Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

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.

 

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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.

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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.

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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.

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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.

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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.
 

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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.
 

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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.
 

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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.

 

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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. 
 

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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.

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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 here.  Toxicological 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.

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