Freeman v. Hoffman-La Roche, Inc.

Nebraska Supreme Court Online Library
www.nebraska.gov/apps-courts-epub/
07/13/2018 12:09 AM CDT
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Nebraska Supreme Court A dvance Sheets
300 Nebraska R eports
FREEMAN v. HOFFMAN-LA ROCHE, INC.
Cite as 300 Neb. 47
A imee Freeman, appellant, v.
Hoffman-La Roche, Inc., and
Roche Laboratories, Inc.,
appellees.
___ N.W.2d ___
Filed May 18, 2018. No. S-17-800.
1. Trial: Expert Witnesses: Appeal and Error. An appellate court reviews
de novo whether the trial court applied the correct legal standards for
admitting an expert’s testimony.
2. ____: ____: ____. When the trial court has not abdicated its gatekeeping
function under Schafersman v. Agland Coop, 262 Neb. 215, 631 N.W.2d
862 (2001), an appellate court reviews the trial court’s decision to admit
or exclude the evidence for an abuse of discretion.
3. Judgments: Words and Phrases. An abuse of discretion occurs when a
trial court’s decision is based upon reasons that are untenable or unrea-
sonable or if its action is clearly against justice or conscience, reason,
and evidence.
4. Summary Judgment: Appeal and Error. An appellate court will
affirm a lower court’s grant of summary judgment if the pleadings and
admitted evidence show that there is no genuine issue as to any material
facts or as to the ultimate inferences that may be drawn from those facts
and that the moving party is entitled to judgment as a matter of law.
5. Trial: Expert Witnesses. Under the framework established by Daubert
v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786,
125 L. Ed. 2d 469 (1993), and Schafersman v. Agland Coop, 262 Neb.
215, 631 N.W.2d 862 (2001), if an expert’s opinion involves scientific or
specialized knowledge, a trial court must determine whether the reason-
ing or methodology underlying the testimony is valid (reliable). It must
also determine whether that reasoning or methodology can be properly
applied to the facts in issue.
6. ____: ____. A trial court can consider several nonexclusive factors in
determining the reliability of an expert’s opinion: (1) whether a theory
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FREEMAN v. HOFFMAN-LA ROCHE, INC.
Cite as 300 Neb. 47
or technique can be (and has been) tested; (2) whether it has been
subjected to peer review and publication; (3) whether, in respect to a
particular technique, there is a high known or potential rate of error; (4)
whether there are standards controlling the technique’s operation; and
(5) whether the theory or technique enjoys general acceptance within a
relevant scientific community.
7. Expert Witnesses. Absent evidence that an expert’s testimony grows
out of the expert’s own prelitigation research or that an expert’s research
has been subjected to peer review, experts must show that they reached
their opinions by following an accepted method or procedure as it is
practiced by others in their field.
8. Courts: Expert Witnesses. The objective of the trial court’s gatekeep-
ing responsibility is to make certain that an expert, whether basing
testimony upon professional studies or personal experience, employs in
the courtroom the same level of intellectual rigor that characterizes the
practice of an expert in the relevant field.
9. Evidence: Proof. Failure of proof concerning an essential element of the
nonmoving party’s case necessarily renders all other facts immaterial.
Appeal from the District Court for Douglas County: Leigh
A nn R etelsdorf, Judge. Affirmed.
Jeffrey A. Silver, and Walter G. Campbell, Jr., and Noreek
Davitian, of Krupnick, Campbell, Malone, Buser, Slama,
Hancock & Liberman, P.A., and Michael D. Hook, of Hook,
Bolton, Mitchell, Kirkland & McGhee, P.A., for appellant.
Jill Vinjamuri Gettman, of Gettman & Mills, L.L.P., Michael
X. Imbroscio and Paul W. Schmidt, of Covington & Burling,
L.L.P., and Colleen M. Hennessey, of Peabody & Arnold,
L.L.P., for appellees.
Heavican, C.J., Miller-Lerman, Cassel, Stacy, and Funke,
JJ., and R iedmann, Judge, and M artinez, District Judge.
Cassel, J.
I. INTRODUCTION
In this product liability action, the district court excluded the
claimant’s expert’s testimony regarding causation. Summary
judgment for the manufacturer and distributor followed. On
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FREEMAN v. HOFFMAN-LA ROCHE, INC.
Cite as 300 Neb. 47
appeal, the claimant asserts that the exclusion exceeded the
court’s “gatekeeping” function. Because the record supports
the court’s conclusion that the expert’s methodology was unre-
liable and conclusion-driven, we find no abuse of discretion in
the exclusion and affirm the judgment.
II. BACKGROUND
Aimee Freeman brought a product liability action against
Hoffman-La Roche, Inc., and Roche Laboratories, Inc. (col-
lectively Roche), alleging that she developed a chronic medi-
cal condition and other side effects as a result of ingesting
Accutane. Accutane, also known as isotretinoin, is a pharma-
ceutical drug manufactured and distributed by Roche for the
treatment of chronic acne.
Freeman initially alleged that she suffered from ulcerative
colitis—a type of inflammatory bowel disease (IBD)—which
is a chronic condition characterized by ulceration of the colon
and rectum. However, the expert witnesses generally agreed
that Freeman had actually developed Crohn’s disease—another
type of IBD—which causes chronic inflammation and ulcers in
any part of the gastrointestinal tract and tends to extend beyond
and penetrate all layers of the gastrointestinal tract wall. Both
ulcerative colitis and Crohn’s disease share many of the same
symptoms. But, as Freeman acknowledges, “there are differ-
ences in the clinical presentation of the disease[s] and the trig-
gers statistically associated for developing [them].”1
As a material element for her product liability claims,
Freeman was required to prove her injury was proximately
caused by Roche’s actions or inactions in manufacturing and
distributing isotretinoin.2 In other words, she had to show that
ingesting isotretinoin could cause the development of Crohn’s
1
Brief for appellant at 6.
2
See, Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 618 N.W.2d 827
(2000); King v. Burlington Northern Santa Fe Ry. Co., 277 Neb. 203, 762
N.W.2d 24 (2009).
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disease and that her ingestion of isotretinoin did in fact cause
her to develop the disease.3 In order to meet this burden of
proof, Freeman intended to call Dr. David B. Sachar as an
expert witness to render opinions on the general and specific
causation of her Crohn’s disease.
Before trial, Roche filed a motion in limine seeking to pre-
clude Sachar’s testimony and challenged his opinions under
the Daubert/Schafersman framework.4 They did not suggest
that Sachar was unqualified to testify as an expert; rather, they
alleged that his opinions on causation were not based upon a
properly applied and reliable methodology.
After conducting a Daubert/Schafersman hearing, the dis-
trict court entered a 42-page order precluding Sachar from
testifying. In its order, the court summarized the admit-
ted evidence as well as the conclusions derived from the
evidence. It also highlighted the key testimony of each of
the experts concerning the evidence presented. In reviewing
Sachar’s analysis of and reliance on the different types of
evidence, the court found Sachar’s methodology was unre-
liable due to his inconsistent approach criticizing studies
adverse to his theory. It further found that his “unabashedly
cherry-pick[ing] supporting studies from an overwhelming
contrary body of literature indicated, in no uncertain terms,
his methodology was conclusion-driven.” Additional facts
and findings from the hearing and order are set forth in our
analysis below.
After the court sustained the motion in limine, Roche filed
a motion for summary judgment. The district court found
that with the exclusion of Sachar’s testimony, Freeman had
no admissible expert evidence to establish a causal associa-
tion between Accutane and IBD. Because Freeman could not
3
See King v. Burlington Northern Santa Fe Ry. Co., supra note 2.
4
See, Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113
S. Ct. 2786, 125 L. Ed. 2d 469 (1993); Schafersman v. Agland Coop, 262
Neb. 215, 631 N.W.2d 862 (2001).
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FREEMAN v. HOFFMAN-LA ROCHE, INC.
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raise a genuine dispute of material fact on causation with-
out expert testimony, the court granted the motion for sum-
mary judgment.
Freeman timely appealed.
III. ASSIGNMENTS OF ERROR
Freeman assigns, restated and combined, that the district
court erred in (1) concluding that her expert witness’ opinions
were not based upon valid reasoning or methodology; (2) pre-
cluding the testimony of her expert witness; and (3) granting
summary judgment in favor of Roche on the issue of general
causation when her expert witness’ testimony, if allowed into
evidence, would create an issue of fact on that issue.
IV. STANDARD OF REVIEW
[1-3] An appellate court reviews de novo whether the trial
court applied the correct legal standards for admitting an
expert’s testimony.5 When the trial court has not abdicated its
Schafersman6 gatekeeping function, an appellate court reviews
the trial court’s decision to limit or exclude the evidence for
an abuse of discretion.7 An abuse of discretion occurs when a
trial court’s decision is based upon reasons that are untenable
or unreasonable or if its action is clearly against justice or con-
science, reason, and evidence.8
[4] An appellate court will affirm a lower court’s grant of
summary judgment if the pleadings and admitted evidence
show that there is no genuine issue as to any material facts
or as to the ultimate inferences that may be drawn from those
facts and that the moving party is entitled to judgment as a
matter of law.9
5
King v. Burlington Northern Santa Fe Ry. Co., supra note 2.
6
Schafersman v. Agland Coop, supra note 4.
7
Hemsley v. Langdon, 299 Neb. 464, 909 N.W.2d 59 (2018).
8
Putnam v. Scherbring, 297 Neb. 868, 902 N.W.2d 140 (2017).
9
Edwards v. Hy-Vee, 294 Neb. 237, 883 N.W.2d 40 (2016).
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Nebraska Supreme Court A dvance Sheets
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FREEMAN v. HOFFMAN-LA ROCHE, INC.
Cite as 300 Neb. 47
V. ANALYSIS
1. Exclusion of Expert Testimony
Freeman argues that the district court deviated from its
proper gatekeeping function and improperly determined the
weight and credibility of Sachar’s testimony. She does not
contend that the court abdicated its role,10 but, rather, that it
required too much.11 She suggests that Sachar’s opinions were
based on good grounds and should have been admitted to be
evaluated by a jury. We disagree.
[5] Under our Daubert/Schafersman framework, if an
expert’s opinion involves scientific or specialized knowledge,
a trial court must determine whether the reasoning or meth-
odology underlying the testimony is valid (reliable).12 It must
also determine whether that reasoning or methodology can be
properly applied to the facts in issue.13
[6] A trial court can consider several nonexclusive fac-
tors in determining the reliability of an expert’s opinion: (1)
whether a theory or technique can be (and has been) tested;
(2) whether it has been subjected to peer review and publica-
tion; (3) whether, in respect to a particular technique, there
is a high known or potential rate of error; (4) whether there
are standards controlling the technique’s operation; and (5)
whether the theory or technique enjoys general acceptance
within a relevant scientific community.14 But, as we have pre-
viously stated, different factors may prove more significant
in different cases, and additional factors may prove relevant
under particular circumstances.15
10
See Hemsley v. Langdon, supra note 7.
11
See King v. Burlington Northern Santa Fe Ry. Co., supra note 2.
12
State v. Braesch, 292 Neb. 930, 874 N.W.2d 874 (2016).
13
Id.
14
Id.
15
See Epp v. Lauby, 271 Neb. 640, 715 N.W.2d 501 (2006).
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FREEMAN v. HOFFMAN-LA ROCHE, INC.
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(a) Accepted Methodology
[7] Absent evidence that an expert’s testimony grows
out of the expert’s own prelitigation research or that an
expert’s research has been subjected to peer review, experts
must show that they reached their opinions by following an
accepted method or procedure as it is practiced by others in
their field.16
In this case, Sachar acknowledged that he had not writ-
ten or published his opinions concerning isotretinoin use and
Crohn’s disease—limited to the colon or as a whole—despite
writing over 220 published papers on IBD and approximately
60 books or book chapters on gastroenterology. He reached
his opinion by employing what we have characterized as a
“weight-of-the-evidence methodology,”17 by reviewing data
from different scientific fields, including animal tests, case
reports, and epidemiological studies.
We have already determined that the weight-of-the-­evidence
methodology is a generally accepted method of determin-
ing causation.18 Therefore, the focus shifted to whether the
method was reliably applied. We limit our discussion to the
factors that help to inform this analysis.
(b) Consistent Standards
Sachar opined that isotretinoin use was “a risk factor for the
onset, development, triggering, [and] exacerbation of ulcer-
ative colitis.” And although he recognized that no study spe-
cifically determined that the same could be said for Crohn’s
disease, he theorized that isotretinoin would also be a risk fac-
tor for Crohn’s disease of the colon, which he suggested was
the appropriate diagnosis for Freeman’s condition.
16
State v. Braesch, supra note 12.
17
See King v. Burlington Northern Santa Fe Ry. Co., supra note 2, 277 Neb.
at 221, 762 N.W.2d at 39.
18
See id.
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Nebraska Supreme Court A dvance Sheets
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FREEMAN v. HOFFMAN-LA ROCHE, INC.
Cite as 300 Neb. 47
In reaching this conclusion, Sachar discredited all but one
of the epidemiological studies finding no significant rela-
tion between isotretinoin use and IBD, because they did not
distinguish between IBD as a whole and ulcerative colitis
and Crohn’s disease. Similarly, he found those studies that
reported no association between isotretinoin use and Crohn’s
disease “wastes everybody’s time,” because they did not
separately consider the different manifestations of Crohn’s
disease. However, Sachar acknowledged that the scientific
community has yet to agree that a distinction between the
different manifestations of Crohn’s disease is necessary when
studying Crohn’s disease as a whole. And although he admit-
ted that Crohn’s disease has a different clinical presentation
and different causes than ulcerative colitis, Sachar relied on
the one epidemiological study concerning ulcerative coli-
tis as “the closest surrogate we have to Crohn’s disease of
the colon.”
Based upon this reasoning, Sachar disregarded what the
other two expert witnesses found to be the most probative evi-
dence. And one of those experts testified that Sachar’s reasons
were not supported by the scientific community. Significantly,
Sachar did not require the same narrow focus on Crohn’s
disease of the colon in data from other scientific sources.
In fact, in reviewing case reports, Sachar relied upon case
reports of Crohn’s disease and did not limit his examination to
only those cases where disease of the colon was specifically
reported. This suggests that Sachar was unduly critical of the
majority of the studies which were adverse to his theory. And
as the district court noted, it indicates that his methodology
was conclusion-driven.
[8] While other factors may also suggest that Sachar’s meth-
odology was unreliably applied, we need not address them.
The objective of the trial court’s gatekeeping responsibility is
to make certain that an expert, whether basing testimony upon
professional studies or personal experience, employs in the
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Nebraska Supreme Court A dvance Sheets
300 Nebraska R eports
FREEMAN v. HOFFMAN-LA ROCHE, INC.
Cite as 300 Neb. 47
courtroom the same level of intellectual rigor that character-
izes the practice of an expert in the relevant field.19 Clearly,
cherrypicking studies from an overwhelmingly contrary body
of literature without valid, supporting reasons for why the
other studies were disregarded does not meet the standard of
intellectual rigor required of expert witnesses. Accordingly,
we cannot find that the district court abused its discretion in
excluding Sachar’s testimony.
2. Summary Judgment
[9] Two principles of law control our review of the sum-
mary judgment that followed. For one of them, we recall
the well-known standard applicable to summary judgments,
which we already have stated above. The other is a corollary
of the first: Failure of proof concerning an essential element
of the nonmoving party’s case necessarily renders all other
facts immaterial.20
Freeman was required to establish causation to prevail at
trial. Without Sachar’s expert testimony, she could not meet this
burden of proof. At oral argument, Freeman’s counsel seemed
to suggest otherwise. Specifically, counsel stated, “Roche,
in their internal documents, admits there’s an association—a
causal association. The document I’m referring to is signed
off by their Global Head of Safety. . . . Their very label on
this drug says Accutane is associated with inflammatory bowel
disease.” To the extent that these documents are included in
our record, we find no admission of a causal association. In
fact, the cited document mentioned only an association, not
a causal association. Similarly, the label states merely that
“Accutane has been temporally associated with inflammatory
bowel disease.” And an association does not necessarily equate
to causation.
19
See Schafersman v. Agland Coop, supra note 4.
20
Roskop Dairy v. GEA Farm Tech., 292 Neb. 148, 871 N.W.2d 776 (2015).
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FREEMAN v. HOFFMAN-LA ROCHE, INC.
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Because there was no genuine issue of fact as to the ele-
ment of causation, Roche was entitled to judgment as a matter
of law.
VI. CONCLUSION
The district court did not abuse its discretion in excluding
the expert testimony after finding that the expert’s methodol-
ogy was unreliable and conclusion-driven. With the exclusion
of this expert testimony, there remained no issue of material
fact. Consequently, the district court did not err in granting
summary judgment in favor of Roche. We affirm.
A ffirmed.