Summary Judgment Granted on Product Identification

Sometimes simpler is better.  In product liability litigation nothing is more basic, perhaps, than proof the plaintiff used defendant's product.  Last week, a federal judge granted summary judgment against two plaintiffs' making claims in multi-district litigation over injuries allegedly related to the painkillers Darvocet and Darvon. See In Re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, No. 2:11-md-02226 (E.D. Ky.). The issue was this basic cause in fact element.

Summary judgment is appropriate when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); see Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

Defendant argued that it was entitled to summary judgment because neither plaintiff demonstrated the ingestion of a propoxyphene product manufactured, sold, or distributed by the defendant. In their Amended Complaint, both plaintiffs allege that they ingested propoxyphene products manufactured by Lilly. It is indeed a general principle of products liability law in Texas and Georgia (the applicable rules under choice of law in an MDL) that a plaintiff must allege sufficient facts to allow the reasonable inference that the injury-causing product was sold, manufactured, or distributed by the defendant. Plaintiffs could not dispute that they failed to establish the ingestion of a Lilly  product.

Instead, Lilly presented evidence demonstrating that plaintiffs represented that they intended to pursue only claims that relate to generic drugs; that is, they would seek to hold Lilly liable for
the injuries allegedly arising out of their taking of generic drugs made by someone else.

Such arguments were already rejected by the Court in this MDL.  The Court had previously found unpersuasive the plaintiffs’ argument that a brand-name manufacturer may be held liable under a misrepresentation theory of liability to a plaintiff who ingested generic propoxyphene. The prevailing rule regarding misrepresentation claims against brand-name manufacturers has its origins, noted the Court, in Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), which rejected “the contention that a name brand manufacturer’s statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer’s drug.” Id. at 170.

The majority of courts that have addressed similar claims have followed the Fourth Circuit’s lead. Notably, federal district courts in Texas have repeatedly found that “the Texas Supreme Court would conclude that a brand-name manufacturer does not owe a duty to warn users of the risks related to another manufacturer’s product.” Finnicum v. Wyeth, Inc., 708 F. Supp. 2d 616, 621 (E.D. Tex. 2010); see also Burke v. Wyeth, Inc., No. G-09-82, 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29,
2009).  And, similarly, there can be no recovery under Georgia law, “[u]nless the manufacturer’s defective product can be shown to be the proximate cause of the injuries . . .” Hoffman v. AC&S, Inc., 548 S.E.2d 379, 382 (Ga. Ct. App. 2001) (“To survive summary judgment, [the plaintiff] clearly
needed to present evidence that she was exposed to defendants’ products.”).

Defendant thus sufficiently established that there was no genuine dispute concerning the only
material fact that determined the viability of these plaintiffs’ misrepresentation claims: the identity
of the propoxyphene product ingested.  Therefore, the plaintiffs’ claims failed as a matter of law.

 

 

 

Federal Court Reaffirms Summary Judgment in NORM Case

A federal court recently reaffirmed its prior ruling that a plaintiff's expert failed to establish causation in a suit alleging increased risk of cancer from radioactive scale deposited inside pipes.  See Hill v. Exxon Mobil Corp., No. 11-2786 (E.D. La. 4/30/13).

Plaintiff worked at Tuboscope Vetco International. He alleged he was exposed to radioactive scale
(naturally occuring radioactive materials or "NORM") when he cleaned pipes at work. Hill sued Shell Oil
Co. and Chevron U.S.A. Inc. alleging that these companies sent used pipes containing radioactive scale to Tuboscope to be processed and that he was exposed to the radioactive scale in these pipes.

Earlier this year, the court granted defendants' motion for summary judgment on the grounds that Hill could not prove that he was exposed to radiation attributable to Shell or Chevron.  A fundamental cause in fact issue. His evidence only supported general inferences about radiation at Tuboscope but nothing that showed (1) he actually cleaned used pipe containing scale with NORM or (2) that these pipes were attributable to Shell or Chevron. Hill's evidence required an impermissible chain of speculation to find that he was exposed to radiation in these defendants' pipes.

Plaintiff then moved to alter and amend the summary judgment arguing that the court should amend or reconsider its judgment because of new evidence. The court concluded that the new evidence, largely depositions taken after the motion was pending but before it was ruled on, was not grounds for altering the court's judgment. 
 
Defendants argued that these depositions were not the proper basis for a Rule 59(e) motion to amend because the evidence was available before the judgment issued. See Rosenzweig v. Azurix Corp., 332 F.3d 854, 863-864 (5th Cir. 2003).  Hill deposed these witnesses before the court issued its judgment, and he apparently made no attempt to supplement the record. Accordingly, this evidence was not "newly discovered." See Russ v. Int'l Paper Co., 943 F.2d 589, 593 (5th Cir. 1991).

Even if this evidence was considered, however, the court noted that plaintiff's motion still would fail.  For example, one expert testimony did not establish that Hill was exposed to radioactive scale attributable to Shell and Chevron. No party disputed that new pipe does not have scale, and not all used pipe has scale. Further, not all used pipe with scale contains NORM.  The later expert's calculation of the average radiation dose of pipes that do have scale containing NORM does not provide any proof that Hill was actually exposed to (1) used pipes that have scale containing NORM or (2) that these pipes were attributable to defendants. Accordingly, this kind of "new" testimony was irrelevant to proving Hill's exposure to NORM attributable to Shell and Chevron. The evidence did not show that Hill handled defendants' NORM-containing pipes and did not create an issue of material fact. Motion denied.


 

DES Plaintiff's Reach for Market Share Liability Rejected Again

If asbestos is the grandfather of mass torts, the DES litigation may be the grandmother, with claims continuing today for harm allegedly caused by in utero exposure to diethylstilbestrol decades ago. DES is a drug once prescribed during pregnancy to prevent miscarriages or premature deliveries. In the U.S. an estimated 5 to 10 million persons were exposed to DES from 1938 to 1971, including pregnant women prescribed DES and their children. So we are 40 years out now, with some litigation remaining.

Recently, a federal court in New York held that a DES plaintiff could not meet the product identification requirement under applicable Texas law.  See Bezuidenhout v. Abbott Laboratories,  No. 10-CV-1011(E.D.N.Y., 1/17/13).

Readers may recall that what is often termed "product identification" is part of the cause in fact requirement of every tort claim.  A plaintiff must show that he or she has been injured not just by a type of product but by a product actually made or sold by the defendant.  In the context of DES, product identification may be especially challenging because the plaintiff's exposure may be in utero and the manifestation of the injury may not come for many years after the exposure.  A tiny minority of jurisdictions have flirted with weakening the traditional cause in fact requirement by adopting some form of the "market share" doctrine, under which defendants may be held proportionately liable to a plaintiff who cannot show which manufacturer sold the product that caused the injury, based on that defendant's sales of the product in the "relevant market."  Flawed and unfair, the concept did not gain wide acceptance.

Bezuidenhout was born in 1957 in Texas. While pregnant, her mother allegedly took DES, which was prescribed to her in Texas, according to the amended complaint. Decades later, plaintiff alleged various personal injury and increased risk of future injuries.  Defendants moved for summary judgment, asserting that plaintiff could not identify which manufacturer made the DES her mother took, as required under Texas law.

Plaintiff argued that Texas law was unsettled, that Texas courts had not clearly rejected the market share theory.  The court said it  need not wade too deeply into Bezuidenhout's "pool of hypotheticals", since it rested upon a false premise—that Texas law, as to proof of causation, is unsettled..."It is not.”  Indeed, the court opined that one of the goals of this case was to unsettle it. Texas does not permit recovery under a collective liability or market share theory. The courts in In re Fibreboard Corp., 893 F.2d 706 (5th Cir. 1990), and Cimino v. Raymark Indust., Inc., 151 F.3d 297, 312 (5th Cir. 1998), held that in Texas, it is a fundamental principle of traditional products liability law that the plaintiff must prove that the defendants supplied the product which caused the injury. Plaintiff tried to bootstrap to an "alternate reality," said the court. The Texas Supreme Court has never chosen to adopt market share liability.  

With the market share approach rejected, plaintiff had not proffered sufficient evidence to identify the defendant as a manufacturer of her mother's DES. Her mother's affidavit contradicted her prior sworn deposition testimony about whose product she might have used.  And, at best, a log from the pharmacist indicated that defendant's DES was among the many medications available at the pharmacy, but did not show which DES her mother took. The court thus found plaintiff failed to raise a genuine issue of material fact regarding the identity of the DES manufacturer.

State Supreme Court Clarifies Causation Standard in Asbestos Case

The unique and overwhelming features of the grandfather of all mass torts, asbestos, has created bad law in many jurisdictions, procedurally and substantively.  One important example is the issue of causation, and the questions that arise from an injury possibly associated with multiple  exposures to multiple products over many years.  Last year, we posted about a Pennsylvania decision that rejected the plaintiff position that an expert can opine that any level of exposure to a toxic substance is a substantial contributing factor to a disease that is governed by a dose-response relationship.

Recently, the Virginia Supreme Court adopted a new “multiple sufficient causes” analysis as the standard for Virginia mesothelioma cases involving multiple asbestos exposures. See Ford Motor Co. v. Boomer, No. 120283 (Va. 1/10/13).

Plaintiff was diagnosed with mesothelioma, a malignant cancer of the pleura of the lungs.  He asserted that his job duties required that he observe vehicle inspections wherein mechanics used compressed air to blow out brake debris (dust) to allow for a visual inspection of the vehicle's  brakes. He testified that he observed vehicle inspections in approximately 70 garages a month, for five to six hours a day, ten days each month. He testified that his rotations included supervising inspections at a Ford dealership. He said he also specifically remembered Oldsmobile dealers on his rotation. Plaintiff could not identify the type of brake linings being inspected, but presented some circumstantial evidence as to the likely manufacturer of the brake linings being Bendix.

Plaintiff's experts opined that the exposure to dust from Bendix brakes and brakes in Ford cars were both substantial contributing factors in his mesothelioma. And they opined that the current medical evidence suggests that there is no safe level of chrysotile asbestos exposure above background levels in the ambient air. However, plaintiff also testified that he worked as a pipefitter at the Norfolk Naval Shipyard in the early 1940s. His own work and the work of those immediately around him involved packing sand into pipes so that the pipes could be bent to fit the ships. Defense experts opined that his profile was more consistent with a person who had exposure to amosite asbestos at a shipyard sixty years ago than a person exposed to chrysotile brake products.

The jury found in favor of the plaintiff; the trial court denied Bendix' and Ford's motions to strike the expert testimony and their motions to set aside the verdict or for a new trial. Bendix and Ford timely appealed, including on the issue that the court had instructed the jury to determine whether Ford's or Bendix' negligence was a "substantial contributing factor" to plaintiff's mesothelioma. Defendants challenged the use of the substantial contributing factor language as contrary to prevailing Virginia law as to causation.

The court reviewed the traditional Virginia law of causation, which in most instances requires proof that but for the defendant's actions the plaintiff would not have been injured.The 'but for' test is a useful rule of exclusion in all but one situation, said the court: where two causes concur to bring about an event and either alone would have been sufficient to bring about an identical result.  Thus, state law has long provided a means of holding a defendant liable if his or her negligence is one of multiple concurrent causes which proximately caused an injury, when any of the multiple causes would have each have been a sufficient cause.

Causation in a mesothelioma case, however, observed the court, presents a challenge beyond even that standard concurring negligence instruction. Mesothelioma is virtually a signature disease: it was uncontroverted at trial that in most situations the cause of mesothelioma is exposure to asbestos at some point during an individual's lifetime. The long latency period of the disease, however, makes it exceedingly difficult to pinpoint when the harmful asbestos exposure occurred and, in the presence of multiple exposures, equally difficult to distinguish the causative exposures. Further complicating the issue, said the court, although numerous individuals were exposed to varying levels of asbestos during its widespread industrial use before safety measures became standard, not all persons so exposed developed mesothelioma.  It is not currently known why some are more susceptible than others to developing mesothelioma, or why even comparatively lower levels of exposure may cause mesothelioma in some individuals while others exposed to higher dosages never develop the disease. Thus, in the context of a lifetime of various potential asbestos exposures, designating particular exposures as causative presents courts with a unique  challenge.

Certainly, said the court, if the traditional but-for definition of proximate cause was invoked, the injured party would virtually never be able to recover for damages arising from mesothelioma in the context of multiple exposures, because injured parties would face the difficult if not impossible task of proving that any one single source of exposure, in light of other exposures, was the sole but-for cause of the disease. The lower court thus used a "substantial factor" test.  In the last several decades, with the rise of asbestos-based lawsuits, the "substantial contributing factor" instruction has become prominent in some other jurisdictions. See, e.g., Lohrmann v. Pittsburgh Corning Corp., 782 F.2d 1156, 1162-63 (4th Cir. 1986) (upholding Maryland's substantial contributing factor standard in an asbestosis case); Rutherford v. Owens-Illinois, Inc., 941 P.2d 1203, 1219 (Cal. 1997).

Here, the court rejected the “substantial contributing factor” analysis used by these several other jurisdictions.  The Court did not believe that substantial contributing factor has a single, common-sense meaning, and concluded that a reasonable juror could be confused as to the quantum of evidence required to prove causation in the face of both a substantial contributing factor and a proximate cause instruction. In sum, some jurors might construe the term to lower the threshold of proof required for causation while others might interpret it to mean the opposite. The court also agreed with the explicit rejection of substantial contributing factor language in the recent Restatement (Third) of Torts: Liability for Physical and Emotional Harm (2010).  The substantial-factor rubric, says the commentary, tends to obscure, rather than to assist, explanation and clarification of the basis of causation decisions. The latest Restatement provides a rule for finding each of two acts that are elements of sufficient competing causal sets to be factual causes without employing the substantial-factor language of the prior Torts Restatements. There is no question of degree in the new version.  It holds that if multiple acts occur, each of which alone would have been a factual cause of the physical harm at the same time in the absence of the other act(s), each can be regarded as a factual cause of the harm.

The court found this model, as explicated in the comments, quite consistent with its prior rulings regarding concurring causation. A defendant whose tortious act was fully capable of causing the plaintiff's harm should not escape liability merely because of the fortuity of another sufficient cause. So the but-for standard is a helpful method for identifying causes, but it is not the exclusive means for determining a factual cause. Multiple sufficient causes may also be factual causes.  The acts themselves do not have to be concurrent, so long as they are operating and sufficient to cause the harm contemporaneously. As to mesothelioma, said the court, the "harm" occurs not at the time of exposure but at the time when competent medical evidence indicates that the cancer first exists and  thus causes injury. 

 The court said that the separate comment under Restatement § 27, entitled "Toxic substances and disease," should not be applied here.  That approach allows for a finding of causation when multiple exposures combine to reach the threshold necessary to cause a disease, allowing parties who were responsible for some portion of that threshold to be held liable. While it may be the case that this dose-related approach to causation is indeed appropriate for some cancers or diseases, the court did not find it to be necessarily appropriate for mesothelioma from asbestos.

Based on this rule, plaintiff must show that it is more likely than not that his alleged exposure to dust from defendant's brakes occurred prior to the development of cancer and was sufficient to cause his mesothelioma. Given that this approach differs from that taken in the circuit court, the court did not find it appropriate to rule on the sufficiency of the evidence at trial at this time, and instead remanded. On remand, the experts must opine as to what level of exposure is sufficient to cause mesothelioma, and whether the levels of exposure at issue in this case were sufficient.

Fifth Circuit Affirms Exclusion of Plaintiff Causation Experts in Chemical Case

The Fifth Circuit recently affirmed the dismissal of most of a plaintiff's personal injury claims against a chemical company, based on the conclusion that certain expert witness testimony was inadmissible. See Johnson v. Arkema Inc., No.11-50193 (5th Cir. June, 2012).

Plaintiff Johnson worked as a machine repairman at a glass bottling plant in Waco, Texas from May 1998 to the end of 2008. On two separate occasions, first in early June 2007 and again in July 2007, Johnson claims he was directed to perform work in close proximity to a device known as a C-4 Hood, which was designed, manufactured, and installed by defendant. C-4 Hoods are
utilized to apply a chemical coating to the glass bottles as the bottles are transported along a conveyor belt. According to Johnson, the C-4 Hood he worked near to on those two occasions failed to perform its proper functions, resulting in his alleged exposure to harmful chemicals.

Plaintiff sued. Arkema then filed motions to exclude the opinions of Dr. Richard Schlesinger, Johnson’s expert toxicologist, and Dr. Charles Grodzin, Johnson’s expert pulmonologist, under Federal Rule of Evidence 702 and the Supreme Court’s decision in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). Arkema also filed a motion for summary judgment, contending that absent those experts, Johnson was unable to present scientifically reliable evidence establishing that exposure to the chemicals can cause restrictive lung disease and pulmonary
fibrosis (his alleged injury types). The district court granted the motions, and plaintiff appealed. 

On appeal, plaintiff contended that the district court abused its discretion in excluding Dr. Schlesinger’s expert opinion on general causation.  The district court excluded Dr. Schlesinger’s testimony after determining, inter alia, that: (1) Dr. Schlesinger could not cite to one epidemiological or controlled study of humans indicating that exposure to the relevant chemicals could cause restrictive lung disease and pulmonary fibrosis; (2) the scientific literature was devoid of any data or peer reviewed articles indicating that exposure to the two chemicals will result in chronic lung disease, and such a proposition is not generally accepted in the scientific community.

Plaintiff argued that the two fell into a "class" of chemicals that have been shown to cause these injuries. In forming a reliable opinion regarding the effects of exposure to a particular chemical, an expert may extrapolate data from studies of similar chemicals. BUT to support a conclusion based on such reasoning, the extrapolation or leap from one chemical to another must be reasonable and scientifically valid.  Thus, courts are free to reject a theory based on extrapolation when there is simply too great an analytical gap between the data and the opinion proffered. Here, save for highlighting their shared classifications as "irritants," the expert did not attempt to explain any direct correlation or “fit” between the chemicals at issue and the known scientific data concerning exposure to, for example, chlorine, ammonia, or nitric acid vapor. Accordingly, given the diverse chemical structures and toxicities of irritants, which plaintiff acknowledged, the district court did not abuse its discretion in concluding that Dr. Schlesinger’s “class of chemicals” theory presented “too great an analytical gap between the data and the opinion proffered.

The next issue was reliance on language in an MSDS, which is useful for many of our readers in toxic tort cases.  The district court found the "warning" language in a competitor's MSDS to be irrelevant and unreliable because: it did not clearly state a causation conclusion, and, most importantly, Johnson did not provide any science behind the MSDS, such as the duration or concentration of exposure needed to produce the noted effects, or the scientific literature relied upon by the drafter for the statements contained in the MSDS.  Under such circumstances, the MSDS, standing alone, need not have been accorded any weight. Plaintiff also relied on general hazard language in defendant's own MSDS. But could cite no authority for the proposition that material safety data sheets constitute per se reliable support for an expert’s opinion. To the contrary, in exercising its discretion as a gatekeeper, a court may refrain from treating a MSDS as reliable until it is presented with scientific evidence justifying the relevant statements found within the MSDS.

Finally, Johnson contended that he was exposed to amounts of one of the chemicals (HCl) that were between two and ten times the permissible exposure levels set by OSHA, NIOSH, and the Acute Exposure Guideline Levels set by the National Research Council. Regulatory and advisory bodies such as IARC, OSHA and EPA utilize a “weight of the evidence” method to assess the carcinogenicity or toxicity of various substances in human beings and suggest or make prophylactic rules governing human exposure. This methodology results from the preventive perspective that the agencies adopt in order to reduce potential public exposure to possibly harmful substances. The agencies’ threshold of proof is lower (for policy reasons) than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect, and requires a plaintiff to prove that it is more likely than not that another individual has caused him or her harm. See generally Wright v. Willamette Industries, Inc., 91 F.3d 1105, 1107 (8th Cir.1996). Thus, such regulatory chemical guidelines are not necessarily reliable in all toxic tort cases. And a court should confirm the underlying basis for their  proscriptions before an expert’s reliance on them can pass Daubert muster. Here, plaintiff did not provide any scientific data or literature to explain how or why the various exposure limits and guidelines were established for the chemicals. Similarly, he had no evidence that the guidelines and exposure limits existed to protect people from developing severe restrictive lung disease and pulmonary fibrosis, his diseases. Thus, the court concluded that the OSHA, NIOSH, and NRC guidelines and exposure limits, standing alone, were insufficient to demonstrate abuse of discretion on the part of the district court.

As to the other expert, Dr. Grodzin’s research and analysis essentially mirrored Dr. Schlesinger’s save for one key distinction: Dr. Grodzin performed a so-called “differential diagnosis” of Johnson. A reliable differential diagnosis typically, though not invariably, is performed after physical examinations, the taking of medical histories, and the review of clinical tests, including laboratory tests, and generally is accomplished by determining the possible causes for the patient’s symptoms and then eliminating each of these potential causes until reaching one that cannot be ruled out.  Even in jurisdictions that accept this questionable approach to causation, the results of a differential diagnosis are far from reliable per se. For example, before courts can admit an expert’s differential diagnosis, which, by its nature, only addresses the issue of specific causation, the expert must first demonstrate that the chemical at issue is actually capable of harming individuals in the general population, thereby satisfying the general causation standard. In other words, the suspect has to be reasonably and reliably "ruled in."

Here, Dr. Grodzin’s differential diagnosis was based on the presumption that the two chemicals  were actually capable of causing restrictive lung disease and pulmonary fibrosis in the general population. Dr. Grodzin did not present any reliable or relevant scientific evidence to bolster this assumption. Consequently, the fact that Dr. Grodzin claimed he conducted a differential
diagnosis did not save his opinion from the same fate as Dr. Schlesinger’s opinion.

 (Note, the court concluded that plaintiff did not need expert witnesses to demonstrate that his immediate acute injuries after exposure and which allegedly sent him to the emergency room, could have been caused by the chemical.  Thus, this part of the case was remanded.)

 

 

 

State Supreme Court Issues Significant Asbestos Ruling

The Pennsylvania Supreme Court last week issued a potentially highly significant decision in the long-standing asbestos mass tort. See Betz v. Pneumo Abex LLC et al., No. J-87-2011 (Pa. May 23, 2012).

The issue is causation.  Readers know that a tort plaintiff has to establish cause in fact and proximate cause.  Cause in fact can mean "but for" the defendant's conduct, the plaintiff would not have been injured, or, in some cases, that the conduct was a "substantial factor" in causing the harm.  In toxic tort cases, cause in fact includes general causation (the product can cause this type of disease) and specific causation (the product did cause this plaintiff's disease). Often, epidemiological proof is used to establish causation in a toxic tort context, but there are strengths and limitations to that type of evidence, which can show an association between the product and the disease, and which typically demonstrates that there is some specific relationship between the amount of exposure to the product and the amount of disease seen in the exposed population (a dose-response relationship).  What may be unknown from the epidemiology (and other relevant scientific evidence) is whether there is a threshold of exposure below which there is no risk of disease, or whether any level of exposure carries a measurable increased risk of disease.  Plaintiffs' experts often assume there is no safe level of exposure, and regulatory agencies may assume the same as a matter of public health policy; these latter assumptions do not establish legal causation given their cautionary, prophylactic nature. But what proof a plaintiff has that an extremely low level of exposure to a given defendant's product can or did cause his disease is a crucial issue in many toxic tort contexts.

In asbestos, the grandfather of all mass torts, plaintiffs' experts often seek to testify that "one fiber can kill," meaning there is no safe level of exposure to asbestos, and from that to conclude that that any exposure to any amount of asbestos from any defendant was a substantial factor contributing to the asbestos disease the plaintiff has.  They say this even as they admit, as the epidemiology shows, that at all the measurable levels of exposure (no one can find a plaintiff exposed to just one fiber) asbestos-related disease demonstrates a clear dose-response relationship.

Back in 2005, plaintiff Simikian commenced a product liability action against several defendants, asserting causes of action grounded on multiple theories including strict liability. Mr. Simikian
alleged that, throughout a forty-four year career as an automotive mechanic, his exposure to asbestos-containing friction products, such as brake linings, caused his mesothelioma. Plaintiff indicated he would rely on expert opinion that each and every exposure to asbestos -- no
matter how small -- contributed substantially to the development of his asbestos-related
diseases: the the “any-exposure,” “any-breath,” or “any fiber” theory of legal (or substantial-factor) causation. See generally Summers v. Certainteed Corp., 606 Pa. 294, 316, 997 A.2d 1152, 1164-65 (2010) (discussing the requirement for a plaintiff to prove that a defendant’s product was a substantial factor in causing injury). Seeking to preclude such opinion testimony, defendants filed a motion under the Frye test (PA is a general acceptance jurisdiction), arguing that it barred this "novel" scientific evidence from the courtroom until it has achieved general acceptance in the relevant scientific community.

Plaintiffs relied on a Dr. Maddox, who provided for his opinion as to specific and proximate
causation that asbestos-related mesothelioma, like other diseases induced by toxic exposures, is a dose-response disease; that each inhalation of asbestos-containing dust from the use of
products has been shown to contribute to cause asbestos-related diseases, including  mesothelioma. Each of the exposures to asbestos allegedly contributes to the total dose that causes mesothelioma and, in so doing, shortens the period necessary for the mesothelioma to develop. Plaintiff further argued that each exposure to asbestos is therefore a substantial contributing factor in the development of the disease that actually occurs; a court need not look at individual exposures or the identity of the product or the manufacturer. "As a matter of law, you just say, hey, you breathed asbestos from a product, oh, you are going to the jury."

The trial court requested expert reports, and then held an evidentiary hearing. The Common Pleas court centered its focus on the use of extrapolation, from high doses down to a single finer, which it found to be a linchpin of Dr. Maddox’s methodology and opinion supporting a finding of proximate cause. The court expressed concern with an “analytical gap” between the scientific proofs and the expert's conclusion. At the hearing, the expert admitted he did not consider epidemiology appropriate to consult regarding low-dose exposures, offering an "analogy" that has been used in the example of a glass of water. One drops marbles into the glass of water until the water finally overflows from the glass; is it the first marble or the last marble that causes the glass
to overflow? Well, both, or all of them, said the plaintiff expert.

The expert testified, however, that individual exposures differ in the potency of the fiber to
which an individual is exposed, to the concentration or intensity of the fibers to which one is exposed, and to the duration of the exposure to that particular material. Dr. Maddox agreed that scientists presently do not know the mechanism by which asbestos causes mesothelioma. Additionally, he recognized that his opinions were not based on any sort of direct attribution, but rather, were grounded entirely upon an assessment of increased risk.

The trial court sustained the Frye challenge and precluded the plaintiffs from adducing the any-exposure opinion. Overall, Judge Colville could find no credible explanation for how it was that Dr.
Maddox was able to determine if it was exposure to a particular defendant’s friction product that
caused a plaintiff’s mesothelioma, and not some other exposure to asbestos material. Even if one accepts that a single fiber may possibly increase the risk of developing disease, it did not accept that an unquantified (and potentially infinitesimal) increase in risk could serve as proof that a defendant’s product was a substantial cause of a plaintiff’s or decedent’s disease. Generally accepted scientific methodology may well establish that certain “high dose” asbestos exposure causes, or contributes to, a specific hypothetical plaintiff’s disease, but the plaintiffs had not proffered any generally accepted methodology to support the contention that a single exposure or an otherwise vanishingly small exposure has, in fact, in any case, ever caused or contributed to any specific individual’s disease, or even less so, that in this case such a small exposure did, in fact, contribute to this specific plaintiff’s disease.

Plaintiff appealed, and the Superior Court reversed, basically disagreeing with every aspect of the trial court's analysis. It relied on Ferebee v. Chevron Chemical Co., 736 F.2d 1529 (D.C. Cir. 1984), essentially for the proposition that, so long as an expert is willing to testify to an extrapolation, courts should permit its admission. (The notion that courts have no screening function is at odds with the last couple decades of federal court evidence law, just as it was at odds with most federal circuits at the time the DC CIrcuit opinion was written, and with states that have adopted Daubert and also those that still adhere to Frye.) Defendants then appealed.

Appellants (and their amici) offered extensive critiques of Dr. Maddox’s methodology from both scientific and logical perspectives, with the bottom line that the any-exposure opinion remains a hypothesis or assumption, and stressing Dr. Maddox’s inability to identify any peer-reviewed scientific support undergirding the opinion. While plaintiffs offered much argument on the effects of high doses of asbestos, they did not squarely address appellants’ arguments concerning differences in potency among asbestos fibers, or the potential that exposure to asbestos from a defendant’s product might be minimal in comparison to others.

The state Supreme Court noted that this case was selected among test cases for the any-exposure opinion as a means, in and of itself, to establish substantial-factor causation. The plaintiff's efforts to invoke case reports, animal studies, and regulatory standards to support the theory were ineffectual in terms of substantial-factor causation, since the most these can do is suggest that there is underlying risk from the defendants’ products, a proposition with which the trial court did not disagree.  What was more of concern was the assessment of substantiality.
In this regard, Dr. Maddox’s any-exposure opinion was in irreconcilable conflict with itself. Simply put, one cannot simultaneously maintain that a single fiber among millions is substantially causative, while also conceding that a disease is dose-responsive. The any-exposure opinion, as
applied to substantial-factor causation, did not consider the three factors which Dr. Maddox himself explained needed to be considered in trying to estimate the relative effects of different exposures: potency, intensity, duration.

The court took on directly the analogy offered by Dr. Maddox in support of his position: the marbles-in-a-glass illustration changes materially upon the recognition that to be a fair comparison one must include the factors that the marbles are all non-uniform in size and shape, and microscopic so that millions are needed to fill the glass. From this frame of reference, it is very difficult to say that a single one of the smallest of microscopic marbles is a substantial factor in causing a glass of water to overflow.  

Superior Court reversed; trial court affirmed.

Beverage Maker Not Liable for Alleged Failure to Warn

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).


 

Amicus Urges Supreme Court to Reverse Causation Junk Science Decision

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

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

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

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

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

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

 

Substantial Cause Explored in Case of Multiple Exposures

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.

 

State Supreme Court Holds Causation Evidence Insufficient

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).
 

Proof of General Causation in Drug Case Not Automatic

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.

MDL Court in Peanut Butter Litigation Grants Multiple Summary Judgments For Defense

The MDL court overseeing the coordinated federal litigation stemming from a 2007 peanut butter recall recently granted summary judgment to the defendant manufacturer ConAgra Foods in multiple cases.  See Southern v. ConAgra Foods Inc., MDL 1845, No. 09-1544  (N.D. Ga. 9/29/10).

Readers may recall that in 2007, ConAgra Foods Inc. recalled jars of Peter Pan and Great Value peanut butter that were made at its Georgia plant, after the CDC and FDA observed a possible association between these products and reports of salmonella poisoning.  As part of the recall, ConAgra instructed consumers to discard the jar but to save the lid, which contained the product code identifying when and where the peanut butter was manufactured.  After the recall, multiple consumers sued ConAgra, alleging they had contracted salmonella after eating either Peter Pan or Great Value peanut butter. The lawsuits were consolidated in an MDL in the Northern District of Georgia.

To prove causation, each plaintiff must show that it is more likely than not that contaminated peanut butter caused his or her illness. The best way to show that peanut butter is contaminated with Salmonella is to test the peanut butter itself, said the court. The fact that the peanut butter was recalled here does not mean that it was contaminated. In fact, most of the recalled peanut butter was completely free of Salmonella contamination. During discovery, accordingly, ConAgra asked the plaintiffs to provide the product code for the peanut butter that allegedly caused their illnesses. It also asked the plaintiffs whether they submitted a blood, urine, or stool sample to a doctor for testing. Because the symptoms of Salmonellosis are similar to those of other common gastrointestinal illnesses, these samples were important in determining causation, said defendant.

Here, the 19 plaintiffs could not establish causation, as a matter of law. First, they could not show that the peanut butter they ate was manufactured by ConAgra at the Sylvester plant during the outbreak.  Plaintiffs did not know the product codes from their peanut butter. Without these numbers, which indicate when the peanut butter was manufactured, it was impossible to know whether the peanut butter was at risk of contamination.

Second, the plaintiffs did not provide enough evidence to show that they contracted Salmonellosis shortly after eating the peanut butter. Symptoms alone are not enough to permit a reliable diagnosis of this disease because the symptoms of Salmonellosis – usually diarrhea, abdominal cramps, and fever – are more commonly associated with viruses, parasites, fungi, other bacteria, toxins, and various chronic diseases. Indeed, the CDC estimates that nearly 300 million cases of diarrhea and related gastrointestinal symptoms occur each year of other causes. A positive blood, urine, or stool sample is the best way to show that Salmonella caused a plaintiff’s illness. A proper differential diagnosis by a physician who examined and treated a plaintiff during his illness may also support a finding of causation in some cases, said the court.  

But none of the plaintiffs here provided evidence of a differential diagnosis or a positive blood, urine, or stool culture. None of the plaintiffs' available medical records indicated that the plaintiffs’ doctors considered and excluded other causes or performed any form of differential diagnosis or diagnostic tests. To the contrary, the records showed that most plaintiffs did not even visit the doctor until several months after eating the allegedly contaminated peanut butter.

Without more, concluded the court, no reasonable jury could find that it was more likely than not that
contaminated peanut butter caused the plaintiffs’ alleged illnesses.

 

 

Failure to Warn Even When You Warn? Court Rejects Plaintiff's Theory

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.

 

Plaintiff Expert Must Exclude Other Plausible Causation Theories

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. MerrellNo. 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.