By Michael Hoenig - New York Law Journal -
August 9, 2010
What do butter-flavored
microwave popcorn, a tire without nylon cap plies, a child restraint
system, an asbestos-containing product, the chemical phosphorous
pentasulfide, and an orthopedic knee implant have in common? On the
surface, not much. But in the sometimes "Wild West" shootout called
products liability, each has been the subject of claims for injury, each
has involved the proffer of an expert's defect causation theory, each
has undergone the scrutiny of gatekeeping judges, and each has resulted
in recent rulings precluding expert testimony as unreliable.
Let's hone in on these recent decisions and peek at what is going on. Are
lawyers pushing the liability envelope too far? Are experts offering
opinions without doing their homework? Are experts for hire too readily
finding causal connection between product and injury? Are judges probing
more searchingly in executing their gatekeeping task to admit only evidence
that is both relevant and reliable? The answer may be a little of the first
three and a lot of the fourth. It seems as if the claimants' lawyers and
their experts are advancing "associations" between product and injury, but
the courts, as they should, are demanding reliable proofs that comport with
the scientific method and that meet established reliability criteria.
The "microwave popcorn" case is
Newkirk v. Conagra Foods Inc.,1 a federal court
decision from the Eastern District of Washington issued on July 2. Here, a
physician named David Egilman, board certified in occupational and internal
medicine, was "Daubertized" via judicial gatekeeping as a result of
infirmities in his opinions and methodology. The term "Daubertized" is being
used here because of the famous U.S. Supreme Court decision in
Daubert v. Merrell Dow Pharm. Inc.2 and its
progeny calling on trial judges, among other things, to ensure that an
expert witness "employs in the courtroom the same level of intellectual
rigor that characterizes the practice of an expert in the relevant field."3
The Daubert reliability
criteria are reflected in Federal Rule of Evidence 702 and in analogous
state evidence codes or common law rules.
The plaintiff alleged that his exposure to defendant's popcorn with natural
and artificial butter flavorings caused the lung disease condition known as
bronchiolitis obliterans along with damage to his respiratory system,
shortness of breath and reduced life expectancy. The products were Conagra's
Act II Butter and Act II Butter Lovers Popcorn. Plaintiff also sued
suppliers of butter flavorings to Conagra. Plaintiff ate between five to
seven bags of microwave popcorn each day for about 11 years and was eating
the product before he reached this level of daily exposure. He began eating
the product around the time he quit smoking, to suppress his appetite and
avoid gaining weight.
After noticing respiratory symptoms he read an article in 2007 about a
consumer developing "popcorn lung" from inhalation of butter flavoring
fumes. Initial diagnosis was "obstructive lung disease" given his
significant history of smoking. But then he saw another physician (one of
plaintiff's experts) who diagnosed "bronchiolitis obliterans syndrome," as
did Dr. Egilman. Other physicians, however, did not diagnose him with that
disease. The only conclusive means of diagnosis would be a lung biopsy which
has its own risks and which plaintiff did not have performed.
The connection between obstructive lung disease and popcorn with butter
flavorings became a matter of concern for popcorn manufacturers and their
employees in 2000 and 2001. The culprit compound was identified as diacetyl,
a flavoring agent used to provide a buttery taste and a sense of
"creaminess." Some popcorn plant workers who daily inhaled diacetyl in
industrial-level exposures made claims. Defendant and other microwave
popcorn manufacturers stopped using diacetyl in or around 2007.
Dr. Egilman's expert opinion testimony was plaintiff's primary evidence
supporting general causation. Defendants did not contest his qualifications
as an expert. He had served as an expert witness in popcorn worker cases and
was being proffered in at least one other microwave popcorn consumer case.
Defendants challenged his opinions as to general causation, i.e., was the
substance to which plaintiff was exposed capable of causing the particular
lung disease and other respiratory ailments? Dr. Egilman posited that there
is no known safe level of diacetyl exposure. Studies suggest that exposure
below 1 ppm can cause bronchiolitis obliterans and other respiratory
From there he proceeded to state his opinion regarding specific causation,
i.e., whether the plaintiff's disease developed as a result of exposures to
microwave popcorn vapors. He opined that plaintiff's disease was "consistent
with epidemiological evidence linking exposure of butter popcorn flavoring
containing diacetyl to bronchiolitis obliterans." Further, his symptoms were
"comparable" with other known consumer cases as well as industrial cases in
workers exposed in popcorn production plants. Dr. Egilman concluded "within
a reasonable degree of medical certainty" that plaintiff developed lung
disease as a result of inhaling flavors released by microwave popcorn.
After conducting detailed analysis, the court found that certain
foundational statements were not based on sufficient facts or data. None of
the submitted exhibits and reports supported the conclusion at the heart of
this case: "that vapors emitted from a microwave popcorn bag contain the
same proportion of chemicals or that all of the substances in the two
instances are identical." To the contrary, at least one study said that
certain workers may have been exposed to volatile flavoring ingredients that
were "qualitatively different" from those to which others had been exposed.
There was thus an analytical gap. As Addendum B to its opinion, the court
compiled many other examples of conclusions and opinions Dr. Egilman failed
also did not reliably apply principles and methodology to the facts of the
case. Thus, for example, he relied on published studies but drew
"conclusions far beyond what the study authors concluded." Or, he
manipulated data from those studies to "reach misleading conclusions of his
own." The methodology for his conclusions was unreliable. His opinions fell
below the threshold standard of scientific validity in other ways. As the
court observed, "coming to a conclusion first and then doing research to
support it is the antithesis of the scientific method."
also extrapolated "from extremely small samples to make sweeping
conclusions." He extrapolated from animal studies to humans without offering
any explanation for the "how and why" to do so. He included "legal
conclusions" throughout his reports and affidavits. He was guilty of
"internal contradictions" including arrival at contradictory conclusions
using the same methodology. In light of the "too great" analytical gap
between existing data and his conclusions on general causation, and because
the bulk of his conclusions did not rise above "subjective belief or
unsupported speculation," Dr. Egilman's opinion testimony was ruled
The tire case is
v. Bridgestone/Firestone North American Tire, LLC,4
a Tenth Circuit U.S. Court of Appeals decision issued on July 22. A footnote
says the order and judgment is not binding precedent except for limited
purposes but "may be cited, however, for its persuasive value" consistent
with the terms and conditions of Fed. R. App. P. 32.1. The left rear tire of
a 1988 GMC van suddenly deflated causing the vehicle with 12 occupants to
overturn. Plaintiff's expert, David Osborne, opined that the tire was
defective because of defendant's failure to design it with a nylon cap ply
(a layer of rubberized nylon cords wrapped around the tire forming a tight
band and acting like a tourniquet). This, he claimed, would have reduced the
Defendant moved to exclude the testimony as unreliable, asserting that the
expert conducted no tests to support his opinion; had no supporting
scientific studies; had not subjected his opinions or methodology to peer
review; and could not establish the rate of error for his opinions or
methodology. The federal district court in New Mexico granted the motion to
exclude Mr. Osborne's testimony on the nylon cap ply theory. It then granted
summary judgment to defendant.
The Tenth Circuit affirmed, finding no abuse of discretion. Mr. Osborne
conducted no testing on his theory, offered no supportive peer reviewed
studies, offered no empirical data and conceded that no tire standard called
for use of nylon cap plies in tires. Thus, plaintiffs failed to satisfy the
admissibility criteria despite Mr. Osborne having served as an international
expert on tire failures and having extensively examined the accident tire.
The child restraint system case is
Hendrix v. Evenflo Co. Inc.,5 a decision in the
U.S. Court of Appeals for the Eleventh Circuit issued on June 22. The claim
is somewhat unique. Plaintiff alleged that her 15-day-old son sustained
traumatic brain injuries when the child restraint system malfunctioned
during a minor traffic accident. Plaintiff claimed that the seat dislodged
from its base because it had been "false-latched," i.e., it audibly clicked
leading the installer to believe it is properly latched. Plaintiff further
claimed that those brain injuries caused the child to develop autism
spectrum disorder (ASD) and a spinal cord defect known as syringomyelia.
The infant did suffer a closed-head injury but the parties disputed its
severity. The child exhibited no developmental problems at his 2, 4 or
10-month check-ups. Some 18 months after the accident, however, the infant
began to exhibit developmental problems. The child was diagnosed at age 3 as
having a spinal cord cyst, which plaintiff claims is a syringomyelia that
can be caused by trauma, but defendant labeled it a hydromyelia resulting
from the brain's congenital defect. At age 5 the child was diagnosed with
ASD, a behaviorally defined disorder with qualitatively impaired social
interaction and communication and restrictive repetitive and stereotyped
patterns of behavior, interests and activities. All experts agreed that the
child, as a result of his ASD, will never be gainfully employed.
Two of the doctors who served as experts (a pediatric neurologist and a
medical doctor board-certified in neurodevelopmental disabilities and
developmental-behavioral pediatrics) opined that the injuries sustained in
the accident caused the child to develop ASD and syringomyelia. Prior to
trial, the district court excluded for unreliability the experts' opinions
on the cause of the ASD. It would, however, admit the expert testimony on
the second condition. At that point, though, plaintiff voluntarily dismissed
the remaining claims and filed an appeal.
The Eleventh Circuit affirmed. Neither expert described whether or how
traumatic brain injury could cause the child's individual deficits. One
physician talked about brain abnormalities being "strongly linked" to autism
and an "association" between injury to the developing brain and later
occurrence of autism. But he applied his elaborate causation theory
"explicitly and unambiguously to the child's ASD diagnosis generally and not
to the impairments individually." The other expert concluded that the trauma
was the "most likely cause" of the autism but likewise did not attempt to
parse the causation issue with respect to the child's individual
The experts relied upon the "differential etiology" method (most often
called "differential diagnosis") to link the traumatic brain injury to the
ASD diagnosis. But that entails a two-step analysis. First, a comprehensive
list is prepared of all competing causes generally capable of causing the
symptoms. Then the expert eliminates all causes but one. For each possible
cause "ruled in" at the first stage, the court must ensure that the expert's
opinion on general causation is "derived from scientifically valid
methodology." Here, the district court was correct to apply the
Daubert analysis to the question
whether traumatic brain injury can, in general, cause autism. For example,
mere temporal relationship does not prove a causal relationship.
the second step of "differential etiology," the expert must eliminate all
causes but one. This leads to the "specific causation" inquiry. An expert
must provide reasons for rejecting alternative hypotheses using scientific
methods and procedures. The elimination of hypotheses "must be founded on
more than subjective beliefs or unsupported speculation." Here, the "rule
in" and "rule out" steps did not meet the need to provide useful evidence of
a definitive causal link between traumatic head injuries and autistic
The appellate court "carefully and exhaustively reviewed the literature
cited" by the expert and agreed with the district court's assessment. An
expert's experience and training "does not automatically render every
opinion and statement by that expert reliable." The physician's failure to
"rule out" other possible causes was an additional deficiency. The appellate
panel observed that the medical literature "indicates…a dizzying array of
other factors that have been mentioned as possible causes, including as many
as 90 gene mutations that could play a role in the development of autism."
The court quoted prior case law: "The courtroom is not the place for
scientific guesswork, even of the inspired sort. Law lags science; it does
not lead it."
The asbestos-containing product decision is
Butler v. Union Carbide Corp.,6
a state trial court decision in Georgia issued on June 29. Plaintiff worked
with phenolic molding compounds he said were granular and dusty and
allegedly contained asbestos. Here the expert was a pathologist, John
Maddox, who opined that "any exposure" to asbestos in defendant's product
can cause disease. The theory is also called the "linear non-threshold model
Based on Georgia's equivalent of a Daubert analysis, however, the court found that the "any
exposure" or "non-threshold" theory, as admitted by Dr. Maddox himself, "is
not practically testable and has not been tested." Therefore, it failed the
first of Daubert's test for
scientifically valid knowledge. Moreover, it is "improper for an expert to
presume that the plaintiff must somehow have been exposed to a high enough
dose to exceed the threshold [necessary to cause the illness], thereby
justifying his initial diagnosis. This is circular reasoning."
The expert's claim that there is no known safe level of exposure does not
mean that none exists; it simply means science today has not or cannot, with
current scientific expertise or relying on existing studies, determine what
that level of exposure is. For example, "Dr. Maddox admitted that everybody
has breathed some asbestos fibers…. Yet the admitted extreme rarity of
mesothelioma demonstrates that logically there is a threshold exposure for
harm. Otherwise, the huge exposed population of people receiving low or even
moderate doses would more frequently have this terrible disease." Dr. Maddox
also stated that there are idiopathic causes of mesothelioma. Without
quantification of the dose-response and its threshold for asbestos, when
does one "scientifically" rule out another cause of the disease and not
Dr. Maddox's "any exposure" theory is, at most, "scientifically-grounded
speculation: an untested and potentially untested hypothesis." Further, in
science, a nontestable hypothesis cannot have an error rate. So Dr. Maddox's
"any exposure" theory did not meet Daubert's "error rate" admissibility factor. Reliance by
plaintiff on so-called "general acceptance" of his hypothesis is "far
outweighed by its lack of scientific validity." Further, when a proposed
expert is a "quintessential expert for hire," the trial judge should apply
the Daubert factors with
"greater rigor." During Dr. Maddox's live testimony at the hearing on the
motion to exclude, his "behavior seemed much more consistent with an
advocate than a dispassionate scientist/witness." For the foregoing reasons,
and more, the expert's opinion testimony was ruled inadmissible.
The chemical phosphorous pentasulfide (P2S5) case is
Barrett v. Rhodia Inc.,7 a decision by the U.S.
Court of Appeals for the Eighth Circuit issued on May 24. Here a technician
at a hazardous waste disposal facility brought a toxic tort action against
the manufacturer of a chemical used during ash fixation to accelerate the
stabilization of the waste material. If the chemical's dust is inhaled it
reacts with lung moisture to form hydrogen sulfide gas.
Plaintiff presented experts who opined a brain injury caused by hydrogen
sulfide gas exposure coming from a P2S5 drum opened by another employee.
Defendant's expert presented an alternative explanation for the injuries,
based on tests he performed in opening drums and gas dispersion. The drum
opening exposure was too weak. Instead, plaintiff likely inhaled the dust at
another point when not wearing a protective breathing apparatus.
The Eighth Circuit affirmed the district court's exclusion of the experts'
testimony. Here, although the experts were qualified to opine on symptoms
and their consistence with exposure, they were held not qualified to render
opinions about the dispersal of hydrogen sulfide gas, the concentration
level of the worker's exposure or whether the injuries were caused by gas
released from the opened P2S5 drum.
The knee implant case is Fuesting v.
Zimmer Inc.,8 a "nonprecedential disposition"
published in the Federal Appendix. Here, the expert, James Pugh, opined that
the design of a knee implant that failed was defective because of oxidation
caused by a deficient sterilization process. The trial court, the U.S.
District Court for the Central District of Illinois, rejected a motion to
exclude the opinion as unreliable, and the jury awarded plaintiff $650,000.
The U.S. Court of Appeals for the Seventh Circuit reversed, however, holding
that Dr. Pugh's testimony was unreliable. He failed: to bridge the
"analytical gap between his opinion about the sterilization process and the
failure of plaintiff's implant in particular; to show his methods were
subject to peer review and approval; to rule out alternative possibilities
for causation; and to show that better sterilization methods were available
in 1991.9 On remand, plaintiff hired a new expert, Dr. Robert
Rose, whose testimony was excluded by the trial judge. On appeal (again) the
Seventh Circuit held that "Dr. Rose's testimony fails for essentially the
same reasons that Dr. Pugh's did." The appellate court then proceeded to
detail deficiencies in the reliability criteria.
Michael Hoenig is a
member of Herzfeld & Rubin.
1. No: CV-08-273-RMP, U.S. Dist. Ct. (E.D. Wash. July 2, 2010)
(Judge Rosanna Malouf Peterson).
2. 509 U.S. 579 (1993).
3. Kumho Tire Co., Ltd. v.
Carmichael, 526 U.S. 137, 152 (1999).
4. No. 08-2242 (10th Cir. July 22, 2010).
5. No. 09-10079 (11th Cir. June 22, 2010).
6. Civil Action No. 2008CA114 (Ga. Super. Ct., Morgan Co., June 29,
7. 606 F.3d 975 (8th Cir. 2010).
8. 362 Fed. Appendix 560 (7th Cir. 2010).
Fuesting v. Zimmer Inc., 448 F.3d 936 (7th Cir. 2006).
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