophic personal injury and products liability claims, and construction litigation, representing clients ranging from high-net-worth individuals to large corporations in federal and state courts and in arbitration. He has obtained directed verdicts, summary judgments, and favorable jury verdicts for clients in commercial, products liability, and construction disputes nationwide, including a Fifth Circuit opinion establishing Texas case law on the enforceability of releases in construction contracts, and has secured dismissals and favorable resolutions in trade secret, non-compete, intellectual property, and securities litigation matters. Craig also has a particular interest in the United Kingdom and Norway, assisting clients headquartered in those regions with legal issues arising from doing business in the United States and Mexico.
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Kate Skagerberg is a Partner at Kirkland & Ellis LLP practicing in the firm’s Nashville office. She focuses on high-exposure products liability and commercial litigation, serving as trial counsel for clients in federal and state courts nationwide, working closely with them to guide cases to successful resolutions. She has obtained multiple defense verdicts for medical device and commercial products manufacturers facing design defect, failure to warn, and negligence claims, defended a major tobacco company in Engle progeny litigation in Florida federal courts, and successfully represented a family in challenging a series of wills that diverted a significant portion of a widow’s estate to her stockbroker.
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