Meade v. Ethicon, Inc.

IN THE UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF ARKANSAS

CENTRAL DIVISION

DANA MEADE, et al. PLAINTIFF

v. Case No. 4:20-cv-00694-KGB

ETHICON, INC., et al. DEFENDANTS

ORDER

Before the Court is a motion to limit the case-specific opinions and testimony of Konstantin

Walmsley, M.D., and a motion to limit the opinions of pathologist Elizabeth A. Laposata, M.D.,

filed by defendants Ethicon, Inc., Ethicon LLC, and Johnson & Johnson (collectively, “Ethicon”)

(Dkt. Nos. 39; 41). Plaintiffs Dana Meade and Glen Meade (collectively, “the Meades”) have

responded in opposition to Ethicon’s two motions (Dkt. Nos. 43; 44).

For the following reasons, the Court grants in part and denies in part defendants’ motion

to limit the case-specific opinions and testimony of Dr. Walmsley (Dkt. No. 39), and the Court

denies defendants’ motion to limit the opinions of pathologist Dr. Laposata (Dkt. No. 41). As to

those matters about which the Court grants an in limine motion, all parties, their counsel, and

witnesses are directed to refrain from making any mention through interrogation, voir dire

examination, opening statement, arguments or otherwise, either directly or indirectly, concerning

the matters about which the Court grants an in limine motion, without first approaching the bench

and obtaining a ruling from the Court outside the presence of all prospective jurors and the jurors

ultimately selected to try this case. Further, all counsel are required to communicate this Court’s

rulings to their clients and witnesses who may be called to testify in this matter.

I. Background

The Meades filed suit in this case against defendants on September 27, 2013 (Dkt. No. 1).

This case was originally filed in the United States District Court for the Southern District of West

Virginia and was related to Multi-District Litigation 2327 (“Ethicon MDL”), 2:12-md-2327, one

of seven MDLs assigned to United States District Judge Joseph R. Goodwin by the Judicial Panel

on Multidistrict Litigation and totaling over 100,000 cases since inception (Dkt. Nos. 1; 48, at 1;

49-1). The Ethicon MDL includes as plaintiffs women who had one or more of defendants’ pelvic

mesh products inserted into their bodies to treat medical conditions, primarily pelvic organ

prolapse and stress urinary incontinence (Dkt. No. 49-1, ¶ 1). Plaintiffs to the Ethicon MDL also

include the spouses and intimate partners of the aforesaid women, as well as others with standing

to file claims arising from defendants’ products (Id., ¶ 2). Plaintiffs filed suit directly in the Ethicon

MDL on September 27, 2013, but served Ethicon on June 7, 2013, pursuant to a delayed filing

agreement (Dkt. Nos. 1; 2). On May 14, 2020, Judge Goodwin entered a transfer order transferring

35 cases from the Ethicon MDL to various appropriate jurisdictions (Dkt. No. 48). Judge Goodwin

concluded that transferring these 35 cases to the venues from which they arose would better

convenience the parties and promote the final resolution of these cases (Id., at 1). As a result,

Judge Goodwin transferred the Meades’ case to this Court (Id., at 4).

Ms. Meade had a pelvic mesh product called a TVT-Obturator (“TVT-O”) implanted on

August 14, 2012, to treat stress urinary incontinence, cystocele, and rectocele by Charles

McKnight, M.D., in Little Rock, Arkansas (Dkt. Nos. 1, ¶¶ 8-12; 35-1, at 4). Ms. Meade had the

TVT-O partially removed on November 27, 2012, by Robert Summit, M.D., at Baptist Memorial

Hospital for Women in Memphis, Tennessee, and Ms. Meade had an additional portion of the

TVT-O removed on November 7, 2014, by Dionysios Veronikis, M.D., at Mercy Hospital St.

Louis (Dkt. No. 35-1, at 5). Plaintiffs allege that Ms. Meade suffered a variety of bodily injuries

resulting from the implantation of the TVT-O, including: exposed sling mesh; pelvic pain; vaginal

mesh erosion; dyspareunia; bladder lesion; bladder mesh erosion; infection; urinary

urgency/frequency; recurrent incontinence; bowel problems; organ perforation; fistulae; bleeding;

neuromuscular problems; vaginal scarring; hematuria; bladder spasms; dysuria; urinary tract

infection; and cystitis (Id.). Plaintiffs claim that Ms. Meade started experiencing symptoms

attributable to the TVT-O in August 2012, but Ms. Meade did not associate those symptoms with

the TVT-O until November 2012 (Id., at 6).

Plaintiffs were residents of Arkansas at the time of Ms. Meade’s implantation surgery and

remained residents through July 2013 (Dkt. No. 36, at 3). Plaintiffs subsequently moved to Punta

Gorda, Florida, from July 2013 through August 2014 (Id.). In August 2014, plaintiffs moved to

Heber Springs, Arkansas (Id.). Ms. Meade separated from Mr. Meade in March 2015, and the two

subsequently divorced (Id.). Ms. Meade moved to Florence, Alabama, in March 2015, and Ms.

Meade moved again to Highlands, California, in March 2016 (Id.).

In their complaint, plaintiffs assert against defendants, among other claims: Count I –

Negligence (apart from negligent manufacturing defect); Count III – Strict Liability – Failure to

Warn; and Count V – Strict Liability – Design Defect (Dkt. Nos. 1, ¶ 13; 95).

II. Legal Standard

Federal Rule of Evidence 702 provides that:

A witness who is qualified as an expert by knowledge, skill, experience, training,

or education may testify in the form of an opinion or otherwise if:

(a) the expert’s scientific, technical, or other specialized knowledge will help the

trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the

case.

Fed. R. Evid. 702. “Rule 702 reflects an attempt to liberalize the rules governing the admission

of expert testimony. The rule clearly is one of admissibility rather than exclusion.” Lauzon v.

Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir. 2001) (internal quotations and citations omitted).

In determining whether expert testimony should be admitted, the district court must decide

if the expert’s testimony and methodology are reliable, relevant, and can be applied reasonably

to the facts of the case. David E. Watson, P.C. v. United States, 668 F.3d 1008, 1015 (8th Cir.

2012); Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir. 2010). Under Daubert v. Merrell

Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the district court must conduct this initial

inquiry as part of its gatekeeping function. Watson, 668 F.3d at 1015. The Court must be

mindful that “Daubert does not require proof with certainty.” Sorensen By & Through Dunbar

v. Shaklee Corp., 31 F.3d 638, 650 (8th Cir. 1994). Rather, it requires that expert testimony be

reliable and relevant. Id. “The inquiry as to the reliability and relevance of the testimony is a

flexible one designed to ‘make certain that an expert, whether basing testimony upon

professional studies or personal experience, employs in the courtroom the same level of

intellectual rigor that characterizes the practice of an expert in the relevant field.’” Marmo v.

Tyson Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir. 2006) (quoting Kumho Tire Co. v.

Carmichael, 526 U.S. 137, 152 (1999)).

The proponent of the expert testimony has the burden of establishing by a preponderance

of the evidence the admissibility of the expert’s testimony. Id. at 757-58. To satisfy the

reliability requirement for admission of expert testimony, “the party offering the expert

testimony must show by a preponderance of the evidence that the expert is qualified to render

the opinion and that the methodology underlying his conclusions is scientifically valid.” Barrett,

606 F.3d at 980 (internal quotation marks and citation omitted). To satisfy the relevance

requirement for the admission of expert testimony, “the proponent must show that the expert’s

reasoning or methodology was applied properly to the facts at issue.” Id. (citing Marmo, 457

F.3d at 757).

The Court examines the following four non-exclusive factors when determining the

reliability of an expert’s opinion: (1) “whether it can be (and has been) tested”; (2) “whether the

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

rate of error”; and (4) “[the method’s] ‘general acceptance.’” Presley v. Lakewood Eng’g & Mfg.

Co., 553 F.3d 638, 643 (8th Cir. 2009) (quoting Daubert, 509 U.S. at 593-94). These factors are

not exhaustive or limiting, and the Court must use the factors as it deems fit to tailor an examination

of the reliability of expert testimony to the facts of each case. Id. In addition, the Court can weigh

whether the expertise was developed for litigation or naturally flowed from the expert’s research;

whether the proposed expert ruled out other alternative explanations; and whether the proposed

expert sufficiently connected the proposed testimony with the facts of the case. Id. While

weighing these factors, the Court must continue to function as a gatekeeper who separates expert

opinion evidence based on good grounds from subjective speculation that masquerades as

scientific knowledge. Id.

The Court recognizes that experts may, at times speculate, “but too much [speculation] is

fatal to admission.” Grp. Health Plan, Inc. v. Philip Morris USA, Inc., 344 F.3d 753, 760 (8th Cir.

2003) (citations omitted). Thus, speculative expert testimony with no basis in the evidence is

inadmissible. Weisgram v. Marley Co., 169 F.3d 514, 518-19 (8th Cir. 1999), aff’d, 528 U.S. 440

(2000) (reversing a district court for allowing a witness who was qualified as a fire investigator

“to speculate before the jury as to the cause of the fire by relying on inferences that have absolutely

no record support”).

Likewise, expert opinion is inadmissible if its sole basis is studies that do not provide a

sufficient foundation for the opinion. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 145 (1997).

When studies form a basis for an expert’s opinion, then, the Court must determine if there is an

adequate basis for the experts’ opinion and whether there is “too great an analytical gap between

the data and the opinion proffered.” See id. at 146.

“As a general rule, the factual basis of an expert opinion goes to the credibility of the

testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for

the opinion in cross-examination.” Bonner v. ISP Techs., Inc., 259 F.3d 924, 929 (8th Cir. 2001)

(internal citation omitted). “Only if the expert’s opinion is so fundamentally unsupported that it

can offer no assistance to the jury must such testimony be excluded.” Id. at 929-30 (quoting Hose

v. Chi. Nw. Transp. Co., 70 F.3d 968, 974 (8th Cir. 1996)).

In this Order, the Court focuses on arguments made, and rules on objections raised,

pursuant to Rule 702. The Court reserves ruling on any other objections to the anticipated

testimony until the time of trial. The parties may make contemporaneous objections at trial.

III. Ethicon’s Motions To Exclude Expert Testimony

Ethicon moves the Court to exclude expert testimony of Dr. Walmsley and Dr. Laposata

pursuant to Federal Rule of Evidence 702 and the standards set forth in Daubert and its progeny

(Dkt. Nos. 39; 41).1 Though Ethicon’s two motions are similar, the Court will discuss and consider

them separately.

1 When Ethicon filed these motions, this case was still before Judge Goodwin as a part of

the Ethicon MDL. As a result, Ethicon’s arguments in favor of these motions and the Meades’

arguments in response rely heavily on case law and precedent from the United States Court of

A. Defendants’ Motion To Limit The Case-Specific Opinions And

Testimony Of Dr. Walmsley

Defendants move to exclude certain case-specific testimony and opinions offered by Dr.

Walmsley (Dkt. No. 39, at 1). Specifically, defendants move for the Court to preclude Dr.

Walmsley from offering the following expert testimony and opinions at trial in this case: (1)

general causation opinions, including opinions regarding complications not experienced by Ms.

Meade; (2) opinions regarding Ethicon’s state of mind, corporate conduct, and marketing; (3)

opinions containing legal conclusions, standards, and terms of art; (4) opinions regarding Ethicon’s

warnings for the TVT-O device, as well as opinions regarding informed consent; and (5) opinions

regarding allegedly safer alternatives for the treatment of stress urinary incontinence (Dkt. No. 40,

at 1-2).

1. Dr. Walsmley’s Opinions And Testimony

Dr. Walmsley is a board-certified urologist and a licensed physician in the State of New

Jersey, and the Court has reviewed Dr. Walsmley’s expert report (Dkt. No. 39-1, at 1-21). In his

report, Dr. Walmsley “offers his opinions on causative factors of Ms. Meade’s vaginal pain,

dyspareunia, pelvic pain, infection, voiding dysfunction, urinary urgency, urgency urinary

incontinence, leg pain, urethral scarring, recurrent urinary tract infections, nerve entrapment

syndrome, and chronic mesh pain syndrome” (Dkt. No. 44, at 1-2). Dr. Walmsley’s opinions are

based on his review of medical records, his extensive clinical experience treating women like Ms.

Meade, his education and training, and his knowledge of the relevant medical literature (Id., at 2).

Appeals for the Fourth Circuit and district courts therein (Dkt. Nos. 39; 40; 41; 43; 44). On July

28, 2020, the parties submitted a joint status report stating, in part, that these two Daubert motions

are ready to be ruled upon by this Court (Dkt. No. 85, at 8-9). Accordingly, the Court has

considered the factual arguments raised in these motions and will assess those arguments in the

light of case law and precedent from the United States Court of Appeals for the Eighth Circuit and

district courts therein.

Dr. Walmsley opines that Ms. Meade should not have been implanted with Ethicon’s TVT-

O “because the poor design of the device increased the risk of serious complications and caused

her specific complications” (Dkt. No. 39-1, at 11). Dr. Walmsley opines that Ethicon’s

construction mesh used in the TVT-O is not suitable for its intended application as permanent

prosthetic implants for stress urinary incontinence because the pore size changes post-

implantation, its heavy weight, its degradation over time, and its ability to cause chronic foreign

body reactions, fibrotic bridging, mesh contracture/shrinkage, fraying, particle loss, biofilm

formation, and infections (Id., at 11-12). Dr. Walmsley opines that Ethicon knew that its TVT-O

was not appropriate for use but failed to modify or change the mesh to make it more suitable

“because of its economic interest in maintaining its competitive advantage in the market,”

according to Ethicon’s internal documents (Id., at 12). Dr. Walmsley opines that the TVT-O “has

design flaws because they cannot adequately describe, inform, or explain to physicians how to

properly ‘tension’ the device” and because “the devices shrink, contract, rope, and curl making it

difficult or impossible to tension in a safe manner for patients” (Id.). Dr. Walmsley opines that

“Ethicon’s meshes are not suitable for permanent implant because the Material Safety Data Sheet

(‘MSDS’) for the polypropylene resin used to manufacture Ethicon’s polypropylene states that its

polypropylene is incompatible with strong oxidizers such as peroxides which are readily found in

the vagina” (Id.). Dr. Walmsley opines that Ethicon’s mesh devices are “not suitable for permanent

implant because the toxicity testing of the polypropylene mesh revealed that it was cytotoxic which

can cause cell death and complications” (Id.). Dr. Walmsley opines that “Ethicon’s warnings and

disclosures of adverse events in their Instructions for Use (‘IFU’) for these devises have been

inadequate based on the adverse reactions and risks associated with them that have been known to

Ethicon from the time these devices were first sold and marketed” and that “Ethicon did not

disclose information to physicians in their IFU regarding characteristics of their devices that makes

them unsuitable for their intended application as a permanent prosthetic implant for pelvic floor

repair” (Id., at 13). Dr. Walmsley opines that “[t]he design of these devices are flawed because

they are not designed for special patient populations, nor does the IFU nor marketing documents

inform physicians that certain patients will have poorer outcomes and higher risks” (Id.). Dr.

Walmsley opines that “Ethicon failed to reveal material facts about complication and conflicts of

interest regarding key studies in key marketing documents” (Id.). Dr. Walmsley opines that “[t]he

benefits of these mesh products are outweighed by the severe, debilitating, and life[-]changing

complications associated with them and there were safer alternative options available” (Id.).

Summarizing these opinions, Dr. Walmsley opines that “[a]s a result of the defects in these meshes,

[Ms.] Meade suffered and continues to suffer life-long injuries” (Id.). Of additional relevance, Dr.

Walmsley also opines that Dr. McKnight’s treatment of Ms. Meade met the standard of care and

that the pre-operative evaluations of Ms. Meade met the standard of care (Id., at 13-14).

Based on Dr. Walmsley’s review of the entire body of literature, his experience, his review

of Ms. Meade’s medical records, and the deposition testimony provided to him by counsel, “it is

[his] opinion, to a reasonable degree of medical certainty, [Ms.] Meade would not have developed

the aforementioned symptoms, or the need to undergo additional treatments to the extent that she

has, had the Ethicon [TVT-O] never been implanted” (Id., at 17). Dr. Walmsley opines that “there

were reasonably feasible alternatives available to Ethicon’s mesh devices” for the treatment of Ms.

Meade that “would have been a safer alternative to the Ethicon mesh implanted in Ms. Meade”

(Id.). Dr. Walmsley opines that “[i]f any of these safer alternative designs [had] been used for Ms.

Meade, she would not have suffered the injuries [Dr. Walmsley] set forth in [his] report, as her

injuries were caused by the specific design flaws of the Ethicon [TVT-O] device” (Id., at 18).

2. Application Of Rule 702 To Dr. Walmsley’s Opinions And

Testimony

Defendants argue that the Court should exclude Dr. Walmsley’s general causation opinions

offered in his case-specific report (Dkt. No. 40, at 3-6). Defendants argue that Dr. Walmsley has

not been designated as a general causation expert, that Dr. Walmsley offers no foundation for the

general causation opinions offered in his case-specific report, and that general causation opinions

regarding complications not experienced by Ms. Meade are irrelevant (Id.). Defendants maintain

that the Court should exclude Dr. Walmsley’s case-specific opinions regarding corporate

knowledge, state of mind, conduct, and marketing (Id., at 6-7). Defendants argue that the Court

should exclude Dr. Walmsley’s opinions containing legal conclusions and legal terms of art (Id.,

at 7). Defendants argue that the Court should exclude Dr. Walmsley’s opinions regarding

Ethicon’s warnings and informed consent because Dr. Walmsley is not qualified to offer opinions

regarding the adequacy of the TVT-O IFU and because Dr. Walmsley’s opinions regarding the

informed consent process are irrelevant and contain improper state of mind opinions (Id., at 8-10).

Finally, defendants argue that the Court should limit Dr. Walmsley’s opinions regarding safer

alternative treatments and procedures (Id., at 10-14). Defendants assert that Dr. Walmsley’s

opinions regarding safer alternatives are irrelevant and unreliable, that Dr. Walmsley’s opinion

that erosion/extrusion does not occur in the absence of mesh is unreliable, and that Dr. Walmsley’s

opinion that a sling constructed out of Ultrapro mesh constitutes a safer alternative is unreliable

(Id., at 11-14).

In response, the Meades argue that Dr. Walmsley can opine on “most common”

complications related to the TVT-O (Dkt. No. 44, at 3). The Meades assert that Dr. Walmsley will

not testify regarding Ethicon’s corporate knowledge, state of mind, or corporate conduct (Id., at 3-

4). The Meades assert that Dr. Walmsley’s opinions do not contain legal conclusion or terms of

art and are relevant and admissible (Id., at 4). The Meades assert that Dr. Walmsley’s opinions

will inform the jury on the risks contained in the IFU when Ms. Meade was implanted with the

TVT-O (Id., at 5-6). Finally, the Meades argue that Dr. Walmsley’s opinion that safer alternative

designs existed at the time of Ms. Meade’s implant is relevant and admissible (Id., at 6-8).

The Court understands that Dr. Walmsley is not being offered as a general causation expert;

to the extent defendants attempt to characterize him as such and challenge his opinions as “general

causation opinions,” the Court rejects that characterization. The Court understands that plaintiffs

intend to offer Dr. Walmsley as a case-specific expert, and the Court understands Dr. Walmsley’s

opinions to be case-specific. Dr. Walmsley directly relates his opinions to Ms. Meade’s care and

treatment, and Ms. Meade has experienced most of the complications that Dr. Walmsley mentions.

Additionally, the Court understands Dr. Walmsley’s case-specific opinions to be properly

supported. Dr. Walmsley provides his background, education, training, and experience; notes his

review of the scientific literature, corporate documents from Ethicon, and other case-specific

materials; details Ms. Meade’s medical records and medical history; and describes his use of

differential diagnosis and differential etiology methodology to “rule in” potential causes of Ms.

Meade’s injuries and, by process of elimination, “rule out” the least likely causes to arrive at the

most likely cause. Thus, to the extent defendants attempt to claim Dr. Walmsley is an improperly

presented general causation expert and that the entirety of his testimony should be excluded on

this basis, the Court rejects defendants’ attempt.

Defendants are correct that expert testimony regarding Ethicon’s knowledge, state of mind,

or other matters related to corporate conduct and ethics would not be appropriate subjects of expert

testimony because opinions on these matters will not assist the jury. However, the Meades insist

that “Dr. Walmsley only intends to testify as to Ethicon corporate documents at trial for the purpose

of explaining how the results of Ethicon’s internal studies are consistent with his opinions in this

case” (Dkt. No. 44, at 3-4). The Court grants defendants’ motion to the extent that this Court will

not permit Dr. Walmsley to testify to Ethicon’s knowledge, state of mind, or other matters of this

sort, but the Court does not understand Dr. Walmsley’s report to suggest that he intends to offer

such testimony at trial. The Court will not prohibit under Rule 702 Dr. Walmsley from testifying

at trial as to Ethicon’s corporate documents for the purpose of explaining his case-specific expert

opinions, specifically as the Meades suggest “how the results of Ethicon’s internal studies are

consistent with this opinions in this case.” (Dkt. No. 44, at 4). To the extent defendants challenge

this anticipated testimony on grounds other than Rule 702, defendants may raise contemporaneous

objections to such testimony at trial, and the Court will rule at that time.

As to defendants’ contention that Dr. Walmsley’s opinions contain legal conclusions and

legal terms of art, expert testimony regarding legal matters is inadmissible. See S. Pine

Helicopters, Inc. v. Phoenix Aviation Mangers, Inc., 320 F.3d 838, 841 (8th Cir. 2003); Williams

v. Wal-Mart Stores, Inc., 922 F.2d 1357, 1360 (8th Cir. 1990). Insofar as Dr. Walmsley imposes

legal duties on defendants or applies a standard of reasonable care to defendants in order to testify

that they breached that standard, such testimony represents legal conclusions and analysis

improper for expert testimony. To the extent Dr. Walmsley intends to offer such testimony, the

Court grants defendants’ motion and excludes such testimony pursuant to Rule 702.

The Meades maintain that Dr. Walmsley’s opinions related to Ethicon’s alleged failure to

act are admissible as they go to the reasonableness of Ethicon’s actions in the light of the legal

obligation to warn adequately and label products pursuant to federal regulations. To the extent Dr.

Walmsley intends to testify regarding Ethicon’s warnings as communicated in the TVT-O’s IFU,

the Court does not consider Dr. Walmsley qualified to offer such opinions. As an initial matter,

the Court notes that Dr. Walmsley has previously been excluded from offering opinions regarding

whether a particular “IFU should have included warnings about particular complications,” because

“Dr. Walmsley is not an expert in the development of warning labels” and does not “possess the

additional expertise to offer expert testimony about what an IFU should or should not include.” In

re: Ethicon, Inc., MDL No. 2327, 2016 WL 4961675, at *3 (S.D. W. Va. Aug. 25, 2016). Nothing

in the record indicates that Dr. Walmsley has any experience in drafting IFUs for medical devices,

improving existing warnings, preparing alternatives for medical devices, or reviewing the warning

labels of similar products. Instead, the Meades have presented no relevant experience Dr.

Walmsley possesses with respect to warnings of any kind. While Dr. Walmsley has demonstrated

his competency to testify about the risks associated with TVT-Os and related devices, that

expertise does not equate to expertise regarding the product IFUs and the adequacy of the warning

information contained therein. To the extent Dr. Walmsley intends to offer such testimony, the

Court grants defendants’ motion and excludes such testimony pursuant to Rule 702.

Additionally, while Dr. Walmsley’s opinions regarding the informed consent process

would typically be relevant and admissible given that Dr. Walmsley is a practicing urologist with

ample experience implanting mid-urethral mesh and non-mesh slings, the Court agrees with

defendants that such testimony here would operate to provide a restated opinion that Ethicon’s

warnings for the TVT-O were inadequate. Dr. Walmsley’s proposed testimony opines that Dr.

McKnight could not obtain informed consent because of Ethicon’s allegedly inadequate warnings.

The Meades have failed to meet their burden to demonstrate by a preponderance of the evidence

that Dr. Walmsley is qualified to offer expert testimony on the adequacy of defendants’ warnings

or informed consent in the specific context of Dr. Walmsley’s expert opinions before the Court.

Accordingly, defendants’ motion to exclude Dr. Walmsley’s opinions and testimony on the

adequacy of defendants’ warnings and the informed consent process will be granted pursuant to

Rule 702.

Finally, to the extent defendants challenge Dr. Walmsley’s opinions regarding safer

alternative treatments and procedures, the Court denies defendants’ motion. As a practicing

urologist who has implanted both mesh and non-mesh slings, Dr. Walmsley is qualified to educate

the jury on alternative procedures that were available to Ms. Meade and that were possibly safer

options. The Court will not exclude this anticipated testimony pursuant to Rule 702. To the extent

defendants challenge this anticipated testimony on grounds other than Rule 702, defendants may

raise contemporaneous objections to such testimony at trial, and the Court will rule at that time.

For the foregoing reasons, consistent with the terms of this Order, the Court grants in part

and denies in part defendants’ motion to limit the case-specific opinions and testimony of Dr.

Walmsley (Dkt. No. 39).

B. Defendants’ Motion To Limit The Opinions Of Pathologist Dr.

Laposata

Defendants move to limit the opinions of Dr. Laposata (Dkt. No. 41). Specifically,

defendants ask the Court to preclude Dr. Laposata from providing general causation opinions and

preclude as beyond her qualifications opinions regarding biomechanical “changes” of mesh in the

body, such as degradation, and pain (Id., at 1). At the time this motion was filed, defendants had

not yet deposed Dr. Laposata and reserved the right to supplement this motion following her

deposition (Id.). Shortly thereafter, defendants deposed Dr. Laposata on October 17, 2019 (Dkt.

Nos. 47; 85, at 6). Defendants have not supplemented this motion, and the parties maintain that

this motion is ripe for consideration (Id., at 9).

1. Dr. Laposata’s Opinions And Testimony

Dr. Laposata is a forensic pathologist with prior experience as a medical examiner, and the

Court has reviewed Dr. Laposata’s expert report (Dkt. No. 41-2). Dr. Laposata “was asked to

examine the surgical pathology slides prepared from tissues and materials removed from [Ms.

Meade] to determine whether the specimens reveal abnormal tissue reactions and, if so, to

determine the cause(s)” (Id., at 3). Dr. Laposata was also “asked to identify the anatomic,

physiologic, and pathologic events that resulted in the production of clinical signs and symptoms

observed by the treating physician(s) and experienced by” Ms. Meade (Id.). Dr. Laposata’s review

of the above-referenced slides and the relevant literature led her to conclude that the “histologic

picture” in this case “is consistent with the adverse tissue effects of mesh” (Id., at 16). Dr. Laposata

opines that “[n]erve distortion and compression by mesh-associated fibrosis produced Ms.

Meade’s pelvic and urethra pain” (Id.). Dr. Laposata opines that “[t]he bridging fibrosis causes

mesh contraction and the potential for mesh migration through tissue and filament erosion through

mucosal surfaces as [Ms. Meade] experienced in her bladder” (Id.). Dr. Laposata opines that “[t]he

presence of skeletal muscle fibers, some with evidence of degeneration, causes pelvic muscular

dysfunction and confirms mesh migration” (Id.). Dr. Laposata further opines that “[c]hronic

inflammation with foreign body giant cell formation indicated continued, ongoing tissue irritation

by the implanted mesh” (Id.).

Based on these conclusions, Dr. Laposata opines that “to a reasonable degree of medical

certainty that the complications and injuries suffered by Ms. Meade, including erosion,

dyspareunia, pain at the urethra, pelvic pain, groin pain and urinary retention are consistent with

my pathological findings and were a result of the mesh and associated tissue changes caused by

the mesh” (Id., at 17). Dr. Laposata opines that “[a]ll abnormalities in the tissue were related to

the mesh and there was no other evidence of alterations or abnormalities in the tissues” (Id.). In

coming to these opinions, Dr. Laposata “considered and ruled out Ms. Meade’s prior medical and

surgical conditions such as degenerative disc disease, fibromyalgia, mitral valve prolapse, right

ovarian cystectomy, appendectomy, and bilateral tubal ligation as potential causes of her

complications and symptoms” (Id.).

2. Application Of Rule 702 To Dr. Laposata’s Opinions And

Testimony

Ethicon asserts that this Court should limit the opinions of Dr. Laposata for three primary

reasons: (1) she is not qualified to opine as to supposed changes in the mesh after implantation;

(2) she is not qualified to offer opinions regarding Ms. Meade’s pain; and (3) she improperly offers

general causation opinions (Dkt. No. 41, at 2-4).

On the first point, Ethicon states that Dr. Laposata opines throughout her report that

polypropylene mesh degrades and that degraded mesh can cause problems in patients; however,

Ethicon asserts that Dr. Laposata has previously admitted that she is not an expert in mesh

degradation (Dkt. Nos. 41, at 2; 41-2, at 4-17, 12, 16-17; 41-3, at 3-4). Thus, Ethicon asserts that

Dr. Laposata’s opinions regarding mesh degradation are outside her area of expertise and that she

lacks any specialized knowledge about mesh degradation (Dkt. No. 41, at 2-3). Dr. Laposata is a

board-certified pathologist with over 30 years of experience examining tissue from various parts

of the human body to identify and determine the cause of injuries, diseases, and death and with

extensive recognition and achievements in the field (Dkt. No. 43, at 4-5). Based upon the materials

presented in support of plaintiffs’ response to this motion, Dr. Laposata’s work, training, and the

literature for her field qualify her to opine on the possibly degraded mesh in bodily tissue and the

properties of that mesh. Dr. Laposata studies and works with the interaction between implanted

materials and human tissue, and the Court considers Dr. Laposata’s opinions on this issue

admissible pursuant to Rule 702.

On the second point, Ethicon asserts that Dr. Laposata, as a forensic pathologist with

experience as a medical examiner, is not qualified to offer opinions regarding pain and suffering

(Id., at 3). Dr. Laposata is not a clinical physician, and she does not treat or otherwise manage

pain of living patients (Id.). Thus, Ethicon asserts that there is no evidence that Dr. Laposata is

qualified to opine regarding pain (Id.). However, the Court considers it within the expertise of a

pathologist to opine as to pain. Dr. Laposata studies human tissue and determines cause of injuries

and diseases, and Dr. Laposata both works as a pathologist and teaches medical students in a

diagnostic lab. The Court considers Dr. Laposata’s opinions on the issue of pain to be admissible

pursuant to Rule 702.

On the third point, Ethicon asserts that Dr. Laposata’s general opinions go beyond her

designation as a case-specific expert and should be excluded on that basis alone (Id.). Further,

Ethicon argues that Dr. Laposata’s general opinions as to some “changes” in the mesh that she

believes can occur—including degradation, movement stress shielding, infection, and mesh

folding—and the symptoms that can be caused by these changes are not relevant to her analysis of

Ms. Meade’s case as these changes and symptoms were not experienced by Ms. Meade (Id., at 4).

Based upon the Court’s review, Dr. Laposata does not hold herself out as a general causation

expert. Instead, the Court acknowledges that Dr. Laposata’s report does offer some general

background on the basic science and pathology of tissue reaction to foreign biomaterials and

descriptions of changes in tissue after mesh implantation. However, Dr. Laposata provides this

general information to then show how this information correlates with physical symptoms of the

sort Ms. Meade experienced and to provide a basis upon which her case-specific opinions are

founded. The Court considers Dr. Laposata’s opinions to accord with her role as a case-specific

expert in this matter, and those case-specific opinions are admissible pursuant to Rule 702.

For the foregoing reasons, the Court denies defendants’ motion to limit the opinions of

pathologist Elizabeth A. Laposata, M.D. (Dkt. No. 41).

IV. Conclusion

Accordingly, consistent with the terms of this Order, the Court grants in part and denies in

part defendants’ motion to limit the case-specific opinions and testimony of Dr. Walmsley (Dkt.

No. 39). The Court denies defendants’ motion to limit the opinions of pathologist Dr. Laposata

(Dkt. No. 41). As to those matters about which the Court grants an in limine motion, all parties, their

counsel, and witnesses are directed to refrain from making any mention through interrogation, voir dire

examination, opening statement, arguments or otherwise, either directly or indirectly, concerning the

matters about which the Court grants an in limine motion, without first approaching the bench and obtaining

a ruling from the Court outside the presence of all prospective jurors and the jurors ultimately selected to

try this case. Further, all counsel are required to communicate this Court’s rulings to their clients and

witnesses who may be called to testify in this matter.

It is so ordered this 2nd day of November, 2020.

Kush A: Palin

KristineG. Baker”

United States District Judge

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