California appellate court bucks national trend, allows plaintiff experts to opine that “every asbestos exposure is a substantial factor”

By on March 4, 2016

Courts from around the country have rejected efforts by plaintiff experts to testify that every asbestos exposure is a substantial factor in causing disease. On March 3, 2016, California’s second appellate district went the other way, and held in Davis v. Honeywell International, Inc. that the controversial “every exposure counts” theory is admissible under governing expert witness law.   Thus, although trial courts are supposed to play a “gatekeeper” role in keeping out unreliable expert evidence (Sargon Enterprises, Inc. v. University of Southern California (2012) 55 Cal.4th 747), Davis breaks the gate wide open in allowing a jury, not the trial court in its “gatekeeper” role, to decide whether to accept the theory.

Davis was aGATEPICTURE wrongful death case.  Sam Davis  worked as an auto mechanic and home remodeler from approximately 1963 to 1979.  He performed “one or two” brake jobs per day, and always used Bendix brake linings (for which defendant Honeywell was responsible). These linings contained 50 percent chrysotile asbestos by weight.  He was also allegedly exposed to asbestos as a result of his home remodel work.

Prior to trial, Honeywell filed a motion in limine to preclude plaintiff from presenting expert opinion testimony that every exposure to asbestos above background contributed to decedent’s disease. The motion was denied, and plaintiff’s pathologist (James A. Strauchen, M.D.) and pulmonologist (William Rom, M.D.) were permitted to testify and advance the theory. Ultimately, the jury found for plaintiffs, and Honeywell appealed.

Honeywell’s primary basis for appeal was that the “every exposure counts” testimony of Dr. Strauchen should have been excluded. Honeywell advanced four arguments:  (1) the testimony was speculative and illogical; (2) the regulatory standards Strauchen relied upon cannot establish causation; (3) no appropriate scientific literature supports the theory; and (4) the theory is contrary to California causation law espoused in Rutherford v. Owens Illinois (1997) 16 Cal.4th 953, which held that not every exposure to asbestos is a “substantial factor” in causing disease.

Davis rejected each of Honeywell’s arguments. “Having reviewed much of the commentary and scientific literature cited in support of and against the ‘every exposure’ theory, we conclude that the theory is the subject of legitimate scientific debate.   Because in ruling on the admissibility of expert testimony the trial court ‘does not resolve scientific controversies (Sargon), it is for the jury to resolve the conflict between the every exposure theory and any competing expert opinions.”  The court focused largely on the mere existence of evidence that supported the “every exposure counts” theory, and declined to weigh the evidence or any competing inferences.   “While Honeywell is generally correct that in many (or even most) instances epidemiological studies provide the best evidence of causation, its implied argument that it is improper for an expert to rely upon any other tools to determine causation, such as case reports, is not universally accepted.”  As to Honeywell’s argument that “every exposure” contravenes Rutherford, Davis  interpreted Rutherford as not requiring a “dose level estimation,” instead issuing a sweeping statement interpreting Rutherford as supporting the conclusion that even a very small “dose” could increase the risk of asbestos-related cancer.  Davis distinguished the many cases from other jurisdictions rejecting this argument, including Betz v. Pneumo Abex, LLC (2012) 615 Pa. 504, Bostic v. Georgia-Pacific Corp. (Tex. 2014) 439 S.W.3d 332 and Moeller v. Garlock Sealing Technologies, LLC (6th Cir. 2011) 660 F.3d 950. “[W]e simply disagree” that the “every exposure” theory could not be “reconciled with the fact that mesothelioma and other asbestos-related diseases are dose-dependent.”

The Davis court did state, however, that “[w]e caution that our discussion of the materials Dr. Strauchen relied upon should not be seen as approval of either side in that scientific dispute.  Rather, we rely upon the rule of Sargon that although trial courts ‘have a substantial ‘gatekeeping’ responsibility,’ in evaluating proposed expert opinion . . . the gate tended is not a partisan checkpoint . . . If the opinion is based on materials on which the expert may reasonably rely in forming the opinion, and flows in a reasoned chain of logic from those materials rather than from speculation or conjecture, the opinion may pass, even though the trial court or other experts disagree with its conclusion or the methods and materials used to reach it.”  (emphasis added)

Further, although much of the discussion relates to the “any exposure” theory, Davis pointed out that the case did not hinge on that theory.  “In this case, Dr. Strauchen was presented with a hypothetical based on the facts surrounding Davis’ exposure to dust from his work on Bendix brake linings, and testified as to estimates of the amount of asbestos fibers contained in visible dust. Therefore, his conclusion that Davis’ exposure to Bendix brake linings was a substantial factor in contributing to the risk of mesothelioma was not based simply on “any exposure” to asbestos, but instead related to an estimate of actual exposure.”

The decision is not yet final. It is still subject to a petition for rehearing, which could result in a change in the opinion, and to either or both a request for depublication and a petition for review to the California Supreme Court, either of which if granted would make this decision uncitable in California courts, though not necessarily elsewhere.

Filed under Asbestos, asbestos exposures, Daubert, every exposure counts, evidence, Expert Opinions, Expert Reports, expert testimony, Expert Witness, Frye, gatekeeper, Low Dose, Sargon, scientific literature, single fiber theory, Substantial Factor, Theories of Liability, Uncategorized

Frye Decision in BMW Case Results in Exclusion of Plaintiff’s Experts

By on January 17, 2013

In a thoughtful decision handed down in Reeps v. BMW of North America, LLC, 2012 N.Y. Slip Op. 33030(u), on December 16, 2012 in New York County Supreme Court, the Hon. Louis B. York excluded the expert testimony of plaintiff’s two key causation experts in a toxic tort case where plaintiff alleged that a child’s birth defects were attributable to the mother’s in utero exposure to gasoline vapors.

In an earlier article on this blog about the same case, we examined the decision by the First Department, on an interlocutory appeal, which determined that: (1) defendants had failed to demonstrate that the infant’s parents disposed of their BMW with knowledge of its potential evidentiary value; and (2) that plaintiff’s claims against the BMW dealer, sounding in product liability and breach of implied and express warranty, should be dismissed because the dealer was a service provider, not a product seller.

 In that article, we also discussed plaintiff’s burden in having to prove general causation at trial, that is, whether exposure to chemical components in gasoline fumes have been associated in the scientific literature with cerebral palsy and the other abnormalities alleged. We discussed that if plaintiff is able to prove general causation, she will then have to prove specific causation, that is, whether the dose and duration of exposure to the purported teratogen was sufficient to cause the specific birth defect.

 In a Frye decision (tantamount to a dismissal), Judge York analyzed plaintiff’s expert disclosures made pursuant to CPLR 3101(d) for Shira Kramer, Ph.D., and Linda Frazier, M.D., M.P.H. Both experts submitted detailed reports. In support of its Frye motion, BMW submitted affidavits by its own experts, Anthony Scialli, M.D. and Peter Lees, Ph.D. Dr. Scialli is an OB-GYN and reproductive toxicologist. Dr. Lees is a specialist in industrial hygiene and environmental health science. The experts on both sides of the dispute were highly credentialed with impressive CV’s.

The timeline of events leading up to the filing of the case is as follows:

1991-In March and again in November, the Reeps bring their 1989 BMW 525i to Hassel Motors, a licensed BMW dealer, to fix an exhaust odor inside the car. Dealer fails to identiify an exhaust odor in March, but later identifies problem as a split fuel hose and repairs it under warranty.

1992-In May, Sean Reeps is born with birth defects, including cerebral palsy, which plaintiffs attribute to Debra Reep’s inhalation of gas fumes early in her pregnancy.

1994-BMW recalls BMW525i vehicles due to a safety defect that caused odor due to feed fuel hose.

Plaintiff’s experts attributed the child’s birth defects to gasoline vapors his mother inhaled during the first trimester of her pregnancy while driving her BMW. Dr. Kramer offered the opinion that gasoline vapors and specific chemical constituents of gasoline, such as toluene and other solvents, are casually related to an elevated risk of birth defects among children exposed to these chemicals in utero. Dr. Kramer applied a “weight-of-evidence” assessment of the association between exposure to gasoline vapors, and the chemical constituents of gasoline vapors, and an increased risk of birth defects and other adverse birth outcomes. She based her assessment on the epidemiological, medical and toxicological literature.

For her part, Dr. Linda Frazier opined that the mother was exposed to developmental hazards due to substances and compounds found in gasoline vapors, which included toxic substances capable of severely damaging a developing fetus during the first trimester. She was able to determine that the exposure levels by the mother to gasoline were high, based upon her reported symptoms of headache, nausea and irritation of the throat. Studies have found that these symptoms occur at gasoline vapor concentrations of at least 1,000 ppm.

 As noted by the Court, Dr. Scialli concluded that no scientific publication has ever established a causal relationship between the inhalation of gasoline during pregnancy and the birth defects diagnosed in Sean Reeps. Further, he criticized Dr. Kramer’s reliance on two human case report articles suggesting an association between leaded gasoline and birth defects for lack of “specificity.” The adverse outcomes in those studies were different from those in Sean Reeps’ case. Other studies cited by plaintiff’s experts discuss the effects of gasoline’s ingredients (such as toluene, ethylbenzene, zylene and benzene) on reproductive and developmental outcomes. However, taken together, these components account for no more than 2% gasoline vapors. To have inhaled a significant amount of these gasoline components would have had fatal consequences for the mother.

Finally, Dr. Scialli asserted that plaintiff’s experts failed to consider causes other than gasoline vapor inhalation for the developmental delays diagnosed in Sean Reeps. For example, intrauterine infection is among the most common causes of cerebral palsy. Mrs. Reeps had a history of herpes simplex infection and a rash during her pregnancy.

 In ruling on the motion, the Court made several significant holdings, which defense lawyers should find useful. My observations about  some of the notable points in Judge York’s decision are as follows:

1. Plaintiff contended that a motion for a Frye hearing should be precluded by the procedural posture of the case. Plaintiff pointed out that defendant had already made and lost a summary judgment motion. In response, the Court determined that a Frye hearing is evidentiary, separate from dispositive motions, and can be held prior or during the trial. Thus, the Court found it appropriate, at this juncture in the case, to consider a Frye challenge. Although trial courts may apply different procedural rules, it may be not always be necessary for the defendant to mount  Frye challenge as part of a dispositive motion;

2. Under Frye, it is not sufficient to merely utilize accepted methodology in reaching an opinion. Rather, it is necessary that the accepted technologies be properly performed and generate results accepted as reliable within the scientific community.  Plaintiff’s experts, Judge York determined, were merely playing lip service to accepted methodology “while pursuing a completely different enterprise”. Thus, the court should explore not just whether plaintiff’s expert cites to an accepted methodology, but whether than methodology was properly applied by the expert in reaching a causation opinion;

3. Plaintiff’s failure to submit affidavits from their experts in opposing defendant’s motion proved fatal in hindsight. In bringing a Daubert or a Frye motion, or in responding to a Daubert or a Frye motion, it is generally sound practice to submit an expert affidavit on behalf of the challenged expert to either explain, or to bolster, the expert’s opinion. Here, defendant’s motion provided plaintiff a roadmap report to the purported weaknesses in the experts’ arguments. Affidavits responding to the criticism of their reports could only have helped their cause.

4. Judge York drew an analogy to a deficiency in Dr. Kramer’s expert report to the expert report in the landmark Court of Appeals case, Parker v. Mobil Oil Corp. In Parker, plaintiff’s expert concentrated on the relationship between benzene and the risk of developing AML – an association that was not in dispute. Key to the Parker litigation, however, was the relationship, if any, between gasoline containing exposure as a component and AML

In the instant case, the Court found that Dr. Kramer was essentially mixing apples and oranges in attempting to extrapolate from the studies concerning gasoline components to gasoline itself.  Parker remains the touchstone in New York toxic tort jurisprudence.

5. According to the decision, Dr. Kramer’s conclusion on general causation was inadequate because Dr. Kramer failed to state unambiguously that exposure to gasoline vapors during early gestation is causally related to the specific conditions diagnosed in the infant plaintiff specifically.

6. Dr. Kramer failed to meet the Parker v. Mobil Oil Corp. requirement that the expert assess the threshold level at which maternal exposure to gasoline vapors is capable of producing adverse effects generally, or in the case at bar, specifically. Citing Parker, Judge York held that “the threshold level of exposure is an element of general causation.”

 7. The expert’s statement that there is an “association” between a specific chemical and an adverse birth outcome is not sufficient to establish “causation.” Citing the Appellate Division’s decision in Fraser v. 301-52 Townhouse Corp,  the Court held that “association” is not equivalent to “causation.”  Words matter–how the expert characterizes her opinion is important.

Reflecting the importance that New York state courts need to give to proof of both "general" and "specific" causation, the Court summarized its view as follows:

 “Dr. Kramer’s and Dr. Frazier’s opinions do not comport with methodologies prevailing in the epidemiological and toxicological scientific communities and on occasion depart from generally accepted rules of drawing conclusions from premises. They provide insufficient support for the conclusion that exposure to gasoline in some unidentified concentration in the first trimester of pregnancy can cause cerebral palsy, microcephaly or any other condition found in Sean Reeps (general causation), or that such exposure actually led to his illness (specific causation).

 In words that any defendant’s trial counsel would want to hear, the Court held,
“The Frye’s ‘general acceptance’ test is intended to protect juries from being misled by expert opinions that may be couched in formidable scientific terminology but that are based on fanciful theories.”

The Court found that conducting a separate Frye hearing would be “redundant” considering that plaintiff’s extensive reports fully presented their arguments.

 It is likely that this decision will be appealed given what is at stake. Stay tuned.

 

Filed under Anthony Scialli, M.D., birth defects, Frye, Frye v. U.S., Hon. Louis B. York, Linda Frazier, M.D., M.P.H, New York State Litigation, New York Supreme Court, Parker v. Mobil, Peter Lees, Ph.D., Reeps v. BMW of North America, LLC, Shira Kramer, Ph.D., teratogenicity Tagged with , , , , , ,

Toxic Tort Plaintiff’s Feet Held To Fire On Causation Evidence In New York

By on October 18, 2012

New York’s appellate courts continue to hold toxic tort plaintiffs and their experts to rigorous standards when it comes to proof of causation. To escape an adverse summary judgment ruling, it is not enough for a plaintiff to merely allege, with the support of an expert, that she was exposed to a toxic substance, and that this exposure resulted in the illness alleged. Rather, the plaintiff must raise a triable issue of fact as to her “exposure to a specific toxin or allergen; quantify the level of exposure to some degree; and posit that such level of exposure was sufficient to produce the alleged injuries.” Such was the holding of the Appellate Division, First Department, in Cleghorne v. City of New York, (2012 NY Slip Op 06648), decided on October 4, 2012.

Cleghorne was a school teacher employed by the New York City Board of Education. She claims that after her school was relocated to the Bronx in 2000, she developed respiratory problems while cleaning her classroom at the new location. Thereafter, she was diagnosed with asthma and bronchitis. After returning to work about a month later, she had an asthma attack at the school and was hospitalized. At her General Municipal Law § 50-h examination in September 2001, Cleghorne testified that she developed a persistent cough while cleaning her classroom and a storage area in the new building and that afterward her condition deteriorated. In October 2001, she commenced an action against the Board of Education and others.

In 2010, both sides moved for summary judgment. Each side presented their own experts’ medical affidavits. The defendants’ physician, Jack J. Adler, a pulmonologist, determined that plaintiff had developed asthma prior to moving to the new school location. Adler opined that the environmental contaminants at the school did not cause the condition. He reported that plaintiff suffered from atopic or allergic asthma and that she was allergic to several common allergens, including tree and ragweed pollen, dust mites, dogs, cats, cockroaches, mold, spores and mouse and rat antigens, none of which were exclusive to her school. Because these environmental contaminants are extremely prevalent, Dr. Adler opined that she would have similar symptoms in any urban environment.

Cleghorne stated in her affidavit (which the court noted was executed more than nine years after the relevant events) that the school premises “were replete with rodents, rodent carcases, rodent droppings, cobwebs, cockroaches, cockroach and other bug carcasses, mildew, thick-black dust, and excessive dirt, and had numerous ceiling tiles that were water damaged and broken.” In addition, mold was in the ceiling tiles by the vents, on the walls, and in the closets. Her daily routine was to clean out all of this material before starting class. Cleghorne had her worried validated by basement waterproofing contractors from her neighborhood in Maryland.

Based upon Cleghorne’s affidavit, her expert, Dr. Hugh Cassiere, opined that Cleghorne was exposed to a “high level” of daily inhalation of these allergens, which caused her to develop “airway hyperresponsiveness.” Faced with two sets of dueling summary judgment motions, the trial court determined that questions of fact required the denial of both motions.

In its opinion, the Appellate Division, First Department, unanimously reversed, holding that the trial court should have dismissed plaintiff’s case. Relying on the Court of Appeals landmark case, Parker v. Mobil Oil Corp., the First Department held that Cleghorne had failed to raise a triable issue of fact as to the specific toxin or allergen; that she had failed to quantify the level of exposure; and that she had failed to posit (through her expert) that such level of exposure was sufficient to produce the alleged injury.

In pertinent part, the Court held,

“While Parker recognizes that the level of exposure need not always be quantified “precisely,” it is still necessary that “whatever methods an expert uses to establish causation [they be] generally accepted in the [medical] community”… such methods include “mathematical modeling or comparing plaintiff’s exposure level to those of study subjects whose exposure levels were precisely determined.”

In Cleghorne, the court found that the only so-called “method” plaintiff’s expert used to establish specific causation was to “accept, at face value, the anecdotal allegations of plaintiff’s uncorroborated affidavit that she was exposes to dust, bugs, rodent droppings and carcases in unspecified quantities and began experiencing asthma, purportedly for the first time, as a result.”
Although plaintiff’s expert characterized  Cleghorne’s exposure as “high level,” the Court found that this assessment was an insufficient basis for his causation theory and that plaintiff’s use of the term “replete” in her affidavit was a “meaningless and vague quantifying adjective.”

Significantly, the court held that an expert’s calculation of the level of exposure may not be based upon assumptions not supported by the record and faulted the plaintiff’s expert for not providing any scientific measurement or employing any accepted method of extrapolating such a measurement. Moreover, plaintiff offered no other evidence concerning the “level of allergens or toxins present in the school.” Although Dr. Cassiere did cite six studies in support of his theory of causation, he failed to compare plaintiff’s exposure level to those of any of the study subjects.

What lessons does Cleghorne provide?

1. Although New York state trial courts are generally reluctant to dismiss the personal injury claim of a sympathetic plaintiff, there is strong precedent in the appellate courts that favors dismissal of toxic tort lawsuits without appropriate scientific support. Therefore, making a strong appellate record below, either on summary judgment or at trial, is essential for achieving a successful outcome;

2. Although some commentators are critical of the Frye rule in New York state court (preferring instead the federal Daubert rule), New York has developed some rigorous Frye jurisprudence. Therefore, all is not lost if you are in New York state court and seek to exclude plaintiff’s expert;

3. A rigorous analysis of plaintiff’s expert’s opinions, expressed either in his affidavit or CPLR 3101(d) expert witness disclosure, is essential. As reflected in Cleghorne, plaintiff’s expert must be able to quantify the level of exposure albeit not “precisely.” However, plaintiff’s methodology must include “mathematical modeling” or, alternatively, a comparison of plaintiff’s exposure level to the exposure level of study subjects in the scientific studies cited by the expert in support of his theory of causation. It is not sufficient to use words like “replete” or “daily” in quantifying an exposure to a toxin or allergen; and

4. The trial court should be cautioned that, in opposing a motion for summary judgment, it is not sufficient for plaintiff’s expert to rely solely on plaintiff’s “anecdotal” remarks seeking to link cause and injury.

Filed under Appellate Division, First Department, Asbestos, Cleghorne v. City of New York, Frye, Parker v. Mobil Oil Corp, proof of causation, Toxic Tort/Product Liability Litigation Tagged with ,