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

The Ninth Circuit late last month upheld the dismissal of a proposed class action concerning alleged off-label marketing of the drug Actimmune.  In re: Actimmune Marketing Litigation, Nos. 10-17237 and 10-17239 (9th Cir. 12/30/11).

The panel, in an unpublished opinion, affirmed the judgment of the district court “for the reasons set forth in the district court's orders.”  See In re Actimmune Marketing Litig., 614 F.Supp.2d 1037
(N.D. Cal. 2009) (Actimmune I); In re Actimmune Marketing Litig., 2009 WL 3740648 (N.D. Cal. Nov. 6, 2009)(Actimmune II ); In re Actimmune Marketing Litig., 2010 WL 3463491 (N.D. Cal. Sept. 1, 2010) (Actimmune III).

In September 2010, the trial court had issued a ruling dismissing the amended complaints filed by consumers and an insurer, who alleged that defendants had improperly marketed Actimmune as a treatment for idiopathic pulmonary fibrosis.  Despite the additional allegations included in plaintiffs' latest amended pleadings, plaintiffs still failed to properly allege that defendants' conduct caused plaintiffs' injuries. Therefore, plaintiffs lacked standing to pursue their off-label marketing claims under the asserted consumer fraud claims.  Establishing that a defendant violated a law only accomplishes part of a plaintiff's burden; plaintiffs were also required to prove that they were injured “as a result of” defendants' alleged law-violating conduct.

In the context of the instant case, the “as a result of” language placed the burden on plaintiffs to establish that they actually relied upon the representations delivered through defendants' off-label marketing. Plaintiffs failed to allege a plausible causal chain of injury as required by Iqbal/Twombly.

The shortcoming in the consumer plaintiffs' pleadings was simple: all of the consumer plaintiffs failed to allege that their doctors believed that Actimmune was an effective treatment for IPF “as a result of” defendants' off-label promotion of Actimmune. With respect to each plaintiff, the complaint alleged only that their doctors were “exposed to at least some of InterMune's unfair and unlawful off-label marketing.”  That was not enough;  claims dismissed.

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The maker of  a drink containing alcohol and caffeine was not liable to a woman allegedly injured when the driver of the motorcycle on which she was a passenger crashed, after the driver consumed the beverage.  See Cook v. MillerCoors LLC, No. 11-1488 (M.D. Fla., 10/28/11).

The operator of the motorcycle in the accident was killed, and plaintiff Cook, who was a passenger, was injured.  Prior to the crash, the driver allegedly had consumed several “Sparks”
alcoholic beverages containing caffeine and other stimulants, manufactured by defendant.

Cook argued that alcoholic beverages such as Sparks containing stimulants are “uniquely dangerous” because they appeal to younger drinkers and because the addition of caffeine enables one to drink more alcohol without feeling as intoxicated as one normally would. Thus, she alleged, consumers of these beverages are more likely to “engage in dangerous behavior such as driving.”  She asserted the driver did not appear impaired, even though toxicology reports from his autopsy revealed that his blood alcohol level was 0.10 at the time of the crash.

Defendant responded that the risks associated with operating a motor vehicle while under the influence of alcohol are well known; therefore, it could not be held responsible for the operator's choice to consume Sparks then illegally operate his motorcycle. The addition of other ingredients to the beverage did not lessen his responsibility to refrain from operating his motorcycle after having consumed the alcohol, and his actions, not the manufacture of Sparks,
proximately caused Cook’s injuries.  The crux of the defense motion to dismiss thus was that there is no cause of action against a manufacturer of alcoholic beverages for injuries resulting from their consumption because the effects of alcohol consumption are well known. With a response from plaintiff that the legion of such holdings in courts everywhere apply to “conventional” alcoholic beverages, not to an alcoholic beverage mixed with stimulants which allegedly suppress the consumer’s subjective awareness of alcohol’s well-known effects.

Regarding the failure to warn theory, a plaintiff must establish the existence of a duty. A manufacturer’s duty to warn arises when there is a need to inform consumers of dangers of which they are unaware.  The effects of alcohol and the need to not drink and drive are universally known.  While plaintiff argued about the unconventionality of this product, plaintiff did not and could not allege that the driver was unaware that he was drinking alcohol. His alleged subjective awareness of the speed or impact of those effects did not alter the legal reasoning of precedent that holds that there is no duty to warn because of the universal recognition of all potential dangers associated with alcohol. 

Plaintiff also failed to adequately allege how the product was unreasonably dangerous for the design defect claim. The effects of alcohol are universally and objectively well known, irrespective of the operator's alleged subjective awareness of them. The defectiveness of a design is determined based on an objective standard, not from the viewpoint of any specific user, said the court.

Moreover, plaintiff's theories failed as to proximate cause. Plaintiff alleged that the manufacturer's negligence caused the driver to become intoxicated to the point of impairment,
causing the crash and Cook’s injuries. In Florida, however, voluntary drinking of alcohol is the proximate cause of an injury from an intoxicated driver, rather than the manufacture or sale of those intoxicating beverages to that person.  This doomed the negligence claim.

Readers can readily see why the court was reluctant to make an exception to the rule for the "unconventional" beverage.  There are hundreds of alcohol-containing products that are not "conventional" in one way or another, by taste, ingredients, color, manufacturing process, advertising... To shift responsibility from the person who over-consumes one of these and then drives impaired is to send the absolutely wrong policy message.

Courts have typically recognized no duty on the maker, regardless of plaintiff's attempt to differentiate either themselves or the product. See, e.g., Malek v. Miller Brewing Co., 749 S.W.2d 521 (Tex. App. 1988) (finding no duty to warn despite claim that advertising led plaintiff to believe that “Lite” beer was less intoxicating than other beer); Pemberton v. Am. Distilled Spirits Co., 664 S.W.2d 690 (Tenn. 1984); Greif v. Anheuser-Busch Cos., Inc., 114 F. Supp. 2d 100 (D. Conn. 2000)(particular, alleged tolerance of an individual consumer); MaGuire v. Pabst Brewing Co., 387 N.W.2d 565 (Iowa 1986).

 

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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.

 

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The Sixth Circuit issues and interesting opinion last week, exploring plaintiff's burden to prove that exposure to defendant's product caused his injury in the context in which plaintiff was exposed to numerous other similar products. See Moeller v. Garlock Sealing Technologies LLC, No. 09-5670, (6th Cir., 9/28/11).

Plaintiff was a pipefitter who worked with asbestos-containing gaskets made by Garlock from about 1962 until about 1970. But from 1962 until about 1975, he also sustained significant exposure to asbestos insulation. He contracted mesothelioma and sued, alleging that his exposure to Garlock’s asbestos-containing gaskets was a substantial factor in causing his injuries.

At trial, plaintiff's expert testified that exposure to asbestos from Garlock gaskets, along with his other exposures, contributed to the mesothelioma. And one of the treating oncologists opined  that if plaintiff had worked for many years (as he did) scraping and grinding asbestos gaskets, and if plaintiff breathed those fibers, then that exposure would have caused his cancer. In rebuttal, Garlock presented evidence that plaintiff had sustained substantial exposure to asbestos insulation products for 13 years. It also presented evidence that whereas asbestos insulation was banned in the 1970s, leading asbestos safety authorities believed that gaskets, such as those sold by Garlock, posed “no health hazard,” and were sold lawfully in the United States. Garlock also suggested that the plaintiff had only installed Garlock gaskets (an activity that both parties agree did not create a risk of injury), and had not ever removed them (the activity that the plaintiff alleges caused the injuries).

The jury returned a verdict for plaintiff, and defendant appealed.

To prevail on a negligence claim, Kentucky law requires a plaintiff to prove that a defendant’s conduct was a substantial factor in bringing about the harm. Deutsch v. Shein, 597 S.W.2d 141, 144 (Ky. 1980). Causation requires a link between the specific defendant’s conduct and the plaintiff’s injuries. See Estes v. Gibson, 257 S.W.2d 604, 607 (Ky. 1953) . Substantial causation refers to the probable cause, as opposed to a possible cause. One measure of whether an action is a substantial factor is the number of other factors which contribute in producing the harm and the extent of the effect which they have in producing it.

The appeals court concluded that the plaintiff failed to prove that Garlock’s product was a substantial factor in bringing about the harm. The plaintiff presented various witnesses to support the claim that the mesothelioma was caused by his exposure to Garlock gaskets. But one expert never actually said that the exposure to Garlock gaskets was a substantial factor in causing the  cancer; the others testified that all types of asbestos can cause mesothelioma and that any asbestos exposure counts as a “contributing factor.”  That testimony does not establish that exposure to Garlock gaskets in and of itself was a substantial factor.

Moreover, the evidence presented was insufficient to allow a jury to infer that exposure to Garlock gaskets was a substantial cause of the cancer. Plaintiff here presented no evidence quantifying  exposure to asbestos from Garlock gaskets. There was testimony that he removed gaskets for several years, and that some of those gaskets were Garlock’s. But the plaintiff failed to establish how many Garlock gaskets he removed, or how frequently he removed—as opposed to installed—them. The record also shows that plaintiff regularly tore out asbestos insulation during the relevant years, and that his exposure to asbestos from insulation would have been thousands of times greater than his exposure from removing gaskets.

Thus, while his exposure to Garlock gaskets may have contributed to his mesothelioma, the record simply does not support an inference that it was a substantial cause of his mesothelioma. Given that the Plaintiff failed to quantify his exposure to asbestos from Garlock gaskets and that the Plaintiff concedes that he sustained massive exposure to asbestos from non-Garlock sources, there is simply insufficient evidence to infer that Garlock gaskets probably, as opposed to possibly, were a substantial cause of the injury.

The court summed it up: saying that exposure to Garlock gaskets was a substantial cause of plaintiff’s mesothelioma would be akin to saying that one who pours a bucket of water into the
ocean has substantially contributed to the ocean’s volume.

 

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The Vermont Supreme Court recently held that a plaintiff's evidence that exposure to benzene allegedly caused his cancer was insufficient to get to the jury.  Blanchard v. Goodyear Tire & Rubber Co.,  No. 2010-250 (Vt. 8/5/11).

Plaintiff was diagnosed with non-Hodgkin's lymphoma, and he attributed the onset of the disease to benzene exposure that allegedly occurred between 1968 and 1973 while he was a teenager playing on a ball field on the grounds of the former Goodyear rubber manufacturing plant. That  plant operated in Windsor, Vermont from 1936 to 1986. He sued, alleging that the field itself was polluted and that there was a gully in the outfield that transported foul-smelling and oily stormwater discharge away from the manufacturing plant.

Defendants moved for summary judgment. The lower court concluded that plaintiff was not entitled to present his case to a jury because he had provided insufficient evidence to support an inference that he had been exposed to benzene in any amount, let alone an amount that could have caused his illness, nor sufficient expert testimony sufficient to eliminate other potential causes of his disease. On appeal, plaintiff argued that his circumstantial evidence of causation was sufficient to present his case to the jury.

The state Supreme Court noted that the plaintiff could not survive the motion for summary judgment on his toxic tort claim unless he was able to point to evidence suggesting a probability, rather than a mere possibility, that (1) he was exposed to the specified chemical at a level that could have caused his physical condition (general causation); and (2) the exposure to that chemical did in fact result in the condition (specific causation).  In a toxic tort case, general causation addresses whether a substance is capable of causing a particular injury or condition in a population, while specific causation addresses whether a substance caused a particular individual's alleged injury. E.g., King v. Burlington Northern Santa Fe Ry. Co., 762 N.W.2d 24, 34 (Neb. 2009). General causation is typically shown through epidemiological studies, and plaintiffs in toxic exposure cases in Vermont generally must demonstrate specific causation by submitting evidence concerning the amount, duration, intensity, and frequency of exposure. Citing  Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1157 (E.D. Wash. 2009) (citing several appellate court cases holding that experts testifying as to specific causation must pay careful attention to amount, intensity, and duration of exposure).

The court recognized that in some toxic tort cases it is impossible to quantify exposure with hard proof, such as the presence of the alleged toxic substance in the plaintiff's blood or tissue and the precise amount of the toxic substance to which an individual plaintiff was exposed. Plourde v. Gladstone, 190 F. Supp. 2d 708, 721 (D. Vt. 2002).  Therefore, expert testimony on toxic injuries may be admissible where dosage or exposure levels have been established through sufficient reliable circumstantial evidence. While it is not always necessary for a plaintiff to quantify exposure levels precisely, the courts generally preclude experts from testifying as to specific causation without having any some measurement or reasonable estimate of a  plaintiff's exposure to the allegedly harmful substance. Finally, a defendant's concession that its product contains a carcinogen, say benzene, does not excuse a plaintiff from having to show the benzene contained in defendant's product is capable of causing the illness at issue.

When direct evidence of the precise amount of exposure to a toxic substance is limited, some courts have allowed expert witnesses to use a differential diagnosis process as a method of proving specific causation. We have posted before about the mis-use and mischaracterization of this process.  Differential diagnosis is a scientific analysis entailing the weighing of relevant evidence, listing all likely explanations of the patient's observed symptoms or injury, then eliminating all but one.  Some courts have made the leap from allowing the process designed to arrive at a diagnosis (what disease caused the symptoms) to arrive at a cause (what substance caused the disease). However, said the state court, even the courts that do recognize differential diagnosis are reluctant to admit causation testimony based on a differential diagnosis where the proffered expert possesses only weak circumstantial evidence that some exposure occurred and makes insufficient effort to scientifically evaluate or estimate the degree of exposure or dosage. Also, and significantly, standing alone, the presence of a known risk factor is not a sufficient basis for ruling out idiopathic origin in a particular case, particularly where most cases of the disease have no known cause. In such cases, analysis beyond a differential diagnosis is required.

Here, plaintiff pointed to three bits of circumstantial evidence. First, he offered statements made by himself and boyhood friends concerning their alleged exposure to chemicals from the Goodyear plant when they were teenagers playing ball on a field adjoining the plant.  Second, plaintiff relied on the testimony of the project manager for an environmental firm hired by Goodyear in 2007 to conduct a site investigation in response to a clean-up agreement reached by Goodyear and the State of Vermont. The 2009 report stemming from the investigation listed contaminants of concern, including petroleum products containing benzene, that could have been released into the environment. Third, plaintiff relies upon the testimony of his two experts, who testified that occupational exposure to benzene is generally associated with a risk of non-Hodgkin's lymphoma, and that plaintiff's cancer was not caused by an immunodeficiency disorder, one of the known causes of that form of cancer.

That evidence "falls well short" of what plaintiff would be required to show in order to prevail in a jury trial. Indeed, if a jury were to find in favor of plaintiff on the evidence relied upon by plaintiff, said the court, "we would have to overturn the verdict." In the end, plaintiff's suspicion that his cancer was caused by exposure to benzene on the Goodyear ball field when he was a teenager was purely speculative. There was no way to know whether any benzene-containing product actually contaminated the ball field.  And there was no evidence indicating the amount or concentration of benzene that was present, even assuming some was. Nor was there any evidence indicating plaintiff's level of exposure to any benzene that may have been present on the field. Nor was plaintiff able to point to studies indicating a risk of cancer posed by exposure to limited amounts of benzene from petroleum products in an outside environment.  

Further, plaintiff could not rely upon differential diagnosis to overcome the complete lack of evidence as to the level of any exposure to benzene. A large percentage of cases of plaintiff's type of lymphoma are of unknown origin. Thus plaintiff's experts could not rule out all other causes, an essential part of the differential diagnosis.  E.g., Whiting v. Boston Edison Co., 891 F. Supp. 12, 21 n.41 (D. Mass. 1995) (concluding that differential diagnosis cannot be used to explain disease where 90% of cases of disease are of unknown origin).
 

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A federal court in New York last week denied plaintiffs' motion for class certification in a case alleging that the run-flat tires on defendant BMW's MINI Cooper S were defective. See Oscar v. BMW of North America LLC, No. 1:09-cv-00011-RJH (S.D.N.Y. 6/7/11).

Oscar purchased a new 2006 MINI Cooper S from BMW-MINI of Manhattan, an authorized MINI dealership, but prior to purchasing the MINI did not do any sort of research. Nor did he take the car for a test drive. The car came with run-flat tires (RFTs), an innovation that allows drivers to drive to the nearest service station even after the tire was flat. As of December 2, 2009, a period of about three years, Oscar had had five flat tires.  Plaintiff alleges that  his troubles stemmed from the fact that his car was equipped with RFTs rather than with standard radial tires. He considered the number of flat tires he experienced to be evidence of a widespread defect.

Plaintiff proposed a nationwide class (or a New York class) of all consumers who purchased or leased new 2005, 2006, 2007, 2008, and 2009 MINI vehicles equipped with Run-Flat Extended Mobility Technology tires manufactured by Goodyear and sold or leased in the United States whose Tires have gone flat and been replaced.

On the first prerequisite of Rule 23(a), the court offered an interesting discussion arising from the fact that most of plaintiff's evidence of numerosity did not correlate directly to his class definition: data that may have included other vehicles, or non-RFT tires, or makers other than Goodyear. But the opinion noted that courts have relied upon "back-of-the-envelope calculations in finding numerosity satisfied."  Conservative assumptions leading to a likelihood of numerosity have at times sufficed. This case fell "right on the border between appropriate inference and inappropriate speculation."  Accordingly, numerosity was satisfied for the proposed national class but not the New York class.

Turning to the Rule 23(b)(3) requirements, the court confronted the choice of law issues inherent in a national class. Although plaintiff conceded that the law of the fifty states plus the District of Columbia would apply to the members of the nationwide class, he argued that the differences between the states’ laws on implied warranty claims were negligible because the implied warranty is a Uniform Commercial Code claim. But numerous courts have recognized that there are significant variances among the interpretation of the elements of an implied warranty of merchantability claim among the states. See Walsh v. Ford Motor Co., 807 F.2d 1000, 1016 (D.C. Cir. 1986); In re Ford Motor Co. Ignition Switch Litig., 194 F.R.D. 484, 489 (D.N.J. 2000).  In particular, several states still require privity; so, plaintiff advanced a theory of privity-by-agency. But this theory has not been accepted in all states. Readers know that choice of law issues impact, among other things, the manageability of the class and the superiority of the use of the class device.

The court also found that plaintiff failed to demonstrate that common questions of fact predominate. Plaintiff was unable to articulate and allegedly common defect, merely hypothesizing that the failure rate could stem from the RFTs’ "stiffness" and stating that further discovery would be necessary to ascertain the precise nature of the defect. Plaintiff did not provide the court with any evidence that Goodyear RFTs are likely to fail because of a particular common defect. The failure to specify an alleged common defect provided a further basis for concluding that plaintiff had not demonstrated predominance. See Am. Honda Motor Co. v. Allen, 630 F.3d 813, 819 (7th Cir. 2010) (holding predominance was not satisfied where forty-one plaintiffs owners alleged that their motorcycles wobbled, but failed to provide competent evidence that a common defect underlay their claims).

Even if Oscar had put forth evidence of a common defect, breach of warranty suits like this one often involve complicated issues of individual causation that predominate over common questions regarding the existence of a defect. See, e.g., In re Bridgestone/Firestone, Inc., 288 F.3d 1012, 1018-19 (7th Cir. 2002) (noting that class treatment of tire defect litigation was unmanageable in part because individual factors could affect the alleged tire failure); Sanneman v. Chrysler Corp., 191 F.R.D. 441, 451-52 (E.D. Pa. 2000) (declining to certify a class of vehicle owners whose paint had delaminated allegedly because of faulty painting process in part because the paint could delaminate for reasons other than the alleged defect); In re Ignition Switch Litig., 194 F.R.D. at 490-91 (declining to certify a class of vehicle owners whose passenger compartments caught on fire allegedly because of a faulty ignition switch because issues of individual causation would predominate); Feinstein v. Firestone Tire and Rubber Co., 535 F. Supp. 2d 595, 603 (S.D.N.Y. 1982) (declining to certify a class of tire purchasers because of “myriad [individual] questions,” including “other possible causes of the problem encountered”); see also Wolin v. Jaguar Land Rover N. Am., LLC, 617 F.3d 1168, 1172-74 (9th Cir. 2010).

Here, individualized issues of causation would swamp the common inquiry into an as yet to be identified tire design defect.  Even if the plaintiffs were to show that the Goodyear RFTs suffered from a common defect, they would still need to demonstrate that this defect caused each class member’s RFT to puncture. But tires can puncture for any number of reasons, and not all of these reasons will relate to the alleged defect. RFTs can go flat for reasons that would also cause a standard radial tire to go flat -- for example, if the driver ran over a nail, tire shredding device, or large pothole, or if a vandal slashed the tire. In order to demonstrate liability, plaintiff would have to demonstrate in each individual class member's case that the tire punctured for reasons related to the defect, rather than for a reason that would cause any tire to fail.

Similarly, under the state consumer fraud law claim, where the link between the defendant’s alleged deception (about the tires) and the injury suffered by plaintiffs is too attenuated and requires too much individualized analysis, courts will not certify a class. See, e.g., Pelman v. McDonald’s Corp., 272 F.R.D. 82 (S.D.N.Y. 2010) (declining to certify a class allegedly misled by McDonald’s claims that its food was healthy).  Again, determining whether each tire failed as a result of the allegedly concealed defect or as a result of unrelated issues, e.g., potholes or reckless driving habits, would devolve into numerous mini-trials.

Certification denied.

 

 

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The Third Circuit last week affirmed the exclusion of expert testimony in a toxic tort suit in which plaintiff alleged defendants' insecticide products gave him non-Hodgkin's lymphoma. Pritchard v. Dow AgroSciences, et al., No.10-2168 (3d Cir. 2011).

Plaintiff claimed that he contracted cancer from a pesticide produced by defendant Dow AgroSciences. His wife claimed to have suffered derivative injuries. In support of their complaint, the Pritchards solicited the expert testimony of Dr. Bennet I. Omalu, who provided the District Court with a report and, later, a declaration, stating that Dursban caused the cancer.  Although the trial court found Dr. Omalu to be a qualified expert, it ruled (on Dow's motion) that his proposed testimony was unreliable and therefore inadmissible at trial under Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The exclusion of Dr. Omalu's testimony doomed the lawsuit, because plaintiffs had no other evidence of causation.  Plaintiffs appealed.

The appeal tried to raise the issues surrounding the intersection of federal law, rules of evidence underlying Daubert, and state law, which supplies the elements of a claim (including causation) in a diversity case. Plaintiffs argued that in the course of finding that Dr. Omalu's testimony was unreliable, the District Court erroneously relied on principles that were supposedly at odds with state (Pennsylvania) substantive law governing the level of certainty required to establish causation, having to do with idiopathic disease and epidemiological studies.

It is true that the trial court noted that Dr. Omalu did not rule out unknown or idiopathic causes; that the court considered the fact that the epidemiological study on which the doctor wished to rely showed only a relative risk of 2.0; and that the court observed that the proposed testimony was not grounded in science as Dr. Omalu has not presented any statistically significant evidence showing an association between the chemical agent at issue and non-Hodgkins lymphoma. See Pritchard v. Dow Agro Sciences, 705 F. Supp. 2d 471, 492, 486, 493 (W.D. Pa. 2010).

However, the trial court considered these factors among “a host of other deficiencies,” as components of a determination that the proffered testimony failed to satisfy the admissibility standard. The trial court did not adopt any bright-line rules, but instead evaluated the plaintiffs' proffer using a flexible approach as directed by the Court of Appeals in Heller v. Shaw Industries, 167 F.3d 146 (3d Cir. 1999).  This was an evidentiary ruling, separate and distinct from any substantive question regarding causation (which the court never had reason to reach).

Plaintiffs also argued that the court had engaged in some kind of improper balancing of plaintiffs' scientific evidence vs. defendants'. But the district court engaged in no such balancing. Instead, it rightly concluded that Dr. Omalu's proposed testimony was unreliable due to numerous cracks in its scientific foundation.  He cited only one specific study in support of his general causation conclusion that Dursban causes cancer — and in fact, he relied not on the study itself but on his own reinterpretation of the study's findings using a lower confidence interval. (That is, he recalculated the study's conclusions so as to serve plaintiff's litigation needs, said the court.)   Moreover, the plaintiffs offered no clear explanation of the methods through which he recalculated the study's results, leaving the court unable to evaluate the reliability of his methodology.

And the expert's specific causation conclusion that Dursban had caused Mr. Pritchard's illness was not supported by evidence in the medical records, discovery responses, deposition testimony, application records, or any other information regarding Mr. Pritchard's exposure to pesticides.  Significantly, Dr. Omalu also failed to adequately address possible alternative causes of the cancer.

Accordingly, the trial committed no error in excluding the expert testimony, and in the absence of proof of causation, the case was properly dismissed. Affirmed.

 

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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.

 

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The Arkansas Supreme Court upheld recently the decision of a state trial court to bar a methodologically unsound expert report that sought to link fertilizer to a child's cancer.  Green v. George's Farms Inc., No. 10-26 (Ark. 2/17/11).

Defendants/Appellees were engaged in the poultry-production business in northwest Arkansas. For decades, their feeds have included the additive 3-Nitro, an FDA-approved product that is used to promote growth and prevent disease. Feed turns into excrement. Growers typically remove the chicken litter from poultry houses once a year, and the litter is then applied as fertilizer -- in this case to the fields surrounding plaintiffs' home, including areas near several schools. The chicken litter is spread primarily in the spring and fall, commonly at a ratio of two tons per acre. Sounds like good recycling.  But, said the court, roxarsone, an organic derivative of arsenic, comprises twenty percent of the ingredients contained in 3-Nitro. Arsenic, said the court, is a carcinogen and is considered both a cancer-causing agent and a promoter of cancer. The roxarsone that is fed to the chickens degrades into an inorganic form of arsenic that is excreted by the chickens.

Plaintiff Michael Green, was born and raised in the neighborhood near the schools and fields. In the fall of 1999, he experienced unexplained bruising, and was eventually diagnosed with a rare form of leukemia called chronic myelogenous leukemia (CML). He sued, alleging that the arsenic-laced litter produced by roxarsone-fed chickens polluted the air as a result of ventilating the chicken houses, and that dust clouds formed when the litter is spread, and that exposure to this inorganic arsenic caused his leukemia. (Other plaintiffs joined in the complaint, but the trial court severed the claims of the other plaintiffs.)  

In pretrial rulings, the circuit court granted summary judgment in favor of defendants on the issue of causation. Additionally, the court excluded under the Daubert rule all testimony pertaining to certain parts of a report entitled “Exposures to Carcinogenic Arsenicals and Other Toxic Substances in Washington County, Arkansas,” prepared by plaintiffs’ expert, Dr. Rod O’Connor.

On the (first) appeal the supreme court held that a question of fact remained on the issue of causation. Green I, 373 Ark. at 396, 284 S.W.3d at 42–43. However, the court found no abuse of discretion in the circuit court’s decision to exclude the testimony. Id. at 408, 284 S.W.3d at 51. On remand, the trial court granted a directed verdict, and this, the second appeal, ensued.

Noting that the lack of publication and peer review had influenced the court’s earlier decision, appellants asserted that Dr. O’Connor’s work had since been peer reviewed and published, and thus it should have been admitted on remand. Defendants responded that the law-of-the-case
doctrine precluded reconsideration of this issue. The trial court found that the published article utilized the same unreliable methodology to estimate peak air exposure concentration that it had previously ruled inadmissible. The trial court also stated that the expert's calculations were based on unreasonable assumptions and scientifically unsound mathematical extrapolations from dust samples collected in the area, and that Dr. O’Connor continued to use a formula that the EPA had warned should only be used to determine air levels of lead. The trial court found that the theory advanced by the expert had never been tested and still had not been sufficiently tested by any other scientist.

The doctrine of law of the case prohibits a court from reconsidering issues of law and fact that have already been decided in a case. The doctrine also provides that a decision of an appellate court establishes the law of the case for the trial upon remand and for the appellate court itself upon subsequent review. The law-of-the-case doctrine in some forms also prevents consideration of an argument that could have been raised at the first appeal and is not made until a subsequent appeal.  The doctrine serves to effectuate efficiency and finality in the judicial process, and its purpose is to maintain consistency.  The law-of-the-case doctrine is conclusive only where the facts on the second case/appeal are substantially the same as those involved in the prior appeal, and it does not apply if there was a material change in the facts.

And that was one of the issues here. The record reflected that the rejected parts of Dr. O’Connor’s report included his calculations relating to inhalation exposure reconstruction that were based on a formula for converting measurements of arsenic in dust to measurements of arsenic in air.  Plaintiffs argued that publication and peer review of his methodology represented a material change in circumstances that would permit reconsideration of this issue. However, the court recognized that publication is not a talisman or "get out of jail free" card from our favorite old board game. It was not apparent to the court whether the specific inhalation exposure reconstruction reflected in the report was indeed subjected to peer review in the article. The fact of publication (or lack thereof) in a peer reviewed journal thus is a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised. 

Here, the absence of peer review and publication was but one factor in the overall assessment of the validity of Dr. O’Connor’s methodology. Given the serious flaws exposed in the expert's methods, the court was not persuaded that the publication of the article in a peer-reviewed journal constitutes a new fact that is sufficiently material to overcome the law-of- the-case doctrine. Further, plaintiffs’ argument that criticisms of his methods should only affect the weight but not the admissibility of the evidence was also barred by law of the case.

 

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A federal court granted summary judgment to defendant Snapple in a lawsuit accusing
Snapple Beverage Corp. of misleading consumers by labeling drinks as "all natural" even though they are sweetened with high fructose corn syrup. Weiner et al. v. Snapple Beverage Corp., No. 1:07-cv-08742 (S.D.N.Y.).

We have commented on the growing and alarming trend of plaintiffs' lawyers concocting consumer fraud class action claims against products, even when consumers were not injured and got basically what they paid for, because of some alleged ambiguity in the label or old-fashioned puffing.

Snapple Beverage Corporation was founded in New York’s Greenwich Village in 1972. Snapple began selling and marketing its teas and juice drinks in the late 1980s. In marketing its beverages, Snapple focused on, among other things, flavor, innovation, and humor. Snapple became known for its quirky personality and funny advertising, as well as its colorful product labels and beverage names. For instance, Snapple’s television advertisements featured, among other things, Snapple bottles dressed in wigs and hats, singing in a Backstreet-esque “boy-band,” running with the bulls (hamsters with cardboard horns) in Spain, and performing synchronized swimming.

When Snapple entered the beverages market in the late 1980s, it avoided putting preservatives, which were then commonly found in some similar beverages, in its teas and juice drinks. Snapple was able to do so by using a “hot-fill” process, which uses high-temperature heat pasteurization to preserve products immediately before bottling. Snapple also used 16-ounce glass bottles instead of aluminum cans or plastic. Hence the term on their label "All Natural."

From their inception, Snapple’s beverages were sweetened with high fructose corn syrup. HFCS is made from corn ( a natural product last time we checked), and its primary constituents are glucose and fructose, the sugars that comprise table sugar and honey (which also sound pretty natural). It is undisputed that Snapple disclosed the inclusion of HFCS in the ingredient list that appears on the label of every bottle of Snapple that was labeled “All Natural.”

Readers may recall from our previous post, that here plaintiffs sued seeking to represent a nationwide class of consumers who made purchases between 2001 and 2009 in New York of Snapple beverages labeled “all natural” and which contained high fructose corn syrup.  The plaintiffs alleged they paid a premium for the company's drinks as a result of the all natural claim.

Judge Cote denied the plaintiffs' motion for class certification last year, finding that plaintiffs had not proposed a suitable methodology for establishing the critical elements of causation and injury on a class-wide basis. Without a reliable methodology, plaintiffs had not shown that they could prove at trial, using common evidence, that putative class members in fact paid a premium for the beverage. Because individualized inquiries as to causation, injury, and damages for each of the millions of putative class members would predominate over any issues of law or fact common to the class, plaintiffs’ claim could not be certified under Rule 23(b)(3).

Snapple then moved for summary judgment on the two named plaintiffs' individual claims
under New York's consumer protection laws, as well as claims of unjust enrichment and breach of express warranty.

Jurisdiction was predicated on CAFA, so a preliminary issue was whether the court retained jurisdiction after the denial of class certification. The statute does not speak directly to
the issue of whether class certification is a prerequisite to federal jurisdiction, and the Second Circuit has not addressed the issue. The circuits that have considered the issue, however, have uniformly concluded that federal jurisdiction under CAFA does not depend on class certification. See Cunningham Charter Corp. v. Learjet, Inc., 592 F.3d 805, 806 (7th Cir. 2010); United Steel, Paper & Forestry, Rubber, Mfg., Energy, Allied Indus. & Serv. Workers Int’l Union, AFL-CIO, CLC
v. Shell Oil Co., 602 F.3d 1087, 1092 (9th Cir. 2010); Vega v. T-Mobile USA, Inc., 564 F.3d 1256, 1268 n.12 (11th Cir. 2009).

The court granted the motion, finding that the named plaintiffs had failed to show that they were injured as a result of Snapple's labeling.  According to Snapple, because the plaintiffs had not offered evidence showing either the price they paid for Snapple or the prices charged by competitors for comparable beverages, they could not demonstrate that they paid a premium for the “All Natural” Snapple product and thus could not show harm stemming from the allegedly misleading label.  Neither of the plaintiffs had any record of his purchases of Snapple. Their most recent purchases were made in 2005 and 2007, or 3 to 5 years before their deposition testimony was taken. Not surprisingly, they had only vague recollections of the locations, dates, and prices of their purchases of Snapple. Besides being unable to establish the actual price they paid for the Snapple products at issue here, the plaintiffs have offered no other evidence from which to
calculate the premium they paid for Snapple. The court agreed that plaintiffs failed to prove that they paid more for Snapple's products than they would have for comparable beverages.

As for the breach of expressed warranty claim, an injured party is entitled to the benefit of its bargain, measured as the difference between the value of the product as warranted by the manufacturer and its true value at the time of the transaction. Because the plaintiffs
had not demonstrated that they purchased Snapple's drinks in reliance on the “all natural”
label, they could not show any such difference in value. 

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One of the dangers for defendants of claims based on state consumer fraud acts is the reluctance of some state courts to recognize the reliance and causation elements inherent in most such statutes.  The absence of a reliance element allows plaintiffs to argue that such claims are more amenable to class treatment, removing a significant individual element.  West Virginia's high court recently confirmed, however, that plaintiffs alleging affirmative misrepresentation claims under West Virginia's consumer protection law must show actual reliance on the allegedly misleading statement. White v. Wyeth, No. 35296 (W. Va., 12/17/10).
 

The underlying consumer fraud suit was filed pursuant to the WV Consumer Protection Act by purchasers of prescription hormone replacement therapy (“HRT”) drugs.  Plaintiffs alleged that the defendants used unfair and deceptive practices in promoting HRT prescription drug products to doctors and patients for treatment of serious menopausal disorders by allegedly using misleading statements in advertising, marketing and labeling.  Following completion of class certification discovery, defendant Wyeth filed alternative motions for dismissal or summary judgment, arguing that plaintiffs could not establish that they had standing to sue because they failed to meet their burden of showing a causal connection between their individual claims of injury and any alleged unfair or deceptive conduct attributed to Wyeth.

Defendant Wyeth particularly noted the lack of evidence demonstrating that plaintiffs decided to purchase HRT drugs because of anything they learned from Wyeth, or that their treating physicians considered information from Wyeth when they issued the prescriptions for HRT drugs. Plaintiffs responded that the statutory language only requires that they prove causation by alleging that Wyeth engaged in deceptive practices and that Respondents were harmed. They maintained that reliance on deceptive statements or practices need not be demonstrated.  In essence, plaintiffs read out of the WVCCPA the requirement that they “suffered ascertainable loss”  as a "result of” various unfair and deceptive acts of Wyeth. W. Va. Code § 46A-6-106(a).  Wyeth argued that the “as a result of” language contained in the statute requires plaintiffs to allege that they relied, or their doctors relied, on Wyeth’s allegedly deceptive actions when they made the decision to purchase hormone replacement therapy -- the phrase “as of result of” has to be read to mean that a plaintiff relied on the improper act or practice alleged in order to satisfy standing requirements.  Plaintiffs, in turn, argued that if the plaintiffs received drugs that were different from or inferior to that which they were entitled to receive, they did not receive the benefit of their bargain, and they therefore suffered an ascertainable loss.

The court noted that the private cause of action provisions of twenty-eight states' consumer fraud acts contain the “as a result of” language.  Many of the decisions addressing the issue of reliance in the context of private consumer protection causes of action show courts struggling to arrive at a way to be faithful to the purposes of consumer protection statutes – promoting fair and honest business practices and protecting consumers – without inviting nuisance lawsuits which impede commerce. In determining the meaning of the phrase “as a result of” in the WVCCPA, the court agreed with those decisions requiring proof of a causal nexus between the deceptive conduct giving rise to the private cause of action and the ascertainable loss, and the conclusion that this may require proof of reliance in some but not all instances.  The court found that reliance and causation are twin concepts, "often intertwined, but not identical."

Following this reasoning, when consumers allege that a purchase was made because of an express or affirmative misrepresentation, the causal connection between the deceptive conduct and the loss would necessarily include proof of reliance on those overt representations. Where concealment or omission is alleged, and proving reliance is an impossibility, the causal connection between the deceptive act and the ascertainable loss is established by presentation of facts showing that the deceptive conduct was the proximate cause of the loss. In other words, the facts have to establish that “but for” the deceptive conduct or practice a reasonable consumer would not have purchased the product and incurred the ascertainable loss. 

The court determined that this approach best serves the WVCCPA’s dual purpose of protecting the consumer while promoting “fair and honest competition.” W. Va. Code § 46A-6-101. Thus, a private cause of action under the provisions of West Virginia Code § 46A-6-106(a) of the West Virginia Consumer Credit and Protection Act must allege: (1) unlawful conduct by a seller; (2) an ascertainable loss on the part of the consumer; and (3) proof of a causal connection between the alleged unlawful conduct and the consumer’s ascertainable loss. Where the deceptive conduct or practice alleged involves affirmative misrepresentations, reliance on such misrepresentations must be proven in order to satisfy the requisite causal connection

The court went on to address an important second issue, finding that prescription drug cases are not the type of private causes of action contemplated under the terms and purposes of the WVCCPA.  The consumer cannot and does not decide what product to purchase. The intervention by a physician in the decision-making process necessitated by his or her exercise of judgment whether or not to prescribe a particular medication protects consumers in ways respecting efficacy that are lacking in advertising campaigns for other products. Accordingly, the court found that the private cause of action afforded consumers under West Virginia Code § 46A-6-106(a) does not extend to prescription drug purchases. See also New Jersey Citizen Action v. Schering-Plough Corp., 842 A.2d 174 (N.J. Super. 2003). , in which a New Jersey appeals court emphasized the difference between the pharmaceutical industry and other companies. According to the West Virginia court, the New Jersey court noted that physician intervention in prescribing decisions protects consumers and observed that the high degree of federal regulation of prescription drug products “attenuates the effect product marketing has on a consumer's prescriptive drug purchasing decision.”
The court remanded for dismissal.
 

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Insecticide manufacturers held on to summary judgment as the Eight Circuit affirmed the lower court's causation ruling under Daubert.  Junk v. Terminix International Co., No. 08-3811 (8th Cir., 12/9/10).

The plaintiffs'  home had been infested with spiders during the mother's pregnancy, and she contacted Terminix about the problem.  Defendant thereafter sprayed a pesticide inside and outside the Junks' home, approximately 20 times, the last occurring two years after her son's birth. Junk alleged that the child's multiple medical conditions were caused by exposure to ingredients in Dursban, an insecticide manufactured by Dow, distributed by Terminix.

The defendants moved to exclude the causation testimony of plaintiffs' two medical experts, and for summary judgment.  The trial court first excluded the testimony of Dr. Richard Fenske, who had been retained to determine whether the son had been exposed to an unsafe level of the insecticide during his mother's pregnancy and after his birth. Dr. Fenske testified that when making toxic exposure and dosage estimates he usually relied on a "deterministic modeling" method in which he creates an exposure model that accounts for numerous variables. In this case, however, he did not have sufficient data to perform such an analysis. Instead, he compared what he knew about the circumstances of the child's exposure with those in published studies. This comparative analysis led him to conclude that plaintiff had been exposed to an unsafe level. Observing that Dr. Fenske had not followed his own usual methodology and concluding that he had relied on a number of ungrounded assumptions in his comparative approach, the district court excluded his opinion on the ground that his methodology was not sufficiently reliable.

Dr. Cynthia Bearer's testimony was also excluded. She was a neonatologist and board certified pediatrician whom Junk retained to give her opinion on general and specific causation.  Because Dr. Bearer's opinion on specific causation relied on Dr. Fenske's conclusions, after the court excluded Dr. Fenske's testimony, it found Dr. Bearer's opinion on specific causation also lacked a scientific factual basis and declined to admit it.

Plaintiffs appealed.

The court of appeals agreed that Dr. Fenske's comparative analysis depended on various unsupported assumptions. He did not account for differences between conditions in the Junk household and those described in the articles he consulted. In one instance, his only basis for comparison was the fact that the Junk household and those in a particular study were all treated with the Dursban ingredient chlorpyrifos. In another, he relied on a study where the only common variable between the Junks' experience and the homes studied was the total amount of chlorpyrifos applied. Dr. Fenske thus disregarded other important variables such as where and how chlorpyrifos was applied in the household and whether the homes in a comparison study were the same size as the Junks' home.

While Dr. Fenske was not required to produce a mathematically precise table equating levels of exposure with levels of harm, he was required to have a "scientifically valid" method to estimate that plaintiff's exposure exceeded a safe level. The expert's failure to follow his own general practice and his reliance on unfounded assumptions in his comparative method created "too great an analytical gap" between his opinion and the data on which it relied.

Because Dr. Bearer's differential diagnosis depended on Dr. Fenske's opinion on exposure, the district court did not abuse its discretion in excluding it. A differential diagnosis begins with an expert's "ruling in" plausible causes of an injury. See Kudabeck v. Kroger Co., 338 F.3d 856, 860–61 (8th Cir. 2003). Then the expert "rules out" less likely causes until the most likely cause remains. Without a scientific basis for including unsafe chlorpyrifos exposure in her differential, her opinion amounted to speculation.

To succeed in her claims, Junk needed to present expert testimony showing that the chlorpyfiros could have caused the son's injuries and that it did in fact cause those injuries. Junk's  experts did not survive the district court's Daubert analysis. After the court properly excluded Dr. Bearer's
testimony, Junk could not prove specific causation as required under Iowa law. As there was no longer a genuine issue of material fact as to that necessary element, Dow and Terminix were entitled to judgment.

 

 
 

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A West Virginia federal court has granted summary judgment against a plaintiff alleging that the heartburn drug metoclopramide caused her tardive dyskinesia.  Meade v. Parsley, et al., 2010 WL 4909435 (S.D.W.Va.,  11/24/10).

Since its approval by the Food and Drug Administration in 1980, metoclopramide has been widely used to treat gastroesophageal reflux disease (“GRD”), nausea, and gastroparesis.  Plaintiff's treater, Dr. Deidre Parsley, prescribed metoclopramide to Mrs. Meade in order to treat her
GRD, nausea, and loss of appetite. Plaintiff  never read any written materials accompanying her metoclopramide prescriptions, which included a statement that therapy longer than 12 weeks has not been evaluated and cannot be recommended.  Dr. Parsley likewise did not read the metoclopramide package insert or any other written materials produced by PLIVA before prescribing the drug to Mrs. Meade. After the drug usage, the FDA added a black box warning about tardive dyskinesia.  But, save for the placement of the warning in a black box, the previous warning seemed not too different.

Plaintiffs contended that the warnings were inadequate in that they misleadingly invited long term use that has never been approved by the FDA, despite the fact that the warning did state that therapy longer than 12 weeks has not been evaluated and cannot be recommended. In addition,
plaintiffs claim that the warnings downplayed the seriousness and potential irreversibility of the risk of tardive dyskinesia in long term use, but the warning did state that the risk is highest among the elderly, especially elderly women (like this plaintiff), and that the likelihood of irreversibility is believed to increase with the duration of treatment and the total cumulative dose. 

Defendant moved for summary judgment, contending that there were no genuine issues of material fact inasmuch as (1) plaintiffs could not establish causation; (2) Dr. Parsley was aware of the risks of using metoclopramide when she prescribed the drug to Mrs. Meade; (3) PLIVA satisfied any alleged duty to warn by providing a package insert explaining potential side effects of
metoclopramide.  The court never had to reach the third argument.

In a pharmaceutical products liability action, a plaintiff must initially establish both general and specific causation for his injuries. Bourne ex rel. Bourne v. E.I. Dupont de Nemours & Co., 189 F. Supp. 2d 482, 485 (S.D. W. Va. 2002).  General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury. In re Rezulin Prods. Liab. Litig., 369 F.
Supp. 2d 398, 402 (S.D.N.Y. 2005); In re Hanford Nuclear Reservation Litig., 292 F.3d 1124, 1129 (9th Cir. 2002). General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease.

In addition to general and specific causation, plaintiffs must establish proximate causation.To
show proximate causation in a failure-to-warn case based on an allegedly inadequate drug label, a plaintiff must show that a different label or warning would have avoided the plaintiff’s injuries. The court noted that the West Virginia Supreme Court has not had occasion to clarify whether a drug manufacturer must warn both the patient and the physician, or just the patient.  But it did not need to resolve this issue in evaluating proximate causation, however, because the undisputed evidence shows that an adequate warning would not have changed either Mrs. Meade’s or Dr. Parsley’s behavior in a manner which would have avoided Mrs. Meade’s injury.  Rather than merely showing that “adequate warnings would have changed behavior,”  as plaintiff argued, plaintiffs must
establish that an adequate warning would have changed behavior in a manner which would have avoided the plaintiff’s injury.  Mrs. Meade testified that she never read the package insert or any other documents accompanying her metoclopramide prescription.  Dr. Parsley likewise testified that she did not read the metoclopramide warning. And while Dr. Parsley did read the PDR for
the brand name version of the drug, it is undisputed that the defendant did not create that PDR.

The more interesting part of the opinion for our readers is the treatment of the issue of general causation.  It seems that none of plaintiffs’ retained experts offered any opinions regarding general
causation. So plaintiffs were left to argue that several of Mrs. Meade’s treating physicians (whom plaintiffs began referring to as “non-retained experts”) testified regarding the causal link between metoclopramide and tardive dyskinesia. None of these non-retained experts provided written
reports, and in deposition none of these physicians testified directly as to general causation. They assumed causation as a prelude to a specific causation opinion, but this mere assumption does not establish general causation. The law is clear that a mere possibility of causation and, more
specifically, indeterminate expert testimony on causation that is based solely on possibility is not sufficient to allow a reasonable juror to find causation. 

As an alternative basis for general causation, plaintiffs tried to rely on the fact that defendant's own package inserts and brand name warnings refer to a "causal link” between metoclopramide and tardive dyskinesia. Plaintiffs could cite no authority for the proposition that a plaintiff in a pharmaceutical products liability case can satisfy his or her burden of proving general causation by relying on the defendant manufacturer’s drug label warnings. Moreover, this contention was undermined by the general principle that causation evidence in toxic tort cases must be in the form of expert scientific testimony.  PLIVA’s drug label, which merely warns of metoclopramide’s potential side-effects without explaining the scientific basis for the warning, was no substitute for expert testimony that establishes causation in terms of reasonable probability.

Third, plaintiffs also tried to cite, as evidence of general causation, the subsequent FDA directive requiring drug manufacturers to insert a black box warning on metoclopramide labels to convey a
greater risk of tardive dyskinesia. The court, as have several other courts have, however, rejected reliance on agency determinations as a basis for general causation. Inasmuch as the cost-benefit balancing employed by the FDA differs from the threshold standard for establishing causation in tort actions, this court likewise concluded that the FDA-mandated tardive dyskinesia warning cannot establish general causation.

 Summary judgment granted.

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In the right case, we are big fans of the "Lone Pine" order as a tool of case management.  Named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986), Lone Pine orders are designed to handle the complex issues and potential burdens on the parties and the court in mass tort and toxic tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).   The term refers to case management orders that require the plaintiffs to make a showing regarding causation, injury, and/or damages to demonstrate, typically at an early stage, some minimal level of evidentiary support for the key components of their claims which will be in dispute.

While the 1986 New Jersey Superior Court case involved traditional toxic tort claims, the device has gotten good use in drug cases as well.  E.g., In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010). After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement.  The order required non-settling plaintiffs to notify their health-care providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply eventually resulted in dismissal of several of the plaintiffs' claims with prejudice.

And the federal judge overseeing the MDL for Celebrex and Bextra found that a “Lone Pine” order was appropriate for managing the claims of the remaining, non-settling plaintiffs. In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No. M:05-cv-01699 (N.D. Cal.) (Pretrial Order No. 29, Aug. 1, 2008).

In the drug context, a Lone Pine order might require plaintiffs to submit a case-specific expert report on the issue of medical causation; or to turn over medical records that documented an injury, prescription records that showed medication history and dosages prescribed, and/or proof of dosage in relation to the injury. The benefit to the court of requiring plaintiffs to supply this information is that the parties will not have to engage in protracted discovery in hundreds or thousands of cases just to see whether each one has some threshold evidence of medical causation. The production of such basic and threshold evidence is simply a part of a good-faith investigation that should precede the filing of a lawsuit.

Requiring plaintiffs to identify basic information about injuries and causation is not unreasonable given the costs that mass tort claims have on the legal system, and on defendants in particular. Lone Pine orders allow courts to weed out the frivolous suits where there is insufficient exposure, or no sufficient scientific connection between injury and exposure. Accordingly, Lone Pine orders can be effective when entered early in the game. Early disposal of frivolous claims allows the parties to focus their attention on the serious cases. Ideally, the order will actually phase discovery, and motions practice as well, with the Lone Pine issues pushed up front.

But the device also has a role later in mature mass torts when, as seen above, a chunk of the litigation has settled and there still remain numerous claims of questionable strength.

In the MDL involving the the diabetes medication Avandia, In re Avandia Marketing, Sales Practices, and Products Liab. Litig., MDL No. 1871 (Pretrial Order No. 121)(E.D. Pa. Nov. 15, 2010), the federal court has recently adopted a Lone Pine order.  The court found that many of the remaining claims lacked sufficient support or detail even after submission of the Plaintiff Fact Sheets.  Thus, additional detail about the plaintiffs' claims was necessary in furtherance of settlement agreements, for the selection of cases for bellwether trials, and for the timely remand of cases to the transferor courts for resolution.

The court's overriding concern was having sufficient information to objectively identify which of the many thousands of remaining plaintiffs have injuries that could credibly be linked to the drug usage.  The order calls for information that the court said the plaintiffs should have had before filing their claims.

Specifically, plaintiffs have to have a licensed physician identify the plaintiff's Avandia usage, the alleged injury, the time lag between drug usage and injury, and a certification that the drug usage caused the injury.

Failure of a plaintiff to submit these required expert certification (and supporting documents) in a timely fashion may result in the dismissal of that plaintiff's claims with prejudice.

A defendant in such litigation should not bear the burden of winnowing cases that never should have been filed, nor should the court be saddled with consideration of claims that would not have survived reasonable pre-complaint investigation.

 

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Plaintiffs have failed in a proposed class action against McDonald's in which they alleged that the food company's advertising somehow misleads customers into believing that they can eat fast food daily without any potential health consequences.  Pelman v. McDonald's Corp., No. 02-civ-07821 (S.D.N.Y. 10/27/10).  Yes, loyal readers, you read that correctly: the claim is that the people of New York only know about fast food what they read in (or into) ads.

Plaintiffs in this action were New York State consumers claiming, pursuant to Section 349 of New York’s General Business Law, injury from defendant McDonald’s Corporation’s allegedly deceptive marketing scheme.  Plaintiffs claimed that the effect of defendant’s marketing – from 1985 until the filing of this case in 2002 – was to mislead consumers into falsely believing that defendant’s food products can be consumed on a daily basis without incurring any adverse health effects.  They alleged that, as a result of this marketing scheme, class members suffered injury. Specifically, plaintiffs alleged that defendant attempted to mislead plaintiffs and putative class members with misleading nutritional claims, in widespread advertising campaigns, that its foods were healthy, nutritious, of a beneficial nutritional nature, and/or were easily part of anyone’s healthy daily diet, each and/or all claims supposedly being in contradiction to medically and nutritionally established acceptable guidelines. Plaintiffs claimed that  they suffered injury in the form of the financial costs of defendant’s  products; “false beliefs and understandings" as to the nutritional content and effects of defendant’s food products, and physical injuries in the nature of obesity, elevated levels of  cholesterol, pediatric diabetes, high blood pressure, etc.

Plaintiffs moved for class certification pursuant to Federal Rule of Civil Procedure 23(b)(3).  The court "begins and ends" its analysis of class certification with consideration of the predominance requirement of Rule 23(b)(3). The court concluded that establishment of the causation and injury elements of plaintiffs’ claims would necessitate extensive individualized inquiries; the questions of law and fact which would be common to putative class members would not predominate over questions affecting only individual members. Accordingly, certification of this action for class litigation under Rule 23(b)(3) was not appropriate. 

The court found that the focus was on whether the elements of plaintiffs’ cause of action under GBL § 349 may be established by common, class-wide proof.  The court had earlier in the case ruled that in accordance with GBL § 349’s requirement that plaintiffs’ injuries be "by reason of" defendant’s conduct, the plaintiffs had be aware of the nutritional scheme they alleged to have been deceptive, and that the injuries that were suffered by each plaintiff  were by reason of defendant’s alleged deceptive marketing.  However, allegations of “false beliefs and understandings” did not state a claim for actual injury under GBL § 349.  Neither did allegations of pecuniary loss for the purchase of defendant’s products. (In some states that kind of "the product worked and didn't harm me but I wouldn't have purchased it" argument does fly.)

Accordingly, the only alleged injuries for which putative class members could claim damages under GBL § 349 were those related to the development of certain medical conditions; and the causal connection, if any, for those kinds of injuries depended heavily on a range of factors
unique to each individual. Defendant’s nutritional expert concluded there are many factors that contribute to obesity and to obesity-related illnesses, and thus it is improper to generalize and make assumptions as to causation in any individual.  Many foods, not just defendant's, are high in fat, salt, and cholesterol, low in fiber and certain vitamins, and contain beef and cheese, and there is no evidence to suggest that all who consume such foods develop the kinds of medical conditions which were at issue in this case. 

Moreover, whether or not plaintiffs’ claims (that they ate McDonald’s food because they believed it to be healthier than it was in fact) are true for any particular person was an inquiry which also required individualized proof. A person’s choice to eat at McDonald’s and what foods (and how much) he eats may depend on taste, past experience, habit, convenience, location, peer
choices, other non-nutritional advertising, and cost, etc.

Plaintiffs also argued for issue classes, asserting that the 1) existence; 2) consumer-orientation; and 3) materially misleading nature of the marketing scheme alleged by plaintiffs were each
questions which could be settled upon a showing of objective evidence and legal  argument. Even if true, the court noted that all elements of the class action rule have to be met even for issue classes. Named plaintiffs did not present any specific evidence about the number of other persons within the relevant age group who were exposed to the nutritional marketing at issue, then regularly ate at McDonald’s, and subsequently developed the same medical injuries as those allegedly suffered by named plaintiffs.  So they hadn't even shown numerosity.

 

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A court of appeals has affirmed the dismissal of multiple claims alleging that negligent dredging operations before Hurricane Katrina led to the failure of levee systems in Louisiana.  See In Re: In the Matter of the Complaint of Great Lakes Dredge & Dock Co. LLC, No. 08-30738 (5th Cir. Oct. 14, 2010). Claimants were Hurricane Katrina flood victims who filed claims alleging negligence on the part of operators of dredging vessels along the Mississippi River Gulf Outlet. Plaintiffs argued that they suffered damages from the flooding of Orleans and St. Bernard Parishes when several levee systems failed as a result of the erosion of protective wetlands allegedly caused by the defendants’ negligent dredging operations.

The Mississippi River Gulf Outlet  (“MRGO”) is a 76-mile navigational channel that connects the Gulf of Mexico with the Industrial Canal in New Orleans, bisecting the marshy wetlands of St. Bernard Parish and Chandeleur Sound. It was built between 1958 and 1965 by the United States Army Corps of Engineers.  Beginning in 1993, the Corps of Engineers contracted with numerous private dredging companies, including the defendants, to assist the Corps of Engineers in maintenance dredging along the MRGO. From 1999 to 2004, the Corps of Engineers awarded more than 150
contracts to private dredging companies to dredge the length of the MRGO channel.

Plaintiffs, who numbered in the tens of thousands, were individuals, businesses, and other entities who owned property that was damaged due to flooding after Hurricane Katrina made landfall on August 29, 2005. (BTW, for readers, there is a fascinating new exhibit at the Newseum in Washington, DC, on the media coverage of Katrina.)  Plaintiffs contend that the defendants'  maintenance dredging operations caused severe damage to the Louisiana wetlands, which had been providing a natural barrier against tidal surge from storms and hurricanes. This damage to the wetlands allegedly caused an amplification of the storm surge in the New Orleans region
during Hurricane Katrina, which increased the pressure on the levees and flood walls along the MRGO, leading eventually, they alleged, to levee breaches and the subsequent flooding of St. Bernard Parish and Orleans Parish.

These allegations were different from some earlier Katrina claims, adding that their injuries resulted from the erosion to the wetlands caused by the negligent dredging, performed in breach of the standards set out in their Corps of Engineers contracts and various rules and regulations
alleged to apply to their operations, to try to defeat the dredgers’ government contractor immunity defenses, as well as the dredgers’ entitlement to exoneration from or limitation of liability under the Limitation of Liability Act.

Defendants moved to dismiss.  The district court dismissed the claims, and plaintiffs appealed. The 5th Circuit noted that to avoid dismissal, a complaint must contain sufficient factual matter,
accepted as true, to state a claim to relief that is plausible on its face.  Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 554, 570 (2007)). To be plausible, the complaint’s factual allegations must be enough to raise a right to relief above the speculative level. In deciding whether the complaint states a valid claim for relief, we accept all well-pleaded facts as true and construe the complaint in the light most favorable to the plaintiff.

Defendants argued that they could not have foreseen that discrete acts of negligent dredging could have resulted in the absolutely devastating and cataclysmic damages that occurred to St.
Bernard and Orleans Parishes.  Plaintiffs asserted that it is well known, as a matter of general knowledge, that the wetlands provide storm surge mitigation; that the levees protecting cities and towns in the coastal areas were designed with the assumption that the buffering action provided by the wetlands would remain intact; and that dredging activities cause damage to the wetlands.

Duty and forseeability were the key concepts here, and maritime law on this issue mirrored general negligence law.  Determination of the tortfeasor’s duty is a question of law.  A duty may be owed only with respect to the interest that is forseeably jeopardized by the negligent conduct. Thus, if the injuries suffered allegedly as a result of the negligent dredging were not foreseeable, the defendants owed no duty; to show a duty, plaintiffs had to show that each dredger reasonably should have foreseen that the sequence of events leading to their damages—the amplification of the storm surge during Hurricane Katrina, the failure of the levee systems, and the subsequent flooding of Orleans and St. Bernard Parishes—would be a probable result of its negligent acts and the marginal erosion to the wetlands caused thereby.

The 5th Circuit agreed with the trial court that the defendants in this case had no knowledge of an immediate and pending natural disaster that would affect how they conducted their dredging operations. Furthermore, it cannot be said that any dredger could have foreseen that performing its dredging activities negligently—as opposed to in conformity with the Corps of Engineers’ specifications— would probably result in the series of events culminating in the catastrophic damages that occurred during Hurricane Katrina. No reasonable dredger could have anticipated that its negligence would make the difference between the levee systems holding or failing in the event of a hurricane. The damages alleged here were beyond the pale of general harm which reasonably might have been anticipated by negligent dredgers.

The court cautioned that that was not to say that it could never be foreseen that dredging could create conditions that would result in flooding after a hurricane. Rather, it was not foreseeable that the marginal erosion caused by any act of negligence by a defendant here would substantially affect the impact of the hurricane such that the failure of the levee systems and subsequent flooding would be the probable result. The causal sequence alleged in the present case was just far too attenuated.

 

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The Connecticut Supreme Court recently took a second look at a case offering guidance on the application of the learned intermediary defense, and affirming a judgment for pacemaker manufacturer Medtronic Inc. See Hurley v. Heart Physicians PC, 298 Conn. 371, 2010 WL 3488962 (9/14/10).

The plaintiff was born with a congenital complete heart block condition that interfered with her heart's capacity to produce a safe heart rhythm. When she was seven days old, her physicians implanted a cardiac pacemaker manufactured by the defendant. Every few years, plaintiff received a new pacemaker manufactured by the defendant, allowing her to grow and live a normal life. When the plaintiff was fourteen years old, her pacemaker's elective replacement indicator signaled that the pacemaker battery was nearing the end of its life cycle and was wearing down. The plaintiff's cardiologist asked a representative of the defendant, to attend an examination of the plaintiff and to test the battery in her pacemaker. In so doing, in part because of issues about replacing the entire unit, the rep allegedly presented to the doctor the option of lowering the rate. He explained that, by taking the rate from sixty to forty paces per minute, it would give them more time before a device would hit the "end point," and thus more time to work on the "replacement situation."

The approach was taken, but a few weeks later the plaintiff went into cardiac arrest while at school, and allegedly suffered permanent brain damage.  Plaintiff sued, and the trial court granted summary judgment in favor of the device company on the failure to warn claim, based on the learned intermediary doctrine. The state supreme court reversed this judgment with respect to the plaintiff's product liability claim, finding that an issue of material fact existed as to whether the rep's words and actions were in derogation of the pacemaker's technical manual --whether he undercut the warning that was given. After remand, a jury trial was held, and the jury returned a verdict in favor of the defendant. The trial court rendered judgment in accordance with the verdict, and this (second) appeal followed.

The plaintiff's claim before the trial court (both times) was based on the assertion that the defendant's representative had made statements to plaintiff's treating physician, and had engaged in conduct (recommending that the pacemaker's function level be reduced), which nullified the warnings regarding battery replacement that were contained in the pacemaker's technical manual.  The plaintiff claimed that, because the statements and conduct nullified the pacemaker's adequate published warnings about the risks inherent in setting the pacemaker at a reduced level, the defendant had, net, failed to properly warn her of the potential risks associated with reducing the pacemaker's function in lieu of replacing the battery.  Defendant contended that the plaintiff's physician was a learned intermediary and stood in the best position to evaluate and to warn the plaintiff of any risks associated with reducing the pacemaker's function and, as a result, it was not their obligation to warn the plaintiff.

Concerning the trial after remand, plaintiff claimed that the trial court improperly required her to prove that the rep's advice and conduct “actually contradicted,” and therefore “vitiated” and “nullified” the warnings in the manual. She contended that she should have been required to prove only that his actions were “inconsistent” with the manual, which she contended was a less onerous requirement than the one applied by the trial court.

On appeal again, the state supreme court found that the trial court properly reviewed its mandate within the context of the entire opinion and proceeded properly with a jury trial in order to secure a factual finding by the jury as to whether the advice and conduct were in accordance with the pacemaker's manual. The trial court based the relevant jury charge and the jury interrogatory on the factual issue that it had determined could not be resolved as a matter of law. Indeed, the trial court carefully tracked the language used in the first appeal.  The relevant interrogatory asked the jury to determine whether “the [p]laintiff [has] proven by a fair preponderance of the evidence that [rep], by his oral communications to [doctor] that turning down the pacemaker was an option, accompanied by his physical adjustment of the pacemaker to forty paces per minute, actually contradicted the technical manual thereby vitiating and nullifying the manual's warnings....” 

The court disagreed with the plaintiff that the trial court imposed a heightened burden of proof because, first, the trial court directly cited what the supreme court had determined to be the remaining triable factual issue, and, second, the words “contradict” (used by the trial court)and “inconsistent”  (used by the supreme court) are interchangeable.  In this context, the words are synonymous, said the court.  No error in the instruction, so no reversal of the jury verdict.

 

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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.

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A federal appeals court last week reversed an order by a district court certifying a class action of insurers, labor unions, and pension funds who alleged that they overpaid for a drug when the manufacturer allegedly didn't reveal all of the drug's adverse side effects. UFCW Local 1776, et al. v. Eli Lilly & Co., No. 09-0222 (2d Cir. 9/10/10).

Plaintiffs acted as third-party payors (TPP) who underwrite the purchase of prescription drugs by their members or insureds; they brought a putative class action against Eli Lilly, manufacturer of the drug Zyprexa, alleging that Lilly had misrepresented Zyprexa’s efficacy and side effects to physicians. The putative class alleged they paid for the many Zyprexa prescriptions. Plaintiffs argued that they were injured in two ways: first, by paying for Zyprexa prescriptions that would not have been issued but for the alleged misrepresentations; and second, by paying a higher price for Zyprexa than would have been charged, absent the alleged misrepresentations.

In a nearly 300-page opinion issued in  2008, Judge Jack Weinstein of the Eastern District of New York granted class certification to the third-party payors. Specifically, the district court certified a class of TPPs on RICO claims predicated on the overpricing theory of damages, but refused to certify a class related to state consumer protection law claims. The lower court concluded that the proposed TPP class presented common questions of law and fact because the “only difference among class third-party payors is how much of the total overcharge each shall receive in damages.” The lower court  had  addressed whether the losses suffered by the class could be established with sufficient precision, a huge issue in these kinds of cases, concluding that damages could be estimated based on the difference between what was paid for Zyprexa and the actual value of the product. The computation would supposedly require: (i) estimating the total out-of-pocket expenditures for the class members and (ii) using "well-accepted  techniques" in applied economics to determine the actual value or appropriate launch price of Zyprexa.

The district court also found that reliance could be proven for the class simply because the alleged fraud was “directed through mailings and otherwise at doctors who relied, causing damages in overpayments by plaintiffs.” This reliance, the district court concluded, could appropriately be shown by generalized proof, but without resort to the “fraud on the market” theory rejected in cases like McLaughlin v. Am. Tobacco Co., 522 F.3d 215 (2d Cir. 2008).

Defendant appealed.  The Second Circuit noted that to determine whether the proposed TPP class was properly certified, it had to consider whether substantial elements of the claim against Lilly may be established by generalized, rather than individualized, proof.  (Predominance of common or individual issues under Rule 23(b) was the focus.)  Even if the issue whether an act of marketing of the drug was in violation of RICO is considered common, Lilly disputed that the other elements required to recover damages – proof of an injury and proof that such injury was by reason of the RICO violation – were common to the proposed class.  To show injury by reason of a RICO violation, a plaintiff must demonstrate that the violation caused his injury in two senses. First, he must show that the RICO violation was the proximate cause of his injury, meaning there was a direct relationship between the plaintiff’s injury and the defendant’s injurious conduct. Second, he must show that the RICO violation was the but-for (or transactional) cause of his injury, meaning that but for the RICO violation, he would not have been injured.

Traditionally, to show causation in a fraud context, reliance needed to be shown. But in Bridge v.
Phoenix Bond & Indemnity Co., 128 S. Ct. 2131, 2134 (2008), the Court lessened the emphasis on traditional reliance as an element of the RICO fraud claim to show causation in some cases.  But how a plaintiff can or must prove causation is bound up in what the factual claim is. The Bridge Court also said that in “most cases, the plaintiff will not be able to establish even but-for causation if no one relied on the misrepresentation.” 128 S.Ct. at 2144.  Here, while reliance may not be an element of the cause of action, there was no question that the plaintiffs alleged, and thus had to prove, third-party reliance as part of their factual chain of causation.  Plaintiffs alleged an injury that was caused by physicians relying on Lilly’s supposed misrepresentations and prescribing Zyprexa accordingly. Because reliance was a necessary part of the factual causation theory advanced by the plaintiffs, they had to show it to prevail, and show it by generalized proof if they wished to proceed in a class action.

The court of appeals concluded that plaintiffs’ excess price theory was not susceptible to generalized proof with respect to either but-for or proximate causation, and therefore class certification based on this theory was an abuse of discretion.

The evidence in the record made clear that prescribing doctors do not generally consider the price of a medication when deciding what to prescribe for an individual patient. Any reliance by doctors on alleged misrepresentations as to the efficacy and side effects of a drug, therefore, was not a but-for cause of the price that TPPs ultimately paid for each prescription.  Moreover, the TPP plaintiffs, who unlike the doctors were in a position to negotiate the prices of drugs in their formularies, were unable to show proximate causation.  The TPP plaintiffs drew an alleged chain of causation in which Lilly distributed misinformation about Zyprexa, physicians relied upon that misinformation and prescribed Zyprexa for their patients, and then the TPPs overpaid.  But this narrative skipped several crucial steps: after the doctors prescribe the drug, TPPs relying on the advice of Pharmacy Benefit Managers and their Pharmacy and Therapeutics Committees, placed Zyprexa on their formularies as approved drugs, and then TPPs failed to negotiate the price of Zyprexa below the level set by Lilly.  Thus, in this case, the conduct directly causing the harm was distinct from the conduct giving rise to the fraud. The plaintiff TPPs could not and did not allege that they themselves relied on Lilly’s alleged misrepresentations. But because only the TPPs were in a position to negotiate the price paid for Zyprexa, the only factual reliance that might show proximate causation with respect to price was reliance by the TPPs, not reliance by the doctors.

Since plaintiffs could not show the entire factual causal chain by generalized proof, individual issues would abound, and class certification was improper. The court of appeals also remanded for reconsideration of defendant's summary judgment motion in light of its ruling.

 

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The Sixth Circuit last week vacated one of the rare plaintiff verdicts in the welding rod litigation.  Tamraz  v. Lincoln Electric Co., et al., 2010 WL  3489002 (6th Cir. 9/8/10).  The key issue in the appeal was the trial court's decision to allow a causation expert, Dr. Walter Carlini, to testify on behalf of the plaintiff Jeff Tamraz over defendants' Daubert challenge.

From roughly 1979 to 2004, Jeff Tamraz worked as an independent-contracting welder in California, on bridges and buildings.  Plaintiffs contended that Mr. Tamraz suffers from manganese-induced Parkinsonism as a result of exposure to manganese-containing welding fumes on these jobs.

The case went to trial in 2007, and the jury in the Northern District of Ohio (plaintiffs are from Oregon) returned a plaintiff verdict, awarding $17.5 million to Jeff Tamraz in compensatory damages and $3 million to his wife, Terry Tamraz, for loss of consortium.

Defendants, including Lincoln Electric, Hobart Brothers Co. and ESAB Group Inc., appealed on various grounds, including the trial court's decision to permit the testimony of Dr. Carlini on causation issues despite the Daubert challenge.

The opinion offers a number of useful observations for toxic tort litigation, especially on the almost-always central issue of causation.

It begins with a nice overview of the science on the spectrum of movement disorders often termed "parkinsonism" that have different causes and different but overlapping symptoms.  No one disputed that plaintiff here suffered from parkinsonism; the questions were what kind and from what cause. Apparently, every doctor to examine Tamraz reached a different conclusion about one or both of those issues.  Plaintiff's expert concluded that Tamraz suffers from “manganese-induced parkinsonism,” but not in the sense of a manifestation of the disease "manganism," as that phrase is sometimes used in these welding cases. Rather, he believed that manganese exposure caused something closely akin to traditional Parkinson's Disease in Tamraz.  Dr. Carlini hypothesized that Tamraz might have a genetic predisposition to Parkinson's Disease, and that manganese in lower levels than necessary to cause true manganism might nevertheless “trigger” the symptoms of Parkinson's Disease, like “the straw that broke the camel's back.” He did not believe that Tamraz has Parkinson's Disease in the strict medical sense, but manganese caused a disease that he believed to be otherwise similar to Parkinson's Disease. 

Defendants disputed this conclusion that manganese exposure caused the illness; that is, they challenged Dr. Carlini's etiology (what caused the disorder diagnosed?), not the methodology to arrive at his general spectrum diagnosis (what disorder caused the set of symptoms observed?).  And the Sixth Circuit agreed there were serious issues here. The problem here was that, when Dr. Carlini testified that manganese exposure caused Tamraz's condition, he went beyond the boundaries of allowable testimony under Rule 702.

The opinion was at most a working hypothesis, not admissible scientific “knowledge.” Fed.R.Evid. 702. His theory was a "plausible hypothesis. It may even be right. But it is no more than a hypothesis."  For example, the expert admitted that the literature hypothesizing a link between environmental toxins and latent genetic Parkinson's Disease was “all theoretical.”  He also conceded there were no studies finding a link between manganese and true Parkinson's Disease.  He further he conceded that he was speculating that Tamraz had an underlying predisposition to Parkinson's Disease, even though Tamraz had no family history of Parkinson's Disease. 

And finally, even if manganese could cause Parkinson's Disease in someone like Tamraz, that did not show that manganese did cause Tamraz's Parkinson's Disease. Parkinson's Disease occurs commonly in the general population and usually without any known cause. Any given case of Parkinson's Disease thus might have occurred regardless of the manganese exposure, making it hard to attribute one case to manganese exposure over all of the other possible causes.

Plaintiffs stressed on appeal that Dr. Carlini opined “with a reasonable degree of medical certainty,” but the court of appeals correctly noted that the phrase --the conclusion by itself-- does not make a causation opinion admissible. The “ipse dixit of the expert” alone is not sufficient to permit the admission of an opinion. General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). Minus that one phrase, nothing in this testimony took the opinion beyond speculation, theory, hypothesis. 

Plaintiffs, understandably, also tried to bolster the opinion by emphasizing areas of agreement among experts on the general diagnosis of some parkinsonism disorder.  But in conflating “manganese-induced parkinsonism” with manganism, plaintiff conflated diagnosis with etiology, erasing the distinction between Tamraz's disease and what caused it. Diagnosis and etiology, however, both were in play in this case. Because Dr. Carlini diagnosed Tamraz with something akin to Parkinson's Disease, not manganism, and because Parkinson's Disease unlike manganism has no standard etiology and lots of idiopathic cases, Dr. Carlini's etiology opinion had to rise or fall on its own.

Plaintiffs also trotted out the standard "differential diagnosis" argument, the tent that supposedly (and too often does) covers all kinds of unreliable causation opinions from medical experts.  The court here made some very useful observations about this issue. 

1) Most treating physicians have more training in and experience with diagnosis than etiology. See D. Faigman, Judges as “Amateur Scientists”, 86 B . U. L.Rev. 1207, 1221-22 (2006); E. Imwinkelried, The Admissibility and Legal Sufficiency of Testimony About Differential Diagnosis (Etiology), 56 Baylor L.Rev. 391, 405 (2004); M. Henefin, Reference Guide on Medical Testimony, in Reference Manual on Scientific Evidence 439, 471-72 (2d ed.2000). 

2) When physicians think about etiology in a clinical setting, moreover, they may think about it in a different way from the way judges and juries think about it in a courtroom. 

3) Getting the diagnosis right matters greatly to a treating physician, as a bungled diagnosis can lead to unnecessary procedures at best and death at worst. See Bowers v. Norfolk S. Corp., 537 F.Supp.2d 1343, 1361 (M.D.Ga.2007). But with etiology, the same physician may often follow a precautionary principle: If a particular factor might cause a disease, and the factor is readily avoidable, why not advise the patient to avoid it? Such advice  --telling a worker, say, to use a respirator-- can do little harm, think the doctors, and might do some good. See J. Hollingsworth & E. Lasker, The Case Against Differential Diagnosis: Daubert, Medical Causation Testimony, and the Scientific Method, 37 J. Health L. 85, 98 (2004). A lower threshold for making a causation decision serves well in the clinic but not in the courtroom, said the court. 

Of course, some courts permit the physician to testify as to etiology using this methodology, e.g., Hardyman v. Norfolk & W. Ry. Co., 243 F.3d 255, 260-67 (6th Cir.2001), but even these courts must apply the Daubert principles carefully in considering it. The ability to diagnose medical conditions is not remotely the same as the ability to deduce, in a scientifically reliable manner, the causes of those medical conditions. Gass v. Marriott Hotel Servs., Inc., 501 F.Supp.2d 1011, 1019 (W.D.Mich.2007), rev'd on other grounds, 558 F.3d 419 (6th Cir.2009). Doctors thus may testify to both, at least in the Sixth Circuit, but the reliability of one does not guarantee the reliability of the other. 

Thus, whether plaintiffs described Dr. Carlini's causation methodology as “differential etiology” or “differential diagnosis,” that label does not make it reliable. Using the differential diagnosis method is not some "incantation that opens the Daubert gate.”  The issues remain, did the expert make an accurate diagnosis of the nature of the disease? Did the expert reliably rule in the possible causes of it? 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. See Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171, 179 (6th Cir .2009).

Here, Dr. Carlini's opinion failed the last two prongs because his efforts to “rule in” manganese exposure as a possible cause, or to “rule out” other possible causes, turned on speculation and theory and hypothesis, not a valid methodology. 

While expressing sympathy for the plaintiffs, the court observed that ignoring Rule 702 — allowing the law to "get ahead of science" — would be just as unfair. Such an approach eventually would destroy jobs and stifle innovation unnecessarily, because it would impose liability on business based on speculation, not science.

Case remanded for new trial, with different evidence obviously. 

(The dissent would have found the challenge going to the weight, not admissibility of the testimony, and the trial court's decision not an abuse of discretion.)

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Comic Dimitri Martin notes, "I'm sorry" and "I apologize" mean the same thing -- unless you are speaking to the widow at a funeral.  The lesson? Context is key.

The New Jersey appeals court last week vacated a jury verdict for a woman who used the acne drug Accutane and allegedly developed inflammatory bowel disease (IBD).  See Kendall v. Hoffmann-LaRoche Inc.,No. A-2633-08T3 (N.J. Super. Ct.,  8/5/10). The court found that the trial court erred by restricting the defendant's use of evidence concerning the incidence of IBD in the general population to set a proper context.

Readers know that defendants frequently want to put evidence in a fuller context and give the jury a full picture.  Plaintiffs seem much less concerned that a jury will take evidence (a word in an email, a phrase in a memo, a point of data) out of context.

Some background- In 1982 the Food and Drug Administration approved the use of Accutane to treat recalcitrant nodular acne. Patients using Accutane have reported a number of common side effects. The alleged side effect that was centrally at issue in this case was the alleged propensity of Accutane to cause patients to suffer from inflammatory bowel disease. The exact scientific causes of IBD have not been conclusively established, said the court. IBD has been statistically associated with several factors, including family history, prior infections, frequent use of antibiotics, and possibly the use of contraceptives and nonsteroidal anti-inflammatory drugs.

Plaintiff underwent several courses of treatment. She had taken four courses of Accutane before she developed IBD, with no apparent gastrointestinal effects. Her medical records indicated that plaintiff's mother informed the treating physician that plaintiff had been diagnosed with an IBD, and that disease "has nothing to do with her Accutane use, according to her G.I. doctors."  Plaintiff took two courses of Accutane after she developed IBD, with "no evidence of exacerbation" of the
IBD.  But in early 2005, plaintiff suffered from excessive diarrhea, bowel incontinence, bloody diarrhea, fatigue, cramping, and abdominal pain. As 2005 progressed, plaintiff's symptoms
worsened, leading to surgery.

Plaintiff contends that if she had been warned that Accutane use could cause, or exacerbate, her IBD, she would not have taken the drug. She alleged that there was no specific reference to IBD, or that Accutane use could cause IBD, in any of the materials she personally received from 1997 to 2003.  However, prior to the use of Accutane by plaintiff, defendant revised the various warnings that it supplied concerning the drug. Roche amended the "WARNINGS" section of the Accutane package insert provided to physicians to include language about Inflammatory Bowel Disease.  In a "Dear Doctor" letter, dated August 1998, which was sent to board-certified dermatologists, Roche warned that patients taking Accutane should be monitored for IBD. Roche subsequently revised its product warnings for Accutane, with FDA approval, in 2000 and again in 2002. Plaintiff's expert opined that even the amended warnings contained in the later label were inadequate.

The appeal presented several issues, including statute of limitations, but for our readers we want to focus on the argument that the trial court abused its discretion in preventing Roche from adducing evidence as to the number of Accutane users and in limiting Roche's arguments to the jury concerning such data.

In opening, in her trial proofs, and in her counsel's closing arguments to the jury, plaintiff relied heavily upon the number of adverse case reports for Accutane and other quantitative evidence as
proof of at least two critical issues: (1) that a patient's use of Accutane can cause IBD and other gastrointestinal problems, and (2) that Roche allegedly acted too slowly and ineffectively in
responding to those risks with more forceful product warnings. Roche contended that the trial court unfairly curtailed its ability at trial to defend that numbers-oriented evidence and advocacy.

Prior to the trial in this case, plaintiff moved to bar defense counsel from presenting certain proofs and arguments concerning the background incident rates of IBD in the general population. In
essence, plaintiff argued, those general background rates are unreliable because symptoms of IBD are frequently under-reported.  The trial court agreed and precluded Roche from referring at trial
to the background rates of IBD in the general population to disprove causation. The order did allow Roche to present "factual testimony" to show that it acted reasonably based on such background rates, but only if "the numbers are not told to the jury."  The trial court did not, however, impose any
restrictions upon plaintiff in her own use of numerical proofs at trial, other than a restriction against using the numbers in a specific formula.

Thus, during opening statements, plaintiff's counsel noted that she would present proof that Roche was aware of at least 104 reported cases of IBD, of which thirty-three cases were supposedly given a causality rating of possible or probable by the company. Plaintiff's counsel also cited in opening argument to an internal Roche report stating that, in 2002, there had been sixty-four reports of
Crohn's disease.  The trial court ruled that Roche could not argue that a comparison of those AERs vs. the background rate was a scientifically-valid way to evaluate the risk of a drug. Defendant was also curtailed in cross-examination of plaintiff's labeling expert,  particularly with regard to how Roche had analyzed certain data on Accutane that it had presented to the FDA.

During the defense case in chief, the trial court did loosen her ruling and did permit a defense expert to explain to the jury that, in calculating the number of IBD cases in the exposed population, Roche had assessed the reported adverse events. Because it was suspected such events are under-reported, Roche factored in under-reporting. In calendar year 1988, when approximately one million patients took Accutane, there were only seven reports of IBD. From 1982 to 1999, when more than 32 million patients took the drug, there were only 206 case reports of IBD.

However, the trial court gave the jury a limiting instruction on this evidence that defendant on appeal argued was especially harmful, by accentuating to the jurors that Roche's internal corporate use of background numbers was supposedly, at least in some respects, "unscientific."  Defendant argued that the trial court's directive to the jurors that at least one use of the background numbers was not "scientifically accepted," placed a prejudicial and unnecessary spin on the proofs, to Roche's detriment.

The appellate court concluded it lacked confidence that this trial, when considered as a whole, provided a full and fair opportunity for Roche to contest, present, and advocate the relevant "numbers" evidence. Specifically, the trial court erred in forbidding Roche from placing into
evidence (and arguing) statistics about Accutane usage that could have made Roche's conduct and labeling decisions appear far more reasonable to the jury. The number of users evidence  could have given the jurors very relevant contextual background, and possibly led the jury to be more indulgent of Roche's alleged delay in upgrading the risk information on Accutane's label and package insert.  Even accepting, for the sake of argument, plaintiff's contention that adverse events are heavily under-reported, the quantity of actual users of a drug logically is a significant part of the
numerical landscape. At a minimum, the actual usage data for Accutane would go to "safety signaling" concerns, i.e., whether Roche had received sufficiently frequent adverse "signals" to take corrective action. Had Roche been allowed to fully present the statistics on users and other related counter-proofs, the jury would have had a fuller and more balanced picture of the data bearing upon the company's conduct in changing its label. See McCarrell v. Hoffman-La Roche, Inc., No. A-3280-07 (App. Div. Mar. 12, 2009), certif. denied, 199 N.J. 518 (2009).

The court recognized that the trial court's attempted conceptual boundary between using background data for purposes of evaluating "signals" and company conduct, but not for "causation," is a technical and somewhat elusive distinction. In fact, there logically appear to be some implicit causation aspects of a drug company using background incidence data for evaluating signal strength. Increased reports of a medical condition occurring in a drug's users, as
contrasted with the general population, may well provoke a drug maker to strengthen its labeling, because such adverse reports may suggest that the product is, in fact, "causing" such adverse
results. In any event, the court of appeals felt there was no need here to draw the boundaries
between causation and conduct with precision or with definiteness. The point remains that, even accepting, arguendo, as reasonable the trial court's prohibition upon Roche using background numbers to disprove causation (because of a concern about reporting), the trial as a whole
did not provide Roche with a sufficient opportunity to make full and legitimate uses of such contextual evidence as part of its trial advocacy.  In particular, the jury instruction issued by the court went too far in characterizing to the jurors the use of background numbers to prove or disprove causation as "unscientific."

The case was remanded for a new trial.  And on remand, the defense will not be foreclosed from attempting to use the numbers evidence to show not only that the company acted reasonably in the manner in which it developed and modified the Accutane product warnings, but also to attempt (if it chooses to do so) to disprove causation

Roche has successfully defended IBD claims in the federal cases brought to date, obtaining dismissals in each case that have been affirmed on appeal by the United States Court of Appeals for the Eleventh Circuit.

 

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One of the fascinating and disturbing things about failure to warn claims is the endless supply of creative, far-fetched, fantastic, implausible, fanciful, incredible, questionable, even bizarre theories that plaintiff lawyers sometimes come up with to support this type of claim.

Last week, a Pennsylvania appeals court rejected just such a theory. Specifically, plaintiff alleged that a failure to warn caused her injury -- nothing strange there.  But the manufacturer DID warn specifically of the condition she developed.  So, what was the plaintiff's failure to warn theory?  That a drug maker may be liable for failure to warn despite warning of the condition plaintiff developed, because a warning about a different medical issue —one that she did not develop— would somehow have caused her doctor to not prescribe the drug.  Cochran v. Wyeth Inc., 2010 WL 2902717 (Pa. Super. Ct., 7/27/10).

Plaintiff ingested the prescription weight-loss drug dexfenfluramine, which was manufactured by Wyeth and sold under the brand name Redux. Wyeth informed the prescriber that Redux may cause primary pulmonary hypertension (“PPH”). The doctor, in turn, warned plaintiff of the risk of PPH prior to prescribing her Redux. At the time of his decision, however, the prescriber claimed he was unaware of the risk that Redux may cause valvular heart disease (“VHD”).  Later, plaintiff was diagnosed with PPH, which she had been warned about.  But she claimed that the doctor would not have prescribed Redux to her had he been warned that Redux could cause VHD.

Proximate cause is an essential element in a failure to warn case.  A proximate, or legal cause, is defined under Pennsylvania law as a substantial contributing factor in bringing about the harm in question. That is, a plaintiff must establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.   Wyeth argued that even if its warnings with regard to VHD were inadequate, its failure to warn of VHD was not the proximate cause of plaintiff's PPH.  To establish proximate causation, plaintiff must prove that the warnings failed to disclose the risk of her particular injury (PPH).

The trial court agreed. On appeal, the court found an absence of clear authority on the issue, but strong guidance in those cases that have addressed a plaintiff's burden of proving proximate causation in the informed consent context.  Finding the torts of informed consent and failure to warn analogous, the superior court was persuaded by those jurisdictions that have concluded a plaintiff cannot establish proximate causation where the non-disclosed risk never materialized into an injury.

Here, the risk of VHD did not develop into the actual injury of VHD. Although the prescriber testified in deposition that he would not have prescribed Redux had he known of the risk of VHD, this does not alter the fact that while Wyeth allegedly failed to disclose the risk of VHD the plaintiff suffered from PPH. In these circumstances, the relationship between the legal wrong (the alleged failure to disclose the risk of VHD) and the injury (PPH) was  "not directly correlative and is too remote" for proximate causation.

Summary judgment for defendant affirmed.

(Dechert has represented Wyeth in diet drug litigation, but not this case.)
 

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The Sergeant Joe Friday character on Dragnet was created and played by actor Jack Webb.  Like so many famous lines, the immortal words, "Just the facts, ma'am," were apparently never uttered by the character.  What Friday actually said in early episodes is "All we want are the facts, ma'am."  

Either way, that's our motto when we post about litigation the firm has been involved in.  But with that limitation, a noteworthy decision is In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010).

After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement (MSA).  PTO 28 required non-settling plaintiffs to notify their healthcare providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply could result in dismissal of the plaintiffs' claims with prejudice.

PTO 28 is characterized as a Lone Pine order, named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986). Lone Pine orders are designed to handle the complex issues and potential burdens on the aprties and the court in mass tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).

The trial court extended deadlines, but eventually defendant Merck moved for an Order to Show Cause as to sixty-one plaintiffs for alleged failure to provide a case-specific expert report as required by PTO 28. The plaintiffs filed responses, arguing that they were in substantial compliance with PTO 28 and that state substantive law only required general forms of causation proof. In April 2009, the district court dismissed these plaintiffs' complaints with prejudice for failure to comply with PTO 28.

A district court's adoption of a Lone Pine order and decision to dismiss a case for failing to comply with a Lone Pine order are reviewed for abuse of discretion. Acuna, 200 F.3d at 340-41. The district court stated that “it is not too much to ask a plaintiff to provide some kind of evidence to support their claim that Vioxx caused them personal injury.”

The court of appeals had previously held that such orders are issued under the wide discretion afforded district judges over the management of discovery under Federal Rule 16. The court had held that the Lone Pine orders essentially required information which plaintiffs should have had before filing their claims pursuant to Rule 11.  Each plaintiff should have at least some information regarding the nature of his injuries, the circumstances under which he could have been exposed to harmful substances, and the basis for believing that the named defendants were responsible for his injuries.

The Fifth Circuit reaffirmed its view that it is within a trial court's discretion to take steps to manage the complex and potentially very burdensome discovery that these mass tort cases would require. The court of appeals thus affirmed the judgment of the district court.
 

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A federal judge has issued an opinion explaining her Daubert and summary judgment rulings in a case brought by a consumer who alleged he contracted lung disease from the fumes of microwave popcorn. Newkirk et al. v. ConAgra Foods Inc., No. 2:08-cv-00273 (E.D. Wash. 7/2/2010).

Readers of MassTortDefense may be familiar with the so-called "popcorn lung" litigation in which plaintiffs have alleged they contracted a series of diseases, including Bronchiolitis obliterans, from inhaling the chemical diacetyl which had been used in the artificial butter on microwave popcorn.  Most of the claims have been made by workers with alleged industrial-level exposures on a daily basis in popcorn factories several years ago.  There are, however, a handful of cases by consumers claiming they somehow had sufficient exposure in their homes to have the same respiratory injuries.  These latter cases raise significant issues of general and specific causation, arising from the central tenet of toxicology: the dose makes the poison.  The studies relied on by plaintiffs noted that the cumulative exposure to diacetyl was correlated with chronic effects on lung function in plant workers.

Plaintiff Newkirk claimed that the natural and artificial butter flavoring in ConAgra's Act II Butter and Act II Butter Lovers popcorn products caused him severe and progressive damage to the respiratory system, extreme shortness of breath, and reduced life expectancy.  He claimed that he ate between five and seven bags of ConAgra's popcorn every day for more than a decade.

The motions centered around plaintiff's burden to prove causation. Plaintiffs in toxic tort cases must establish both general and specific causation. Golden v. CH2M Hill Hanford Group, Inc., 528 F.3d 681, 683 (9th Cir.2008). Evidence supporting general causation addresses “whether the substance at issue had the capacity to cause the harm alleged.” In re Hanford Nuclear Reservation Litigation, 292 F.3d 1124, 1133 (9th Cir.2002). Specific causation, by contrast, concerns whether a particular individual suffers from a particular ailment as a result of exposure to the substance. Defendants challenged plaintiff's proof of both under Daubert.

Plaintiffs retained Dr. Egilman to offer an opinion on general causation, as well as to examine Mr. Newkirk, diagnose him, and offer an opinion regarding the specific cause of his condition. The expert opinion testimony of Dr. Egilman was the plaintiffs’ primary evidence supporting general causation. (All of the Newkirks’ other causation expert witnesses assumed that general causation already has been established.)  He opined that,  “There is no known safe level of diacetyl exposure. Existing scientific studies also suggest that levels of diacetyl exposure below and around 1 ppm can cause BO and other respiratory illnesses.”

The court found, however, that Dr. Egilman's attempt to analogize kitchen to industrial exposures failed. He offered no sufficient basis or methodology for support for the conclusion that there is no important (medically relevant) qualitative difference between the vapor from butter flavoring slurry in a mixing vat in a popcorn plant and the vapor from butter flavoring that is emitted from microwave popcorn in the home. There was nothing to support Dr. Egilman’s conclusions that were at the heart of this case: that the vapors emitted from a microwave popcorn bag contain the same proportion of chemicals or in sufficient doses or that all of the substances in the two instances are identical. In other parts of his reports and testimony, the court found, Dr. Egilman relied on some existing data, mostly in the form of published studies, but drew conclusions far beyond what the study authors concluded.

Or, Dr. Egilman manipulated the data from those studies to reach misleading conclusions of his own. Slip opin. at 25. For example, he relied on statements by a Dr. Cecile Rose, on a patient (and another consumer plaintiff), Mr. Watson, who allegedly contracted disease from popcorn fumes. But this was in the nature of a single case report, and in it even Dr. Rose did not assert that her conclusions could be extrapolated to other consumers in the absence of publication or peer review; Dr. Egilman acknowledged that Dr. Rose did not publish the exposure levels measured in Mr. Watson’s home -- so no such comparison was possible.  Dr. Rose herself qualified her conclusions: “It is difficult to make a causal connection based on a single case report. We cannot be sure that this patient’s exposure to butter flavored microwave popcorn from daily heavy preparation has caused his lung disease.” 
 

The expert also relied on testing conducted by Dr. John Martyny in a kitchen (not of a consumer), despite that doctor's own reflections that the methodology underlying the work could not support extrapolating to general causation for a broader group of consumers.  The expert also relied on animal studies. Expert opinion relying on animal studies to reach an opinion on causation in humans is usually admissible only when the expert explains how and why the results of the animal toxicological study can reliably be extrapolated to humans. General Electric Co. v. Joiner, 522 U.S. 136, 143-45 (1997).  Dr. Egilman offered no such analytical bridge between the animal studies finding harm from high levels of diacetyl exposure to lab rats and his conclusion that those studies demonstrate that diacetyl exposure causes decreased lung function in humans. He offered no sufficient explanation for how and why the results of those studies could be extrapolated to humans, let alone low-dose consumer contexts.

Without Dr. Egilman's testimony to support causation, the plaintiffs' other expert witnesses couldn't establish this element either.

Note also that the court excluded Dr. Egilman's "legal conclusions" from his expert report and affidavits, since the witness was no more capable than the fact-finder to draw such a conclusion. See Nationwide Transp. Fin. v. Cass Info. Sys., 523 F.3d 1051, 1059-60 (9th Cir.2008) (expert witness cannot give an opinion as to her legal conclusion, i.e., an opinion on an ultimate issue of law). For example, Dr. Egilman tried to opine that about what the defendant "knew" and "failed to warn" consumers. This is another useful precedent against plaintiffs' mis-use of the conduct "expert" who provides mere legal conclusions and invades the province of the jury.

(Dechert is involved in the diacetyl litigation, but not this case.)

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In an interesting products/fire case, the Texas Supreme Court confirmed last week that a plaintiff's expert must explain or disprove alternative causation theories to establish plaintiff's causation theory. See Wal-Mart Stores Inc. v. Merrell,  No. 09-0224  (Tex. 6/18/10).

Plaintiffs' decedents died from smoke inhalation in the bedroom of their rented home. When police officers arrived, they found in the living room a badly burned recliner, a damaged pole-style floor lamp, and other furniture covered in soot and smoke. There were candles, melted wax, an ashtray, and smoking paraphernalia throughout the house, including ash trays, a "bong," and marijuana cigarette butts. The fire marshal declared the fire accidental and of unknown origin. Then, plaintiffs brought wrongful death and survival claims against Wal-Mart, alleging that a halogen lamp in the apartment, purchased from Wal-Mart, caused the fire.

Merrell’s expert, Dr. Beyler, attributed the fire to “nonpassive failure" of the lamp igniting the recliner below it.  He opined that the lamp’s halogen bulb exploded, sending burning glass shards onto the recliner, which smoldered for several hours. Beyer admitted there were possible other mechanisms.  But he purported to rule out smoking materials as the cause because none
were found in the immediate “area of origin” of the fire. He also purported to rule out the candles as the cause of the fire because, had the candles been the source of ignition, the candle wax on the
table allegedly would not have survived the exposure.

Wal-Mart’s expert, John Lentini, testified that the more likely cause of this fire was careless disposal of smoking materials.

Wal-Mart contended on appeal that even if Beyler’s testimony was properly admitted, it constituted no evidence of causation because his opinion lacked factual substantiation and therefor was too
conclusory.  Specifically, Wal-Mart contended that Beyler’s testimony did not show that the lamp was more likely to have caused the fire than any other obvious potential sources.

The general rule here is that opinion testimony that is conclusory or speculative is not relevant evidence, because it does not tend to make the existence of a material fact more probable
or less probable. Such conclusory statements cannot support a judgment. 

The Court conducted a careful review of the record, reminding readers how important the details, nuances, language of expert reports and testimony can be, especially in close cases. While much attention is given to the support the expert has for the chosen theory, equal attention should be given to the expert's attempt to rule out other possible mechanisms.

The Court concluded that Beyler did not really answer why a burning cigarette could not have caused the fire. He dismissed as irrelevant the fact that post-mortem toxicology reports revealed that the decedents had been smoking the very night of the fire because, according to Beyler, that
evidence did not provide data relevant to the investigation of causes available in the area of
origin.  But, relating to the recliner, it was unexplained why not having found evidence of burnt cigarettes right there was significant when there was likewise no evidence of charred or exploded glass either in the recliner or anywhere else in the house -- which was his adopted theory. So, while Beyler did undertake to eliminate one potential cause of the fire that might otherwise seem on a par with the lamp theory, the melted candle wax, he provided no coherent explanation for why lit smoking materials could not have been the source.

An expert’s failure to explain or adequately disprove alternative theories of causation makes his or her own theory speculative and conclusory. See Gen. Motors Corp. v. Iracheta, 161 S.W.3d 462, 470 (Tex. 2005) (expert eliminated the obvious possibility that fuel or vapors from the tank filler neck ignited only by saying so, offering no other basis for his opinion. Such a bare opinion was not
enough.).

Causation opinion insufficient. Judgment for defendant.

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A federal appeals court recently affirmed a judgment for the maker of a drug used to treat Parkinson's disease in litigation alleging that the drug caused plaintiff's compulsive gambling.  Wells v. SmithKline Beecham Corp., 2010 WL 1010591 (5th Cir. 2010).

Wells sued GlaxoSmithKline, the manufacturer of Requip, alleging that GSK had failed to warn patients about the alleged side effect of pathological gambling.  For Wells to win under Texas law,  he had to show that the failure to warn caused his injury.  Causation has two levels, general and specific, and a plaintiff must prove both. General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury. Sequence matters, said the 5th Circuit: a plaintiff must establish general causation before moving to specific causation. Without the predicate proof of general causation, the tort claim fails.

Wells engaged three expert witnesses to address general causation, that the drug supposedly could cause pathological gambling. In reaching their conclusions, the experts relied upon: (1) published articles documenting case-specific correlations between Requip and gambling; (2) a single unpublished study allegedly showing a nexus between Parkinson's medicines generally and gambling; (3)  internal data supposedly revealing case-specific associations between Requip and gambling; and (4) the fact that GSK has since changed the Requip label to warn about possible gambling side-effects. (Of course, on the last point a regulatory agency can require a warning based on a lesser level of proof than is required to recover in a tort action.) Defendant challenged the evidence under Daubert, and the district court granted summary judgment.  Plaintiff appealed.

Readers know that Daubert requires admissible expert testimony to be both reliable and relevant.  This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.  Although there are “no certainties in science,” the expert must present conclusions grounded in the methods and procedures of science.  In short, the expert must employ in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.

The court of appeals found that each of the three experts had, in deposition, in essence conceded that there exists no scientifically reliable evidence of a cause-and-effect relationship between Requip and gambling, that the state of the art was mere association, not cause.  That alone would doom the plaintiff's case.

But more interesting for readers is when the court went on, in the alternative, to address the methodologies and fit. 

The studies relied on were, each expert conceded, not statistically significant epidemiology. They were, in fact, case studies. Although case-control studies are not per se inadmissible evidence on general causation,  the courts have frowned on causative conclusions bereft of statistically significant epidemiological support. While the court agreed that in epidemiology hardly any single study is ever conclusive, and it did not suggest that an expert must back his or her opinion with multiple published studies that unequivocally support his or her conclusions, here there was simply too great an analytical gap between the data and the opinion proffered.  Bottom line-- the bases for the experts' conclusions passed none of the applicable Daubert factors: that Requip causes problem gambling is not generally accepted, has not been subjected to peer review and publication, and is not backed by studies meeting requisite scientific standards.

Without the expert testimony, Wells could not prove general causation.  Here's a useful quote:  "Wells urges the law to lead science -- a sequence not countenanced by Daubert."  See also Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996) (“Law lags science; it does not lead it.”).

 

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A recent state supreme court decision offers an interesting take on the use of experts in product liability cases. Watson v. Ford Motor Company , No. 26786 (S.C. March 15, 2010).

Plaintiffs filed a products liability suit against Ford, alleging that the cruise control system on the accident vehicle was defective and the cause of a serious accident. Watson testified that when she entered the interstate, she promptly set the cruise control, but shortly thereafter, the vehicle began to suddenly accelerate. Watson testified that she pumped her brakes to no avail before crashing. Plaintiff's theory of the case was that the vehicle's cruise control system was defective because it allowed electromagnetic interference (EMI) to affect the system. To support this theory, they presented Dr. Antony Anderson, an electrical engineer, who testified as to his theory that EMI can interfere with the speed control component of a cruise control system and cause a vehicle to suddenly and uncontrollably accelerate. Dr. Anderson further opined that this was the cause of the accident, and that Ford could have employed a feasible alternative design to prevent EMI.  Plaintiffs also presented testimony from Bill Williams who was qualified as an expert on “cruise control diagnosis.”

The jury found Ford liable on the cruise control products liability claim, and awarded compensatory damages of $15 million to Watson and $3 million to the estate of passenger Patricia Carter.

The appeal presented three issues: did the trial court err in qualifying Bill Williams as an expert in cruise control systems; did the trial court err in allowing Dr. Anderson’s expert testimony regarding EMI and alternative feasible design; did the trial court err in allowing evidence of other incidents of alleged sudden acceleration in Explorers?

On question one, the court found error. Williams testified that he had worked in the automotive industry since the early 1980s and was currently conducting seminars to train automobile technicians who focus on the brake systems in vehicles. While Williams may have been qualified as an expert in other aspects of automobile components, such as the brake system, the trial court failed to properly evaluate Williams’ qualifications specific to cruise control systems. Notwithstanding this error, the court did not believe that this error alone prejudiced Ford’s defense. Williams’ testimony essentially consisted of a description of the system accompanied by models and diagrams of the components. Furthermore, the trial court prohibited Williams from testifying to matters outside of his scope, specifically noting he could not testify as to electrical engineering matters.

On the second issue, the court addressed an issue that reflected the lack of fit between the opinion and the witness' qualifications in the particular area of expertise. Beyond that, Ford claimed that Dr. Anderson's theory regarding EMI as the cause of the sudden acceleration failed to meet the reliability requirements for the admission of expert testimony. The court reiterated several factors that the trial court should consider when determining whether scientific expert evidence is reliable:(1) the publications and peer review of the technique; (2) prior application of the method to the type of evidence involved in the case; (3) the quality control procedures used to ensure reliability; and (4) the consistency of the method with recognized scientific laws and procedures.

Dr. Anderson’s background involved working with massive generators which have entirely different electrical wiring systems and different voltage levels. He had no experience in the automobile industry, never studied a cruise control system, and never designed any component of a cruise control system. Dr. Anderson had not even operated an automobile with a cruise control system before this litigation; yet, he offered testimony regarding EMI and its effect on the cruise control system.  While he was an expert, perhaps not in the area he opined about.

Even assuming Dr. Anderson was properly qualified as an expert in this area, his testimony was found not reliable. Dr. Anderson declared that the alternative design (twisted pair wiring) would have prevented EMI but did not explain how twisted pair wiring could be incorporated in to a cruise control system and did not offer any model comparison. Furthermore, Dr. Anderson concluded that this design was economically feasible, but offered no basis to support this conclusion.

Dr. Anderson admitted that his theory had not been peer reviewed, he had never published papers on his theory, and he had never tested his theory. He also admitted that he would not be able to determine exactly where the EMI (which he opined caused the cruise control to malfunction) originated or what part of the system it affected. He further testified that it would not be possible to replicate the alleged EMI malfunction of a cruise control system in a testing environment.

The court concluded that there was no evidence indicating that Dr. Anderson’s testimony contained "any indicia of reliability." He had never published articles on his theory nor had he tested his theory. Importantly, Dr. Anderson admitted that it was not possible to test for EMI. Furthermore, although it is not a prerequisite in South Carolina that scientific evidence attain general acceptance in the scientific community before it is admitted, the court found it instructive that not only had the underlying science not been generally accepted, Dr. Anderson’s theory was rejected in the scientific community.  Next, the court found that Ford was prejudiced by the admission of this testimony. Indeed, the only evidence plaintiffs presented to support their theory that the vehicle was defective was Dr. Anderson’s testimony.

On the third issue, evidence of similar accidents, transactions, or happenings is admissible in South Carolina where there is some special relation between the accidents tending to prove or disprove some fact in dispute. Typically, a plaintiff must present a factual foundation for the court to determine that the other accidents were substantially similar to the accident at issue. The court will look at whether (1) the products are similar; (2) the alleged defect is similar; (3) causation related to the defect in the other incidents; and (4) exclusion of all reasonable secondary explanations for the cause of the other incidents.

Here, plaintiffs failed to show that the incidents were substantially similar and failed to establish a special relation between the other incidents and the relevant accident. The other incidents involved Explorers that were made in different years and were completely different models with the driver’s seat located on the right side of the vehicle. More importantly, plaintiffs failed to show a similarity of causation between the malfunction in this case and the malfunction in the other incidents. Plaintiffs presented only the testimony of the other drivers and did not present any expert evidence to show that EMI was a factor in the malfunction in the other incidents.

This evidence was highly prejudicial. Courts require a plaintiff to establish a factual foundation to show substantial similarity because evidence of similar incidents may be extremely prejudicial. Plaintiffs' counsel highlighted this improper evidence in closing arguments and thereby possibly induced the jury to speculate as to other causes of the accident not supported by any evidence.

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A federal appeals court recently affirmed judgment for the maker of an anti-depressant drug, ruling that the plaintiff could not show that an allegedly inadequate warning caused the injury at issue. Dietz v. Smithkline Beecham Corp., 2010 WL 744273 (11th Cir. 2009).

The case reminds readers about the importance of the testimony of the prescriber in a pharmaceutical case. The plaintiff's physician diagnosed him with major depression and offered him hospitalization for psychiatric treatment, which Dietz declined. The doctor then prescribed him Paxil, a selective serotonin reuptake inhibitor (“SSRI”) antidepressant.  Eight days after having filled and begun his Paxil prescription, Dietz apparently committed suicide by throwing himself in front of a train.

Appellant filed a diversity suit. During discovery, the parties deposed Dietz's physician, who testified that he had considered the potential risks and benefits of prescribing Paxil to Dietz when he wrote the prescription in 2002.  He also testified that, even in retrospect, he agreed with his decision to treat Dietz with Paxil and would do so again today under the same circumstances.

Within the context of prescription drugs, Georgia employs the learned intermediary doctrine, which alters the general rule which imposes liability on a manufacturer for failing to warn an end user of the known risks or hazards of its products. According to the doctrine, the manufacturer of a prescription drug does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the manufacturer. The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication involves professional assessment of potential medical risks in light of the physician's knowledge of a patient's particular needs.

Here the court affirmed summary judgment for the manufacturer since the appellant could not demonstrate that any alleged failure to warn the treater about increased suicide risks associated with Paxil proximately caused Dietz to commit suicide. The doctor provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, he still would have prescribed Paxil for Dietz's depression. Pursuant to Georgia's learned intermediary doctrine, this assertion severs any potential chain of causation through which appellant could seek relief. 

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Last week, the Ninth Circuit upheld summary judgment for the maker of an artificial disc on a claim that the company's alleged off-label promotion of the device constituted negligence per se. See Carson v. DePuy Spine Inc.,  No. 08-56698 (9th Cir., 2/16/10)(unpublished).

Readers know that alleged violations of state or federal regulations can be used by plaintiffs in a number of ways, including the allegation that the violation constitutes negligence per se under state law.  The artificial disc involved in this action was a class III medical device that had received pre-market approval from the FDA in 2004. All devices approved by the agency carry labels that describe the uses and patient conditions for which they may be used. Any use by a physician that differs from the label is considered an off-label use.  Here, plaintiff argued that the defendant was negligent in allegedly promoting off-label use for its product. 

The court noted that he FDCAct expressly protects off-label use: “Nothing in this chapter shall be
construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” 21U.S.C. § 396. In addition, the Supreme Court has emphasized that off-label use by medical professionals is not only legitimate but important in the practice of medicine. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001). And a manufacturer is not liable merely because it sells a device with knowledge that the prescribing doctor intends an off-label use.
 

Plaintiffs argued  that the FDA has adopted regulations that limit a drug or device manufacturer’s
ability to promote a drug or device for off-label use. Therefore, while doctors may use a drug or device off-label, the marketing and promotion of a Class III device for an unapproved use violates Section 331 of the FDCA, 21 U.S.C. § 331, claimed plaintiff.  Thus, plaintiff asserted a state law negligence per se theory predicated on violation of federal law.   

In California, negligence per se is not a separate cause of action but is the application of an evidentiary presumption. Quiroz v. Seventh Avenue Center, 140 Cal. App. 4th 1256, 1285-86 (Cal. 2006). In California, there are four elements required to establish a viable negligence per se theory: (1) the defendant violated a statute or regulation; (2) the violation caused the plaintiff's injury; (3) the injury resulted from the kind of occurrence the statute or regulation was designed to prevent; and (4) the plaintiff was a member of the class of persons the statute or regulation was intended to protect. See Alejo v. City of Alhambra, 75 Cal.App.4th 1180, 1184-1185 (Cal.App. 1999).

The court of appeals found that the district court had correctly concluded that Carson had failed to present sufficient evidence to create a genuine issue as to two of the elements: violation of
federal law and causation. There was no evidence in the record to support the claim that defendant illegally promoted an off-label use of the products, that the physician was influenced by such promotion, or that the off-label use of the disk caused the injury. Indeed, there was uncontroverted testimony that plaintiff developed a spinal condition that put undue stress on the device, and that the surgeon broke the disc himself during revision surgery.

Summary judgment affirmed.

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A New Jersey appellate court recently affirmed a trial court's decision that an Accutane plaintiff's expert's study must be excluded as unreliable. See Palazzolo v. Hoffmann La Roche Inc., 2010 WL 363834 (N.J. Super. Ct., 2/3/10).

Plaintiffs filed a product liability and consumer fraud complaint against defendants claiming that Accutane, a drug used to treat acne, caused their family member to develop depression which led to his suicide. They contended that at the time of his death in 1997, Accutane should have carried a warning label concerning the possibility that the drug could cause depression and suicide.

As one element of their product liability cause of action, plaintiffs needed to establish “general causation,” by showing that Accutane can cause depression and suicide. See Kemp v. State, 174 N.J. 412, 417 (2002); Coffman v. Keene Corp., 133 N.J. 581, 594 (1993). On that issue, plaintiffs retained Dr. James Bremner, as an expert.  Plaintiffs paid Bremner to undertake a study of the issue; there was no dispute that the study was commissioned specifically for use in this litigation.

In the study at issue, Bremner and a team of other scientists used positron emission tomography (PET) technology to compare changes in brain metabolism between two groups of subjects being treated for acne. One group was receiving antibiotic treatment and the other group was being treated with Accutane.  According to Bremner, the PET study demonstrated that the subjects treated with Accutane showed decreased metabolism in the orbital frontal cortex, a portion of the brain associated with depression. He published an article about the study in a scientific journal, describing his methodology and his conclusions. Based largely but not entirely on the PET study, he issued an expert report opining that Accutane can cause depression and suicide.

Defendants challenged the evidence. In deposition and at a hearing, Bremner was repeatedly confronted with potential problems in the PET study, including missing data, inaccurate data, and deviations from the methodology he claimed to have followed. As a result, in the middle of the Rule 104 hearing, the court permitted Bremner to re-work his study data and issue a supplemental expert report and allowed defendant to re-depose him. The trial court then excluded the evidence.

The court of appeals affirmed. First, Bremner did not actually use the methodology he claimed to have used. Although his PET scan article was peer-reviewed, he admitted that he did not in fact follow the steps described in the article. Significantly, contrary to representations made in the article, he did not get before-and-after questionnaires from many of the subjects.  Those questionnaires were designed to elicit the extent to which the subjects might be worried about their acne. This was relevant because some scientists were of the view that worrying, as well as depression, could affect activity in the orbital frontal cortex.

Secondly, Bremner also could not document much of the data on which his published results were based. Third, he admitted that some of the statistical analysis was inaccurate. For example, in the hearing session, Bremner admitted that, for each study participant, comparing the activity in the orbital frontal cortex with the activity in the whole brain revealed no difference between the subjects who took Accutane and those who took antibiotics.

The court noted that an expert's scientific peers cannot fairly judge the expert's written work, including whether it is worthy of publication, if his article does not accurately represent either the underlying data or what the author did to produce his results. In essence, Bremner's study was not  soundly and reliably generated.

There also was no error in precluding Bremner from providing supplemental reports or information after the Rule 104 hearing record closed. The judge allowed Bremner multiple opportunities to correct errors in his study before the record closed. The orderly conduct of litigation demands that expert opinions reach closure. See Miller v. Pfizer, Inc., 356 F.3d 1326, 1334 (10th Cir.), cert. denied, 543 U.S. 917 (2004).

The court of appeals remanded the case for consideration whether, even without the PET study, Dr. Bremner can still offer an opinion that Accutane can affect the brain and produce depression.

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Just about a year ago, we posted about an interesting device case in which the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product. Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09).

Last week  the federal appeals court affirmed the judgment for the knee implant maker.  Fuesting v. Zimmer Inc., 2010 WL 271728 (7th Cir. 1/25/10).  Fuesting had alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. The expert testimony as to defect also failed.

On appeal, the Seventh Circuit stated that Dr. Rose's testimony did not show that his theory that these knee implants oxidize “in vivo” had sufficient acceptance in the scientific community.  He failed to point to any peer reviewed studies that discuss the oxidation rates of this type of implant in vivo.  Dr. Rose failed to cite any articles or studies that he or any one else conducted regarding how one can discern whether the alleged oxidation occurred before or after implantation.  Dr. Rose also did not rule out possible alternative methods of causation.  Nor did he explain how the device's oxidation caused the device to fail, as the mere presence of oxidation does not prove that the oxidation caused the device to malfunction.

Dr. Rose also failed to “bridge the analytical gap” between the accepted fact that GIA sterilization causes at least some amount of oxidation and his ultimate conclusion that Fuesting's knee implant in particular failed because GIA, rather than another sterilization method, was used. Last, Dr. Rose failed to show that better sterilization alternatives existed in 1991. He concluded, in one sentence of his report, and without any support, that the industry standard was to sterilize implants in an inert gas instead of air. In fact, no manufacturer at that time employed any of  the proffered methods, and Dr. Rose cited no contemporary articles counseling the use of such methods.  For all these reasons, the district court did not abuse its discretion in excluding Dr. Rose's testimony.


 

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A recent federal court  decision explores a seemingly small but potentially crucial issue involving a product liability plaintiff's treating physicians.  In Re: Ortho Evra Products Liability Litigation, No. 1:06-40000, MDL Docket No. 1742 (N.D. Ohio).

Many product liability suits turn on a battle of the experts on issues of injury and causation.  In many cases, a key set of witnesses, therefore, are the plaintiffs' treating physicians. When the views of the treater are on the side of one party, that party will typically emphasize the "neutral" status of the witness and the fact that the treater has had more and closer contacts with the plaintiff.  Whichever side disagrees with the treater will try to emphasize that the doctor is not the "world class" expert on the relevant scientific issues, and that his or her real function was to treat the injury/illness, not figure out whether a particular product caused it.  Accordingly, the deposition of treating physicians -- and the preparation for those depositions -- can be a critical stage of products liability litigation.

In this MDL, defendants moved to regulate ex parte contacts with plaintiffs’ treating physicians. Defendants sought to prevent what many see as an unfair advantage by plaintiffs lobbying their theories of liability and causation upon the treating physicians during such ex parte contact -- often on the eve of deposition. 

Defendants asserted that this issue had been taken up by the New Jersey court in the Zometa/Aredia Litigation litigation.  In that New Jersey litigation, Gaus v. Novartis Pharmaceuticals Corp., No. MID-L-007014-07-MT (New Jersey, Oct. 29, 2009), the court emphasized the “unique set of practical concerns presented in mass tort cases” as well as the number of plaintiffs in determining that the court’s resources would be impaired by a flood of discovery disputes regarding each treating physician. To ensure the same right of access and promote an efficient discovery process, the court there ordered all parties to proceed by way of formal deposition of plaintiffs’ treating physicians. See also In re NuvaRing Products Liability Litigation, 2009 WL 775442 (E.D. Mo., 2009).

Here, the MDL court allowed plaintiffs’ counsel to have ex parte contact with treating physicians with an important limitation. Specifically, plaintiffs’ counsel can meet ex parte to discuss the physicians’
records, course of treatment and related matters, but not as to liability issues or theories, product warnings, defendant's research documents, or related materials. Violations of this approach, the court said, will result in sanctions.

 

 

 

 

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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.
 

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A federal court has dismissed a case against Ford Motor Co. brought on behalf of a minor who was severely hurt when she was struck by a Ford pickup truck while riding her bike.  The court concluded that plaintiff offered insufficient evidence that the alleged defect in the truck (absence of front-wheel anti-lock brakes) caused the accident and thus the ensuing injuries. BancFirst v. Ford Motor Co., 2009 WL 5168342 (W.D.Okla. 12/21/09). 

A seven-year-old rode her bicycle into the path of an oncoming Ford F150 pickup truck driven by Brandon Moore. Although he took evasive action, Moore was unable to avoid hitting the child, who was severely injured as a result of the impact. Plaintiff alleged that the truck wheels locked and the truck began to rotate in a counter-clockwise direction. The truck slid on wet pavement through the intersection, and the child was hit by the right rear corner of the truck as it passed through the inside lane.  Plaintiff brought an action against the manufacturer of the truck, Ford Motor Company, alleging that the truck was unreasonably dangerous because it lacked front-wheel anti-lock brakes (“ABS”).  Ford moved for summary judgment.

Under either a strict liability or negligence theory, plaintiff must show that the lack of front-wheel anti-lock brakes on the F-150 truck caused the accident. In support of its contention that the failure to equip Moore’s truck with ABS on all four wheels caused the accident, plaintiff offered the opinion of William Medcalf, a registered professional engineer. During his deposition, plaintiff’s expert conceded that he could not testify to a reasonable degree of engineering certainty that the alleged defect – lack of all-wheel ABS – caused the accident in this case. Expert testimony in this regard was crucial to plaintiff’s case as the efficacy and functionality of anti-lock braking systems are not within the understanding of ordinary jurors.

So far, so good. A basic failure of an expert to perform at deposition the way the plaintiff probably hoped he would.  But its what happened next that makes the case more useful.

The plaintiff offered a later affidavit from the same expert, but it was ignored because it was based on the same data he had when he gave his first opinion.  Readers of MassTortDefense may be interested in the discussion of another tactic, as the expert attempted to change his previous testimony to avoid summary judgment, through an errata sheet to his deposition, the court said. While Rule 30(e) of the Federal Rules of Civil Procedure permits "corrections" to deposition transcripts, it does not permit wholesale changes to sworn testimony. Coleman v. Southern Pac. Transp. Co., 997 F.Supp. 1197, 1205 (D. Ariz.1998) (discrediting deposition testimony directly contradicted by errata sheet); S.E.C. v. Parkersburg Wireless, L.L. C., 156 F.R.D. 529, 535 (D.D.C. 1994) (noting trend in which courts do not allow a party “to make any substantive change she so desires” in deposition testimony); Rios v. Bigler, 847 F.Supp. 1538, 1546-47 (D. Kan.1994) (court will consider only those changes which clarify the deposition, and not those which materially alter it); Greenway v. International Paper Co., 144 F.R.D. 322, 325 (W.D. La. 1992) (suppressing deponent's attempt to rewrite material answers given in deposition); Barlow v.. Esselte Pendaflex Corp., 111 F.R.D. 404, 406 (M.D.N.C. 1986) (refusing to consider changes to deposition that were made in bad faith).

The changes here were not a clarification; they were substantive changes diametrically opposed to the answers given during the deposition, said the court. Moreover, although Medcalf stated that his new answers were just clarifications to the record, there was no indication that he was confused during the deposition. That the expert treated the deposition like a "take home examination" was clear to the court not only from his proposed changes, but also from the timing of the errata sheet, which appeared only after Ford moved for summary judgment.

Plaintiff had no competent evidence that the accident would not have occurred had Moore’s truck been equipped with four-wheel ABS. It thus had no evidence that the alleged defect caused the accident and the subsequent injuries to plaintiff.  And the last minute attempts to fix that problem were of no avail. Defendant was therefore entitled to summary judgment in its favor. 

 

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A federal court has granted defendant CSX Transportation, Inc.’s Motion for Summary Judgment in a medical monitoring case arising from a train accident. See Mann v. CSX Transportation, et al., NO. 1:07-cv-3512 (N.D. Ohio Nov. 10, 2009).

The case arises from the derailment of 31 rail cars, nine of which contained hazardous materials, and the subsequent fire that burned for around sixty hours. Ohio emergency personnel oversaw an
evacuation of a one half mile radius. The next day, plaintiffs filed a putative class action complaint in state court, which was removed to the Northern District of Ohio. Plaintiffs’ complaint, under
theories of strict liability and negligence, primarily sought the establishment of a judicially administered medical monitoring program.

After discovery had been completed, defendant filed its motion for summary judgment. The court began by noting that Ohio law recognizes medical monitoring as a form of remedy for an underlying tort. See Wilson v. Brush Wellman, 817 N.E.2d 59, 63 (Ohio 2004). (Readers will note some states consider it a separate cause of action.) Therefore, medical monitoring is only granted if a plaintiff is able to prove all the elements of the underlying tort and the elements of medical monitoring. On the first part, in order to avoid summary judgment, plaintiffs thus must make a showing of a genuine issue of material fact as to the elements of a negligence claim under Ohio law: (1) defendant had a duty to plaintiffs, (2) defendant breached that duty, and (3) plaintiffs suffered damages directly and proximately caused by defendant’s breach. See, e.g., Menifee v. Ohio Welding Products, 15 Ohio St. 3d 75, 77 (Ohio 1984).

The first two issues were not contested for purposes of the motion. On injury and causation, the court noted the overlap with typical medical monitoring requirements, such that to meet this aspect of their negligence claim plaintiffs must demonstrate a genuine issue of material fact that: (1) the chemicals (dioxins) released into the air by the fire are known causes of human disease; and (2) that the plaintiffs were exposed to the dioxins in an amount sufficient to cause a significantly increased risk of disease such that a reasonable physician would order medical monitoring.

Plaintiff experts relied on classifications of the chemicals as carcinogens as their only evidence that dioxins cause the various endpoint diseases for which they seek medical monitoring.  Plaintiffs’ experts also failed to provide an independent assessment of the causal link between dioxins and disease.  Instead they "parroted" the conclusions of other experts and cited to EPA, IARC and NTP documents labeling dioxins as known carcinogens. This was an insufficient showing, said the court.

But even if plaintiffs could demonstrate a causal relationship between dioxins and cancer, plaintiffs had failed to establish that they were exposed to dioxins in an amount warranting a reasonable physician to order medical monitoring. See Day v. NLO, 851 F.Supp.869, 881 (S.D. Ohio 1994).

Plaintiffs’ theory was that they were at an increased risk of disease because they lived for eighteen months with alleged contamination from the fire inside and around their homes. However, none of the named plaintiffs presented evidence that a physician has examined them or their medical records and opined that they are at an increased risk of disease. Similarly, plaintiffs’ experts had not conducted any measurement of dioxin inside or outside of the homes of five of the seven named plaintiffs. At least three of the seven had not even lived in their air dispersion modeling expert's "impact zone" long enough to qualify for his proposed medical monitoring program. Even for those that did, mere residence in the so-called impact zone is insufficient evidence of sufficient contamination and increased risk because it ignores any individual variables, including other sources, and most notably, at what level each of the named plaintiffs was actually exposed to dioxins. The Sixth Circuit has stated “generalized proofs will not suffice to prove individual damages.”  Sterling v. Velsicol Chem. Corp., 855 F.2d 1188, 1200 (6th Cir. 1988).

Again, even if plaintiffs had presented sufficient evidence of the amount of named plaintiffs’ dioxin exposure, plaintiffs did not demonstrate that a reasonable physician would order medical monitoring based on this exposure. Plaintiffs attempted to rely upon the EPA soil cleanup level after the accident as a basis for justifying medical monitoring. The court found two fatal defects in using this EPA soil cleanup level. First, demonstrating why regulatory guidelines are often not useful in the tort litigation context, see Rowe v. E.I. DuPont de Nemours & Co., 2008 WL 5412912 (D.N.J. Dec. 23, 2008); Redland Soccer Club, Inc. v. Dep’t of the Army, 55 F.3d 827 (3d Cir. 1995), the EPA soil cleanup level represented a threshold for the cleanup of contaminated soil, not a danger point
above which individuals would require medical monitoring. And even if government regulations were relevant to showing increased risk, a conservative soil cleanup level should not be used in place of a medically based risk assessment or evidence of the actual dose level at which dioxin truly causes cancer – the danger point critical to a medical monitoring determination.  Second, the EPA’s threshold soil cleanup level represents an increase in the risk of developing cancer from the baseline level for the general population of one in a million. Thus, even assuming there were a million members in this class who had been exposed to this level of dioxin over their entire lives, and assuming causation, only one of them would develop cancer because of the exposure. Plaintiffs thus sought to commence medical monitoring based on this one-in-a-million risk, but this risk and indeed risks higher, have been found insignificant as a matter of law.  Medical monitoring typically requires a significantly increased risk. Plaintiffs' expert opinion to the contrary was a legal conclusion, and thus it did not create a genuine issue of material fact.

In sum, the court concluded that the plaintiffs had not presented a genuine issue of material fact that the circumstances would warrant a reasonable physician to order medical monitoring. Medical monitoring in Ohio is a form of relief which should only be granted "with prudence."  Interestingly, the court concluded that plaintiffs’ proposed program would likely be extremely expensive, said the court, and inconvenience thousands of people for many years in the future. (Note to readers, the potential down-sides of medical monitoring must be explored in each case.) Plaintiffs had not presented enough evidence for a reasonable jury to conclude that such a burdensome program is warranted.

 

 

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A while back we posted about an interesting toxic tort case involving important causation issues. See Zandi v. Wyeth, 2009 WL 2151141 (Minn.App.).  A Minnesota appeals court recently refused to rehear its prior affirmance of summary judgment for defendants in a suit by a woman who alleged hormone replacement drugs caused her breast cancer.  2009 Minn. LEXIS 648. 

Plaintiff alleged that between approximately 1981 and 2001, she ingested hormone replacement therapy (HRT) drugs manufactured, designed, packaged, marketed, and distributed by defendants. In November 2001, Zandi alleges she was diagnosed with "hormone-dependent breast cancer." She contended that the HRT drugs caused her cancer. 

The trial court found that plaintiff's specific causation evidence did not satisfy Minnesota's standard for admissibility of expert testimony. Zandi offered testimony from Dr. Lester Layfield and Dr. Gail Bender to try to prove that HRT drugs caused her cancer. Minnesota courts use the Frye standard to determine the admissibility of novel scientific evidence. Zandi's claims were based on the following propositions: 1) it is supposedly generally accepted that HRT causes hormone-dependent breast cancer, and 2) there is a generally accepted method of diagnosing the cause of hormone-dependent breast cancer in an individual. The appellate issues revolved around the second.

Plaintiff's experts based their specific causation opinions in part on "differential diagnosis."  As readers of MassTortDefense know,  differential diagnosis, sometimes called “differential etiology”  is a process through which all the scientifically plausible causes of an injury are “ruled in,” and the expert then “rules out” the less plausible causes until reaching the one that theoretically cannot be ruled out.  If you've watched "House" on TV, you have seen the use of differential diagnosis to discover what disease a patient is suffering from.  Less traditional, and more questionable, is the use of the technique to discover what is the cause of the disease in the patient.  Most doctors don't care as much about the cause of the disease as getting the right disease and treating it.  As used by toxic tort plaintiffs, differential diagnosis adopts a process of elimination to identify not just the injury (which may be debated) but also the cause; in theory, it seeks to eliminate the possibility of competing causes or confounding factors. 

Again, in performing a differential diagnosis, a physician begins by ruling in all scientifically plausible causes of the patient's injury. The physician then rules out the least plausible causes of injury until the most likely cause remains. Yet, breast cancer does not lend itself to such a differential diagnosis because the scientific community has not accepted that breast cancer has a limited number of discrete and recognized possible causes such that ruling out one or a few causes would necessarily implicate another. For differential diagnosis to be sufficiently reliable to even come close to proving causation, even assuming one accepts the method in this context, the diagnostician should rule out all other hypotheses, or at least explain why the other conceivable causes are excludable. But additional risk factors that plaintiff failed to adequately account for here in this case included family history. When faced with this dilemma, as is common when a disease has many idiopathic cases, plaintiff's experts simply suggest that it is possible to conduct a reliable differential diagnosis without ruling out other hypotheses, as long as "major" or "most" explanations are ruled out.  Courts should be wary of this.

Courts generally recognize that the proffered expert must have a sufficient basis to “rule in” the drug or toxic substance at issue as a plausible cause of plaintiff’s injury. E.g., Jazairi v. Royal Oaks Apts., 217 Fed. Appx. 895 (8th Cir. 2007).  But this case is a good reminder that the plaintiff's expert testimony must also reliably “rule out” the other plausible causes of the injury--  again, especially difficult when its causes are largely unknown.  On this record, the court said, “We conclude that there is not a method of diagnosing the specific cause of a particular woman's breast cancer that is generally accepted in the relevant scientific community. This reality leaves Zandi without a legally sufficient ability to prove specific causation.”  See also Perry v. Novartis, 564 F. Supp.2d 452 (E.D. Pa. 2008).

This clear reasoning can be contrasted with the inexplicable finding of the 8th Circuit in Scroggin v. Wyeth, 2009 WL 3518245 (8th Cir. Nov. 2, 2009), which accepted plaintiff's carefully constructed circular reasoning.  Unable to prove that the breast cancer was caused by hormone therapy drugs, plaintiff's expert simply re-diagnosed the disease as hormone-induced breast cancer.  This allowed the expert to engage in a so-called differential diagnosis to determine the cause of the breast cancer simply by ruling out the two possible sources of these hormones: (1) plaintiff produced the hormones herself, or (2) they came from the hormone replacement therapy she had allegedly taken for the past eleven years.  Under this circular reasoning, any form of cancer can easily be linked to the defendant's product because it will be re-characterized as the sub-type of disease caused by the substance at issue. 
 

 

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An appellate court in Florida last week overturned a verdict in favor of a plaintiff in the Accutane litigation.  Hoffmann-LaRoche Inc. v. Mason, 2009 WL 3430190 (Fla. 1st DCA 10/27/09). The opinion reminds readers of the crucial nature of the causation inquiry during discovery, especially in a warnings context.

Plaintiff developed severe acne while in middle school, which caused him to seek treatment from  a dermatologist. After the acne failed to respond to topical agents and antibiotics, Dr. Fisher prescribed Accutane, which was also later prescribed by plaintiff's family practitioner, Dr. Kenneth Counselman, until November 2000, at which time he was diagnosed with Crohn's Disease, a form of Irritable Bowel Disorder.

Plaintiff filed suit under theories of strict liability and negligent failure to warn alleging that Accutane's warning label was inadequate to warn his physicians about the risk of developing IBD. Specifically, plaintiff presented an expert witness who testified that the warning was insufficient because it allegedly did not adequately describe the relationship between Accutane and IBD. At the close of plaintiff's case, defendant moved for a directed verdict, arguing that plaintiff had failed to establish that his injury was proximately caused by any inadequacies in the warning. The trial court denied the motion after the jury returned its verdict in favor of plaintiff in the amount of $7 million.

The issue on appeal was the adequacy of the warnings testimony, and on particular, the causation issue. 

While plaintiff presented testimony that the warning label was allegedly inadequate to warn physicians that Accutane use could lead to IBD, Dr. Fisher, the prescribing physician, testified that he understood the warning label to mean that there was at least a possibility of a causal relationship between Accutane and IBD. (Dr. Fisher testified that he understood the phrase “temporally associated” to mean that there was a possibility of a causal relationship.)  He testified that he would still be willing to prescribe Accutane to his patients even if there was evidence showing that it could cause IBD in rare cases. He also testified that even if the warning label contained all of the additional information suggested by plaintiff's expert, he would still have prescribed the medication. Thus, any alleged inadequacies in Accutane's warning label could not have been the proximate cause of plaintiff's injury because Dr. Fisher understood that there was a possibility that use of the drug could lead to plaintiff developing IBD. And he made an informed decision to prescribe the drug for this patient despite this risk.  Dr. Counselman admitted that he did not consult a prescribing reference manual before prescribing the drug, and thus a different warning would not have mattered to him. 

While a jury found that the alleged failure to provide an adequate warning was a substantial contributing cause of plaintiff's development of IBD, plaintiff actually presented no evidence to establish proximate cause. The trial court erred in denying the motion for a directed verdict. Again, because plaintiff presented no evidence from either treating physician that a differently worded warning would have resulted in either physician not prescribing Accutane for his extreme acne, plaintiff failed to establish that the allegedly deficient warning was the proximate cause of his injury; judgment reversed.

 

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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.

 

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In the Digitek MDL, the parties have been wrangling over the defense motion for a Lone Pine order. See generally Lore v. Lone Pine, No. L-336006-85, 1986 WL 637507 (N.J. Super. Ct. Nov. 18, 1986).

Dozens of product liability cases alleging that defendants Actavis Totowa LLC, Actavis Inc. and Actavis Elizabeth LLC marketed Digitek tablets containing double the appropriate dosage were transferred to an MDL assigned to Chief Judge Goodwin of the Southern District of West Virginia last summer. In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.).
 

Defendants recently moved for a Lone Pine order under which each plaintiff must submit an "affidavit from a medical expert in each case establishing that there is medical evidence of digoxin toxicity." Readers of MassTortDefense recognize this important and logical procedural tool for management of mass toxic tort litigation.  When the major factual battles will be over injury and causation, it may make sense to focus discovery on these issues, and prior to resorting to expensive and time-consuming discovery, to require plaintiffs to come forward with some prima facie showing of injury and specific causation, or as the court put it, "some evidence of certain elements of their claims, e.g. medical causation, to support a credible claim."

The plaintiffs in the federal Digitek multidistrict litigation filed a brief opposing the motion, arguing that the discovery in the MDL is still in its "incipient stages."  As they typically do, the plaintiffs argued that such orders "effectively function as untimely and unjust summary judgment devices and violate the discovery rules for expert witness disclosures and reports." They also argued that they have provided significant case-specific discovery in the form of Plaintiffs' Fact Sheets and records authorizations.

The court entered PTO #43 (Order re Request for Lone Pine Order), saying the motion is taken under advisement pending completion of basic fact discovery of Group 1 cases. Under the latest schedule, Plaintiff shall serve their reports from liability experts no later than March 15, 2010.  The parties shall complete their depositions of Plaintiffs’ liability experts no later than May 28, 2010.  Defendants shall serve their reports from liability experts no later than June 15, 2010. The parties shall complete their depositions of Defendants’ liability experts no later than August 31, 2010. 

At the November 20, 2009, conference each party is to present to the court their choice of five cases that they believe to be representative plaintiffs for trial in accordance with PTO #38, governing the creation of a trial pool upon completion of basic fact discovery, including but not limited to the depositions of plaintiffs, plaintiffs’ physicians who prescribed Digitek® to them, physicians who treated Plaintiffs for alleged digoxin toxicity, and pharmacists who filled plaintiffs’ prescriptions for Digitek®.
 

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The Indiana Supreme Court issued a decision recently, reminding us of the importance of fully developing the causation case, in addition to the response to plaintiff's defect allegations. Kovach v. Caligor Midwest, 2009 WL 2871172 (Ind. September 8, 2009).

The plaintiffs alleged their son was given a fatal overdose of pain medication by a nurse after a surgical procedure. The plaintiffs sued the manufacturers and distributors of the medicine cup used to administer the medication, alleging that defects in design of the cup made it unsuitable for the precise measurements necessary for drugs, and alleging a failure to warn that the cup was not suitable for precision measurement. The interior of the cup bore translucent markings to measure its contents, and graduations delineated both 15 and 30 mL. The nurse had used that type of cup frequently, both at this surgical center and at other hospitals, and she had no difficulty reading its markings. The nurse testified she filled the cup approximately half-way and administered 15 mL of medication to plaintiff's decedent.  According to decedent's father, however, who was present when the drug was administered, the nurse gave the son a full cup of medicine.

So, as is frequently the case, a potential malpractice claim is turned into a product liability claim against an ostensibly deeper pocket, unencumbered by med mal tort reform restrictions.

The plaintiffs presented expert evidence opining that the cup was defective in design and warnings, evidence that was challenged by the defense.  Plaintiffs also argued that if the medicine cup had been better suited as a precision measuring device or had contained a warning that it was not suitable for precision measurement, the decedent would not have received an overdose -- the alleged causal link.  The court did not have to reach the issues surrounding the alleged defects and the expert affidavit which plaintiffs had put forward to support their theory of defect, because the facts established that there was no such causal connection. The results of an autopsy revealed that the decedent had more than twice the recommended therapeutic level of codeine in his blood stream. The undisputed evidence thus demonstrated that if there was an overdose in this case, it was not caused by an imprecise measurement of medication attributable to less than readily discernible marks. (The plaintiff expert had estimated that the cup's imprecision could result in up to a 20% to 30% margin of error.) Rather, if the drug was the medical cause of the death, it was due to an erroneous, double dosage; the accident therefore cannot be attributed in a legal cause sense to any alleged defects in the cup itself.

Plaintiffs tried to then rely on the "read-and-heed" presumption -- i.e., the notion in some jurisdictions that the jury can presume that if an adequate warning had been given it would have been heeded. Such a presumption may aid a defendant when a warning was given.  Plaintiffs often try to use the presumption to attempt to clear the causation hurdle when no warning is given.  But the presumption does not completely dispose of the causation issue in a failure-to-warn case, said the court. The most the presumption does is establish that a warning would have been read and obeyed. It does not necessarily establish that the defect in fact caused the plaintiff's injury. The plaintiff invoking the presumption must still show that the danger which allegedly would have been prevented by an appropriate warning was the danger that actually materialized in the plaintiff's case.  

Plaintiffs could not show that element, given the circumstances of the drug usage. The judgment of the trial court granting summary judgment in favor of the cup defendants was affirmed. 

 

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A new study published in the European Respiratory Journal is generating media attention, and some observers assert it may have far-reaching implications for the nano-tech industry. Is this warranted?

In this study, Song, et al., Exposure to nano-particles is related to pleural effusion, pulmonary fibrosis and granuloma, 34(3) Eur. Respir. J. 559-567 (2009), researchers at China's Capital University of Medical Sciences linked lung disease in seven Chinese workers, two of whom reportedly died, to nano-particle exposures in a print plant where a paste containing nano-particles was sprayed onto a polystyrene substrate, with subsequent heat-curing.

The study reported that seven young female workers (ages 18–47), exposed to nano-particles for 5–13 months, were admitted to the hospital, all with shortness of breath and pleural effusions. Polyacrylate, consisting of nano-particles, was confirmed in the workplace. Pathological examinations of the patients' lung tissue displayed non-specific pulmonary inflammation, pulmonary fibrosis, and foreign-body granulomas of pleura. By transmission electron microscopy, nano-particles were observed to have lodged in the cytoplasm and caryoplasm of pulmonary epithelial and mesothelial cells, but also were located in the chest fluid.

The authors expressed concern that long-term exposure to some nano-particles may be related to serious damage to human lungs.  But, putting the media reception aside, this study appears to do more to highlight the common sense need to follow good industrial hygiene practices than to provide compelling evidence of any unique health risks posed by engineered nano-particles. The plant sprayed a strong chemical paste and then heated plastic material in an enclosed space apparently lacking ventilation.  The room in which the women worked was small and unventilated for a significant part of their exposure period. Only on occasion, they wore mere "cotton gauze masks." 

From the study it appears that the workers had a complicated exposure history to a mix of chemicals; while there was a reported association of nano-particles with lung disease, it is unclear which, if any, of the chemical exposures might have contributed to the lung issues. Readers of MassTortDefense know that an association is not causation.  For example, formation of thermodegradation fume products are known to cause significant occupational disease, and paint spraying has been shown to be potentially harmful long before nano-sizing of chemicals was utilized. 

Moreover, sufficient exposure information necessary to even begin to think about a causal connection between exposure to nano-sized particles in the paste/dust and lung and heart disease in the workers was missing.  Clearly, there may be alternative explanations for what the study authors described finding in the patients.

As noted here before, NIOSH emphasizes the use of a variety of engineering control techniques, implementation of a risk management program in workplaces where exposure to nanomaterials exists, and use of good work practices to help to minimize worker exposures to nanomaterials.
 

 

 

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The federal judge overseeing the multidistrict litigation involving the erectile dysfunction drug Viagra has decided to exclude the testimony of the plaintiffs' key expert witness on causation. In re: Viagra Products Liability Litigation, case number 06-md-01724 (D. Minn. 8/19/09).

The litigation stems largely from an announcement in July, 2005 by the FDA that it was updating its labeling requirements for Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to nonarteritic anterior ischemic optic neuropathy (NAION), an eye condition that can result in partial or total blindness.  An MDL consolidated hundreds of product liability lawsuits alleging a link between Viagra and NAION.
 

Judge Paul Magnuson of the U.S. District Court for the District of Minnesota had ruled last year that the general causation opinions of three of  the plaintiffs' experts should be excluded.  This motion related to plaintiffs' sole remaining general causation expert, Dr. Gerald McGwin.  This expert had authored a study, published in the British Journal of Opthalmology, which indicated that male Viagra users with a history of heart attacks had a statistically significant increased risk of suffering NAION. The court had originally denied Pfizer’s Daubert challenge to Dr. McGwin, largely because his study was peer-reviewed, published, contain[ed] known rates of error, and seemingly resulted from generally accepted epidemiological research.  In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071, 1081 (2008). In January, Judge Magnuson ruled that Pfizer could seek additional discovery related to McGwin's study, and in July, the judge denied the plaintiffs’ motion to have McGwin provide live testimony at a Daubert rehearing.
 

That additional discovery revealed that the study contained discrepancies that raised “serious concerns” about its reliability. In fact, the study contained numerous “acknowledged inaccuracies,” chief among them the inclusion of numerous patients in McGwin's data-set who had not taken Viagra until after they were diagnosed with NAION.  Dr. McGwin acknowledged that the statistics
in his study would have been different had those individuals (11 of 27 patients who
reported drug use) been coded as unexposed rather than as exposed. The discrepancies between the dates of first use on the original survey forms and in Dr. McGwin’s later electronic data set weaken the McGwin study’s assessment of temporality, thereby impair the study’s ability to contribute meaningfully to Dr. McGwin’s opinion about general causation.

Second, the statistical methods actually used to produce the numbers in the McGwin study as published were not the statistical methods that the study said were used. Even if a later reanalysis purportedly confirmed  the findings of the original study, the fact that the methodologies described in the study were not the actual methodologies used clearly also undermines the reliability of the McGwin study as published.

Third, the study was unreliable because it mischaracterizes one of its main findings—that men with a personal history of myocardial infarction and drug use have a significantly higher risk of NAION. The patients were actually asked whether they had a family history of myocardial infarction; no one was asked about personal history. These mis-codings regarding myocardial infarction added yet another layer of unreliability to the McGwin study as published.

The judge concluded that "Almost every indicia of reliability the Court relied on in its previous
Daubert Order regarding the McGwin Study has been shown now to be unreliable. Peer
review and publication mean little if a study is not based on accurate underlying data."

Lastly, Judge Magnuson denied the plaintiffs' motion for leave to file a supplement to McGwin's expert report, which included a reanalysis of the data, concluding that the report's untimely
submission was neither harmless nor justified. The reanalysis lacked even the basic indications of reliability — peer review and publication — that the original had seemingly had, and it had also been produced simply in response to concerns raised in the litigation.

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Here at MassTortDefense we often talk about the sufficiency of expert opinions, including on causation, from a legal Daubert or Frye standpoint.  A recent state court case from Texas reminds us about the rules on jury consideration of opinions that survive such legal challenges.

In Rentech Steel LLC v. Teel, No. 11-07-00318-CV (Tex. App., 11th Dist., 8/13/09), the plaintiff, who was working as a summer employee at Rentech's steel fabrication plant, suffered severe bilateral hand injuries while cleaning a power roller machine, a device that draws in steel plates and rolls them into cylinders. Rentech acknowledged some degree of fault but argued that some responsibility also rested with the settled manufacturer of the machine and the supplier.  The jury found Rentech negligent, but found no liability on the part of the other companies. Rentech appealed the finding of sole liability.

Expert William W.R. Purcell, a certified safety professional with degrees in civil and safety engineering and 40 years of experience, was retained by the plaintiff, but actually called by Rentech as an expert at trial.  He blamed the other defendants for inadequate warnings and instruction, and marketing defects, as well as agreeing there was negligence on the part of Rentech. Despite this uncontroverted expert testimony, the jury assigned liability only to Rentech.

The court of appeals noted that in Texas the jury is the sole judge of the witnesses’ credibility and the weight to give to their testimony.  Jurors may choose to believe one witness and disbelieve another and may disregard even uncontradicted and unimpeached testimony from disinterested witnesses.  Furthermore, even uncontroverted expert testimony does not bind the jury unless the subject matter is one for experts alone – one for which jurors “cannot properly be assumed to have or be able to form correct opinions of their own based upon evidence as a whole and aided by their own experience and knowledge of the subject of inquiry.”  Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 338 (Tex. 1998).

In this case, causation was not a matter for experts alone and did not require a technical or
scientific explanation, said the court;  it was within the jury’s ability to determine on its own what caused the accident and resulting injuries. See K-Mart Corp. v. Honeycutt, 24 S.W.3d 357, 361 (Tex. 2000)(holding that it was within jury’s ability to determine on its own whether lack of a railing caused the accident). Because causation was not an issue for experts alone, the jury could have disregarded Purcell’s conclusion as to causation.  The jury was free to conclude based upon the evidence presented at trial that Rentech failed to provide by a preponderance of the evidence (1) that the negligence of the other sellers was a cause of the accident and (2) that a marketing or design defect was a cause of the accident.

Other evidence before the jury included pictures of the actual roller machine and the warnings already located on the machine; testimony from a Rentech employee who operated the machine that a manual containing operating instructions had previously been supplied to Rentech; and testimony indicating that the Rentech employee operating the machine was knowingly violating the safety warnings and company policy at the time of the incident. Furthermore, the jury could have found that evidence proving a safer alternative design was lacking.

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A Minnesota appeals court recently affirmed summary judgment for defendants in a suit by a woman who alleged hormone replacement drugs caused her breast cancer. Zandi v. Wyeth, 2009 WL 2151141 (Minn.App.)

Plaintiff alleged that between approximately 1981 and 2001, she ingested hormone-replacement-therapy (HRT) drugs manufactured, designed, packaged, marketed, and distributed by defendants.   In November 2001, Zandi was diagnosed with "hormone-dependent breast cancer."  She contended that the HRT drugs caused her cancer.  She brought claims for negligence, strict liability, breach of implied warranty, breach of ex-press warranty, fraud, misrepresentation, and violation of the Minnesota fraudulent advertising act, the Minnesota Prevention of Consumer Fraud Act, and the Minnesota Uniform Deceptive Trade Practices Act.

The trial court  found that plaintiff's specific causation evidence did not satisfy Minnesota's standard for admissibility of expert testimony.  Zandi offered testimony from Dr. Lester Layfield and Dr. Gail Bender to prove that HRT drugs caused her cancer. Minnesota courts use the Frye standard to determine the admissibility of novel scientific evidence. Goeb v. Tharaldson, 615 N.W.2d 800, 814 (Minn.2000). Under Minnesota's version of this standard, the proponent of scientific evidence must establish that the scientific theory is generally accepted in the relevant medical or scientific community and that the principles and methodology used are reliable.  McDonough v. Allina Health Sys., 685 N.W.2d 688, 694 (Minn.App.2004). When novel scientific evidence is offered, (1) the trial court must determine whether it is generally accepted in the relevant scientific community; (2) the particular scientific evidence in each case must be shown to have foundational reliability.

Zandi's claims were based on the following propositions: 1) it is generally accepted that HRT causes hormone-dependent breast cancer, and 2) there is a generally accepted method of diagnosing the cause of hormone-dependent breast cancer in an individual.  The appellate issues revolved around the second.  Defendants alleged that even if one assumes the relevant scientific community generally accepts that HRT causes hormone-dependent breast cancer, Zandi had failed to establish that the relevant scientific community generally agrees that there is a method of diagnosing the cause of breast cancer in a particular person.

Plaintiff's experts based their specific causation opinions on epidemiological studies and differential diagnosis. But  the science of epidemiology does not address the cause of an individual's disease. Epidemiology is concerned with the incidence of disease in populations and does not address the question of cause of an individual's disease. Epidemiology has its limits at the point where an inference is made that the relationship between an agent and a disease is causal (general causation) and where magnitude of excess risk attributed to the agent has been determined; that is, epidemiology addresses whether an agent can cause disease, not whether an agent did cause a specific plaintiff's disease. See Green et al., Reference Guide on Epidemiology, in Reference Manual on Scientific Evidence 333, 381-82 (Fed.Jud.Ctr.2d ed.2000).

Plaintiff's experts also relied on differential diagnosis. As used by plaintiffs, differential diagnosis adopts a process of elimination to identify cause; it  seeks to eliminates the possibility of competing causes or confounding factors. Goeb, 615 N.W.2d at 815.  In performing a differential diagnosis, a physician begins by ruling in all scientifically plausible causes of the patient's injury. The physician then rules out the least plausible causes of injury until the most likely cause remains.  Yet, breast cancer does not lend itself to such a differential diagnosis because the scientific community has not accepted that breast cancer has a limited number of discrete and recognized possible causes such that ruling out one cause would implicate another. For differential diagnosis to be sufficiently reliable to prove causation, the diagnostician should rule out all other hypotheses, or at least explain why the other conceivable causes are excludable.

Additional risk factors that plaintiff failed to adequately account for here included family history. Indeed, plaintiff's experts suggested that it is possible to conduct a reliable differential diagnosis without ruling out other hypotheses.

On this record, the court said, “We conclude that there is not a method of diagnosing the specific cause of a particular woman's breast cancer that is generally accepted in the relevant scientific community. This reality leaves Zandi without a legally sufficient ability to prove specific causation.”
 

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

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

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

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

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

 

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In what appears to be the first substantive decision to come out of the multiple suits alleging that a pain pump medical device damages patients, a federal court has granted summary judgment to the defendant. Kilpatrick v. Breg, Inc., No. 4:08-cv-10052 (S.D. Fla. 6/26/09). Judge Michael Moore ruled in favor of medical device manufacturer Breg, finding that the plaintiff, who alleged damage to his shoulder cartilage, did not provide enough reliable expert evidence to link the condition to the defendant's shoulder pain pump.

Plaintiff Kilpatrick underwent arthroscopic shoulder surgery in 2004 after an orthopedic specialist discovered a tear in his shoulder socket.  To help with post-operative pain, the surgeon inserted a pain pump into plaintiff's shoulder, which would allow the doctor to administer an anesthetic via a catheter in the patient's arm. The surgeon injected bupivacaine into the pump's attached catheter and further filled it with 100 cc's of anesthetic, which was to be delivered into Kilpatrick's shoulder over the next 48 hours.  Plaintiff alleges that he began experiencing severe pain in his shoulder in 2006. An orthopedic surgeon diagnosed the pain as glenohumeral chondrolysis, a deterioration of the cartilage, and Kilpatrick underwent shoulder replacement surgery. He then brought suit, alleging negligence, strict products liability, and violations of Florida's Deceptive and Unfair Trade Practices Act.  Kilpatrick claimed that using the Breg pain pump to administer local anesthetic directly into his shoulder joint caused him to develop post-arthroscopic glenohumeral chondrolysis.

The reliability prong of the Rule 702 analysis was the central issue.  Breg argued, and plaintiff apparently did not contest, that the case should be treated like a toxic tort case for purposes of the Daubert inquiry, in that plaintiff had to offer proof of both general and specific causation. “If anything, determining causation in this case requires an even more complex logical chain than the typical toxic tort case, because the key issue is not merely whether a chemical compound could and did cause injury, but whether that compound as delivered via a particular medical device inserted in a particular location (within Kilpatrick's shoulder joint) could and did cause injury,” the court found.

The summary judgment motion focused first on general causation, and the ability of plaintiff's expert to opine adequately under Daubert that the device can cause this type of injury.  The causes of chondrolysis remain disputed, and experts in the medical community have pointed to autoimmune deficiencies, certain kinds of sutures, thermal energy procedures and contrast dyes made from gentian violets as possible risk factors.  Plaintiff's expert admitted it was a still developing science.

Plaintiff's expert relied on several published studies to attempt to show causation, which were not directly on point, and the Court found that his extrapolations from the studies were not warranted either.  None of the articles were based on controlled, randomized epidemiological studies of human beings, which are the best evidence. “Significantly, none of the articles explains the mechanism by which bupivacaine damages cartilage, each has important limitations that Poehling does not take into account, and none of them offers an ultimate conclusion as to the general causation of glenohumeral chondrolysis,” the court noted. At most they suggest a possible association.  Association is not causation.  As for the animal studies, the expert did not explain the possible differences in dose-response relationship between humans and rabbits, an important factor to consider in evaluating whether an alleged exposure caused an adverse effect. 

As to specific causation, as is typical of many plaintiff experts, Poehling described a process of so-called "differential diagnosis," trying to rule out other suspected causes such as thermal energy and gentian violet, the contrast dye sometimes used during arthroscopic surgery. This approach cannot, observed the court, make up for a fundamental lack of adequate proof about the general toxicity of the substance.  To "rule in" one cause, even while ruling out other causes, requires a sufficient general causation proof.  At its base, however, the conclusion on specific causation still would be unreliable, the court said, as it was "ultimately rooted in nothing more than temporal relationship.”   That before/after focus is not the basis of good science, the court said, “and Poehling's dependence upon it further weakens the reliability of his methodology.”  Significantly, the expert had not offered a sufficient explanation of the background risk for genohumeral chondrolysis, casting further doubt on the reliability of the chosen method. He admitted that not only the pain pump — as a kind of drug delivery system — could have caused the injury, but also the anesthetic delivered via the pain pump.  Poehling's concession that the current state of medical literature is still unsettled about the cause of the plaintiff's condition seriously undermines the reliability of his methodology, the court concluded.  His methodology had no known rate of error, and thus all he had was a hypothesis that “may be exactly right,” but that currently is “merely plausible, not proven.”

It will be interesting to see what impact the approximately 300 suits pending against pain pump manufacturers in state and federal courts.   

 

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

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

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

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

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

 

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Zyprexa is a mature mass tort, as the defendant has settled approximately 31,000 individual product liability lawsuits over the drug, which was widely used in the treatment of psychiatric disorders. The federal court overseeing the multidistrict litigation over Eli Lilly and Co.'s product has made an important ruling on a Daubert challenge to a plaintiff expert in 13 cases involving 20 of the remaining claimants. In re Zyprexa Products Liability Litigation, MDL No. 1596 (E.D.N.Y. May 12, 2009).

Plaintiffs proposed to call an expert to establish the specific causal relationship between the Zyprexa taken and the onset or worsening of their diabetes. After briefing and an extensive evidentiary hearing, Senior Judge Jack B. Weinstein granted Eli Lilly's motion to disqualify Dr. Stephen J. Hamburger, M.D. While the expert met the necessary educational and experiential qualifications warranting the admissibility of his expert opinions, the court found his testimony lacked sufficient scientific reliability.

The court noted that in longstanding and highly complex litigation (read mass tort), particular emphasis must be placed on the reliability and scientific validity of the expert's opinions. Particularly in a mature mass tort ("advanced stage" described the court) when the issues of the benefits and risks of the drug have been a focus of the scientific community for some time, precision with respect to the relevant scientific knowledge and its application to the facts of the individual cases is expected, said the court.

The record demonstrated to the court that this expert's opinions relied on "a subjective methodology, a fast and loose application of his scientific theories to the facts, and conclusion-driven assessments on the issues of causation in the cases on which he proposes to testify,” the order said. In particular, the court pointed to the opinion that Zyprexa supposedly has a direct adverse effect on cells essential to the body's production of insulin, even in cases in which there was no documented weight gain. This opinion was not based on sufficient facts or data, nor was it the product of a reliable method.

In applying this theory to the facts of the cases (the "fit" required by Daubert), the expert had been, in the view of the court, “shockingly careless” about the scientific facts in these cases, including whether weight gain preceded or followed the plaintiffs' use of Zyprexa, and whether there was any weight gain at all. When confronted with these issues, he merely "shrugged off" factual discrepancies in his analyses or shifted to new theories on the fly.

Significantly, the court correctly observed that other mass torts had been subject to a kind of junk science, and it it could not "permit a major pharmaceutical litigation to become the subject of the kind of 'rubber-stamp' expert opinions that have so marred mass litigations such as those involving asbestos and breast implants.”

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

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

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

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

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

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

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

The proposed legislation would overturn that clear and compelling logic.

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The New Jersey Superior Court issued an interesting decision in the Accutane litigation last week.  See  McCarrell v. Hoffman-La Roche, Inc., And Roche Laboratories, Inc., 2009 WL 614484 (N.J.Super.A.D.) (March 12, 2009).

Plaintiff alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease ("IBD"). The IBD led to the surgical removal of his colon and other serious medical complications. A jury returned a verdict in plaintiff's favor on his products liability claim against Roche, but not on his consumer fraud claim, and awarded him compensatory damages.

By order dated May 2, 2005, the state Supreme Court had designated all pending and future statewide actions involving Accutane as a mass tort.  Thus, all Accutane cases, including plaintiff's lawsuit, were transferred to Atlantic County to be heard on a coordinated basis. Discovery in the state cases proceeded in tandem with discovery in the federal Accutane multidistrict ("MDL") litigation.

On appeal from the jury verdict, Roche specifically argued, inter alia, that the trial court erred in admitting the opinion testimony of plaintiff's causation expert Dr. Sachar because his methodology was unreliable and thus improper under  N.J.R.E. 702; and that the trial court denied Roche a fair trial in admitting the testimony about causality assessments based on Accutane ADEs, but in restricting the defense in presenting competing quantitative proofs to put the ADEs in context, including the actual number of Accutane users.

On the issue whether Dr. Sachar's causation testimony was sufficiently reliable in the field of scientific research to be admitted, the court noted that in New Jersey the standard of review of such
rulings under Rule 702 is a narrow one. "In reviewing a trial court's evidential ruling, an appellate court is limited to examining the decision for abuse of discretion."

On the merits, the defendant objected to the expert's heavy reliance on animal studies. The NJ  Supreme Court has previously recognized that animal studies can be an accepted scientific method to study the safety and efficacy of drugs.  Even though the dose administered in the animal studies was far different than the medicinal dose, "Trained experts commonly extrapolate from existing data." Gen. Elec. v. Joiner, 522 U.S. 136, 146 (1997). In assessing the results of animal studies, which frequently involve high doses, experts should be careful to consider the dose-response differential between animals and humans. Magistrini v. One Hour Martinizing
Dry Cleaning, 180 F. Supp. 2d 584, 593 (D.N.J. 2002), aff'd, 68 Fed. App'x. 356 (3d Cir. 2003).

Defendants also challenged the use of anecdotal case reports as a basis for the causation opinion. The court recognized that "[c]ausal attribution based on case studies must be regarded with caution." Federal Judicial Center, Reference Manual on Sci. Evidence 497 (2d ed. 2000).
That is so because case reports typically reflect reported observations, and do not themselves contain scientific analyses. For instance, case reports may lack controls, may fail to screen out alternative causes, and may omit relevant facts about the patient's condition that can be pertinent to a causation assessment. Consequently, a number of courts have concluded that anecdotal case reports are not a scientifically reliable basis for an expert's opinion on causation.

Nevertheless, some other courts have allowed consideration of case reports as an acceptable basis for showing causation, particularly when accompanied by other reliable scientific evidence. New Jersey courts have previously upheld the admission of expert testimony that has relied, at least in part, upon case reports or comparable anecdotal evidence. The court also found significant that the case reports here included dechallenge and rechallenge reports. Dechallenge and rechallenge reports are a type of case report. Dunn v. Sandoz Pharms. Corp., 275 F. Supp. 2d 672, 682 (M.D.N.C. 2003). Such reports, although they surely have limitations, have been considered valuable in ascertaining causation because they measure a patient's reaction to a drug, said the appellate court.

The New Jersey court recognized that it was issuing a causation decision contrary to the ruling in the Accutane MDL.  The court declined to follow the federal court's decision because (1) the causation expert in the Florida case was not Dr. Sachar, and that particular expert's methodology was not as "demonstrably sound" as that of Dr. Sachar; (2) the standards for expert admissibility under N.J.R.E. 702 are not identical to F.R.E. 702; and (3) the testimonial record in this case, having proceeded to trial, was more developed than it was in the Florida case on a pretrial motion, lending greater confidence to a conclusion to sustain the trial judge's decision to admit Dr. Sachar's testimony.

Defendant also challenged the expert's testimony about the company's intent and motive and mind-set, a typical plaintiffs' tactic in mass torts.  Totally improper, highly prejudicial, and ignored by some courts because they seem overwhelmed by the plaintiff's characterization of the defendant's conduct.  Well-reasoned opinions exclude such testimony. See In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1053 (D.Minn. 2007) (observing that "[p]ersonal views on corporate ethics and morality are not expert opinions"); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) (holding that the objected-to opinions of expert witnesses on intent, motives, or state of mind of a corporation had no basis in any relevant body of knowledge or expertise).  Here, the court seemed not to understand the impact and purpose of this improper testimony, finding that although Dr. Sachar's testimony sharply criticized Roche, his criticisms did not rise to "such an inflammatory level" that would cause the appeals court to find an abuse of discretion by the trial court in not excluding it.

Finally, there was what has been described as the "numbers" issue. The issue refers to the fact that the trial court allowed plaintiff's witnesses and counsel to refer, on repeated occasions, to the number of adverse incidents reported from Accutane users or from other sources while, at the same time, the court restricted Roche's attempt at trial to place those adverse numbers into a larger quantitative context. Specifically, the judge precluded Roche witnesses from more
fully informing the jury about the large number of persons who had taken Accutane before it was prescribed to plaintiff in 1995, and the comparative significance of those figures.

The court ultimately concludes that it was unfair to Roche for the trial court to have precluded such "numbers" counter-proof and that the court abused its discretion on this evidentiary issue. Had Roche been allowed to present the statistics showing five million Accutane users and other related counter-proofs, the jury would have had a fuller and more balanced picture of the data bearing upon the company's actions in changing its label. "Principles of completeness and fairness warranted the presentation of this contextual information to the fact-finder."

 

 

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The 11th Circuit has affirmed a trial court’s exclusion of key expert causation proof in a suit against the manufacturer of Remicade, finding the expert evidence was not adequately supported by scientific studies or literature. Goldstein v. Centocor Inc., 2009 WL 275322 (11th Cir. 2/05/09).

Plaintiff-appellant contended that the prescription medication Remicade caused his pulmonary fibrosis, requiring a bilateral lung replacement. The trial court excluded plaintiff’s expert testimony on general causation, pursuant to Fed.R.Evid. 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). The court of appeals reviews a trial court's Daubert rulings under an abuse of discretion standard. McClain v. Metabolife Intern'l, Inc., 401 F.3d 1233, 1238 (11th Cir.2005).

Plaintiff’s expert did not rely on any epidemiological studies that connect Remicade with pulmonary fibrosis. This is not necessarily fatal, said the 11th Circuit, but it makes a plaintiff’s task to show general causation more difficult. See Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1198 (11th Cir.2002).

In the absence of epidemiological studies, the expert reviewed four sources to make his general causation assessment. The first category, plaintiff's lung and bowel pathology reports, was not relevant to general causation; its focus on the plaintiff made it relevant to specific causation. See McClain, 401 F.3d at 1239 (“General causation is concerned with whether an agent increases the incidence of disease in a group and not whether the agent caused any given individual's disease.”). The second category, MedWatch case reports submitted by doctors who observed possible reactions to Remicade, have a limited weight. Such reports are made without medical controls or scientific assessment, and while they may support other proof of causation, alone they cannot prove causation. Id. at 1199. (putting aside an expert’s reliance on such reports, they are hearsay and do not fall within any of the exceptions to the hearsay rule; also, the prejudicial effect of these reports outweighs their probative value.)

The third category, a review of medical textbooks, revealed no relevant general causation information, only extended analogies. The fourth category, a review of abstracts of four articles linking Remicade with pulmonary fibrosis, is relevant to general causation but provided only very limited information.

A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. General Elec. Co. v. Joiner, 522 U.S. 136, 146, (1997). The district court did so here, and the 11th Circuit found no abuse of discretion in its determination.
 

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Two recent federal cases illustrate important Daubert principles in the medical device context.

In Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09), the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product.  In contrast, in Jaske v. Zimmer Inc., 2009 WL 150946 (N.D. Ill., 1/20/09), the Northern District of Illinois reversed an earlier decision to exclude two expert witnesses for the plaintiff. On a motion for reconsideration, the court ruled that plaintiff can present testimony from two experts in polymer science as to why his prosthetic knee, manufactured by defendant Zimmer, allegedly failed.

Fuesting alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

Under Rule 702 and the Daubert standard, expert testimony must be both relevant and reliable. The district court must act as a “gatekeeper” making a preliminary assessment of the reasoning or methodology underlying the testimony. Daubert factors include: (1) whether the scientific theory can be and has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the theory's known or potential rate of error when applied; and (4) whether the technique or theory has been ‘generally accepted’ in the scientific community. 

On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. To bridge the gap, rhe expert needed to show, with respect to Fuesting's implant in particular, what quantum of each variable is required to set the alleged causal chain reaction in motion. That is, the causation opinion must be specific to the plaintiff, and each chain in the causal link must be supported by adequate science. Gaps included how much radiation does it take to cause oxidation, and to what degree? How much oxidation must occur to render polyethylene more susceptible to delamination? And once polyethylene becomes more susceptible to delamination, how then does oxidation affect delamination? Are all forms of polyethylene, including that used by Zimmer (which the company claims to be oxidation-resistant), susceptible to delamination? What effect, if any, does implantation into the human body have on the rate of oxidation?

The expert testimony as to defect also failed. Oxidation can occur in implants sterilized by any method. However, plaintiff’s expert did not know of any peer-reviewed studies or articles that compared oxidation rates for implants sterilized by GIA to those sterilized through other methods. While the prosthesis showed significant oxidation when it was tested, that testing occurred more than six years after the knee joint was explanted, and plaintiff failed to account for oxidation that may have occurred after the joint was removed.

Having granted Zimmer's motion to exclude the expert testimony, the court had no alternative but to also grant the company's motion for summary judgment.

In Jaske, Plaintiff had his left knee replaced with a prosthesis to alleviate recurring pain. When the prosthesis allegedly failed, he filed suit against the manufacturer. Last year, the district court granted defendant's motion to exclude the testimony of two of plaintiff's experts in polymer science, who, while qualified to offer some opinions, used a test as the basis for their opinions that was not reliable. (A Fourier Transform Infrared Spectroscopy (“FTIR”)). Plaintiff moved for reconsideration.

The court had determined that the proffered testimony was unreliable for two reasons. First, the results of the FTIR test may have been skewed because lipids and proteins from Jaske's body had permeated the product. And, second, even if the test results were accurate, they did not determine when the oxidation took place. Originally, plaintiff offered nothing but a naked expert opinion on this issue. On reconsideration, plaintiff presented new evidence that any biological material present would absorb the infrared spectrum used in the FTIR at a different frequency than oxidized polyethylene, and that the FTIR is the accepted standard of the American Society of Testing and Manufacturing for this purpose.

The court had also originally noted that the FTIR test measured the amount of oxidation present in the prosthesis only at the time the test was conducted. It did not provide historical readings. Plaintiff clarified that his experts developed their theory independent of the test results. Instead of relying on the FTIR results to arrive at their theory, they said, the FTIR simply provided support for it. In other words, the results of the FTIR are merely consistent with the theory. The theory that gamma irradiation sterilization in air causes oxidation has been recognized, asserted plaintiff, for some time in the scientific community.

This second case demonstrates one of the potential dangers of the Daubert challenge: if the court is going to give plaintiff a second bite of the apple, the Daubert motion turns into a roadmap for the plaintiff on what holes to fix.  See our post on reasons why you might not file a credible motion.
 

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An interesting little case: a personal injury class gets certified, defendant stipulates to key elements of liability, and defendant wins the trial anyway.

The Louisiana appeals court has affirmed a lower court ruling in favor of E.I. du Pont de Nemours & Co. in a case involving an accidental chemical release at a DuPont facility in Reserve, Louisiana. See Johnson v. E.I. du Pont de Nemours & Co., 2009 WL 91481 (La.App. 5 Cir. 2009).

The named plaintiffs filed a class action petition in 1994, alleging they were injured by the release of toxic chemicals at a DuPont facility after a small chemical accident. The trial court certified the matter as a class action in September, 1997. DuPont stipulated to certain elements of liability in 2000, but reserved their right to trial on damages, causation, the nature of the chemicals released, and the area affected. The plaintiffs apparently agreed to waive all claims for punitive damages in the stipulation.

At a bench trial in 2006, the trial court ruled in favor of DuPont, finding that the plaintiffs had not met their burden on causation. The plaintiffs failed to show exposure to harmful levels of chemicals, and to show that plaintiffs' injuries were caused by the chemical explosion.

The Louisiana Court of Appeal has agreed, saying that plaintiffs' sole medical expert did not establish that the plaintiffs' injuries— nausea, eye and skin irritation, coughing, and headaches—were caused by the chemical release. Plaintiff’s expert treated the plaintiffs at the time of their alleged injury and had diagnosed them with “fume inhalation,” but based entirely on the history provided by the plaintiffs.

The court also rejected plaintiffs’ challenge to the testimony of a DuPont witness about plaintiffs' alleged injuries, because such testimony was about his observations of plaintiffs' alleged injuries, not testimony as a medical expert. Although he was closer to the incident than plaintiffs, he did not hear any explosion, did not smell anything, and did not experience nausea, headaches, eye irritation, or other symptoms.
 

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The Ninth Circuit has affirmed that the trial court did not err in granting summary judgment for defendant Merck under California's learned intermediary doctrine in a failure to warn case. Latiolais v. Merck & Company, Inc., 2008 WL 5157705 (9th Cir. 2008).

Latiolais appealed the district court's grant of summary judgment on her claim that Merck failed to adequately warn, as a result of inadequate testing, of claimed suicide risks associated with the cholesterol-lowering medication Zocor.

Under California's learned intermediary doctrine, a prescription drug manufacturer's duty to warn runs to the physician. A product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the prescribing physician's conduct. See Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir.2004).

Here, there was no genuine issue of material fact as to causation made out by the prescriber’s deposition testimony. It indicated that the drug inserts accompanying Zocor did not play a role in his decision to prescribe that medication. Furthermore, Dr. Oppenheim was not equivocal regarding whether he would have prescribed Zocor in light of a supposed warning of suicide risk associated with Zocor. Such a warning was deemed “hypothetical” by the court, and, in any event, could come into play only after one makes several assumptions on issues that include whether Merck was obligated to issue a suicide risk warning for Zocor, whether Dr. Oppenheim would have read or heeded such a warning, and what information Mr. Davis would have disclosed to Dr. Oppenheim with respect to his mental state. Such speculation did not create an issue of fact.

 

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The Third Circuit recently upheld a judgment for the U.S. following a bench trial, in a suit by a couple who alleged that contaminated polio vaccine caused the husband's brain cancer. Gannon v. United States, 2008 WL 4151665 (3d Cir. 2008).

Plaintiffs alleged that an oral polio vaccine (OPV) received between 1973 and 1976 was contaminated with SV40, a simian virus found in both monkeys and humans. The Gannons claimed that the government was negligent in failing to prevent the manufacturer from making the OPV available to the public, and as a result, the contaminated vaccine caused Mr. Gannon to develop a form of brain cancer. Gannon and his wife filed an administrative claim against the government under the Federal Tort Claims Act and, later, a suit in the Eastern District of Pennsylvania.

The Court, for the convenience of the witnesses and to prevent recalling the experts later in the trial, decided to combine a Daubert hearing with the expert bench trial testimony on the issue of causation. Thus, the trial began with the Daubert examination of plaintiffs' expert, Dr. Adi Gazdar, who presented his full testimony on the issue of causation. He testified that SV40 plays a causal role in this type of cancer.

The district court denied the Daubert motion, but rejected the testimony as insufficient on the issue of general causation.  Safe approach in a bench trial, here it and then decide. The ruling came pursuant to Rule 52(c), which states that a trial court can enter judgment after hearing evidence on only one issue, provided the party against whom judgment has been entered is fully heard. (The appeals court rejected the plaintiffs' argument that they were not fully heard on causation: The plaintiffs asserted they would have called two other witnesses to testify, but those witnesses were not relevant to causation because their testimony would principally address the issue of contamination.) Interestingly, the United States did not offer an alternate source of causation but merely asserted that SV40 did not cause brain tumors and offered expert testimony to that effect.

Although Dr. Gazdar testified that it was his opinion that to a reasonable degree of medical certainty SV40 plays a causal role in the formation of medulloblastomas, the Court decided that the plaintiffs had not met their burden of proof on causation. Specifically, the Court found that Dr. Gazdar's testimony failed to satisfy the “Bradford Hill” criteria. The Bradford Hill criteria are broadly accepted criteria for evaluating general causation based on epidemiology;  they are: (1) Strength of Association, (2) Consistency, (3) Specificity, (4) Temporality, (5) Biologic Gradient, (6) Plausibility, (7) Coherence, (8) Experimental Evidence, and (9) Analogy.

On appeal, the Third Circuit observed that causation is an essential part of the plaintiffs' negligence claim. Based upon its thorough consideration of the record evidence, the Third Circuit could not say that the district court clearly erred in its findings of fact or that it erred in concluding that the Gannons had not met their burden of proof on the issue of causation.
 

• The Court relied upon the fact that all three defense experts used established scientific frameworks and cited both biological and epidemiological evidence. Each of those experts opined that the evidence did not support the conclusion that SV40 causes human cancer.
• The Court relied upon a 2003 Institute of Medicine report, which concluded that “ ‘the evidence is inadequate to accept or reject a causal relationship’ “ between SV40 and cancer.
• Dr. Gazdar, the plaintiffs' expert, testified that he agreed that current epidemiological evidence does not support the conclusion that SV40 causes brain cancer.
• He relied upon testing on rodents, which defense experts stated were not a good brain model for humans; even Dr. Gazdar admitted the results could not necessarily be extrapolated to humans.

Most importantly, the court considered each of the nine Bradford Hill criteria for causation and found that Dr. Gazdar's opinion did not meet the criteria.  The general causation opinion was thus rejected on the merits.
 

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The 8th Circuit has upheld the trial court’s decision that a plaintiff who alleged she was injured by drinking water from a bottle filled with freon did not have adequate and valid expert evidence of causation. Bland v. Verizon Wireless, 2008 WL 3474178 (8th Cir. August 14, 2008).

Plaintiff alleged that she inadvertently left her water bottle behind in a store, and an employee of defendant sprayed compressed air into her water bottle “as a joke,” believing the water bottle belonged to a fellow employee. At home, plaintiff opened the bottle which “made a-kind of pressurized noise.” She took a drink, then decided to smell the contents, taking a big whiff which made her cough. She then allegedly took another drink.

Plaintiff later reported to her doctor that after drinking from the bottle she coughed, which persisted for nearly an hour. She also described a “sore sensation in her throat” and for the next few days a “raspy sensation in her lungs.” Plaintiff alleged she developed a headache which persisted for about two weeks. Later testing at the University of Iowa Lab determined the bottle contained 820 parts per million (ppm) (.08%) of difluoroethane, a freon compound.

Plaintiff was later seen by a Dr. Sprince, complaining of shortness of breath when running. Her lung function test results were basically normal. Dr. Sprince eventually diagnosed her as having “exercise-induced asthma.” Dr. Sprince later theorized that “[b]ased on the initial clinical findings, [a] strong temporal relationship between the inhalation of freon and the occurrence of respiratory symptoms, and the subsequent response to pre-exercise treatment with inhaled bronchodilator” that plaintiff's exercise-induced asthma was caused by the inhalation of freon.

Plaintiff sought to use the testimony of this treating physician, Dr. Sprince, to establish a causal link between inhalation of freon and the alleged exercise-induced asthma. The district court excluded Dr. Sprince's testimony because Dr. Sprince's proffered testimony as to causation did not satisfy the standards for admission of expert scientific testimony under Daubert.

The 8th Circuit affirmed, noting first that a treating physician's expert opinion on causation is subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for purposes of litigation.

The first problem with Dr. Sprince's causation testimony was that she failed scientifically to eliminate other possible causes as part of her differential diagnosis. In particular, her own testimony acknowledged the cause of exercise-induced asthma in the majority of cases is unknown. Where the cause of the condition is unknown in the majority of cases, an expert cannot properly conclude, based upon a simple differential diagnosis, that exposure, here to freon, was the most probable cause of the injury. As a practical matter, Dr. Sprince's causation opinion could not possibly be based upon a reasonable degree of medical certainty. Where the majority of cases of exercise-induced asthma have no known cause, and where Dr. Sprince failed to do an investigation and analysis of plaintiff's home or other environments in search of other possible causes, the district court did not abuse its discretion in determining Dr. Sprince's differential diagnosis did not satisfy Daubert.

Second, plaintiff’s expert did not know what amount of exposure to freon causes, or involves an appreciable risk of causing, asthma, and had no good grounds for determining whether plaintiff  was exposed to a sufficient dose to have caused her asthma. Dr. Sprince could not determine or estimate the amount of freon plaintiff was actually or probably exposed to. The expert could not extrapolate from the existing data because the gap between the data identified (exposure facts) and Dr. Sprince's proffered opinion was simply too great an analytical gap to support admissibility. Critical to a determination of causation is characterizing exposure. In a toxic tort case, the magnitude or concentration of an exposure should be estimated and the temporal aspects of the exposure should be determined --whether the exposure was short-term and lasted a few minutes, days, weeks, or months, or was long-term and lasted for years. Dr. Sprince lacked knowledge regarding what level of exposure to freon constitutes an appreciable risk of causing asthma and the specific concentration and degree of exposure to the freon. Similarly, plaintiff’s expert did not offer as evidence any personal experience with treating other patients following a similar exposure, admitting she had no such experience.

Finally, the expert’s heavy reliance on temporal proximity, without more, was insufficient to establish causation. In the absence of an established scientific connection between exposure and illness, or compelling circumstances, the temporal connection between exposure to chemicals and an onset of symptoms, standing alone, is entitled to little weight in determining causation. See Moore v. Ashland Chem., Inc., 151 F.3d 269, 278 (5th Cir.1998). It is not always irrelevant, said the court. The temporal relationship often will be one of several factors, and the weight to be given to the temporal relationship will differ depending on the strength of that relationship. But in this case, the district court properly discounted all the other factors supporting Dr. Sprince's opinion leaving only temporal proximity to support Dr. Sprince's causation opinion. And that was not enough, especially when plaintiff did not make an appointment with a doctor until two to three weeks after the incident.
 

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The federal judge overseeing the MDL for Celebrex and Bextra has sided with defendants' view that a “Lone Pine” order is appropriate for managing the claims of the remaining, non-settling plaintiffs. In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No. M:05-cv-01699 (N.D. Cal.) (Pretrial Order No. 29, Aug. 1, 2008).

“Lone Pine” orders take their name from a 1986 New Jersey Superior Court case involving toxic tort claims; they refer to case management orders that require the plaintiffs to make a showing regarding causation, injury, and/or damages to demonstrate, typically at an early stage, some minimal level of evidentiary support for the key components of their claims which will be in dispute.

Defendants had first asked the court for a Lone Pine order in late June, arguing that each plaintiff should be required to submit a case-specific expert report on the issue of medical causation. The motion also sought to compel each plaintiff to turn over medical records that documented an injury, prescription records that showed medication history and dosages prescribed, and proof of dosage in relation to the confirmed injury. The benefits to the court of requiring plaintiffs to supply this information is that the parties would not have to engage in protracted discovery in thousands of cases just to see whether each one has some threshold evidence of medical causation. The production of such basic and threshold evidence was argued to be simply a part of a good-faith investigation that should precede the filing of a lawsuit.

Plaintiffs argued that the proposed order would be overly burdensome, was not needed, and was a retaliation for not settling. Plaintiffs also suggested that Lone Pine orders are generally issued as sanctions against plaintiffs who provide no other information to the defendants about the filed case. But the court disagreed with plaintiffs.

The court appeared mindful of what had happened on the eve of the first trial in the MDL, as the scheduled cases began to disappear. Thus, under the Order, plaintiffs will have 45 days to have a physician or other medical expert offer a case-specific expert report for each plaintiff including a review of the plaintiffs’ medical records, the dates they used Celebrex and/or Bextra, and whether they experienced a myocardial infarction, ischemic stroke, sudden death, or any other injury while taking the medications.

The court observed that all of this information should be already readily available to plaintiffs through the plaintiff fact sheets process. The court apparently expects that cases in which plaintiffs cannot show drug usage, injury, or causation, will drop from the docket before being scheduled for trial. Without threshold proof of Celebrex or Bextra usage, a compensable injury, and a link between usage and an injury, there could have been no good-faith basis for a lawsuit in the first place.

Moreover, requiring plaintiffs to identify basic information about injuries and causation is not unreasonable given the costs that mass tort claims have on the legal system, and on defendants. Lone Pine orders allow courts to weed out the frivolous suits where there is insufficient exposure, or no sufficient scientific connection between injury and exposure. Accordingly, Lone Pine orders can be effective when entered early in the game. Early disposal of frivolous claims allows the parties to focus their attention on the serious cases. Ideally, the order will actually phase discovery, and motions practice as well, with the Lone Pine issues pushed up front.

With their focus on causation, Lone Pine orders are especially useful when multiple plaintiffs claim a variety of different injuries, allege injuries incurred over a long period of time, and/or when plaintiffs allege diverse exposures.

 

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The Indiana Court of Appeals has ruled that the trial court correctly granted summary judgment to DaimlerChrysler Corporation in two separate toxic exposure cases involving visiting workers at the company's New Castle, Ind., facility. See Coomer v. DaimlerChrysler Corp., Ind. Ct. App., No. 33A01-0712-CV-582, 7/11/08); and Gregory v. DaimlerChrysler, Ind. Ct. App., No. 33A01-0712-CV-581, 7/11/08). In affirming the rulings of the Indiana Circuit Court, the Court of Appeals held that the expert in both cases, Dr. George Rogers, did not adequately specify the level, concentration, or duration of plaintiffs' alleged exposure to unspecified chemicals. Accordingly, the workers failed to present sufficient expert evidence to establish causation.

Plaintiffs Matthew Gregory and Darrin Coomer were employees of Smoot Construction, and alleged they were doing work at the DaimlerChrysler New Castle Machining and Forging Facility. Three months after starting work, Coomer experienced a seizure while playing video games at home. Coomer’s treating neurologist diagnosed him with juvenile myoclonic epilepsy (JME), the “most common genetic or inherited form of epilepsy . . . [which is] thought to be caused by an abnormal gene on the short arm of chromosome 6.”  About 7 months after he began working, plaintiff Gregory, who was twenty-seven years old, allegedly experienced his first seizure after returning home from work. An IME showed he suffered from idiopathic seizure disorder.

Gregory and Coomer, in two separately filed complaints against Daimler/Chrysler Corp., Methadone Corp., and NC-M Chassis Systems LLC, alleged that the seizures were caused by their exposure to allegedly contaminated soil, water, and toxins at the facility. Defendant moved for summary judgment on the issue of causation. In response, plaintiffs presented their own expert, a professor of pediatrics and pharmacology/toxicology, who concluded that Coomer and Gregory were "clearly'' exposed to a "complex mixture of potentially toxic materials.''  The expert opined that many of the materials identified on the site, including some solvents and metals, can cause seizures with excess exposure. “I think it is reasonable to conclude that [plaintiffs'] occupational exposure to this mix of toxic chemicals may have contributed to the onset" of their disorders.

The Court of Appeals noted that an expert’s opinion is insufficient to establish causation when it is based only upon a temporal relationship between an event and a subsequent medical condition. In particular, when an expert witness testifies in a chemical exposure case that the exposure has caused a particular condition because the plaintiff was exposed and later experienced symptoms, without having analyzed the level, concentration or duration of the exposure to the chemicals in question, and without sufficiently accounting for the possibility of alternative causes, the expert’s opinion is insufficient to establish causation. Dr. Rodgers did not identify which chemicals plaintiffs were allegedly exposed to. He did not specify the level, concentration, or duration of their alleged exposure to the unspecified chemicals. Instead, Dr. Rodgers made vague assertions regarding plaintiffs’ alleged exposure to a mixture of “potentially toxic materials.” MassTortDefense has posted about the importance of evidence of dose here.

In toxic tort cases in Indiana, one way an expert may approach the causation issue is by way of a “differential diagnosis,”  testing to rule out alternative causes of the plaintiff’s ailments. But the expert never addressed the independent medical examiner’s conclusion that Gregory had an idiopathic seizure disorder, and he also failed to address the possible impact of a skull fracture Gregory sustained in an accident as a child. The expert failed to respond to the fact that Coomer’s own physician concluded that Coomer’s seizures were the result of a genetic form of epilepsy.

In sum, because Dr. Rodgers did not identify specific chemicals, analyze the level, concentration, or duration of Coomer’s alleged exposure, or account for the possibility of alternative causes, his opinion was insufficient to establish causation.

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Judge Stewart Dalzell of the U.S. District Court for the Eastern District of Pennsylvania granted summary judgment to Novartis Pharmaceuticals Corp. in a suit that alleged the company's eczema drug, Elidel, caused plaintiff’s lymphoma. Perry v. Novartis Pharmaceuticals Corp., 2008 WL 2683047 (E.D. Pa. July 09, 2008). Although we typically focus on appellate opinions at MassTortDefense, this well-reasoned opinion is worth a look.

The Perrys filed suit against Novartis in October, 2005 alleging that the company had failed to warn about the risks of Elidel. Their son allegedly developed eczema shortly after his birth, and a pediatrician prescribed Elidel in 2003. He was diagnosed with lymphoma a few months later.

Defendant challenged plaintiffs’ expert evidence on causation. As is frequently the case, if plaintiffs’ expert testimony does not meet the Daubert standard, summary judgment for failure of proof on causation follows. The court noted that the core issue that the jury would have to address in this case is whether Perry's exposure to Elidel was a substantial cause of his disease. Courts in toxic tort cases often separate the causation inquiry into general causation (whether the substance is capable of causing the observed harm in general), and specific causation (whether the substance actually caused the harm a particular individual suffered). Plaintiffs' experts did the same, each drawing conclusions about both the capacity of the drug to cause Non-Hodgkins Lymphoma (NHL) in humans and its particular effect in Perry's case.

An expert's journey from general causation to specific causation need not be just a two-step process. So long as, taken together, the expert is able to draw a chain of scientifically reliable causal links that meets plaintiff's requirements under the substantive tort law, the evidence is admissible, and it will be left to the jury to establish the relative credibility of the parties' competing experts. Where, however, the expert reports leave wide, unexplained gaps in the causal chain, the evidence is not helpful to the trier of fact and must be excluded. In Daubert terms, just as there is no fit where there is simply too great an analytical gap between the data and the opinion offered, see Soldo v. Sandoz Pharms. Corp., 244 F.Supp.2d 434, 527 (W.D. Pa. 2003) (quoting General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997)), “there is also no fit when there is too great an analytical gap between an expert's general causation conclusion and the specific causation question the jury must ultimately answer,” said the court.

One problematic gap concerned epidemiology. Although it has not been held by the Third Circuit that epidemiological studies are an indispensable element in the presentation of a prima facie drug product liability case, Lanzilotti v. Merrell Dow Pharms. Inc., 1986 WL 7832 (E.D.Pa. July 10, 1986) at *2, epidemiology is the primary generally accepted methodology for demonstrating a causal relation between a chemical compound and a set of symptoms or a disease. See Soldo, 244 F.Supp. at 532 (quoting Conde v. Velsicol Chem. Corp., 804 F.Supp. 972, 1025-26 (S.D. Ohio 1992)). Thus, while an expert's conclusions reached on the basis of other studies could perhaps be sufficiently reliable where no epidemiological studies have been conducted, no reliable scientific approach can simply ignore the epidemiology that does exist.

A second issue concerned the state of the art. The court made clear that the non-existence of good data does not allow expert witnesses to speculate or base their conclusions on inadequate supporting science. In cases where no adequate study shows the link between a substance and a disease, expert testimony will generally be inadmissible, even if there are hints in the data that some link might exist. This may mean that early victims of toxic torts are left without redress because they are unable to prove their cases with the scientific data that currently exists. While this is a “regrettable result in those individual cases,” said the court, it is an unavoidable reality of the structure of our legal system and is necessary to protect the interests of defendants who might otherwise be subject to crippling verdicts on the basis of slender scientific evidence. As the Seventh Circuit has noted, the courtroom is not the place for scientific guesswork, even of the inspired sort. “Law lags science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996).

Focusing next on specific causation, the court noted that each plaintiff expert engaged in a differential diagnosis. MassTortDefense notes the increasing use, and misuse, by plaintiffs of so-called differential diagnosis. The process by which a doctor views symptoms and test results to rule out possible alternative diseases in the diagnostic process to arrive at a conclusion concerning what ails the patient, has morphed into a process by which experts can tell the jury what caused the condition of the plaintiff – a far different thing. Here, after finding that no other risk factor for NHL was present, the experts concluded that because the drug was the only risk factor present and because the disease is rare, plaintiff’s treatment with Elidel was a substantial factor in his presentation with the disease. However, in order to result in an admissible conclusion, a differential diagnosis should reliably rule out reasonable alternative causes of the alleged harm including idiopathic causes. Soldo, 244 F.Supp.2d at 567. Admissible expert testimony need not rule out all alternative causes, but where a defendant points to a plausible alternative cause and the doctor offers no explanation for why he or she has concluded that it was not the sole cause, that doctor's methodology is unreliable.

Here, the differential diagnoses by plaintiff experts failed to exclude the likelihood that Perry's lymphoma had no known cause. Most NHL cases are idiopathic, having no known cause. Courts have excluded experts' differential diagnoses where they failed to adequately account for the likelihood that the disease was caused by an unknown factor. Doe v. Ortho-Clinical Diagnostics, Inc., 440 F.Supp.2d 465, 478 (M.D.N.C. 2006); Whiting v. Boston Edison Co., 891 F.Supp. 12 (D. Mass.1995). This is not to say, cautioned the court, that where most diagnoses of a disease are idiopathic it is impossible to prove specific causation. But in those cases, analysis beyond a differential diagnosis will likely be required.

Plaintiffs' experts' general causation conclusions were primarily based on animal studies and their failure to satisfactorily address epidemiology (and the gap related to dosage levels in the studies vs. plaintiff’s exposure) undermined the usefulness of those conclusions to a jury. Since plaintiffs' experts failed to form a scientifically grounded chain of inference between their general causation finding and their specific causation finding, their opinions were excluded. Summary judgment followed.

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The MDL transferee court has denied the summary judgment motion of the manufacturer of an allegedly toxic ingredient in Stand 'n Seal grout sealer. In re Stand 'N Seal Products Liability Litigation, 2008 WL 2622793 (N.D.Ga.), No. 1:07-MDL-01804 (6/26/08). The motion focused on the apparent inability of 67 plaintiffs to demonstrate exposure to the product, which in turn meant they could not show causation. Proof of exposure is a recurring theme in toxic tort litigation, and MassTortDefense has blogged on it here.

Stand 'n Seal originally contained an ingredient called Zonyl, according to the court’s recitation. The manufacturers substituted one ingredient, Innovative Chemical Technologies, Inc.’s product, Flexipel S-22WS, for Zonyl in 2005; some users then complained of respiratory problems, leading to a recall. Numerous personal injury actions were consolidated in a multidistrict litigation overseen by Judge Thomas W. Thrash of the U.S. District Court for the Northern District of Georgia.

ICT’s motion sought to dismiss the group of 67 plaintiffs on the basis that they could not prove their exposure to the Stand 'n Seal product with Flexipel. Generally, plaintiffs must show that the product that allegedly caused their injuries was, in fact, manufactured or supplied by the defendant in this case.

According to Judge Thrash, some of these plaintiffs lacked a can identification number – typical product identification evidence – because they threw away their cans of Stand 'n Seal. Others, he said, retain a can that contains Zonyl, but claim they used more than one can of Stand 'n Seal. The court found that under applicable Georgia law such plaintiffs could use circumstantial evidence to meet their burden of proving exposure to the ingredient. In an interesting turn of phrase, the court stated that ICT had not presented clear and positive evidence that all of the Plaintiffs used cans containing only Zonyl. Under the summary judgment standard, defendant as the moving party did not have that burden. Rather, defendant needed to show there was genuine issue of fact, and plaintiffs’ lack of relevant evidence was certainly part of that showing.

The court concluded that the plaintiffs subject to this motion should be allowed to present individualized circumstantial evidence that they were exposed to cans containing Flexipel. “Such evidence could include testimony concerning the smell of the product. It could include testimony as to the date and place of the purchase of the product.” In a typical case, the plaintiff would have had to make such a showing to defeat summary judgment. But here, in the MDL. the timing of summary judgment motions can be atypical. Accordingly, the court held that the presentation of such individualized evidence by the plaintiffs could occur following remand to the transferor courts or before bellwether trials in this MDL court.

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Typically, MassTortDefense will post about significant opinions issued on product liability issues. A recent decision, without opinion, by the California Supreme Court is worth a mention. Just recently, the court declined to review the intermediate appellate court’s affirmance of a $3.9 million asbestos verdict. It thus left standing the appellate court’s view on the important issue whether so-called de minimis exposures are sufficient to satisfy the substantial factor test. Norris v. Crane Co., 2008 WL 638361 (Cal.App. 2d Dist. 2008). The California rule raises significant issues for asbestos and potentially other toxic tort defendants, and stands in contrast to the better view in many other jurisdictions.

Background
The plaintiff, former Naval worker Joseph Norris, had been awarded $3.9 million by the jury, 50% liability assigned to defendant Crane Co. The company appealed the verdict, arguing that plaintiff failed to present substantial evidence linking asbestos in the Crane valves to the decedent's mesothelioma. The Second District Court of Appeal disagreed, and affirmed the verdict. On June 25th, the state Supreme Court denied the petition for review.

The court of appeals found sufficient the evidence that the U.S. Navy purchased several types of Crane Co. valves, and that the defendant was aware that parts of these valves would have to be replaced at some point. Norris was allegedly "within a few feet" of other workers who were grinding Crane valves and replacing gaskets on the product. The jury could infer that this process released fibers that contributed to the dust in the air plaintiff breathed as he waited. Also, Norris slept in quarters with two small Crane valves, and when the valves were overhauled, dust was released and was not cleaned up.

Expert testimony was offered to the effect that every exposure to asbestos fibers increased the total dose in his lung that led to the development of his disease. Each dose added more fibers that could stay in the lung. There was substantial evidence plaintiff’s “exposure to asbestos from materials in Crane valves increased his risk of developing mesothelioma and, therefore, was a substantial factor in causing his injury." Thus, the plaintiff successfully proved a causal link between the Crane Co. valves and Norris' mesothelioma, said the court.

 
What’s Wrong With This Picture?
Tort law requires that the allegedly defective product have caused the injury. In the toxic substance context, plaintiff must have been exposed to defendant’s product, and exposed to a sufficient dose that is capable of causing the disease, and actually did cause the disease in plaintiff. Dose refers to the amount of chemical that enters the body, and is arguably the single most important factor to consider in evaluating whether an alleged exposure caused a specific adverse effect. Indeed, a founding principle of toxicology is that the “dose makes the poison.”

The problem with the California opinion is that the plaintiff had improperly been allowed to submit evidence of "any exposure," which rule would allow exposed persons to sue thousands of new defendants whose supposed “contribution” to the disease is trivial at best, and certainly far below the type of doses actually known to cause or increase the risk of disease in any meaningful way.

It is common for plaintiffs to submit expert affidavits attesting that any exposure to asbestos, no matter how minimal, is a substantial contributing factor in asbestos disease. Such generalized opinions ought not suffice to create a jury question in a case where exposure to the defendant's product is de minimis, particularly in the absence of evidence excluding other possible sources of exposure (or in the face of evidence of substantial exposure from other sources). See generally Borg-Warner Corp. v. Flores, 232 S.W.3d 765 (Tex. 2007)(rejecting view that if plaintiff can present any evidence that a company's asbestos-containing product was at the workplace while plaintiff was at the workplace, jury question has been established as to whether that product proximately caused plaintiff's disease).

A far different take on this issue is seen in other jurisdictions. The Pennsylvania Supreme Court, for example, reached conclusions contrary to the California appellate court's ruling in Gregg v. V.J. Auto Parts Inc., 943 A.2d 216, 226-227 (2007). That court concluded that it is not a viable solution to indulge in a fiction that each and every exposure to asbestos, no matter how minimal in relation to other exposures, raises a fact issue concerning substantial-factor causation. The result of that approach would be to subject defendants to full joint-and-several liability for injuries and fatalities in the absence of any reasonably developed scientific reasoning that would support the conclusion that the product sold by the defendant was a substantial factor in causing the harm.

Other courts will thus apply the frequency, regularity, proximity factors in asbestos litigation, Lohrmann v. Pittsburgh Corning Corp., 782 F.2d 1156 (4th Cir.1986), if not as a rigid standard with an absolute threshold necessary to support liability, then at least as an aid in distinguishing cases in which the plaintiff can adduce evidence that there is a sufficiently significant likelihood that the defendant's product caused his harm, from those in which such likelihood is absent on account of only casual or minimal exposure to the defendant's product. The California court missed this opportunity.

(Any readers interested in a copy of the Amicus brief on this issue in the court of appeals can email me and I will send you a copy.)

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In another in a series of rulings on expert issues, the MDL court in the MTBE litigation has excluded parts of the proffered testimony of a plaintiffs' expert, while permitting others. Judge Shira Scheindlin of the U.S. District Court for the Southern District of New York issued an order permitting Dr. Myron Mehlman to testify that MTBE causes adducts to form on DNA and is a probable human carcinogen. Judge Scheindlin found that the plaintiffs proved that this part of his testimony is the product of reliable principles and methods. However, he may not testify that plaintiffs have a reasonable basis for their alleged fear of cancer.

The suits in the MDL generally allege that MTBE, which was added to gasoline at varying levels between 1979 and 2007, has leaked from underground storage tanks and contaminated groundwater. The defendants in this particular case within the MDL are the owners of two gas stations and their suppliers who allegedly contaminated 50 private water wells in the town of Fort Montgomery, N.Y. See In re: Methyl Tertiary Butyl Ether Products Liability Litigation, case number 1:00-cv-01898.

Defendants argued that Mehlman's opinion should be excluded because his methods are not generally accepted in the scientific community and because he hadn't applied those methods reliably to the facts. The absence of general acceptance in the community remains a relevant factor under Daubert.

The court noted that if a method hasn't gained general acceptance, it may be properly viewed with skepticism. But “viewing a method with skepticism is a far cry from the bright-line rule of exclusion.” The expert relied on the peer reviewed MTBE-DNA Adducts study, as well as numerous studies allegedly showing exposure to MTBE has led to cancer in animals. The court held that a vigorous cross examination by defendants at trial was the proper way to handle the issues concerning the expert’s methodology as well as its underlying assumptions. “After evaluating the evidence from both sides, the jury may well agree with defendants that MTBE does not cause cancer in humans,” the court noted.

However, the expert cannot testify that specific plaintiffs suffered subcellular damage or have a reasonable fear of cancer because he did not adequately quantify their alleged exposure. While the levels of exposure to toxic substances is sometimes difficult to precisely quantify, this does not excuse Dr. Mehlman from attempting to analyze plaintiffs' exposure levels if he intended to testify that they have a basis for their fear of cancer.

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