Lewert v. Boiron, Inc.
Lewert v. Boiron, Inc.
Opinion of the Court
Proceedings: [In Chambers] ORDER DENYING Motions for Summary Judgment (Dkt. Nos. 242, 244), DENYING Defendants’ Motion to Strike (Dkt. No. 273), and DENYING in part and GRANTING in part Plaintiffs Motion to Strike (Dkt. No. 272)
Before the Court are Plaintiffs Motion for Partial Summary Judgment (“Pl.’s MSJ”), filed October 13, 2015 (Dkt. No. 242); Plaintiffs Motion to Strike Certain Expert Opinions Submitted by Defendants (“Pl.’s Motion to Strike”), filed November 16, 2015 (Dkt. No. 272); Defendants’ Motion for Summary Judgment (“Defs.’ MSJ”), filed October 13, 2015 (Dkt. No. 244); and Defendants’ Motion to Strike Plaintiffs Expert (“Defs.’ Motion to Strike”), filed November 16, 2015 (Dkt. No. 273).
I. BACKGROUND
The crux of the parties’ dispute is whether Defendants’ products, Oscillocoe-cinum and Children’s Oscillococcinum (the “Products” or “Oseillo”), provide relief for flu-like symptoms as promised on the Products’ packaging. 2d Am. Compl. (“SAC”) ¶ 1, Dkt. No. 128; PL’s MSJ at 1; Defs.’ MSJ at 1. Oseillo is a homeopathic drug labeled as containing the active ingredient Anas Barbariae Hepatis et Cordis extractan 200ck HPUS (“Anas Barbari-ae”), derived from crushed and incubated duck hearts and livers and the inactive ingredients sucrose and lactose. SAC ¶2; Pl.’s MSJ at 2; Defs’ Separate Statement of Genuine Issues of Material Fact (“Defs.’ SGD”) Nos. 4-6, 11. It is undisputed that the Anas Barbariae is incorporated into Oseillo by mixing 1 ml of a solution with the starting material with 99 ml of a solvent such as water and then repeating this dilution process 200 times according to a method of manufacturing known as the Korsakovian method (thus explaining the number “200CK” in the active ingredient title). SAC ¶ 4; Defs.’ SGD Nos. 23-26. After the 200CK dilutions are completed, the final solution is then “impregnated” onto sugar granules made from sucrose and lactose. Defs.’ SGD No. 47.
Plaintiff alleges in this class action that Defendants are liable for violations of California’s Unfair Competition Law (“UCL”), codified at California Business and Professions section 17200, and California’s Consumer Legal Remedies Act (“CLRA”), codified at California Civil Code section 1750, because Plaintiff purchased Oseillo in reliance on Defendants’ affirmative representations on its label that Oseillo would relieve Plaintiffs flu-like symptoms and taking Oseillo did not relieve Plaintiffs symptoms as represented. SAC ¶¶ 21-48, 56-78.
Plaintiff now argues in his Motion for Summary Judgment (and Opposition to Defendants’ Motion for Summary Judgment) that Oscillo’s labeling is false as a matter of law because, as found by Plaintiffs expert Dr. Siavash Kurdistani, the active ingredient in Oseillo has been diluted to essentially zero and thus cannot possibly work to relieve flu-like symptoms. Pl.’s MSJ at 8-11; Pl.’s Reply in support of MSJ at 5-12; PL’s Opp. to Defs.’ MSJ at 16-20. Defendants respond and argue in their Motion for Summary Judgment (and Opposition to Plaintiffs Motion for Summary Judgment) that, to the contrary, Plaintiff cannot meet his burden to prove Oseillo is ineffective because Dr. Kurdista-ni is unqualified to offer an opinion in this case and because, even if he were qualified, Dr. Kurdistani’s work shows only that Oseillo is highly diluted, while Defendants have presented their own expert testimony and studies to show that Oseillo is still effective to relieve flu-like symptoms despite its dilution. Defs.’ MSJ at 16-18; Defs.’ Reply in support of MSJ at 2-11; Defs.’ Opp. to PL’s MSJ at 7-13. Defendants also argue that, regardless of the parties’ evidence concerning Oseillo, Plaintiffs claims are barred by the doctrines of implied preemption and primary jurisdiction because the Federal Drug Administration (“FDA”) and Federal Trade Commission (“FTC”) are currently considering whether to revise their regulations on homeopathic drugs. Defs.’ MSJ at 11-15.
The parties’ Motions to Strike follow in line with the parties’ primary arguments in
II. IMPLIED PREEMPTION / PRIMARY JURISDICTION
Before turning to the merits of the parties’ arguments concerning'Oscillo, the Court must first' address the threshold question raised in Defendants’ MSJ regarding whether Plaintiffs claims are barred by the doctrines of implied preemption and primary jurisdiction. In August 2013, the Court denied Defendants’ Motion for Judgment on the Pleadings on the issues of implied preemption and primary jurisdiction, concluding that Plaintiffs state law claims did not seek to impose any requirements in conflict with federal law (thus excluding the possibility of implied preemption) and recognizing that, although the FDA has regulatory authority over homeopathic drugs and special expertise, Defendants had failed to demonstrate that Plaintiffs claims turned on any particular technical issue that required resolution by the agency. Dkt. No. 78 (“August 2013 Order”) at 17-19. Defendants now argue, however, that “significant developments in the Federal government’s handling of homeopathy” require the Court to postpone adjudication of the action. Defs.’ MSJ at 11-14. Defendants’ arguments are not persuasive.
First, as it concerns implied preemption, a plaintiffs state law claims are impliedly preempted by federal statute “when compliance with both state and federal law is impossible, or when the state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 698-99, 104 S.Ct. 2694, 81 L.Ed.2d 580 (1984) (citations and internal quotations omitted) as cited in Defs.’ MSJ at 12 and August 2013 Order at 17.
Second, as it concerns primary jurisdiction, Defendants argue that since August 2013, the FDA and the FTC have begun “actively evaluating” their current regulations concerning homeopathic drugs, but Defendants have failed to identify any potential changes in either agency’s regulations that would impact whether Oscillo’s current label misleads consumers—the question raised by Plaintiffs’ claims. “The primary jurisdiction doctrine allows courts to stay proceedings or to dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency ... [and] is to be used only if a claim involves an issue of first impression or a particularly complicated issue Congress has committed to a regulatory agency, and if protection of the integrity of a regulatory scheme dictates preliminary resort to the agency which administers the scheme.” Clark v. Time Warner Cable, 523 F.3d 1110, 1114 (9th Cir. 2008) (quotations and citations omitted) (emphasis added); see also Syntek Semiconductor Co. v. Microchip Tech., Inc., 307 F.3d 775, 781 (9th Cir. 2002) (recognizing four factors to consider in applying primary jurisdiction as “(1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.”).
Here, Defendants have presented evidence that, since March 2015, the FDA and FTC have held hearings and workshops to evaluate their current regulations concerning homeopathic drugs generally and that the FTC has recommended that the FDA reconsider its regulatory framework for greater consistency with FTC advertising requirements. See Defs.’ MSJ at 13-14; Defs.’ Request for Judicial Notice, Exhibit K, Dkt. No. 245. But to date, none of these developments have resulted in policy changes or even policy change recommendations that show the FDA or the FTC are considering issues related to whether Oscillo’s labeling is misleading, and none of these developments demonstrate that the FDA or FTC currently are or will be providing necessary technical guidance on any issues that would impact the outcome of this litigation. The doctrine of primary jurisdiction does not require the Court to delay this litigation based purely on the possibility that the FDA or the FTC might issue new regulations sometime in the future that might change how homeopathy drugs are labeled, particularly when Plaintiffs current claims focus solely on the non-technical question of whether Oscillo’s labels are false or misleading.
III. MOTIONS TO STRIKE EXPERT TESTIMONY
As noted above, the parties have moved for summary judgment primarily on the grounds that the other side’s expert testimony should be stricken. The Court will thus first address the parties’ Motions to Strike and then apply its ruling on these Motions to the parties’ MSJs.
A. Legal Standard
Under Rule 702 of the Federal Rules of Evidence, “[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,” provided that:
(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.
“In applying Rule 702, the Court functions as a gatekeeper, determining whether proffered expert testimony meets the requirements of Rule 702 by a preponderance of the evidence.” In re Countrywide Fin. Corp. Mortgage-Backed Sec. Litig., 984 F.Supp.2d 1021, 1026 (C.D. Cal. 2013) (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) (“Daubert 7”)). Thus, before admitting expert testimony, courts must make a “preliminary assessment” of (1) whether the expert is qualified to present the opinion offered, (2) “whether the reasoning or methodology underlying the testimony is scientifically valid,” and (3) “whether that reasoning or methodology properly can be applied to the facts in issue.” Daubert I, 509 U.S. at 592-93, 113 S.Ct. 2786; see also In re Silicone Gel Breast Implants Prods. Liab. Litig., 318 F.Supp.2d 879, 889-93 (C.D. Cal. 2004) (using three-part inquiry under Rule 702 to test expert’s qualifications, the reliability of the testimony, and the usefulness of the testimony).
In making this preliminary assessment, the court should not weigh conflicting expert testimony or attempt to determine whether the conclusions are correct. See Wyler Summit P’ship v. Turner Broad.
“To this end, the party proffering the expert testimony ‘must show that the expert’s findings are based on sound science’ by providing ‘objective, independent validation of the expert’s methodology.’ ” In re Countrywide Fin. Corp. Mortgage-Backed Sec. Litig., 984 F.Supp.2d at 1026 (quoting Daubert II, 43 F.3d at 1316). This test for reliability is flexible, however, and the court has “broad latitude” in applying it. Kumho, 526 U.S. at 141-42, 119 S.Ct. 1167. The court may consider such factors as (1) the “general acceptance of the method in the scientific community”; (2) “whether the method has been subject to publication or peer review”; (3) “whether the known or potential error rate is acceptable”; (4) “whether the testimony is based on independent research or prepared specifically for litigation”; and (5) “whether the expert points to an objective source to show that she has followed the scientific method.” In re Countrywide Fin. Corp. Mortgage-Backed Sec. Litig., 984 F.Supp.2d at 1026 (citing Daubert II, 43 F.3d at 1316-19). But ultimately, “the circumstances of the particular case will dictate which factors the district court should consider in making its determination.” Id. (citing Kumho, 526 U.S. at 150, 119 S.Ct. 1167).
B. Defendants’ Motion to Strike
The Court begins with Defendants’ Motion to Strike, as it is focused solely on the opinions of Dr. Kurdistani, Plaintiffs expert. According to Dr. Kurdistani’s expert report, Plaintiff has retained him “to address whether the purported ‘active ingredient’ listed on the labeling of Oscillo, ‘Anas Barbariae Hepatis Et Cordis Ex-tractum—200 CK’, includes any of the Anas barbariae hepatis et cordis (duck liver and heart) and whether clinical studies support the claims made on the packaging of Oscillo.” Declaration of Elliott Henry in support of Defs.’ Mot. to Strike (“Henry Deck”), Ex. A (“Kurdistani Report”), ¶ 6. Based on his analysis of Oscillo’s reported preparation and assessment of Defendants’ clinical studies, Dr. Kurdistani concludes that Oscillo is “nothing more than a sugar pill with no active ingredients whatsoever” and that “the reported clinical trials that have assessed Oscillo’s efficacy are fundamentally flawed and therefore cannot be used to substantiate the claims made by Boiron on the packaging.” Id. at ¶ 7.
Beginning with the first prong of the court’s assessment under Daubert I, Defendants argue that Dr. Kurdistani is not
In both arguments, however, Defendants have misconstrued the qualification requirements for expert testimony. To render his opinion on Oscillo’s dilution, Dr. Kurdistani analyzed Oscillo’s reported dilution processes and calculated that, based on these processes, it is “practically impossible to have any molecule of the original material [of the active ingredient] left after 200CK dilution regardless of the concentration of the starting material.” Kurdista-ni Report at ¶ 16. Dr. Kurdistani recognized both in his report and in deposition that the dilution principles he applied in reaching this conclusion “are taught in any introductory chemistry course at the high school or beginning graduate level” and that “[a]nyone with a rudimentary knowledge of chemistry would know these fundamental principles which are discussed in any basic chemistry textbook.” Id. at ¶ 10; Henry Deck, Ex. B (“Kurdistani Depo”) at 229:7-12, 232:16-19. Defendants use these statements to argue that Dr. Kurdistani offers no “specialized knowledge, skill or expertise” on the issue of dilution. Defs’ Mot. to Strike at 5. But under Rule 702, an expert’s testimony need not be complicated to offer specialized expertise. See, e.g., Microsoft Corp. v. Motorola, Inc., No. C10-1823, 2013 WL 4008822, at *6 (W.D. Wash. Aug. 5, 2013) (recognizing there,is no “implicit requirement in Federal Rule of Evidence 702 that the proffered expert make complicated mathematical calculations” and admitting accounting expert’s testimony where expert’s basic role was to “compile the costs and do the math” using general accounting principles); PixArt Imaging, Inc. v. Avago Tech. Gen. IP (Singapore) Pte. Ltd., No. C 10-00544, 2011 WL 5417090, at *5 (N.D. Cal. Oct. 27, 2011) (admitting expert testimony on calculation of damages as helpful to the trier of fact despite party’s objection that the testimony offered only “basic mathematical calculations”). Even if a knowledgeable high
Defendants further argue that Dr. Kurdistani is unqualified to opine on four clinical studies Defendants rely upon to prove the efficacy of Oscillo—the “Ferley” study, the “Papp” study, and two “Cassa-nova” studies
Concerning the second prong of the Daubert analysis, Defendants next argue that Dr. Kurdistani’s methodology is inherently unreliable because (1) he conducted
Concerning the first point, Defendants contend that Dr. Kurdistani failed to consider “obvious alternative explanations” in the form of other clinical studies that might show Oscillo is effective. Id. at 10-11 (quoting Fed. R. Evid. 702 cmt.). Defendants fail to recognize, however, that this rule simply expresses one form of an unacceptable methodology, and it focuses on whether the expert reviewed alternative explanations for the data collected, not on whether the expert considered alternate data sources. As explained in Pooshs v. Phillip Morris USA, Inc., 287 F.R.D. 543 (N.D. Cal. 2012), “[s]cientific evidence is reliable if it is based on an assertion that is grounded in methods of science—the focus is on principles and methodology, not on conclusions.” 287 F.R.D. at 546 (quoting Metabolife Int’l, Inc. v. Wornick, 264 F.3d 832, 841 (9th Cir. 2001)). Thus, in addition to the four factors listed above in Section III.A, such as general acceptance and error rate, courts may consider other factors such as “whether an expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion, see General Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997); or whether an expert has adequately accounted for obvious alternative explanations, see Claar v. Burlington Northern R. Co., 29 F.3d 499, 502 (9th Cir. 1994).” Id. Claar, as cited in the advisory notes to Rule 702, provides one example. There, the court held that the opinions of two expert doctors were unreliable in part because the experts had not followed accepted scientific methods of medical diagnosis because they failed to rule out other causes of the injuries that the plaintiffs sustained. 29 F.3d at 502. The conclusion in Claar was not that expert opinion is unreliable unless the expert researches all possible alternative sources of data leading to a contrary conclusion. Rather, the conclusion in Claar expresses .the principle that “[a] methodology may not be reliable if an expert ‘fail[s] to address and exclude alternative explanations for the data on which he bases his findings’ or ‘reject[s] studies reporting contrary empirical findings.’ ” Pooshs, 287 F.R.D. at 546 (quoting Carnegie Mellon Univ. v. Hoffmann-LaRoche, Inc., 55 F.Supp.2d 1024, 1034-35 (N.D. Cal. 1999)) (emphasis added).
Applying this rule here, Dr. Kurdistani is not required to research additional clinical studies regarding the overall effectiveness of Oscillo in order to make his conclusions about its chemical makeup reliable. Instead, Defendants’ critique would apply only if there were obvious alternative explanations for the dilution data that Dr. Kurdistani considered or if there were obvious alternative explanations for why the four clinical trials that he reviewed were sound. Defendants have not made either showing, however, and their first reliability argument thus fails. See, e.g., Bergen v. F/V St. Patrick, 816 F.2d 1345, 1352 n.5 (9th Cir. 1987) opinion modified on reh’g, 866 F.2d 318 (9th Cir. 1989) (“The relative weakness or strength of the factual underpinnings of the expert’s opinion goes to weight and credibility, rather than admissibility.”) (quotations omitted); In re Toyota Motor Corp. Hybrid Brake Mktg., Sales Practices and Prods. Liab. Litig., No., MDL 10-02172, 2012 WL 4904412, at *3 (C.D. Cal. Sept. 20, 2012) (recognizing that whether an expert’s “reasonable assumptions are true and whether his opinions
For similar reasons, Dr. Kurdistani’s decision not to run his own chemical analysis is also not fatal to his opinions. The Ninth Circuit has expressly held that an expert’s opinion is not unreliable as a matter of law simply because the expert’s opinions “are based on data collected by others.” Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134, 1141—42 (9th Cir. 1997); see also Fed. R. Evid. 703. Rather, as long as his testimony is based on “the scientific method, as it is practiced by (at least) a recognized minority of scientists in the field” the expert’s opinion is sufficiently reliable to meet the Daubert standard for reliability. Id: (quotations omitted). Here, Dr. Kurdistani’s work appears to conform to this method. He begins with the data supplied by Oscillo regarding its dilution, calculates how this process would dilute the active ingredient, and then reaches the conclusion that, based on his calculations, the 200ck dilution process would virtually eliminate the active ingredient in Oscillo before the solution was impregnated onto the sugar crystals forming the pill. Kurdis-tani Report at ¶¶ 12-17. Defendants have offered no reason why this process does not conform to the scientific method—arguing only that his conclusion must be speculation because he did not perform the actual dilution process. Defs.’ Mot. to Strike at 11. This again goes to weight rather than admissibility.
Concerning the final prong of the Dau-bert test, Defendants argue that Dr. Kur-distani’s testimony should be excluded under both Rule 702 and Rule 403 because his opinion is likely to confuse the jury rather than assist them in evaluating the evidence. Defs’ Mot. to Strike at 15-18. Of the three arguments Defendants offer on this point, two have already been resolved—the Court has determined that Dr. Kurdistani’s opinions are sufficiently reliable to pass Rule 702’s standards and that any remaining issues concerning the reliability of his opinions (even those concerning what Defendants describe as “conjecture”) may be addressed on cross-examination, and as addressed below, the Court has found that Dr. Kurdistani should supplement his report and will decide at trial whether any of Dr. Kurdista-ni’s opinions should be excluded as previously undisclosed.
Lastly, apart from the Daubert test, Defendants argue that Dr. Kurdista-ni’s testimony should be excluded under Rule 37(c)(1) of the Federal Rules of Civil Procedure for failure to comply with Rule 26(a)(2)(B) of the Federal Rules of Civil Procedure. Under Rule 26(a)(2)(B), an expert must disclose in his report “a complete statement of all opinions the expert will express and the basis and reasons for them” and “the data or other information considered by the witness in forming them.” Fed. R. Civ. Proc. 26(a)(2)(B)(i)-(ii). The purpose of this rule is “to require the disclosure of ‘information regarding expert testimony sufficiently in advance of trial that opposing parties have a reasonable opportunity to prepare for effective cross examination and perhaps arrange for expert testimony from other witnesses.’ ” In re Google Adwords Litig., No. C08-03369, 2010 WL 5185738, at *2 (N.D. Cal. Dec. 8, 2010) (quoting Fed. R. Civ. P. 26 cmt 1993 Amend.). And under Rule 37(c)(1), a party who fails to disclose the required materials in its expert report may be barred from using that expert unless there was “substantial justification” for the failure or the failure was “harmless.” Fed. R. Civ. Proc. 37(c)(1).
Defendants first argue that Dr. Kurdistani failed to disclose all of the materials he considered in developing his opinions and his opinions should thus be excluded under Rule 37(c). Defs.’ Mot. to Strike at 11-15. This argument has some merit. Dr. Kurdistani testified in his deposition that he reviewed other materials concerning Oseillo in preparing his report but that he did not recall all of those materials and could not provide a list of them. Kurdistani Depo. at 29:24-25, 36:5-12, 36:17-24, 37:3-12, 56:2-58:24, 203:16-25, 227:2-11, 59:1-16. Plaintiff contends that Dr. Kurdistani did not rely on these materials in reaching his conclusions because he did not believe them relevant and thus had no obligation to disclose them in his report. Pl.’s Opp. to Defs.’ Mot. to Strike at 17-18. But as recognized within the Ninth Circuit:
The scope of discovery should not be limited to documents relied on by the expert in support of his opinions, but should extend to documents considered but rejected by the testifying expert in reaching opinions. In fact, the documents considered but rejected by the expert trial witness could be even more important for cross-examination than those actually relied upon by him.
United States v. City of Torrance, 163 F.R.D. 590, 593-94 (C.D. Cal. 1995) (citations and quotations omitted); see also In re Google Adwords Litig., 2010 WL 5185738, at *3 (“Rule 26(a)(2)(B)(ii) is worded specifically to provide the opposing party with access to all materials reviewed or considered by the expert.”) (quotations omitted) (emphasis added). Defendants are thus entitled to know what materials Dr. Kurdistani reviewed but rejected as irrelevant just as much as they are entitled to know what materials Dr. Kurdistani relied upon in forming his opinions. See, e.g., Propat Int’l Corp. v. Rpost, Inc., No. SACV031011, 2005 WL 5957834, at *1 (C.D. Cal. Sept. 19, 2005) (“Rule 26 requires that an expert disclose, among other things, ‘the data or other information considered by the witness in forming the opinions’ which he expresses. The scope of ‘considered’ data and information is not limited to material upon which the expert relies. As the case law elaborates, the concept of ‘consider’ encompasses ‘to reflect on: think about with a degree of care or caution; to think of, regard or treat in an attentive, solicitous, or kindly way.’ Another court formulated the test this way: ‘The
Contrary to Defendants’ arguments, however, wholesale exclusion of Dr. Kurdistani’s testimony is not required under Rule 37(c)(1) at this time. “A district court has ultimate discretion in imposing discovery sanctions under Federal Civil Procedure Rule 37.” Nat’l R.R. Passenger Corp. v. Young’s Commercial Transfer, Inc., No. 113CV01506, 2016 WL 1573262, at *2 (E.D. Cal. Apr. 19, 2016) (citing Payne v. Exxon Corp., 121 F.3d 503, 507 (9th Cir. 1997)). Here, Dr. Kurdistani is Plaintiffs primary expert, and as demonstrated in Plaintiffs MSJ, Dr. Kurdistani’s testimony concerning the chemical makeup of Oscillo is critical to Plaintiffs theory of the case. See PL’s MSJ at 8-11. Thus, if the Court were to exclude Dr. Kurdistani, it would severely prejudice Plaintiff and controvert the public policy favoring deposition of cases on their merits. It further appears that Dr. Kurdistani’s failure of disclosure may be corrected via supplementation and a limited deposition, neither of which is likely to delay trial, which is currently set for June 7, 2016. See Dkt. No. 322. Dr. Kurdistani’s failure to disclose the materials he reviewed may thus be harmless if Dr. Kurdistani supplements his report to disclose all materials he reviewed in preparing his opinions and if he is subject to deposition on those materials. Accordingly, assuming Dr. Kurdistani is able to provide such supplementation, the Court finds that exclusion under Rule 37(c)(1) is not warranted. This case is thus narrowly distinguishable from Propat Int’l Corp., 2005 WL 5957834, at *2, where the court excluded an expert’s testimony for failure to disclose materials he considered because the trial was only a week away and it was unclear whether further deposition would cure the prejudice to the other party. If Dr. Kurdistani is unable to supplement his report to include all information he reviewed or if he is not made available for deposition before trial, however, the Court will consider at that time whether complete exclusion is appropriate.
Defendants argue additionally that Dr. Kurdistani’s opinions should be excluded because he testified at deposition that he may offer thoughts concerning the Ferley and Papp clinical studies that are not listed in his report. Defs.’ Mot to Strike at 13-14. Defendants are entitled to a full disclosure of the opinions Dr. Kurdistani intends to present. However, Plaintiff correctly notes that Rule 26(a)(2)(B) “does not limit an expert’s testimony simply to reading his report” and “contemplates that the expert will supplement, elaborate upon, and explain his report in his oral testimony.” Fahmy v. Jay Z, No. 2:07-cv-05715, 2015 WL 5680299, at *6 (C.D. Cal. Sept. 24, 2015). Dr. Kurdistani’s deposition testimony cited in Defendants’ Motion does not definitively establish that Dr. Kurdistani intends to present undisclosed opinions at trial, and without additional context at trial, the Court cannot decide in a vacuum how to limit Dr. Kurdistani’s testimony on this point. Accordingly, the Court will reserve ruling on this issue until trial. The Court thus DENIES Defendants’ Motion to strike Dr. Kurdistani’s testimony under Rule 26, without prejudice to renewed objection at trial.
C. Plaintiffs Motion to Strike
The Court next turns to Plaintiffs Motion to Strike. Plaintiff moves to strike six categories of expert testimony on various grounds, seeking to exclude (1) Dr. Du-Mont’s testimony regarding general homeopathy as irrelevant under Rules 401, 403, and 702 of the Federal Rules of Evidence; (2) the declarations of Drs. Kulik-Carlos,
Concerning Plaintiffs relevance arguments, Plaintiff first seeks to exclude Dr. DuMont’s testimony on homeopathy generally and Dr. Spingarn’s testimony on the Chikramane articles on the grounds that this case concerns only Oscillo’s efficacy, and thus testimony concerning general homeopathy and dilution principles is inadmissible. Pl.’s Mot. to Strike at 3-4. Dr. DuMont’s report contains several paragraphs discussing the history, principles, and preparation of homeopathy drugs, which Dr. DuMont offers as context for his opinion that Oscillo is effective because it acts in the same way as other effective homeopathic remedies. Dkt. No. 244-11 (“DuMont Report”) at ¶¶ 23-48. Similarly, Dr. Spingarn’s report contains several paragraphs discussing the Chikramane articles on dilution principles generally, which Dr. Spingarn offers in support of his rebuttal to Dr. Kurdistani that the active ingredient in Oscillo may still be present in the drug despite extreme dilution. Dkt. No. 267-7 (“Spingarn Report”) at ¶9-12. Plaintiff contends that none of this testimony is relevant to any issues in this case and thus should be excluded under Rule 702 and Rule 403. The Court rejects this argument, however.
Under Rule 702, an expert’s testimony is relevant if it “ ‘logically advance[s] a material aspect of the party’s case.’ ” United States v. Pritchard, 993 F.Supp.2d 1203, 1207 (C.D. Cal. 2014) (quoting Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457, 464-65 (9th Cir. 2014)). While Plaintiff maintains that his case focuses solely on the efficacy of Oscillo, Defendants seek to educate the jury on the principles of homeopathy and homeopathic dilution to show why Plaintiffs evidence concerning the molecular makeup of Oscillo is not disposi-tive of its effectiveness. Defendants are entitled to make this argument, and its
For similar reasons, Plaintiff also seeks to exclude testimony from Dr. Du-Mont and the physicians responsible for the Physician Declarations because they offer anecdotal evidence from their patients as to the efficacy of Oscillo, which Plaintiff contends is unreliable as a matter of law. Pl.’s Mot. to Strike at 11-15. Just as Defendants attempted in their Motion to Strike, however, Plaintiff argues that anecdotal medical evidence is irrelevant and unreliable primarily because Plaintiffs own expert intends to offer that opinion.
Plaintiffs arguments against the Physician Declarations under Rule 26 are equally unpersuasive. Plaintiff first argues that the Physician Declarations must be excluded as “irrelevant fact testimony” because they contain no opinions and should not be considered expert testimony in a way that would exclude them from the reaches of the rule against hearsay in Rule 801. Pl.’s Mot. to Strike at 7-8. The Court has already concluded, however, that the patient statements in the declarations fall under the hearsay exception for medical diagnosis (see supra n. 8), and Defendants indicated at oral argument that they intend to present the physicians as live witnesses. The Court has also recognized above that anecdotal evidence is relevant to support of Defendants’ theory concerning Oscillo’s efficacy. As a result, to extent the Physician Declarations may be considered purely factual testimony, Plaintiff has failed to provide sufficient grounds to exclude the Physician Declarations.
Plaintiff then argues in the alternative that the Physician Declarations should be excluded because, if they are considered expert opinion, Defendants have failed to disclose any reports for those physicians as required under Rule 26(a)(2)(B). But under Rule 26(a)(2)(B), the only expert witnesses who must provide a written report of their opinions are experts who are “retained or specially employed to provide expert testimony in the case or one whose duties as the party’s employee regularly involve giving expert testimony.” Fed. R. Civ. Proc. 26(a)(2)(B). There is no indication in the record that Defendants have specially retained the physicians providing the Physician Declarations, nor has Plaintiff established that it is part of the physicians’ duties as employees to provide expert testimony, nor has Plaintiff demonstrated that the physicians are offering any opinion formed outside the scope of their treatment of patients (see Goodman v. Staples The Office Superstore, LLC, 644 F.3d 817, 826 (9th Cir. 2011)). Accordingly, these witnesses will not be excluded based on their failure to provide a report.
Plaintiff further argues under Rule 26 that, if the physicians supplying the Physician Declarations are considered experts, Dr. Pam Middleton (one of those physicians) should be excluded because she was not disclosed until November 10, 2015, and the expert disclosure deadline was September 14, 2015. Pl.’s Mot. to Strike at 15-16. Defendants acknowledge that Dr. Middleton was not disclosed until November 2015, but argue that Rule 37(c) should not apply to exclude Dr. Middleton because this late disclosure was harmless—Plaintiff had the opportunity to review Dr. Middleton’s declaration and seek to depose her before the expert discovery cut-off. Defs.’ Opp. to PL’s Mot. to Strike at 13. The Court agrees. Plaintiff has not countered Defendants’ argument with any showing of prejudice due to Dr. Middleton’s late disclosure, and the record does not indicate any such harm. Accordingly, for all of the above reasons, the Court DENIES Plaintiffs Motion to Strike the testimony in the Physician Declarations under Rule 26.
Finally, turning to Plaintiffs arguments regarding the Ferley and Papp studies, Plaintiff has failed to show how Dr. Isaac-man’s testimony concerning the Ferley and Papp studies is unreliable, outside the testimony of Plaintiffs own expert Dr. Kurdistani. Plaintiff argues that Dr. Isaac-man’s opinions on the Ferley and Papp studies, which Defendants have submitted in rebuttal to Dr. Kurdistani’s opinions on the studies, should be excluded because his analysis did not conform to the scientific requirements for a “meta-analysis” and be
The Court does not reach the same conclusion concerning Dr. DuMont’s testimony regarding the Ferley and Papp studies, however. Dr. DuMont purports to offer testimony in his report that, based on his experience and education, he has “determined” that the Ferley and Papp studies are reliable. DuMont Report at ¶ 54. Dr. DuMont testified in deposition, however, that he has no expertise in statistical analysis or study design and has no ability to judge the quality of either study. DuMont Depo. at 120:5-8, 121:11-15, 133:9-18, 140:16-24, 143:1-18. Given this admission, Dr. DuMont is not qualified to render an opinion that the Ferley and Papp studies are “reliable,” even if such an opinion is caveated that he offers it only as a practitioner, because such an opinion would be inherently subjective and potentially misleading to the jury. See, e.g., Nelson v. Matrixx Initiatives, No. C 09-02904, 2012 WL 3627399, at *12 (N.D. Cal. Aug. 21, 2012), aff'd sub nom. Nelson v. Matrixx Initiatives, Inc., 592 Fed.Appx. 591 (9th Cir. 2015) (“[C]linical judgment does not provide an adequate basis for an opinion on an issue foreign to [an expert’s] clinical practice. This is the type of subjective belief and unsupported speculation that Daubert guards against.”). Accordingly, the Court DENIES Plaintiffs Motion to Strike Dr. Isaacman’s analysis of the Ferley and Papp studies but GRANTS Plaintiffs Motion to Strike Dr. DuMont’s opinions concerning the reliability of the Ferley and Papp studies.
IV. SUMMARY JUDGMENT
Having ruled on the parties’ Motions to Strike, the Court now turns the parties’ Motions for Summary Judgment. Summary judgment is proper where the pleadings, discovery, and affidavits show that there is “no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). In assessing evidence at the summary judgment stage, “the judge does not weigh conflicting evidence with respect to a disputed material fact. Nor does the judge make credibility determinations with respect to statements made in affidavits, answers to interrogatories, admissions, or depositions.” T.W. Elec. Serv., Inc. v. Pac. Elec. Contractors Ass’n, 809 F.2d 626, 630 (9th Cir. 1987). The Court must view the evidence and the inferences therefrom in the light most favorable to the non-moving party, and the moving party bears the initial burden to demonstrate the absence of a genuine issue of fact for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 251-52, 256, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Once the moving party has met its initial burden, the burden shifts to the non-moving party to show a genuine issue for trial by establishing that the fact in contention is material (i.e. affecting the outcome of
Given the Court’s rulings above, there are numerous and clear disputes of material facts that preclude summary judgment in either side’s favor. Plaintiff argues that he is entitled to summary judgment because the “irrefutable scientific facts” established in Dr. Kurdistani’s testimony show that Oscillo is a sugar pill. Pl.’s MSJ at 6, 9-10. But contrary to Plaintiffs characterization, Dr. Kurdista-ni’s testimony is not “irrefutable.” Rather, Defendants have presented sufficient expert testimony to establish a genuine dispute as to whether Oscillo’s dilution methods render the product ineffective. See supra Section III.C. Defendants likewise argue in their MSJ that Plaintiff cannot possible meet his burden to show Oscillo is ineffective because Dr. Kurdistani’s opinion is unreliable.
y. CONCLUSION
For the foregoing reasons, the Court DENIES Plaintiffs Motion for Partial Summary Judgment (Dkt. No. 242) and DENIES Defendants’ Motion for Summary Judgment (Dkt. No. 244). The Court DENIES Defendants’ Motion to Strike (Dkt. No. 273), but ORDERS that Plaintiff shall disclose, within 7 days of this Order, a supplemental report for Dr. Kurdistani in accordance with this Order and make Dr. Kurdistani available for deposition, within 7 days of disclosing the supplemental report, limited to the topic of the new information included in the supplemental report. Finally, the Court GRANTS Plaintiffs Motion to Strike (Dkt. No. 273) as it concerns Dr. DuMont’s opinions concerning the reliability of the Ferley and Papp studies and otherwise DENIES Plaintiffs Motion to Strike.
IT IS SO ORDERED.
. Also before the Court is Plaintiffs Motion to Strike Defendants' Response to Plaintiff’s Statement of Additional Facts and Statement of Genuine Disputes of Material Fact. Dkt. No. 312. The Court does not rely on Defendants’ Response to Plaintiff’s Statement of Additional Facts and Statement of Genuine Disputes of Material Fact in reaching its con-elusions in this Order. Accordingly, the Court DENIES AS MOOT Plaintiff’s Motion to Strike this document. Additionally, the Court has reviewed the parties’ objections to the evidence submitted in support of both Motions for Summary Judgment. Unless otherwise addressed in this Order, these objections are OVERRULED as raised here.
. Defendants do not appear to argue that Plaintiffs claims are barred by the doctrine of implied- "field” preemption. Accordingly, the Court will address only implied “conflict” preemption. See August 2013 Order at 17; Defs’ MSJ at 12-14.
. In reaching this conclusion, the Court respectfully disagrees with the holding in Herazo v. Whole Foods Mkt., Inc., No. 14-61909-CIV, 2015 WL 4514510, at *4 (S.D. Fla. July 24, 2015), cited by Defendants. Defs.' MSJ at 14. In Herazo, the court stayed the case involving similar allegations against Whole Foods concerning their homeopathic “Cold Ease” and “Flu Ease” under the doctrine of primary jurisdiction because the plaintiffs were “challenging the Indications for Use that the Food and Drug Administration mandates for homeopathic medicine.” Herazo, 2015 WL 4514510, at *4-5. In reaching this conclusion, however, the court relied on Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 232 (3d Cir. 1990), where the court held that the issue of whether a non-homeopathic over-the-counter (“OTC”) drug’s ingredient was properly labeled "active” or “inactive” under the FDA’s standards warranted the court's abstention. Unlike OTC drugs, which require FDA approval after being evaluated for effectiveness, the efficacy of
. Based on this ruling, the Court also DENIES AS MOOT Defendants’ Request for Judicial Notice (Dkt. No. 245).
. Ferley, J.P.; Zmirou, D.; D'Adhemar D. and Balducci F., A controlled evaluation of a homeopathic preparation in the treatment of influenza-like syndromes, BR. J. PHARMA-COL., 27, 329-335 (1989); Papp, R.; Schuback, G.; Beck, E; et al. Oscillococcinum in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation, BR. HOMEOPATHIC J., 87, 69-76 (1989); Cassanova, P., Gerard, R., A study of the therapeutic action of Oscillococcinum in influenza syndromes, (Boiron Inc., 1985) (unpublished); Cassanova, P., The evaluation of 100 randomized observations of Oscillococcinum/Placebo in the influenza syndrome (Boiron Inc., 1983) (unpublished).
. Defendants also argue, without citation to in-circuit authority, that Dr. Kurdistani should be excluded due to the fact that he "affirmatively represented that he wanted to serve as an expert in the case” and thus demonstrated impermissible bias. Defs.’ Mot. to Strike at 8-9. This is not a sufficient ground to exclude an expert on a Daubert analysis. See United States v. Abonce-Barrera, 257 F.3d 959, 965 (9th Cir. 2001) ("Generally, evidence of bias goes toward the credibility of a witness, not his competency to testify, and credibility is an issue for the jury.”); see also, e.g., IGT v. All. Gaming Corp., No. 2:04-CV-1676, 2008 WL 7084608, at *2 (D. Nev. Oct. 21, 2008) ("The case law is clear that bias is not a bar to admission of expert testimony, and in this case, the bias is not so prejudicial as to outweigh the probative value of his testimony under Federal Rule of Evidence 403. Plaintiff IGT will have ample opportunity to point out the alleged bias at trial on cross-examination.”). And even if it were, the Court does not find that Dr. Kurdistani’s mere interest in serving as an expert—after being approached by Plaintiff—demonstrates bias warranting exclusion. Any retained expert receiving compensation for their time presumably has expressed at least some desire to serve in that capacity.
. Defendants also suggest, without authority in support, that Dr. Kurdistani’s opinions concerning possible bias in the execution of the Boiron clinical studies should be excluded because it is based on "conjecture.” Defs.’ Mot. to Strike at 16-17. Dr. Kurdistani offers support for this opinion in his report, however, based on his understanding that Boiron employees were involved in the clinical trials and that Boiron copyrighted the studies. See Kurdistani Report at ¶ 24. Thus, his opinion is sufficiently support to pass the threshold test under Rule 702, and any weaknesses in his conclusion may be addressed on cross-examination.
. Plaintiff also argues that these declarations are inadmissible hearsay under Rule 801 of the Federal Rules of Evidence. Pl.’s Mot. to Strike at 10. Defendants have adequately established, however, that the hearsay patient statements discussed in these declarations are statements for the purpose of medical diagnosis, which is an express exception to the rule against hearsay. See Fed. R. Evid. 803(4); c.f Defs.’ Opp. to Pl.’s Mot. to Strike at 12; Pl.’s Reply in support of Mot. to Strike at 6. Accordingly, the Court finds that, to the extent these declarations are admitted under Rule 26 and Rule 401, the patient statements they contain fall under the exception for statement made for medical diagnosis or treatment in Rule 803(4).
. Contrary to Plaintiff's suggestion, Dr. Du-Mont did not testify that anecdotal evidence is unreliable; rather, he testified that practicing physicians in the medical community rely heavily on anecdotal evidence but acknowledged that the scientific community does not regard anecdotal evidence as “proof.” See Ex. B in support of Pl.’s Mot. to Strike ("DuMont Depo”) at 144:3-23, 145:4-145:23, Dkt. No. 272-3. Nor does Plaintiff's evidence concerning the FDA's position on anecdotal evidence indicate that the medical and scientific communities have universally rejected anecdotal evidence. Rather, the cases Plaintiff cites clearly pertain to the FDA’s regulation of OTC drugs, not homeopathic drugs, and the FDA’s statements concerning anecdotal evidence concerns what evidence is acceptable for the FDA’s evaluation of an OTC drug’s efficacy, not the standards for admissibility of expert testimony on the efficacy of a homeopathic drug. See, e.g, Simeon Management Corp. v. F.T.C., 579 F.2d 1137, 1143 (9th Cir. 1978); E.R. Squibb and Sons, Inc. v. Bowen, 870 F.2d 678, 685 (D.C. 1989); Pharmaceutical Mfrs. Ass’n v. Richardson, 318 F.Supp. 301, 309-10 (D. Del. 1970).
. Defendants also summarily conclude that Plaintiff cannot possibly meet his burden to show that Oscillo did not work for him personally because he relies only on his own declaration for that evidence. Defs.’ MSJ at 15-16. Defendants offer no contrary evidence concerning Plaintiff’s symptoms nor any authority to suggest why Plaintiff’s declaration is insufficient to meet Plaintiff’s burden. The Court thus rejects Defendants’ argument on this point.
Reference
- Full Case Name
- Christopher LEWERT v. BOIRON, INC. and Boiron, USA, Inc.
- Cited By
- 5 cases
- Status
- Published