Obesity Research Institute, LLC v. Fiber Research International, LLC et al

Filing 334

ORDER denying 189 Motion to Exclude the Report and Testimony of Dr. Laura Lerner. Dr. Lerner is qualified because of her education and experience to testify on the subject matter of her report. The contents of Dr. Lerner's report are relevant to the case. Dr. Lerner used reliable methods for her conclusions. Signed by Judge Cynthia Bashant on 3/29/2017. (jah)

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1 2 3 4 5 6 7 8 9 10 UNITED STATES DISTRICT COURT 11 SOUTHERN DISTRICT OF CALIFORNIA 12 13 OBESITY RESEARCH INSTITUTE, LLC, 14 Plaintiff, 15 16 17 Case No. 15-cv-595-BAS(MDD) v. FIBER RESEARCH INTERNATIONAL, LLC, et al., ORDER DENYING DEFENDANT’S MOTION TO EXCLUDE THE REPORT & TESTIMONY OF DR. LAURA LERNER [ECF No. 189] Defendants. 18 19 20 AND RELATED COUNTERCLAIM. 21 22 On March 16, 2015, Plaintiff Obesity Research Institute, LLC (“ORI”) filed a 23 Complaint for Declaratory Judgment against Defendant Fiber Research International, 24 LLC (“FRI”) asking the Court to declare that it has no liability under either the 25 Lanham Act, the Federal Food, Drug, and Cosmetic Act (“FFDCA”), California’s 26 Unfair Competition Law (“UCL”), and California’s False Advertising Law (“FAL”). 27 (ECF No. 1.) On April 13, 2015, FRI filed its Answer and Counterclaims. (ECF No. 28 16.) –1– 15cv595 1 Presently before the Court is FRI’s Motion to Exclude the Report and 2 Testimony of Dr. Laura Lerner, an expert witness for ORI, arguing that Dr. Laura 3 Lerner is unqualified and her testimony is irrelevant and unreliable. ORI opposes. 4 The Court finds this motion suitable for determination on the papers submitted 5 and without oral argument. See Fed. R. Civ. P. 78(b); Civ. L.R. 7.1(d)(1). For the 6 following reasons, the Court DENIES FRI’s motion. 7 8 I. INTRODUCTION 9 On March 10, 2015, FRI sent a letter to ORI claiming ORI was in violation of 10 the Lanham Act and the FFDCA. (Ferrell Decl. Ex. 1, ECF No. 24-4.) FRI alleged 11 that the glucomannan used in ORI’s trademarked Lipozene is not equivalent to the 12 grade of glucomannan used in Shimizu Chemical Corporation’s (“Shimizu”) 13 trademarked Propol.1 (Ferrell Decl. Ex. 1.) ORI allegedly relied on studies of the 14 effectiveness of glucomannan in Propol, including the Walsh and the Kaats Studies, 15 as a basis for marketing the effectiveness of Lipozene.2 (Id.) FRI contends that the 16 results of Lipozene are not comparable to the results in the studies because the 17 glucomannan in Lipozene has a lower viscosity than the glucomannan in Propol. (Id.) 18 Due to the purported differences between the glucomannan in Lipozene and Propol, 19 FRI asserts that ORI has substantially harmed FRI’s business. (Id.) 20 In response to FRI’s letter, ORI filed a Complaint for Declaratory Judgment, 21 which resulted in FRI responding with Counterclaims on May 28, 2015. (ECF No. 1, 22 24.) ORI contends that the studies it relied upon never mentioned what grade of 23 glucomannan was used and that Lipozene contains the same active ingredients as the 24 products used in the aforementioned studies. (Non-Retained Expert Witness 25 26 27 28 FRI has the right to sell Shimizu glucomannan products in the United States, including Propol. (Ferrell Decl. Ex. 1.) 2 ORI references scientific studies on its website that supposedly “confirm Lipozene’s active ingredient, Glucomannan, is safe and effective for weight loss and fat loss.” (Answer & Countercl. Ex. 1.) FRI contends that these studies do not support the effectiveness of Lipozene, rather they only confirm the effectiveness of Propol. (Answer & Countercl. ¶¶ 33-35.) 1 –2– 15cv595 1 Designations (“Witness Designations”) 3:25-4:1-2, ECF. No. 220-5, Ex. 1.) Further, 2 ORI takes the position that “Propol is nothing more than a trade mark” under which 3 Shimizu sells glucomannan. (Witness Designations 4:24-25.) 4 FRI retained Dr. Thomas Wolver as an expert witness to testify on whether 5 ORI can rely on the scientific studies of glucomannan to make certain representations 6 about Lipozene. (Wolver Report ¶ 6, ECF No. 189-3.) In his report, Dr. Wolver 7 opines that Lipozene has a different effect on the body than Propol clinical strength 8 (“Propol CS”). (Wolver Report ¶ 10.) Therefore, Dr. Wolver believes it is 9 “scientifically inappropriate” for ORI to use the Walsh and the Kaats Studies to 10 substantiate the effectiveness of Lipozene. (Wolver Report ¶ 11.) Further, Dr. Wolver 11 opines that the ingredients used in Lipozene “likely has little or no benefit for weight 12 loss.” (Wolver Report ¶ 12.) 13 To rebut Dr. Wolver’s testimony, ORI retained Dr. Lerner as an expert witness. 14 (Lerner Report, ECF No. 189-5.) Dr. Lerner’s report first pointed to the fact that 15 neither the Kaats nor Walsh Study purported to use Propol CS. (Lerner Report 3.) 16 Dr. Wolver assumed that Propol CS was used, but has no actual knowledge of what 17 variation was used in the studies. (Lerner Report 3, 9-10.) Dr. Lerner rebuts Dr. 18 Wolver’s conclusion that Lipozene is less effective than Propol by analyzing the 19 results of various peer-reviewed studies. (Lerner Report 13.) Dr. Lerner concludes 20 that there is no basis in either scientific literature or lab testing results to support Dr. 21 Wolver’s conclusion that Lipozene is less effective than the glucomannan tested in 22 the Kaats or the Walsh Studies. (Lerner Report 3, 13.) 23 24 II. LEGAL STANDARD 25 Federal Rule of Evidence 702 governs the admissibility of expert witnesses. 26 Expert witnesses can testify to “scientific, technical, or other specialized knowledge” 27 that will assist the “trier of the fact [in] understand[ing] the evidence or to determine 28 a fact in issue.” Fed. R. Evid. 702. –3– 15cv595 1 Expert testimony is admissible pursuant to Rule 702 if it is both relevant and 2 reliable. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993). Evidence 3 is relevant when it has “any tendency to make the existence of any fact that is of 4 consequence to the determination of the action more probable or less probable than 5 it would be without the evidence.” Fed. R. Evid. 401. Reliability requires that an 6 expert’s testimony “have a reliable basis in the knowledge and experience of his 7 discipline.” Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457, 462 (9th Cir. 8 2014) (quoting Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 141 (1999)). 9 The inquiry into the admissibility of an expert witness’ testimony does not 10 “require a court to admit or exclude evidence based on its persuasiveness.” Ellis v. 11 Costco Wholesale Corp., 657 F.3d 970, 982 (9th Cir. 2011). A trial court will not 12 weigh the correctness of an expert witness, rather the court must determine if the 13 expert’s testimony is reliable. Advisory Committee Notes to Rule 702, 2000 14 Amendments (proponents do not have to show by a “preponderance of the evidence 15 that the assessments of their experts are correct, they only have to demonstrate to the 16 judge by a preponderance of evidence that their opinions are reliable . . . . the 17 requirement of reliability is lower than the merits standard of correctness”) (quoting 18 In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 744 (3d Cir. 1994)). 19 A witness is qualified to give expert testimony by her “knowledge, skill, 20 experience, training, or education.” Fed. R. Evid. 702. The qualifications for expert 21 witnesses under Rule 702 should be construed broadly. See Thomas v. Newton Int’l 22 Enters., 42 F.3d 1266, 1269 (9th Cir. 1994). It is an abuse of discretion for a court 23 to disqualify an expert witness that is generally qualified. Id. (holding court abused 24 discretion by narrowly construing expert witness’ qualifications under Rule 702); see 25 also In re Silicone Gel Breasts Implants Prods. Liab. Litig., 318 F. Supp. 2d 879, 889 26 (C.D. Cal. 2004). 27 When considering the admissibility of an expert witness, the court acts as a 28 “gatekeeper” rather than a fact finder. Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. –4– 15cv595 1 2010) (citing Daubert, 509 U.S. at 594, 596). Shaky but admissible evidence can be 2 attacked by “vigorous cross-examination, presentation of contrary evidence, and 3 careful instructions on the burden of proof.” Daubert, 509 U.S. at 596. Where the 4 expert witness meets the criteria of Rule 702, the trial court has broad discretion 5 whether to admit the evidence. Id. (finding juries should be given leave to act as a 6 fact finder on the conclusions of an expert witness). 7 8 9 III. DISCUSSION A. Dr. Lerner’s Opinion Is Relevant. 10 FRI argues that Dr. Lerner’s testimony should be excluded because it is 11 irrelevant. (FRI’s Mot. 5:13-18, ECF No. 189.) The Court finds that each of Dr. 12 Lerner’s four opinions are relevant to rebut the report and testimony of Dr. Wolver. 13 As ORI correctly notes, FRI’s contentions relate to the weight of Dr. Lerner’s 14 testimony rather than the admissibility. See Clicks Billards, Inc. v. Sixshooters, Inc., 15 251 F.3d 1252, 1262-63 (9th Cir. 2001); Prudential Ins. Co. of Am. v. Gibraltar Fin. 16 Corp. of Cal., 694 F.2d 1150, 1156 (9th Cir. 1982). FRI disagrees with many of Dr. 17 Lerner’s findings, but this does not affect the relevance of her testimony. See 18 Daubert, 509 U.S. at 587 (quoting Fed. R. Evid. 401) (finding relevant evidence is 19 anything that makes “the determination of the action more or less probable”). 20 First, FRI argues that Dr. Lerner’s opinion is irrelevant because she does not 21 have an opinion “one way or another” about the efficacy of Lipozene compared to 22 Propol. (FRI’s Mot. 5:13-18.) This mischaracterizes Dr. Lerner’s report and 23 misconstrues the context of her findings. Dr. Lerner stated her opinion as to the 24 effectiveness of Propol compared to Lipozene, by opining that the glucomannan in 25 Lipozene is equivalent in viscosity to the glucomannan of the Propol tested in the 26 Kaats Study. (Lerner Report Ex. 3, Ex. A at 9, 13, ECF No. 191-1.) The effectiveness 27 of the glucomannan in Propol compared to Lipozene for weight loss is essential to 28 the merits of this case because FRI contends that ORI mischaracterized the –5– 15cv595 1 effectiveness of Lipozene by using studies of Propol. (FRI’s Answer & Countercl. ¶ 2 42, ECF No. 16.) Relevant evidence should be admitted for the trier of the fact to 3 determine the merits of the case. See Daubert, 509 U.S. at 587. Therefore, Dr. 4 Lerner’s opinion as to the effectiveness of the glucomannan in Propol is relevant. 5 Second, FRI contends that Dr. Lerner’s report is irrelevant because FRI 6 disagrees with Dr. Lerner’s conclusions about the viscosity needed for glucomannan 7 to be effective.3 (FRI’s Mot. 5:19-22.) In Dr. Wolver’s report, he discussed the 8 superiority of Propol over Lipozene, stating that there was a sustained viscosity of 9 100,000 cps for over 72 hours in a study on Propol. (Wolver Report Ex. 1 ¶¶ 12-13, 10 ECF No. 189-3.) Dr. Lerner opined that Dr. Wolver failed to show that a viscosity of 11 100,000 cps sustained for 72 hours is necessary for glucomannan to be effective in 12 weight loss. (Lerner Report 3.) The Court does not have to decide which scientific 13 opinion has the “best provenance,” rather the Court must determine if the testimony 14 helps the trier of the fact understand the evidence. Fed. R. Evid. 702. Because a 15 central issue of the case rests on whether ORI properly relied on the studies of Propol, 16 Dr. Lerner’s opinion regarding the viscosity of Propol is relevant. 17 Third, FRI argues that Dr. Lerner’s opinion as to the materials in the Kaats 18 Study compared to those of Lipozene is irrelevant. (FRI’s Mot. 7:4-5.) Dr. Lerner 19 opined that the Kaats Study was performed on the same active ingredients found in 20 Lipozene. (Lerner Report 3.) If FRI disagrees with the definition of “active 21 ingredients” or believes that the materials studied in the Kaats Study are not similar 22 to Lipozene, this can be addressed by cross examining Dr. Lerner. See Daubert, 509 23 U.S. at 696. 24 In sum, FRI attempts to argue the correctness of Dr. Lerner’s opinion rather 25 than confronting Dr. Lerner’s opinion on a relevance standard. This type of 26 contention does not weigh on the admissibility of Dr. Lerner’s opinion under the 27 28 Two of Dr. Lerner’s opinions, both addressing glucomannan’s viscosity, are substantially similar. (See ORI’s Opp’n 11:4-13:8.) Thus, the Court analyzes the opinions together in this order. 3 –6– 15cv595 1 applicable relevance standard. See Ruiz-Troche v. Pepsi Cola, 161 F.3d 77, 85 (1st 2 Cir. 1998). Rather, this is an issue that FRI should confront during cross examination. 3 Daubert, 509 U.S. at 596 (“Vigorous cross-examination, presentation of contrary 4 evidence, and careful instruction on the burden of proof are the traditional and 5 appropriate means of attacking shaky but admissible evidence.”). Thus, the Court 6 concludes Dr. Lerner’s opinion is relevant. 7 8 B. Dr. Lerner Is Qualified To Render an Opinion. 9 Dr. Lerner’s education and experience qualifies her to render an opinion on 10 glucomannan, viscosity, and the chemical differences between Lipozene and Propol. 11 (Lerner Report 1.) FRI contends that Dr. Lerner is not qualified because she has not 12 served as an expert before, did not apply her expertise to the case, is not a medical 13 doctor, and has not performed human clinical studies. (FRI’s Mot. 8:15-23.) 14 Dr. Lerner has a master’s degree in Chemical Engineering and a Ph.D. in 15 Biomedical Engineering from John Hopkins University. (Lerner Report 1.) For the 16 past 30 years, Dr. Lerner has analyzed biological molecules, “develop[ed] and 17 validat[ed] assays” on the quality of active pharmaceutical ingredients, and compared 18 chemical qualities of drugs, including the viscosity. (Id.) She is a trained chemical 19 engineer and is qualified in both education and experience to discuss the differences 20 between Lipozene and Propol. (Id.) Dr. Lerner is educated and experienced in the 21 fields of chemistry and biology, and regularly compares drug products in her work. 22 (Id.) If Dr. Lerner lacks the specialization of working with human subjects, this would 23 affect the weight of testimony rather than the admissibility. See In re Silicone Gel 24 Breasts Implants Prods. Liab. Litig., 318 F. Supp. 2d 879, 889 (C.D. Cal. 2004) 25 (holding arguments regarding expert’s qualifications go more towards weight than 26 admissibility because jurors can determine who is “best” qualified). 27 Because Dr. Lerner has both the education and professional experience relating 28 to the subject matter of this case, she is qualified to testify as an expert witness. See –7– 15cv595 1 Thomas, 42 F.3d at 1269 (finding qualifications of an expert witness should be 2 broadly construed). Any concerns regarding Dr. Lerner’s qualifications can be 3 addressed through cross examination. See Daubert, 509 U.S. at 596. 4 5 C. Dr. Lerner Used Reliable Methods For Her Conclusions. 6 FRI moves to exclude Dr. Lerner’s testimony and report on the grounds that 7 her monosaccharide and viscosity analysis was completed using unreliable methods. 8 (FRI’s Mot. 9:15, 11:14.) Dr. Lerner applied her specialized knowledge of chemical 9 and bioengineering to rebut Dr. Wolver’s contentions about the effectiveness of 10 Lipozene. (See generally Lerner Report.) Although Dr. Lerner compares studies she 11 did not conduct herself, such methods are permitted by the Federal Rules of 12 Evidence. See Fed. R. Evid. 703 (“An expert may base an opinion on facts or data in 13 the case that the expert has been made aware of or personally observed.”). 14 Dr. Lerner properly relies on existing independent research and publications 15 to draw her conclusions. See Daubert v. Merrell Dow Pharms., 43 F.3d 1311, 1317 16 (9th Cir. 1995) (finding experts who base their conclusions on existing research are 17 less likely to be biased). FRI argues Dr. Lerner cannot “adequately compare and draw 18 conclusions from the various results” of the viscosity necessary for glucomannan to 19 be effective from the studies alone. (FRI’s Mot. 11:23-24.) Rather, FRI contends that 20 Dr. Lerner needs to know more information about the studies or conduct studies 21 herself. (FRI’s Mot. 13:3-5.) But expert witnesses do not have to conduct their own 22 experiments to be considered reliable. See Daubert, 43 F.3d at 1317. In fact, Dr. 23 Lerner’s reliance on previously existing studies suggest that her conclusion 24 “comports with the dictates of good science.” See id. 25 Moreover, this Court will not use FRI’s motion as a means to decide which 26 expert opinion is most correct. See Daubert, 43 F.3d at 1318 (finding the standard 27 for reliability is lower than that of correctness). The determination of correctness 28 should be left to the trier of the facts. See id. Dr. Lerner used her expertise to analyze –8– 15cv595 1 the chemical properties of Lipozene and Propol. (Lerner Report 1, 3.) Dr. Wolver, 2 unlike Dr. Lerner, is not a chemist and applied appropriate methods for an expert 3 with his qualifications as a medical doctor. (Wolver Report ¶ 2.) To rebut Dr. 4 Wolver’s opinions, Dr. Lerner is applying her technical background to the same 5 information, using different methodologies than that of Dr. Wolver’s. (Lerner Report 6 3, 13.) Although Dr. Lerner and Dr. Wolver used different methodologies for their 7 respective analyses, this does not require the Court to conclude Dr. Lerner’s methods 8 are unreliable. See Advisory Committee Notes to Rule 702, 2000 Amendments; see 9 also Ruiz-Troche, 161 F.3d at 85 (“Daubert neither requires nor empowers trial 10 courts to determine which of several competing scientific theories has the best 11 provenance.”). In sum, Dr. Lerner’s report and testimony are admissible because she 12 used reliable methods based on peer reviewed scientific studies. 13 14 IV. CONCLUSION & ORDER 15 For the foregoing reasons, the Court DENIES FRI’s Motion to Exclude the 16 Report & Testimony of Dr. Laura Lerner. Dr. Lerner is qualified because of her 17 education and experience to testify on the subject matter of her report. The contents 18 of Dr. Lerner’s report are relevant to the case, and Dr. Lerner used reliable methods 19 for her conclusions. 20 IT IS SO ORDERED. 21 22 DATED: March 29, 2017 23 24 25 26 27 28 –9– 15cv595

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