First Circuit Affirms Exclusion of Specific Causation Opinion

The First Circuit recently affirmed the exclusion of plaintiff's expert in a toxic tort claim, leading to summary judgment. See Milward v. Rust-Oleum Corp., No. 13-2132, 2016 WL 1622620 (1st Cir. 4/25/16).

Plaintiff Milward worked as a pipefitter and refrigerator technician for over thirty years. During the course of his employment, Milward was exposed to varying levels of benzene from paints and other products manufactured by (among others) Rust–Oleum Corporation. In 2004, he was diagnosed with Acute Promyelocytic Leukemia (“APL”). Three years later, Milward and his spouse sued Rust–Oleum.

To succeed against Rust–Oleum, the Milwards had the burden of establishing, through expert testimony, general and specific causation. In other words, they needed to show that exposure to benzene can cause APL (general causation), and that exposure to benzene was, in fact, a substantial factor in the development of Brian's APL (specific causation). The district court bifurcated the proceedings; it planned first to address the admissibility of expert testimony on general causation, and then to consider the specific causation issue.  

The issue on this appeal was specific causation. The Milwards retained occupational medicine physician Dr. Sheila Butler to serve as their expert witness, and the admissibility of her opinion testimony was at the heart of this appeal.  In her proposed testimony, Dr. Butler presented three theories.  First, she testified that although benzene is naturally occurring, there is no safe level of benzene exposure. This was her predominant theory, and she consistently reiterated her hypothesis. She emphasized that she reached this conclusion by examining “the biology, the pathophysiology, what the substance does to the person and the disease process.” And, she noted, she was able to do so without relying on any of the relevant epidemiological studies. Given this no-safe level theory, Dr. Butler maintained that Milward's exposure was likely the cause of his APL. The district court rejected this hypothesis because it could not be properly tested with any known rate of error. The Milwards did not meaningfully challenge the district court's conclusion on appeal.

Second, Dr. Butler rather cursorily concluded that even beyond the no-safe level hypothesis, certain epidemiological studies have established that an individual's “relative risk” of developing APL increases when exposed to specified amounts of benzene. She then compared Milward's exposure levels to those that had been found to be dangerous in that research. Since Milward's alleged exposure was higher than the amounts found to be hazardous, Dr. Butler reasoned that benzene exposure was likely the cause of his APL. Notably, she did not explain why she chose the studies on which she relied, nor did she address any study with contrary findings. In fact, during Dr. Butler's deposition, defendant's counsel asked her a number of questions about her ability and willingness to engage with the relevant epidemiological research. For instance, counsel asked, “Are you aware of any studies which find that there is no relationship between benzene exposure and APL,” to which she answered “Yes ... the literature has support for both.” Counsel then asked, “Do you intend in this case to weigh the different epidemiological studies and offer an opinion as to which ones we should rely on and which ones we should discount,” to which she replied, “No.”


Finally, Dr. Butler engaged in a so-called “differential diagnosis” to conclude that benzene exposure likely caused Milward's APL. Through this method (essentially a process of elimination) Dr. Butler “ruled out” some of the more common factors associated with APL, among them obesity and smoking. She then determined that since benzene exposure was a potential cause, she could also “rule out” an idiopathic diagnosis (or, a diagnosis without a known cause). Thus, since benzene exposure was the only significant potential cause remaining, she concluded that it was likely the culprit.

The court of appeals noted that it is NOT true that scientific studies must present diametrically opposing conclusions to be in tension with one another. Here, a number of studies were identified that showed a correlation between APL and benzene exposure at a specific level, while other studies do not show that correlation. In order to establish specific causation by the relative risk method, Dr. Butler was required to choose a study, or studies, to serve as a baseline to which she could then compare this case. There can be no serious question that choosing a study that showed a correlation above a specific level, rather than one that did not exhibit any such correlation, yields a vastly different comparison. The district court did not clearly err in finding that the studies were sufficiently distinct from one another such that utilizing one, rather than another, would necessarily lead to different testimony.  Generally, where an expert's medical opinion is grounded exclusively on scientific literature, a district court acts within its discretion to require the expert to explain why she relied on the studies that she did and, similarly, why she disregarded other, incompatible research. See, e.g., Kuhn v. Wyeth, Inc., 686 F.3d 618, 623–24 & 633 (8th Cir.2012) (permitting testimony where the expert witness relied on methodologically reliable studies and provided an explanation for why those studies were chosen); Norris v. Baxter Healthcare Corp., 397 F.3d 878, 886 (10th Cir.2005) (noting in the context of a general causation finding that the expert witness's inability to address contrary views made the opinion unreliable).

It is self-evident that, when an expert engages in a relative risk analysis in the manner that Dr. Butler did here, the district court is on firm ground in requiring such an explanation, since the validity of the approach depends on the reliability of the studies chosen. See 3 Mod. Sci. Evidence § 23:27 (2014–2015 Ed.) (discussing the use of the relative risk approach in establishing specific causation).  So, the district court reasonably ruled that there needed to be some indication of why Dr. Butler utilized the studies that she did. Indeed, her complete unwillingness to engage with the conflicting studies (irrespective of whether she was able to or not) made it impossible for the district court to ensure that her opinion was actually based on scientifically reliable evidence and, correspondingly, that it comported with Rule 702.

On the third issue, while a “differential diagnosis” can be a “reliable method of medical diagnosis: in some contexts, see Granfield v. CSX Transp., Inc., 597 F.3d 474, 486 (1st Cir.2010), an expert must still show that the steps taken as part of that analysis—the “ruling out” and the “ruling in” of causes—were accomplished utilizing scientifically valid methods. See Ruggiero v. Warner–Lambert Co., 424 F.3d 249, 254 (2d Cir.2005).  Since Dr. Butler was only able to “rule out” an idiopathic APL because she had “ruled in” benzene as a cause, the validity of her differential diagnosis turns on the reliability of that latter conclusion. See Ruggiero, 424 F.3d at 254 (noting that an expert must use reliable scientific methods to “rule in” causes); see also Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171, 179 (6th Cir.2009); Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989 (8th Cir.2001). Indeed, the reliability of that decision was particularly critical here given the extensive number of APL cases that are idiopathic. Under such circumstances, eliminating a number of potential causes—without properly and explicitly “ruling in” a cause—is simply “of little assistance.” Restatement (Third) of Torts; Phys. & Emot. Harm § 28, cmt. c(4)(2010).  

Dr. Butler “ruled in” benzene exposure solely by relying on her two other theories. But, both of these theories were unreliable. Given that the record did not contain a scientifically reliable basis to “rule in” benzene, Dr. Butler needed some other method to “rule out” an idiopathic diagnosis. She did not provide one. As such, the district court acted within its discretion to conclude that the extraordinary number of idiopathic APL cases, coupled with the lack of a reliable means to rule out an idiopathic diagnosis here, muted Dr. Butler's ability to reliably apply this methodology.

Once the district court excluded Dr. Butler's testimony, it then correctly granted Rust–Oleum's motion for summary judgment. As is well-established under Massachusetts law, “expert testimony is required to establish medical causation.” Reckis v. Johnson & Johnson, 28 N.E.3d 445, 461 (Mass.2015).

 

TSCA Reform Bill May Move Forward

The U.S. Senate appears to be moving closer to acting on a bill that would update the Toxic Substances Control Act. We have posted about this long effort several times

A version of the bill was passed by the House last June (TSCA Modernization Act, H.R. 2576), and the Senate version (now known as the "Frank Lautenberg Chemical Safety for the 21st Century Act" after the late Senator from NJ) came out of the Environment and Public Works Committee in the Spring. Recently the number of Senate co-sponsors jumped to approximately 60, suggesting movement may come. 

Both versions are intended to update TSCA, and the Senate bill will likely include  increased funding for EPA from fees on industry,and simplification of the waiver process for states. Possible sticking points include the degree of preemption of state law, a feature that really is necessitated by the need to have some national uniformity.

 

Medical Monitoring Class Action Rejected at Pleading Stage

A federal court recently rejected a proposed medical monitoring class action brought by alleged Pepsi drinkers.  The case reminds readers of the importance of the causation element of medical monitoring claims, even though plaintiffs don't need to allege traditional personal injury.  See Riva v. Pepsico, Inc., No. C-14-2929 EMC, 2015 WL 993350 (N.D. Cal.,  3/4/15).

Plaintiffs alleged that two of defendant's beverages contained levels of a chemical, 4–MeI, that caused them to experience an “increased risk of cancer,” specifically bronchioloalveolar cancer.  Plaintiffs sought  medical monitoring as a remedy; specifically, seeking an order requiring Pepsi to establish a “fund from which those individual class members can seek monetary recovery for the costs of actual or anticipated medical monitoring expenses incurred by them.”  Plaintiffs alleged that outcomes in bronchioloalveolar cancer show a clinically significant benefit from early evaluation, detection, and diagnosis. 

California is one of the few states that recognizes a claim for medical monitoring. “In the context of a toxic exposure action, a claim for medical monitoring seeks to recover the cost of future periodic medical examinations intended to facilitate early detection and treatment of disease caused by a plaintiff’s exposure to toxic substances.” Potter v. Firestone Tire & Rubber Co., 6 Cal.4th 965, 1004–05, 25 Cal.Rptr.2d 550, 863 P.2d 795 (1993). In Potter, the California Supreme Court identified five factors in determining the reasonableness and necessity of monitoring:
(1) the significance and extent of the plaintiff’s exposure to chemicals;
(2) the toxicity of the chemicals;
(3) the relative increase in the chance of onset of disease in the exposed plaintiff as a result of the exposure, when compared to
(a) the plaintiff’s chances of developing the disease had he or she not been exposed, and
(b) the chances of the members of the public at large of developing the disease;
(4) the seriousness of the disease for which the plaintiff is at risk; and
(5) the clinical value of early detection and diagnosis.

Based on such factors, the trier of fact decides, “on the basis of competent medical testimony, whether and to what extent the particular plaintiff’s exposure to toxic chemicals in a given situation justifies future periodic medical monitoring.” Id.

Defendant attacked the medical monitoring claim under Rule 12(b)(6), particularly as to the Potter factors related to whether medical monitoring is reasonable and necessary.  Accordingly, the Court examined the allegations related to these critical Potter factors: plaintiff’s exposure to chemicals; the toxicity of the chemicals; and the relative increase in the chance of onset of disease in the exposed plaintiff as a result of the exposure, when compared to (a) the plaintiff’s chances of developing the disease had he or she not been exposed, and (b) the chances of the members of the public at large of developing the disease.

To demonstrate the proximate causation element of the claim, a plaintiff seeking medical monitoring must. among other things, show the significance of her exposure to the toxic chemical. Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795; see also Abuan v. Gen. Elec. Co., 3 F.3d 329, 335 (9th Cir.1993) (applying comparable Guam law on medical monitoring). The California Supreme Court has explained, “[e]vidence of exposure alone cannot support a finding that medical monitoring is ... necessary.” Lockheed Martin Corp., 29 Cal.4th at 1108–09, 131 Cal.Rptr.2d 1, 63 P.3d 913. A plaintiff must demonstrate sufficient severity of exposure (its significance and extent) and that “the need for future monitoring is a reasonably certain consequence of [the] toxic exposure” Id. at 1109, 131 Cal.Rptr.2d 1, 63 P.3d 913 (citation omitted).

In this case, Plaintiffs alleged that the chemical had been found to cause lung tumors in laboratory animals -- at a daily dose thousands of times higher than the amount in soda.  Plaintiffs sought to represent a class of all persons who purchased Diet Pepsi or Pepsi One within a four-year period, regardless of consumption amount. What was missing was any allegation of what the significance of this unspecified exposure to the chemical may be; they did not allege what threshold level of exposure allegedly created the increased risk.

Thus, there was insufficient information about the significance and extent of exposure of the class to make the necessary ultimate showing that “the need for future monitoring is a reasonably certain consequence of [the] toxic exposure” Lockheed Martin Corp., 29 Cal.4th at 1109, 131 Cal.Rptr.2d 1, 63 P.3d 913. They simply failed to demonstrate a credible risk of bronchioloalveolar cancer resulting from the human consumption of cola products at the levels alleged by the named plaintiffs. In fact, if anything, the specific scientific finding incorporated into the Complalnt from the mice study was that the amounts of 4–MeI ingested in cola products “may not be significant.”

The Court also found that Plaintiffs had not sufficiently pled their injury or shown the toxicity of 4–MeI. It was not enough thatt 4–MeI is on the Proposition 65 list of known carcinogens, that a toxicologist has stated that there is “no safe level of 4–MeI,” and that advocacy groups have called for the FDA to ban 4–MeI.  The full picture was that “caramel coloring” (the manufacturing of which allegedly produces 4–MEI as a byproduct) is “generally recognized as safe” when used in accordance with good manufacturing practice and as a food color additive. Under the FDCA, the inclusion of “caramel color” as a “color additive” means that the FDA has determined that caramel coloring has not been found “to induce cancer when ingested by man or animal.” 21 U.S.C. § 379e(b)(5)(B).

So while Plaintiffs adequately pled that 4–MeI is toxic and is, generally speaking, a carcinogen—i.e., that 4–MeI is capable of causing cancer, they had not adequately pled their specific theory of injury—an increased risk for bronchioloalveolar cancer sufficient to warrant medical monitoring—“above the speculative level.” Twombly, 550 U.S. at 555. Plaintiffs are not mice, and there was nothing in the Complaint, or the studies incorporated by reference, to suggest that 4–MeI causes this specific form of lung cancer in humans. The same mouse study found no increased cancer in rats and discussed a “species difference” identified in previous studies in terms of how various species absorb, distribute, metabolize, and excrete this very chemical. So this study did not lead to a plausible inference that these Plaintiffs are at increased risk of the specific lung cancer for which they request screening. 


In short, the  Plaintiffs failed to plead factual content to show they had been injured due to a “significant” increase in their risk of lung cancer sufficient to justify medical testing in the absence of any symptoms or present injury. See Potter, 6 Cal.4th at 1008–09, 25 Cal.Rptr.2d 550, 863 P.2d 795. The only factual content supporting the allegation of increased risk of lung cancer came from scientific studies, which had no demonstrable bearing on cancer toxicity for humans at the consumption levels alleged in the case at bar.

A plaintiff seeking medical monitoring must show a need for “specific monitoring beyond that which an individual should pursue as a matter of general good sense and foresight.” Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795. In this case, Plaintiffs sought CT scans of their lungs and molecular screening for lung cancer. Lung scans are not needed to remedy injury absent a credible showing that 4–MeI causes this lung cancer in humans.

The Court took the Prop 65 argument head on.  Proposition 65 is broad; its listing embraces “ substances listed as human or animal carcinogens. In other words, “the Proposition 65 list includes chemicals that are known to cause cancer in animals, even though it has not been definitively established that the chemicals will cause cancer in humans.” Baxter Healthcare, 120 Cal.App.4th at 352, 15 Cal.Rptr.3d 430. Furthermore, listing under Proposition 65 only requires one excess case of cancer in an exposed population of 100,000, assuming lifetime exposure at the level in question. Because the burden on a defendant to fund medical screening for thousands, potentially millions, of people is so substantial, the Potter factors serve a critical gatekeeping function, regulating a potential flood of costly litigation; Potter requires a higher level of proof of health risk than that required for inclusion of a substance on the Proposition 65 list.

Finally, the Court addressed the increased risk above background, and other possible sources of exposure.  There can be many possible “causes,” indeed, an infinite number of circumstances which can produce an injury or disease. A possible cause only becomes “probable” when, in the absence of other reasonable causal explanations, it becomes more likely than not that the injury was a result of its action. This is the outer limit of inference upon which an issue may be submitted to the jury. As a result, under California personal injury law the mere possibility of causing cancer alone is insufficient to establish a prima facie case.

The Court said that this concept of causation inheres in the Potter test for the reasonableness of medical monitoring; the trier of fact considers, among other factors, “the relative increase in the chance of onset of disease in the exposed plaintiff as a result of the exposure, when compared to (a) the plaintiff’s chances of developing the disease had he or she not been exposed, and (b) the chances of the members of the public at large of developing the disease.” Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795. Consistent with this approach, the Ninth Circuit has affirmed a grant of summary judgment where plaintiffs seeking medical monitoring failed to introduce facts regarding the “quantitative (or even qualitative) increased risk to individuals.” Abuan, 3 F.3d at 335.

The Complaint admitted that there are many sources of consumption of 4–MeI, including “baked goods, confectionary, extruded breakfast cereals, instantaneous soups, and dark beers” as well as “soy sauce and coffee.” The many alternative sources of 4–MeI was problematic to the establishment of any causation between the Pepsi products at issue and the Plaintiffs’ alleged consumption of 4–MeI “at or above certain threshold levels” (whatever those threshold levels, if any, may be). The many sources of 4–MeI prevented these Plaintiffs from satisfying the third Potter factor.

Where the pleadings reveal so many commonly consumed foods with similar levels of a chemicaI, it is implausible to conclude that any alleged increased risk of cancer is “more likely than not” caused by drinking/using one product, said the Court.  As a result, the Plaintiffs’ claims were dismissed. See Twombly, 550 U.S. at 557 (“something beyond the mere possibility of loss causation must be alleged”).

 

 

Upcoming Seminar of Interest

Our readers may be interested in the upcoming seminar: Chemical Products Liability and Environmental Litigation.  

It's scheduled for April 22-23 in New Orleans, and includes topics such as Recent Developments In Fracking Litigation, and Navigating the Litigation Threat Stemming from Potentially Disruptive Regulatory Changes.

Your humble blogger is on the faculty.  I have the privilege of moderating a panel on In-House Perspectives: Thinking like Litigation Counsel, Analyzing Litigation Trends, and Sharing Insight about Docket Management.  The panel features Jennifer L. Ferratt, Esquire, of Chevron USA; Scott A. King, Esquire, from Occidental Chemical Corporation, and Eric S. Sarner, Esquire, of Praxair, Inc.

This is the 6th Annual conference and the prior years' drew great reviews from litigators in the toxic tort and environmental fields. 

Worth checking out.

State Supreme Court Reinstates Defense Jury Verdict in Silica Litigation

The Mississippi Supreme Court confirmed last week that the jury could have properly determined that plaintiff's evidence failed to prove in a silica case that he was exposed to harmful quantities of a particular supply company's sand product.  See Dependable Abrasives v. Pierce,  No. 2013-IA-01162-SCT (Miss., 1/29/15).  "Product id", as it is often called, is really part of cause-in-fact, and part of plaintiff's causation burden in a toxic tort case.

Plaintiff sued a number of defendants, alleging their sand products were responsible for his diagnosis of silicosis. According to Pierce's trial testimony, his job involved a work week of five to seven days, depending on weather, and workdays of eight to ten hours, operating a sandblasting machine.  It would shoot out sand at a high rate of speed through a nozzle, which was wielded by the machine's user, in order to clean surfaces for painting. Pierce testified that the sand proceeds from the nozzle at a rate of 500 miles per hour and that, when sand hits metal, it ricochets back in the direction of the machine's user. Plaintiff's expert testified that the warning on defendants' sand products were grossly inadequate, because it failed to inform the user of the product of the latent, danger of respirable silica.

At trial, the parties disagreed about whether the plaintiff was actually exposed to this defendant's sand. Pierce claimed he remembered the bag and could identify the logo.  He recalled there was a warning on the bag, but when asked the color of the sand he used from Dependable, he was certain it was white sand.  Dependable Abrasives had bought the sand, processed it, and at the relevant time mostly sold it in tanker trucks.  It was "in the beginning mostly probably around 90 percent bulk sand; 10 percent bag sand." Dependable offered evidence that while its competitors sold white sand, defendant sold brown sand "mined out of the red clay hills of Wiggins, Mississippi."

The jury returned a defense verdict, but the appellate court entered an order granting the plaintiff a new trial after that court found the verdict to be "against the overwhelming weight of the evidence presented at trial."

The Supreme Court noted that the fact of product exposure is a threshold question in products liability cases: "[I]t is incumbent upon the plaintiff in any products liability action to show that the defendant's product was the cause of the plaintiff's injuries." Banks ex rel. Banks v. Sherwin-Williams Co., 134 So. 3d 706, 710 (Miss. 2014). Even accepting as true Pierce's allegation that the warnings on the Diamond Blast sand were "grossly inadequate," as posited by his expert, there could be no recovery if Pierce failed to prove that the Defendant's sand "caused the damage for which recovery is sought."

Dependable contended that the evidence showed that there were only narrow time periods during which Pierce could possibly claim exposure, and that Pierce could not recall where or when he used or was exposed to Defendant's brand of sand. While Pierce was able to identify the Dependable Abrasives bag, he could not correctly identify the sand itself. He testified that the sand was white, but there was un-contradicted testimony that this company's sand was distinctly brown in color, due to its extraction from the red clay hills in or near Wiggins, Mississippi. There was testimony that defendant never sold sand, directly at least, to any of the companies for which Pierce had worked.

The Supreme Court decided that the circuit court had failed to analyze whether the jury's determination of causation truly was against the overwhelming weight of the evidence. Even though evidence was presented regarding the extent of Pierce's exposure to respirable silica, with respect to Dependable Abrasives, the evidence on product identification was mixed.  Pierce remembered the bag and the warning label, but could not accurately recall the color of the sand, the very product that he alleged had caused his injuries. If he was exposed at all, the time frame in which Pierce could have worked with Defendant's sand was minimal. Indeed, said the court, the evidence in this case was more favorable to the defense than to the plaintiff.  So, under the facts presented, this jury's  conclusion cannot be said to have been "against the overwhelming weight of the trial evidence.  The jury should have been permitted to pass upon the question of fact raised by this conflicting evidence, and it did so.  No new trial.

State High Court Rejects Mold Expert Opinion

Here's an interesting expert analysis that arises in the less common Frye context.  In Chesson v. Montgomery Mut. Ins. Co., No. 97 (Md., 9/24/13), the Maryland high court affirmed the exclusion of an expert's methodology for linking alleged mold exposure and the plaintiffs' illness; among other things, the approach failed to take into account the level of mold exposure plaintiffs experienced.

The case at hand originated in workers’ compensation claims filed by six employees of the Baltimore Washington Conference of the United Methodist Church. The employees claimed that they had sustained physical injury, specifically neurocognitive and musculoskeletal symptoms, as a result of exposure to mold in the Baltimore Washington Conference’s office. To prove causation, the employees proffered Dr. Ritchie Shoemaker as their expert. Montgomery Mutual, however,
sought to exclude Dr. Shoemaker under Frye (called Reed in this state), arguing that his methodology to determine causation was not generally accepted in the relevant scientific community.

After some procedural events, the lower court eventually held a Frye-Reed hearing, in which the judge considered whether the relevant scientific community generally accepted as reliable and
valid Dr. Shoemaker’s methodologies and theory that identified mold exposure as the cause
for the neurocognitive and musculoskeletal symptoms allegedly suffered by the employees.  At the hearing, Dr. Shoemaker testified that the indoor air of a water-damaged building known to contain mold caused neurocognitive and muscuoloskeletal symptoms. He based his opinion on something he called his “Repetitive Exposure Protocol,” in which he would identify the presence of mold in the building, through visual identification of mold, detecting a musty smell, or lab testing of a sample, such as a piece of drywall. The individual at issue would then be removed from the subject building and, for two weeks, receive a treatment to relieve the symptoms allegedly related to mold exposure, and then be returned to the subject building for three days, during which, he
opined, the individual would report that the symptoms had redeveloped.

The trial court allowed the testimony but the Court of Appeals held that Dr. Shoemaker’s testimony was not admissible under Frye-Reed, reasoning that his methodology was flawed and not generally accepted because it failed to account for the levels of mold exposure. The Court, moreover, concluded that based on an examination of relevant scientific journal articles that the scientific community remained uncertain as to Dr. Shoemaker’s techniques and conclusions.  The plaintiffs appealed.

The high court noted that in Maryland when an expert opinion is offered to support the existence of new or novel scientific theory or methodology, “the basis of that opinion must be shown to be generally accepted as reliable within the expert’s particular scientific field.” Reed v. State, 283 Md. 374, 381, 391 A.2d 364, 368 (1978), citing Frye v. United States, 293 F. 1013, 1014 (1923). The general acceptance test imposes a significant gate-keeping role on the judge to determine whether a scientific theory or methodology should be admitted for consideration by jury.  Moreover, validity and reliability are the linchpins of  the scientific method: validity, having been defined as the extent to which something measures what it purports to measure, and reliability, characterized as the ability of a measure to produce the same result each time it is applied to the same thing.

The court stressed that on cross-examination, Dr. Shoemaker admitted that he did not test any of the buildings, either the Baltimore Washington Conference’s office or any others in which an
individual resided or worked who underwent his “Repetitive Exposure Protocol,” to determine the level of mold exposure that an individual working or residing therein would have experienced. According to Dr. Shoemaker, the mere "identification" of mold in a building, even by the presence of a musty smell alone, was sufficient to conclude that an individual residing or working in that building inhaled mold that caused neurocognitive and musculoskeletal symptoms, without any further assessment of not only the level of mold, but also what other chemicals the plaintiff may have been exposed to.

Defendants called a Dr. Cheung who testified that Dr. Shoemaker’s “Repetitive Exposure Protocol”
was not generally accepted as valid in the relevant scientific community, not only because it was experimental as well as controversial in its “second tier” of biological markers approach and use of treatment drugs in an off-label fashion, as well as in its failure to account for stress levels in individuals, but also primarily because it failed to measure the levels of mold exposures by individuals in the water-damaged buildings. Mold exposure can be low to medium to high, he testified, and should include consideration of the pathways that mold must travel to reach an individual, such as the building’s ventilation system, walls, or ceiling, as well as the pressure or air flow of the building.  Dr. Cheung also testified to a survey that he had commissioned relative to whether Dr. Shoemaker’s diagnosis was generally accepted and found it was not.  Most importantly, Dr. Cheung testified regarding the absence of any study utilizing the scientific method that confirmed the relationship of mold exposure to neurocognitive and musculoskeletal symptoms.

The court also noted that other jurisdictions have determined that Dr. Shoemaker’s theory, based on his “Repetitive Exposure Protocol,” is neither generally accepted nor reliable. See Young v. Burton, 567 F. Supp. 2d 121, 130-31 (D.D.C. 2008) (also listing Virginia, Florida, and Alabama as jurisdictions rejecting Dr. Shoemaker’s theory).

The Court of Appeals agreed with the intermediate appeals court, finding that the expert's failure to account for the level of mold exposure was a fundamental flaw in his methodology .Without an expert's admissible opinion on causation, plaintiffs were unable to prove that mold in the walls of their office building was the cause of their neurocognitive and musculoskeletal symptoms.

 

Lone Pine Issue Appealed to State Supreme Court

Defendants in a fracking toxic tort case last week petitioned the Colorado Supreme Court to overrule an appeals court decision which had struck down a Lone Pine order issued by the trial court in the case. See Antero Resources Corp. et al. v. William G. Strudley et al., No. 2013SC576 (Colo. S. Ct.).

Readers may recall that we posted on this case before, describing the significant discovery and cost burdens presented by a case of this nature; the trial court had endeavored to invoke a more efficient procedure than we see in the standard case management order. The court required plaintiffs, before opening full two-way discovery, to make a prima facie showing of exposure and causation, a form of a Lone Pine order. See Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 635707 (N.J. Sup. Ct. Nov. 18, 1986). The court further determined that the prima facie showing requirement should not prejudice plaintiffs because ultimately they would need to come forward with this data and expert opinion on exposure and causation in order to establish their claims anyway.

Last month, the appeals court struck down the order finding there was no showing of "extraordinary circumstances" to require departure from the civil rules of procedure. Defendants sought an extension of time for filing a petition for writ of certiorari, which the Colorado Supreme Court granted.

Defendants recently filed a petition for writ of certiorari noting that the appeals court’s decision contradicts the many state cases endorsing active case management by trial courts. Those trial courts are vested with wide discretion to adopt non-standard case management procedures and to customize discovery based on the unique circumstances and needs of each case, particularly cases involving complex scientific or technical issues. 

The "good cause” to modify the standard case management order is fact-specific and thus a trial court finding it is entitled to deference on appeal. It unduly handcuffs and hamstrings the trial courts to suggest that it is beyond a trial court’s discretion to enter a modified case management order requiring toxic tort plaintiffs to come forward with basic evidence of exposure, injury and/or causation in an appropriate case.

This is definitely one to watch.

Failure of General Causation Proof Leads to Summary Judgment in Chemical Case

The Ohio appeals court ruled recently that a plaintiff could not pursue her chemical exposure toxic tort suit since her sole general causation expert's testimony was properly deemed unreliable by the lower court.  See Cooper v. BASF Inc., No. 26324 (Ohio Ct. App. 6/28/13).

The plaintiffs alleged they contacted a defendant Pest Control Company due to a termite infestation in various parts of their home, and the company applied Termidor SC, which contains the chemical fipronil, inside an open wall in the Coopers' bedroom, underneath a bathroom drain which is accessed through an opening under a sink cabinet, and around the perimeter of the house. A few months later, Mrs. Cooper was hospitalized complaining of various symptoms and was diagnosed with hypothyroidism and related encephalopathy, of unknown etiology. The plaintiffs claimed that the symptoms were caused by alleged exposure to pesticides.  The Coopers filed a complaint alleging: (1) negligence against the chemical manufacturer and the Pest Control Company; (2) strict products liability claims; and (3) fraud against the Pest Control Company.

The trial court ordered the Coopers to identify one or more expert witnesses who would support their theory of general and specific causation in this matter, and to make a submission that the expert was prepared to testify that  the chemical generally is capable of causing the medical conditions about which plaintiff complained and that in this specific instance there was a good faith basis for believing that her conditions were caused by her exposure to this chemical.  The Coopers identified Richard L. Lipsey, Ph.D., as their general causation expert.  Defendants moved to exclude the expert and for summary judgment.

The trial court granted the motions, finding that the expert had not based his opinion regarding general medical causation on reliable scientific, technical, or other specialized information. None of the articles or studies he reviewed showed a causal connection between Fipronil exposure and plaintiff's disease. The key epidemiological study of 103 workers exposed to Fipronil in the factory manufacturing flea collars found that symptoms associated with Fipronil exposure were temporary, and workers' conditions improved when no longer exposed. The animal studies cited by Dr. Lipsey failed to establish any correlation across species, and the expert had to admit that the animals used were not appropriate models for humans.

The court of appeals affirmed.  Ohio follows the Daubert test. And here the expert reached this conclusion without adequate scientific proof of a causal link between fipronil and hypothyroidism in humans. The record contained no evidence of any generally accepted methodology that has been adopted by the scientific community to establish a causal link between fipronil and hypothyroidism in humans. The court also noted, beyond the factors stressed by the lower court, that the expert testified that: (1) he had never written any peer-reviewed articles concerning the effects of pesticides on the human thyroid, (2) he had not done a dose reconstruction as to the amount of fipronil Mrs. Cooper was allegedly exposed to, and (3) there was no biological sampling done on Mrs. Cooper's blood or fatty tissue to prove that she had been exposed to a significant level of the chemical.

Without an expert opinion, summary judgment was appropriate as plaintiff could not prove the causation element of each cause of action.

Prop 65 Reforms Proposed

Our readers know how Prop 65 has created numerous issues for product sellers and created much litigation mischief in the hands of overzealous plaintiffs. Interesting that earlier this week, California Gov. Jerry Brown (D) said he now advocates reforms to California's law to frivolous lawsuits that do nothing to protect consumers.

The administration, through the California Environmental Protection Agency, wants to work closely with the state Legislature to revamp Proposition 65 by ending frivolous “shake-down” lawsuits. 

Voters approved Proposition 65 in 1986. The measure requires the Governor to annually publish a list of chemicals allegedly "known to the state to cause cancer or reproductive toxicity." If a business in California sells a product containing such chemicals listed by the state in excess of certain levels, the business must provide warnings to users or in the workplace.

The Governor wants reforms to:
• Cap or limit attorney’s fees in Proposition 65 cases.
• Require stronger demonstration by plaintiffs that they have information to support claims before litigation begins.
• Require greater disclosure of plaintiff’s information.
• Set limits on the amount of money in an enforcement case that can go into settlement funds in lieu of penalties.

The administration is worried about "lawyers who bring nuisance lawsuits to extract settlements from businesses with little or no benefit to the public or the environment." Since 2008, nearly 2,000 complaints have been filed by so-called “citizen enforcers.” Goofy suits include litigation against banks for failing to prevent second-hand smoke near their ATM machines.

The devil is always in the details, so it will be important to keep an eye on this.

 

Hearing Questions EPA Stance on Fracking

The House Subcommittee on Energy and Environment held a hearing earlier this week to review federal hydraulic fracturing research activities. The hearing examined research activities by the Environmental Protection Agency (EPA), Department of Energy (DOE) and the Department of Interior (DOI) in an inter-agency effort to “address the highest priority challenges” related to the production of domestic unconventional oil and natural gas resources.  Readers may recall we have posted about fracking issues before. 

Chairman Lamar Smith (R-Texas) noted a widely publicized handful of unsubstantiated charges that fracking pollutes ground water; the EPA is at the center of this debate, linking fracking to water contamination in at least three cases, only to be forced to retract their statements after further scrutiny.

Members questioned administration witnesses on the objectives of the interagency initiative as they relate to the administration’s regulatory intentions and track record of unsubstantiated attacks on the safety of hydraulic fracturing.  

Witnesses included:

Dr. Kevin Teichman, Senior Science Advisor, Office of Research and Development, Environmental Protection Agency
Mr. Guido DeHoratiis, Acting Deputy Assistant Secretary for Oil and Gas, Office of Fossil Energy, Department of Energy
Dr. David Russ, Regional Executive, Northeast Area, U.S. Geological Survey
Dr. Robin Ikeda, Acting Director, Agency for Toxic Substances and Disease Registry, Department of Health and Human Services

The hearing also noted the administration’s interagency working group had committed to release a draft of their research plan by October 2012 and complete the final plan by January 2013. The Administration has yet to even release a draft for public comment. 

Energy Subcommittee Chairman Cynthia Lummis (R-Wyo.) noted that her home state of Wyoming is at the center of this issue since the EPA put it in the national spotlight with a “draft” report implying that fracking was somehow responsible for the quality of the water. However, in the days and weeks that followed this announcement, the State of Wyoming, industry, and other federal agencies exposed EPA’s study as deeply flawed.

Environment Subcommittee Chairman Chris Stewart noted that largely as a result of the expanded use of cheap natural gas from 2005 to 2011, the U.S. has decreased its carbon dioxide output more than any other nation, including those countries that have implemented aggressive green energy agendas, such as Germany and Spain.  It is perhaps ironic that many of the most passionate advocates for action on climate change also oppose fracking.

CAFA Local Exception Rejected

 A federal court in Georgia ruled last week that a proposed class action alleging injury from chemical exposures was properly removed under the Class Action Fairness Act of 2005.  See Anderson v. King America Finishing Inc., No. 1:11-cv-2258-JEC (N.D. Ga., 3/25/13).


Plaintiffs alleged that defendant King America Finishing released a toxic chemical into the Ogeechee River from its manufacturing plant in Dover, Georgia. According to plaintiffs, the toxic chemical release caused damage to surrounding land downstream from the Dover plant. In addition, plaintiffs claimed that certain individuals who swam in the Ogeechee River suffered from physical injuries due to the release. Plaintiffs filed a class action complaint in Fulton County Superior Court. They purported to represent a property damage class defined to include “[a]ll possessors of property affected, directly or indirectly, by [the May, 2011] release of chemicals into
the waters of the Ogeechee River.” One named plaintiff also purported to represent a personal injury class defined to include “[a]ll persons who have been exposed, directly or indirectly, with the waters of the Ogeechee River that had been contaminated by the Release.”


Defendants removed the case to federal court pursuant to the Class Action Fairness Act (“CAFA”), 28 U.S.C. §§ 1332(d) and 1453. CAFA generally provides for the removal of any class action in which there is: (1) minimal diversity, (2) at least 100 putative class members and (3) $5 million in alleged damages. 28 U.S.C. §§ 1332(d)(2) and 1453. It was undisputed that these requirements were met in this case. Plaintiffs conceded that all of the named plaintiffs were diverse from defendant, that the putative class exceeded 100 members, and that the claims exceeded $5 million in damages.

Nevertheless, plaintiffs filed a motion to remand the case to state court, based on the “local controversy” exception to CAFA jurisdiction, which provides for the remand of a class action that “uniquely affects a particular locality to the exclusion of all others.” Evans v. Walter Indus., Inc., 449 F.3d 1159, 1164 (11th Cir. 2006). Specifically, a “local controversy” is defined by CAFA as a class action in which: (1) greater than two-thirds of the class members are citizens of the state in which the action was originally filed, (2) at least one “significant” defendant is a citizen of the state in which the action was filed and (3) the principal injuries alleged in the action were incurred in the state in which the action was filed. 28 U.S.C. § 1332(d)(4)(A).

Defendants did not dispute elements 2 and 3. The argument among the parties centered on the two-thirds requirement.  Under CAFA, plaintiffs bear the burden of proving that the exception applies. In order to meet their burden on the two-thirds requirement, plaintiffs had to present evidence from which a court could credibly adduce that more than two-thirds of the purported class members were Georgia citizens. Plaintiffs used tax and voter registration records,  reference to the Secretary of State’s Corporation website, and interviews of personal injury class members who were determined by interview to be Georgia citizens, to just get over the threshold.

The court rejected their calculations, finding no sound evidentiary basis for including several of these groups in the calculation. For example, with regard to the legal entities, the Secretary of State’s website merely lists a Georgia office address for each entity. The website does not indicate that any of these entities have their “principal place of business” in Georgia. In addition to the evidentiary issues with the numerator in plaintiffs’ equation, there were serious questions about the denominator as well. Both the property and the personal injury classes were defined broadly in the complaint to include all land and persons directly or indirectly allegedly impacted by the May, 2011 release. Given that broad definition, the property class likely included many more members than the 900 or so landowners in the particular geographical area chosen by plaintiffs’ attorneys for their showing. Likewise, there could be many more individuals who were “indirectly” injured by the release than the 20 potential class members interviewed by plaintiffs.  The court could not simply speculate about the citizenship of these unaccounted for class members.
Accordingly, the court denied the plaintiffs' motion for remand.

Medical Monitoring at Issue in Oklahoma Federal Court

Readers know that medical monitoring is a recurring topic here at MassTortDefense.  Here is one to keep an eye on, as a defendant recently asked the Oklahoma federal court to reject plaintiffs' claim for medical monitoring in a putative class action. Mitchell McCormick, et al. v. Halliburton Co., et al., Np. 5:11-cv-0127 (W.D. Okla.).

Plaintiffs, about three dozen residents of Duncan, Okla., are seeking, inter alia, medical monitoring, establishment of a class-wide medical registry, and payment for medical research to assist alleged disease identification, prevention and treatment, based on allegations  that defendants exposed the town's residents to toxic substances.

Defendants have moved to dismiss, arguing that there is no cognizable claim for a medical monitoring remedy under Oklahoma law. Defendants noted the absence of any Oklahoma statutes or state court decisions recognizing or even suggesting the availability of medical monitoring, and the important public policy considerations that disfavor medical monitoring relief. Specifically, medical monitoring for uninjured plaintiffs (1) encourages highly speculative claims and equally conjectural awards; (2) diverts scarce medical resources away from truly injured individuals who need them most; (3) subjects defendants to open-ended liability; and (4) places significant strain on a judicial system that is generally ill-equipped to formulate and then supervise complex medical monitoring regimes.

Such fears are reflected in the prevailing trend in other jurisdictions to reject such claims. See Rhodes v. E.I. duPont de Nemours & Co., 657 F. Supp. 2d 751, 774 (S.D. W. Va. 2009) (noting post-Buckley trend); Norwood v. Raytheon Co., 414 F. Supp. 2d 659, 667 (W.D. Tex. 2006) (discussing “the recent trend of rejecting medical monitoring as a cause of action” in light of Buckley); see also Zarov et al., A Medical Monitoring Claim for Asymptomatic Plaintiffs: Should Illinois Take the Plunge?, 12 DEPAUL J. HEALTH CARE L. 1, 2 (2009).

The defendants cited additional authority: Hinton v. Monsanto Co., 813 So. 2d 827, 830 (Ala. 2001) (“To recognize medical monitoring as a distinct cause of action . . . would require this Court to completely rewrite Alabama’s tort-law system, a task akin to traveling in uncharted waters, without the benefit of a seasoned guide. We are unprepared to embark upon such a voyage.”); Badillo v. Am. Brands, Inc., 16 P.3d 435, 441 (Nev. 2001) (en banc) (“[W]e hold that Nevada common law does not recognize a cause of action for medical monitoring”); Wood v. Wyeth-Ayerst Labs., Div. of Am. Home Prods., 82 S.W.3d 849, 857 (Ky. 2002) (“We are supported in rejecting prospective medical monitoring claims (in the absence of present injury) by both the United States Supreme Court and a persuasive cadre of authors from academia. These authorities explain that, while well-intentioned, courts allowing recovery for increased risk and medical screening may be creating significant public policy problems.”); Henry v. Dow Chem. Co., 701 N.W.2d 684, 703 (Mich. 2005) (“To recognize a medical monitoring cause of action would essentially be to accord carte blanche to any moderately creative lawyer to identify an emission from any business enterprise anywhere, speculate about the adverse health consequences of such an emission, and thereby seek to impose on such business the obligation to pay the medical costs of a segment of the population that has suffered no actual medical harm.”); Paz v. Brush Engineered Materials, Inc., 949 So. 2d 1, 5-6 (Miss. 2007) (refusing to recognize a claim for medical monitoring allowing a plaintiff to recover medical monitoring costs for mere exposure to a harmful substance without proof of a current actual bodily injury); Lowe v. Philip Morris USA, Inc., 183 P.3d 181, 187 (Or. 2008) (“[W]e hold that negligent conduct that results only in a significantly increased risk of future injury that requires medical monitoring does not give rise to a claim for negligence.”). 

But see Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424, 431 (W. Va. 1999); Meyer v. Fluor Corp., 220 S.W.3d 712, 717-18 (Mo. 2007); Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891, 901 (Mass. 2009).

 

Medical Monitoring Claim Rejected by Federal Court

Readers know that medical monitoring claims are a focus of MassTortDefense.  In a recent case, a federal trial court granted summary judgment on a medical monitoring claim with an opinion that makes a salient point.  See Sahu v. Union Carbide Corp., 2012 WL 2422757 (S.D.N.Y. June 26, 2012.)

Plaintiffs filed suit as members of a putative class against Union Carbide Corporation, seeking monetary damages and medical monitoring for injuries allegedly caused by exposure to soil and drinking water polluted by wastes allegedly produced by the Union Carbide India Limited plant in Bhopal, India.  After years of discovery and tens of thousands of pages of document produced, defendants were able to move for summary judgment as to all theories of liability.  Specifically, plaintiffs brought negligence, public and private nuisance, and strict liability claims against UCC, seeking compensatory and punitive damages, as well as medical monitoring, for injuries allegedly caused by the Bhopal Plant operations.  But our focus in this post is on the medical monitoring claims.

Plaintiffs in the "Medical Monitoring Class” sought  a “court-ordered medical monitoring program for the early detection of various illnesses which they may develop as a result of exposure to the contaminants and pollutants to which they have been exposed"   The court rejected the claim, noting that medical monitoring was not a feasible remedy,  and was one which would face insurmountable hurdles: locating thousands of people who have resided 8,000 miles away in Bhopal, India, over a span of more than thirty years would be nearly impossible. Plaintiffs sought  relief on behalf of themselves, their families, their minor children, and a putative class of similarly situated people who “continue to reside in the municipal wards and residential areas in the vicinity of the UCIL plant and continue to be exposed to toxins” from contaminated soil and groundwater. Administration of such a program would require identification of every resident considered to be living “in the vicinity” of the Bhopal Plant site, and then further identification of those residents who “continue to be exposed to toxins.” To confirm exposure, it would be necessary to test the soil and drinking water supply throughout Bhopal. Literally construed, plaintiffs' complaint seemed to seek medical monitoring for every current resident of the Bhopal area—an impossible task.

This analysis is a refreshing counterpoint to the alarming feature of some recent medical monitoring decisions, in which the difficulty of identifying and ascertaining class members is somehow de-coupled from class certification and from the elements of the medical monitoring claim, and somehow relegated to an "administrative" feature of the relief program.

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).
 

Amicus Urges Supreme Court to Reverse Causation Junk Science Decision

DRI (the Defense Research Institute) last week submitted an amicus brief urging the Supreme Court to review a federal appeals court decision that threatens to undermine the gatekeeper role of the trial courts on expert testimony. United States Steel Corp. v. Milward v. Acuity Specialty Products Group Inc., No. 11-316 ( U.S., amicus petition filed 10/12/2011).

Most of our readers know that DRI is an international organization that includes more than 23,000 attorneys involved in the defense of civil litigation.  DRI has long been a voice in the ongoing effort to make the civil justice system more fair, efficient, and—where national issues are involved—consistent. (Your humble blogger is a member.)

In this case, the plaintiff alleged that he contracted a rare form of cancer, acute promyelocytic leukemia (APL), through exposure to benzene or benzene contaminants. The plaintiff’s expert acknowledged that science has not determined what causes or can cause APL, but opined that, based on his own "judgment," the "weight of evidence" supported a conclusion that APL could be caused by benzene exposure. After a four-day hearing, the district court excluded the expert testimony as unreliable under Daubert, and Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997)(district courts need to exclude proof that is connected to the data only by the ipse dixit of an expert), finding that it amounted to no more than a plausible hypothesis. The U.S. Court of Appeals for the First Circuit reversed and reinstated the case, holding that it was an abuse discretion to exclude this evidence as to possible causation.

The First Circuit in this case appeared to think that district courts not only may but must admit speculative expert testimony that rests on nothing more than the expert’s subjective judgment that an untested hypothesis is supported by the “weight of the evidence.”  That decision conflicts with Supreme Court guidance and with the decisions of other circuits holding that expert testimony is admissible only when it rests on a reliable scientific foundation, and that a district court is not required to accept an expert’s ipse dixit but must instead carefully examine the methods and data underlying the expert’s opinion to ensure that the expert has reliably applied valid scientific principles. Without such an inquiry, the “gatekeeper” function the Federal Rules of Evidence envision for the district court judge becomes meaningless.

DRI correctly points out that the weight-of-the-evidence methodology the court of appeals endorsed does not satisfy the criteria Daubert adopted for assessing the reliability of expert testimony. It is neither testable nor falsifiable; it is not governed by any objective standards; and it has not been generally accepted by the scientific community as a means to assess medical causation absent an observed association between the substance and disease at issue. The fact that some regulatory agencies use an arguably similar, lower bar, methodology to assess risks to public health based on the available data does not mean that it yields “scientific knowledge” admissible under the very different standards governing a court proceeding.

Moreover, the district court’s essential gate-keeping role is particularly important on the issue of medical causation. That issue is often dispositive in toxic tort and product liability cases, which can involve enormous stakes not only for the parties, but also for the national economy. The lay jurors who decide these complicated issues are likely to be greatly influenced by testimony that appears to be scientific in nature coming from a witness whom the court has admitted as an "expert." The decision by the First Circuit undermines the critical screening function district courts perform to prevent juries from being misled by speculation masquerading as scientific knowledge.

 

State Appeals Court Rejects Medical Monitoring

The Wisconsin court of appeals last week affirmed the dismissal of a plaintiff's medical monitoring complaint for failure to state a claim.  Alsteen v. Wauleco Inc.,  No. 2010AP1643 (Wis. Ct. App., 6/14/11).

Plaintiff alleged that, while living in a nearby neighborhood, she was exposed to carcinogenic
chemicals that defendant Wauleco allegedly released from the Crestline window factory. Alsteen did not allege that she suffered any present health problems due to this exposure; however, she contended she was at an increased risk of developing cancer in the future. She therefore sought damages for future medical monitoring expenses.

From approximately 1946 to 1986, operations at the Crestline site included treatment of wood products with a preservative called “Penta.”  Plaintiff alleged that Penta contains hazardous chemicals, including dioxins, pentachlorophenol, and benzene. These chemicals, plaintiff asserted, are harmful to human health and some are classified as possible carcinogens. As a result, the air, soil, surface water, and groundwater in her River Street neighborhood allegedly  became contaminated with dangerous levels of these hazardous chemicals. Current and former residents of the neighborhood had ingested, inhaled, and absorbed these chemicals, the complaint averred.

Some neighbors sued for personal injuries; others sued for property damage.  A third group, including plaintiff, sued for medical monitoring.  Readers know we have posted on medical monitoring issues before.

The trial court dismissed the action for failure to state a claim.  The key issue on appeal was whether Wisconsin law recognized a cause of action for medical monitoring, for increased risk of future disease in the absence of present injury. The court of appeals affirmed, relying on Wisconsin case law that requires actual injury before a plaintiff may recover in tort;  on the reasoning of the Supreme Court’s decision in Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424 (1997)(asymptomatic railroad worker who had been exposed to asbestos could not recover medical monitoring expenses under FELA); and on the persuasive reasoning of courts in several other jurisdictions that have addressed the issue and have articulated sound policy reasons for refusing to recognize medical monitoring claims in the absence of actual injury.

Increased risk of future harm is not an actual injury under Wisconsin law.  Meracle v. Children’s Service Society of Wisconsin, 149 Wis. 2d 19, 437 N.W.2d 532 (1989), and mere exposure to a chemical is not an affront to plaintiff's body that constitutes an actual injury. Dyer v. Blackhawk Leather, LLC, 313 Wis. 2d 803, 758 N.W.2d 167 (2008).  The court recognized that while medical monitoring in essence substitutes the increased risk of future disease for the traditional tort injury element, this argument is inconsistent with Wisconsin law, which requires plaintiffs to prove present injury. This "argument turns tort law on its head by using the remedy sought —compensation for future medical monitoring — to define the alleged injury."  See also Henry v. Dow Chem. Co., 701 N.W.2d 684, 691 (Mich. 2005). Similarly, other courts have rejected the argument that the "need" for medical monitoring itself is an injury, reasoning, “With no injury there can be no cause of action, and with no cause of action there can be no recovery. It is not the remedy that supports the cause of action, but rather the cause of action that supports a remedy.” Wood v. Wyeth-Ayerst Labs., 82 S.W.3d 849, 855 (Ky. 2002).

The state court also found persuasive the worries of the Supreme Court in Buckley: First, it recognized that medical monitoring claims present  special difficulties for judges and juries who will be forced to identify which costs are the extra monitoring costs, over and above those otherwise recommended. This problem is compounded by uncertainty among medical professionals about just which tests are most usefully administered and when. The Court also expressed concern that permitting a medical monitoring claim without actual injury could lead to unlimited and  unpredictable liability.

Importantly, the state court here recognized that many of the policy concerns identified in Buckley also apply in the context of a court-supervised medical monitoring fund (as opposed to damages). Specifically, the Supreme Court’s concerns regarding the difficulty of assessing the costs of the remedy, unlimited and unpredictable liability, and confusion over application of secondary sources of payment, apply regardless of the form of remedy.

Finally the court aligned itself with the trend in recent cases around the country to reject such claims: E.g., Henry, 701 N.W.2d 684; Hinton v. Monsanto Co., 813 So. 2d 827 (Ala. 2001); Lowe v. Philip Morris USA, Inc., 183 P.3d 181(Or. 2008); Badillo v. American Brands, Inc., 16 P.3d 435 (Nev. 2001); Paz v. Brush Eng’d Materials, Inc., 949 So. 2d 1, 3, 5 (Miss. 2007).

The court accordingly refused to “step into the legislative role and mutate otherwise sound legal
principles” by creating a new medical monitoring claim that does not require actual injury.

 

.

 

Appeals Court Upholds Summary Judgment Based on Daubert in Benzene Case

The Sixth Circuit last week upheld the dismissal of a plaintiff''s claim that benzene exposure caused her cancer. Pluck v. BP Oil Pipeline Co., No. 09-4572 (6th Cir.,  5/12/11).  The central issue was the exclusion of plaintiff's causation expert's opinion based on a "differential diagnosis" that failed to reliably rule in benzene exposure as a potential cause of plaintiff's cancer, and to rule out some other potential exposures.

This case arose from benzene contamination allegedly caused by gas-pipeline releases allegedly resulting in the seepage of gasoline into the surrounding soil and groundwater. Benzene, a component of gasoline, is a known carcinogen in sufficient doses under certain exposure circumstances, and is also ubiquitous in the ambient air and is a component or constituent of vehicle exhaust and cigarette smoke, said the court. Plaintiffs purchased a home in the area,  and used well water to drink, wash, shower, and irrigate their yard and garden. In October,  1996, plaintiffs say they noticed a gasoline odor in their home and water, and benzene was first detected in the well on their property in the amount of 3.6 parts per billion (“ppb”).  They began drinking bottled water in lieu of tap water, although they claim to have resumed drinking tap water upon the drilling of a new, deeper well. Between 1997 and May 2002, the new well tested negative for benzene twenty-two times.

Mrs. Pluck was diagnosed with Non-Hodgkins lymphoma (“NHL”) in 2002 at age forty-eight. She filed suit, alleging claims of strict liability for hazardous activity, negligence, and loss of consortium. To support their claims, plaintiff and spouse retained Drs. Joseph Landolph and James Dahlgren as experts on causation to demonstrate that benzene is generally capable of causing NHL and specifically caused Mrs. Pluck’s NHL. Defendant filed motions in limine to exclude the testimony of Dahlgren and Landolph on the grounds that their testimony failed to satisfy the standard for reliability set forth in Daubert. In particular, BP argued that Dr. Dahlgren’s testimony on specific causation was unreliable because he formulated a specific causation opinion without evidence of dose, and subsequently performed an unreliable dose reconstruction in an attempt to support his opinion.  Dahlgren then submitted a supplemental declaration in which he evaluated Mrs. Pluck’s illness under a "differential-diagnosis" methodology. The district court granted the motions, and plaintiff appealed.

In a toxic tort case, as here, the plaintiff must establish both general and specific causation through proof that the toxic substance is capable of causing, and did cause, the plaintiff’s alleged injury.  As to specific causation, the plaintiff must show that she was exposed to the toxic substance and that the level of exposure was sufficient to induce the complained-of medical condition (based on a dose-response relationship). Both causation inquiries involve scientific assessments that must be established through the testimony of a medical expert. Without this testimony, a plaintiff’s toxic tort claim will fail.

The Plucks had to concede that the expert Dr. Dahlgren did not establish dose; they instead argued that Dahlgren used differential diagnosis to determine specific causation. Defendant argued that Dr. Dahlgren did not apply differential diagnosis in either his expert opinion or his deposition, but did so only in an untimely supplemental declaration filed five months after the deadline for expert reports. And in any event, his approach was flawed. The Sixth Circuit has recognized differential diagnosis, properly done, as an appropriate method for making a determination of causation for an individual instance of disease. Differential diagnosis -- originally a standard technique for determining what disease caused a patient's symptoms -- has been adapted in some courts as an acceptable scientific technique for identifying the cause of a medical problem by eliminating the likely causes until the most probable one is isolated. A physician who applies differential diagnosis to determine causation considers all ("rules in") relevant potential causes of the symptoms and then eliminates ("rules out") alternative causes based on a physical examination, clinical tests, and a thorough case history.

Even in courts that accept this adapted method, not every opinion that is reached via a differential-diagnosis method will meet the standard of reliability required by Daubert.  Calling something a “differential diagnosis” or “differential etiology” does not by itself answer the reliability question but prompts at least three more:

(1) Did the expert make an accurate diagnosis of the nature of the disease?

(2) Did the expert reliably rule in the possible causes of it?

(3) Did the expert reliably rule out the rejected causes?

If the court answers “no” to any of these questions, the court must exclude the ultimate conclusion reached.

Here the court agreed that Dahlgren could not reliably “rule in” benzene exposure as the cause of Mrs. Pluck’s NHL. In recognition of the fact that benzene poses a health concern at certain levels of exposure, the EPA has stated that the maximum permissible contaminant level for benzene in
drinking water is 5 ppb. 40 C.F.R. § 141.61(a)(2). Dahlgren, however, did not ascertain Mrs. Pluck’s level of benzene exposure, nor did he determine even whether she was exposed to quantities of benzene exceeding the EPA’s safety regulations. The levels of benzene in the Plucks’ wells never exceeded the maximum permissible contaminant level of 5 ppb designated by the EPA.

Dahlgren’s opinion that Mrs. Pluck’s “low-level exposure” to benzene caused her NHL was thus not grounded in “sufficient facts or data,”  nor did it reflect the “reliable principles and methods” required by Rule 702. It was, instead, pure conjecture.  Although the Plucks argued that the district court required too much specificity regarding Mrs. Pluck’s dose, this argument was also without merit. The mere existence of a toxin in the environment is insufficient to establish causation without proof that the level of exposure incurred could cause the plaintiff’s symptoms. See also McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1242 (11th Cir. 2005) (causation “requires not simply proof of exposure to the substance, but proof of enough exposure to cause the plaintiff’s specific illness”).

Finally, even if Dr. Dahlgren had properly “ruled in” benzene exposure as the cause plaintiff's NHL, he failed to “rule out” alternative causes of her illness, as is required under the differential-diagnosis methodology. See also Wills v. Amerada Hess Corp., 379 F.3d 32, 50 (2d Cir. 2004) (expert’s opinion suffered from a “fatal flaw” when he acknowledged that cigarettes and alcohol were risk factors for developing squamous-cell carcinoma but failed to account for these variables in concluding that decedent’s cancer was caused by exposure to toxic chemicals such as benzene and PAHs).  In this case, Dahlgren acknowledged in his deposition that Mrs. Pluck was
exposed to other sources of benzene, from her extensive smoking habit and from other organic solvents.  Yet, Dr. Dahlgren neither identified these other solvents nor determined Mrs. Pluck’s potential level of exposure to these other possible sources of benzene.Thus, Dahlgren failed to “rule out” alternative causes of Mrs. Pluck’s NHL.

The court of appeals determined that the district court did not abuse its discretion in concluding that the expert did not perform a reliable differential diagnosis.  And summary judgment properly followed.

 

Court of Appeals Vacates Class Certification in Toxic Tort Case

The Fifth Circuit has vacated the decision of the trial court in granting class status to a group of plaintiffs alleging that a refinery exposed them to toxic dust. Madison v. Chalmette Refining LLC, No. 10-30368 (5th Cir. 4/4/11).

Back in 2007, a number of schoolchildren, chaperoned by parents and teachers, participated in a historical reenactment at the Chalmette National Battlefield, the site of the January 8, 1815, Battle of New Orleans, the last great battle of the War of 1812 and “the site along the Mississippi River where Andrew Jackson gave the British their comeuppance.” D. BRINKLEY, The Wilderness Warrior: Theodore Roosevelt and the Crusade for America,p. 414 (2009). Adjacent to the battlefield is the Chalmette Refinery, which allegedly released an amount of petroleum coke dust that migrated over the battlefield. Plaintiffs sued on behalf of a class of all persons or entities located at the Chalmette National Battlefield in St. Bernard Parish, Louisiana, in the early afternoon of Friday, January 12, 2007 and who sustained property damage, personal injuries, emotional, mental, or economic damages and/or inconvenience or evacuation as a result of the incident.

The District Court granted the motion to certify, and defendants appealed. The court of appeals reviews the district court's decision to certify a class for an abuse of discretion. See, e.g., McManus v. Fleetwood Enters., Inc., 320 F.3d 545, 548 (5th Cir. 2003). The decision to certify is within the discretion of the trial court, but that discretion must be exercised within the framework of Rule 23. Castano v. Am. Tobacco Co., 84 F.3d 734, 740 (5th Cir. 1996).  The Supreme Court requires district courts to conduct a rigorous analysis of Rule 23 prerequisites.

The crux of this appeal was the legal basis for and sufficiency of evidence supporting the district court’s findings of superiority and predominance under Rule 23(b)(3). Before certifying a class under Rule 23(b)(3), a court must determine that questions of law or fact common to the members of the class predominate over any questions affecting only individual members and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy. Determining whether the plaintiffs can clear the predominance hurdle set by Rule 23(b)(3) requires district courts to consider how a trial on the merits would be conducted if a class were certified.

Chalmette Refining cited the advisory committee note to Rule 23(b)(3), which has been quoted numerous times by the Fifth Circuit as highlighting the “relationship between predominance and superiority in mass torts.” See Castano v. American Tobacco Co., 84 F.3d 734, 745 n.19 (5th Cir. 1996). According to the note, a  “mass accident” resulting in injuries to numerous persons is ordinarily not appropriate for a class action because of the likelihood that significant questions, not only of damages but of liability and defenses to liability, would be present, affecting the individuals in different ways. In these circumstances an action conducted nominally as a class action would degenerate in practice into multiple lawsuits separately tried.

Here, the district court abused its discretion by failing to afford its predominance determination the “rigorous analysis” that Rule 23 requires. In particular, the district court did not meaningfully consider how plaintiffs’ claims would be tried.  Plaintiffs cited, and the trial court relied on, two cases that are among the very few certifying a tort injury class action. In Watson v. Shell Oil, the court certified a class of over 18,000 plaintiffs seeking damages stemming from an explosion at a Shell plant. 979 F.2d 1014, 1016 (5th Cir. 1992). Notably the court of appeals now clarified that "whether Watson has survived later developments in class action law–embodied in Amchem and its progeny–is an open question."  But even in Watson, the district court had a detailed four-phase plan for trial. Similarly, in Turner v. Murphy Oil USA, Inc., the district court granted class certification to a class of plaintiffs who suffered damages resulting from a post-Hurricane Katrina oil storage tank spill. 234 F.R.D. 597, 601 (E.D. La. 2006). Critical to the court’s predominance inquiry was the fact that plaintiffs had submitted a detailed proposed trial plan to the court, calling for bifurcation of certain issues.

In contrast, here there was no analysis or discussion regarding how the court would administer the trial.  Robinson v. Tex. Auto. Dealers Ass’n, 387 F.3d 416, 425–26 (5th Cir. 2004). The court failed to identify the substantive issues that would control the outcome, assess which issues will predominate, and then determine whether the issues are common to the class. Absent this analysis, it was impossible for the court to know whether the common issues would be a significant portion of the individual trials, much less whether the common issues predominate.  Instead, the trial court appears to have "adopted a figure-it-out-as-we-go-along approach." 

Even among the named class representatives, significant disparities existed, in terms of exposure, location, and whether mitigative steps were taken. The primary issues left to be resolved would turn on location, exposure, dose, susceptibility to illness, nature of symptoms, type and cost of medical treatment, and subsequent impact of illnesses on individuals.

 


 

District Court Upholds Punitives in Surprising Decision

In a surprising and somewhat questionable decision, the U.S. District Court for the Northern District of Ohio recently upheld a jury verdict awarding punitive damages with a ratio of more than 6-1 between punitive and compensatory damages. Cooley v. Lincoln Electric Co., No. 1:2005-cv-17734 (N.D. Ohio, 3/7/11).

The case was part of the welding fumes mass tort.  Plaintiff Curt Cooley used welding rods at work and home for about 40 years. After being diagnosed with a form of manganese poisoning, Cooley  sued several welding rod manufacturers, alleging that defendants knew that inhaling welding fumes presented a risk of irreversible neurological injury but failed to adequately warn of the risk.

The overwhelming majority of welding rod verdicts have been for defendants, but here a jury returned a verdict for plaintiffs, awarding $787,000 in compensatory damages, after reduction for the allocated plaintiff's comparative fault of 37%, and $5 million in punitive damages.

In post-trial motions, defendants moved, inter alia, for reduction of the punitive damages. In BMW
of North America, Inc. v. Gore
, the Supreme Court articulated three guideposts for lower courts to use in evaluating whether a punitive damages award is excessive. These guideposts are: (1) “the degree of reprehensibility” of defendants’ conduct; (2) “the disparity between the harm or potential harm suffered by [Cooley] and his punitive damages award;” and (3) “the difference between this remedy and the civil penalties authorized or imposed in comparable cases.”  The court here seemed overwhelmed by the first factor and gave insufficient weight to the second and third.

In State Farm Mutual Automobile Ins. Co. v. Campbell, the Supreme Court articulated five criteria for evaluating the degree of reprehensibility: (1) “the harm caused was physical as opposed to economic;”  (2) “the tortious conduct evinced an indifference to or a reckless disregard of the health or safety of others;” (3) “the target of the conduct had financial vulnerability;” (4) “the conduct involved repeated actions or was an isolated incident;” and (5) “the harm was the result of intentional malice, trickery, or deceit, or mere accident.”

The trial court found that the first two criteria allowed the jury to find a high degree of  reprehensibility. Here, the harm to Cooley was physical, but not fatal. Yet, the court rejected defendants' argument that this factor is not as strong as it is in cases where a person died as a result of a defendant's conduct.  The court concluded  that the jury was entitled to conclude defendants knew manganese in welding fumes could cause permanent neurological injury, but chose to give an inadequate warning.

The second guidepost looks to the mathematical relationship between compensatory and
punitive damages. The trial court stressed that the Supreme Court has avoided imposing a bright-line ratio between compensatory and punitive damages, and ignored the numerous cases questioning high single-digit multipliers, which are less likely to comport with due process. The trial court rejected the observation that for some defendants the ratio was close to 9-1. The jury awarded $1.25 million in compensatory damages, but assigned 37% fault to Cooley,
reducing the compensatory award to $787,500. It awarded punitive damages in the total amount of
$5 million, allocated among the defendants as: ESAB, $1.75 million; Hobart, $1.75 million; Lincoln, $750,000; and BOC, $750,000. Using a logical approach, the ratios are as follows: ESAB, 8.9:1; Hobart, 8.9:1; Lincoln, 3.8:1; and BOC, 3.8:1. But, if, instead, the ratio is not calculated for each individual defendant, the overall ratio is still $5 million divided by $787,500, or 6.3:1. The court was persuaded by the fact that all of these ratios, using either of these different approaches, are single-digit.  The court also found that the reprehensible conduct supported a higher ratio.

The court went on to twist the next factor - the comparison of punitives to compensatories-  right around.  It noted that whether viewed as $1.25 million or $787,500, the compensatories were "not large considering Cooley’s circumstances."   For example, Cooley testified he is depressed and
impotent, which are symptoms of manganese poisoning. All things considered, the jury’s award of
compensatory damages was "relatively conservative, making for a low denominator in the ratio." And since the denominator was "conservative" and "low," the higher ratio when compared to punitives was permitted.  However, the same jury that found punitive damages level conduct, found plaintiff 37% at fault, and awarded all of the damages it thought were appropriate to fully compensate the plaintiff.  This is not a case where the multiplier was high because the  compensatory damages are merely a nominal sum in recognition of an injury difficult to quantify in monetary terms.  As the court noted, this case involves a significant injury, and the jury awarded what it awarded.  The court seemed to be approaching the line of substituting its assessment of damages for the jury's, and upholding the punitive award because the compensatory award was too "conservative."

Defendants also argued that the punitive damages award was excessive because, using the factor of comparison to other fines and penalties, civil penalties under OSHA would be limited to approximately $70,000, the maximum fine per violation. The court rejected this because OSHA has never found a violation or fined defendants, and thus "analysis of this issue is necessarily speculative."  In fact, the comparison is not just to actual fines assessed, but to potential fines in order to give the court an idea of how the legislature and society would assess a penalty for the conduct alleged. If it was is unclear whether OSHA would treat the conduct in plaintiff's workplace as a single violation subject to a maximum fine of $70,000, as defendants argued, or impose a fine separately for pieces of the conduct, as plaintiff argued, the issue should have been decided, not pushed aside.

Finally the court rejected any relevance to any aspect of the punitive damages ratio analysis of the fact that Cooley's injury might have been avoided had he read a warning or a Material Safety Data Sheet, particularly those sent in the last decade of his career. This was only relevant to comparative fault for compensatory damages, said the court. But, in reality, it should have been considered a major factor in the reprehensibility analysis.

 

 

CPSC and CDC Release Report on Alleged Drywall Deaths

The Consumer Product Safety Commission released a report of an investigation it had requested be performed by the CDC's National Center for Environmental Health regarding deaths allegedly associated with exposure to imported drywall.  The report concludes that the drywall was not a contributing factor in the deaths of the people who had previously lived in or visited homes reported to contain problem drywall.

The investigation included reviews of the pertinent medical records,  interviews of witnesses, and available information from state public health authorities.   The CDC review confirms the results of previous reviews conducted by CPSC itself.  The cause of death in each case was clearly a primary, and often secondary, pre-existing chronic health condition.  Subjects typically had multiple long-term, severe, pre-existing conditions.  

We have posted about the drywall issues here and here


 

Multi-State Coalition On Chemicals Management Formed

Readers have been following our posts on new state efforts on chemical regulation, such  as California's Green Chemistry initiative. Now comes word that environmental officials from 10 state and local governments have formed an umbrella organization - the Interstate Chemicals Clearinghouse (IC2) - with the stated goals of promoting a clean environment, healthy communities, and a vital economy through the development and use of safer chemicals and products.

The states joining IC2 include California, Connecticut, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, and Washington.

The goals of the IC2 are to:

  • Avoid duplication and enhance efficiency and effectiveness of state, local, and tribal initiatives on chemicals through collaboration and coordination
  • Build agency capacity to identify and promote safer chemicals and products
  • Ensure that state, local, and tribal agencies, businesses, and the public have ready access to high quality and authoritative chemicals data, information, and assessment methods

Launched under the auspices of the Northeast Waste Management Officials' Association (NEWMOA), the new Clearinghouse says it will support state, local, and tribal health and environmental agencies with development and implementation of programs to promote use of safer chemicals and products; support the development of alternative assessment methods and identification of safer alternatives; share data and information on chemical use, hazard, exposure, and alternatives; share strategies and outcomes on chemicals prioritization initiatives; and build the capacity of agencies by sharing materials, strategies, and trainings.  IC2 has a number of projects planned in these areas.

The Northeast Waste Management Officials Association's announcement of the IC2 comes just as many chemical manufacturers are expecting that the federal government (including through an update to TSCA) will take the lead in regulating chemical products, not state regulatory agencies and legislatures.

Industry groups, including the American Chemistry Council, continue to believe that a patchwork of state and local programs has the potential to create more confusion for consumers and manufacturers, and may ultimately simply hamper investment, and threaten future job creation.  As we have noted, some of the bills introduced in the last Congress would have set an impossibly high hurdle for all chemicals in commerce, and were guaranteed to produce significant technical, bureaucratic and commercial barriers. 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.



 

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.

Third Circuit Rejects Medical Monitoring in Device Case

The Third Circuit has properly recognized that a claim for medical monitoring claim does not lie against the manufacturer of a medical device product. See M.G. v. A.I. DuPont Hospital for Children, No. 09-1426 (3d Cir., 8/24/10).

Readers may recall the post about this appeal last year.  Doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware, had implanted a Cheatham Platinum stent (“CP stent”) in plaintiffs, who alleged that they had been injured or were at risk of injury from the use of the CP stent. After discovery, the trial court granted summary judgment to defendants on a number of the claims, but summary judgment was denied on Count VI, the medical monitoring claim. The trial court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action if presented with the facts of these cases.

The trial court recognized that there were substantial grounds for disagreement over whether Delaware will actually recognize a cause of action for medical monitoring. Even if the Delaware Supreme Court were to recognize a medical monitoring claim, there were substantial grounds for disagreement over whether plaintiffs here could state a claim. Plaintiffs' specific theory that medical devices can be the basis for a medical monitoring claim is novel, at best (and has been rejected in many states: Drugs and devices do not present the same policy issues as involuntary exposure to environmental toxins). The trial court was satisfied that plaintiff's novel theory here was one in which certification of an interlocutory order for appeal was appropriate.

The Third Circuit noted that plaintiff’s claim entitled “Medical Monitoring” contended that “[a]s a direct result of defendants’ acts, omissions, and conduct, plaintiffs . . . who have received NuMED CP stent have been exposed to a hazardous procedure and product, and suffered a significantly increased risk of the side effects caused by this device. This increased risk makes periodic diagnostic and medical examinations reasonable and necessary.”

While the district court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action, the appeals court didn't have to reach that broader question because it concluded that plaintiffs were unable to establish the elements necessary to state a claim for medical monitoring.

Defendants contended on appeal  that the trial court erred in extending Delaware law beyond the bounds of the recognized medical monitoring claim (in those minority of states that accept it) in which a plaintiff alleges long-term involuntary exposure to a proven toxic substance with known tendencies to produce serious future medical injuries. The Third Circuit agreed, finding no persuasive cases anywhere in which a free-standing medical monitoring claim has been allowed to proceed although the plaintiff has not demonstrated significant exposure to a toxic (poisonous) or proven hazardous substance. The lower court’s prediction that the Delaware Supreme Court would permit a claim for medical monitoring on this record thus requires several “leaps” from the current state of the law, generally, let alone Delaware law.

Specifically, here, there was no toxic or hazardous substance, as such. While unapproved devices are termed “adulterated”, they are not necessarily harmful, and certainly not toxic. Moreover, the risk here is not a risk of  “contracting a serious latent disease.” Rather, it is a risk of the need for further care. Further examinations are not to “monitor” the risk of disease, but to perform routine
oversight of the device. Thus, even if the Delaware Supreme Court would recognize a “standard” medical monitoring claim --one which requires a plaintiff to demonstrate that a defendant’s
negligence caused the plaintiff to be exposed to a proven hazardous substance that resulted in a significantly increased risk of contracting a serious latent disease -- the plaintiff here could not demonstrate that she had been exposed to a proven hazardous substance, nor could she prove that such exposure resulted in a significantly increased risk of contracting a serious latent disease.

Accordingly, the court found that plaintiff was unable to establish the elements necessary to make out a claim for medical monitoring.  Summary judgment should have been granted.

On a personal note, also on the winning brief was my former partner, the late R. Nicholas Gimbel, Esq., an outstanding advocate, in one of his last cases.  On the amicus brief for PLAC was my colleague James M. Beck, Esq.
 

California Takes Next Steps On "Green Chemistry"

Readers know how California's often extreme statutory and regulatory initiatives can influence toxic tort litigation.  Now comes word that California regulators last week released a proposed framework for forthcoming regulations to reduce certain chemicals in consumer products, as part of its “green chemistry” initiative.

The California Department of Toxic Substances Control’s release of an outline of the Draft Regulations for Safer Products is a second step in identifying "chemicals of concern" in California. The outline proposes guidelines for scientific and systematic prioritization of chemicals and products of concern, certification of alternatives assessment and development of DTSC’s regulatory response. Those responses may include banning substances or products, and end-of-life management issues. It also described a process manufacturers could use to evaluate the chemicals and safer have to perform an "Alternatives Assessment" for the product. Note that any public or private entity or individual may petition the Department to evaluate a chemical or a chemical and product combination during the prioritization process.

DTSC called for feedback on the outline.  The next step will be creating actual draft regulations based on the outline. The agency said that draft regulations will be released in the very near future, and that it will begin a formal rule-making process. State law requires the regulations be adopted by January 1, 2011.

California's green chemistry initiative, a statutory mandate since 2008, is an effort to identify and to reduce the use of chemicals that regulators conclude pose the greatest risk to public health and the environment. 

 

Safe Chemicals Bill Introduced in Senate

Sen. Frank R. Lautenberg, D-N.J., chair of the Senate Subcommittee on Superfund, Toxics
and Environmental Health, introduced this week the "Safe Chemicals Act of 2010," which would
amend the the Toxic Substances Control Act of 1976.

Over the last several months, Congress has held a series of hearings focusing on chemical safety and possible ways to modernize TSCA. Chemical business leaders, public officials, scientists, doctors, academics, and liberal environmental organizations have expressed support for varied methods of reforms to the principal toxic substance law. The “Safe Chemicals Act of 2010” comports with the reform principles laid out by the Obama Administration and groups such as the Safer Chemicals Healthy Families Coalition, and purports to address issues with TSCA identified by the GAO.

The bill (summarized here) is supposed to:

  • provide EPA with sufficient information to judge a chemical’s safety, by requiring manufacturers to develop and submit a minimum data set for each chemical they produce, while also preventing duplicative or unnecessary testing. EPA will have full authority to request additional information needed to determine the safety of a chemical.
  • Prioritize chemicals by having EPA categorize chemicals based on risk, and focus resources on evaluating those most likely to cause harm.
  • Place a new burden of proof on chemical manufacturers to prove the safety of their chemicals, including all foreseeable uses, before the chemical may enter the market or continue to be used.
  • Create more access to chemical information, by establishing a public database to catalog the information submitted by chemical manufacturers and the EPA’s safety determinations. The EPA will impose requirements to ensure the information collected is "reliable."
  • Promote innovation and development of green chemistry, through grant programs and research centers to foster the development of safe chemical alternatives, and bring some new chemicals onto the market using an expedited review process.


     

It is clear that safety must be the primary goal of chemical regulatory reform, and the scientific and technological advances made since the passage of TSCA should allow industry and the regulatory agency to achieve a high degree of safety.  Certainly,  the need to prioritize chemicals for evaluation, a proper risk-based approach to EPA safety reviews, and a reduction in animal testing, are all aspects that should generate bi-partisan support. However, the bill’s proposed decision-making standard may be both legally and technically impossible to meet. Readers know how the articulation and application of the burden of proof can be outcome determinative. It is impossible to prove that something is "safe,” if one means risk-free. Every substance, even water, is hazardous to health at some levels in some exposure contexts. It would be devastating for our economy if this bill was merely a back-door attempt to make the so-called precautionary principle the law in this country, as it is in Europe. It is simply scientifically false that every chemical that is dangerous at high doses is also hazardous at low doses;  it is patently false that every chemical that causes effects in lab animals will also cause those effects in human beings.

And the proposed changes to the new chemicals program could very well hamper innovation in new products, processes, and technologies. In addition, the bill undermines business certainty by appearing to allow states to adopt their own regulations and create a lack of regulatory uniformity for chemicals and the products that use them.

Congressmen Henry Waxman and Robert Rush have proposed a "discussion draft" on the House side, and that may afford an opportunity for a transparent and meaningful discussion by all key stakeholder groups to ensure that TSCA reforms are based on sound science and protect the safety of all consumers, while promoting jobs and innovation.  In these uncertain economic times, the last thing needed is another expensive government program that risks doing more harm than good.

 

Federal Court Denies Medical Monitoring Class Action

A federal district court recently denied class certification in toxic tort litigation alleging that a chemical plant's long-term airborne release of vinyl chloride had risked their health and lowered property values. Gates v. Rohm and Haas Co.,  2010 WL 774327 (E.D. Pa. 3/5/10).

Plaintiffs alleged that vinyl chloride released from Rohm & Haas’s specialty chemicals manufacturing facility in Ringwood, Illinois contaminated the groundwater in and around McCollum Lake Village, as well as the air in the Village. Plaintiffs allege that between 1968 and 2002, the vinyl chloride evaporating from the shallow plume blew over the Village, contaminating the air in the Village and causing some Village residents to breathe varying amounts of it. Plaintiffs claimed that the levels of vinyl chloride in the Village air are higher than the background level. 

They asked the court to certify two classes: (1) a medical monitoring class, and (2) a property damage class.  On the latter, although plaintiffs alleged that the Village’s water and air have been contaminated, plaintiffs sought class certification only on the “outdoor air” theory. On the former class, the parties disputed whether, and the extent to which, exposure to vinyl chloride is associated with brain cancer in humans. Plaintiffs alleged that exposure to vinyl chloride placed Village residents at a higher-than-normal risk of contracting brain cancer, requiring periodic monitoring. In support of the medical monitoring program, plaintiffs submitted the report of an expert who opined that a class-wide medical monitoring regime using MRI's was medically reasonable given the alleged exposure to vinyl chloride.

Plaintiffs moved for certification of their property class under Rule 23(b)(3) and for certification of their medical monitoring class under both Rule 23(b)(2) and (b)(3). Rule 23(b)(2) permits certification where “the party opposing the class has acted or refused to act on grounds generally applicable to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole.” Fed. R. Civ. P. 23(b)(2). Rule 23(b)(3) permits class actions where “the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy.” Fed. R. Civ. P. 23(b)(3).

The Third Circuit has clarified the legal standard for class certification and the district courts’ attendant duties in In re Hydrogen Peroxide Antitrust Litigation, 552 F.3d 305 (3d Cir. 2008).  The decision to certify a class calls for findings by the court, not merely a threshold showing by a party, that each requirement of Rule 23 is met.  Proper analysis under Rule 23 requires rigorous consideration of all the evidence and arguments offered by the parties.  Weighing conflicting expert testimony at the certification stage is not only permissible; it may be integral to the rigorous analysis Rule 23 demands. The court may not decline to resolve a genuine legal or factual dispute because of concern for an overlap with the merits. See also Hohinder v. United Parcel Service, Inc., 574 F.3d 169 (3d Cir. 2009).

As is typical, the battleground was the predominance and cohesiveness requirements of the rule.  (The court found that the individual issues that defeat the predominance requirement of Rule 23(b)(3) also defeat the cohesion requirement of Rule 23(b)(2)).

Regarding the elements of a medical monitoring claim, the court noted that whether vinyl chloride is a hazardous substance, whether a responsible monitoring procedure exists that makes the early detection of the disease possible, and whether the prescribed monitoring regime is different from that normally recommended in the absence of the exposure, did not here appear to present individualized questions in the context of this case.  (However, they can present individual issues in other cases depending on the substance, exposure, and risk.)

Next was the exposure element of the claim, with the key question being whether each plaintiff in the proposed class was exposed to a level greater than the normal background level. Plaintiffs must demonstrate that common proof may be used to determine whether each and every Class Member was exposed to a minimum level of vinyl chloride by Rohm and Hass that exceeds the applicable background levels.  While admitting individual exposure will vary depending on factors such as the time spent in the Village, plaintiffs asserted that class treatment is appropriate because there is a common minimum average daily exposure rate over time for any point within the Village. However, a rigorous analysis of plaintiffs’ expert evidence revealed that it does not reflect that all class members were exposed to vinyl chloride at a minimum level above  background, or that this determination could be made with common proof. Plaintiff's expert's  methodology  employed an averaging technique, making certification is inappropriate. Suffice it to say, an average is an average is an average. It is, in essence, a convenient fiction made up of numbers that are higher and lower than the average; it does not reflect whether every putative class member was exposed to vinyl chloride at a level above background, let alone at a level that carries a significantly increased risk of a latent disease. Exposures in the Village would vary  from year to year, such that a putative class member’s exposure would depend on the particular year or years in which he or she lived there. Individual class members’ locations and lifestyles potentially could result in significant differences in exposure, making Plaintiffs’ calculation of an “average exposure” even less useful. The time that each Village resident spent indoors, as opposed to outdoors, and the time that each individual spent away from the Village at work, away at school, on extended vacations, for example, are other factors that raise significant individual issues with respect to exposure levels. The evidence reflected that the putative class members’ habits, work schedules, and school schedules may have caused significant variations in the time that class members actually spent in the Village.

Of course, said the court, plaintiffs are not charged with the duty of calculating the precise exposure of any given individual, much less all of them, in order to secure class certification. However, plaintiffs must demonstrate that they can use common proof to demonstrate that each individual was exposed to a level above background levels. This, they had not done.

On the significant risk element, the court noted that it was impossible to tell from plaintiffs’ presentation of the average level of exposure to vinyl chloride - which itself is based on an average of certain vinyl chloride levels that were detected in certain test spots - whether every class member has a significantly increased risk of contracting a serious latent disease.  The first problem is that the level used by plaintiffs, derived from a regulatory figure, was not developed with an appropriate methodology for calculating a danger point for purposes of a medical monitoring claim. The value identified by plaintiffs only reflected the level of vinyl chloride at and below which a mixed population is safe, in the opinion of a public health agency. It did not, however, demonstrate the opposite, i.e., that any extra levels above the level are significantly harmful to necessitate medical monitoring.  Such a regulatory risk assessment cannot and does not support an opinion that each individual class member has experienced a significantly increased risk of disease.  The value may be appropriate as a prophylactic safety marker, perhaps for regulatory use, to minimize potential risks and protect the groundwater and air of a mixed population of individuals; however, it ought not be used as a predictive measure of actual risks for every individual in that population.  Precautionary measures to keep the general population safe are a fundamentally distinct form of relief from the medical monitoring cause of action. 

The court then turned to the question of whether the prescribed monitoring regime (that is, serial MRI exams) was reasonably necessary according to contemporary scientific principles. The court recognized that a medical monitoring program cannot be left open for the class members to fashion at will, but must consist of a specific form of monitoring different from what class members would ordinarily receive from regular physicals.  Plaintiffs argued  that serial MRIs are reasonable for the proposed class, but that in any event, the scheme could be modified after certification or allow individuals to tailor it to their particular circumstances (for example, a CAT scan for people who cannot tolerate MRIs).

The court had two problems with this argument.  One issue was what we may call the "more harm than good" calculus.  A blanket prescription for serial MRIs in asymptomatic individuals, coupled with the risks and drawbacks of serial MRI procedures, only strengthened the denial of class certification. For instance, the proposed class includes all residents of the Village, including children. The administration of MRIs to young children presents certain challenges because the children must lie still in the MRI machine for long periods of time. Conducting MRIs on children may require administering drugs to sedate or anesthetize them, a process that may prompt side effects of its own. The contrast agent used may pose risks for patients with kidney disease, for whom it can lead to nephrogenic systemic fibrosis, a potentially fatal condition; therefore, gadolinium is not recommended for use with such patients. In addition, medical monitoring in general, and MRIs in particular, can lead to stress and other adverse psychological consequences, and may induce claustrophobia in some patients.

The second problem with plaintiffs' flexible approach to their plan (i.e., that individual differences and medical needs can be accommodated through the use of CAT scans, open MRI machines, and other neurological exams. later), is that the determination of which accommodation, if any, is appropriate for which patient necessarily involves individual questions that cannot be determined on a class-wide basis. Moreover, the problems with the monitoring scheme can not be alleviated by a decision to just “deal with it later” at the summary judgment stage. Although the court may alter a monitoring scheme after the certification stage of the litigation has passed, that does not mean that problems with a monitoring plan can be ignored at the certification stage.

Turning to the property damage class, plaintiffs focused on "liability" as a common issue.  But the court found that even assuming that the fact of contamination was provable by common proof here, liability alone could not be proven with common proof. Common evidence may offer one potential source of the contaminants, but many other explanations may exist that are specific to a particular property. See Fisher v. Ciba Specialty Chems. Corp., 238 F.R.D. 273, 307 (S.D. Ala. 2006); see also Thomas v. FAG Bearings Corp., 846 F. Supp. 1400, 1404 (W.D. Mo. 1994).This can be especially true in this case, where differing levels of potential contamination over time affected different portions of the Village to different extents, depending on location, all of which must be compared to
the background level.

Finally, the court’s concerns about the number, complexity, and scope of issues that are plaintiff-by-plaintiff determinations also went to the superiority issue. Even if the court were to certify alleged common issues, the subsequent separate proceedings necessary for each plaintiff would undo whatever efficiencies such a class proceeding would have been intended to promote. Even more problematic, because a jury may be called upon to weigh the potential impact from Rohm and Haas’s actions on a particular property against those of another source of contamination, the “second” jury could well wind up re-considering the evidence of Rohm and Haas’s actions presented in the class proceeding.  


 

Class Action Motion Rejected in Human Tissue MDL

We have posted before about the interesting Human Tissue litigation.  The multidistrict litigation consolidated hundreds of cases filed either by plaintiffs who received allografts — transplants from cadavers — harvested by defendants allegedly without obtaining proper consent and following appropriate regulations, or by those plaintiffs who allegedly had allografts improperly taken from deceased relatives. The MDL court last week denied the latter plaintiffs' motion for class certification. In re: Human Tissue Products Liability Litigation, No. 06-135/MDL 1763 (D.N.J.).

According to the named representative plaintiffs, each of the class members had a deceased family member whose body went to one of the defendant funeral homes; plaintiffs claim that the funeral homes, after taking possession of the bodies, allowed another defendant to extract bones and tissue from the decedents. Following this, the harvested tissue then allegedly was given to other defendants, tissue banks. The purported class consisted of “all next of kin relatives of decedents whose bodies were desecrated by [defendants] for the harvesting and sale of human body parts."

Two parts of the opinion will be of the most interest to readers.  First, under the Rule 23(a) prerequisites, the court found that the typicality element was not established because of the highly individualized nature of the claims in this action.  Plaintiffs asserted emotional distress claims against the funeral homes that handled the donor decedents' remains and the tissue processors who allegedly received the harvested tissue. The Third Circuit has stated that class certification is inappropriate in mass tort claims, generally, because they often present questions of individualized issues of liability. In re Life USA Holding Inc., 242 F.3d 136, 145 (3d Cir. 2001). This observation is particularly true where the tort claims alleged are premised on emotional distress. The factual circumstances underlying each of the individual claims – including but not limited to plaintiffs' relationships with the decedents and the injuries allegedly suffered – were sufficiently personal and specific as to prevent any finding of similarity with regard to their claims.  

Also, plaintiffs were bringing contractual claims against the funeral home defendants, which again hinged on different factual circumstances that also might give rise to different defenses. There was no allegation that the individual contracts made with the funeral homes concerning final arrangements for the donor decedents were identical; in fact, since they were drafted and negotiated by different funeral home representatives and family members, they likely contained different representations, again subject to different defenses. For example, the meetings between funeral home personnel and the decedents' family members involved representations regarding the specific services requested and potential tissue donation. "These are all very personalized discussions," said the court.  All in all, the court found sufficient factual differences among the contracts negotiated with the different funeral homes to preclude a finding of typicality. See In re Schering Plough Corp. ERISA Litig., 589 F.3d 585, 598 (3d Cir. 2009)(“Ensuring that absent class members will be fairly protected required the claims and defenses of the representative to be sufficiently similar not just in terms of their legal form, but also in terms of their factual basis and support.”); see also In re Life USA Holding, Inc., 242 F.3d at 144-46 (vacating class certification in part because plaintiffs' claims of deceptive insurance sales practices arose from individual and non-standardized presentations by numerous independent agents).

It is significant that the court put some teeth into the 23(a) element. While the court acknowledged that factual differences will not automatically render a claim atypical if the claim arises from the same event or practice or course of conduct that gives rise to the claims of the class members, and if it is based on the same legal theory, here plaintiffs failed to demonstrate, other than through a bald assertion, that any practice or course of conduct existed among the funeral homes or among the tissue processors.

The same differences undermined a showing of predominance and superiority under Rule 23(b)(3), which provides for certification when the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy.

The individual factual circumstances, including contractual arrangements, personal relationships with the decedents, injuries suffered, etc. precluded a 23(b)(3) class.  The superiority inquiry compels a court to balance, in terms of fairness and efficiency, the merits of a class action device against those of alternative available methods of adjudication.  Here, the multitude of individualized issues presented in plaintiffs' claims would entail complicated mini-trials within the class action itself.  The claims presented by plaintiffs and their unique factual underpinnings would require such extensive individual consideration that it would be neither more fair nor more efficient to proceed with this matter as a class action.  Class rejected.


 

Court Excludes Toxic Tort Causation Testimony

A federal court has excluded plaintiffs' expert testimony in litigation alleging personal injury and property damage from releases at a Midwest refinery.  Baker, et al. v. Chevron USA Inc., et al., No. 05-cv-00227 (S.D. Ohio Jan. 6, 2010). In the absence of necessary expert testimony, the claims were subject to summary judgment.

Plaintiffs in this case were residents of the villages of Hooven and Cleves, Ohio, who asserted claims for personal injury and property damage allegedly resulting from the Gulf Oil refinery, now owned by defendant Chevron USA.  Gulf operated a gasoline refinery which was situated on the eastern edge of Hooven from 1930 to 1985. Gulf also refined diesel fuel, jet fuel, and fuel oil at the refinery and operated an asphalt plant at this location. Gulf and Chevron merged in 1985, and Chevron closed the refinery in 1986.

Plaintiffs alleged that Gulf’s operation of the refinery resulted in the release of millions of gallons of gasoline and diesel fuel.  But these plaintiffs did not claim injuries resulting from groundwater contamination. Rather, they asserted injuries allegedly caused by air emissions from the refinery and, in particular, the benzene contained in those emissions. Benzene is ubiquitous in the ambient air and is a component or constituent of vehicle exhaust and cigarette smoke. In the petroleum industry, benzene is found in small amounts in gasoline.

For case management purposes, the matter was bifurcated between personal injury claimants and property damage claimants. The parties were permitted to select bellwether plaintiffs for each trial group. This opinion dealt with the claims of the bellwether personal injury claimants, and a key issue, as is often the case in toxic tort litigation, was causation.

Regarding their alleged benzene exposure, plaintiffs offered a three-step procedure. First, expert Dr. Cheremisinoff calculated a gross amount of benzene released from the refinery through emissions. Then, using those calculations, Dr. Rosenfeld, plaintiffs’ second expert, used an air flow model to calculate the cumulative dose of benzene to which each plaintiff was exposed. Third, using those dose estimates, a third expert, Dr. Dahlgren, submitted opinions that each plaintiff’s dose of benzene was sufficient to cause her illness. 

Chevron moved to exclude Dr. Dahlgren's opinions under Daubert, and for summary judgment contingent  upon the striking of  plaintiffs' causation evidence. The principal argument raised was that Dr. Dahlgren’s opinions were unreliable because there was an insufficient scientific or medical basis to conclude that the doses of benzene to which plaintiffs’ were exposed were large enough to have caused their illnesses. Relatedly, Chevron contended that there is an insufficient scientific or medical basis to conclude that benzene even causes some of the illnesses alleged. The Court held a hearing on Chevron’s Daubert motion during which Dr. Dahlgren and Chevron’s medical expert also testified.

In a toxic tort case, the plaintiff must present evidence of both general causation and specific causation. General causation establishes whether the substance or chemical at issue is capable of causing a particular injury or condition. Specific causation relates to whether the substance or chemical in fact caused this plaintiff’s medical condition. Without expert medical testimony on both general causation and specific causation, a plaintiff’s toxic tort claim will fail.

In this case, Dr. Dahlgren offered causation opinions based largely on epidemiological studies. (Epidemiology is the study of the incidence, distribution, and etiology of disease in human populations.) Epidemiology is usually considered highly probative evidence on general causation in toxic tort cases. The court may nonetheless exclude expert testimony based on epidemiological studies where the studies are insufficient, whether considered individually or collectively, to support the expert’s causation opinion. Nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may thus conclude that there is simply too great an analytical gap between the data and the opinion proffered.

A couple of parts of the court's detailed analysis are worth highlighting for readers of  MassTortDefense:

First, Dr. Dahlgren’s reliance on the “one-hit” or “no threshold” theory of causation in which exposure to one molecule of a cancer-causing agent has some finite possibility of causing a genetic mutation leading to cancer. The court noted that while the one-hit theory has been accepted for purposes of establishing regulatory safety standards, it has not been accepted as a reliable theory for causation under Daubert standards.  See Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 199 (5th Cir. 1996) (“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 plaintiffs’ burden in a toxic tort case.”); McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1240 (11th Cir. 2005) (holding that district court erred by not excluding plaintiff’s expert’s causation opinion because he neglected dose-response relationship); Henricksen v. ConocoPhillips Co., 605 F. Supp.2d 1142, 1162 (E.D. Wash. 2009) (excluding expert’s opinion pursuant to Daubert where “he presumed that exposure to benzene in gasoline can cause AML in any dose.”); National Bank of Commerce v. Associated Milk Producers, Inc., 22 F. Supp.2d 942, 961 (E.D.Ark. 1998), aff’d, 191 F.3d 858 (8th Cir. 1999); Sutera v. Perrier Group of Am., Inc., 986 F. Supp. 655, 667 (D. Mass.
1997). Moreover, since benzene is ubiquitous, causation under the one-hit theory could not be established because it would be just as likely that ambient benzene was the cause of plaintiffs’ asserted illnesses.

Second, the court noted that to the extent that Dr. Dahlgren relied on the evidence that plaintiffs were exposed to benzene in excess of regulatory levels, that is insufficient to make his opinions admissible. The mere fact that plaintiffs were exposed to benzene emissions in excess of mandated limits is insufficient to establish causation. Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244, 252-53 (6th Cir. 2001); David L. Eaton, Scientific Judgment and Toxic Torts- A Primer in Toxicology for Judges and Lawyers, 12 J.L. & Pol’y 5, 39 (2003) (“regulatory levels are of substantial value to public health agencies charged with ensuring the protection of the public health, but are of limited value in judging whether a particular exposure was a substantial contributing factor to a particular individual’s disease or illness.”). This is because regulatory agencies are charged with protecting public health and thus reasonably employ a lower threshold of proof in promulgating their regulations than is used in tort cases. Allen, 102 F.3d at 198.

Third, the court focused on the issue of the link between cited literature and the actual specific opinion given. The court recognized that an expert’s opinion does not have to be unequivocally supported by all epidemiological studies in order to be admissible under Daubert. But here, the opinions expressed in Dr. Dahlgren’s revised report were based "on a scattershot of studies and articles which superficially touch on each of the illnesses at issue." The expert had not differentiated the cases in any way and simply assumed that each reference supported his causation opinion on each and every illness. That clearly was not the case. Also, none of the cited studies supported an opinion that benzene can cause the illnesses from which plaintiffs suffer at the extremely low doses or exposures experienced in this case. Even if it is medically accepted that benzene can cause disease at high doses, Dr. Dahlgren could not cite any paper finding that the relevant low cumulative exposure significantly increases the risk of developing the injuries.

The court, therefore, found that the expert's causation opinions were not reliable under the standards enunciated by Daubert and, consequently, inadmissible. Without Dr. Dahlgren's testimony, the plaintiffs were unable to establish that their illnesses were caused by alleged emissions from the plant, the court observed, and so granted Chevron's motion for summary judgment on all four bellwether personal injury plaintiffs.
 

EPA Releases First Chemical Action Plan

The Environmental Protection Agency recently issued its first Chemical Action Plan (CAP).  The plan deals with  phthalates, which are found in some food packaging and cosmetics.  But anyone in the chemical industry should take notice, as this CAP comes as part of EPA’s efforts to enhance the existing chemicals program under the Toxic Substances Control Act. EPA has identified an initial list of widely recognized chemicals, including phthalates, for action plan development based on one or more of the following factors: their presence in humans; persistent, bioaccumulative, and toxic  characteristics; use in consumer products; or production volume.

Although many in industry support  EPA’s effort to update agency actions for prioritized chemicals under TSCA, there is much to question in this effort so far, including the fact that the initial set of chemicals seem to have been selected based on their current “high-profile” nature. EPA should prioritize chemicals for the CAP program based on scientific criteria that reflect available hazard, use, and exposure information.  Despite the new Administration's campaign promises, there has been little transparency, and in fact great uncertainty, over the scientific basis for the selection of these chemicals.  Unfortunately, the CAP process to date provides no evidence of a systematic, science-based approach to chemicals management.

A large body of scientific data already exists about phthalates, and these products have been subject to numerous government safety assessments.  Bio-monitoring data shows that exposure to phthalates in the general public are below safety limits established by the EPA and the European Union. In assessing potential future restrictions on certain phthalates, EPA plans to weigh the relative toxicity and feasibility of phthalate substitutes. Identification of safer and affordable non-phthalate substitutes will be an important consideration in any action that would restrict the use
of these chemicals.  EPA intends to conduct a Design for the Environment and Green Chemistry alternatives assessment by 2012. The information developed could be used to encourage industry to move away from phthalates in a non-regulatory setting to expand risk management effects beyond whatever regulatory action might be taken under TSCA, or could be used as input to a regulatory action. 

EPA also intends to lay the groundwork to consider initiating in 2012 rulemaking under TSCA section 6(a) to further regulate phthalates. Readers know how regulatory events can spawn and impact toxic tort litigation.  It should be noted  that an Action Plan is intended to describe the courses of action the Agency plans to pursue in the near term to address its concerns. The Action Plan does not constitute a final Agency determination or other final Agency action.

 

 

 

 

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.

 

Federal Inter-agency Task Force Releases Preliminary Test Results On Chinese Drywall

The federal inter-agency task force investigating alleged problems with Chinese-made drywall released initial results of three studies last week, which may impact the MDL litigation. The CPSC, the EPA, HUD, the CDC, and the Agency for Toxic Substance and Disease Registry are members of the task force. Health departments in Florida, Louisiana, and Virginia have also participated in the task force. An executive summary of the studies, and the draft studies themselves are available here.


To date, close to 2000 consumers have contacted the CPSC to report alleged problems in their homes. The primary issues reported are: 1) corrosion, or blackening, of indoor metals, such as electrical components and central air conditioning system evaporator coils; and 2) various health symptoms, including persistent cough, bloody and runny noses, headaches, difficulty in breathing and irritated and itchy eyes and skin. Imported drywall from China came into more widespread use after hurricanes in 2004 and 2005 led to a surge in home reconstruction and caused shortages of North American-made drywall.

In sum, the three studies involved:
(1) Elemental and Chemical Testing: The study of the elemental and chemical composition of drywall samples showed higher concentrations of elemental sulfur and strontium in Chinese drywall than in non-Chinese drywall. The elemental and chemical testing of Chinese and non-Chinese drywall samples was undertaken to characterize the specific chemical composition of the drywall. The results were expected to identify differences between the two sets of drywall that might account for the reported corrosion and health issues. While the studies have discovered certain differences between Chinese and non-Chinese drywall, further studies must be completed, said the report, to determine any nexus between the drywall and the reported health and corrosion issues. The analysis was conducted on 17 samples of drywall collected from warehouses, suppliers and manufacturers. These samples were unpainted and uninstalled.

(2) Chamber Studies: Preliminary results of ongoing testing to detect gases emitted from drywall in laboratory chambers showed higher emissions of total volatile sulfur gases from Chinese than from non-Chinese drywall. The chamber studies, conducted by Lawrence Berkeley National Laboratory, were intended to isolate the chemicals emitted from drywall. From these chamber studies, said the task force, it was possible to isolate the drywall emissions from the interferences of other materials or furnishings in a house that might emit or absorb such emissions. No comprehensive exposure and risk assessment has yet been carried out.

(3) Indoor Air Studies: Indoor air testing of 10 homes in Florida and Louisiana was conducted to identify and measure contaminants and to inform a drywall home indoor air testing protocol. The tests did not detect the presence or found only very limited or occasional indications of sulfur compounds of particular interest to the task force – hydrogen sulfide, carbon disulfide, and carbonyl sulfide. Concentrations of two known irritant compounds, acetaldehyde and
formaldehyde, were detected at concentrations that could exacerbate conditions such as asthma in sensitive populations, but were found in both homes with and without Chinese drywall. The levels of formaldehyde were not unusual for new homes, however, said the report. The results of the air testing in this very small sample of homes was being reported to offer a very preliminary indication of what compounds may be present in the indoor environments of homes in Florida and Louisiana with and without Chinese drywall.


The agencies expect the results of an air-sampling study of 50 homes in late November. An engineering analysis of electrical and fire safety issues is also forthcoming. .A study of long-term corrosion issues, that seeks to simulate decades of exposure and corrosion, will not be completed until June of 2010.

The study follows in the wake of the four-day U.S.-China summit that aimed to reinforce the notion that the United States—specifically the CPSC—will hold accountable importers of products into the United States if their products pose hazards or violate safety standards. The CPSC delegation reportedly discussed drywall safety concerns with Chinese government officials.

The CPSC stressed that this report was preliminary; the findings of each report released today must be considered within the limitations of each study and viewed in the context of the overall drywall investigation, which is still ongoing. While the studies have discovered certain differences between Chinese and non-Chinese drywall, further studies must be completed to determine any nexus between the drywall and the reported health and corrosion issues.
 

Foreign Toxic Tort Judgment Cannot Be Enforced in U.S.

A federal court has ruled that a $97million judgment issued against Dole Food Co. and Dow Chemical in a Nicaraguan court cannot be enforced in the U.S. courts.  See Osorio v. Dole Food Co., No. 1:07-22693 (S.D. Fla.).

Plaintiffs in this case had alleged that 150 banana farmers had suffered a number of injuries because of exposure to pesticides. Specifically,the workers on Dole’s banana plantations in Nicaragua between 1970 and 1982 claimed they were harmed by their exposure to the chemical compound dibromochloropropane (DBCP) which has been linked to sterility, according to plaintiffs. The Nicaraguan Legislature enacted a statute in 2000 specifically to handle DBCP claims there.  More than 10,000 plaintiffs have filed approximately 200 DBCP lawsuits in Nicaragua, most of which are still pending. Already, however, Nicaraguan courts have handed down over $2 billion in judgments to these plaintiffs. A few Nicaraguan plaintiffs have brought DBCP suits in the United States, with the California state courts, for example, concluding that the DBCP claims before it were the direct result of a widespread conspiracy to commit fraud by attorneys in Nicaragua, Nicaraguan doctors and judges (including the Nicaraguan trial judge who issued the judgment in this case), and some of the plaintiffs themselves.

Here, pursuant to this new law, the trial court awarded $97.4 million to compensate the plaintiffs for the alleged DBCP-induced infertility and psychological effects, about $647,000 per plaintiff.

The U.S. District Court for the Southern District of Florida held that defendants had “clearly established” their entitlement to nonrecognition of the award.  States are not required to recognize judgments rendered in foreign countries under the Full Faith and Credit Clause of the Constitution of the United States. U.S. CONST. art. IV, § 1; Guinness PLC v. Ward, 955 F.2d 875, 883 (4th Cir. 1992). In the absence of a treaty, the effect given to a foreign judgment has historically been governed by the more flexible doctrine of comity, which, though often couched in the language of mutual respect and obligation, is most accurately described as a matter of grace. See, e.g., Hilton v. Guyot, 159 U.S. 113, 166 (1895).

Here, the district court found: (1) the Nicaraguan trial court lacked personal and/or subject matter jurisdiction under the Special Law 364; (2) the judgment was rendered under a system which does not provide procedures compatible with due process of law; (3) enforcing the judgment would violate Florida public policy; and (4) the judgment was rendered under a judicial system that lacks impartial tribunals.

A few highlights: the federal court noted that the Nicaraguan attorney general had found that this Special Law violates the country’s constitution because, among other things, it assumed that the plaintiffs will automatically prevail and does not even contemplate the possibility that DBCP defendants might succeed in defeating the plaintiffs’ claims.  While the Nicaraguan Supreme Court later upheld the law, it is clear that absent the presumption of causation, there was no evidence before the Nicaraguan trial court sufficient to determine that DBCP exposure caused the plaintiffs’ injuries.  And the irrefutable presumption of causation resulted in findings that were incompatible with medical and scientific facts. The majority of the plaintiffs were awarded damages even though they allegedly suffered exclusively from conditions not scientifically linked to DBCP exposure. About one-fifth of the prevailing plaintiffs had fathered children in the years since their last alleged exposure to the chemical -- undercutting the infertility claim in a somewhat conclusive way.

In every year from 1999 through 2008, the Country Reports prepared by the State Department have concluded that Nicaragua lacks an effective civil law system.  In 2002, the year this case was filed in Nicaragua, the State Department found that  “Judges’ political sympathies, acceptance of bribes, or influence from political leaders reportedly often influenced judicial actions and findings."   The Special Law was upheld as constitutional by the Nicaraguan Supreme Court because it allowed a defendant to opt-out of jurisdiction there if the defendant agreed to jurisdiction in the U.S.  Here, the defendants consented to jurisdiction in the United States and waived their defenses under the forum non conveniens doctrine. Their initial pleadings contested the foreign trial court’s jurisdiction and attempted to exercise their opt-out rights.  Yet, in December 2004, 14 months after the Nicaraguan Supreme Court issued its opinion clarifying that Special Law 364 was constitutional because it permitted defendants to opt out of Nicaragua’s jurisdiction, the trial court denied Dole and Dow’s jurisdictional challenges.

In sum, Special Law 364 contained numerous unique provisions that apply only to a narrow class of defendants, and operate to their distinct disadvantage in a pronounced discriminatory fashion. The court also found that Special Law 364’s disparate treatment of defendants is fatally unfair and discriminatory, fails to provide the minimum level of due process to which all foreign defendants are entitled, and is, therefore, incompatible with the requirements of due process under Florida law.

 

Chinese Drywall Update

On the eve of the 3rd biennial United States--China Consumer Product Safety Summit, to be held in China, the head of the Consumer Product Safety Commission reported she will press Chinese officials on whether new regulatory standards need to be set for drywall composition. CPSC Chairwoman Inez Tenenbaum said she also would inquire whether the Chinese were willing to provide compensation for the damage from tainted drywall.

In its latest status report on the Chinese drywall issues, the CPSC noted that it had received 1192 consumer complaints, from 24 different states. The majority of the reports continue to be from Florida, Louisiana, and Virginia. The focus of the federal drywall team has remained pursuing the scientific bases of the possible problems, and tracing the chain of commerce of the drywall.

CPSC reports it has completed principal field work for a 50 home indoor air sampling program, coordinated the state and federal response to allegations of radioactive phosphogypsum in Chinese drywall, and completed 75 in-depth site investigations, with another 20 in progress. Long-term air sampling tests will be completed later this month. The evaluation of the results is expected to be complete before November. (Phosphogypsum is a gypsum that has elevated levels of naturally occurring potassium, thorium and uranium radionuclides and decay products.) The CPSC coordinated testing and reporting results for radioactive phosphogypsum contamination in drywall with the Florida Department of Health and the EPA National Air and Radiation Environmental Laboratory. The results of the technical review showed that no radiological hazard was present. EPA is conducting elemental analyses of 15 drywall samples. EPA expects to complete its analyses of drywall samples in the next few weeks.

CPSC continues to analyze the information received from consumers, builders, importers, manufacturers, and suppliers of drywall to determine how much imported drywall may be affected and where that drywall has been installed. To date, CPSC staff has confirmed that during 2006, 6,997,456 sheets of Chinese drywall were imported into the U.S.

As readers of MassTortDefense know, litigation has been filed over the drywall issues, alleging that sulfur levels in the Chinese-made products are abnormally high, causing problems with air conditioning systems, appliances, internal wiring and other electrical systems.  Approximately 200 cases are pending in the MDL. In re: Chinese-Manufactured Drywall Products Liability Litigation, No. 09-md-02047 (E.D. La.).

In the MDL , the next status conference is scheduled for Thursday, November 19, 2009. Recently, the court  issued an order regarding a "Revised Exporter, Importer, or Broker Defendant Profile Form.”  All defendant drywall exporters, importers, or brokers must complete this Profile Form.  The form, inter alia, requires information on exemplar transactions concerning the exportation/importation/brokering of Chinese Drywall for import/export to the United States between 2001 and 2009, including but not limited to purchases, sales, consignments, shipments, transfers, deliveries, receipts, or other distributions.  The form requires information to identify any markings on the Chinese Drywall product (e.g., lot number, batch number, serial number, color markings, UPC codes, etc.) involved in this transaction; a list all trademarks of the product, and any markings or means of identification employed to track or identify the Chinese Drywall.

The issue of linking the specific product that allegedly harmed a plaintiff to the defendants who made and sold that particular product -- often termed "product identification" -- is an essential aspect of the cause in fact inquiry and is often problematic in toxic tort litigation.

 

 

Class Certification Denied In Beryllium Exposure Case

A California appellate court last week affirmed a trial court ruling denying class certification to a group of Boeing employees suing over alleged exposure to harmful levels of beryllium. Marin v. Brush Wellman Inc.,  No. B208202 (Calif. Ct. App., 2nd Dist. Aug. 24, 2009).

The plaintiffs alleged that Brush Wellman, a contractor of their employer, misrepresented the permissible limit for beryllium exposure. Beryllium is a potentially toxic metal that is used in aircraft construction and other industrial applications because of its light weight and great strength. However, some exposed persons are beryllium sensitization, which can be a precursor to chronic beryllium disease, which is a serious illness. 

The court of appeals agreed with the trial court that common issues did not predominate. In a toxic tort case, the plaintiff must first establish some threshold exposure to the defendant's defective, toxic products, and must also establish to a reasonable medical probability that a particular exposure or series of exposures was a legal cause of his injury, i.e., a substantial factor in bringing about the injury. This typically requires expert testimony about the level of exposure that is unsafe, and expert testimony that exposure above a certain level will cause injury or disease. The significance of this is  that when individual claimants differ both in their makeup and in the amount of their exposure to the substance, the evidence of their injuries will differ from individual to individual.

Here, each of the class members would have to show where he worked, when he worked within each location or facility, what the beryllium levels were at these locations, and how much of the beryllium was Wellman's.  It is patent that each such package of facts will be largely unique to each claimant.  The six named plaintiffs worked at six different facilities, some of which had multiple buildings, over differing periods covering up to 40 years. Boeing's air monitoring and industrial hygiene records showed non-uniform results. In other words, the levels of exposure varied widely among the facilities over time, and even within a single facility. The sales and use evidence that could be used to trace the beryllium to Wellman implicated a necessarily individualized inquiry, not a common one.

In an effort to salvage a class, plaintiffs' counsel explained at oral argument that the proposed class was only for those who required medical monitoring. Those persons who actually contracted illness would be excluded from the class as their claims would be necessarily unique and individualized.  Even assuming this issue was properly presented to the trial court, the plan to certify a class of persons requiring medical monitoring and, in addition to such a class, allowing the more serious cases to proceed individually and separately, was to the court "an invitation to a litigation disaster."   Recourse to such a class would do nothing to streamline this litigation but would most probably convert it into a nightmare.

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.


 

Senate Holds Hearing on Chinese Drywall

A variety of public health officials testified last week at a hearing before the Consumer Protection, Product Safety, and Insurance Subcommittee of the U.S. Senate’s Committee on Commerce, Science, and Transportation, on the issue of allegedly toxic Chinese drywall installed in recently built homes.

Officials from the Centers for Disease Control and Prevention, the Consumer Product Safety Commission, the EPA, and Florida's Department of Health outlined the plan to study the effects of the drywall in a small number of test homes, to be completed by the end of June, and then expand the studies to a large-scale sample. The CPSC is also working with China's Administration for Quality Supervision, Inspection and Quarantine to find out how the drywall was made and to resolve significant difficulties in tracking the drywall's source.

The testifying officials warned that efforts to mitigate the drywall effects on homeowners shouldn't lead legislators to legislate policy ahead of scientific investigation. For example, Lori Saltzman, division director of the Office of Health Sciences at the CPSC, cautioned senators against legislation rushing to address any drywall issues before the ongoing studies are complete. And another panelist noted that a provision banning imported drywall composed of more than 5 percent organic material in a bill by Sen. Nelson, D-Fla., could shut down virtually all U.S. drywall imports, not just those from China suspected of being toxic.
 

According to allegations of homeowners, certain Chinese-made drywall — imported in the time frame 2005-2007 to meet an uptick in homebuilding demand after Hurricane Katrina — can cause respiratory problems and other health issues, produce a rotten smell, and corrode copper and metal fixtures, leading to fire hazards.

Randy Noel, a representative to the National Association of Home Builders, estimated the cost of replacing the Chinese-made drywall to be as much as $100,000 per home. More than 60 lawsuits have already been filed in seven states over the drywall, without conclusive scientific proof of its toxicity. Noel advocated a stay of the litigation until the CPSC and other agencies have concluded their investigations, identifying the scientific cause of the problems associated with the drywall and establishing a workable remediation strategy. He made the committee aware of a troubling new development in the area of drywall testing: the dramatic increase in the number of companies in the marketplace claiming to have the capability to test someone’s home to determine whether or not they have, or will have, a “toxic drywall” problem.
 

Not everyone has the same notion towards litigation: Saltzman reportedly remarked that the CPSC does not want to jeopardize any potential remedy for homeowners by having inadequate scientific proof to support and advance a possible court case.

 

Bills Introduced to Ban Chinese Drywall

Rep. Robert Wexler, D-Fla., has introduced a bill to temporarily ban drywall with high levels of organic compounds. The bill H.R. 1977 would also commission a study on imported Chinese drywall. Sens. Bill Nelson, D-Fla., and Mary Landrieu, D-La., introduced the Senate version of the legislation, the Drywall Safety Act of 2009, recently in the U.S. Senate.

Some U.S. residents have complained that the imported Chinese drywall installed in their homes emits a sulfur smell and causes electrical problems. As posted on before, such drywall is now the subject of litigation, after the Florida Department of Health reported it can emit a sulfur smell when exposed to heat and moisture.

The House bill would require the U.S. Consumer Product Safety Commission to create a standard to regulate the composition of drywall. It would also require the commission to work with the National Institute for Standards and Technology and the U.S. Environmental Protection Agency to study drywall imported from China between 2004 and 2007, and used in U.S. homes. If the bills are passed, such a study on Chinese drywall could be significant in the lawsuits.  The CPSC said in February it had begun an investigation of complaints about Chinese drywall, focusing on whether the sulfur-based gases emitted from the drywall are corroding household wiring and posing a potential safety hazard in that respect. 

Between 60,000 and 100,000 homes across the nation contain tainted drywall, the two sponsoring senators have said. About 36,000 homes in Florida are thought to contain Chinese-made drywall.  According to the allegations of the litigation, a shortage of drywall made in the U.S. caused many builders to use imported Chinese drywall during Florida's construction boom between 2004 and 2006. Much of the drywall was used in construction after Hurricane Katrina. There is speculation that some of that drywall may have been kept at sea for months waiting to enter the U.S., at which point it may have been exposed to humidity that allegedly caused the fume problems.
 

FEMA Trailer MDL Selects First Bellwether Trial

Judge Engelhardt of the U.S. District Court for the Eastern District of Louisiana, overseeing the MDL relating to the alleged formaldehyde contamination of FEMA trailers used in the aftermath of Hurricane Katrina, has chosen a lawsuit by a New Orleans woman and her son to serve as the first bellwether case in this MDL. See In re: FEMA Trailer Formaldehyde Products Liability Litigation, MDL-1873 (E.D. La.).  Plaintiffs generally allege that trailers issued by the government following Hurricane Katrina exposed residents to high levels of the chemical formaldehyde.

The court had ordered the parties to submit the names of no less than 50 potential bellwether trial plaintiffs. From these names, one plaintiff for each of four bellwether jury trials was to  be selected. The manufacturer defendants for these four trials had to be the four estimated to have the most emergency housing units at issue in this proceeding. (These four manufacturers are Gulf Stream, Fleetwood, Forest River, and Keystone RV.)  Only plaintiffs who have identified and sued one of the four manufacturers, the relevant contractor, and the Government, were eligible to serve as bellwether trial plaintiffs. In addition, the bellwether plaintiffs must be selected from those plaintiffs for whom Plaintiff Fact Sheets already have been obtained and provided to the defendants. In addition, actions chosen for bellwether trials must have proper venue in the Eastern District of Louisiana, unless the parties in question consent to trial in this district.  The court, from that list, selected the case brought by Alana Alexander and Christopher Cooper against Gulf Stream Coach Inc. to be the first that will be tried in federal court. The trial is set for Sept. 14, with three other cases against the other different defendants scheduled to follow as the court approached the hundreds of suits through a series of bellwether trials.

Readers will recall that last December, the court properly refused to grant class certification to the six proposed subclasses of plaintiffs, finding they did not meet the standards required for class certification under Rule 23. The plaintiffs had sought certification of four state subclasses of individuals who resided in trailers provided by the Federal Emergency Management Agency in Louisiana, Texas, Alabama and Mississippi following hurricanes Katrina and Rita, as well as a future medical monitoring subclass, and an economic loss subclass.

The U.S. Judicial Panel on Multidistrict Litigation consolidated a number of suits against the
government and a handful of trailer manufacturers over the alleged formaldehyde exposure
in October 2007, despite defendants’ objections. The Centers for Disease Control and Prevention  released in 2008 the results of a study which it commissioned concerning formaldehyde levels in mobile homes provided to residents of the Gulf Coast affected by Hurricane Katrina in 2005.  CDC has been working with FEMA and other agencies to investigate possible levels of formaldehyde in the trailers and mobile homes.