“Every Exposure” Theory of Causation Rejected by Georgia Supreme Court

The highest court in Georgia recently excluded a standard plaintiff argument that “every exposure” to asbestos causes mesothelioma. In Scapa Dryer Fabrics, Inc. v. Knight, the court overturned a plaintiff verdict and reversed both the trial court and intermediate appellate court, holding that a medical expert’s opinion that “every exposure above background contributed to cause plaintiff’s mesothelioma” is legally unsound and “does not ‘fit’ the legal standard for causation”, which requires that an exposure be more than de minimis or trivial. The Georgia Supreme Court reversed, resulting in judgment for the defendant.

7-11The defendant, a textile manufacturer in the late 60’s and early 70’s, produced dryer felts. Some felts contained asbestos that was released into the air during manufacture, at a facility where some of the pipes were insulated with material containing asbestos. Plaintiff was an outside sheet-metal contractor who worked at defendant’s facility on multiple occasions over a four-year period. Plaintiff was sometimes present when the manufacturing process was underway, worked in ventilation ducts that had collected dust, and on one occasion cut into pipe insulation and breathed that dust.

Over defendant’s objection, the trial court allowed plaintiffs’ expert pathologist, Dr. Jerrold Abraham, to testify to the following syllogism: “background asbestos is not known to cause mesothelioma;” “the precise point at which cumulative exposure is sufficient to cause any particular person to develop mesothelioma is not scientifically knowable;” “when a person has mesothelioma, it can only be attributed to his cumulative exposure as a whole;” “each and every exposure to respirable asbestos in excess of the background contributes to the cumulative exposure;” therefore, “each exposure in excess of background is a contributing cause of the resulting mesothelioma, regardless of the extent of each exposure.” Dr. Abraham went so far as to testify that “a causal connection would be lacking only if ‘there was no asbestos exposure’ attributable to [defendant]’, that “one fiber [of asbestos] above ambient levels would be causative for someone who had  mesothelioma”, that “he did not need to determine the extent of [plaintiff’s] exposure, but only need to know that the exposure was more than ‘zero’”, and that “if someone gets the disease from a trivial exposure, it is still asbestos-related.’”

This is a common position taken by plaintiffs’ experts in toxic tort litigation. It is known by many names: “single fiber,” “any exposure,” “every exposure” or, in this case, the “cumulative exposure” theory of causation. The theory has been rejected by the supreme courts of Pennsylvania and Texas and many other courts; a recent California appellate court, in dicta, refused to reject this theory outright, but affirmed the plaintiff’s burden as requiring proof that the defendant’s product “was a substantial factor in contributing to the risk of developing asbestos-related cancer.” (See our earlier post on the California case.)

The jury in Scapa assessed 40% fault to the defendant and awarded plaintiffs $4 million.

The Supreme Court of Georgia analyzed this issue first by examining the relevant standards for admissibility of expert testimony. It noted that the question of admissibility of expert testimony is a question “committed to the sound discretion of the trial court.” However, using language much like the United States Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1999), the court held that it is incumbent upon the trial court to “act as a ‘gatekeeper’ to ensure the relevance and reliability of expert testimony.” Dr. Abraham’s qualifications were not in dispute. Instead, the defendant challenged his “single fiber” theory as “junk science”, and also argued that the testimony was not relevant because it did not “fit” the legal standard for causation under Georgia law. The court agreed with the second point (and hence did not reach the question whether the “cumulative exposure” theory is scientifically valid), holding that because this opinion “does not ‘fit’” the legal standard for causation, and for that reason, the admission of his testimony … was not helpful to the jury and amounted to an abuse of discretion.”

To prove causation in an asbestos personal injury case under Georgia law, a plaintiff must therefore show that an exposure was a “contributing factor” in bringing about the disease. It need not be “substantial”, but it must be “meaningful” and not “de minimis.”

Though the court recognized that the plaintiffs in that case “may well have presented evidence of more than a de minimis exposure” at defendants’ facility, defendants presented evidence to the contrary. But by admitting the opinion of Dr. Abraham that “any asbestos above background … was a contributing cause of the mesothelioma” (i.e., even a de minimis exposure), the trial court allowed the jury to resolve this dispute in a manner inconsistent with Georgia law.

The court cautioned: “That is not to say that expert testimony premised upon a cumulative exposure theory could never be relevant to causation.” But the court held fast to the notion that de minimis or trivial exposures are not causative. Had Dr. Abraham also presented reliable evidence that the exposures in question were “more than de minimis,” and had he based his ultimate causation opinion on exposures that were more than de minimis, “the opinion then might ‘fit’ the pertinent causation inquiry, notwithstanding that the extent of exposure is disputed.” The court pointed out that in other cases Dr. Abraham’s “cumulative exposure” theory has been allowed when coupled with a review of the evidence of the extent of exposure and of studies showing such exposures present an increased risk of developing mesothelioma.

While a precise quantitative exposure analysis is not required, a qualitative assessment is. Thus, an opinion that a “de minimis” or “any” exposure could cause mesothelioma is inadmissible (at least in Georgia), while an opinion that each “significant” or “sustained” exposure to asbestos” is a cause would be admissible.

Recent SCIENCE Article a Potential Game Changer for Arguing Medical Causation in Cancer Cases: Stem Cell Division and “Bad Luck”

This month’s Science Magazine features a paper by two Johns Hopkins scientists that provides support for a more refined theory of causation in a number of types of cancer.  The article by Drs. Christian Tomasetti and Bert Vogelstein entitled “Variation in Cancer Risk Among Tissues Can Be Explained By The Number of Stem Cell Divisions” includes the following abstract:

Some tissue types give rise to human cancers millions of times more often than other tissue types. Although this has been recognized for more than a century, it has never been explained. Here, we show that the lifetime risk of cancers of many different types is strongly correlated (0.81) with the total number of divisions of the normal self-renewing cells maintaining that tissue’s homeostasis. These results suggest that only a third of the variation in cancer risk among tissues is attributable to environmental factors or inherited predispositions. The majority is due to “bad luck,” that is, random mutations arising during DNA replication in normal, noncancerous stem cells. This is important not only for understanding the disease but also for designing strategies to limit the mortality it causes.

This finding may have broad implications in determining what may cause the cancer at issue in a particular case.  This article concludes that the incidence or lifetime risk of many cancers directly correlates to the number of stem cell divisions in the tissue involved in the cancer.  This correlation appears to be, in many cases, independent of any environmental or external factors.  Because the article provides a potential explanation for the cause of many types of cancer, this may allow experts to use rate of stem cell division as a causation argument in lieu of saying the cause is “idiopathic.”

Interestingly, among the cancers that have a higher rate of stem cell divisions are acute myelogenous leukemia and chronic lymphocytic leukemia, two types of cancer that are prevalent in matters involving allegations of exposure to trace benzene. This fact will certainly be the source of future argument regarding general causation.  We expect there to be future scientific inquiry into the findings in this article, but the findings alone do raise important issues.  Further studies in this area may provide further support for arguing against an environmental correlation between cancer risk and exposure in cases where the cancer involved has a high rate of stem cell division.  We expect that this study and future studies will have a significant effect in matters involving allegations of toxic exposure.

To Spoil or Not to Spoil? Why Speculation Carried the Day for the Defense Against Plaintiff’s Spoliation Claims

This holiday season has been good to the asbestos defense bar.  On December 16, 2014, the Illinois Fourth District Appellate Court decided a case which emphasizes the need for a plaintiff to properly prove causation by non-speculative evidence.  In the process, the court rejected a “sham” spoliation of evidence claim, finding that defendant’s spoliation of evidence was immaterial in light of the witness testimony presented by the plaintiff.  This is the first published decision in this State pertaining to spoliation.

In Holloway v. Sprinkmann Sons Corp., 2014 IL App (4th) 131118, plaintiff Carol Holloway brought a negligence action against defendant Sprinkmann, an alleged asbestos insulation supplier, alleging that  defendant delivered and installed asbestos-containing insulation at plaintiff’s jobsite  while she worked as at the Eureka vacuum cleaner factory in Bloomington, IL.  As an alternative theory, plaintiff argued that Sprinkmann wrongfully destroyed evidence that plaintiff needed to prove her case.  Plaintiff specifically alleged that Sprinkmann destroyed records indicating the types of insulation it sold and to whom the insulation was sold.  Destroying this evidence, plaintiff argued, prevented her from demonstrating which specific asbestos-containing products were sold and delivered by Sprinkmann to her jobsites.

At trial, plaintiff called Arthur B. Kremers, Sprinkmann’s former owner.  When Kremers began working for Sprinkmann in 1969, old records dating back to the 1950s were kept in the basement of the company’s Peoria office.  These records showed the brand and manufacturer of each product defendant had sold and delivered, as well as which employees had installed each product.  Apparently, as early as 1957, Sprinkmann employees began making claims for asbestos-related disease, relying on the basement records to show which brands of insulation the employees had installed.Sometime in the 1980s, however, Kremers shipped the basement records to a recycling center because “defendant was running out of space.”  The destruction of the records, according to Kremers, was consistent with Sprinkmann’s document retention policy, under which sales contracts and invoices were to be retained for only three years.

Crying foul over the alleged “spoliation” of evidence, plaintiff called co-worker witness Ellis Carlton and read into evidence an affidavit of another deceased witness, Wesley Klein.  This evidence was uncontroverted, and – as the documents themselves would have done – established that asbestos-containing insulation supplied by defendant Sprinkmann was present at plaintiff’s jobsite and installed by it.

The jury nonetheless returned a general verdict in defendant’s favor, prompting plaintiff to file a motion for a new trial, which was denied by the trial court.  On appeal, plaintiff argued that the jury might have found for plaintiff if it had had the benefit of reviewing the destroyed records establishing that the products were present at plaintiff’s worksite.

The appellate court affirmed the trial court’s judgment.  In doing so, it focused on the fact that the uncontradicted evidence of Klein and Carlton already established that the products were present at the facility.  To the extent that the “spoliated” records would have done nothing more than supply the same information, the jury could have reasonably concluded that the destroyed records would have made no difference in plaintiff’s case.   Thus, the “spoliated” records were no consequence.  For this reason, the court found that plaintiff failed to meet her burden of proving that, but for the destruction of the records, she would have had a reasonable probability of prevailing. The court then expressly addressed the key issue in this case:  that “the real problem in plaintiff’s case was causation, which the records would not have addressed.”  Indeed, the court hammered home the fact that “all plaintiff offered in the trial was speculation that her asbestosis resulted from repair work on the pipe-covering insulation in the Eureka plan, although she never saw any repair work being done on the insulation and there was no other evidence placing her near any such repair work.”

Plaintiff attempted to substantiate her exposure using the testimony medical expert Dr. Arthur Frank in conjunction with her own testimony that she was “in all the different parts of the plant for one reason or another.”   Dr. Frank espoused the “re-entrainment” theory, testifying  that individuals who had never worked hands-on with an asbestos-containing product could still be exposed to asbestos fibers because these fibers drifted around the factory and could be carried a long way by air currents.  According to Dr. Frank, all asbestos-containing products, including steam pipe insulation, released such fibers.  In fact, simply the “passage of time” would release these fibers.  On the other hand, Frank also conceded that a person needed to cross a threshold of a certain amount of exposure before getting asbestosis; Frank could not clarify what the threshold was, though he insisted that, for someone with asbestosis, “each and every exposure to any asbestos product had to be regarded as a cause.”

The court, however, was unpersuaded by plaintiff’s interpretation of her own testimony.  Specifically, the court noted that saying that plaintiff was “in all the different parts of the plant for one reason or another” is not quite the same as saying she “worked all over the plant.”  For argument’s sake, the court assumed that Dr. Frank’s theories were correct, that when asbestos-containing insulation had to be repaired, it created asbestos dust, and that such dust stayed around for a long time and wafted through the air.  However, the court concluded that Frank’s testimony was ultimately irrelevant, as there was no evidence that the buildings in the Eureka plant shared the same air, nor was there any evidence presented suggesting that the buildings in the plant shared a common ventilation system.  Plaintiff could therefore not clearly connect the allegedlyomnipresent “asbestos dust”  to her own inhalation.  Even if she had, the court pointed out problems with the testimony of plaintiff’s “expert,” noting that Frank’s testimony provided no solid, non-speculative evidence that the amount of asbestos dust breathed in by plaintiff under such circumstances would be sufficient to cause asbestosis.

Holloway v. Sprinkmann places great importance on a plaintiff’s burden to show causation with non-speculative evidence.  For plaintiffs like Holloway, certain expert testimony may seem like a home run (eg., the “re-entrainment” theory), but, at the very heart of the matter, such evidence is nothing more than conjecture. In rejecting plaintiff’s spoliation argument, the Sprinkmann court further demonstrated that it will not permit “red herring” issues to distract the court from a lack of admissible evidence of causal links.  This decision from the Illinois appellate court provides further support for defendants seeking to attack speculative evidence, without fear that extrinsic issues that have no bearing on their ultimate liability will alter the result.

Texas Supreme Court Reaffirms Standard of Proof in Mesothelioma Cases: Bostic v. Georgia-Pacific

On July 11, 2014, the Texas Supreme Court released an opinion of major importance in Bostic v. Georgia-Pacific — an opinion Gordon & Rees partner William A. Ruskin recently commented on in a Law360 article.  The court’s decision reaffirmed the bedrock significance of the concept of dose in toxic tort litigation and rejected out of hand the argument that a less rigorous standard should be applied in a mesothelioma case than in an asbestosis case.  Bostic articulated that plaintiffs must prove substantial factor causation in all toxic tort litigation in general and in asbestos litigation in particular.

ETT BLOG_texasTimothy Bostic’s relatives sued Georgia-Pacific and 39 other asbestos-related product manufacturers claiming that Bostic’s fatal mesothelioma was caused by exposure to their products.  At trial in 2006, the jury allocated 25 percent of the causation to Knox Glass Co., the decedent’s former employer, and 75 percent to Georgia-Pacific. An amended judgment awarded plaintiffs over $11 million in compensatory and punitive damages. The Court of Appeals reversed the trial court’s decision holding that the plaintiffs failed to prove that the exposure to Georgia-Pacific’s asbestos was a substantial factor in bringing about Bostic’s death.
In affirming the Court of Appeals, the Texas Supreme Court held that the substantial factor causation standard applies to all asbestos cases involving multiple sources of exposure. To meet this standard, proof of “some exposure” or “any exposure” did not suffice to establish causation.  Instead, there must be defendant-specific evidence relating to the approximate dose to which the plaintiff was exposed, along with evidence that the dose was a substantial factor in causing the asbestos-related disease.

Bostic elaborates upon the Texas Supreme Court’s prior decision in Borg-Warner Corp. v. Flores, an asbestosis case. Flores addressed the issue of why the plaintiff’s causation evidence was legally insufficient in the absence of evidence of how much asbestos the plaintiff might have inhaled. Flores explained that proof of frequency, regularity, and proximity to a toxic substance alone is not sufficient to support causation, because it does not demonstrate that the defendant-specific dose was a substantial factor in causing the disease. Bostic expressly rejected the plaintiffs’ attempted distinction between a mesothelioma case and an asbestosis case. Rather, the court held the “framework for reviewing the legal sufficiency of causation evidence lends itself to both types of cases.”

Fundamentally, a plaintiff must show that the defendant supplied the product that caused the injury. Hence, the court viewed plaintiff’s “any exposure” theory as “illogical,” in part because it does not take into account a background dose of exposure.  In asbestos-related cancer cases, plaintiffs are not required to show that specific fibers from a defendant’s products were the ones that actually caused the asbestos-related cancer. Instead, it must be shown that exposure to a defendant’s product was a substantial factor in contributing to the total dose of asbestos the plaintiff inhaled, and therefore to the risk of developing asbestos-related disease.

The Supreme Court disagreed with the lower court, however, stating that the plaintiffs do not have to meet the heightened standard of “but-for” causation. Although the court recognized that “producing cause” or “but-for” is the level of causation applicable to most products liability cases, it was unwilling to apply that standard in a case with 40 defendants.

Acknowledging that causation is difficult to prove in multidefendant cases, the court referenced its prior holding in Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706 (Tex. 1997), which offers an alternative method for establishing causation in the absence of direct proof. Havner recognized the possibility of using epidemiological studies to prove a population exposed to a toxin faces the increased risk of injury as compared to an unexposed or general population. Under Havner, the epidemiological evidence must show that the plaintiff’s exposure to the defendant’s product more than doubled the plaintiff’s risk of contracting the disease.

In essence, the Texas Supreme Court found the causation evidence in Bostic to be legally insufficient to uphold the trial verdict. The plaintiffs did not establish any approximation of dose resulting from Bostic’s exposure to Georgia-Pacific’s products. Bostic rejected the plaintiffs’ “any exposure” standard and instead reaffirmed adherence to substantial factor causation.

Alexana Gaspari is a law clerk in Gordon & Rees’s New York office.

Image courtesy of Flickr by Ray Bodden

Will the Exception Swallow the Rule? The Northern District of Illinois’ Take on the Bare Metal Defense

The bare metal defense has become a “go-to” defense for defendants involved in national asbestos litigation.  Predominantly asserted by manufacturers of industrial equipment, the defense provides that those defendants that manufactured products composed only of metal have no duty to warn of asbestos-containing components later installed by others post-sale.  It also rejects liability for “affixed” external materials – typically thermal insulation and flange gaskets manufactured by others – placed on the metal products by someone other than the defendant.

While the defense has been the subject of numerous cases, its application has not been uniform.  However, the decisions fall into three main categories:

(1) a defense-friendly category, holding that manufacturers have no duty to warn of asbestos-containing replacement parts supplied by a third party;

(2) a plaintiff-friendly category, holding that manufacturers have a duty to warn whenever it is foreseeable that asbestos-containing material may be used with their products; and

(3)  a “middle ground,” holding that manufacturers generally have no such duty, but do have a duty to warn when the use of asbestos-containing materials (a) was specified by a defendant, (b) was essential to the proper functioning of the defendant’s products, or (c)         was for “some reason so inevitable that, by supplying the product, the defendant was responsible for introducing asbestos into the environment at issue.”

Recently, the Northern District of Illinois expressly adopted the middle ground. In Quirin v. Lorillard Tobacco Co., 2014 U.S. Dist. LEXIS 18744 (N.D. Ill. Feb. 14, 2014), the court ultimately denied Crane Co.’s summary judgment motion under an exception to the middle-ground approach, namely that the plaintiff was able to proffer evidence that Crane Co. specified the asbestos-containing replacement components or that the asbestos-containing components were necessary for the metal products to function.

Quirin arose out of the plaintiff’s alleged exposure to asbestos-containing Crane Co. valves during the plaintiff’s service in the U.S. Navy.  Although the valves themselves were composed of “bare metal,” they included an internal bonnet gasket and stem packing at the time of shipment that may have contained asbestos. In addition, Crane Co. sold asbestos-containing replacement gaskets, gasket material and packing.  Crane Co. moved for summary judgment, arguing that its valves were bare metal and, accordingly, Crane Co. had no duty to warn of asbestos-containing components manufactured by others and ultimately applied by the Navy, the end user of the product.

Quirin looked to other jurisdictions for guidance, expressly citing the California Supreme Court’s ruling in O’Neil v. Crane Co., 53 Cal. 4th 335 (2012), noting that “manufacturers are not required to investigate and warn of the potential risks of any other products that might be used with a Crane Co. product.  The duty attaches only when the manufacturer incorporated the asbestos-containing material into its product, meaning that asbestos would inevitably be introduced into the stream of commerce along with the product.”  The Quirin court, however, found that the O’Neil court “qualified its conclusion” and “left room for an exception to the rule” because the plaintiffs in O’Neil did not prove the equipment at issue needed asbestos to function.

Quirin relied on evidence that Crane Co. valves were used for high heat applications, that at least some of its valves needed asbestos-containing components to function properly, and that Crane Co. provided specifications for such use.  Taken together, the court concluded that a jury could find that Crane Co. had a legal duty to warn about the hazards of asbestos exposure from working with its valves.

On one hand, the fact that the Quirin court cited the O’Neil case with approval is encouraging for equipment defendants in Illinois.  However, the adoption of the middle-ground approach by the Northern District of Illinois is troubling. Practically speaking, there is minimal difference between the middle-ground approach and the plaintiff-oriented foreseeability approach, since the plaintiffs will merely proffer expert testimony to prove the “bare metal” product at issue was used for hot applications and “needed asbestos” to function properly.  As presently interpreted by the Northern District, then, defendants need to be particularly aware of the bare metal defense’s limitations; it does not provide a complete bar for bare metal defendants, even those that never manufactured asbestos-containing products or provided asbestos-containing components with their products.

Fortunately, however, development of the bare metal defense is still in its infancy in Illinois.  Indeed, there has yet to be a definitive ruling rendered by an Illinois appellate court on the issue.  In fact, just before the ruling in Quirin, the Asbestos MDL remanded an asbestos lawsuit to the Southern District of Illinois to determine whether the state even recognized the bare metal defense.  For now, equipment defendants in federal court in Illinois are well advised to argue the policy and rationale of O’Neil and push at the state and federal level for a bright-line rule of nonliability for other parties’ products.

New Jersey: No Liability for Other Parties’ Asbestos Products

New Jersey has joined the list of jurisdictions that hold a defendant is not liable for asbestos in replacement parts supplied by others, regardless of whether there was asbestos in the same part as originally supplied.

Hughes v. A.W. Chesterton Co. is a generally good result for asbestos defendants. Notably, it did not get to the result the same way that other cases (e.g., California, Washington, and the asbestos MDL) did.

Hughes held that there was a duty to warn, but found no liability as a matter of causation. Many other cases coming to the same result as Hughes held that there is no duty to warn. (For example, California’s O’Neil, Washington’s Braaten and Simonetta, the Sixth Circuit’s Lindstrom, the MDL’s Prange, etc.)

Hughes imposed a duty to warn on the grounds that it was reasonably foreseeable at the time the Goulds pumps were sold that original gaskets and packing would be regularly replaced with gaskets and packing that contained asbestos. “Since the risk of exposure continued and was perhaps increased by the replacement process, a warning given at the time of the initial sale would ensure that this information was available to be considered in subsequent decisions regarding the choice of replacement parts and any additional safeguards for workers who made the replacements. We therefore conclude that it would be reasonable, practical, and feasible to impose a duty to warn upon Goulds under the facts here.”

“We do not agree that plaintiffs may prove causation by showing exposure to a product without also showing exposure to an injury-producing element in the product that was manufactured or sold by defendant.” The court rejected plaintiffs’ argument that causation may be proved by mere likelihood that defendant’s equipment would be used with asbestos-containing replacement parts, requiring instead proof that such parts were “manufactured or sold by the defendant.”

“California law,” as O’Neil  says in contrast, “does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together. Were it otherwise, manufacturers of the saws used to cut insulation would become the next targets of asbestos lawsuits.”

It is unclear whether the Hughes/New Jersey/causation approach will lead to more consistently positive results for defendants than the O’Neil/California/no duty approach. For example, California courts have since split on whether cases against various defendants, including some that never made any asbestos-containing products but only products that were used with such products, fall within O’Neil exceptions. Such exceptions to O’Neil may be irrelevant to a causation analysis under Hughes. Another potential difference is that it ought generally to be easier to win summary judgment on duty, a legal issue, than on causation, which will involve facts. On the other hand, it’s still all about one question: “was it the defendant’s product that contained the asbestos?”

A Cautionary Note Regarding Expert Opinions on Causation in U.S. District Court

In an April 17 order, U.S. District Court Judge Stephen Wilson of the Central District of California in Los Angeles strictly applied federal rules and the Daubert standard to exclude causation testimony from Dr. Barry Horn and Dr. Arnold Brody.

In Sclafani v. Air & Liquid Systems Corp., the court applied California’s liberal causation standard found in Rutherford v. Owens-Illinois, Inc. (substantial factor contributing to the risk) and distinguished the recent unfortunate California Court of Appeal decision in Hernandez v. Amcord, Inc.  The result was good – defendants won summary judgment – but some of Judge Wilson’s rationale may also limit defense experts in future cases.

Citing Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, the court excluded causation opinions of both plaintiff experts.  In excluding the opinions of Brody, the court noted that he admitted his opinions regarding “every fiber” contributing to the risk had not been published in peer-reviewed literature and could not be tested. The court found that other opinions of Brody, supported by citation to four published papers that were not attached, were nevertheless inadmissible, as the papers themselves must be provided. These rulings caution that defense expert opinions may also be excluded if (a) not published in peer-reviewed literature or (b) to the extent based on studies that are not submitted along with the expert’s report.

The court further ruled that Horn’s opinions offered in deposition, but not found in his earlier Rule 26 report, were inadmissible. If this same standard were applied to defense expert Dr. Victor Roggli and his brief reports, for example, one can anticipate significant problems.

Physician’s Failure To Read Trumps Drug Company’s Failure To Warn

When the prescribing physician in a pharmaceutical product liability case admits that at her deposition that she never reviewed the manufacturer’s label before treating her patient and that the label played no role in her decision to prescribe the drug, plaintiff’s claim that the label should have contained a stronger warning is rendered moot.

Often the physician, a trained clinician, will testify that she was familiar with the risks in question and did not need to be provided a warning. Alternatively, the physician may testify that a stronger warning would not have influenced her decision to prescribe the drug and that she still prescribes the drug. Under either scenario, it may be argued on summary judgment that the learned intermediary did not rely on the allegedly inadequate warning and that, therefore, the plaintiff cannot establish that the alleged failure to warn was a proximate cause of plaintiff’s injury.

In an article on his Drug and Device Law blog on October 17, 2013 titled, “Don’t Forget About a Prescribing Physician’s Failure to Read Warnings,” James M. Beck, Counsel resident in the Philadelphia office of Reed Smith, provides an exhaustive survey of cases dismissing claims where the learned intermediary physician failed to read the warnings. Beck reports on and provides summaries of decisions from 42 jurisdictions.

As Beck observed in another blog post on October 28, 2011, “After all, there is a causation element to every warning claim – the defect (whatever is allegedly wrong with the warning) has to cause the injury. If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.”
 

The Role Of The Heeding Presumption In Failure To Warn Litigation

In many jurisdictions, a product liability plaintiff is not permitted to testify concerning what he or she would have done had there been an adequate warning on a product; such testimony is considered both self-serving and speculative. In the absence of such testimony, some states have adopted the Heeding Presumption.

This rebuttable presumption instructs the jury that had an adequate warning accompanied the product, they are to presume that plaintiff would have “heeded” or followed the warning. This presumption establishes causation by permitting the inference that an adequate warning would have altered plaintiff’s conduct.  

In a compelling article published in the Bloomberg BNA Prduct Safety & Liability Reporter on August 23, 2012, titled," ‘If Only I would Have Been Told…..’ A Failure to Warn Discussion: Causation, the Uncertainty Principle, the Benign Experience Principle", William O. ("Skip") Martin Jr., a partner at Haight Brown and Bonesteel in Los Angeles, discusses the Heeding Presumption and provides strategies for defense counsel to overcome the presumption at trial.

In Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), the Fifth Circuit adopted the Heeding Presumption and described it as follows:

Where a consumer, whose injury the manufacturers should have reasonably foreseen, is injured by a product sold without a required warning, a rebuttable presumption will arise if the consumer would have read any warning provided by the manufacturer, and acted so as to minimize the risks. In the absence of evidence rebutting the presumption, a jury finding that the defendant’s product was the producing cause of the plaintiff’s injury would be sufficient to hold him liable. 

Martin advises that the Heeding Presumption may be rebutted by demonstrating either that the plaintiff did not read or look for any warning, or that plaintiff failed to follow adequate warnings on the product. In the article, Martin provides good case law examples of both scenarios. If it can be demonstrated that the plaintiff would not have read the warning or, if he or she had read them, would not have heeded the warning, the Heeding Presumption is overcome. The key to a successful defense of a failure to warn claim is to require plaintiff to demonstrate that his or her failure to warn claim was a proximate cause of the injury. Often, trial judges overlook that it is plaintiff’s legal burden to establish that an allegedly inadequate or missing warning was a cause of the injury.

In addition to his discussion of the Heeding Presumption, Martin also provides a good outline for taking the deposition of an adversary human factors or warnings expert. Most plaintiff warnings experts fail to present any competent evidence as to whether a warning would have altered the plaintiff’s conduct. Human factors/warnings experts criticize the existing warning or lack of a warning on a product label, but often have done little or nothing to determine how a different warning would have altered the outcome. Again, by focusing on the causation element in plaintiff’s burden of proof, a defendant can reduce the “sting” of plaintiff’s failure to warn allegation.

 

Breach Of Warranty & Product Liability Claims Dismissed Against Auto Service Provider

In 2008, the parents of Sean Reeps, brought suit against BMW, Martin Motor Sales and Hassel Motors ("Hassel"), alleging that Sean’s mother, Debra, was exposed to gasoline fumes in the family’s BMW during her pregancy, which resulted in Sean being born with birth defects. The Complaint alleged causes of action in (1) negligence; (2) strict products liability; (3) breach of express warranty; and (4) breach of implied warranty (merchantability) . The timeline of events is as follows:

1991-In March and again in November, 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’s  inhalation of gas fumes early in pregnancy.

1994-BMW recalls BMW525i vehicles due to safety defect that caused odor due to feed fuel hose. Car is no longer with plaintiffs at the time.

On summary judgment, BMW argued that plaintiff’s claims were barred by the doctrine of spoliation because plaintiff could not establish a prima facie case without the car or the fuel hose to show the actual alleged defect.  BMW’s expert testified by affidavit that the Reeps’ leakage was caused by a split in the fuel hose, not by the defect that was the subject of the recall.  Thus, in the absence of the actual fuel hose, BMW argued, plaintiff could not demonstrate a defect. 

The trial court rejected BMW’s spoliation argument, holding that there was no evidence of “willful or contumacious conduct” by plaintiff in disposing of the car. Remarkably, the Reeps’ BMW was actually found, but clearly not in the same condition as it was in 1991 and, not surprisingly, without the original fuel hose. The trial court held that plaintiff was not “barred from pursuing his claim, but rather he will have the onerous trial burden of proving his case solely by circumstantial evidence.”

New York law requires that to establish a prima facie case for strict product liability or design defect, a plaintiff must show that the manufacturer marketed a product that was not reasonably safe in its design; that it was feasible to design the product in a safer manner; and that the defective design was a substantial factor in causing the plaintiff’s injury. When the product at issue is no longer available, and the plaintiff seeks to prove a manufacturing defect by circumstantial evidence, the plaintiff must not only establish that the product did not perform as intended, but must also exclude all other causes of failure not attributable to the manufacturer.

The trial court denied Hassel’s motion for summary judgment. The gravamen for plaintiff’s claims against Hassel was that it was negligent in failing to find the split fuel hose when the Reeps first complained of fuel odor in March 1991. Plaintiffs argued that if Hassel had identified and repaired the problem, Mrs. Reeps would not have inhaled any fumes during her pregnancy. In denying the dealer’s motion for summary judgment, the court observed that there is a high bar for obtaining summary judgment in a negligence action. As the court noted, “Simply put, Hassel must prove that it was not negligent when it failed to find a source of the gas fumes complained of by the Reeps in March 1991. It has not done so.”

In its decision, dated April 5, 2012, the Appellate Division, First Department, weighed in on both the spoliation issue and the motion for summary judgment by Hassel. On the spoliation issue, the Appellate Division held that the defendants “failed to demonstrate that the parents disposed of the vehicle with knowledge of its potential evidentiary value.” Moreover, the court discussed the existence of other available evidence, including BMW’s Recall Bulletin and Hassel Motors-service records for the relevant period, which served to mitigate the loss of the vehicle. Basically, the court examined two of the key factors in evaluating spoliation sanctions – prejudice and intent – and determined that the movants had failed to establish either element in seeking sanctions.

As to plaintiff’s claims against Hassel, the Appellate Division held that the product liability and breach of implied and express warranty claims should be dismissed because the service provider did not design, manufacture, distribute or sell the vehicle. This holding may be the most important in the case because it clarifies that service providers, as opposed to product sellers, can not be held liable under strict product liability or breach of warranty theories of liability. Therefore, the only remaining claim against Hassel sounds in negligence, which may be difficult for plaintiff to establish at trial after a twenty year hiatus.

Apart from its other burdens, plaintiff will have to demonstrate general causation at trial, that is, whether exposure to chemical components in gasoline fumes have been associated in the scientific literature with the specific teratogenic effects alleged, including cerebral palsy. If plaintiff is able to prove general causation, he will then have to prove specific causation, that is, whether the dose of the purported teratogen was high enough, and lasted for a sufficient duration, to cause the specific birth defect.

The plaintiff attributes his injury to Debra Reeps’ inhalation of gas fumes during the first couple of months of her pregnancy between August 1991 and November 1991, when the problem with the vehicle was fixed. Are the alleged teratogenic effects associated with a toxic exposure early in pregnancy? How often did Debra Reeps ride in the automobile during those first couple of months? If the odor problem was significant, is it likely that the Reeps would not have returned their BMW 525i, which was under warranty, to the dealership before November? Because there is no expert deposition discovery under New York state practice, we will have to await trial to learn how these issues plays out.