Quidel Corporation v. Siemens Medical Solutions USA, Inc. et al
Filing
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ORDER denying Plaintiff's 151 Motion to Exclude Rebuttal Opinions of Arthur L. Caplan. Signed by Judge Cynthia Bashant on 9/27/2019. (jah)
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UNITED STATES DISTRICT COURT
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SOUTHERN DISTRICT OF CALIFORNIA
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QUIDEL CORPORATION,
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Case No. 16-cv-3059-BAS-AGS
Plaintiff,
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v.
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SIEMENS MEDICAL SOLUTIONS
USA, INC., et al.,
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ORDER DENYING PLAINTIFF’S
MOTION TO EXCLUDE
REBUTTAL OPINIONS AND
TESTIMONY OF ARTHUR L.
CAPLAN
[ECF No. 151]
Defendants.
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Plaintiff Quidel Corporation and Defendants Siemens Medical Solutions USA,
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Inc. and Siemens Healthcare Diagnostics Inc. have filed motions seeking to exclude
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the opinions of the other party’s expert. The Court first turns to Plaintiff’s motion to
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exclude the rebuttal opinions and testimony of Defendants’ expert Dr. Arthur L.
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Caplan. (“Caplan Mot.,” ECF No. 151.) For the foregoing reasons, the Court denies
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the Motion.
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I.
Relevant Background 1
On January 11, 2019, the deadline for expert designation disclosure, Quidel
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A more extensive background and summary of allegations is available in prior orders. Therefore,
the Court only includes background information here that is relevant to the present Motion.
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designated Dr. George J. Kahaly as a scientific expert, and submitted his opening
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expert report. (“Roosevelt Decl.,” ECF No. 151-2, at ¶ 2.) Dr. Kahaly opined
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generally that Defendants’ assay IMMULITE is “not specific for the detection of
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TSI.” (“Kahaly Report,” Exhibit 32 to ECF 156-1, at 23.) He relied, inter alia, on
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two publications authored by him and other scholars:
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• T. Diana, C. Wuster, M. Kanitz, G. Kahaly, Highly variable sensitivity
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of five binding and two bio-assays, Journal of Endocrinological
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Investigation (April 2016); and
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• T. Diana, C. Wuster, P. Olivo, A. Unterrainer, J. Konig, M. Kanitz, A.
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Bossowski, B. Decallonne, G. Kahaly, Performance and Specificity of
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Immunoassays for TSH Receptor Antibodies: A Multicenter Study,
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European Thyroid Journal (August 2017).
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(Id. at 27.) The Court will refer to the two studies as “Diana 2016” and “Diana 2017”
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respectively. Diana is listed as the lead author for both studies, but Kahaly also
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participated in the studies and is listed as an author for both.
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On March 29, 2019, the deadline for rebuttal expert disclosures, Defendants
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served the Expert Rebuttal Report of Dr. Arthur L. Caplan. (Roosevelt Decl. ¶ 3.)
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Caplan’s report was submitted “to respond to and rebut the opinions offered by
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Kahaly in this case.” (“Caplan Report,” Exhibit A to ECF No. 153, at 2.) In his
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report, Caplan provides that he was advised that Kahaly’s opinions largely depend
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on Diana 2016 and Diana 2017. Caplan wrote the report to address the adequacy of
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the authors’ disclosures made in the two publications and how this affected the
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publications’ scientific integrity. (Id.) Caplan was provided information regarding
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Quidel’s relationship with Kahaly and the other authors. (Id. at 6–10.) Caplan
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believes that the relationships were not sufficiently disclosed to the publisher before
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the studies were published. Specifically, in the journals’ “conflict of interest”
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sections for both studies, Diana and Kanitz stated they had “nothing to disclose” and
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Kahaly said he “consults for Quidel.” (Id. at 12, 14.)2 Caplan opined that the conflict
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of interest disclosures “are inconsistent with widely accepted ethical disclosure
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standards, the represented disclosure standards of the two publishing journals, and
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[the Johannes Gutenberg University Medical Center]’s disclosure standards as stated
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by Kahaly.” (Id. at 15.) According to Caplan and the information he was provided,
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Quidel “funded both studies and paid for Diana [and Kanitz] to work full time on
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Quidel-funded studies since 2011” and this should have been disclosed. (Id. at 15,
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16.) The studies were “initialed by Quidel, supervised by Quidel, and resulted in
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findings that directly benefited Quidel and its commercial interests.” (Id. at 16.) This
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adversely affects the scientific integrity of the studies. (Id.) In sum, “Kahaly’s expert
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opinions have limited (if any) probative value, particularly to the extent his opinions
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rely on the Diana 2016 and Diana 2017 publications.” (Id. at 22.)
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II.
Analysis
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Quidel seeks to exclude the opinions and testimony of Dr. Caplan. Quidel’s
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argument is three-fold: first, Dr. Caplan’s rebuttal opinions are not actually made in
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rebuttal, second, Dr. Caplan’s opinions do not meet the Daubert standard of
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reliability and relevance, and third, Dr. Caplan’s opinions are likely to mislead and
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confuse the jury and will encroach on the jury’s function to make credibility
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determinations.
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A.
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Whether Caplan’s Report is Appropriately a Rebuttal Report
1.
Legal Standard for Rebuttal Reports
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Expert rebuttal reports must be “intended solely to contradict or rebut evidence
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on the same subject matter identified by another party” in that other party’s expert
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Defendants provide an in-depth background section laying out the details of Kahaly and Quidel’s
relationship, along with over a dozen exhibits providing evidence of the relationship. (“Caplan
Opp’n,” ECF No. 154, at 3–9; ECF No. 154-1.) The details of the relationship are irrelevant. What
is relevant is that Kahaly had a relationship with Quidel before he conducted the studies, he
disclosed to the publishing journal that he was a “consultant,” and Caplan opined the disclosure
was insufficient.
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disclosures. Fed. R. Civ. P. 26(a)(2)(D)(ii). The phrase “same subject matter” should
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be read narrowly because a broad reading that “encompass[es] any possible topic that
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relates to the subject matter at issue[ ] will blur the distinction between ‘affirmative
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expert’ and ‘rebuttal expert.’” Vu v. McNeil–PPC, Inc., No. CV 09–1656, 2010 WL
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2179882, at *3 (C.D. Cal. May 7, 2010). “Accordingly, a careful analysis of each of
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the Plaintiff’s expert[’]s proposed testimony and the corresponding [Defendant’s]
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expert[’]s rebuttal testimony is required to determine if the rebuttal testimony is
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proper.” Hellman–Blumberg v. Univ. of Pac., No. 12–cv–00286, 2013 WL 3422699,
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at *2 (E.D. Cal. July 8, 2013).
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If a disclosed rebuttal expert is not proper, “Rule 37 ‘gives teeth’ to Rule 26’s
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disclosure requirements by forbidding the use at trial of any information that is not
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properly disclosed.” Goodman v. Staples the Office Superstore, LLC, 644 F.3d 817,
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827 (9th Cir. 2011) (citing Yeti by Molly, Ltd. v. Deckers Outdoor Corp., 259 F.3d
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1101, 1106 (9th Cir.2001)). Rule 37(c)(1)’s exclusion sanction is mandatory unless
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failure to disclosure is substantially justified or harmless. Fed. R. Civ. Pro. 37(c)(1).
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2.
Analysis
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Quidel argues Caplan is not a rebuttal expert to Kahlay because the report is
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not a response to Kahaly’s. Specifically, Caplan opines on conflict of interest
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disclosures, but Kahaly has not been designated and is not providing expert opinions
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on conflict of interest disclosures. (Caplan Mot. at 6.)
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The Court disagrees. Caplan is responding to a portion of Kahaly’s report.
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Kahaly relies on and cites Diana 2016 and Diana 2017 in his report. (Kahaly Report
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at 27.) Caplan opines that the studies are flawed, and therefore, the report is flawed
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to the extent it relies on the studies. The Court finds that this is sufficiently a rebuttal
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report. Indeed, there is no requirement that “a rebuttal expert read[] the opening
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expert report cover to cover, and then write[] a rebuttal report outlining each and
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every criticism of the opening expert’s opinions.” Pinterest, Inc. v. Pintrips, Inc.,
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No. 13-cv-4608, 2015 WL 2268498, at *2 (N.D. Cal. May 14, 2015). Caplan
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responds to what Defendants deem to be a “fundamental flaw” in Kahaly’s report.
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Id. “That [Caplan’s] work was targeted at a specific topic identified by counsel—as
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opposed to addressing all purported defects in the [Kahaly report]—makes
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[Caplan’s] testimony no less proper as rebuttal evidence.” Id. Rebuttal testimony is
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permitted to “question the assumptions and methods” of an opposing expert.”
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LaFlamme v. Safeway, Inc., No. 09-cv-514-ECR-VPC, 2010 WL 3522378, at *8 (D.
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Nev. Sept 2, 2010). Caplan’s report does so, questioning a partial basis of Kahaly’s
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report. Caplan’s report is appropriately deemed a rebuttal report and the Court
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declines to strike the report for this reason.
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B. Whether Dr. Caplan’s Opinions Are Reliable, Relevant, and
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Appropriate
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1.
Legal Standard
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Rule 702 of the Federal Rules of Evidence governs the admissibility of expert
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testimony. Ollier v. Sweetwater Union High Sch. Dist., 768 F.3d 843, 859 (9th Cir.
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2014). Rule 702 provides that a witness “qualified as an expert by knowledge, skill,
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experience, training, or education may testify in the form of an opinion or otherwise
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if”:
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(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;
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(d) the expert has reliably applied the principles and methods to the
facts of the case.
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Fed. R. Evid. 702. Under Rule 702, expert testimony must be both relevant and
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reliable. Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457, 462 (9th Cir. 2014).
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Relevancy simply requires that “[t]he evidence . . . logically advance a material aspect
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of the party’s case.” Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007). Reliability
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requires that an expert’s testimony “have a reliable basis in the knowledge and
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experience of his discipline.” Estate of Barabin, 740 F.3d at 462 (quoting Kumho
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Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 148 (1999)).
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Courts are not concerned with the “correctness of the expert’s conclusions but
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the soundness of his [or her] methodology.” Primiano v. Cook, 598 F.3d 558, 564
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(9th Cir. 2010) (quoting Daubert v. Merrell Dow Pharms., 43 F. 3d 1311, 1318).
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“For scientific opinion, the court must assess the reasoning or methodology, using as
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appropriate such criteria as testability, publication in peer reviewed literature, and
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general acceptance, but the inquiry is a flexible one.” Id. at 564. “Shaky but
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admissible evidence is to be attacked by cross examination, contrary evidence, and
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attention to the burden of proof, not exclusion.” Id.; see also Daubert, 509 U.S. at
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595–96.
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The duty falls upon the district court to act “in a gatekeeping role, to assess
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whether the reasoning or methodology underlying the testimony is valid and whether
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that reasoning or methodology properly can be applied to the facts in issue.” Ollier,
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768 F.3d at 860 (quoting Daubert, 509 U.S. at 592–93) (internal quotation marks
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omitted). The party seeking to offer the testimony bears the burden of establishing
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its admissibility. In re ConAgra Foods, Inc., 302 F.R.D. 537, 549 (C.D. Cal. 2014).
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2.
Analysis
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Quidel argues Caplan’s opinions are “speculative and unhelpful.” (Caplan
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Mot. at 7.) In making this argument, Quidel focuses on the substance of the Kahaly
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report, arguing that Caplan does not discuss “whether the science in the two journal
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articles or in Dr. Kahaly’s report is valid or invalid.” (Id.) But this is irrelevant.
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Caplan specifically stated he is “not offering any opinions in this case on the science
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relating to Grave’s [sic] disease testing.” (“Caplan Depo.,” Exhibit B to ECF No.
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153, at 17:8–12.) Therefore, his report did not, and actually should not, focus on the
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underlying science, but instead focused on one specific aspect: conflict of interest
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disclosures. This does not mean his report is “unhelpful.” It is also not relevant that
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Caplan may be unaware “to what extent” Kahaly relied on the Diana articles.
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(Caplan Mot. at 7.) Caplan opined that to the extent Kahaly’s report is based on the
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two articles, the opinions have little if any probative value. The value of Kahaly’s
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report as it depends on the two publications is relevant and therefore not speculative.
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The Court declines to strike the report for this reason.
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Quidel next argues Caplan’s opinions are unreliable because he is not qualified
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to testify on the adequacy of disclosures in scientific journal articles. (Caplan Mot.
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at 8.) Quidel provides almost no detail behind this argument besides stating that
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Caplan has not previously been retained as an expert on the subject. But an expert
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can be qualified “by knowledge, skill, experience, training, or education.” Fed. R.
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Evid. 702. And Quidel admits Caplan has written “8 or 9 articles on the topic of
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adequacy of disclosures in journal articles.” (Id. at 3.) 3 Caplan analyzed what
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conflicts the two journals require authors to disclose, and what other relevant
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authorities require. Based on this, he opines the authors’ disclosures for both Diana
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studies were insufficient. Caplan is therefore qualified based on his knowledge,
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experience, and studies. A criticism that Caplan did not consider enough material in
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forming his opinion is not a proper objection. Kennedy v. Collagen Corp., 161 F.3d
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1226, 1231 (9th Cir. 1998) (“Disputes as to the strength of [an expert’s] credentials,
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faults in his use of [a particular] methodology, or lack of textual authority for his
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opinion, go to the weight, not the admissibility, of his testimony.” (internal quotation
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marks omitted)).
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Quidel’s further argues that the Diana studies were “accepted for publication”
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and therefore the peer review process before publication shows the studies were
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“good science” and should not be questioned here. (Caplan Mot. at 11.) This
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argument has no merit. Simply because an article is deemed sufficient for publication
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Quidel strangely focuses on the fact that Caplan has written approximately 800 articles in his
career, and Quidel points out that “only” 8 or 9 of this large number of articles were written on the
topic of disclosures. (Caplan Mot. at 3.) Caplan’s breadth of knowledge is completely irrelevant.
Simply because someone is widely published on a variety of topics does not mean that he cannot
be qualified to provide an opinion on one of those topics.
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does not mean that the publisher looked for any possible conflict of interest. Instead,
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there is no evidence that the publisher did not simply accept the authors’ submissions
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that there was no relevant conflict of interest. A “peer review” showing that the study
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was “good science” has nothing to do with whether the authors operated under a
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conflict of interest.
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Quidel’s last argument is that Caplan is improperly trying to evaluate Kahaly’s
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credibility, which is a jury function. (Caplan Mot. at 9.) This is not true. Caplan
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opines on the soundness of Kahaly’s expert report based on the evidence he cited;
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this has nothing to do with whether Kahaly is a credible witness. Caplan’s report
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should not be struck for this reason.
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The Court finds Caplan’s report to be sufficiently reliable and relevant, and
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that it does not invade the province of the jury.
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III.
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Conclusion
For the foregoing reasons, the Court DENIES Plaintiff’s Motion to Strike,
(ECF No. 151).
IT IS SO ORDERED.
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DATED: September 27, 2019
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