Alabama Legislature Enacts Causation in Fact Requirement

There is likely no more fundamental notion in product liability law than the recognition that the defendant's product must cause the injury complained of, and thus a product maker or seller ought not be held liable for injuries caused by a product it actually didn't make or sell.  This is basic causation-in-fact, and the few courts that have tried to ignore this fundamental principle have needed to perform legal contortions and Olympic-level gymnastics to invent unworkable alternate rules.  "Market share liability" is an older, nearly extinct example, and a more modern excursion is the notion that the maker of a branded pharmaceutical product can somehow be held liable for injuries caused by the plaintiff's use of a generic version of the product, which defendant didn't make or sell.

Recently, the Alabama Legislature passed a bill to reverse their state supreme court's decision in Wyeth Inc. v. Weeks, which had allowed a patient allegedly injured by the generic drug to sue the maker of the name-brand product.  Gov. Bentley recently signed the bill, which had overwhelming bipartisan support in the Alabama House and was passed unanimously in the state Senate.

The vast majority of state and federal courts hold that a plaintiff must have used the defendant's actual product, and the law returns Alabama to this column.  SB80 requires that in any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among the other traditional elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not just a similar or allegedly equivalent product.  Thus designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury.

The measure will take effect six months after becoming law. It appears to do away with not only so-called innovator liability, but also market share liability, alternative liability, conspiracy liability, and the other outlier industry-wide theories of liability in product cases. 


MDL Court Rejects Plaintiffs' New Causation Experts

The MDL judge in the Denture Cream Products coordinated litigation has rejected all of plaintiffs' general causation experts. See In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga (S.D. Fla. Jan.. 28, 2015).

Over three and a half years ago, in Chapman. v. Procter & Gamble Distributing LLC, Case No. 9:09-
CV-80625, the MDL court had granted Procter & Gamble’s motion to exclude the opinions of Plaintiffs’ general causation experts. See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345 (S.D. Fla. 2011) . Since Chapman, Plaintiffs claimed to have obtained new evidence in support of their argument that products like Fixodent can cause copper deficiency myeloneuropathy (“CDM”), including clinical, epidemiological, background risk of disease, and dose-response relationship. Defendants filed an omnibus Daubert Motion challenging the reliability and significance of Plaintiffs’ alleged new general causation evidence and opinions — in particular a Fixodent Blockade Study and "Dr. Lautenbach’s cohort study."  The motion argued the previously identified analytical gaps in Plaintiffs’ chain of general causation still remained. In particular, Defendants contended that Plaintiffs still could not establish any of the following, that: (1) someone can ingest enough zinc from Fixodent to place the body in a negative copper balance; (2) a prolonged negative copper balance from denture cream use can lead to a copper deficiency; (3) a dose-response relationship exists between Fixodent and copper deficiency, much less myeloneuropathy; (4) Fixodent users face a greater risk of developing myeloneuropathy than the general population; or (5) a physiological mechanism explains how a copper deficiency can lead to a myeloneuropathy.

The alleged decades’ worth of underlying scientific literature” Plaintiffs relied on to prove general causation — most of which was presented in Chapman — pertained to excess zinc and copper deficiency, or copper deficiency and neurological disorders; it is not specific to the zinc compound in Fixodent. Particularly in light of the millions of consumers who have regularly used Fixodent for
decades without complaint, see Chapman, 766 F.3d at 1304 , the Court concluded first that Plaintiffs had not demonstrated the medical community generally recognizes the zinc compound in Fixodent as a known toxin, and thus the Court undertook an extensive Daubert analysis on the general question of whether Fixodent can cause CDM, in light of the allegedly new evidence. The Court examined Plaintiffs’ new evidence in support of proving general causation, including epidemiological studies, dose-response analysis, and the background risk in particular.

The opinion is quite lengthy, and worth a close read for readers with Daubert issues in toxic tort cases.  A few highlights:  Plaintiffs sought to rely on a recently conducted study supposedly showing the short term effects of zinc in the body.  But the Court could not "turn a blind eye to the myriad, serious methodological flaws in the Fixodent Blockade Study," which did not go just to the weight of the evidence. While some of these flaws, on their own, might not have been serious enough to justify exclusion of the Fixodent Blockade Study; taken together, the Court found this Fixodent Blockade Study was not “good science,” and was not admissible.   Consequently, Plaintiffs still had no evidence of the zinc in Fixodent’s ability to inhibit copper absorption at the relevant site of action — the intestines.

Plaintiffs relied on the opinions of a Dr. Grainger, on dose-response and relying on in vitro studies. Defendants argued Dr. Grainger’s opinions were unreliable because Dr. Grainger did not offer any explanation of how zinc dissociation properties observed in in vitro release designs would transfer to a live human, and did not consider factors that might allow him to make such an extrapolation. The court agreed that Dr. Grainger’s opinions were unreliable. The in vitro dissociation studies were the foundation for all of Dr. Grainger’s conclusions. The portion of his report dedicated to these studies was completely devoid of any pertinent details or analysis. His comments regarding “various in vitro release designs”  lacked support citations, and lacked any discussion about the study designs or methodology, and any details about the individual study results. See Ballard v. Keen Transp., Inc., No. 4:10-cv-54, 2011 WL 474814, at *4 (S.D. Ga. Feb. 3, 2011) (expert’s failure to cite any specific chapter, page, or line on which he based his conclusions “makes it appear that he is not being as careful in his litigation consulting as he is in his ordinary professional work.”).  Dr. Grainger’s failure to explain the relevancy of the in vitro studies to humans or to account for factors needed to make a proper extrapolation was notable given his critique of studies the defendants had relied on.  Accordingly, the court concluded, "In short, Plaintiffs are not much better off than they were at the time of Chapman."

The MDL court also noted that epidemiology is “generally considered to be the best evidence of causation in toxic tort cases.” Kilpatrick, 613 F.3d at 1337 n.8.  Epidemiology is the field of public health and medicine that studies the incidence, distribution, and etiology of disease in human populations. . . . Epidemiologic evidence identifies agents that are associated with an increased risk of disease in groups of individuals, quantifies the amount of excess disease that is associated with an agent, and provides a profile of the type of individual who is likely to contract a disease after being exposed to an agent. Epidemiology focuses on the question of general causation (i.e., is the agent capable of causing disease?) Green, REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 3d ed., at 551–52.  There are two classes of epidemiological evidence: analytical and descriptive. See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d at 1353–54.  Analytical evidence consists of randomized controlled trials, case control studies, and cohort studies, while descriptive evidence consists of case studies and case series. 

Plaintiffs claimed they now had analytical epidemiological evidence to support their theory of general causation — Dr. Lautenbach’s cohort study.  However, Dr. Lautenbach’s cohort study did not account for the lack of information pertaining to the subjects’ denture cream usage, and it was based on the assumption this information was appropriately taken into account by the underlying treating physicians.  Dr. Lautenbach also assumed the treating physicians took into account the amount of denture cream use, claiming it was obviously a volume high enough to trigger that as a designation for physicians.  The court concluded that the extent of Dr. Lautenbach’s reliance was a
complete delegation of his responsibilities as an epidemiologist to assess the subjects’ exposure. The study had severe limitations as a reliable foundation for building a cohort study to formally assess the association between zinc-containing denture cream and CDM. At its core, the basis for Dr. Lautenbach’s cohort study was merely a summary of a collection of case reports, with severely inadequate information about denture cream usage. The layers of unsupportable estimations and
approximations, added to this already shaky foundation, confirmed the Court’s finding that Dr.
Lautenbach’s cohort study was unreliable evidence of general causation.

While plaintiffs had presented "a superficially appealing hypothesis that prolonged use of very large amounts of Fixodent may cause copper deficiency," the law requires more than a general theme to support causation, said the court.  Without Dr. Lautenbach’s cohort study, Plaintiffs continued to have no analytical epidemiological evidence on which to base their inference of causation. In addition to the absence of any analytical epidemiological studies, the absence of data on the background risk of CDM also remained a substantial weakness in Plaintiffs’ experts’ causal reasoning. When analyzing an expert’s methodology in toxic tort cases, the court should pay careful attention to the expert’s testimony about the dose-response relationship. The dose-response  relationship is a relationship in which a change in amount, intensity, or duration of exposure to an agent is associated with a change — either an increase or decrease — in risk of disease. For most types of dose-response relationships following chronic (repeated) exposure, thresholds exist, such that there is some dose below which even repeated, long-term exposure would not cause an effect in any individual.  See generally CASARETT AND DOULL’S TOXICOLOGY: THE BASIC SCIENCE OF POISONS Chs. 1, 4 (McGraw Hill 6th ed.2001).  Often low dose exposures — even for many years — will have no consequence at all, since the body is often able to completely detoxify low doses before they do any damage.  Even Plaintiffs conceded that Fixodent “is safe when used in moderate amounts.” 

So, the Court again found Plaintiffs had not presented sufficient proof of general causation using the indispensable primary methodologies identified by the Eleventh Circuit.


State Supreme Court Reinstates Defense Jury Verdict in Silica Litigation

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

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

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

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

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

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

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

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.

Appeals Court Upholds Summary Judgment Based on Daubert in Benzene Case

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

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

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

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

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

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

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

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

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

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

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

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

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

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


Update on Jurisdiction Cases Pending in Supreme Court

We alerted readers recently that the Supreme Court had granted review in two product liability cases that raise cutting edge personal jurisdiction issues that may not only impact foreign manufacturers but and may also alter due process/personal jurisdiction jurisprudence generally. See J. McIntyre Machinery Ltd. v. Nicastro, U.S., No. 09-1343 (certiorari petition granted 9/28/10); Goodyear Luxembourg Tires SA v. Brown, U.S., No. 10-76 (certiorari petition granted 9/28/10).

Personal jurisdiction, of course, addresses the reach of the court’s power over a party, and without such jurisdiction, any ruling by the court is not binding on the party. Plaintiff lawyers focus on personal jurisdiction as part of the equation where they can sue; defendants as part of where they can be sued properly. As a very general matter, a defendant can only be sued where it has sufficient minimum contacts with the state such that a suit there does not offend traditional notions of fair play and substantial justice.

The issue framed in Nicastro is: Whether, consistent with the Due Process Clause and pursuant to the stream-of-commerce theory, a state may exercise in personam jurisdiction over a foreign manufacturer when the manufacturer targets the general, overall U.S. market for the sale of its product and that product is purchased by a forum state consumer. The corresponding issue in Brown is: Whether a foreign corporation is subject to general personal jurisdiction, on causes of action not arising out of or related to any contacts between it and the forum state, merely because other entities distribute in the forum state products placed in the stream of commerce by the defendant.

"Stream of commerce" personal jurisdiction, debated frequently in the lower courts, if recognized by the Supreme Court, might allow any state to assume jurisdiction over any product manufacturer whose product found its way into the state, no matter how many independent, separate distributors the product had passed through in separate legal transactions. The original stream of commerce idea had included the element of a manufacturer's expectation that its products will be purchased in the specific forum state. Many foreign and out-of-state manufacturers reasonably should know that their products are distributed through a system that might result in sales in any given state. Should that be enough? Readers may recall that the Supreme Court took a look at "stream of commerce" jurisdiction over 20 years ago, and split with no majority decision. But a plurality rejected the "stream of commerce" concept in Asahi Metal Industry Co. v. Superior Court of California, 480 U.S. 102 (1987).

The foreign companies appealing the two state court rulings in two product liability cases recently filed merits briefs. See J.  McIntyre Machinery Ltd. v. Nicastro, No. 09-1343 (U.S. brief submitted 11/12/10); Goodyear Luxembourg Tires SA v. Brown,  No. 10-76 (U.S. brief submitted 11/12/10). There's a link to the Goodyear brief from the ABA Supreme Court Preview, and the McIntyre brief. Also, amici curiae filed briefs, including PLAC, Dow Chemical Canada ULC, the former ATLA now know as American Association for Justice, the Chamber of Commerce of the United States of America, and  the Organization for International Investment and Association of International Automobile Manufacturers Inc. 

In the NJ case, the defendant asks how a “new reality” of “a contemporary international economy” permits a state to exercise in personam jurisdiction over a foreign manufacturer pursuant to the stream of commerce theory solely because the manufacturer targets the US market for the sale of its product and the product is purchased by a forum state consumer?  The petitioner argues that the analysis in Justice O’Connor’s concurring opinion in Asahi is the better view; first, it embodies the requirement of active engagement, of personal agency, that the Supreme Court has made the centerpiece of its formulations of personal jurisdiction limits under the Constitution. Second, it avoids the subjectivity that inheres in the test of mere awareness advanced by
Justice Brennan on the other side of the Asahi split. A concrete formulation is especially valuable in giving out-of-state actors the fair notice that the Court  has  deemed essential in allowing persons to conform their behavior to avoid, if they choose, the possibility of being haled into the courts of a state.  A defendant must intentionally act and direct that action at, and sufficiently in, the very state that seeks to exercise power over that person. Only through purposeful availment a producer will have a fair opportunity to conform its conduct so as to avoid state power if the producer chooses. To predicate jurisdiction on anything less leads to a rule where every seller of chattels would in effect appoint the chattel his agent for service of process and his amenability to suit would travel with the chattel.

The Goodyear brief notes that, unlike specific jurisdiction—which inherently must adapt to the permutations raised by varying claims—general jurisdiction, which does not vary from claim to claim, is more susceptible to precise rules. Indeed, one of its primary functions is to provide a certain and predictable place where a person can be reached by those having claims against him. No Supreme Court decisions have held that a manufacturer’s mere participation in the stream of
commerce could create general jurisdiction wherever the manufacturer’s products were distributed. To the contrary, most courts have repeatedly indicated that injecting a product, even in substantial volume, into a forum’s stream of commerce, without more, does not support general jurisdiction. General jurisdiction based on the stream of commerce theory violates traditional notions of fair play and substantial justice because essentially universal jurisdiction would exist in every state’s courts over every significant seller of goods, foreign or domestic. Because general jurisdiction must be justified solely by reference to the relationship between the state and the defendant, that relationship must be so significant — sufficiently substantial and of such a nature — as to give the state a basis for global judicial authority over all of the defendant’s conduct, wherever it occurs.

The Supreme Court has set argument in the two cases for Jan. 11, 2011. They will be argued separately.