In re: INCRETIN-BASED THERAPIES PRODUCTS LIABILITY LITIGATION, JEAN ADAMS, On… v. Novo Nordisk A/s

NOT FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
In re: INCRETIN-BASED THERAPIES
PRODUCTS LIABILITY LITIGATION,
______________________________
JEAN ADAMS, On Behalf of Herself and
All Other Similarly Situated Plaintiffs,
Plaintiff-Appellant,
v.
NOVO NORDISK A/S,
Defendant-Appellee.
No. 21-55342
D.C. No.
3:13-md-02452-AJB-MDD
MEMORANDUM*
Appeal from the United States District Court
for the Southern District of California
Anthony J. Battaglia, District Judge, Presiding
Argued and Submitted March 7, 2022
San Francisco, California
Before: S.R. THOMAS and McKEOWN, Circuit Judges, and ORRICK,** District
Judge.
FILED
MAR 28 2022
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
* This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
** The Honorable William Horsley Orrick, United States District Judge
for the Northern District of California, sitting by designation.

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Jean Adams, on behalf of herself and similarly situated plaintiffs, appeals the
summary judgment granted by the district court in favor of Novo Nordisk A/S
(“Novo”) on plaintiffs’ claim that Novo’s product liraglutide can cause pancreatic
cancer, and that Novo failed to adequately warn of this risk.
Because the parties are familiar with the factual and procedural history of
this case, we need not recount it here. We review orders granting summary
judgment de novo, but we review for abuse of discretion the district court’s
decision to exclude the testimony of an expert witness. Wendell v.
GlaxoSmithKline, 858 F.3d 1227, 1231 (9th Cir. 2017). We affirm.
I
The district court did not abuse its discretion in excluding the testimony of
Dr. Robert Gale after conducting an extensive hearing pursuant to Daubert v.
Merrell Dow Pharms., Inc., 509 U.S. 579 (1993). Considerations relevant to
evaluating the reliability of an expert’s theory include, but are not limited to,
whether the theory can be tested or has been subject to peer review, its known error
rate, and whether it is generally accepted in the scientific community. Id. at
593–94. On appeal, we afford the district court “the same broad latitude when it
decides how to determine reliability as it enjoys in respect to its ultimate reliability
determination.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 142 (1999).
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In making its Daubert determination, the district court properly relied on the
uncontested fact that Dr. Gale did not independently review studies that had been
published between 2015 and Dr. Gale’s final 2019 report, all of which found no
causal relationship between liraglutide use and the development of pancreatic
cancer.
The district court did not abuse its discretion in finding that Dr. Gale’s
reliability was further impeded by his failure to explain his “weight-of-the-
evidence” methodology. To demonstrate testability under Daubert, an expert must
provide sufficient explanation for their methodology such that “[s]omeone else
using the same data and methods [would] be able to replicate the result[s].” City of
Pomona v. SQM N. Am. Corp., 750 F.3d 1036, 1047 (9th Cir. 2014) (first alteration
in original) (citation and internal quotation marks omitted). The record supports
the district court’s conclusion that the expert’s reports did not provide a
meaningful methodological explanation. In the absence of such an explanation, the
district court had no means to ensure that Dr. Gale’s “conclusions were not mere
subjective beliefs or unsupported speculation.” Claar v. Burlington N. R.R. Co., 29
F.3d 499, 502 (9th Cir. 1994).
Finally, the district court properly considered the fact that Dr. Gale is
“alone” in the scientific community in concluding that the relevant compounds
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cause pancreatic cancer, “despite years of research into the pancreatic safety of
incretin mimetics conducted by various medical, scientific, and regulatory
entities.” See Daubert, 509 U.S. at 594.
Our decision in Wendell is not to the contrary. There, we did emphasize that
experts may rely on their own “extensive clinical experience,” in combination with
a review of all relevant existing literature, in carrying out a differential diagnosis
and formulating an opinion on specific causation. See 858 F.3d at 1234–35, 1237.
But the expert reports here did not provide any differential diagnoses or opinions
on specific causation, and nothing in Wendell absolves expert witnesses of the
general and longstanding requirement that they explain their methods with enough
detail that their results can be replicated. See Claar, 29 F.3d at 502.
For these and the other reasons provided by the district court, we conclude
that the district court did not abuse its considerable discretion in excluding Dr.
Gale’s testimony under Daubert.
II
Plaintiffs asserting a failure-to-warn claim in the pharmaceuticals context
must prove general causation—that is, that “the substance at issue had the capacity
to cause the harm alleged.” In re Hanford Nuclear Reservation Litig., 292 F.3d
1124, 1133 (9th Cir. 2002). Proving this element generally requires expert witness
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testimony. See Lust by and through Lust v. Merrell Dow Pharms., Inc., 89 F.3d
594, 598 (9th Cir. 1996). Dr. Gale’s expert testimony was the only evidence in the
record that directly supported the plaintiffs’ theory of general causation. Thus,
with the exclusion of the expert testimony on causation, the district court properly
entered summary judgment.
Given our resolution of this case, we need not—and do not—opine on any
other theory or argument urged by the parties, or the alternate basis for summary
judgment given by the district court.
AFFIRMED.
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