EPA Releases Draft BPA Report

Last week, the EPA released a draft analysis of chemicals that may substitute for bisphenol A's use in thermal paper -- that's the material often used in sales receipts, supermarket labels, parking tickets, airline tickets, and similar items.

Readers may recall that in 2010, EPA released a chemical action plan that summarized hazard, exposure, and use information on bisphenol A (BPA) and identified various actions EPA was considering.  Part of that action plan was to help industries consider alternative chemicals and provide a basis for informed decision-making by developing an in-depth comparison of potential human health and environmental impacts of chemical alternatives. Representatives from industrial, academic, governmental, and non-governmental organizations worked with EPA to select and evaluate alternatives to BPA in thermal paper and develop this report.

By way of background, BPA (a topic we have posted on before) is a high production volume (HPV) chemical with a U.S. volume estimated at 2.4 billion pounds in 2007 and an estimated value of almost $2 billion. It is a monomer used in manufacturing most polycarbonate plastics, the majority of epoxy resins, and other chemical products such as flame retardants.  Approximately 94% of BPA is used as a monomer to make polycarbonate plastic and epoxy resins. Although most human exposure to BPA is believed to come from food and beverage packaging made from these materials, less than 5% of the BPA produced is used in food contact applications.  BPA-based materials are also used in automotive and other transportation equipment, optical media such as DVDs, electrical/electronics equipment, construction, linings inside drinking water pipes, thermal paper coatings, foundry casting, and elsewhere.  It has been an extraordinarily useful product.

The BPA in Thermal Paper Alternatives Assessment is an evaluation of potential hazards associated with thermal paper developers that are likely to be functional alternatives to BPA. Thermal paper systems include a developer and other components such as dyes and sensitizers. (EPA recognized that a change in the developer may require additional adjustments to the system.) This draft report summarizes the outcomes of the alternatives assessment, and aims to improve understanding of the potential environmental and human health impacts of BPA and alternative developers in thermal paper throughout their life cycles. Importantly, this draft report does not identify functional chemicals with no or even low concern for all human health and environmental hazard endpoints; all of the alternatives are associated with some trade-offs. For example, a chemical may have a lower concern for human health but a higher concern for aquatic toxicity. Finding and choosing substitutes is not always as easy as plaintiff attorneys and advocacy groups try to suggest.

Comments on EPA's draft alternatives assessment are due Oct. 1, 2012, at baier-anderson.caroline@epa.gov.
 

Fifth Circuit Affirms Exclusion of Plaintiff Causation Experts in Chemical Case

The Fifth Circuit recently affirmed the dismissal of most of a plaintiff's personal injury claims against a chemical company, based on the conclusion that certain expert witness testimony was inadmissible. See Johnson v. Arkema Inc., No.11-50193 (5th Cir. June, 2012).

Plaintiff Johnson worked as a machine repairman at a glass bottling plant in Waco, Texas from May 1998 to the end of 2008. On two separate occasions, first in early June 2007 and again in July 2007, Johnson claims he was directed to perform work in close proximity to a device known as a C-4 Hood, which was designed, manufactured, and installed by defendant. C-4 Hoods are
utilized to apply a chemical coating to the glass bottles as the bottles are transported along a conveyor belt. According to Johnson, the C-4 Hood he worked near to on those two occasions failed to perform its proper functions, resulting in his alleged exposure to harmful chemicals.

Plaintiff sued. Arkema then filed motions to exclude the opinions of Dr. Richard Schlesinger, Johnson’s expert toxicologist, and Dr. Charles Grodzin, Johnson’s expert pulmonologist, under Federal Rule of Evidence 702 and the Supreme Court’s decision in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). Arkema also filed a motion for summary judgment, contending that absent those experts, Johnson was unable to present scientifically reliable evidence establishing that exposure to the chemicals can cause restrictive lung disease and pulmonary
fibrosis (his alleged injury types). The district court granted the motions, and plaintiff appealed. 

On appeal, plaintiff contended that the district court abused its discretion in excluding Dr. Schlesinger’s expert opinion on general causation.  The district court excluded Dr. Schlesinger’s testimony after determining, inter alia, that: (1) Dr. Schlesinger could not cite to one epidemiological or controlled study of humans indicating that exposure to the relevant chemicals could cause restrictive lung disease and pulmonary fibrosis; (2) the scientific literature was devoid of any data or peer reviewed articles indicating that exposure to the two chemicals will result in chronic lung disease, and such a proposition is not generally accepted in the scientific community.

Plaintiff argued that the two fell into a "class" of chemicals that have been shown to cause these injuries. In forming a reliable opinion regarding the effects of exposure to a particular chemical, an expert may extrapolate data from studies of similar chemicals. BUT to support a conclusion based on such reasoning, the extrapolation or leap from one chemical to another must be reasonable and scientifically valid.  Thus, courts are free to reject a theory based on extrapolation when there is simply too great an analytical gap between the data and the opinion proffered. Here, save for highlighting their shared classifications as "irritants," the expert did not attempt to explain any direct correlation or “fit” between the chemicals at issue and the known scientific data concerning exposure to, for example, chlorine, ammonia, or nitric acid vapor. Accordingly, given the diverse chemical structures and toxicities of irritants, which plaintiff acknowledged, the district court did not abuse its discretion in concluding that Dr. Schlesinger’s “class of chemicals” theory presented “too great an analytical gap between the data and the opinion proffered.

The next issue was reliance on language in an MSDS, which is useful for many of our readers in toxic tort cases.  The district court found the "warning" language in a competitor's MSDS to be irrelevant and unreliable because: it did not clearly state a causation conclusion, and, most importantly, Johnson did not provide any science behind the MSDS, such as the duration or concentration of exposure needed to produce the noted effects, or the scientific literature relied upon by the drafter for the statements contained in the MSDS.  Under such circumstances, the MSDS, standing alone, need not have been accorded any weight. Plaintiff also relied on general hazard language in defendant's own MSDS. But could cite no authority for the proposition that material safety data sheets constitute per se reliable support for an expert’s opinion. To the contrary, in exercising its discretion as a gatekeeper, a court may refrain from treating a MSDS as reliable until it is presented with scientific evidence justifying the relevant statements found within the MSDS.

Finally, Johnson contended that he was exposed to amounts of one of the chemicals (HCl) that were between two and ten times the permissible exposure levels set by OSHA, NIOSH, and the Acute Exposure Guideline Levels set by the National Research Council. Regulatory and advisory bodies such as IARC, OSHA and EPA utilize a “weight of the evidence” method to assess the carcinogenicity or toxicity of various substances in human beings and suggest or make prophylactic rules governing human exposure. This methodology results from the preventive perspective that the agencies adopt in order to reduce potential public exposure to possibly harmful substances. The agencies’ threshold of proof is lower (for policy reasons) than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect, and requires a plaintiff to prove that it is more likely than not that another individual has caused him or her harm. See generally Wright v. Willamette Industries, Inc., 91 F.3d 1105, 1107 (8th Cir.1996). Thus, such regulatory chemical guidelines are not necessarily reliable in all toxic tort cases. And a court should confirm the underlying basis for their  proscriptions before an expert’s reliance on them can pass Daubert muster. Here, plaintiff did not provide any scientific data or literature to explain how or why the various exposure limits and guidelines were established for the chemicals. Similarly, he had no evidence that the guidelines and exposure limits existed to protect people from developing severe restrictive lung disease and pulmonary fibrosis, his diseases. Thus, the court concluded that the OSHA, NIOSH, and NRC guidelines and exposure limits, standing alone, were insufficient to demonstrate abuse of discretion on the part of the district court.

As to the other expert, Dr. Grodzin’s research and analysis essentially mirrored Dr. Schlesinger’s save for one key distinction: Dr. Grodzin performed a so-called “differential diagnosis” of Johnson. A reliable differential diagnosis typically, though not invariably, is performed after physical examinations, the taking of medical histories, and the review of clinical tests, including laboratory tests, and generally is accomplished by determining the possible causes for the patient’s symptoms and then eliminating each of these potential causes until reaching one that cannot be ruled out.  Even in jurisdictions that accept this questionable approach to causation, the results of a differential diagnosis are far from reliable per se. For example, before courts can admit an expert’s differential diagnosis, which, by its nature, only addresses the issue of specific causation, the expert must first demonstrate that the chemical at issue is actually capable of harming individuals in the general population, thereby satisfying the general causation standard. In other words, the suspect has to be reasonably and reliably "ruled in."

Here, Dr. Grodzin’s differential diagnosis was based on the presumption that the two chemicals  were actually capable of causing restrictive lung disease and pulmonary fibrosis in the general population. Dr. Grodzin did not present any reliable or relevant scientific evidence to bolster this assumption. Consequently, the fact that Dr. Grodzin claimed he conducted a differential
diagnosis did not save his opinion from the same fate as Dr. Schlesinger’s opinion.

 (Note, the court concluded that plaintiff did not need expert witnesses to demonstrate that his immediate acute injuries after exposure and which allegedly sent him to the emergency room, could have been caused by the chemical.  Thus, this part of the case was remanded.)

 

 

 

NTP Proposes Changes to Process for Next Report on Carcinogens

The National Toxicology Program is accepting comments on a revised process for reviewing substances that may be added to its widely cited "Report on Carcinogens." NTP is accepting comments up to Nov. 30th.

The Report is required by Congress to be published every two years, and is designed to provide
information on substances that may pose a hazard to human health by virtue of their  carcinogenicity.  Substances are listed in the report as either known or reasonably anticipated human carcinogens. The 12th Report was published in June, 2011. But now, the NTP is proposing changes to the review process for listing substances in the 13th Report.

The NTP will hold a listening session on November 29, 2011, from 1–5 p.m. (EST), as well, to receive oral comments on the proposed review process.

Under the proposed process, NTP says it would make its substance review process more flexible, and more descriptive of the  reasoning it used to develop a proposed classification of an agent, and  thus would summarize the relevant science and also the agency's reasoning about how the agent should be classified.

Toxic tort practitioners among our readers may want to take a look (and have their experts do so).
 

European Regulators Reaffirm Stance on BPA

Readers of MassTortDefense are accustomed to European regulatory approaches that are much stricter than in North America, under a co-called "precautionary" approach.  So what does it say about the hysteria in the U.S. over BPA when the European Food Safety Authority (EFSA) concludes that there is no new evidence to suggest the tolerable daily intake (TDI) for bisphenol A  needs to be changed?  EFSA recently reconfirmed that current levels of exposure pose no significant threat to human health.

Bisphenol A is a chemical used as a monomer in polycarbonate plastic and epoxy resins, in food contact materials used in the manufacture of some plastic bottles and food and drink can linings.  EFSA had an expert panel perform a detailed and comprehensive review of recent scientific literature and studies on the toxicity of bisphenol A at low doses.  The latest work carried out by EFSA scientists followed a request from the European Commission to: a) carry out a review of recent scientific literature on the toxicity of BPA to assess whether the TDI should be updated; b) assess a new study on possible neurodevelopmental effects (i.e. possible effects to the brain and central nervous system) of BPA in rats, known as the Stump study; and c) advise on the BPA risk assessment by Denmark’s DTU Food Institute.

The agency reaffirmed its positions stated over the last couple years, and concluded that it would maintain the current TDI of 0.05mg/kg/bodyweight.  The scientists on the EFSA CEF Panel concluded they could not identify any new evidence which would lead them to revise the current Tolerable Daily Intake for BPA as set by EFSA in its 2006 opinion and re-confirmed in its 2008 opinion. (In 2006, EFSA set the TDI for BPA at 0.05 mg BPA/kg body weight (b.w.)/day. This is based on the No-Observed-Adverse-Effect-Level (NOAEL) of 5 mg/kg b.w./day that has been identified in multi-generation reproductive toxicity studies in rodents, where the critical effects were changes in body and organ weights in adult and offspring rats and liver effects in adult mice, respectively. In 2008, EFSA reaffirmed this TDI, concluding that age-dependent toxicokinetics differences of BPA in animals and humans would have no implication for the TDI.) 

Moreover, the research pointed to by those out to ban BPA had “many shortcomings” and uncertain relevance to human health.   In particular, the panel dismissed concerns over the alleged neurobehavioral toxicity of BPA attributed to the Stump study and a risk assessment by Denmark's National Food Institute,  finding the alleged link uncertain and pointing out a variety of flaws in the analysis of the Stump data after further evaluation from EFSA’s Assessment and Methodology group. The careful review of the scientific literature failed to provide any convincing evidence that BPA has any adverse effects "on aspects of behavior, such as learning and memory.”

EFSA's conclusions, after intense scientific scrutiny, get little play in the mainstream press, but continue to reaffirm the safety of BPA in food contact applications.

  

Federal Court Grants Daubert Motion and Summary Judgment in Toxic Tort Cases

A federal court last week dismissed consolidated toxic tort suits brought against Alcoa Inc. and other defendants brought by employees of Lockheed Martin Corp. who claimed they were exposed to beryllium used in the manufacture of airplanes. Neal Parker et al. v. Brush Wellman Inc. et al., No. 04-cv-606; Timothy Berube et al. v. Brush Wellman Inc. et al., No. 08-cv-2725(N.D. Ga. 9/17/10).

The dozen plaintiffs in the cases were current or former employees of Lockheed Martin Corp.at its Marietta, Georgia plant site; plaintiffs alleged they had a variety of job responsibilities, time periods of employment, and work areas at the Lockheed facility. Lockheed’s Marietta Facility was purchased by the U.S. Government in 1942 and is leased and operated by Lockheed. Since 1952, Lockheed has produced the beryllium-containing C-130 Hercules airlifter, the C-5 Galaxy, the C-141 Starlifter, and the F/A-22 Raptor Air Dominance Fighter at its Marietta location. Each defendant was alleged to have manufactured component parts for Lockheed using copper-beryllium or aluminum-beryllium alloys.  Plaintiffs alleged that defendants failed to provide Lockheed with sufficient and accurate warnings pertaining to the beryllium contained in the manufactured products. Specifically, plaintiffs asserted a failure to warn claim, arguing that the warning materials that the defendants provided did not adequately communicate the health risks associated with the use of beryllium nor did they describe the methods that would reduce such risks.

Defendants filed a Daubert motion to exclude the testimony of Dr. John Martyny, plaintiffs' causation expert, and a companion motion for summary judgment. The Court ordered a Daubert hearing to clarify the evidentiary and factual background for the expert witness’s opinion and an evidentiary hearing regarding the motions to compel and summary judgment.

Since beryllium is generally recognized in the medical community as being able to cause the type of harm plaintiffs alleged –beryllium-related sickness– the Daubert analysis here focused on specific or individual causation to the plaintiffs, the plaintiff-specific questions: was plaintiff exposed to the toxin, was plaintiff exposed to enough of the toxin to cause the alleged injury, and did the toxin in fact cause the injury? The Eleventh Circuit has recognized that in order to carry
this causation burden in a toxic tort case, a plaintiff must demonstrate the levels of exposure that are hazardous to human beings as well as the plaintiff’s actual level of exposure to the defendant’s toxic substances before he or she may recover.

Here, the link between the expert’s opinion and the dose relationship was a key element of the analysis. Indeed, the hallmark of the science of toxic torts is the dose-response  relationship.  Exposure is only the opportunity for contact. Dose is what enters the body. While Dr. Marytny indicated, based on his experience and anecdotal evidence, that plaintiffs may have been exposed to beryllium at the plant, he did not indicate the level, frequency, duration or particle size of this exposure which would indicate the dose from these defendants’ products.  Importantly, Dr. Marytny did not produce any evidence that even a low-dose exposure resulted from defendants’ products. In fact, Dr. Martyny admitted that he could not opine as to the individual product or products that were the source of the alleged exposure.

Secondly, Dr. Martyny’s theory had not been appropriately tested.  The company itself did some sampling, and every air sample indicated that airborne beryllium concentrations were below the analytical reporting limit (<0.001 μg/sample) and thus also less than the OSHA PEL for beryllium.  Theoretically, defendants’ products could have been placed in an environmental chamber and the various machining procedures could have been reenacted to determine the particle production and size. While clearly this would not be as conclusive as personal sampling data for each plaintiff, this evidence would at least minimally indicate that bio-available beryllium from defendants’ products was possible, said the court.  But plaintiffs did no such testing.  Furthermore, no published studies documented levels of beryllium released by workers working with beryllium-aluminum in the aircraft industry.

Without such data, the expert's opinion merely assumed that plaintiffs’ injuries must have been caused by defendants’ products because the defendants produced  beryllium parts which were sold to Lockheed. However, nothing in his opinion linked these products to the alleged exposure of the plaintiffs nor ruled out other manufacturers’ products that were also present at the Marietta facility. 

Thus, the expert's opinion was excluded, and absent a reliable causation opinion, summary judgment was also appropriate.

The court the offered an alternative basis for the summary judgment on the failure to warn claim -- the sophisticated user doctrine. If a sophisticated user’s employees have knowledge that a particular risk of harm exists and yet allow the harm to occur, this knowledge may bar other employees’ claims against the product manufacturer. The supervising employees’ knowledge –the knowledge of the sophisticated user– can bar other employee’s claims against the product manufacturer. And the user’s knowledge does not need to encompass the precise, physical nature of the hazard presented by his use of the product; it is sufficient if he is aware generally that the use being made of the product is dangerous.

Here, Lockheed was a sophisticated user of beryllium alloys. Lockheed, as a part of the beryllium
industry, had as much access to information regarding beryllium safety as anyone else. For more than forty years, Lockheed  used the Department of Defense’s “Handbook for Metallic Materials and Elements for Aerospace Vehicle Structures” which provides guidelines for proper beryllium use. Lockheed issued its own “Safety and Industrial Hygiene Standard" which recognized that beryllium dust and vapors can cause respiratory problems. Lockheed recognized that it should order “medical monitoring” for those within the exposed worker population. The record made clear that the employer was a sophisticated user; summary judgment was appropriate on this basis as well.

California's Proposed "Green Chemistry" Regulations Move Forward

California's proposed "green chemistry" regulation took another step closer to completion last week, as the state Department of Toxic Substance Control (DTSC) submitted the draft regulations to begin the final official rulemaking process.  The public has until Nov. 1, 2010 to make comments.  Under state law passed in 2008, the regulations must be finalized before 2011.

As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."  Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals.  The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

Earlier in 2010, the agency released a draft Safer Consumer Product Alternatives regulation, then held public meetings and workshops and took written comments.  Last week, the final, slightly revised draft, was issued. DTSC’s regulations call for identifying and prioritizing chemicals in consumer products, for conducting an alternatives assessment, and then an appropriate  regulatory response.

The proposed regulations call for creation of a proposed initial list of Chemicals under Consideration by June 1, 2012, and, from that an eventual list of Priority Chemicals by July 1, 2012. Similarly, the agency is to create a proposed initial list of Products under Consideration (because they contain the relevant chemicals) by March 1, 2013, and eventually a final list of Priority Products by December 1, 2013. In making this determination, the regulations offer a long list of relevant factors, including usage, distribution, disposal and life cycle issues, use by sensitive sub-populations, and a host of toxicity parameters.  One thing for manufacturers to watch: it is unclear how the DTSC will weigh and balance these and other factors. Especially important will be the relative emphasis on realistic, feasible exposure scenarios and dose, as opposed to theoretical risks in the lab.  A second area of potential concern here is that while the proposed regulations include a fairly detailed (and likely lengthy) petition process to challenge regulatory response decisions, they apparently do not include a similar ready process to seek removal of a chemical or product from the priority lists.  Thus, manufacturers and relevant trade associations will have to closely monitor the draft/proposed lists and jump into the comment period before the lists are finalized. Food, drugs, and a few other products are exempt, but the potential list of "consumer products" is quite large.

In the second phase involving Alternative Assessments, product makers will have to provide what may become a quite complex and expensive assessment of potential alternatives to the chemical/product, including a look at hazards, potential exposures, and life cycle.  For example, if the lead of the assessment team works for the manufacturer, the Assessment must be reviewed and verified by an independent third-party consultant.  It is unclear what data DTSC will want to see here, including whether the agency will require additional, new toxicity testing of a product or an alternative.  This may be especially onerous for smaller companies, and for newer technologies (think nano?) in which the existing body of data may not be as robust. One area for companies to watch here is the protection, or lack thereof, of trade secret information.  Ingredients in a product, and possible alternatives that make the product safer, are often a key part of intellectual property, a competitive advantage.  The regulations purport to offer some trade secret protection, but it s not crystal clear how the DTSC will apply this principle.

After receiving the Alternative Assessment, the DTSC is to decide on the best method, if any, to mitigate paternal risks with the product, ranging from no further action to recalls and bans.

The regulations offer a good reminder to double-check company knowledge and comfort with the supply chain, components and agreements, risk sharing provisions, insurance coverage, etc.

Senate Hearing on Toxic Chemicals Legislation

The Senate Committee on Environment and Public Works and the Subcommittee on Superfund, Toxics, and Environmental Health held a joint hearing yesterday, entitled “Oversight Hearing on the Federal Toxic Substances Control Act.”

The Senators heard testimony from Lisa Jackson, head of EPA; John Stephenson, Director of Natural Resources and Environment for GAO; and Linda Birnbaum, head of NIEHS and the National Toxicology Program.

Administrator Jackson argued that the Toxic Substances Control Act is in urgent need of reform because of "troubling gaps" in knowledge about many chemicals that have come into wide use since. She asserted that manufacturers of various “grandfathered” chemicals weren’t required to develop and produce the data on toxicity and exposure that are needed to properly and fully assess potential risks. [In a bit of drama, EPA’s Jackson was asked about some of the troubling emails recently disclosed about the apparent concerted effort of some to quash any scientific dissent to an aggressive view of global warming.]

The American Chemistry Council has noted that updating the legislation in certain respects made good sense, favoring a comprehensive approach, rather than the current patchwork of state and federal laws governing chemicals.

GAO’s representative testified that TSCA generally places the burden of obtaining data about existing chemicals on EPA rather than on chemical companies. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the over 83,000 chemicals already in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce each year for toxicity, and companies generally do not voluntarily perform such testing.

Dr. Birnbaum encouraged Congress to call for utilization of the new kind of toxicological testing that is less expensive and also gives an improved understanding of the actual effects of chemicals on humans. Toxicology is advancing from a mostly observational science using disease-specific models, she said, to a better, predictive science focused upon a broad inclusion of target-specific, mechanism-based, biological observations. This means using alternative assays targeting the key pathways, molecular events, or processes linked to disease or injury, and incorporating them into a research and testing framework.

Democratic legislators, including Sen. Lautenberg (D-NJ) have called for increased requirements for chemicals testing, and that “It's time to sound the alarm.” In an attempt to respond to industry concerns, Lautenberg argued that stronger regulations would somehow protect chemical companies from product liability suits—an ironic assertion at best as Democrats actively work to overturn express preemption for medical devices and extol the Wyeth v. Levine decision restricting implied preemption of drugs.

Of particular concern to readers of MassTortDefense would be efforts to eliminate the current risk-based review system under TSCA and force EPA to use the so-called precautionary principle.

It seems more supportable that any overhaul of TSCA should include the notion that scientific reviews must use data and methods based on the best available science and risk-based assessment; must include cost-benefit considerations for the private-sector and consumers; must protect proprietary business information, and should logically prioritize reviews for existing chemicals.

 

Update On China Drywall MDL

The judge handling the MDL involving the consolidated litigation involving Chinese manufactured drywall claims has issued a first order. Pursuant to Pretrial Order #1, the initial pretrial conference was set for July 9, 2009,  in the Courtroom of Judge Fallon. Earlier this summer, the U.S. Judicial Panel on Multidistrict Litigation agreed to consolidate a number of the suits in the U.S. District Court for the Eastern District of Louisiana. The suits have named as defendants the Chinese-based manufacturers, as well as importers, contractors, suppliers and others, including Knauf Gips KG, Knauf Plasterboard Tianjin Co., Taishan Gypsum Co., L&W Supply Corp., USG Corp. and Lennar Corp., the country’s second-largest home builder by volume.

The items listed in the Manual for Complex Litigation (Sections 22.6, 22.61, 22.62, and 22.63) were, to the extent applicable, set as a tentative agenda for the conference. (That may include adding parties, pleadings and motions, issue identification and development. ) Counsel were ordered to confer and seek consensus to the extent possible with respect to the items on the agenda, including a proposed discovery plan, any amendment of pleadings, consideration of any class action allegations and motions, and be prepared to select trial dates.

Plaintiffs and defendants were to submit to the Court before the conference a brief written statement indicating their preliminary understanding of the facts involved in the litigation and the critical factual and legal issues. (These statements will not be filed with the Clerk, will not be binding, will not waive claims or defenses, and may not be offered in evidence against a party in later proceedings.)

The Order covers a host of housekeeping issues for a new MDL. The Clerk will maintain a master docket case file under the style "In Re: CHINESE MANUFACTURED DRYWALL PRODUCTS LIABILITY LITIGATION” and the identification "MDL No. 2047 ".  All parties and their counsel were reminded of their duty to preserve evidence that may be relevant to this action. The duty extends to
documents, data, and tangible things in possession, custody and control of the parties to this
action, and any employees, agents, contractors, carriers, bailees, or other non-parties who possess materials reasonably anticipated to be subject to discovery in this action.

Prior to the initial conference, counsel for the plaintiffs and counsel for the defendant(s) were required to confer and seek consensus on the selection of a candidate for the position of liaison counsel for each group who will be charged with essentially administrative matters.

It is the Court’s intention to appoint a Plaintiffs’ Steering Committee (“PSC”) to conduct and coordinate the discovery stage of this litigation with the defendant’s representatives or committee.  The main criteria for membership in the PSC will be: (a) willingness and availability to commit to a time-consuming project; (b) ability to work cooperatively with others; and (c) professional experience in this type of litigation (d) willingness to commit the necessary resources to pursue this matter.

Behind the scenes, history suggests that a key issue underlying parts of the litigation the litigation will be whether the pollution exclusion applies. Insurers will likely argue that the alleged off-gassing of sulfur compounds from the Chinese drywall clearly constitutes the actual, alleged or threatened discharge, dispersal, seepage, migration, release or escape of pollutants (referencing terms of the typical exclusion clause).  There is a split of authority on the scope of such a pollution clause.  Some states have narrow definitions which favor policyholders, while the more broad definitions in other jurisdictions typically favor insurers. Choice of law may be the determining factor on this.

One builder (Dragas Management) has already been named in a declaratory judgment action by its insurer, Builders Mutual Insurance Co.  In addition to relying on a pollution exclusion argument, insurers seem intent on showing that each installation of drywall constitutes a separate “occurrence” under the policy, and as such, a separate deductible would apply to each. Builders would undoubtedly prefer a single deductible for the installation within an entire development or project.

Concerns over the drywall have prompted legislators, including Sens. Nelson, D-Fla., and Landrieu, D-La., to introduce the Drywall Safety Act of 2009, which seeks to impose a recall and a temporary ban on imports until federal drywall safety standards are put in place.

 

Summary Judgment For Defense In Dry Cleaning Chemical Case

The Seventh Circuit has affirmed the entry of summary judgment in favor of the defendant in a toxic tort case arising from dry-cleaning chemicals. See Cunningham v. Masterwear Corp., 2009 WL 1751429 (7th Cir. 6/23/09).

The plaintiffs, Bill and Mary Ann Cunningham, alleged that after they moved their photo studio next to a dry-cleaning business operated by defendant, Masterwear Corp., they began developing severe headaches, and Mr. Cunningham developed a bad cough. In December 2003, the Indiana Environmental Protection Agency allegedly told them that the level of perchloroethylene (PCE) levels in the building could be significantly high and may pose a health concern over the long term.  Plaintiffs contended that the PCE vapors detected were the result of improper storage of chemicals by Masterwear.   When the Cunninghams went to sell the building (which they also had started living in) after learning about the alleged danger from PCE, they claim they had to sell it at well below market price because of the vapors.

Judge Richard A. Posner, writing for the panel, held that the plaintiffs' medical expert did not  establish that the level and duration of plaintiffs' exposure of PCE could have caused their symptoms.  The plaintiffs' expert, a respiratory doctor, had never treated a respiratory illness caused or aggravated by PCE.  He relied on a report that showed that PCE can cause respiratory symptoms and headaches, but the reported concentration levels were well above the dose that plaintiffs were exposed to. Readers of MassTortDefense know that the founding principle of toxicology is that the dose makes the poison. The expert did not present, either directly or by citation to a scientific literature, a theory that would link the level and duration of the exposure of the plaintiffs to PCE to their symptoms.

While the state of Indiana had set safe exposure levels for PCE, plaintiffs' expert had not been able to specify what risks or dangers led the state to choose the “safe level” it did. For example, if exposure at a certain level to a chemical caused birth defects; a person who was exposed to above that level of the chemical and developed asthma could not attribute this to his exposure.

Turning to proof of the economic injury, the alleged impairment of the value of the plaintiffs' property presents a separate issue -contamination can reduce property values without endangering anybody's health, observed the court. But like the health issue, "causation turns out to be the plaintiffs' Achilles heel," said the opinion.  Judge Posner affirmed the district's court finding that the testimony about what the real estate agent thought the property worth and what prospective buyers had told the agent would have been inadmissible hearsay.   Mr. Cunningham proposed to testify that he had to accept a much lower price than the $135,000 he was asking because prospective buyers were concerned about the building being contaminated. Although Indiana law allows a property owner to testify about the value of his property, that information must be based on sufficient facts within his personal knowledge. In this case, it was inadmissible hearsay to testify about what a real estate agent said, and what potential buyers allegedly told the real estate agent.  The plaintiffs did not provide any evidence on the “critical question” related to their property value, i.e., how much they could have sold the building for had it not been for the contamination. What the owner is not allowed to do is merely repeat another person's valuation.


 

Defense Experts Pass Daubert Test in Stand 'n Seal MDL

In the multidistrict product liability litigation over "Stand ‘n Seal," a federal judge is allowing, over plaintiffs' objections, testimony from the defendants' causation experts.  Judge Thomas W. Thrash of the U.S. District Court for the Northern District of Georgia has ruled that three experts, who opined that Stand ‘n Seal does not emit sufficient amounts of the chemical which plaintiffs allege caused their injuries, including chemical pneumonitis, may testify. In Re Stand ‘N Seal Products Liability Litigation, MDL NO. 1804 (N.D. Ga.).

Plaintiffs in the roughly 200 personal injury actions in the MDL assert that Stand ‘n Seal  manufactured with Flexipel S-22WS caused respiratory problems. Stand ‘n Seal is a consumer product used to seal ceramic tile grout in kitchens, bathrooms, and similar areas. The advertised advantage of Stand ‘n Seal was that users can easily stand and spray the sealant onto the grout without the strain of using a brush and manually applying the sealant. The plaintiffs say that the
problems with Stand ‘n Seal began when the manufacturer changed its chemical components to include Flexipel.

Part of the defense has been the dose-response issue that plaintiffs could not have inhaled a harmful amount of the chemical while using Stand ‘n Seal as directed. The plaintiffs urged the court to exclude this expert testimony of Drs. Mark Rigler, William Longo, and Mitchell Sauerhoff.  Rigler and Longo, industrial hygiene experts, tested samples of Stand ‘n Seal and concluded that plaintiffs did not inhale an “analytically detectable” concentration of Flexipel, the specific chemical at issue.  They did not, contrary to plaintiffs' arguments, opine that users of Stand ‘n Seal had absolutely no exposure to Flexipel.  Instead, they have said that users of Stand ‘n Seal were not exposed to “any significant” or “analytically detectable” amounts of Flexipel. In other words, there is a range between zero and the detection limit of their testing, but they believe that range is insignificant.

Instead, said the defense experts, the users of Stand ‘n Seal had a much higher probability of inhaling significant levels of Isopar-G, a solvent used in various formulations of grouting. Defendants intend to offer expert testimony from Mitchell Sauerhoff that overexposure to Isopar-G can cause respiratory injury.  Judge Thrash concluded that the experts’ opinions were admissible. 

“The plaintiffs' experts disagree with Sauerhoff’s opinions, but that disagreement by itself does not make Sauerhoff’s or Rigler and Longo’s testimony inadmissible.”  The court noted that "none of these [potential alternative] explanations seems especially conclusive."  But the alleged generality of the defense experts’ alternate explanations for the cause of the plaintiffs’ injuries affect the weight, not the admissibility, of the expert testimony.”   MassTortDefense notes that plaintiffs often forget that the defendant does not have the burden to disprove causation.  So defense evidence of alternative causes can be admissible even if such evidence would be insufficient when offered by a plaintiff who has the burden of proof on causation.

 

Bills Pending To Overturn Important Causation Decision

Two bills are pending in the Texas legislature to overturn a significant toxic tort decision made by the state's highest court. In Borg-Warner Corp. v. Arturo Flores, 232 S.W.3d 765 (Tex.2007), the court required plaintiffs to prove they had a sufficient level of exposure to the toxic substance, asbestos.

Earlier in April, a committee of the Texas Senate approved by a 6-2 vote a bill relating to the
standard of causation in claims involving mesothelioma caused by exposure to asbestos
fibers. The bill, S.B. 1123, introduced by Sen. Robert Duncan, R-Lubbock, would require a plaintiff to prove that a defendant ’s product or conduct was a substantial factor in causing the exposed claimant ’s injury by presenting qualitative proof that the asbestos exposure attributed to the defendant was substantial, and not merely de minimis, when considering (1) the frequency of the exposure;  (2) the regularity of the exposure; and (3) the proximity of the claimant to the source of the asbestos fibers.  A plaintiff would not be required to prove numerically the dose, approximate or otherwise, of asbestos fibers to which the claimant was exposed that are attributable to the defendant.

A House bill, introduced by Rep. Craig Eiland, D-Texas City, is still pending in committee. H.B. 1811 would require proof that the defendant ’s product or conduct was a substantial factor in causing the exposed person ’s injury, by showing that the exposure to the asbestos fibers for which that defendant is alleged to be responsible contributed to the cumulative exposure of the exposed person and was more than purely trivial when considering the following (same) qualitative factors: (1) the frequency of exposure; (2) the regularity of exposure; and (3) the proximity of the exposed person to the source of the asbestos fibers. Plaintiff need not prove, for any purpose, a quantitative dose, approximate quantitative dose, or estimated quantitative dose of asbestos fibers to which the exposed person was exposed.

Such language would significantly lower the standard for providing causation in mesothelioma litigation. Perhaps the most widely cited standard for proving causation in asbestos cases is the Lohrmann “frequency, regularity, and proximity” test. Lohrmann v. Pittsburgh Corning Corp., 782 F.2d 1156 (4th Cir.1986). The court there rejected a standard that if the plaintiff can present any evidence that a company's asbestos-containing product was at the workplace while the plaintiff was at the workplace, a jury question has been established as to whether that product proximately caused the plaintiff's disease. Instead, the court concluded that to support a reasonable inference of substantial causation from circumstantial evidence, there must be evidence of exposure to a specific product on a regular basis over some extended period of time in proximity to where the plaintiff actually worked.

While the test seemed to be tighter standard than the plaintiffs’ proposed test, since a plaintiff must prove more than a casual or minimum contact with the product, in reality the test has loosened the traditional standards for substantial factor causation. In Borg-Warner, the court held that a “frequency, regularity, and proximity” test does not, in itself, capture the role of causation as an essential predicate to liability. As in many jurisdictions, the word “substantial” in substantial factor is used to denote the fact that the defendant's conduct has such an effect in producing the harm as to lead reasonable people to regard it as a cause, using that word in the popular sense, in which there always lurks the idea of responsibility, rather than in the so-called philosophic sense, which includes every one of the great number of events without which any happening would not have occurred.

Substantial factor in a toxic tort case cannot be analyzed without recognizing that one of toxicology's central tenets is that “the dose makes the poison.” This notion was first attributed to sixteenth century philosopher-physician Paracelsus, who stated that all substances are poisonous-there is none which is not; the dose differentiates a poison from a remedy. Even water, in sufficient doses, can be toxic. Dose refers to the amount of chemical that enters the body, and, is probably the single most important factor to consider in evaluating whether an alleged exposure caused a specific adverse effect. Not all asbestos exposures cause cancer, and the scientific literature shows that more exposure leads to more disease (dose-response).

Plaintiffs showed nothing about how much asbestos Flores might have inhaled. He was exposed to “some asbestos” on a fairly regular basis for an extended period of time. Nevertheless, absent any evidence of dose, the jury could not evaluate the quantity of respirable asbestos to which Flores might have been exposed or whether those amounts were sufficient to cause his disease. Nor did Flores introduce evidence regarding what percentage of that indeterminate amount may have originated in defendant Borg-Warner products. Plaintiffs did not prove the asbestos content of other brands of brake pads or how much of Flores's exposure came from grinding new pads as opposed to blowing out old ones. Plaintiff need not show dose with mathematical precision.  But in a case like this, proof of mere frequency, regularity, and proximity is necessary but not sufficient, said the court, as it provides none of the quantitative information necessary to support causation under Texas law.
 

The proposed legislation would overturn that clear and compelling logic.

EPA Releases New Strategic Plan for Evaluating Potential Toxicity of Chemicals

The U.S. Environmental Protection Agency released a new strategic plan last week that is designed to allow it to better assess potential risks from chemicals by adopting new toxicity testing methods. The “U.S. Environmental Protection Agency’s Strategic Plan for Evaluating the Toxicity of Chemicals” outlines a new scientific approach that will allow EPA to assess risks from many chemicals and mixtures by adopting new toxicity testing methods that use recent advances in molecular biology, genomics, and computational sciences.

Readers of MassTortDefense who have an interest in toxic torts know the impact that government testing and evaluation of chemicals can have on litigation. Under the EPA's traditional risk assessment approach, the agency relied mostly on data generated through the intentional high dosing of experimental animals. While this approach has provided EPA a basis for much regulatory decision-making over the past several decades, such testing has known limitations arising from the dose-response concept and inter-species variations. Traditional testing also has been less useful on complex issues such as cumulative exposures, life-stage vulnerabilities and genetic susceptibilities.

The new approach is to focus more on identifying and evaluating cellular response pathways responsible for adverse health effects when sufficiently perturbed by environmental agents under realistic exposure conditions. The new Strategic Plan is centered on three interrelated components: (1) the use of toxicity pathways identification and use of this information in screening and prioritization of chemicals for further testing; (2) the use of toxicity pathways information in risk assessment; and (3) the institutional transition necessary to implement such practices across EPA.

In addition to the scientific bases, the new forms of testing, when fully implemented, will permit EPA to screen more environmental chemicals more quickly for potentially harmful effects. The strategic plan will also allow EPA scientists to look at how children may react differently to the same chemicals as adults, thus providing better health protection for children, says the Agency.

The EPA plan builds on the 2007 report, Toxicity Testing in the 21st Century: a Vision and a Strategy, of the National Research Council of the National Academies of Science, regarding toxicity testing and risk assessment.
 

Defense Jury Verdict In Welding Rod Trial

Defendants last week secured another jury verdict in the federal welding rod MDL trials. Byers v. Lincoln Electric Co.,et al., N.D. Ohio, No. 04-17033. A jury delivered a verdict in favor of three rod manufacturers, finding they offered adequate warnings to an Alabama welder about potential negative health effects associated with working with their products.

The federal cases in the welding rod litigation are part of an MDL. In re Welding Fume Products Liability Litigation, MDL-1535 (N.D. Ohio). Although plaintiffs secured a significant verdict last December in the Tamraz case (currently on appeal), it was the first plaintiff victory in several years, and juries have found for defendants now, by our count, in 21 of the last 24 plaintiffs’ cases tried in this litigation, including consolidated cases that are heavily weighted toward plaintiffs and cases in jurisdictions that are considered plaintiff-friendly. Indeed, plaintiffs have moved to voluntarily dismiss more than 4,000 cases in the MDL. The total number of cases pending against the welding defendants has dropped by over two-thirds.

In the latest trial, Eddie Byers and spouse alleged his long-term exposure to manganese fumes released during the welding process caused him to suffer neurological problems in the form of a Parkinson's type disease. Plaintiffs claimed that the welding rod manufacturers should be held liable for allegedly failing to warn welders about the harms posed by manganese releases. Defendants, however, presented evidence showing that numerous warnings about the dangers of working around welding rods were given in Material Safety Data Sheets and other documents over the three decades that Eddie Byers worked as a welder.

Some see the jury's decision as an affirmation of what the industry has been saying all along—there is no scientifically proven link between welding rod exposure and neurological problems. But the fact that the jury found that the defendants did not distribute a product with a marketing defect seems as significant to MassTortDefense. In toxic tort litigation, juries can be helped to understand the potentially hazardous nature of chemicals or products which help provide important societal and economic benefits. If the information shared about the products addresses the potential risks, the defense is a long way towards home.
 

Summary Judgment In Benzene Case: Failure To Prove Dose

A federal court has granted summary judgment in a toxic tort suit in which plaintiff alleged he contracted a bone disease because of his long-term exposure to trace amounts of benzene in oil-based paint. Smolowitz v. The Sherwin-Williams Co., 2008 WL 4862981 (E.D.N.Y. Nov. 10, 2008). Plaintiff failed to offer sufficient evidence under New York law of exposure level.


In order to prevail in a toxic tort case, plaintiffs must present sufficient evidence to support a finding that defendants' products caused plaintiffs' injuries. Proof of causation requires establishing both “general” causation and “specific” causation.  General causation bears on whether the type of injury at issue can be caused or exacerbated by the defendant's product. Specific causation bears on whether, in the particular instance, the injury actually was caused or exacerbated by the defendant's product.  The fundamental principle of toxicology is that the dose makes the poison: substances that are benign or even beneficial at a certain level can be toxic at another. Even when general causation is clear, a plaintiff must show that he or she was exposed to a sufficient dose of the substance to have caused the disease. Under New York law, plaintiffs must establish both general and specific causation through expert testimony

Plaintiff Richard Smolowitz worked as a drywall taper and spackler over a thirty year period beginning in the 1950s and ending in the early 1980s. Plaintiff alleges that his exposure to benzene in paints caused him to contract myelodysplastic syndrome (“MDS”).  A central factual issue in this case, said the court, was the level of exposure to which plaintiff was subject, and whether that level of exposure can cause MDS. First, plaintiff was not a painter, but alleged he worked in areas where paint products were regularly used. Second, the solvents used in defendants' oil based paints contained only a trace contamination of benzene due to the fact that the products are based on petroleum, and it is not always possible to remove all of the benzene during the manufacturing process.

In early motion practice, plaintiff's counsel represented that he would provide the testimony of expert witnesses who could prove that plaintiff was exposed to oil based paints with sufficient levels of benzene to cause his illness. Eventually, he relied on the opinions of plaintiff's treating physician, Dr. Silverman, to provide expert testimony on issues of general and specific causation. The doctor reported he was currently treating plaintiff for MDS; that Smolowitz reported a history of exposure to oil based paints, thinners and benzene during a 35-year period; and that in his opinion it was “likely to a reasonable medical probability, that Mr. Smolowitz's exposure to benzene during the years that he worked as a dry-wall mechanic is causative for his current hematologic condition.”

The court concluded that Dr. Silverman's testimony was inadequate to prove either general or specific causation. The conclusory statement that based upon plaintiff's reported history it was likely to a reasonable medical probability that Mr. Smolowitz's exposure to benzene during the years that he worked as a dry-wall mechanic is causative for his current hematologic condition, had substantial deficiencies. First, there was nothing in this statement that suggests that Dr. Silverman was aware of or had quantified the precise amount of benzene to which plaintiff was exposed. No proof of dose. Second, Dr. Silverman did not offer any opinion as to whether that limited level of benzene exposure, whatever it was, can cause the disease. In the absence of sufficient evidence from an expert or a treating physician of the plaintiff's exposure level, plaintiff could not prove the essential causation element of the claim.
 

Latest BPA Update

Here is the latest on BPA:

1. NTP Issues Final Report

The National Toxicology Program issued its final report on bisphenol A (BPA) earlier this month. NTP continued its position from a much publicized draft report (see the post here) that it has some concern that the chemical – used in plastic bottles and other packaging -- could affect the development of the prostate gland and brain and potentially affect the behavior of fetuses, infants, and children. See The Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A.

The report provides the NTP’s current opinion on BPA’s potential to cause harm to human reproduction or development. The report is part of a review of the scientific literature on BPA and takes into consideration public and peer review comments received on the earlier draft report. According to NTP, about 2.3 billion pounds were produced in the United States in 2004, with more than 90 percent of the population being exposed to the substance.

The conclusions are based primarily on animal studies. The literature on experimental animal studies is filled with many conflicting findings, NTP says. And NTP admits that there remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects. NTP also states that more research is clearly needed to understand exactly how these findings relate to human health and development. There are a number of remaining uncertainties in the scientific information on BPA, according to the report.

The NTP is an interagency federal research program at the National Institute of Environmental Health Sciences, part of the National Institutes of Health. The report uses a five-level scale ranging from negligible risk to serious concern.

The report expresses “minimal concern” that BPA exposure will affect development of the mammary gland or accelerate puberty in females. (Previously, NTP said it had some concerns about those effects, but a panel of experts concluded that the program overstated its concerns about mammary gland effects and early puberty.) The NTP expressed “negligible concern” that exposure of pregnant woman to BPA will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring. And the report also expressed “negligible concern” that exposure to BPA causes reproductive effects in non-occupationally exposed adults and “minimal concern” for workers exposed to higher levels in occupational settings.


The FDA responded to the final report, noting that it would consider this final report at FDA's Science Board meeting concerning the FDA’s draft assessment of bisphenol A.  Which brings us to development No.2.

2. FDA Meeting
FDA held a public meeting last week, with a range of scientists, industry representatives, and consumer advocates debating aspect of bisphenol A usage.

The focus of the meeting was the FDA’s draft risk assessment that found continued use of bisphenol A in food-contact materials would be safe. Among the highlights:

An EPA toxicologist who served on NTP's expert panel said the NTP's statements that it has "some concern" meant more research was needed. It did not imply that the NTP expert panel had concluded that harm was being caused by the chemical.

A toxicologist working at the National Institute of Environmental Health Sciences said that NTP reported it had "some concern" about neurological, behavioral, and prostate effects because the animal studies that found those effects involved exposures at levels similar to those expected for infants.

The head of the pediatrics department of the Medical College of Wisconsin suggested that FDA conduct or fund more exposure research to get a better understanding of infants' exposure. FDA’s estimates and NTP’s estimates of typical exposure were slightly different.

A representative of the polycarbonate business unit of the American Plastics Council noted that there have been at least two studies of bisphenol A levels in infant formula since FDA completed its study, including one by the Environmental Working Group. All have found levels comparable to what FDA used.

Other speakers noted that BPA is a relatively well studied chemical, and compounds that could be used as substitutes are unlikely to have as much information available about their safety. Clearly, some uses of bisphenol A, such as in children's bicycle helmets, provide many safety benefits. BPA has also been found to be safe with an unmatched performance in lining cans. The Environmental Working Group, said there are substitutes, in their view, already on the market for uses such as in baby bottles.

A toxicologist from the University of Missouri-Columbia worried that FDA's recommended tests might mean it would take many more years before the agency might take any necessary regulatory action to reduce exposure.

John van Miller of the American Chemistry Council, cited the multi-dose, multigenerational, significant studies conducted in accordance with internationally agreed-upon protocols that have found bisphenol A to be safe. The "Reproductive Health Technologies Project" disagreed and underscored the need for studies in their view.

The Bisphenol A Subcommittee is to brief FDA's Science Board later this Fall on the subcommittee's recommendations. The Science Board will then develop its own recommendations for BPA.


3. JAMA Study
The Journal of the American Medical Association published a study last week which has been reported in the popular press as showing that subjects with higher levels of bisphenol A in their urine were more likely to report that they had heart disease or diabetes. See Association of Urinary Bisphenol A Concentration with Medical Disorders and Laboratory Abnormalities in Adults.

Higher levels of human urinary BPA were reportedly associated with cardiovascular disease, type 2 diabetes, and liver-enzyme abnormalities, according to the study, which was discussed at the FDA public meeting. The study used data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004. The survey involved the measured urinary bisphenol A concentrations of 1,455 adults, ages 18 through 74 years. 
 

The investigators noted that orally administered BPA is rapidly and completely excreted by humans.  On of the limitations of the analysis is its cross-sectional nature: it does not offer longitudinal data demonstrating that BPA concentrations predict later onsets of biochemical change or disease. The authors cautioned that their method may have resulted in false-positive associations. The authors have recommended an independent replication of the study, and follow-up studies to explore their findings and to provide evidence on whether the associations are causal. Not well reported in the media is the fact that the research team used four methods to measure whether bisphenol A was associated with diabetes, but found that association in only one of the four methods. The study thus is primarily useful for generating hypotheses that can be tested, not for drawing any conclusions on human health effects.

 

Federal Court Weighs In On Exposure Element Of Toxic Tort Claim

A federal court has weighed in on the issue of exposure in a toxic tort property damages suit, denying summary judgment and finding the presence of vinyl chloride in the air, even if undetectable, may constitute a physical injury to property under a common law property damage claim. Gates v. Rohm and Haas Co., 2008 WL 2977867 (E.D.Pa., July 31, 2008 ).

Plaintiffs in this putative class action sued Rohm and Haas and others pursuant to CERCLA, and state law, for damages allegedly resulting from contamination of their drinking water by pollutants that the Defendants allegedly generated and released. The proposed property damage class consisted of  about 500 "persons who presently own real property within McCollum Lake Village (‘Village’), or who owned real property within the Village as of April 25, 2006 through the present.” Defendants filed a motion for partial summary judgment with respect to the plaintiffs' common law property claims: public and private nuisance, negligent and intentional trespass, strict liability, negligence and negligence per se for damages arising out of alleged continuing airborne vinyl chloride contamination and past groundwater contamination.

The plaintiffs contended that this alleged “physical invasion” of their property by a carcinogenic contaminant caused a diminution in value of their property, in part due to the stigma caused by the alleged contamination. Rohm and Haas argued that applicable (Illinois) law does not recognize a cause of action for “economic harm” absent physical damage. The plaintiffs' property damage claim thus should fail because there was no evidence in the record of any physical injury to accompany the alleged economic injury (the diminution in value of the property due to supposed “stigma” associated with the alleged contamination).

According to the court, the first issue was the basic factual question of whether there was sufficient evidence of “present” contamination. The second issue was whether any such contamination constitutes a “physical injury.” And, finally, the third issue was whether diminution in value is an appropriate measure of damages based on the type of harm alleged.

A. “Present” Contamination
It was undisputed that at present no vinyl chloride or vinylidene chloride has been detected in any well in McCollum Lake Village. And it is undisputed that any alleged groundwater contamination was purely historical. It was unclear, however, to the court whether under Illinois law such past physical injury, coupled with ongoing alleged economic harm, suffices to permit pursuit of economic losses in tort. The fundamental factual question here for the court was whether there was sufficient evidence of permanent or ongoing physical injury to the plaintiffs' property. Although defendants made a strong showing, the court found a genuine dispute as to whether present levels of airborne vinyl chloride in McCollum Lake Village are below background levels and, accordingly, whether there is current airborne vinyl chloride “contamination.”


B. “Physical” Injury
Even assuming past and present vinyl chloride exposure, the court had to determine whether such exposure constitutes a “physical injury” for purposes of stating common law tort claims. The court reasoned that the presence of harmful chemicals in property loss actions is treated differently than the presence of non-hazardous materials. Notably, there is no requirement that a hazardous chemical be perceptible to the senses. The presence of an undetected hazardous chemical can support a claim for nuisance, thought the court. That the chemical is not immediately perceptible to the senses is not dispositive when when there is evidence of actual physical invasion of class area property.

Moreover, said the court, in contrast to the standards for medical monitoring claims, the exposure level need not necessarily present a health risk to make out a property damage claim. Such a view is not unanimous in the courts. E.g., Rockwell Int'l Corp. v. Wilhite, 143 S.W.2d 604, 620, 627 (Ky.App.Ct.2003); Rose v. Union Oil Co., No. 97-2808, 1999 U.S. Dist. LEXIS 967, at *3-4, *17 (N.D.Cal. Jan. 29, 1999). Nevertheless, this court concluded that the physical presence of vinyl chloride in the air, even if undetectable, constitutes a physical injury to the property for purposes of common law property damage claims.

C. The Appropriate Measure of Damages
Third, the court concluded that in the context of the present case, diminution in value was an appropriate measure of damages. The categorization of harm as “permanent” or “temporary” is not always dispositive. Rather than a compelling legal analysis to respond to defendant's strong argument on this point, the court resorted largely to the the generic policy observation that courts must be mindful of the fact that rules governing the proper measure of damages in a particular case are guides only and should not be applied in an arbitrary, formulaic, or inflexible manner. 
 

Daubert Decision in Mold Case

A legal malpractice case is the somewhat surprising setting for an interesting Daubert toxic tort opinion, but we found one. Young, et al. v. Burton, et al, 2008 WL 2810237 (D.D.C. 7/22/08).

Plaintiffs sued a law firm for allegedly failing to file a timely personal injury lawsuit for their alleged mold-induced injuries. The lawsuit would have sought recovery from a landlord for damages suffered by plaintiffs allegedly as a result of exposure to toxic mold while residing in a DC apartment building. In order to succeed on their legal malpractice claim, plaintiffs needed to show their underlying claim was meritorious. Thus, plaintiffs needed admissible expert testimony as to the cause, nature, and extent of their injuries.

Defendants moved to exclude the expert’s testimony, arguing that his opinions were not based on a reliable methodology.

Following a Daubert hearing, the Court concluded that the diagnosis of plaintiffs, as well as the proffered opinions relating to general and specific causation, were not sufficiently grounded in scientifically valid principles and methods to satisfy Daubert.

Exposure Claim

Plaintiffs resided in the apartment for approximately thirty-four days, during which time plaintiffs contend they could smell noxious fumes from raw sewage. They testified they noticed extensive visible mold growth in an adjacent vacant apartment, although they estimated they were in that apartment for no longer than one or two minutes. There was no documentation of any visible mold growth in plaintiffs', and plaintiffs did not believe the two apartments shared a common air source.

Both plaintiffs submitted extensive medical records to document the health problems that they attribute to their mold exposure, but medical records also indicated significant medical problems prior to moving into the apartment

Plaintiffs’ expert, Dr. Shoemaker, used his own differential diagnostic procedure for mold illness. That procedure involves a two-tiered analysis. To satisfy the first tier, all three of the following factors must be met: (1) the potential for exposure; (2) the presence of a distinctive group of symptoms; and (3) the absence of confounding diagnoses and exposures. The second tier looks at levels of certain hormones and enzymes in the blood which the expert believes are altered by exposure to a biotoxin and thus serve as “biomarkers.”

Defense Argument

Defendants requested a Daubert hearing, arguing that there was no evidence as to the exact substance plaintiffs were exposed to or the level at which they were exposed, and thus formal toxicological causation analysis could not be performed. In addition, the tests Dr. Shoemaker used to reach his diagnosis are experimental and “not generally accepted in the toxicology community.” The traditional causation analysis, relying on the nine “Hill Criteria” that are necessary to establish a causal relationship, does not support a causal association between the dark material on the adjacent apartment walls and the plaintiffs' health complaints. (In a nutshell, the Hill Criteria are: 1) strength; 2) consistency; 3) specificity; 4) temporality; 5) biological gradient; 6) plausibility; 7) coherence; 8) experiment; and 9) analogy).

Mold Disease Causation
Courts throughout the country have varied widely with respect to the level of certainty they require with respect to the issue of causation in mold cases. See Jeffrey J. Hayward, The Same Mold Story?: What Toxic Mold is Teaching us about Causation in Toxic Tort Litigation, 83 N.C. L.Rev. 518, 536-38 (2005). One common method of plaintiffs attempting to demonstrate causation is showing a temporal relationship between exposure to a toxin and subsequent adverse health effects. However, while necessary, temporal association between exposure and illness, without more, is generally insufficient to establish causation. Under the traditional approach, in the absence of an established scientific connection between exposure and illness, the temporal connection between exposure to chemicals and an onset of symptoms, standing alone, is entitled to little weight in determining causation.

The most widely-used method of demonstrating causation in toxic tort cases is to present scientifically accepted information about the dose-response curve for the toxin which confirms that the toxin can cause the health effects experienced by the plaintiff at the dosage plaintiff was exposed to. Indeed, scientific knowledge of the harmful level of exposure to a chemical, plus knowledge that the plaintiff was exposed to such quantities, are minimal facts necessary to sustain the plaintiff's burden in a toxic tort case.

Diagnosis Flawed
Dr. Shoemaker could not show that plaintiffs met his own case definition. In the first tier of Dr. Shoemaker's case definition, the patient must have had exposure; clearly, a person cannot be made ill by mold toxins to which she has not actually been exposed. No environmental tests were conducted in plaintiffs' apartment to provide actual proof that plaintiffs did, in fact, inhale toxic substances when they resided there.

Shoemaker attempted to show that plaintiffs had the requisite exposure in two ways, neither of which was convincing to the court. First, Dr. Shoemaker believed that his case definition allowed him to use the diagnosis of the disease as evidence of actual exposure. In short, the symptoms fundamentally become the basis for explaining themselves. Such circular reasoning is not scientifically or medically acceptable. And factually, plaintiffs' complex of symptoms did not begin immediately after exposure. Also, the symptoms did not remain consistent over time. Finally, Dr. Shoemaker was unable to determine which symptoms are actually attributable to the mold. Rather, he testified that roughly 75% of plaintiffs' symptoms were probably attributable to this mold exposure, although he could not say which ones.

The third element of the first tier of Dr. Shoemaker's diagnostic protocol is that there be an absence of confounding diagnoses and exposures. This requirement is critical to a differential diagnosis, which is to conclude that only the chosen diagnosis could be responsible for the symptoms presented. Nevertheless, Dr. Shoemaker glossed over the explanation of how he ruled out all potential confounding explanations for plaintiffs' symptoms. At points, Dr. Shoemaker brushed off discussion of confounding diagnoses as almost irrelevant.

The most fundamental flaw in Dr. Shoemaker's Tier 2 analysis was that not one of his biomarker tests is generally accepted or clinically validated for the purpose of diagnosing “mold illness.” Additionally, the idea that levels of these biomarkers five years after an exposure is in any way related to that exposure is unsupported by generally accepted science.


General Causation

Shoemaker arrived at his opinions on general and specific causation based on novel and unaccepted theories and methodologies. Plaintiffs’ general causation evidence confronted the problem that there was no way of knowing what substance the plaintiffs were in fact exposed to, as Dr. Shoemaker freely admitted he did not know what molds or bacteria were present in plaintiffs' apartment. Second, his own peer-reviewed publication on “mold illness” was far too limited to stand alone as proof of general causation; only twenty-six subjects participated in the study, and the double-blinded, placebo-controlled clinical trial involved only thirteen of those subjects.

Specific Causation

On specific causation, in short, Shoemaker did not perform his five-step protocol on plaintiffs, and indeed could not possibly have done so, as he first met them long after they left the suspected mold environment. Nor was he able to base his causation opinion on the plaintiffs' response to treatment, for both plaintiffs chose not to take the medication that he had prescribed for them. 
 

Defendants did an outstanding job of holding plaintiff's expert to the standards he himself created, but could not attain.

New BPA Study Released

At MassTortDefense we know the importance of well done scientific studies on causation, whether they be epidemiological studies of relevant populations, in vitro studies, or animal toxicology. While we don’t make a habit of posting about individual studies, BPA has been so much in the news, we thought it worth a mention of a recent animal study just published in the journal Toxicological Sciences. Tyl, et al., Two-Generation Reproductive Toxicity Study of Dietary Bisphenol A (BPA) in CD-1 (Swiss) Mice, with an abstract that can be found hereToxicological Sciences is the official journal of the Society of Toxicology and publishes peer-reviewed, hypothesis-driven, original research articles in all areas of toxicology.


The two-generation study exposed mice to a wide range of doses of bisphenol A, and found the chemical did not cause reproductive or developmental harm. The study was funded by the American Chemistry Council, and conducted under the oversight of the EU Bisphenol A Steering Group. That group, which included reproductive and developmental toxicologists from several countries, also had representatives of the World Wildlife Fund on behalf of nongovernmental organizations. The group impacted the study's design and the specific protocols used, and commented on the draft report analyzing the results.

The study was designed to fill in some of the blanks some felt existed in previous animal studies, by utilizing a species of mice particularly sensitive to hormone disruption; exposing the mice to the low doses where some say reproductive and developmental harm would occur; exposing the mice to the chemical in their feed, to mimic route of exposure; and keeping more of the mice alive longer than is typically done.

Clearly the debate over BPA will continue.