# Olszeski v. Ethicon Women's Health and Urology

> District Court, N.D. Ohio · April 8, 2022

URL: https://www.frixlaw.com/law-library/cases/10370710

## Case

- **Court:** District Court, N.D. Ohio
- **Decided:** April 8, 2022
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10370710

## Opinion text

PEARSON, J.

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
EASTERN DIVISION

JANE OLSZESKI, )
)
) CASE NO. 5:19CV1787
Plaintiff, )
)
v. ) JUDGE BENITA Y. PEARSON
)
ETHICON WOMEN’S HEALTH AND )
UROLOGY, et al., )
) ORDER
Defendants. ) [Resolving ECF Nos. 127, 138, 139]

Pending before the Court is (1) Defendants’ Motions to Exclude the Expert Testimony of
Jimmy Mays, Ph.D. (ECF No. 127), (2) Plaintiff’s Motion to Exclude Certain General Expert
Opinions and Testimony of Juan Carlos Felix, M.D. (ECF No. 138), and (3) Plaintiff’s Motion to
Exclude or Limit the General Opinions and Testimony of Salil Khandwala, M.D. (ECF No. 139).
All three pending motions have been fully briefed. See ECF Nos. 144, 145, 152, 153, 182, 187,
190. For the reasons given below, each of the pending motions to exclude are denied.
I. Background
A. Defendants’ Motions to Exclude the Expert Testimony of Jimmy Mays, Ph.D (“Dr.
Mays”) (ECF No. 127)

Defendants seek to exclude Dr. Mays’ testimony because it is unreliable, irrelevant, and
otherwise inadmissible as (1) Dr. Mays’ opinions do not fit the facts of the case (ECF No. 127-1
at PageID #: 9555), (2) Dr. Mays’ proposed alternatives were not technically or economically
feasible, or safer, at the time of Plaintiff’s surgery (Id. at PageID #: 9556 – 9559), and (3) Dr.
Mays’ opinions are unreliable and do not support his conclusion because they were not tested
adequately (Id. at PageID #: 9556 – 9557, 9559 – 9567).
In opposition, Plaintiff argues that “Dr. Mays is a well-qualified professor of biomedical
engineering, whose career has focused on polymer materials[,]” and “[h]is degradation and

alternative design opinions are relevant to Plaintiff’s product liability claims against Defendants
and based upon a reliable methodology. Moreover, even if Defendants’ criticisms against Dr.
Mays’s opinions were accurate – which they are not – such are merely grounds for cross-
examination and not exclusion.” ECF No. 153 at PageID #: 19756.
B. Plaintiff’s Motion to Exclude Certain General Expert Opinions and Testimony of
Juan Carlos Felix M.D. (“Dr. Felix”) (ECF No. 138)

Plaintiff seeks to exclude Dr. Felix’s testimony because it is not scientifically reliable, but
instead amounts to nothing more than (1) ipse dixit testimony supported by insufficient review of
scientific literature (ECF No. 138 at PageID #: 16078 – 16083, 16086 – 16088), and (2)
“anecdotal evidence, improper extrapolation, speculation, and subjectivity” (ECF No. 138 at
PageID #: 16083 – 16085). In opposition, Defendants argue “Dr. Felix’s opinions serve as a
direct critique of many of [Plaintiff’s expert]’s opinions, particularly those regarding mesh
contracture and degradation.” ECF No. 144 at PageID #: 18313. As support, Defendants further
state that Dr/ Felix’s opinion is based on “(1) his knowledge of female anatomy, tissues, and
TVT placement, (2) a compilation of clinical studies in meta-analysis (citing two peer-reviewed,
published articles), and (3) two published studies showing no mesh contracture interfering with
urine flow.” Id. at PageID #: 18315.
C. Plaintiff’s Motion to Exclude or Limit the General Opinions and Testimony of Salil
Khandwala, M.D. (“Dr. Khandwala”) (ECF No. 139)

Plaintiff seeks to exclude Dr. Khandwala’s testimony because “Dr. Khandwala offers
opinions in this case that exceed the bounds of his qualifications and are founded on insufficient
facts and unreliable methodology” that “present a serious risk of confusing the issues and
misleading the jury in this case.” ECF No. 139 at PageID #: 16502. More specifically, Plaintiff
avers that Dr. Khandwala (1) “is not a regulatory expert and has no experience drafting

[instructions for use], patient brochures, or any other sort of warning labels or marketing
materials for medical products” (Id. at PageID #: 16505 – 16508), (2) “is not a biomaterials
expert, and he further conceded at his deposition that he is not a pathologist or toxicologist[,]”
(Id. at PageID #: 16508 – 16509), and (3) “has no experience designing pelvic mesh products
and was not in any way involved with [Defendants’] design process” (Id. at PageID #: 16509 –
16510).
In opposition, Defendants argue that the expert testimony should be admitted because Dr.
Khandwala (1) based his opinion on “his review of the medical literature, published
complication rates, information gleaned from medical conferences, and medical organization and
FDA statements” (ECF No. 145 at PageID #: 18675 – 18677), (2) “will not be called to testify as

to FDA regulations or the FDA clearance process” (Id. at PageID #: 18677 – 18678), (3) “is well
qualified to testify as to the properties and characteristics of the mesh because he is an
accomplished pelvic surgeon, board certified in [female pelvic medicine and reconstructive
surgery], with extensive experience in implanting and revising pelvic mesh devices, investigating
mesh slings in clinical trials, publishing on mesh surgeries, and training other surgeons in these
procedures” (Id. at PageID #: 18678 – 18680), and (4) possesses “firsthand experience with the
design of related products” (ECF No. 145 at PageID #: 18680 – 18681).
II. Discussion
“When a witness ‘is qualified as an expert by knowledge, skill, experience, training, or
education,’ he may give opinion testimony if his ‘scientific, technical, or other specialized
knowledge will help the trier of fact to understand the evidence or to determine a fact in issue’;

his ‘testimony is based on sufficient facts or data’ and ‘is the product of reliable principles and
methods’; and he ‘has reliably applied the principles and methods to the facts of the case.’”
Babcock Power, Inc. v. Kapsalis, 854 F. App'x 1, 7 (6th Cir. 2021) (quoting Fed. R. Evid. 702).
“The trial court is the ‘gatekeeper’ of expert testimony, and thus it must exclude any opinion
evidence that is unreliable and irrelevant, but it also has ‘considerable leeway’ in determining
reliability. Id. (quoting Conwood Co., L.P. v. U.S. Tobacco Co., 290 F.3d 768, 792 (6th Cir.
2002)). “[A]s long as there is a reasonable factual basis for the expert's opinion, any objections
to his testimony go to its weight and not its admissibility. Id. at 8. (citing In re Scrap Metal
Antitrust Litig., 527 F.3d 517, 529-31 (6th Cir. 2008)).
Applying Fed. R. Evid. 702, all three motions to exclude are denied because they are

tantamount to a disagreement with the opposing expert’s fact-based opinion. Each proffered
expert has set forth proper bases for delivering expert opinion, including, but not limited to,
firsthand professional experience and review of peer-reviewed research. The instant case
involves a highly technical subject matter, and expert testimony will be particularly helpful to the
trier of fact – the very purpose of admitting expert testimony. While parties should certainly
challenge expert testimony, such a challenge is grounds for cross-examination, rather than
exclusion. KSP Invs., Inc. v. United States, No. 1:07-CV-857, 2008 WL 182257, at *5 (N.D.
Ohio Jan. 17, 2008) (ruling that defendant’s expert testimony was permissible because the expert
properly answered questions “by referencing the facts supported by the record and by using
his experience as an international tax attorney to explain the likely financial analysis” relevant to
the case); Grover v. BMW of N. Am., LLC, No. 1:19-CV-12, 2022 WL 205249, at *7 (N.D. Ohio
Jan. 24, 2022) (holding that the requirements of expert testimony were satisfied because
plaintiff’s expert applied “his knowledge and experience to his examination of documents

produced by [Defendant] regarding N63 oil consumption issues, as well as documentation
concerning the specific facts concerning the subject vehicles in this case”). The Court
understands a party’s desire to exclude unfavorable testimony, but “‘juror common sense, cross-
examination, argument by the party-opponent's attorneys, the testimony of the party-opponent's
own expert witnesses, and a cautionary instruction from the Court, if required, will normally
assure that the jury fairly evaluates the expert's testimony.’” Younglove Const., LLC v. PSD
Dev., LLC, 782 F. Supp. 2d 457, 465 (N.D. Ohio 2011) (quoting Conde v. Velsicol Chemical
Corp., 804 F.Supp. 972, 986 (S.D.Ohio 1992)).
III. Conclusion
For the reasons stated above, (1) Defendants’ Motion to Exclude the Expert Testimony

of Jimmy Mays, Ph.D, (ECF No. 127), (2) Plaintiff’s Motion to Exclude Certain General Expert
Opinions and Testimony of Juan Carlos Felix M.D. (ECF No. 138), and (3) Plaintiff’s Motion to
Exclude or Limit the General Opinions and Testimony of Salil Khandwala, M.D. (ECF No. 139)
are each denied.

IT IS SO ORDERED.

April 8, 2022 /s/ Benita Y. Pearson
Date Benita Y. Pearson
United States District Judge

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10370710. Public record. Not legal advice.