Milward, et al v. Acuity Specialty Products Grou, et al
Filing
OPINION issued by Jeffrey R. Howard, Chief Appellate Judge; Rogeriee Thompson, Appellate Judge and Joseph N. Laplante,* U.S. District Judge. Published. *Of the District of New Hampshire, sitting by designation. [13-2132]
Case: 13-2132
Document: 00116989729
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Date Filed: 04/25/2016
Entry ID: 5994173
United States Court of Appeals
For the First Circuit
No. 13-2132
BRIAN MILWARD and LINDA J. MILWARD,
Plaintiffs, Appellants,
v.
RUST-OLEUM CORPORATION,
Defendant, Appellee.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Douglas P. Woodlock, U.S. District Judge]
Before
Howard, Chief Judge,
Thompson, Circuit Judge,
and Laplante,* District Judge.
Steve Baughman Jensen, with whom Allen Stewart, P.C., Ian
McCallister, and Kreindler & Kreindler, LLP, were on brief, for
appellants.
Francis M. Lynch, with whom Cetrulo LLP, was on brief, for
appellee.
April 25, 2016
*
Of the District of New Hampshire, sitting by designation.
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HOWARD,
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Chief Judge.
Date Filed: 04/25/2016
Entry ID: 5994173
In this toxic tort case, we
previously considered the admissibility of testimony from the
plaintiffs' general causation expert.
At issue in the present
appeal is whether the district court abused its discretion in
excluding the testimony of the plaintiffs' specific causation
expert.
We conclude that the district court's ruling was a
supportable exercise of its discretion, and we therefore affirm
the grant of summary judgment to the defendant following that
evidentiary ruling.
I.
Background
Brian Milward worked as a pipefitter and refrigerator
technician for over thirty years.
During the course of his
employment, Milward was exposed to varying levels of benzene from
paints and other products manufactured by (among others) RustOleum
Corporation.
In
2004,
Promyelocytic Leukemia ("APL").
he
was
diagnosed
with
Acute
Three years later, Milward and
his spouse sued a number of defendants on the theory that their
negligence caused Milward's disease.
The only remaining defendant
is Rust-Oleum.
To succeed against Rust-Oleum, the Milwards had the
burden of establishing, through expert testimony, general and
specific causation.
In other words, they needed to show that
exposure to benzene can cause APL (general causation), and that
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exposure to benzene was, in fact, a substantial factor in the
development of Brian's APL (specific causation).
The district
court bifurcated the proceedings; it planned first to address the
admissibility of expert testimony on general causation, and then
to consider the specific causation issue.
In
Milwards'
a
2009
general
ruling,
causation
the
district
expert.
court
excluded
Accordingly,
it
the
entered
judgment in favor of the defendants without proceeding to the
second phase of the case.
The Milwards appealed that decision
and, for reasons specific to their general causation expert, we
reversed.
See Milward v. Acuity Specialty Prods. Grp., Inc., 639
F.3d 11 (1st Cir. 2011).
We remanded the case to the district
court to proceed to the specific causation question.
Under the supervision of a different district court
judge, the parties engaged in discovery on the subject of specific
causation.
Relevant here, the Milwards retained occupational
medicine physician Dr. Sheila Butler to serve as their expert
witness.1
The admissibility of her opinion testimony is at the
1
The Milwards also engaged industrial hygienist Dr. James
Stewart. Dr. Stewart evaluated Brian Milward's exposure to benzene
at various points in his career and calculated the benzene levels
in various products that he used. Based on those considerations,
Dr. Stewart estimated that Milward was exposed to benzene at a
level of 25.6 parts per million-years (the measurement of the
amount of benzene equivalent to what a person would breathe on
average each day of the year a person spent at work). The district
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heart of this appeal, and thus additional background on her opinion
is in order.
Dr. Butler
Dr. Butler, an employee of the Veterans Administration,
specializes
in
clinical
assessments
of
environmental
occupational exposure in combat-exposed veterans.
and
In her proposed
testimony, Dr. Butler presented three theories.
First, she testified that although benzene is naturally
occurring, there is no safe level of benzene exposure.
her
predominant
hypothesis.
theory,
and
she
consistently
This was
reiterated
her
She emphasized that she reached this conclusion by
examining "the biology, the pathophysiology, what the substance
does to the person and the disease process."
was
able
to
do
so
without
epidemiological studies.
relying
on
And, she noted, she
any
of
the
relevant
Given this no-safe level theory, Dr.
Butler maintained that Milward's exposure (as detailed by Dr.
Stewart) was likely the cause of his APL.
The district court
rejected this hypothesis because it could not be properly tested
with any known rate of error.
The Milwards do not meaningfully
challenge the district court's conclusion on appeal.
Accordingly,
we assume that the ruling was correct and bypass further discussion
Oleum now argues that this decision was erroneous.
Given our
disposition of the case, we do not reach this argument.
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See Mills v. U.S. Bank, NA, 753 F.3d 47, 55 (1st
Cir. 2014).
Second, Dr. Butler rather cursorily concluded that even
beyond
the
no-safe
level
hypothesis,
certain
epidemiological
studies have established that an individual's "relative risk" of
developing APL increases when exposed to specified amounts of
benzene.
She then compared Milward's exposure levels to those
that had been found to be dangerous in that research.
Milward's
exposure
was
higher
than
the
amounts
found
Since
to
be
hazardous, Dr. Butler reasoned that benzene exposure was likely
the cause of his APL.
Notably, she did not explain why she chose
the studies on which she relied, nor did she address any study
with contrary findings.
In fact, during Dr. Butler's deposition,
defendant's counsel asked her a number of questions about her
ability
and
willingness
epidemiological research.
to
engage
with
the
relevant
For instance, counsel asked, "Are you
aware of any studies which find that there is no relationship
between benzene exposure and APL," to which she answered "Yes . .
. the literature [] has support for both."
Counsel then asked,
"Do you intend in this case to weigh the different epidemiological
studies and offer an opinion as to which ones we should rely on
and which ones we should discount," to which she replied, "No."
Finally,
diagnosis"
to
Dr.
conclude
Butler
that
engaged
benzene
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in
a
exposure
"differential
likely
caused
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Milward's APL.
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Through this method (essentially a process of
elimination) Dr. Butler "ruled out" some of the more common factors
associated with APL, among them obesity and smoking.
She then
determined that since benzene exposure was a potential cause, she
could also "rule out" an idiopathic diagnosis (or, a diagnosis
without a known cause).
Thus, since benzene exposure was the only
significant potential cause remaining, she concluded that it was
likely the culprit.
Procedural History
Back in court, Rust-Oleum moved both to exclude Dr.
Butler's testimony and for summary judgment.
The district court
evaluated, and rejected, each of the theories that Dr. Butler put
forward to establish specific causation.
For reasons discussed
below, the judge ultimately ruled that Dr. Butler's testimony was
inadmissible under Federal Rule of Evidence 702.
Milwards
could
not
establish
specific
causation
Since the
without
Dr.
Butler's testimony, the district court granted summary judgment in
favor of Rust-Oleum.
Fed. R. Civ. P. 56.
This timely appeal
followed.
II.
We review the district court's decision to admit or
exclude expert testimony for abuse of discretion.
See United
States v. Shay, 57 F.3d 126, 132 (1st Cir. 1995) (noting that we
will only "reverse a decision . . . if (1) the district court based
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the decision on an incorrect legal standard
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. . . or (2) we have
a definite and firm conviction that the court made a clear error
of judgment. . . .").
Predicate factual findings are reviewed for
clear error, while pure questions of law engender de novo review.
Milward, 639 F.3d at 13-14.
decision
to
grant
As for the district court's ultimate
Rust-Oleum
summary
judgment,
because
the
Milwards are proceeding under state-law theories of liability, we
apply Massachusetts law, see Philibotte v. Nisource Corp. Servs.
Co., 793 F.3d 159, 165 (1st Cir. 2015), and review the decision de
novo, see Samaan v. St. Joseph Hosp., 670 F.3d 21, 38 (1st Cir.
2012).
As in the district court, our admissibility inquiry is
guided by Federal Rule of Evidence 702, which provides that:
A witness who is qualified as an expert by
knowledge, skill, experience, training, or
education may testify in the form of an
opinion or otherwise if:
(a) the expert's scientific, technical, or
other specialized knowledge will help the
trier of fact to understand the evidence or to
determine a fact in issue;
(b) the testimony is based on sufficient facts
or data;
(c) the testimony is the product of reliable
principles and methods; and
(d) the expert has reliably applied the
principles and methods to the facts of the
case.
Fed. R. Evid. 702. In applying Rule 702, the district court serves
as the gatekeeper for expert testimony by "ensuring that [it] . .
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. both rests on a reliable foundation and is relevant to the task
at hand." Daubert v. Merrell Dow Pharm., 509 U.S. 579, 597 (1993).
The party seeking to introduce the evidence has the burden of
establishing both its reliability and its relevance.
See id. at
593 n.10; see also Fed. R. Evid. 702, advisory committee's note.
As noted above, the district court rejected each theory
that Dr. Butler put forward to establish specific causation.
We
now focus on the two theories that the Milwards press on appeal:
Dr.
Butler's
relative
risk
conclusion
and
her
differential
diagnosis.2
Relative Risk
The district court rejected Dr. Butler's relative risk
testimony because she had expressly disavowed her intent, and
minimized her ability, to analyze conflicting epidemiological
studies.
The district court reasoned that without such analysis,
2
The Milwards broadly allege that the district court applied
the wrong legal standard when evaluating Dr. Butler's fitness to
serve as an expert witness. They note that the court "held that
Dr. Butler is unqualified because she cannot 'evaluate the relevant
studies' with the 'rigor' of an epidemiologist." This argument
misconstrues the district court's action. The court did not, in
a vacuum, conclude that Dr. Butler was unqualified to provide
expert testimony in this case because she was not an
epidemiologist. Instead, the court stated that since Dr. Butler
was unwilling to provide testimony respecting the epidemiological
literature in the context of the "relative risk" approach, the
Milwards could not rely on that method to prove specific causation.
While we provide more detail about that conclusion below, it
suffices here to say that the district court did not err as the
Milwards allege.
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it was impossible to ensure that the studies she cited were
actually based on a reliable methodology.
The Milwards challenge
this decision in three ways.
First, they assert that in rejecting the testimony, the
district court relied on an incorrect premise: that conflicting
epidemiological studies existed. They note that there were studies
establishing an increased risk of APL after a certain level of
exposure, such as 8 ppm-years.
See, e.g., Deborah C. Glass et
al., The Health Watch Case -- Control Study of Leukemia and
Benzene, 1076 Ann. N.Y. Acad. Sci. 80, 85 (2006); Richard B. Hayes
et al., Benzene and Lymphohematopoietic Malignancies in Humans, 40
Am. J. Indus. Med. 117, 120.
The Milwards also acknowledge that
other studies found no increased risk of leukemia with exposure at
any level less than 40 ppm-years.
See, e.g., Robert A. Rinsky et
al., Benzene and Leukemia: An Epidemiologic Risk Assessment, 316
New England J. Med. 1044 (1987).
They argue, however, that since
the Rinsky study did not affirmatively find the absence of a
relationship, the studies were not actually in conflict.
While it is certainly true that, at least in some cases,
the "absence of evidence" is not the same as "evidence of absence,"
it
is
not
similarly
true
that
the
studies
must
present
diametrically opposing conclusions to be in tension with one
another.
Here, a number of studies have been identified that show
a correlation between APL and benzene exposure at a specific level,
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while other studies do not show that correlation.
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In order to
establish specific causation by the relative risk method, Dr.
Butler was required to choose a study, or studies, to serve as a
baseline to which she could then compare Brian Milward's case.
There can be no serious question that choosing a study that showed
a correlation above a specific level (e.g., the 8 ppm-years in the
Glass study), rather than one that did not exhibit any such
correlation (e.g., the 40 ppm-years in the Rinsky study), yields
a vastly different comparison.
The district court did not clearly
err in finding that the studies were sufficiently distinct from
one another such that utilizing one, rather than another, would
necessarily lead to different testimony.
The Milwards next argue, albeit summarily, that Dr.
Butler did not actually disavow her willingness to consider the
divergent studies.
Instead, they allege that the district court
took her statements out of context.
We make quick work of this argument given the clarity of
the record.
Dr. Butler anchored her testimony to her no-safe
threshold hypothesis, a theory that did not turn on the validity
of any of the epidemiological studies.
Indeed, given that she
acknowledged that she based that theory on "the biology, the
pathophysiology, [and] what the substance does to the person and
the disease process," it was consistent for her to then state that
she had neither the need nor the intent to compare the competing
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epidemiological literature.3
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There was no error in the district
court's decision to give her statements their plain meaning.
Finally, the Milwards argue that even if the district
court did not err in these respects, Dr. Butler's testimony was
nevertheless still based on reliable evidence, and it was therefore
admissible.
In support of this contention, the Milwards defend
the studies that Dr. Butler invoked in her testimony.
They also
cite Schultz v. Akzo Novel Paints, LLC, 721 F.3d 426 (7th Cir.
2013), which they maintain is closely analogous to this case.
Generally, where an expert's medical opinion is grounded
exclusively on scientific literature, a district court acts within
its discretion to require the expert to explain why she relied on
the studies that she did and, similarly, why she disregarded other,
incompatible research.
See, e.g., Kuhn v. Wyeth, Inc., 686 F.3d
618, 623-24 & 633 (8th Cir. 2012) (permitting testimony where the
expert witness relied on methodologically reliable studies and
provided an explanation for why those studies were chosen); Norris
v. Baxter Healthcare Corp., 397 F.3d 878, 886 (10th Cir. 2005)
(noting in the context of a general causation finding that the
expert witness's inability to address contrary views made the
3
Likewise, in discussing the statistical significance of
the reports, Dr. Butler seemingly minimized her ability to analyze
the studies when she said "and I'm not an epidemiologist if you're
going to go there. I'm just saying that to me that's fairly -that's fairly significant."
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opinion unreliable).
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It is self-evident that, when an expert
engages in a relative risk analysis in the manner that Dr. Butler
did here, the district court is on firm ground in requiring such
an explanation, since the validity of the approach depends on the
reliability of the studies chosen.
See 3 Mod. Sci. Evidence §
23:27 (2014-2015 Ed.) (discussing the use of the relative risk
approach in establishing specific causation).
That is, if the
expert is comparing the plaintiff's condition to a study, and the
study is based on an unreliable methodology, then the comparison
itself is futile.
Schultz,
the
case
consistent with this view.
on
which
the
Milwards
rely,
is
In that case, the Seventh Circuit
reversed a district court's decision to exclude specific causation
expert testimony about an individual's exposure level to benzene.
721 F.3d at 428.
The Seventh Circuit found that the testimony was
reliable because the expert "focused specifically on the amount of
benzene to which [the plaintiff] had been exposed and related this
amount to the scientific literature."
Id. at 432.
Importantly,
the expert in Schultz did not simply point to favorable studies
showing an increased risk of leukemia at low levels of exposure.
Instead, the expert in that case explained why he believed that a
conflicting study was unreliable and why, based on his knowledge
of the literature, he chose to rely on the studies that he did.
Id. at 432-33.
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Here, the relevant studies were not only in tension
with one another, but expressly cast each other into doubt.
See,
e.g., EPA Office of Research and Development, Carcinogenic Effects
of Benzene: An Update, at 14 (April 1998).
Given that, the
district court reasonably ruled that there needed to be some
indication of why Dr. Butler utilized the studies that she did.
Indeed, her complete unwillingness to engage with the conflicting
studies (irrespective of whether she was able to or not) made it
impossible for the district court to ensure that her opinion was
actually
based
on
scientifically
reliable
correspondingly, that it comported with Rule 702.
evidence
and,
Not only does
this render this case readily distinguishable from Schultz, but it
also justifies the district court's decision.4
Differential Diagnosis
The
district
"differential diagnosis."
court
also
rejected
Dr.
Butler's
Although the judge did not question Dr.
4
We also note that the Milwards' position yields a further
problem. Absent Dr. Butler's testimony weighing the studies, the
only support for their reliability is the fact that they were peerreviewed, published works. As we have noted though, "an article
does not reach the dignity of a 'reliable authority' merely because
some editor, even a most reputable one, sees fit to circulate it
. . . [and] [m]ere publication cannot make them automatically
reliable authority." Meschino v. N. Am. Drager, Inc., 841 F.2d
429, 434 (1st Cir. 1988).
Given the need for some evidence
establishing the reliability of the studies invoked, the court
likewise did not err in refusing to take judicial notice of their
reliability.
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Butler's decision to "rule out" obesity and smoking as causes of
Brian Milward's APL, the court was concerned about the utility of
the approach given the high percentage of APL cases that are
idiopathic (according to the record, roughly 70-80% of all APL
diagnoses).
The judge also stated that Dr. Butler's reasoning was
circular; she "ruled out" an idiopathic APL by "ruling in" benzene
as a cause, but she had failed to provide a scientifically reliable
method of "ruling in" benzene in the first instance.
The Milwards
contend that in making this decision, the district court ignored
our case law that has blessed an expert's use of a differential
diagnosis to establish causation.
Even if the Milwards' scanty argument in their opening
brief were sufficiently developed as to avoid a waiver finding,
see United States v. Oladosu, 744 F.3d 36, 39 (1st Cir. 2014)
("[b]ecause the argument is underdeveloped, it is waived"), we
nonetheless see no abuse of discretion in the district court's
decision.
diagnosis"
The Milwards are certainly correct that a "differential
can
be
a
"reliable
method
of
medical
diagnosis."
Milward, 639 F.3d at 18; see also Granfield v. CSX Transp., Inc.,
597 F.3d 474, 486 (1st Cir. 2010).
But, they still must show that
the steps taken as part of that analysis -- the "ruling out" and
the
"ruling
in"
of
causes
scientifically valid methods.
--
were
accomplished
utilizing
See Ruggiero v. Warner-Lambert Co.,
424 F.3d 249, 254 (2d Cir. 2005).
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Since
Dr.
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Butler
was
Date Filed: 04/25/2016
only
able
to
"rule
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out"
an
idiopathic APL because she had "ruled in" benzene as a cause, the
validity of her differential diagnosis turns on the reliability of
that latter conclusion.
See Ruggiero, 424 F.3d at 254 (noting
that an expert must use reliable scientific methods to "rule in"
causes); see also Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171,
179 (6th Cir. 2009); Glastetter v. Novartis Pharm. Corp., 252 F.3d
986, 989 (8th Cir. 2001). Indeed, the reliability of that decision
is particularly critical here given the extensive number of APL
cases that are idiopathic.
Under such circumstances, eliminating
a number of potential causes -- without properly and explicitly
"ruling
in"
a
cause
--
is
simply
"of
little
assistance."
Restatement (Third) of Torts; Phys. & Emot. Harm § 28, cmt.
c(4)(2010).
Dr. Butler appears to have "ruled in" benzene exposure
solely by relying on her two other theories.
But, as explained
above, the district court found both of these theories to be
unreliable.
As we agree with the district court's conclusion
regarding the relative risk methodology, and since the Milwards
have
not
challenged
the
district
court's
no-safe
threshold
determination, they have failed to show how Dr. Butler could have
reliably utilized either method to "rule in" benzene exposure.
Nor, we note, have they pointed to other evidence in the record
that Dr. Butler could have conceivably used to "rule in" benzene.
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Given that the record does not contain a scientifically
reliable basis to "rule in" benzene, Dr. Butler needed some other
method to "rule out" an idiopathic diagnosis.
one.
She did not provide
As such, the district court acted within its discretion to
conclude that the extraordinary number of idiopathic APL cases,
coupled with the lack of a reliable means to rule out an idiopathic
diagnosis here, muted Dr. Butler's ability to reliably apply this
methodology.5
III.
Once the district court excluded Dr. Butler's testimony,
it
then
judgment.
correctly
granted
Rust-Oleum's
motion
for
summary
As is well-established under Massachusetts law, "expert
testimony is required to establish medical causation."
Johnson & Johnson, 28 N.E.3d 445, 461 (Mass. 2015).
to both general and specific causation.
Reckis v.
This applies
Id. at 461 n.33.
Without
any other medical expert evidence in the record probative on
specific causation, judgment as a matter of law was necessarily
required.
Fed. R. Civ. P. 56.
5
In their brief, the Milwards also argue that Dr. Butler's
position on specific causation is consistent with the latency
period in Brian Milward's case. The district court did not rest
its decision on that proposition (instead, it just noted a concern
about the issue), and we therefore need not reach the argument.
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Accordingly, we affirm the district court's decision to
exclude Dr. Butler's testimony and its concomitant grant of summary
judgment in favor of Rust-Oleum.
--Dissenting Opinion Follows--
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THOMPSON, Circuit Judge, dissenting.
Setting the Stage
Dr. Butler has quite the CV.
A graduate of Wellesley
College, she has a medical degree from Howard University and a
masters of public health from Columbia University.
Specializing
in occupational medicine, she is board-certified in preventive
medicine and general public health (by the American Board of
Preventive
Medicine)
and
in
anatomic
pathology,
clinical
pathology, and hematology (by the American Board of Pathology).6
This means (according to the American Board of Preventive Medicine)
that
she
has
"core
competencies"
in,
among
other
things,
"epidemiology" and "research into causes of disease and injury in
population groups."7
She has a pretty impressive job too, working
full time as a physician at a VA medical center that deals with
veterans ravaged by diseases after being exposed to toxins during
their service.
Figuring out the causes of chronic illnesses in
patients exposed to toxic substances is what she does day in and
day out.
a
All told, she has (in the district judge's words) over
decade's
worth
of
experience
"as
a
practicing
diagnostic
6
Pathology is a medical specialty focusing on the nature and
causes of diseases. See Stedman's Medical Dictionary 1332 (27th
ed. 2000) ("Stedman's," from here on). And hematology is the study
of blood-related diseases. See id. at 796.
7
Epidemiology is the study of the incidence, distribution,
and control of disease in a population. See id. at 604.
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hematopathologist and as a consultant on occupationally-related
malignancies."
As the Milwards' specific-causation expert, Dr. Butler
testified by report, deposition, and affidavit that — based on her
review of the scientific evidence — there is no "safe" level of
benzene
exposure.8
In
other
words,
increases a person's risk of leukemia.
every
benzene
exposure
But, she added, given our
different genetic makeups, what might be a safe exposure level for
some could be a lethal one for others.
causation
methodologies
—
"relative
Anyway, using two accepted
risk"
and
"differential
diagnosis" — and zeroing in on Brian's benzene-exposure level (set
by Dr. Stewart at 25.6 ppm-years) Dr. Butler concluded that Brian's
"excessive" exposure to benzene caused his leukemia.9
8
Remember — the Milwards had to show that benzene exposure
can cause leukemia (general causation) and that Brian's exposure
was a substantial factor contributing to his leukemia (specific
causation).
A different district judge excluded the Milwards'
general-causation expert as unreliable under Rule 702.
Noting
(among other things) that the judge had taken "sides on questions
that are currently the focus of extensive scientific research and
debate — and on which reasonable scientists can clearly disagree"
— we concluded that the exclusion edict constituted an abuse of
discretion. See Milward, 639 F.3d at 22, 26.
On a different note, because there are two Milwards — Brian
and Linda — it makes sense to use a first name where necessary to
avoid confusion. Obviously I intend no disrespect.
9
As my friends in the majority note, the Milwards hired Dr.
Stewart (an industrial hygienist) to assess Brian's benzene
exposures.
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A quick word about how she applied these methodologies.
Starting with relative risk, Dr. Butler said that even
if there were some threshold level of benzene exposure needed to
cause leukemia, that threshold was exceeded here — and by a
considerable amount.
With Brian's 25.6 ppm-years exposure level
firmly in mind, she pointed to a peer-reviewed epidemiology study
finding that workers exposed to benzene at or above 8 ppm-years
were 7 times more likely than controls to develop leukemia.
she did not stop there.
And
Rather, she went on to spotlight other
studies of the same caliber showing a statistically significant
increased risk of leukemia among workers cumulatively exposed to
benzene at levels below Brian's 25.6 ppm-years.10
In a deposition
she said that she is neither an epidemiologist nor a researcher.
She also agreed that some studies found no relationship between
benzene exposure and leukemia.
Asked by defense counsel if she
"intend[ed] in this case to weigh the different epidemiological
studies" and comment on "which ones we should rely on and which
ones we should discount," she replied, "No" — and then added:
I'm relying on what I know about the biology,
the pathophysiology, what the substance does
to the person and the disease process. Now,
10
See Deborah R. Glass et al., The Health Watch Case — Control
Study of Leukemia and Benzene: The Story So Far, 1076 Ann. N.Y.
Acad. Sci. 80 (2006); Dusica Lazarov et al., Acute Myeloid Leukemia
and Exposure to Organic Solvents: A Case-Control Study, 16 Eur.
J. of Epidemiology 295 (2000); Richard B. Hayes et al., Benzene
and the Dose-Related Incidence of Hematologic Neoplasms in China,
89 J. of the Nat'l Cancer Inst. 1065 (1997).
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if there are studies that support it then
that's even better, but without the studies
based on what I know there is a very — it's
more likely than not that benzene contributes
to the development of [the type of leukemia
Brian suffers from].11
And she later said that "one doesn't just rely on literature" in
formulating a specific-causation opinion.
Turning,
described
by
then,
the
to
majority
differential
as
diagnosis
"essentially
a
(aptly
process
of
elimination"), Dr. Butler "ruled out" possible causes of Brian's
leukemia, like smoking and obesity, leaving only benzene.
She
talked about "'idiopathic' leukemia" too — "idiopathic" being
another way of saying medical professionals do not know why a given
person has the disease.
"[E]very case of leukemia has some
cause[]," she explained, and only "[t]hose cases with unidentified
causes" get hit with the "'idiopathic'" tag.
But given her
conclusion that Brian's "benzene exposures were a substantial
factor causing his [leukemia]," she could "also 'rule[] out' that
his [leukemia] was . . . 'idiopathic.'"
The district judge, however, would have none of Dr.
Butler's talk about benzene being the specific cause of Brian's
leukemia.
Given
epidemiologist'"
and
her
concession
"'not
a
that
she
researcher,'"
11
is
and
"'not
given
an
her
Pathophysiology is the study of the functional changes that
accompany a particular disease. See Stedman's 1333.
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"professed inability to engage with conflicting epidemiological
literature" (these are quotes from the judge's rescript), the judge
excluded her relative-risk analysis as unreliable under Rule 702.12
That meant that Dr. Butler's differential-diagnosis analysis —
through which she "'ruled out' an idiopathic origin of [Brian's]
leukemia by 'ruling in' benzene" (these too are quotes from the
judge's order) — was unreliable too (because she is, the judge
concluded, not qualified to say whether benzene exposure at Brian's
level could have caused his leukemia).
And with the Milwards'
specific-causation expert out of the picture, all that was left
for the judge to do was enter summary judgment against them — which
the judge did.
Fast-forward to the present, with the majority spying no
abused
discretion
here
because
Dr.
Butler's
"complete
unwillingness to engage with the conflicting studies (irrespective
of whether she was able to or not) made it impossible for the
[judge]
to
ensure
that
her
opinion
was
actually
based
scientifically reliable evidence" as required by Rule 702.
on
Call
me unpersuaded. As I see things, the complaints about Dr. Butler's
12
The "conflicting" study that everyone focuses on is Robert
A. Rinsky et al., Benzene and Leukemia:
An Epidemiologic Risk
Assessment, 316 New Eng. J. of Med. 1044 (1987), which found no
increased risk of leukemia in workers exposed to less than 40 ppmyears of benzene.
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specific-causation opinion go to weight, not admissibility — as I
now explain.13
My Take on the Matter
(a)
The Standard of Review Explained
Abuse-of-discretion review is "respectful," certainly.
Corp. Techs. v. Harnett, 731 F.3d 6, 10 (1st Cir. 2013).
But
"respectful" does not mean we must throw up our hands and simply
affirm every discretionary call.
See, e.g., Negron-Almeda v.
Santiago, 528 F.3d 15, 21 (1st Cir. 2008).
standard does involve review, after all.
Review under this
See, e.g., Dopp v.
Pritzker, 38 F.3d 1239, 1253 (1st Cir. 1994).
And we will not
hesitate to find abuse where, for example, the district judge based
his decision on clearly erroneous facts, made a serious legal
error, or suffered a significant lapse of judgment, see, e.g.,
Cent. Pension Fund of the Int'l Union of Operating Eng'rs &
Participating Emp'rs v. Ray Haluch Gravel Co., 745 F.3d 1, 5 (1st
Cir. 2014); Riva v. Ficco, 615 F.3d 35, 43 (1st Cir. 2010); RuizTroche v. Pepsi Cola of P.R. Bottling Co., 161 F.3d 77, 83 (1st
Cir. 1998) — a point made each time we have reversed the exclusion
13
Because the majority jettisons the case by upholding the
judge's decision to exclude Dr. Butler's testimony, I (obviously)
focus my energy on that issue. So, like the majority, I make no
comment on Rust-Oleum's other arguments — i.e., that the judge
should have excluded Dr. Stewart's testimony and that the Milwards
cannot show that the failure to provide certain warnings about
benzene proximately caused Brian's injuries.
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of expert testimony, see, e.g., Milward, 639 F.3d at 13-14, 2325; Ruiz-Troche, 161 F.3d at 79, 83-86.
(b)
A Short Primer on Expert Opinion
Rule
702
governs
the
admission
of
expert-opinion
testimony, with the offering party required to show that such
testimony is relevant and reliable.
See, e.g., Kumho Tire Co. v.
Carmichael, 526 U.S. 137, 149 (1999) (relying on Daubert, 509 U.S.
at 592); Ruiz-Troche, 161 F.3d at 80 (same).
Expert-opinion
testimony
factfinder
is
relevant
if
it
will
understanding and deciding a fact.
at 592.
assist
the
in
See, e.g., Daubert, 509 U.S.
And it is reliable if it has "a reliable basis in the
knowledge and experience of [the pertinent] discipline."14
Id.
Basically then, district judges are supposed to weed out
nonsense opinions by junk scientists.
But in doing so, they must
keep a bunch of things in mind — including the following:
The rule on expert-opinion testimony is notably "liberal,"
with the evidence considered presumptively admissible.
See
4 Jack B. Weinstein & Margaret A. Berger, Weinstein's
14
Because everyone focuses on whether Dr. Butler's testimony
is reliable, I will do likewise.
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Federal Evidence § 702.02[1], at 702-5 (Joseph M. McLaughlin
ed., 2d ed. 2013) ("Weinstein's," to save some keystrokes).
Proponents of expert testimony must show that the proposed
witness is able — through her education, training, or
experience — to offer a meaningful opinion on the issue in
play.
Id. § 702.04[1][c], at 702-57.
An expert can rely, then, on "clinical instinct" — i.e.,
"what experience adds to scientific knowledge and training"
— which is a well-known and accepted part of today's medical
practice.
Mueller v. Auker, 700 F.3d 1180, 1191 (9th Cir.
2012) (quoted approvingly in Weinstein's § 702.05[2][c], at
702-103 n.46).
Judges abuse their discretion if they "exclude testimony
that would otherwise" help the factfinder "understand a
fact in issue, simply because the expert does not have the
specialization" that the judges think "most appropriate."
Pagés-Ramírez v. Ramírez-González, 605 F.3d 109, 114 (1st
Cir. 2010) (internal quotation marks omitted); see also
Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 970
(10th Cir. 2001) (explaining that so long as the expert
keeps "within the reasonable confines of [her] subject area,
.
.
.
a
lack
of
specialization
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not
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opinion,
but
only
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its
weight"
(internal quotation marks omitted)).
Also, an expert need not have epidemiological studies at
the ready to get her opinion in.
See Milward, 639 F.3d at
24 (holding that "[e]pidemiological studies are not per se
required as a condition of admissibility regardless of
context"); see also Daubert, 509 U.S. at 593 (explaining
that
"[p]ublication
.
.
.
is
not
a
sine
qua
non
of
admissibility").
And an opinion, by the way, does not have to conclusively
prove causation to be admissible.
"[M]edical knowledge,"
we can all agree, "is often uncertain.
The human body is
complex, etiology is often uncertain, and ethical concerns
often prevent double-blind studies calculated to establish
statistical proof."
United States v. Sandoval-Mendoza, 472
F.3d 645, 655 (9th Cir. 2006).
But that "does not preclude
the introduction of medical expert opinion testimony when
medical knowledge permits the assertion of a reasonable
opinion."
Critically
Id. (internal quotation marks omitted).
too,
deciding
"which
of
several
competing
scientific theories has the best provenance" is none of the
judges' business — which is just another way of saying that
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judges must focus on the expert opinion's admissibility,
not its correctness.
Here's a biggie:
often
do,
18,
That the parties' experts disagree (they
unsurprisingly)
admissibility.
F.3d
Ruiz-Troche, 161 F.3d at 85.
25
goes
to
weight,
not
See, e.g., Feliciano-Hill v. Principi, 439
(1st
Cir.
2006);
see
also
Weinstein's
§ 702.05[3], at 702-112 n.58 (collecting a cornucopia of
additional cases).
Here's
another
necessarily
biggie:
have
the
An
expert's
burden"
of
backers
disproving
"do
a
not
study
championed by the other side — that is what a case the
majority relies on says.
See Kuhn, 686 F.3d at 626.
Again,
the proponents must "show that [their expert] arrived at
[her]
contrary
opinion
in
a
scientifically
sound
and
methodological fashion." Id. And if they do, "the question
becomes one for the jury to decide."
Id.
(c)
The Instances of Abused Discretion
The ruling my colleagues affirm — that Dr. Butler "is
'not an epidemiologist' and 'not a researcher'" who "professed" an
"inability to engage with conflicting epidemiological literature"
and "thus" is "unqualified" to say whether Brian's level of benzene
exposure could cause his leukemia (quotes lifted from the district
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judge's order) — is filled with errors.
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And these errors rise to
the level of an abuse of discretion.
Take the district judge's fixation on her saying that
she was "not an epidemiologist" and "not a researcher."
Time and
again we have said that one "need not be a specialist in a
particular medical discipline to render expert testimony relating
to
that
discipline."
Gaydar
v.
Sociedad
Instituto
Gineco–
Quirurgico y Planificacion Familiar, 345 F.3d 15, 24 (1st Cir.
2003); see also Pagés-Ramírez, 605 F.3d at 116-17.
And not only
have we talked the talk, but we have walked the walk — reversing
as an abuse of discretion expert-exclusion rulings premised on an
expert's missing the type of specialization the judges think
necessary, even though the testimony would have helped the jury
understand a disputed issue.
at 116-17.
See, e.g., Pagés-Ramírez, 605 F.3d
And given her training and experience — don't forget,
(a) her board certification in preventive medicine shows she has
competency in epidemiology and research into causes of disease,
and (b) she analyzes specific-causation issues as a routine part
of her job — the judge's ruling faulting Dr. Butler for not being
able to "evaluate the relevant studies" with the "rigor" of an
epidemiologist fits that category of error.
The majority tries to
downplay the district judge's comments about her not being an
epidemiologist
by
playing
up
how
concerned
he
was
with
"unwilling[ness]" to analyze the "conflicting" literature.
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her
But
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the fact remains that the judge did add her non-epidemiologist
status
to
his
decisional
mix,
which
(for
the
reasons
just
discussed) is an abuse of discretion, plain and simple.
Now, as for the judge's belief — shared by the majority
— that Dr. Butler "professed [an] inability to engage with the
conflicting
epidemiological
literature,"
there
are
problems
galore.
For starters, I espy no conflict.
made a few paragraphs ago:
To repeat a point I
The studies Dr. Butler relied on show
that benzene-exposure levels below the 25.6 ppm-years endured by
Brian can cause leukemia.
The Rinsky study — the supposedly
"conflicting" study — also shows that benzene exposure at certain
levels can cause leukemia, though the authors found no increased
risk of leukemia among workers exposed to less than 40 ppm-years
of benzene.
According to the district judge, because the Rinsky
study did not find any increased risk of leukemia at lower exposure
levels,
there
is
a
"conflict"
and
"debate
within
the
epidemiological literature" that can only be put to rest by someone
with epidemiologist credentials.
Not only did the judge get the
epidemiologist-credentials part wrong (as I just noted); he got
the "conflict" part wrong too.
For a true conflict to exist, the
Rinsky study would have to show that benzene-exposure levels of
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25.6 ppm-years or lower cannot cause leukemia.
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And the Rinsky
study does no such thing.
Anyhow, even assuming there is a conflict, the judge
still erred in two important ways.
For one thing, despite what
the judge said, Dr. Butler hardly copped to being unable to engage
with the literature.
By my lights, the judge could only say what
he said by misreading her deposition.
Questioned (recall) by
defense counsel about whether she "intended in this case to weigh
the different epidemiological studies and offer an opinion as to
which ones we should rely on and which ones we should discount,"
Dr. Butler said, "No."
That is because, she stressed, (a) one
need not rely just "on literature" and (b) her experience with
"biology," "pathophysiology," and "the disease process" provided
the
specialized
testimony.
knowledge
to
support
her
specific-causation
Statements (a) and (b) square with our caselaw.
See,
e.g., Milward, 639 F.3d at 24 (emphasizing how "[e]pidemiological
studies are not per se required as a condition of admissibility").
And just as importantly, nothing she said there intimated even a
possible whisper of a hint of a suggestion that she could not take
on the relevant literature.
Put differently, she did not say that
she lacks the know-how to assess Rust-Oleum's preferred studies —
only that she did not need to in formulating her expert opinion.
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The word "intend" — I hope we can all agree — does not imply
"can't."
For another thing, despite what the judge indicated,
neither Dr. Butler nor the Milwards had any burden to explain why
the Rinsky study is wrong.
Think back to the primer:
The
proponents of expert testimony, I noted, are not reflexively
obliged to "discredit" a study pushed by their opponents.
a case highlighted by the majority — says as much.
Kuhn —
Sure, the
plaintiffs' expert there tried to poke holes in a study relied on
by the defendants.
And, deeming the criticisms insubstantial, the
judge excluded the expert from testifying.
Significantly for
present purposes, though, the circuit court wrote that the expert
did not have to debunk the study; he only had to show that he
reached his conclusion via a sound methodology.15
F.3d at 626.
See Kuhn, 686
Dr. Butler did that in spades, using two recognized
techniques for identifying causes (relative risk and differential
diagnosis) and relying in part on studies that (as best I can tell)
neither the district judge nor the majority has any problems with.
15
So instead of supporting the majority's position that Dr.
Butler had to explain why she disagreed with "incompatible"
studies, Kuhn rejects that position. And Norris — another case
cited by the majority — is not a difference maker for the majority
either. The court there upheld the exclusion of expert testimony
because the experts did not confront the reality that their
opinions were "flatly contrary to all of the available
epidemiological evidence," see 397 F.3d at 885-86 — which is worlds
apart from our case.
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And having met her burden, a jury should get to decide which
studies to believe (hers or Rust-Oleum's), if any, see id. — just
like a jury would get to do if faced with dueling experts (instead
of dueling studies), see Feliciano-Hill, 439 F.3d at 25.
Summing Up
Because, as discussed, the judge made serious judgment
errors in excluding Dr. Butler's expert testimony — a ruling (in
my view) inconsistent with the "liberal thrust of the Federal Rules
and their general approach of relaxing the traditional barriers to
'opinion' testimony," see Daubert, 509 U.S. at 588 — I would
reverse his ruling as an abuse of discretion.
majority,
though
conscientious,
has
decided
respectfully — but unequivocally — dissent.
- 32 -
And because the
otherwise,
I
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