Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-casd-3_15-cv-00595/USCOURTS-casd-3_15-cv-00595-15/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF CALIFORNIA 

OBESITY RESEARCH INSTITUTE, 

LLC, 

 Plaintiff, 

Case No. 15-cv-595-BAS(MDD) 

ORDER DENYING 

DEFENDANT’S MOTION TO 

EXCLUDE THE REPORT & 

TESTIMONY OF DR. LAURA 

LERNER

[ECF No. 189] 

 v. 

FIBER RESEARCH 

INTERNATIONAL, LLC, et al., 

 Defendants. 

AND RELATED COUNTERCLAIM. 

 On March 16, 2015, Plaintiff Obesity Research Institute, LLC (“ORI”) filed a 

Complaint for Declaratory Judgment against Defendant Fiber Research International, 

LLC (“FRI”) asking the Court to declare that it has no liability under either the 

Lanham Act, the Federal Food, Drug, and Cosmetic Act (“FFDCA”), California’s 

Unfair Competition Law (“UCL”), and California’s False Advertising Law (“FAL”). 

(ECF No. 1.) On April 13, 2015, FRI filed its Answer and Counterclaims. (ECF No. 

16.) 

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 Presently before the Court is FRI’s Motion to Exclude the Report and 

Testimony of Dr. Laura Lerner, an expert witness for ORI, arguing that Dr. Laura 

Lerner is unqualified and her testimony is irrelevant and unreliable. ORI opposes. 

 The Court finds this motion suitable for determination on the papers submitted 

and without oral argument. See Fed. R. Civ. P. 78(b); Civ. L.R. 7.1(d)(1). For the 

following reasons, the Court DENIES FRI’s motion. 

I. INTRODUCTION 

 On March 10, 2015, FRI sent a letter to ORI claiming ORI was in violation of 

the Lanham Act and the FFDCA. (Ferrell Decl. Ex. 1, ECF No. 24-4.) FRI alleged 

that the glucomannan used in ORI’s trademarked Lipozene is not equivalent to the 

grade of glucomannan used in Shimizu Chemical Corporation’s (“Shimizu”) 

trademarked Propol.1

 (Ferrell Decl. Ex. 1.) ORI allegedly relied on studies of the 

effectiveness of glucomannan in Propol, including the Walsh and the Kaats Studies, 

as a basis for marketing the effectiveness of Lipozene.2

 (Id.) FRI contends that the 

results of Lipozene are not comparable to the results in the studies because the 

glucomannan in Lipozene has a lower viscosity than the glucomannan in Propol. (Id.) 

Due to the purported differences between the glucomannan in Lipozene and Propol, 

FRI asserts that ORI has substantially harmed FRI’s business. (Id.) 

 In response to FRI’s letter, ORI filed a Complaint for Declaratory Judgment, 

which resulted in FRI responding with Counterclaims on May 28, 2015. (ECF No. 1, 

24.) ORI contends that the studies it relied upon never mentioned what grade of 

glucomannan was used and that Lipozene contains the same active ingredients as the 

products used in the aforementioned studies. (Non-Retained Expert Witness 

 

1 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.)

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Designations (“Witness Designations”) 3:25-4:1-2, ECF. No. 220-5, Ex. 1.) Further, 

ORI takes the position that “Propol is nothing more than a trade mark” under which 

Shimizu sells glucomannan. (Witness Designations 4:24-25.) 

 FRI retained Dr. Thomas Wolver as an expert witness to testify on whether 

ORI can rely on the scientific studies of glucomannan to make certain representations 

about Lipozene. (Wolver Report ¶ 6, ECF No. 189-3.) In his report, Dr. Wolver 

opines that Lipozene has a different effect on the body than Propol clinical strength 

(“Propol CS”). (Wolver Report ¶ 10.) Therefore, Dr. Wolver believes it is 

“scientifically inappropriate” for ORI to use the Walsh and the Kaats Studies to 

substantiate the effectiveness of Lipozene. (Wolver Report ¶ 11.) Further, Dr. Wolver 

opines that the ingredients used in Lipozene “likely has little or no benefit for weight 

loss.” (Wolver Report ¶ 12.) 

 To rebut Dr. Wolver’s testimony, ORI retained Dr. Lerner as an expert witness. 

(Lerner Report, ECF No. 189-5.) Dr. Lerner’s report first pointed to the fact that 

neither the Kaats nor Walsh Study purported to use Propol CS. (Lerner Report 3.) 

Dr. Wolver assumed that Propol CS was used, but has no actual knowledge of what 

variation was used in the studies. (Lerner Report 3, 9-10.) Dr. Lerner rebuts Dr. 

Wolver’s conclusion that Lipozene is less effective than Propol by analyzing the 

results of various peer-reviewed studies. (Lerner Report 13.) Dr. Lerner concludes 

that there is no basis in either scientific literature or lab testing results to support Dr. 

Wolver’s conclusion that Lipozene is less effective than the glucomannan tested in 

the Kaats or the Walsh Studies. (Lerner Report 3, 13.) 

II. LEGAL STANDARD 

 Federal Rule of Evidence 702 governs the admissibility of expert witnesses. 

Expert witnesses can testify to “scientific, technical, or other specialized knowledge” 

that will assist the “trier of the fact [in] understand[ing] the evidence or to determine 

a fact in issue.” Fed. R. Evid. 702. 

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 Expert testimony is admissible pursuant to Rule 702 if it is both relevant and 

reliable. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993). Evidence 

is relevant when it has “any tendency to make the existence of any fact that is of 

consequence to the determination of the action more probable or less probable than 

it would be without the evidence.” Fed. R. Evid. 401. Reliability requires that an 

expert’s testimony “have a reliable basis in the knowledge and experience of his 

discipline.” Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457, 462 (9th Cir. 

2014) (quoting Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 141 (1999)). 

 The inquiry into the admissibility of an expert witness’ testimony does not 

“require a court to admit or exclude evidence based on its persuasiveness.” Ellis v. 

Costco Wholesale Corp., 657 F.3d 970, 982 (9th Cir. 2011). A trial court will not 

weigh the correctness of an expert witness, rather the court must determine if the 

expert’s testimony is reliable. Advisory Committee Notes to Rule 702, 2000 

Amendments (proponents do not have to show by a “preponderance of the evidence 

that the assessments of their experts are correct, they only have to demonstrate to the 

judge by a preponderance of evidence that their opinions are reliable . . . . the 

requirement of reliability is lower than the merits standard of correctness”) (quoting 

In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 744 (3d Cir. 1994)). 

 A witness is qualified to give expert testimony by her “knowledge, skill, 

experience, training, or education.” Fed. R. Evid. 702. The qualifications for expert 

witnesses under Rule 702 should be construed broadly. See Thomas v. Newton Int’l 

Enters., 42 F.3d 1266, 1269 (9th Cir. 1994). It is an abuse of discretion for a court 

to disqualify an expert witness that is generally qualified. Id. (holding court abused 

discretion by narrowly construing expert witness’ qualifications under Rule 702); see 

also In re Silicone Gel Breasts Implants Prods. Liab. Litig., 318 F. Supp. 2d 879, 889 

(C.D. Cal. 2004). 

 When considering the admissibility of an expert witness, the court acts as a 

“gatekeeper” rather than a fact finder. Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 

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2010) (citing Daubert, 509 U.S. at 594, 596). Shaky but admissible evidence can be 

attacked by “vigorous cross-examination, presentation of contrary evidence, and 

careful instructions on the burden of proof.” Daubert, 509 U.S. at 596. Where the 

expert witness meets the criteria of Rule 702, the trial court has broad discretion 

whether to admit the evidence. Id. (finding juries should be given leave to act as a 

fact finder on the conclusions of an expert witness). 

III. DISCUSSION 

A. Dr. Lerner’s Opinion Is Relevant. 

 FRI argues that Dr. Lerner’s testimony should be excluded because it is 

irrelevant. (FRI’s Mot. 5:13-18, ECF No. 189.) The Court finds that each of Dr. 

Lerner’s four opinions are relevant to rebut the report and testimony of Dr. Wolver. 

As ORI correctly notes, FRI’s contentions relate to the weight of Dr. Lerner’s 

testimony rather than the admissibility. See Clicks Billards, Inc. v. Sixshooters, Inc., 

251 F.3d 1252, 1262-63 (9th Cir. 2001); Prudential Ins. Co. of Am. v. Gibraltar Fin. 

Corp. of Cal., 694 F.2d 1150, 1156 (9th Cir. 1982). FRI disagrees with many of Dr. 

Lerner’s findings, but this does not affect the relevance of her testimony. See 

Daubert, 509 U.S. at 587 (quoting Fed. R. Evid. 401) (finding relevant evidence is 

anything that makes “the determination of the action more or less probable”). 

 First, FRI argues that Dr. Lerner’s opinion is irrelevant because she does not 

have an opinion “one way or another” about the efficacy of Lipozene compared to 

Propol. (FRI’s Mot. 5:13-18.) This mischaracterizes Dr. Lerner’s report and 

misconstrues the context of her findings. Dr. Lerner stated her opinion as to the 

effectiveness of Propol compared to Lipozene, by opining that the glucomannan in 

Lipozene is equivalent in viscosity to the glucomannan of the Propol tested in the 

Kaats Study. (Lerner Report Ex. 3, Ex. A at 9, 13, ECF No. 191-1.) The effectiveness 

of the glucomannan in Propol compared to Lipozene for weight loss is essential to 

the merits of this case because FRI contends that ORI mischaracterized the 

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effectiveness of Lipozene by using studies of Propol. (FRI’s Answer & Countercl. ¶ 

42, ECF No. 16.) Relevant evidence should be admitted for the trier of the fact to 

determine the merits of the case. See Daubert, 509 U.S. at 587. Therefore, Dr. 

Lerner’s opinion as to the effectiveness of the glucomannan in Propol is relevant. 

 Second, FRI contends that Dr. Lerner’s report is irrelevant because FRI 

disagrees with Dr. Lerner’s conclusions about the viscosity needed for glucomannan 

to be effective.3

 (FRI’s Mot. 5:19-22.) In Dr. Wolver’s report, he discussed the

superiority of Propol over Lipozene, stating that there was a sustained viscosity of 

100,000 cps for over 72 hours in a study on Propol. (Wolver Report Ex. 1 ¶¶ 12-13, 

ECF No. 189-3.) Dr. Lerner opined that Dr. Wolver failed to show that a viscosity of 

100,000 cps sustained for 72 hours is necessary for glucomannan to be effective in 

weight loss. (Lerner Report 3.) The Court does not have to decide which scientific 

opinion has the “best provenance,” rather the Court must determine if the testimony 

helps the trier of the fact understand the evidence. Fed. R. Evid. 702. Because a 

central issue of the case rests on whether ORI properly relied on the studies of Propol, 

Dr. Lerner’s opinion regarding the viscosity of Propol is relevant. 

 Third, FRI argues that Dr. Lerner’s opinion as to the materials in the Kaats 

Study compared to those of Lipozene is irrelevant. (FRI’s Mot. 7:4-5.) Dr. Lerner 

opined that the Kaats Study was performed on the same active ingredients found in 

Lipozene. (Lerner Report 3.) If FRI disagrees with the definition of “active 

ingredients” or believes that the materials studied in the Kaats Study are not similar 

to Lipozene, this can be addressed by cross examining Dr. Lerner. See Daubert, 509 

U.S. at 696. 

 In sum, FRI attempts to argue the correctness of Dr. Lerner’s opinion rather 

than confronting Dr. Lerner’s opinion on a relevance standard. This type of 

contention does not weigh on the admissibility of Dr. Lerner’s opinion under the 

 

3 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. 

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applicable relevance standard. See Ruiz-Troche v. Pepsi Cola, 161 F.3d 77, 85 (1st 

Cir. 1998). Rather, this is an issue that FRI should confront during cross examination. 

Daubert, 509 U.S. at 596 (“Vigorous cross-examination, presentation of contrary 

evidence, and careful instruction on the burden of proof are the traditional and 

appropriate means of attacking shaky but admissible evidence.”). Thus, the Court 

concludes Dr. Lerner’s opinion is relevant. 

B. Dr. Lerner Is Qualified To Render an Opinion. 

 Dr. Lerner’s education and experience qualifies her to render an opinion on 

glucomannan, viscosity, and the chemical differences between Lipozene and Propol. 

(Lerner Report 1.) FRI contends that Dr. Lerner is not qualified because she has not 

served as an expert before, did not apply her expertise to the case, is not a medical 

doctor, and has not performed human clinical studies. (FRI’s Mot. 8:15-23.) 

 Dr. Lerner has a master’s degree in Chemical Engineering and a Ph.D. in 

Biomedical Engineering from John Hopkins University. (Lerner Report 1.) For the 

past 30 years, Dr. Lerner has analyzed biological molecules, “develop[ed] and 

validat[ed] assays” on the quality of active pharmaceutical ingredients, and compared 

chemical qualities of drugs, including the viscosity. (Id.) She is a trained chemical 

engineer and is qualified in both education and experience to discuss the differences 

between Lipozene and Propol. (Id.) Dr. Lerner is educated and experienced in the 

fields of chemistry and biology, and regularly compares drug products in her work. 

(Id.) If Dr. Lerner lacks the specialization of working with human subjects, this would 

affect the weight of testimony rather than the admissibility. See In re Silicone Gel 

Breasts Implants Prods. Liab. Litig., 318 F. Supp. 2d 879, 889 (C.D. Cal. 2004) 

(holding arguments regarding expert’s qualifications go more towards weight than 

admissibility because jurors can determine who is “best” qualified). 

 Because Dr. Lerner has both the education and professional experience relating 

to the subject matter of this case, she is qualified to testify as an expert witness. See 

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Thomas, 42 F.3d at 1269 (finding qualifications of an expert witness should be 

broadly construed). Any concerns regarding Dr. Lerner’s qualifications can be 

addressed through cross examination. See Daubert, 509 U.S. at 596. 

C. Dr. Lerner Used Reliable Methods For Her Conclusions. 

 FRI moves to exclude Dr. Lerner’s testimony and report on the grounds that 

her monosaccharide and viscosity analysis was completed using unreliable methods. 

(FRI’s Mot. 9:15, 11:14.) Dr. Lerner applied her specialized knowledge of chemical 

and bioengineering to rebut Dr. Wolver’s contentions about the effectiveness of 

Lipozene. (See generally Lerner Report.) Although Dr. Lerner compares studies she 

did not conduct herself, such methods are permitted by the Federal Rules of 

Evidence. See Fed. R. Evid. 703 (“An expert may base an opinion on facts or data in 

the case that the expert has been made aware of or personally observed.”).

 Dr. Lerner properly relies on existing independent research and publications 

to draw her conclusions. See Daubert v. Merrell Dow Pharms., 43 F.3d 1311, 1317 

(9th Cir. 1995) (finding experts who base their conclusions on existing research are 

less likely to be biased). FRI argues Dr. Lerner cannot “adequately compare and draw 

conclusions from the various results” of the viscosity necessary for glucomannan to 

be effective from the studies alone. (FRI’s Mot. 11:23-24.) Rather, FRI contends that 

Dr. Lerner needs to know more information about the studies or conduct studies 

herself. (FRI’s Mot. 13:3-5.) But expert witnesses do not have to conduct their own 

experiments to be considered reliable. See Daubert, 43 F.3d at 1317. In fact, Dr. 

Lerner’s reliance on previously existing studies suggest that her conclusion 

“comports with the dictates of good science.” See id. 

 Moreover, this Court will not use FRI’s motion as a means to decide which 

expert opinion is most correct. See Daubert, 43 F.3d at 1318 (finding the standard 

for reliability is lower than that of correctness). The determination of correctness 

should be left to the trier of the facts. See id. Dr. Lerner used her expertise to analyze 

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the chemical properties of Lipozene and Propol. (Lerner Report 1, 3.) Dr. Wolver, 

unlike Dr. Lerner, is not a chemist and applied appropriate methods for an expert 

with his qualifications as a medical doctor. (Wolver Report ¶ 2.) To rebut Dr. 

Wolver’s opinions, Dr. Lerner is applying her technical background to the same 

information, using different methodologies than that of Dr. Wolver’s. (Lerner Report 

3, 13.) Although Dr. Lerner and Dr. Wolver used different methodologies for their 

respective analyses, this does not require the Court to conclude Dr. Lerner’s methods 

are unreliable. See Advisory Committee Notes to Rule 702, 2000 Amendments; see 

also Ruiz-Troche, 161 F.3d at 85 (“Daubert neither requires nor empowers trial 

courts to determine which of several competing scientific theories has the best 

provenance.”). In sum, Dr. Lerner’s report and testimony are admissible because she 

used reliable methods based on peer reviewed scientific studies. 

IV. CONCLUSION & ORDER 

 For the foregoing reasons, the Court DENIES FRI’s Motion to Exclude the 

Report & 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, and Dr. Lerner used reliable methods 

for her conclusions. 

IT IS SO ORDERED.

DATED: March 29, 2017 

 

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