Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caed-2_18-cv-02183/USCOURTS-caed-2_18-cv-02183-3/pdf.json

Parties Involved:
Boston Scientific Corporation
Defendant
Joaquinita Sanchez
Plaintiff
Jose Sanchez
Plaintiff

Document Text:

IN THE UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA 

 

CHARLESTON DIVISION

JOAQUINITA SANCHEZ AND JOSE SANCHEZ, 

Plaintiffs, 

v. CIVIL ACTION NO. 2:13-cv-04891 

BOSTON SCIENTIFIC CORPORATION, 

Defendant. 

MEMORANDUM OPINION AND ORDER 

(Daubert Motions) 

Pending before the court are several Daubert motions filed by both the 

defendant and the plaintiffs. Briefing is complete regarding these motions, and the 

motions are now ripe for consideration. 

I. Background 

 

This case resides in one of seven MDLs assigned to me by the Judicial Panel 

on Multidistrict Litigation (“MDL”) concerning the use of transvaginal surgical mesh 

to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the 

seven MDLs, there are more than 75,000 cases currently pending, approximately 

19,000 of which are in the Boston Scientific Corporation (“BSC”) MDL, MDL No. 2326. 

The parties have retained experts to render opinions regarding the elements of the 

case’s various causes of action, and the instant motions involve the parties’ efforts to 

exclude or limit the experts’ opinions pursuant to Daubert v. Merrell Dow Pharm., 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 1 of 32
2 

Inc., 509 U.S. 579 (1993). 

II. Legal Standard 

 

Under Rule 702 of the Federal Rules of Evidence, expert testimony is 

admissible if the expert is “qualified . . . by knowledge, skill, experience, training, or 

education” and if his testimony is (1) helpful to the trier of fact in understanding the 

evidence or determining a fact in issue; (2) “based upon sufficient facts or data;” and 

(3) “the product of reliable principles and methods” that (4) have been reliably applied 

“to the facts of the case.” Fed. R. Evid. 702. The Supreme Court has established a twopart test to govern the admissibility of expert testimony under Rule 702: the evidence 

is admitted if it “rests on a reliable foundation and is relevant.” Daubert, 509 U.S. at 

597. The proponent of expert testimony does not have the burden to “prove” anything 

to the court. Md. Cas. Co. v. Therm-O-Disk, Inc., 137 F.3d 780, 783 (4th Cir. 1998). 

He or she must, however, “come forward with evidence from which the court can 

determine that the proffered testimony is properly admissible.” Id.

 The district court is the gatekeeper. “[E]xpert witnesses have the potential to 

be both powerful and quite misleading,” so the court must “ensure that any and all 

scientific testimony . . . is not only relevant, but reliable.” Cooper v. Smith & Nephew, 

Inc., 259 F.3d 194, 199 (4th Cir. 2001) (citing Westberry v. Gislaved Gummi AB, 178 

F.3d 257, 261 (4th Cir. 1999); Daubert, 509 U.S. at 588, 595). In carrying out this role, 

I “need not determine that the proffered expert testimony is irrefutable or certainly 

correct”—“[a]s with all other admissible evidence, expert testimony is subject to 

testing by ‘vigorous cross-examination, presentation of contrary evidence, and careful 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 2 of 32
3 

instruction on the burden of proof.’” United States v. Moreland, 437 F.3d 424, 431 

(4th Cir. 2006) (quoting Daubert, 509 U.S. at 596); see also Md. Cas. Co., 137 F.3d at 

783 (noting that “[a]ll Daubert demands is that the trial judge make a ‘preliminary 

assessment’ of whether the proffered testimony is both reliable . . . and helpful”). 

Daubert mentions specific factors to guide the court in making the overall 

reliability determinations that apply to expert evidence. These factors include (1) 

whether the particular scientific theory “can be (and has been) tested;” (2) whether 

the theory “has been subjected to peer review and publication;” (3) the “known or 

potential rate of error;” (4) the “existence and maintenance of standards controlling 

the technique’s operation;” and (5) whether the technique has achieved “general 

acceptance” in the relevant scientific or expert community. United States v. Crisp, 

324 F.3d 261, 266 (4th Cir. 2003) (quoting Daubert, 509 U.S. at 593–94). Despite 

these factors, “[t]he inquiry to be undertaken by the district court is ‘a flexible one’ 

focusing on the ‘principles and methodology’ employed by the expert, not on the 

conclusions reached.” Westberry, 178 F.3d at 261 (quoting Daubert, 509 U.S. at 594–

95); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999) (“[T]he factors 

identified in Daubert may or may not be pertinent in assessing reliability, depending 

on the nature of the issue, the expert’s particular expertise, and the subject of his 

testimony.” (citation omitted)); Crisp, 324 F.3d at 266 (noting “that testing of 

reliability should be flexible and that Daubert’s five factors neither necessarily nor 

exclusively apply to every expert”). 

With respect to relevance, the second part of the analysis, Daubert further 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 3 of 32
4 

explains: 

Expert testimony which does not relate to any issue in the case is not 

relevant and, ergo, non-helpful. The consideration has been aptly 

described by Judge Becker as one of fit. Fit is not always obvious, and 

scientific validity for one purpose is not necessarily scientific validity for 

other, unrelated purposes. . . . Rule 702’s helpfulness standard requires 

a valid scientific connection to the pertinent inquiry as a precondition to 

admissibility. 

Daubert, 509 U.S. at 591–92 (citations and quotation marks omitted). 

Ultimately, the district court has broad discretion in determining whether to 

admit or exclude expert testimony, and the “the trial judge must have considerable 

leeway in deciding in a particular case how to go about determining whether 

particular expert testimony is reliable.” Cooper, 259 F.3d at 200 (quoting Kumho Tire, 

526 U.S. at 152). 

III. Preliminary Matters 

I begin by addressing a few preliminary matters that affect many of the 

Daubert motions. First, both parties consistently challenge experts’ opinions as 

improper state-of-mind or legal-conclusion testimony. As I have maintained 

throughout these MDLs, I will not permit the use of experts to usurp the jury’s factfinding function by allowing an expert to testify as to a party’s knowledge, state of 

mind, or whether a party acted reasonably. See, e.g., In re C. R. Bard, Inc., 948 F. 

Supp. 2d 589, 611 (S.D. W. Va. 2013) (excluding expert opinions on the defendant’s 

knowledge, state of mind, alleged bad acts, failures to act, and corporate conduct and 

ethics). The reasonableness of conduct and a party’s then-existing state of mind “are 

the sort of questions that lay jurors have been answering without expert assistance 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 4 of 32
5 

from time immemorial,” and therefore, these matters are not appropriate for expert 

testimony. Kidder v. Peabody & Co. v. IAG Int’l Acceptance Grp., N.V., 14 F. Supp. 

2d 391, 404 (S.D.N.Y. 1998); see also In re Rezulin Prods. Liab. Litig., 309 F. Supp. 

2d 531, 546 (S.D.N.Y. 2004) (“Inferences about the intent and motive of parties or 

others lie outside the bounds of expert testimony.”).1 Likewise, “opinion testimony 

that states a legal standard or draws a legal conclusion by applying law to the facts 

is generally inadmissible.” United States v. McIver, 470 F.3d 550, 562 (4th Cir. 2006). 

An expert may not state his opinion using “legal terms of art,” such as “defective,” 

“unreasonably dangerous,” or “proximate cause.” See Perez v. Townsend Eng’g Co., 

562 F. Supp. 2d 647, 652 (M.D. Pa. 2008). 

I have diligently applied these rules to previous expert testimony, and I 

continue to apply them in this case. This does not mean that each objection to stateof-mind or legal-conclusion testimony raised in these motions is valid. But I will not 

parse the numerous reports and thousand-page depositions for each expert to 

determine the validity of these same objections. Instead, the onus is on counsel to 

tailor expert testimony at trial in accordance with the above directive. Therefore, 

unless otherwise necessary, the remainder of this opinion does not address objections 

brought against an expert based on improper state-of-mind or legal-conclusion 

testimony. 

 

1 On a related note, I caution the parties against introducing corporate evidence through expert 

witnesses. Although an expert may testify about his review of internal corporate documents solely for 

the purpose of explaining the basis for his or her opinions—assuming the opinions are otherwise 

admissible—he or she may not be offered solely as a conduit for corporate information. There is no 

reason why the plaintiffs require an expert to opine on such facts. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 5 of 32
6 

I also note that several of the Daubert motions concern expert opinions entirely 

unrelated to the plaintiffs at bar. For example, some experts have opined on general 

and specific causation with the specific causation portion of the opinion pertaining to 

wave plaintiffs other than the plaintiffs in this particular case. In addition, the 

parties filed a total of sixteen Daubert motions, challenging fifteen different experts, 

which, in many instances, involved duplicative experts. In an effort to remedy this 

problem of blanketed, duplicative Daubert motions, I directed the parties to file 

disclosures, indicating who, out of the fifteen challenged experts, they plan to call at 

trial for each case. See Pretrial Order No. 121, at 5–6 [ECF No. 57]. Through these 

disclosures, I hoped to gain a better understanding of the particular arguments at 

issue, thereby refining my Daubert rulings for the benefit of the receiving judge. 

Rather than aiding the court in this endeavor, however, the parties effectively ignored 

the pretrial order, identifying all fifteen of the challenged experts as probable expert 

witnesses. See BSC’s Disclosure Required by Pretrial Order No. 121 [ECF No. 60]; 

Pl.’s Disclosure Required by Pretrial Order No. 121 [ECF No. 61]. Without guidance 

from the parties to the contrary, I have thus limited my review of the Daubert motions 

to only those arguments and opinions related to the instant plaintiffs. In other words, 

I disregard arguments included in the briefing directed exclusively at other wave 

plaintiffs and, consequently, irrelevant to this case. 

I am also compelled to comment on the parties’ misuse of my previous Daubert

rulings on several of the experts offered in this case. See generally Sanchez v. Boston 

Sci. Corp., No. 2:12-cv-05762, 2014 WL 4851989 (S.D. W. Va. Sept. 29, 2014); Tyree 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 6 of 32
7 

v. Boston Sci. Corp., 54 F. Supp. 3d 501 (S.D. W. Va. 2014); Eghnayem v. Boston Sci. 

Corp., 57 F. Supp. 3d 658 (S.D. W. Va. 2014). The parties have, for the most part, 

structured their Daubert arguments as a response to these prior rulings, rather than 

an autonomous challenge to or defense of an expert’s opinion based on its reliability 

and relevance. In other words, the parties have comparatively examined each expert’s 

opinions and have largely overlooked Daubert’s core considerations for assessing 

expert testimony. Although I recognize the tendency of my prior evidentiary 

determinations to influence subsequent motions practice, counsels’ expectations that 

I align with these previous rulings when faced with a different record are remiss, 

especially when an expert has issued new reports and given additional deposition 

testimony. 

Mindful of my role as gatekeeper of expert testimony, as well as my duty to 

“respect[ ] the individuality” of each MDL case, see In re Phenylpropanolamine Prods. 

Liab. Litig., 460 F.3d 1217, 1231 (9th Cir. 2006), I refuse to credit Daubert arguments 

that simply react to the court’s rulings in Sanchez and its progeny. Indeed, I feel 

bound by these earlier cases only to the extent that the expert opinions and Daubert

objections presented to the court then are identical to those presented now. 

Otherwise, I assess the parties’ Daubert arguments anew. That is, in light of the 

particular opinions and objections currently before me, I assess “whether the 

reasoning or methodology underlying the testimony is scientifically valid” and 

“whether that reasoning or methodology properly can be applied to the facts in issue.” 

Daubert, 509 U.S. at 592–93. Any departure from Sanchez, Eghnayem, or Tyree does 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 7 of 32
8 

not constitute a “reversal” of these decisions and is instead the expected result of the 

parties’ submission of updated expert reports and new objections to the opinions 

contained therein. 

Throughout these MDLs, I have attempted to resolve all possible disputes 

before transfer or remand, including those related to the admissibility of expert 

testimony pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 

(1993). Nevertheless, in some instances I face Daubert challenges where my interest 

in accuracy counsels reserving ruling until the reliability of an expert’s testimonial 

opinion may be evaluated at trial. At trial, the opinions will be tested by precise 

questions asked and answered. The alternative of live Daubert hearings is impossible 

before transfer or remand because of the numerosity of such motions in these seven 

related MDLs. As these MDLs have grown and the expert testimony has multiplied, 

I have become convinced that the critical gatekeeping function permitting or denying 

expert opinion testimony on decisive issues in these cases is best made with a live 

expert on the witness stand subject to vigorous examination. 

In the course of examining a multitude of these very similar cases involving 

the same fields of expertise, I have faced irreconcilably divergent expert opinions 

offered by witnesses with impeccable credentials, suggesting, to me, an unreasonable 

risk of unreliability. The danger—and to my jaded eye, the near certainty—of the 

admission of “junk science” looms large in this mass litigation. 

The parties regularly present out-of-context statements, after-the-fact 

rationalization of opinions, and incomplete deposition transcripts. This, combined 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 8 of 32
9 

with the parties’ practice of recycling expert testimony, objections, and the court’s 

prior rulings, creates the perfect storm of obfuscation. Where further clarity is 

necessary, I believe it is only achievable through live witnesses at trial and I therefore 

reserve ruling until expert opinions can be evaluated firsthand. 

IV. BSC’s Daubert Motions 

 

In this case, BSC seeks to limit or exclude the expert opinions of Drs. Michael 

Thomas Margolis, Niall Galloway, Thomas Barker, Bobby L. Shull, Jimmy Mays, 

Peggy Pence, Russell Dunn, Scott Guelcher, Richard Trepeta, and Vladimir Iakovlev. 

A. Michael Thomas Margolis, M.D. 

BSC seeks to exclude the testimony of Michael Thomas Margolis, M.D. Dr. 

Margolis is a pelvic floor surgeon and urogynecologist who offers general causation 

opinions in this case. 

1. Failure to Consider Studies 

 

First, BSC challenges Dr. Margolis’s failure to consider contrary studies. Dr. 

Margolis has explained his methodology for giving less credence to certain studies 

than to others. Dr. Margolis states that he has examined other studies that counter 

his own opinions. To the extent the defendant challenges the reasons Dr. Margolis 

offers for not relying on certain studies, such challenges go to the weight of Dr. 

Margolis’s opinions, not their admissibility. The defendant is free to cross-examine 

Dr. Margolis regarding studies that cut against his opinions. The defendant’s motion 

is DENIED on this point. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 9 of 32
10 

Second, BSC challenges Dr. Margolis’s opinion that there is a greater than 50 

percent complication rate of pain in women with polypropylene mesh and slings. In 

his deposition, Dr. Margolis acknowledges that contrary studies exist, and I do not 

doubt that Dr. Margolis reviewed contrary studies. However, his methodology may 

be flawed if he does not provide an adequate explanation for why he disagrees with 

those studies. There is no such explanation in this case. Therefore, Dr. Margolis’s 

opinion that more than 50 percent of women implanted with mesh experience pain is 

EXCLUDED as unreliable. This aspect of BSC’s motion is GRANTED. 

Third, BSC challenges Dr. Margolis’s general opinions that complications in 

women with polypropylene mesh products are high. Dr. Margolis explains that, when 

forming his opinion about the complication rates of a medical procedure, he gives the 

benefit of the doubt to the patient. In other words, he assumes the worst-case scenario 

and errs on the side of opining as to a higher complication rate to better protect a 

patient. This is not a reliable, scientific basis for determining the complication rates 

associated with a mesh device. The plaintiffs have failed to demonstrate that Dr. 

Margolis has sufficient scientific support to opine as to these generalized statements. 

Therefore, this testimony is EXCLUDED, and this part of BSC’s motion is 

GRANTED. 

2. Lack of Scientific Basis 

 

 BSC also argues that Dr. Margolis failed to provide any scientific basis for his 

other opinions. The plaintiffs do not address the majority of BSC’s arguments on this 

point, and I decline to raise counterarguments for the plaintiffs when they have failed 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 10 of 32
11 

to address BSC’s arguments in their briefing. The plaintiffs have not “come forward 

with evidence from which the court can determine that the proffered testimony is 

properly admissible.” Md. Cas. Co. v. Therm-O-Disk, Inc., 137 F.3d 780, 783 (4th Cir. 

1998). Therefore, the following opinions from Dr. Margolis are EXCLUDED: (1) that 

the Burch procedure is more effective than polypropylene mesh slings; (2) that 

Xenform slings are more effective than polypropylene slings; (3) that the infection 

rate of polypropylene mesh is up to 100 percent; (4) that the complication rate of 

urethral obstruction is greater than 10 percent with polypropylene mid-urethral 

slings; and (5) that he has removed 10 to 15 percent of BSC products. These portions 

of BSC’s motion are GRANTED. 

Unlike the above opinions, the plaintiffs appear to respond to BSC’s argument 

concerning Dr. Margolis’s opinion about a lack of scientific support for the use of 

mesh. The plaintiffs contend that Dr. Margolis merely opines that there is a lack of 

long-term data. Contradictions in testimony should be addressed on crossexamination. See 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.”). 

Therefore, I do not exclude Dr. Margolis’s opinion on a lack of long-term data on 

reliability grounds.2 Therefore, BSC’s motion regarding this opinion is DENIED. 

 

2 The plaintiffs in prior cases have responded to this same challenge in a different way. See Sanchez, 

2014 WL 4851989, at *14; Tyree, 54 F. Supp. 3d at 519–27; Eghnayem, 57 F. Supp. 3d at 676–80. 

Instead of focusing on long-term data, those plaintiffs informed the court that Dr. Margolis never 

opined that there was no data supporting the benefits of polypropylene mesh, but just that there was 

no credible data on this subject. In those cases, I excluded Dr. Margolis’s opinion because “it [was] still 

unclear why Dr. Margolis believe[d] th[o]se studies lack[ed] credibility.” Sanchez, 2014 WL 4851989, 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 11 of 32
12 

3. Expertise 

 

 BSC argues that Dr. Margolis offers opinions outside the scope of his 

qualifications on (1) biomaterials; (2) polypropylene degradation; (3) foreign body 

reaction; (4) adequate pore size; (5) adequate weight of polypropylene; (6) 

biocompatibility of polypropylene; (7) medical device design and development; and/or 

(8) marketing. The plaintiffs fail to provide any argument addressing how Dr. 

Margolis is an expert on any of the above subject matters, beyond the basic assertion 

that Dr. Margolis is an established urogynecologist with years of experience with 

pelvic mesh products. I will not make arguments for the plaintiffs. Therefore, this 

aspect of BSC’s motion is GRANTED. 

4. Undisclosed Opinions 

 

Finally, BSC argues that Dr. Margolis seeks to offer opinions that were not 

disclosed in his expert report and that Dr. Margolis seeks to discuss materials that 

were not cited to in his expert report. Testimony on direct examination using such 

undisclosed sources as support for his opinions is EXCLUDED on Rule 26 grounds. 

However, the court notes that two articles that BSC alleges were not disclosed—

Vaginal Mesh Contraction: Definition, Clinical Presentation and Management and 

Surgical Management of Pelvic Organ Prolapse in Women—were included in Dr. 

Margolis’s relied-upon list. Dr. Margolis’s testimony on these two articles is not 

excluded under Daubert. Therefore, I find that this aspect of BSC’s motion is 

GRANTED in part and DENIED in part. 

 

at *14. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 12 of 32
13 

For the reasons stated above, I GRANT in part and DENY in part BSC’s 

Motion to Exclude the Testimony of Michael Thomas Margolis, M.D. 

B. Niall Galloway, M.D. 

The defendant seeks to exclude the testimony of Dr. Niall Galloway. The 

plaintiffs do not respond to this motion, and I presume that they concede that Dr. 

Galloway will not testify at trial. Thus, the defendant’s motion GRANTED. 

C. Thomas H. Barker, Ph.D. 

The defendant seeks to exclude the testimony of Dr. Thomas Barker. The 

plaintiffs do not respond to this motion, and I presume that they concede that Dr. 

Barker will not testify at trial. Thus, the defendant’s motion is GRANTED. 

D. Bobby L. Shull, M.D. 

The defendant seeks to exclude the testimony of Dr. Bobby Shull. The plaintiffs 

do not respond to this motion, and I presume that they concede that Dr. Shull will 

not testify at trial. Thus, the defendant’s motion is GRANTED. 

E. Jimmy W. Mays, Ph.D. 

 

The defendant seeks to exclude the testimony of Dr. Jimmy W. Mays. The 

plaintiffs do not respond to this motion, and I presume that they concede that Dr. 

Mays will not testify at trial. Thus, the defendant’s motion is GRANTED. 

F. Peggy Pence, Ph.D. 

The defendant seeks to exclude the testimony of Dr. Peggy Pence. The 

plaintiffs do not respond to this motion, and I presume that they concede that Dr. 

Pence will not testify at trial. Thus, the defendant’s motion is GRANTED. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 13 of 32
14 

G. Russell Dunn, Ph.D. 

 

The defendant seeks to exclude the testimony of Dr. Russell Dunn. The 

plaintiffs do not respond to this motion, and I presume that they concede that Dr. 

Dunn will not testify at trial. Thus, the defendant’s motion is GRANTED. 

H. Scott Guelcher, Ph.D. 

 

The defendant seeks to exclude the testimony of Dr. Scott Guelcher. The 

plaintiffs do not respond to this motion, and I presume that they concede that Dr. 

Guelcher will not testify at trial. Thus, the defendant’s motion is GRANTED. 

I. Richard Trepeta, M.D. 

Richard Trepeta, M.D., is, among other things, a board-certified pathologist 

and a Fellow with the College of American Pathologists and the International Society 

for the Study of Vulvovaginal Disease. 

1. Qualifications 

First, BSC objects to Dr. Trepeta’s opinion testimony on the properties of 

polypropylene mesh. Given Dr. Trepeta’s knowledge and experience as an anatomical 

and clinical pathologist, I find him qualified to testify about mesh degradation, mesh 

shrinkage, and mesh migration, and I therefore DENY BSC’s motion in this respect. 

Second, BSC objects to Dr. Trepeta’s testimony on the human clinical response 

to mesh implants. Dr. Trepeta’s extensive experience and knowledge in the field of 

pathology qualify him to submit these opinions. Part of pathology involves reaching 

a diagnosis through clinical and pathologic correlation. Dr. Trepeta frequently 

engages in this process by providing clinical consultations to physicians, which 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 14 of 32
15 

require him to examine clinical information (through specimens, reports, or physician 

findings) and reach a pathologic diagnosis about a patient. Dr. Trepeta’s 

understanding and application of the pathologic process qualify him to opine on the 

causal relationship between transvaginal mesh implantation and tissue response. 

Therefore, I DENY BSC’s motion as to Dr. Trepeta’s qualifications on this point. 

2. Reliability and Relevance 

BSC raises two objections to the reliability and relevance of Dr. Trepeta’s 

opinion testimony. 

a. Reliability 

BSC contends that Dr. Trepeta’s method of using pathology reports to 

formulate his opinions is unreliable. Dr. Trepeta used various resources to reach his 

expert opinion: (1) he has studied over fifty mesh explant samples in his private 

practice; (2) he has studied the medical literature on mesh implantation and 

determined that his pathological findings corresponded with the published research 

on mesh erosion and exposure in the vaginal wall; and (3) he has reviewed twentyfour pathology reports that he received from the plaintiffs’ counsel and ascertained 

that the pathology reports of excised Boston Scientific products are consistent with 

the acute, sub-acute, and chronic categories of the disease process. 

Dr. Trepeta’s review of the pathology reports has a fatal deficiency—it lacked 

standards to govern the process of selecting the sample of pathology reports to be 

evaluated. The plaintiffs do not explain how or why they chose these twenty-four 

reports for Dr. Trepeta’s review, and without such an explanation, I have no way of 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 15 of 32
16 

assessing the potential rate of error or the presence of bias. Accordingly, Dr. Trepeta’s 

opinions derived solely from his review of the twenty-four pathology reports are 

EXCLUDED. BSC is free to cross-examine Dr. Trepeta at trial to ensure the basis of 

his opinions is consistent with the court’s ruling. 

b. Litigation Driven 

BSC argues Dr. Trepeta’s opinions are unreliable because they are litigation 

driven. I will not exclude an expert on the sole basis that the opinion arose during 

litigation, so long as it is otherwise reliable. BSC’s Motion is DENIED on this point. 

In conclusion, Dr. Trepeta’s general causation opinions are admitted except for 

his opinions based on the pathologic reports selected by the plaintiffs’ counsel for his 

review, which are excluded. Accordingly, BSC’s Motion to Exclude the Opinions and 

Testimony of Dr. Trepeta is GRANTED in part and DENIED in part. 

J. Vladimir Iakovlev, M.D. 

 

Dr. Iakovlev is an anatomical pathologist and director of Cytopathology at the 

Department of Laboratory Medicine at St. Michael’s Hospital in Toronto, Canada. 

1. General Causation 

BSC contends that this court should exclude Dr. Iakovlev’s opinions on 

specimens other than the plaintiff’s. Dr. Iakovlev’s general causation opinions are 

based largely on his examination of the mesh explant samples in his personal data 

pool. However, Dr. Iakovlev provides no information on how the mesh explants were 

chosen or prepared for examination. Dr. Iakovlev testified that plaintiffs’ counsel 

provided approximately 70 percent of the transvaginal mesh explants, but he does 

not know how those explants were chosen or what methodology counsel employed. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 16 of 32
17 

Accordingly, BSC’s motion on this matter is GRANTED, and Dr. Iakovlev’s 

general causation opinions based on his data pool are EXCLUDED. 

2. Specific Causation 

In their response, the plaintiffs state that Dr. Iakovlev will not offer a specific 

causation opinion in this case. Thus, on this issue BSC’s motion is GRANTED. 

In conclusion, BSC’s Motion to Strike and Exclude the Opinions and Testimony 

of Vladimir Iakovlev, M.D. is GRANTED. 

 The Plaintiffs’ Daubert Motions 

In this case, the plaintiffs seek to limit or exclude the expert opinions of Drs., 

Roger P. Goldberg, Christine Brauer, Patrick Culligan, Stephen Spiegelberg, and 

Stephen F. Badylak. 

A. Roger P. Goldberg 

 Dr. Goldberg is the Director of the Division of Urogynecology at NorthShore 

University HealthSystem and an Associate Professor of Obstetrics and Gynecology at 

the University of Chicago Pritzker School of Medicine. He is a member of the board 

of directors for AUGS and is the co-inventor of the Uphold. 3 

1. Conflict of Interest 

 First, the plaintiffs argue that Dr. Goldberg is biased in favor of the Uphold 

because he invented it and because he testified that he has been paid approximately 

$1.4 million from BSC since 2005. I find such an argument unavailing under Daubert. 

 

3 The plaintiffs filed two motions seeking to exclude Dr. Goldberg at ECF Nos. 42 and 43. The 

pleading at ECF No. 43 is more complete than ECF No. 42 and ECF No. 42 contains substantially 

the same arguments as ECF No. 43. Thus, I deny ECF No. 42 as moot and focus my analysis on ECF 

No. 43. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 17 of 32
18 

Bias and witness credibility are appropriate topics for cross-examination. The 

plaintiffs’ motion with respect to this matter is DENIED. 

2. Personal Experience 

 Next, the plaintiffs argue that Dr. Goldberg’s opinions on the Uphold’s safety 

should be excluded as unreliable because they are based solely on his personal 

experience. I disagree. Daubert permits an expert to rely heavily on his experience to 

form opinions. Even so, Dr. Goldberg’s relied-upon list plainly reveals that he also 

considered scientific literature in forming his opinions. I decline to impose a blanket 

exclusion on all of Dr. Goldberg’s safety opinions on the reasoning that they are based 

on his personal experience. The plaintiffs’ motion with respect to this matter is 

DENIED. 

3. Complication Rate 

 The plaintiffs argue that Dr. Goldberg’s opinion that the complication rate for 

the Uphold is less than 3 percent should be excluded because it is based on a 

calculation of cases at his medical center and is not supported by any scientific 

studies. However, it does appear to be supported by scientific studies—specifically, 

Dr. Goldberg’s data was published by a peer-reviewed journal. See Manhan K. Vu et 

al., Minimal Mesh Repair for Apical and Anterior Prolapse: Initial Anatomical and 

Subjective Outcomes, 23 Int. Urogynecol. J. 1753, 1753–61 (2012). Accordingly, I find 

the plaintiffs’ challenges without merit, and the motion as to complication rates is 

DENIED. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 18 of 32
19 

4. Physical Properties of Polypropylene 

The plaintiffs first challenge Dr. Goldberg’s qualification to opine on the 

physical properties of mesh because he is not a materials scientist, biomedical 

engineer, or a pathologist and admits as much. However, his extensive clinical 

experience surgically treating pelvic floor disorders with mesh, as well as his review 

of and contributions to the medical and scientific literature adequately qualify him to 

opine on polypropylene. Accordingly, BSC’s motion as to Dr. Goldberg’s qualifications 

is DENIED. 

The plaintiffs also challenge the reliability of Dr. Goldberg’s opinion on the 

physical properties of mesh—specifically that the device in question does not degrade, 

contract, or encapsulate. Dr. Goldberg claims he based this opinion on his clinical 

experience, during which he did not observe evidence of such mesh properties, and 

upon relevant medical and scientific literature. 

The advisory committee notes to Rule 702 state: 

If the witness is relying solely or primarily on experience, then the 

witness must explain how that experience leads to the conclusion 

reached, why that experience is a sufficient basis for the opinion, and 

how that experience is reliably applied to the facts. The trial court’s 

gatekeeping function requires more than simply “taking the expert’s 

word for it.” 

Fed. R. Evid. 702 advisory committee’s note to 2000 amendment (citing Daubert v. 

Merrell Dow Pharm., Inc., 43 F.3d 1311, 1319 (9th Cir. 1995) (“We’ve been presented 

with only the expert’s qualifications, their conclusions and their assurances of 

reliability. Under Daubert, that’s not enough.”)). 

Yet the Fourth Circuit appears more willing to “take the expert’s word for it” 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 19 of 32
20 

so long as the expert has demonstrated that he or she has experience in a field writ 

large. See, e.g., Eskridge v. Pac. Cycle, Inc., 556 F. App’x 182, 190–91 (4th Cir. 2014) 

(unpublished) (finding a bicycle engineer’s experience with “hundreds of cases of 

accidents” and “decades of experience in the industry in general” provided a reliable 

basis to testify about whether bicycle purchasers read warnings and dismissing 

concerns that the bicycle expert’s testimony was nothing more than personal opinion 

because of his “years of experience” and assurance that all of his opinions were “to a 

reasonable degree of engineering certainty”). 

On the one hand, Dr. Goldberg has based his opinions on his extensive clinical 

experience and a review of the medical and scientific literature, which, in the 

abstract, are reasonable bases from which to form an expert opinion. See Kumho, 526 

U.S. at 156 (“[N]o one denies that an expert might draw a conclusion from a set of 

observations based on extensive and specialized experience.”). 

On the other hand, the court does not have enough information to judge the 

reliability or relevance of these particular clinical observations—as distinguished 

from experience examining mesh explants. Perhaps Dr. Goldberg did not observe 

evidence of mesh contraction because he was not looking. Or perhaps his method of 

identifying and tracking the complications at issue is not scientifically sound. 

Additionally, sweeping statements about support within the medical community or 

medical literature can be difficult to assess. Although the expert report indicates Dr. 

Goldberg reviewed an extensive list of literature in forming his opinions generally, 

the court is directed to minimal specific support for the statements at issue or detail 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 20 of 32
21 

about Dr. Goldberg’s methodology. 

In this specific context, I am without sufficient information at this time to draw 

the fine line between reliable and unreliable expert testimony on physical mesh 

properties based primarily on a doctor’s clinical observations, or lack thereof. 

Accordingly, I RESERVE ruling until further testimony may be offered and evaluated 

firsthand at trial. 

5. Response to Plaintiffs’ Experts’ Claims 

 Lastly, the plaintiffs argue that all of Dr. Goldberg’s opinions in response to 

the plaintiffs’ experts’ claims should be excluded because he is not qualified and his 

method was unreliable. Specifically, the plaintiffs object to Dr. Goldberg’s opinions 

on (1) vaginal mesh implantation, (2) the MSDS, and (3) the severity of complications 

in the DFU. 

a. Vaginal Mesh Implantation 

The plaintiffs challenge the reliability of Dr. Goldberg’s opinion stating that 

the plaintiffs’ experts are wrong that bacteria in the vagina make transvaginal mesh 

surgery inadvisable—specifically that polypropylene does not become routinely 

infected. Dr. Goldberg claims he based this opinion on his clinical experience, during 

which he did not encounter mesh infection, and upon peer-reviewed literature. This 

opinion presents the same challenges to assessing reliability as discussed above. For 

the reasons discussed at length in my analysis of Dr. Goldberg’s opinions on the 

physical properties of polypropylene, I am without sufficient information at this time 

to determine the reliability of his opinions on mesh infection. Accordingly, the I 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 21 of 32
22 

RESERVE ruling until further testimony may be offered and evaluated firsthand at 

trial. 

b. MSDS 

 The plaintiffs argue that Dr. Goldberg is unqualified to opine as to the MSDS 

for polypropylene mesh. The opinions to which the plaintiffs refer are not expert 

opinions. Thus, I need not address them under Daubert. The plaintiffs’ motion with 

respect to this matter is DENIED. 

c. DFU 

 Dr. Goldberg does not provide the court the basis of his opinion relating to the 

DFU, so the court cannot conclude it was the result of a reliable methodology. See 

Daubert, 509 U.S. at 590 (“Proposed testimony must be supported by appropriate 

validation . . . .”). Dr. Goldberg’s opinion is therefore EXCLUDED as unreliable. 

Accordingly, as set forth above, the plaintiffs’ Motion to Exclude the Opinions 

and Testimony of Roger Goldberg, M.D. is GRANTED in part, DENIED in part, and 

RESERVED in part. 

B. Christine Brauer, Ph.D. 

Dr. Brauer is the President of Brauer Device Consultants LLC, where she 

provides consulting services to the medical device industry regarding FDA regulatory 

requirements. The plaintiffs seek to exclude both of Dr. Brauer’s expert reports filed 

on November 21, 2014. The first report (“FDA report”) focuses on the FDA regulatory 

framework for surgical devices, and the second report (“supplemental report”) focuses 

on industry standards that a manufacturer of a medical device must meet. I have 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 22 of 32
23 

repeatedly and thoroughly considered the admissibility of the FDA’s 510(k) process, 

and I have consistently found that the 510(k) process does not relate to safety or 

efficacy. Therefore, the parties may not present evidence regarding the 510(k) 

clearance process or subsequent FDA enforcement actions. Accordingly, the plaintiffs’ 

motion with regard to Dr. Brauer’s FDA report is GRANTED, and her opinions set 

forth in that report are EXCLUDED. 

With regard to the supplemental report, the plaintiffs contend that it is 

nothing more than her FDA report under a different cloak. I agree. Reading the two 

reports side by side, it appears that Dr. Brauer “supplemented” her report by 

removing references to the FDA and substituting the term “industry standard” 

instead. This “industry standard” clearly describes the FDA 510(k) process, which Dr. 

Brauer admits in her deposition. There is far too much overlap between Dr. Brauer’s 

FDA report and supplemental report to avoid a regulatory mini-trial, which I have 

repeatedly and consistently held would confuse and mislead the jury. Accordingly, 

the plaintiffs’ Motion to Exclude or Limit the Testimony of Christine Brauer, Ph.D. 

is GRANTED, and Dr. Brauer’s opinions are EXCLUDED in their entirety. 

C. Patrick Culligan, M.D. 

 Dr. Culligan is a urogynecologist offering general causation opinions related to 

polypropylene products generally and BSC’s Uphold device in particular. 

1. Safety and Efficacy 

First, the plaintiffs challenge the reliability of Dr. Culligan’s opinion that the 

Uphold is safe and effective to treat POP because Dr. Culligan acknowledged that 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 23 of 32
24 

there are only four scientific studies addressing the Uphold. The plaintiffs also 

contend that Dr. Culligan may not reliably base his Uphold opinions on studies about 

other POP products without detailed knowledge of how the products compare. I find 

these arguments unavailing because Dr. Culligan based his opinions on scientific 

literature, including a published study that he conducted on the Uphold. See Culligan 

Report Ex. B. 

 Similarly the plaintiffs challenge Dr. Culligan’s opinion that the Uphold is 

safer and more effective than traditional non-mesh POP procedures because of the 

lack of studies making this comparison.4 However, Dr. Culligan’s method is not 

unreliable just because a direct comparison study does not exist between these 

treatments 

 Next, the plaintiffs argue that Dr. Culligan may not reliably consider his 

personal experience in forming his opinions because Dr. Culligan could not testify as 

to exact statistics about his patients. However, such detail is not required under 

Daubert to opine as to the large-scale safety and efficacy of the relevant device.5

The plaintiffs also point to a comment made during Dr. Culligan’s deposition 

to argue that he failed to account for contrary literature in forming his opinions. I am 

satisfied that Dr. Culligan followed a reliable methodology in reaching his opinions 

on the safety and efficacy of the Uphold device, notwithstanding the deposition 

 

4 BSC contends in its response that the plaintiffs do not challenge this opinion. Upon my reading of 

the plaintiffs’ motion, I disagree. 

5 The plaintiffs also challenge an opinion that Dr. Culligan asserts at his deposition—that the 

complication rate in his patients implanted with the Uphold is one percent. However, this opinion is 

not within Dr. Culligan’s report. Culligan Report 18–19. Thus, I must presume that Dr. Culligan does 

not plan to offer it at trial, and I need not assess the reliability of it. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 24 of 32
25 

testimony. Furthermore, I decline to address Dr. Culligan’s opinion on shrinkage 

here. The plaintiffs bring a separate challenge to such opinions, which is addressed 

below. In summary, the plaintiffs’ Motion as to Dr. Culligan’s safety and efficacy 

opinions is DENIED. 

2. Physical Properties of Polypropylene Mesh 

The plaintiffs challenge the reliability of Dr. Culligan’s opinion on the physical 

properties of mesh, including the nonoccurrence of shrinkage, foreign body response, 

and degradation. Dr. Culligan claims he based this opinion on his clinical experience, 

during which he did not observe evidence of such mesh properties, and upon peerreviewed literature. On the one hand, these are reasonable bases from which to form 

an expert opinion. On the other hand, the court does not have enough information to 

judge the reliability or relevance of these particular clinical observations or the 

methodology. Further, I have no basis to assess claims that Dr. Culligan’s 

observations are supported by the scientific community/literature. 

 For the reasons discussed at length in my analysis of Dr. Goldberg, I am 

without sufficient information at this time to determine the reliability of Dr. 

Culligan’s opinions on the physical properties of mesh. Accordingly, I RESERVE 

ruling until further testimony may be offered and evaluated first-hand at trial. 

3. Mesh Design 

 Next, the plaintiffs contend that Dr. Culligan is not qualified to opine as to the 

mesh design process. I agree. Dr. Culligan testified at his deposition that he has not 

designed any POP products and the court is unpersuaded by BSC’s argument that 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 25 of 32
26 

Dr. Culligan has sufficient experience with pelvic floor repair kits to opine as to the 

Uphold design. Dr. Culligan’s opinions on this matter are EXCLUDED. 

4. DFU 

 The plaintiffs also argue that Dr. Culligan is unqualified to opine as to the 

Uphold DFU. Based on a demonstrated lack of knowledge as to DFUs and an 

admitted lack of expertise in the area, the court finds insufficient indicia of Dr. 

Culligan’s qualification to opine on DFUs. His opinions on the DFU are EXCLUDED. 

5. MSDS 

 I decline to entertain the plaintiffs’ challenge to Dr. Culligan’s opinions 

concerning the MSDS because the parties agreed as to the parameters of his 

testimony on this matter at Dr. Culligan’s deposition. The parties agreed that Dr. 

Culligan could testify that “[he] didn’t know what an MSDS sheet was and that ‘he’d 

never consulted one.” Culligan Dep. 171:19–23, Jan. 12, 2015. Thus, the plaintiffs’ 

motion with respect to Dr. Culligan’s MSDS opinions is GRANTED. 

6. Patient Brochure 

 Although the plaintiffs argue that Dr. Culligan’s opinions on any patient 

brochures should be excluded, BSC concedes he will not offer such opinions at trial. 

Thus, the motion with respect to this matter is GRANTED. 

7. Opinions on FDA 

 Although the plaintiffs argue that Dr. Culligan’s opinions concerning the FDA 

should be excluded, BSC concedes he will not offer such opinions at trial. Id. Thus, 

the motion with respect to these opinions is GRANTED. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 26 of 32
27 

In sum, the plaintiffs’ Motion to Exclude Certain Opinions and Testimony of 

Dr. Culligan is GRANTED in part, DENIED in part, and RESERVED in part. 

D. Stephen Spiegelberg, Ph.D. 

Dr. Spiegelberg is the president and co-founder of Cambridge Polymer Group 

Inc., where he directs a team of scientists who perform contract research, analytical 

testing, and device development for the biomedical and polymer communities. 

1. Position Statements 

First, the plaintiffs argue that Dr. Spiegelberg’s opinions regarding position 

statements should be excluded because (1) they are not contained in his expert report; 

(2) he is not qualified to offer such opinions; and (3) he lacks any reliable methodology. 

Upon review, I agree with BSC that Dr. Spiegelberg does not in fact offer the opinions 

the plaintiffs seek to exclude. Accordingly, the plaintiffs’ motion with regard to 

position statements is GRANTED. 

2. FDA 

Next, the plaintiffs contend that Dr. Spiegelberg is unqualified to opine on the 

FDA 510(k) clearance process and that such opinions should be excluded as 

irrelevant. In response, BSC concedes that Dr. Spiegelberg will not offer opinions on 

the FDA 510(k) clearance process. Accordingly, the plaintiffs’ motion with regard to 

the FDA is GRANTED. 

BSC limits its concession by arguing that Dr. Spiegelberg is qualified to opine 

on ISO standards based on his experience in the field of medical device analysis and 

design. I agree. Dr. Spiegelberg’s current work revolves around medical device 

development and consultation. He is also the Task Force Chairman for the American 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 27 of 32
28 

Society for Testing and Materials (“ASTM”), which establishes standards involving 

the cleanliness of biomedical devices and characterization methods for polymers. 

Consulting on the development of new medical products requires familiarity with the 

applicable industry standards. Therefore, to the extent Dr. Spiegelberg intends to 

opine on ISO standards without referencing the FDA, I find him qualified to do so. 

Accordingly, the plaintiffs’ motion with regard to Dr. Spiegelberg’s qualifications is 

DENIED. 

3. Black Specks or Spots 

Next, the plaintiffs argue that Dr. Spiegelberg’s opinions regarding black 

specks in BSC’s mesh are unfounded and unreliable. In his expert report, Dr. 

Spiegelberg states that the “black spots” are actually reflections of light on the curves 

of the mesh when pictures are taken, rather than inclusions or defects in the mesh. 

The plaintiffs contend that Dr. Spiegelberg’s findings are unreliable because he did 

not review the photographs supplied by the plaintiffs’ expert, Dr. Dunn, nor did he 

take his own photographs. Whether Dr. Spiegelberg took his own photographs does 

not sufficiently undermine the reliability of his analysis here. Challenges to Dr. 

Spiegelberg’s ultimate conclusion with regard to the nature of the black spots are 

better suited for cross-examination. Accordingly, the plaintiffs’ motion with regard to 

black specks or spots is DENIED. 

4. FTIR and EDS 

Last, the plaintiffs seek to limit Dr. Spiegelberg’s general causation opinions 

based on his Fourier Transform Infrared Spectroscopy (“FTIR”) and Electron 

Dispersive Spectroscopy (“EDS”) testing. However, the plaintiffs point out that Dr. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 28 of 32
29 

Spiegelberg’s admissions regarding the limitations of these testings may also be 

grounds for cross-examination and thus seek only qualification or explanation of the 

limitations inherent to the testing in order to avoid misleading or confusing the jury. 

The plaintiffs will have the opportunity to adequately highlight these limitations at 

trial upon cross-examination. Accordingly, the plaintiffs’ motion with regard to Dr. 

Spiegelberg’s FTIR and EDS testing is DENIED. 

In sum, the plaintiffs’ Motion to Exclude the Testimony and Opinions of Dr. 

Stephen Spiegelberg, Ph.D. is GRANTED in part and DENIED in part. 

E. Stephen F. Badylak, D.V.M., Ph.D., M.D. 

 

Dr. Badylak is the Deputy Director of the McGowan Institute for Regenerative 

Medicine, Director of the Center for Preclinical Studies, and a tenured professor with 

the Department of Surgery at the University of Pittsburgh. 

1. Risk-Benefit Analysis or Safety and Efficacy 

The plaintiffs contend that Dr. Badylak should be precluded from opining on 

the safety and efficacy of polypropylene mesh devices because he has not reviewed 

the applicable scientific literature and he has no clinical experience using these 

devices. Dr. Badylak’s expert report indicates that he reviewed more than 200 

relevant scientific publications, including more than twenty publications evaluating 

the safety and efficacy of BSC devices. Furthermore, Dr. Badylak explains that he is 

more familiar with the body of literature reviewing the safety and efficacy of surgical 

mesh generally, versus literature specific to any one device. This explanation does 

not undermine his qualifications but instead clarifies his approach. If there are 

certain device-specific publications that Dr. Badylak failed to review in preparing his 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 29 of 32
30 

expert report, the plaintiffs are free to ask him about those publications on crossexamination. 

Similarly, the plaintiffs’ arguments regarding Dr. Badylak’s clinical experience 

are also without merit. Dr. Badylak has extensive experience in the field of 

biomaterials, including the design of implantable surgical mesh devices. Accordingly, 

the plaintiffs’ motion with regard to Dr. Badylak’s safety and efficacy opinions is 

DENIED. 

2. Degradation 

The plaintiffs argue that Dr. Badylak’s opinions with regard to oxidative 

degradation based on the scientific literature are unreliable because he contradicted 

himself during his deposition by acknowledging the “phenomenon” of oxidative 

reactions. However, the plaintiffs omit Dr. Badylak’s subsequent testimony, where 

he states that he does not believe that oxidative reactions at the surface of 

polypropylene results in the degradation that causes further problems. Upon review 

of the deposition, I do not find Dr. Badylak’s testimony sufficiently contradictory to 

undermine the reliability of his expert opinions. Accordingly, the plaintiffs’ motion 

with regard to degradation is DENIED. 

The plaintiffs’ Motion to Exclude the Opinions and Testimony of Stephen F. 

Badylak, D.V.M., Ph.D., M.D. is thus DENIED. 

VI. Effect of Daubert Ruling 

I emphasize that my rulings excluding expert opinions under Rule 702 and 

Daubert are dispositive of their potential admissibility in these cases, but my rulings 

not to exclude expert opinions are not dispositive of their admissibility at trial. In 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 30 of 32
31 

other words, to the extent that certain opinions might be cumulative or might confuse 

or mislead the jury, they may still be excluded under Rule 403 or some other 

evidentiary rule. I will take up these issues as they arise. 

VII. Conclusion 

 

For the reasons discussed above, my rulings on BSC’s motions are as follows: 

Motion to Exclude the Testimony of Michael Thomas Margolis, M.D. [ECF No. 33] is 

GRANTED in part and DENIED in part; Motion to Exclude the Opinions and 

Testimony of Niall Galloway, M.D [ECF No. 36] is GRANTED; Motion to Exclude the 

Opinions and Testimony of Thomas Barker, Ph.D. [ECF No. 37] is GRANTED; Motion 

to Limit the Opinions and Testimony of Bobby L. Shull, M.D. [ECF No. 40] is 

GRANTED; Motion to Exclude the Opinions and Testimony of Jimmy Mays, Ph.D. 

[ECF No. 41] is GRANTED; Motion to Exclude the Opinions and Testimony of Peggy 

Pence, Ph.D. [ECF No. 46] is GRANTED; Motion to Exclude the Opinions and 

Testimony of Russell Dunn, Ph.D. [ECF No. 47] is GRANTED; Memorandum of Law 

in Support of Its Motion Exclude the Opinions and Testimony of Scott Guelcher, 

Ph.D.6 [ECF No. 48] is GRANTED; Motion to Exclude the Opinions and Testimony of 

Richard Trepeta, M.D. [ECF No. 49] is GRANTED in part and DENIED in part; and 

Motion to Strike and Exclude the Opinions and Testimony of Vladimir Iakovlev, M.D. 

[ECF No. 56] is GRANTED.

My rulings on the plaintiffs’ motions are as follows: Combined Motion and 

 

6 BSC only filed a memorandum regarding Dr. Guelcher and did not file a motion. Thus, the court 

construes this memorandum as a combined motion and memorandum to exclude Scott Guelcher, 

PH.D. 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 31 of 32
32 

Memorandum of Law to Exclude the Opinions and Testimony of Roger P. Goldberg 

[ECF No. 43] is GRANTED in part, DENIED in part, and RESERVED in part; Motion 

to Limit the Testimony of Roger Goldberg, M.D. [ECF No. 42] is DENIED as moot; 

Motion to Exclude or Limit the Testimony of Christine Brauer, Ph.D. [ECF No. 44] is 

GRANTED; Motion to Exclude Certain Opinions and Testimony of Dr. Patrick 

Culligan [ECF No. 45] is GRANTED in part, DENIED in part, and RESERVED in 

part; Motion to Exclude the Testimony and Opinions of Dr. Stephen Spiegelberg, 

Ph.D. [ECF No. 59] is GRANTED in part and DENIED in part; and Motion to Exclude 

the Opinions and Testimony of Stephen F. Badylak, D.V.M., Ph.D., M.D. [ECF No. 

55] is DENIED. 

The court DIRECTS the Clerk to send a copy of this Order to counsel of record 

and any unrepresented party. 

ENTER: May 20, 2016 

Case 2:18-cv-02183-KJM-CKD Document 93 Filed 05/20/16 Page 32 of 32