Sutphin v. Ethicon, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA

CHARLESTON DIVISION

ANNETTE SUTPHIN,

Plaintiff,

v. CIVIL ACTION NO. 2:14-cv-01379

ETHICON, INC.,

Defendant.

MEMORANDUM OPINION AND ORDER

Pending before the court are numerous Motions filed by Plaintiff Anne

Sutphin [ECF Nos. 48, 128, 130, 224, 227, 263, 264, 265] and Defendant Ethicon, Inc.

(“Ethicon”) [ECF Nos. 71, 208, 210, 212, 214, 216, 218, 279, 320]. The parties have

responded and either replied or allowed the time for replies to expire, and the Motions

are now ripe for consideration. For the reasons that follow, ECF Nos. 48, 208, and

216 are GRANTED and ECF Nos. 128, 130, 210, 212, 214, 218, 224, 227, 263, 264,

265, and 320 are DENIED. ECF Nos. 71 and 279 are GRANTED in part and DENIED

in part. Many of the denied Motions were unopposed and have been DENIED AS

MOOT. The parties are expected to abide by their concessions in response to each

Motion.

I. Plaintiff’s Motions

A. ECF No. 48 – Motion to Exclude FDA 510(k) Evidence

Matt Thiesson says on an album cover that: “The only thing worse than beating

a dead horse is betting on one.” Here, defense counsel bets again on a horse long

interred. I assume that this is because, as Thiesson sings: “Opinions are immunity to

being told you’re wrong.” I have repeatedly excluded evidence regarding the FDA’s

section 510(k) clearance process in these MDLs,

, No. MDL 2327, 2020 WL 774239, at *4 (S.D.W. Va.

Feb. 13, 2020), and I will continue to do so in this case, a position that has been

affirmed by the Fourth Circuit. , 81 F.3d 913, 921–23 (4th Cir.

2016) (upholding the determination that the probative value of evidence related to

section 510(k) was substantially outweighed by its possible prejudicial impact under

Rule 403). Because the section 510(k) clearance process does not speak directly to

safety and efficacy, it is of negligible probative value. at 920 (“[T]he clear

weight of persuasive and controlling authority favors a finding that the 510(k)

procedure is of little or no evidentiary value.”); ,

680 F.3d 568, 574 (6th Cir. 2012) (“The 510(k) process does not comment on safety.”).

Delving into complex and lengthy testimony about regulatory compliance could

inflate the perceived importance of compliance and lead jurors “to erroneously

conclude that regulatory compliance proved safety.” , 81 F.3d at

922. Accordingly, evidence or expert testimony related to the section 510(k) clearance

of Defendant’s mesh products, including the TVT-O, or the lack of FDA enforcement

action relative to Defendant’s products, is EXCLUDED. Insofar as this Motion

challenges the FDA-related testimony of the 510(k) clearance process, the FDA

involvement in the TVT-O product, and the lack of FDA enforcement actions, I

GRANT the Motion [ECF. No. 48].

B. ECF No. 128 – Motion to Preclude any Evidence or Argument Related to

the April 14, 2018 [Article] and/or that Plaintiff's Expert

has Interfered in her Medical Treatment

Plaintiff’s Motion seeks to exclude certain evidence or argument

suggesting that Plaintiff’s expert, Dr. Margolis, interfered in Plaintiff’s medical

treatment. Plaintiff has identified two sources of such evidence. First, Plaintiff asks

this Court to exclude an April 14, 2018, article entitled “How

Profiteers Lure Women Into Often Unneeded Surgeries” (“the

article”), which documents a scheme among plaintiffs’ attorneys, doctors, and

litigation finance companies to persuade women with pelvic mesh implants to

undergo unnecessary medical procedures to make their lawsuits against

manufacturers like Ethicon more lucrative. Next, Plaintiff asks the Court to exclude

evidence that Dr. Margolis proactively contacted Plaintiff’s treating physician, Dr.

Stephen Bush, to discuss Plaintiff’s treatment. Plaintiff asserts that this evidence is

irrelevant and prejudicial.

Ethicon has stated that it does not intend to introduce the

article at trial for the purpose of showing that Plaintiff was induced by her attorney

or some other improper source to undergo revision surgery. However, in the event

that Plaintiff attempts to reference the number of women who have filed suit against

pelvic mesh manufacturers like Ethicon or who have undergone surgery to remove

pelvic mesh products, Ethicon argues that it should then be able to present the

article to provide context for the numerous factors driving decisions to

take out pelvic mesh products. Accordingly, I lack the context needed to make a

substantive ruling on this matter and therefore DENY without prejudice the Motion

[ECF No. 128] as it relates to the article.

As far as the evidence that Dr. Margolis proactively contacted Plaintiff’s

treating physician, Dr. Stephen Bush, to discuss Plaintiff’s treatment, I DENY

Plaintiff’s Motion [ECF No. 128]. This evidence goes to the credibility and veracity of

statements made by Dr. Margolis.

C. ECF No. 130 – Motion to Preclude any Evidence or Argument Pertaining to

Plaintiff’s Unrelated Medical Conditions

Plaintiff moves to preclude any evidence or argument pertaining to her prior

unrelated medical conditions and procedures. Ethicon asserts that it does not intend

to introduce evidence of the following six conditions: polycythemia vera, osteoporosis,

sleep apnea, bilateral tubal ligation, colonic polyps, and allergic rhinitis. Ethicon does

intend to introduce evidence of the following two conditions: (1) orthopedic neck

pain/cervical radiculopathy, and (2) osteoarthritis.

As I have previously held, “evidence about preexisting injuries, including neck

and back pain, can conceivably serve various roles in Ethicon’s case, such as

demonstrating [Plaintiff’s] pre-implant quality of life and pain management;

breaking the chain of proximate causation; and establishing damages, or the lack

thereof, existing in this case.” , No. 2:13-CV-22473, 2014 WL

6680356, at *9 (S.D.W. Va. Nov. 25, 2014) (“While the plaintiff argues that these

preexisting medical conditions are ‘wholly unrelated’ to the plaintiff’s claims…the

province of weighing the testimony and determining the relationship, if any, among

[Plaintiff’s] injuries belongs to the jury.”). Accordingly, I DENY the Motion [ECF No.

130] as to the following two conditions: (1) orthopedic neck pain/cervical

radiculopathy, and (2) osteoarthritis, and DENY AS MOOT the Motion as it relates

to the six conditions Ethicon does not intend to introduce.

D. ECF No. 224 – Motion to Preclude Argument or Commentary Regarding

Mesh Litigation As “Lawyer-Driven” and Attorney Advertising Practices

Plaintiff first moves to exclude any argument or commentary that pelvic mesh

litigation is “lawyer-driven.” Ethicon asserts that it does not intent to make this

argument at trial. Accordingly, with respect to this statement, I DENY AS MOOT the

Motion [ECF No. 224].

Plaintiff also moves to exclude any argument or commentary related to

advertising by Plaintiff’s attorneys seeking to represent women in this litigation.

Ethicon responds that the court should not exclude evidence or statements regarding

the specific advertisement that prompted Plaintiff to file this lawsuit as it is relevant

to her credibility. I have previously held that statements related to whether a plaintiff

saw an attorney advertisement prior to filing suit are “probative of her credibility

regarding her injuries.” , Nos. 2:12–MD–02327, 2:12–cv–4301, 2014

WL 505234, at *3 (S.D.W. Va. Feb. 5, 2014). Accordingly, I DENY the Motion [ECF

No. 224] with regard to attorney advertising.

E. ECF No. 227 – Motion to Preclude any Reference to Johnson & Johnson or

its Subsidiaries’ Efforts to Create a Vaccine for or Otherwise Combat

COVID-19.

Ethicon asserts that it does not intend to offer any argument or evidence

relating to Johnson & Johnson’s or any other entity’s efforts to develop a vaccine for

or otherwise combat COVID-19. Accordingly, I DENY the Motion [ECF No. 227] AS

MOOT.

F. ECF No. 263 – Motion to Preclude any Reference to the AUGS/SUFU

Position Statement

I have repeatedly denied similar motions to exclude the AUGS/SUFU Position

Statement because it may be relevant and admissible for multiple reasons.

, 2014 WL 505234, at*2 (S.D.W. Va. Feb. 5, 2014);

, 2014 WL 3861778, at *2 (S.D.W. Va. Aug. 6, 2014);

, 2014 WL 3882186, at *3 (S.D.W. Va. Aug. 7, 2014);

, 2014 WL 5445769, at *14 (S.D.W. Va. Oct. 22, 2014);

, 2016 WL 2983696, at *4 (S.D.W. Va. May 20, 2016). As I have

previously explained,

First, to the extent that the Position Statement is relied

upon by an expert witness, it may be admissible under the

learned treatise exception to the hearsay rule. Second

under Rule 703, experts are permitted to rely on otherwise

inadmissible information provided that they “would

reasonably rely on those kinds of facts or data in forming

an opinion on the subject.” Third, [the defendant’s] state of

mind is relevant to the punitive damages claim, and “[a]n

out-of-court statement that is offered to show its effect on

the hearer’s state of mind is not hearsay under Rule

801(c).”

, No. 2:12-cv-5201, 2014 WL 3861778, at *2 (S.D.W. Va. Aug. 6, 2014)

(citations omitted) (second alteration in original) (quoting Fed. R. Evid. 703;

, 279 F.3d 1043, 1047 (D.C. Cir. 2002)). For these same reasons, I

DENY this Motion [ECF No. 263].

G. ECF No. 264 – Motion to Preclude Evidence or Argument that the TVT-O

is the “Standard of Care” for SUI

I have previously denied similar motions concerning whether TVT was the

“gold standard” or “standard of care” for treating SUI. , ,

2014 WL 505234, at*3 (S.D.W. Va. Feb. 5, 2014). I adopt the same reasoning here.

Whether TVT-O is the “standard of care” is highly probative: “it goes to the very

essence of whether the TVT is unreasonably dangerous or whether there exists a safer

alternative design.” Further, I find that the term “standard of care” will not

confuse the jury. To the extent Plaintiff believes the term is confusing in this case,

she may cross-examine the witnesses on that point. Accordingly, I DENY the Motion

[ECF No. 264].

H. ECF No. 265 – Motion to Preclude Duplicative and/or Cumulative

Testimony from Defendants’ Experts

In essence, this Motion seeks to reaffirm Federal Rule of Evidence 403 which

prohibits the introduction of needlessly cumulative evidence where the probative

value is substantially outweighed. The parties do not need the court to rule on or

restate the obvious. To the extent Plaintiff believes trial testimony becomes

needlessly cumulative, she is free to object at trial. Accordingly, I DENY this Motion

[ECF No. 265] without prejudice.

II. Ethicon’s Motions in Limine

A. ECF No. 71 – Ethicon’s Omnibus Motion

In an effort to consolidate its Motions in Limine, Ethicon filed an Omnibus Motion seeking

to exclude twenty separate pieces of evidence. I address each portion of Ethicon’s Motion

individually below.

1. TO PRECLUDE ANY ARGUMENT OR EVIDENCE REGARDING SPOLIATION

Plaintiff does not intend to present evidence regarding spoliation of evidence.

Accordingly, this motion is DENIED AS MOOT.

2. TO PRECLUDE THE MAGNIFIED, GRAPHIC IMAGES ATTACHED TO THE

SUPPLEMENTAL REPORT OF DR. MARGOLIS, PLAINTIFF’S CASE-

SPECIFIC EXPERT

Ethicon moves to exclude the magnified images of Plaintiff’s vulvar abscesses

and infection of the right labia, which were attached to the supplemental expert

report of Plaintiff’s case-specific expert, Dr. Margolis, and which Plaintiff has

identified as a trial exhibit. Exh. 4: Mar. 30, 2018, Supp. Rep., “Sutphin

Photographs Taken by Michael T. Margolis, MD, on 3/2718”); Pl. Exh. List, Doc. 51,

PageID #819, Exh. 47 (“Rule 26 Expert Report of Michael Thomas Margolis, MD”);

PageID #1038, Exh. 6003 (identifying both initial and supplemental reports). Ethicon

moves to exclude these images under Rules 401, 402, and 403 of the Federal Rules of

Evidence. Specifically, Ethicon argues that the images are irrelevant under Rule 401

because they do not make a consequential fact more or less probable than it would be

without the images. Ethicon does not dispute that Plaintiff had the vulvar abscess

depicted in the images. Instead, the question for the jury is whether the TVT-O device

caused the abscess. Ethicon asserts that the images do nothing to make liability more

or less probable because they do nothing other than show the existence of the abscess

and there is no visible mesh in the images. Further, to the extent I find that the

images have any probative value, Ethicon argues they are still inadmissible under

Rule 403 because the probative value is substantially outweighed by the danger of

unfair prejudice. That is, Ethicon argues the graphic images serve no purpose other

than to shock and inflame the jury.

Plaintiff argues the images are relevant because Dr. Margolis will use them to

support his testimony and make it more probable that the TVT-O caused the abscess.

Plaintiff further argues the images are necessary to show the location of the abscess

and its appearance at the time of Dr. Margolis’ examination, and to show the relevant

anatomical structures. However, recognizing the sensitive nature of the images,

Plaintiff states that she does not intend to display them on any screens during trial.

Instead, Plaintiff argues she should be permitted to move the images into evidence,

place them in a folder, and give them to the jury to review at each juror’s individual

discretion. In its Reply, Ethicon argues Plaintiff’s proposed method of showing the

images to the juror is more inflammatory than simply projecting them on a screen in

the courtroom for the jury to view simultaneously. Ethicon further argues that, in

any event, other diagrams and animations that are less graphic can be used to explain

the location of the abscess and the relevant anatomical structures.

I have previously denied a motion by Ethicon concerning

Photographic or Video Depiction of Actual Prolift Surgery. ,

No. 2:13-CV-22473, 2014 WL 6680356, at *1 (S.D.W. Va. Nov. 25, 2014) (“[T]he

following motions are DENIED…Ethicon's Omnibus Motion No. 5

Concerning Photographic or Video Depiction of Actual Prolift Surgery [Docket 206].”).

Similarly, I DENY Ethicon’s Motion here.

3. TO PRECLUDE EVIDENCE OF COMPLICATIONS NOT ALLEGED BY MS.

SUTPHIN

Ethicon moves to exclude any evidence or argument that the TVT-O can cause

adverse reactions or events other than those alleged by Plaintiff.

I have previously held that, under West Virginia law, “evidence of

complications that no plaintiff experienced is irrelevant and lacking in probative

value. For the claims that require evidence of injury (strict liability for failure to

warn, strict liability for design defect, and negligence), only the injuries experienced

by the complainant are relevant.” , 2014 WL 5445769,

at *6 (S.D.W. Va. Oct. 22, 2014). Therefore, I GRANT this Motion.

4. TO PRECLUDE EVIDENCE OF PAYMENTS TO MEDICAL SOCIETIES

Ethicon argues that evidence of payments to medical societies should be

excluded. To the extent that Ethicon’s motion concerns deposition testimony of

Martina Scheich, Plaintiff agrees that she will not play Ms. Scheich’s deposition

testimony at trial unless her deposition has been completed before then. In this

regard, I DENY the Motion AS MOOT.

However, to the extent that Plaintiff wishes to present evidence of payments

to medical societies and/or the connections between Ethicon and the physicians who

are responsible for certain position statements, or between Ethicon and the authors

of favorable studies, the Motion is DENIED. , No. 2:12-CV-

4301, 2014 WL 505234, at *6–7; *10 (S.D.W. Va. Feb. 5, 2014) (“[E]vidence about [a

witness’s] financial interest is probative of the negligence and punitive damages

claim and is not unduly prejudicial.”).

5. TO PRECLUDE INCOURT DEMONSTRATIONS OR TESTING OF

EXEMPLAR DEVICES

Next, Ethicon argues that Plaintiff should be precluded from introducing into

evidence any mesh exemplar devices, performing in-court demonstrations or testing.

I will allow the exemplar device to be used as a demonstrative aid in court, so I DENY

the motion as to this point. However, as I previously held in , et al.,

Civ. A. No. 2:12-cv-05201 (S.D.W. Va. Sept. 4, 2014), jurors will not be permitted to

physically examine the devices, and the devices will not go back into the jury room.

6. TO PRECLUDE REFERENCE TO “CONFIDENTIALITY” STAMPS ON

PRODUCED DOCUMENTS OR REFERENCE TO ANY DOCUMENT NOT

PUBLICLY DISSEMINATED AS “SECRET” INTERNAL DOCUMENTS

Ethicon moves to exclude any reference to company documents as “secret” or

“confidential.” Specifically, Ethicon requests that I prohibit Plaintiff not only from

referring to “confidential” stamps on documents but also from offering evidence or

argument that Ethicon’s corporate documents were held in confidence before

discovery began. Plaintiff argues that she will not refer to the designation of

documents as confidential. While Plaintiff agrees not to mention that a document or

piece of information was marked “confidential” or kept “secret” or “hidden” in

connection with discovery, Plaintiff argues she should be permitted to inform the jury

that evidence and information, known to Ethicon, was not provided to the medical

community, Plaintiff, or her physicians.

Time after time, this court has ruled that whether a document is designated

as confidential is entirely irrelevant. , No. 2:13-CV-

11601, 2016 WL 3031063, at *3 (S.D.W. Va. May 24, 2016). The court will, as always,

instruct the jury to disregard the confidentiality markings on documents presented

at trial. I GRANT Ethicon’s Motion on this point.

7. TO PRECLUDE EVIDENCE OF POST-IMPLANT REVISIONS TO THE TVT-

O IFU AND PATIENT BROCHURE

Ethicon anticipates that Plaintiff will seek to admit evidence regarding the

2015 revisions to the TVT-O IFU. Ethicon argues that any revisions made after

Plaintiff’s February 24, 2009, implant surgery should be excluded because they are

inadmissible subsequent remedial measures (Fed. R. Evid. 407), are irrelevant (Fed.

R. Evid. 401, 402), and even if relevant, would confuse the issues and mislead the

jury (Fed. R. Evid. 403).

Evidence of subsequent remedial measures is inadmissible to prove

“negligence; culpable conduct; a defect in a product or its design; or a need for warning

or instruction.” Fed. R. Evid. 407. However, the evidence may be admitted “for

another purpose, such as impeachment or—if disputed—proving ownership, control,

or the feasibility of precautionary measures.” In other words, the admissibility of

such evidence depends on the context and method by which Plaintiff seeks to

introduce it. Accordingly, I GRANT Defendant’s Motion as to allowing evidence of

subsequent remedial measures to prove “negligence; culpable conduct; a defect in a

product or its design; or a need for warning or instruction.” ,

628 F.2d 848, 859 (4th Cir. 1980) (“If subsequent warnings are admitted to prove

antecedent negligence simply because FDA required or might have required the

change, then drug companies may be discouraged from taking early action on their

own and from participating fully in voluntary compliance procedures.”);

, No. 2:12-CV-01378, 2015 WL 541933, at *7 (S.D.W. Va. Feb. 10,

2015). To the extent Plaintiff attempts to introduce this evidence for another purpose

at trial, Ethicon may object where appropriate.

8. TO PRECLUDE EVIDENCE THAT ETHICON DOES NOT CONTINUE TO

SELL CERTAIN DEVICES

Plaintiff states that she does not intend to present evidence regarding the

products Ethicon took off the market. Plaintiff asserts, however, that depending on

Ethicon’s presentation of evidence, such evidence and testimony may become

relevant. At this time, I DENY AS MOOT the Motion. Should Plaintiff attempt to

admit such evidence at trial, Ethicon may reassert its Motion.

9. TO PRECLUDE EVIDENCE OF THE WITHDRAWAL OF THE BOSTON

SCIENTIFIC PROTEGEN DEVICE

Plaintiff does not intend to present evidence regarding the withdrawal of the

Boston Scientific Protegen device. Accordingly, I DENY AS MOOT this Motion.

10. TO PRECLUDE EVIDENCE OF OTHER LAWSUITS AGAINST ETHICON,

INCLUDING THOSE CONCERNING ETHICON’S OTHER PRODUCTS

Ethicon argues that evidence of other lawsuits or claims against Ethicon,

including those concerning Ethicon’s other products, is irrelevant to the issues here,

is unreliable hearsay, and serves no purpose other than improperly impugning

Ethicon’s character. Further, if admitted, fairness would compel that Ethicon be

allowed to rebut it, and that would waste trial time on collateral matters.

Evidence of other lawsuits and the factual allegations therein is inadmissible

under Rule 403. , No. 2:12-CV-4301, 2014 WL 505234, at *6

(S.D.W. Va. Feb. 5, 2014). Although other lawsuits may ultimately show that the

TVT-O is defective, the jury must still find that the TVT-O caused Plaintiff’s injuries.

Evidence of other lawsuits is likely to confuse and mislead the jury from that task,

and it is highly prejudicial to Ethicon. Accordingly, I GRANT Ethicon’s Motion on this

issue.

11. TO PRECLUDE EVIDENCE CONCERNING ANY MATERIAL SAFETY

DATA SHEETS, INCLUDING ANY SUGGESTION THAT

POLYPROPYLENE CAUSES OR MAY CAUSE CANCER

Plaintiff asserts that she does not intend to introduce any Material Safety Data

Sheets (“MSDS”) for any product other than the one used in the TVT-O. The MSDS

that relates to the TVT-O here is the Sunoco MSDS for C4001 Polypropylene

Homopolymer (4/13/05) (the “Sunoco MSDS”), attached as Exh. 37; Pl. Exh. List,

Doc. 51, PageID #859 (identifying Exh. 1141). Accordingly, to the extent Ethicon

seeks to exclude any MSDS other than the Sunoco MSDS, I DENY the Motion AS

MOOT.

As to the Sunoco MSDS, this MSDS applies to raw polypropylene, which is an

ingredient, but not to the finished product, used to make Ethicon mesh. Ethicon

argues that the Sunoco MSDS, and any testimony based on it, including any

suggestion that polypropylene causes or may cause cancer, should be excluded.

Ethicon argues that Plaintiff wants to introduce the Sunoco MSDS specifically

because it suggests the raw polypropylene may lead to an increased risk of cancer.

And, as Ethicon points out, I have excluded this same MSDS in another case where

the plaintiff did not have or allege any injuries related to cancer.

, No. 2:12-CV-4301, 2014 WL 505234, at *10 (S.D.W. Va. Feb. 5, 2014). Because

Plaintiff here also does not have or allege any injuries related to cancer, I also GRANT

this Motion in part and EXCLUDE the Sunoco MSDS to the extent that it relates to

an increased risk of cancer.

However, Plaintiff asserts that she has other legitimate reasons to introduce

the Sunoco MSDS. Specifically, Plaintiff points to a warning contained in the MSDS

that the polypropylene was subject to degradation due to oxidizing agents known to

be present in the human body. To the extent Plaintiff seeks to introduce the MSDS

as evidence that Ethicon had notice of this warning, she argues it is not hearsay and

is admissible for a purpose other than the truth. I have previously allowed discussion

of a different MSDS to the extent it was offered to show “that the statements within

it were made or that they had some effect on the future actions of a listener, or for

the more limited purpose of providing relevant context or background.”

, No. MDL 2187, 2013 WL 3282326 at

*3 (S.D.W. Va. June 27, 2017) (internal quotation marks omitted). The Fourth Circuit

affirmed.

, 810 F.3d 913, 926 (4th Cir. 2016) (holding that the MSDS at issue was

admissible to “prove something other than its truth . . . includ[ing] statements used

to charge a party with knowledge of certain information.”).

Accordingly, to the extent Plaintiff seeks to introduce the Sunoco MSDS for a

purpose other than its truth, I DENY the Motion in part.

12. TO PRECLUDE THE DVD CONCERNING KUGEL COMPOSIX HERNIA

MESH

Plaintiff does not intend to play the 2007 video featuring Dr. Todd Heniford

entitled, “The Benefits of Lightweight Meshes in Ventral Hernia Repair.”

Accordingly, I DENY AS MOOT this Motion.

13. TO PRECLUDE THE USE OF DEPOSITION VIDEOS OR TESTIMONY, OR

ANY VIDEO, IN OPENING

Plaintiff states that she does not intend to use video clips during opening

statements. Plaintiff also states that she does not oppose this portion of the Motion,

if the ruling applies to Ethicon as well. I GRANT the Motion. Both Ethicon and

Plaintiff are precluded from the use of deposition videos in openings.

14. TO PRECLUDE BRIAN LUSCOMBE’S INTERNAL MARKETING

PRESENTATION, THE “TOP TEN REASON [SIC] TO PURSUE . . .

GYNECARE TVT OBTURATOR SYSTEM”

Given the Court’s rulings in and on this issue, Plaintiff states

that she will not seek to present evidence of the “Top Ten” PowerPoint. Accordingly,

I DENY this Motion AS MOOT.

15. TO PRECLUDE EVIDENCE OR ARGUMENT ABOUT UNRELATED

INVESTIGATIONS OR RECALLS OF OTHER JOHNSON & JOHNSON OR

ETHICON PRODUCTS

Plaintiff does not intend to present evidence about investigations and/or

government action related to Topamax, Motrin, Risperdal, Doribax or Tylenol, as well

as product recalls concerning potential contamination during manufacturing of these

products. Accordingly, I DENY this Motion AS MOOT.

16. TO PRECLUDE EVIDENCE OR ARGUMENT RELATING TO MEDICAL

DEVICE REPORTS, REPORTS OF ADVERSE EVENTS FURNISHED BY

PHYSICIANS, SUMMARIES OF THOSE REPORTS, AND/OR AGGREGATE

NUMBERS OF MDRS FOR TVT-O OR ANY OTHER PRODUCT

As I have previously stated, an evidentiary ruling on whether to preclude

Medical Device Reports “depends on the particular content of the evidence and

argument, and the context in which the party seeks to introduce it. I simply cannot

make a substantive ruling at this time without additional information. Therefore, a

blanket exclusion of such evidence, argument, or testimony would be premature.”

, No. 2:13-CV-20370, 2015 WL 1395638, at *5 (S.D.W. Va. Mar.

25, 2015). Accordingly, I DENY the Motion without prejudice at this time.

17. TO PRECLUDE EVIDENCE OR ARGUMENT RELATING TO ANECDOTAL

CASE REPORTS OR CASE SERIES OR ARTICLES OR TREATISES BASED

ON THEM

Ethicon argues that at trial, Plaintiff may seek to introduce certain anecdotal

case reports or case series or expert testimony based on the reports to argue that

TVT-O mesh surgery frequently has harmful outcomes. Ethicon argues these reports

should be excluded.

Consistent with my rulings on similar motions in prior cases,

I DENY Ethicon’s motion because I lack the context needed to make a substantive

ruling on this matter at this time. , No. 2:13-CV-

22473, 2014 WL 6680356, at *4 (S.D.W. Va. Nov. 25, 2014);

No. 2:13–cv–07965, 2014 WL 5465741, at *13 (S.D.W. Va. Oct. 28,

2014); No. 2:12–cv–4301, 2014 WL 505234, at

*5 (S.D.W. Va. Feb. 5, 2014).

18. TO PRECLUDE EVIDENCE OF PAYMENTS UNDER THE 1997 LICENSE

AND SUPPLY AGREEMENT BETWEEN MEDSCAND AND JOHNSON &

JOHNSON INTERNATIONAL

Ethicon moves to exclude any reference to or admission of evidence concerning

any “milestone payments” made under a 1997 License and Supply Agreement

between Medscand and Johnson & Johnson International. Ethicon argues that in the

face of overwhelming evidence that Dr. Ulmsten did not bias his testing or act

unethically, there should be no room for speculation about bias in an original study

20 years ago.

I have previously ruled on whether evidence that Professor Ulf Ivar Ulmsten,

the inventor of the TVT, received “milestone payments” during the development of

the TVT should be admitted. , No. 2:12-CV-4301, 2014 WL

505234, at *6–7 (S.D.W. Va. Feb. 5, 2014). In that case, I stated that “evidence about

Professor Ulmsten’s financial interest is probative of the negligence and punitive

damages claim and is not unduly prejudicial.” My ruling here is consistent with

previous rulings. Accordingly, I DENY the motion.

19. TO PRECLUDE EVIDENCE AND ARGUMENT RELATING TO A JULY 2003

EMAIL EXCHANGE BETWEEN TERRY COURTNEY AND DR. MARTIN

WEISBERG

Given the Court’s rulings in on this issue, Plaintiff will not seek to

present Dr. Weisberg’s email referring to the “wire brush thing.” Plaintiff notes that

she does oppose the Motion to the extent Ethicon seeks to preclude emails beyond Dr.

Weisberg’s email referring to the “wire brush thing.” This portion of Ethicon’s Motion

does not address further emails. Accordingly, I DENY the Motion AS MOOT.

20. TO PRECLUDE EVIDENCE AND ARGUMENT RELATING TO THE EMAIL

STRING BETWEEN AXEL ARNAUD AND MARTIN WEISBERG

REGARDING PROLENE SOFT MESH

Given the Court’s ruling in , Plaintiff does not intend to present

evidence relating to Axel Arnaud and Martin Weisberg’s email string discussing

Prolene soft mesh. Accordingly, I DENY the Motion AS MOOT.

B. ECF No. 208 – Motion to Preclude Evidence or Argument Concerning

Lawsuits filed by Patients of Defense Experts

Ethicon anticipates that Plaintiff may attempt to introduce or otherwise rely

upon evidence regarding pelvic mesh lawsuits that have been filed by patients of

Ethicon’s experts. Such lawsuits would not be limited to the TVT-O device at issue in

this case; in fact, Ethicon anticipates that Plaintiff will attempt to introduce evidence

of lawsuits filed by patients who were implanted with pelvic mesh devices

manufactured by companies other than Ethicon. This evidence is unreliable hearsay,

has no probative value, and carries a significant risk of unfairly prejudicing Ethicon

and confusing the jury. If admitted, fairness would compel that Ethicon be allowed to

rebut this evidence, which would waste valuable trial time on 2 collateral matters.

Accordingly, Ethicon asks that this Court preclude Plaintiff from questioning its

expert witnesses or otherwise referring to unrelated lawsuits filed by those experts’

patients.

As I stated earlier, “even though evidence of similar accidents may be

admissible, evidence of lawsuits is generally considered inadmissible hearsay.”

, No. 2:12-CV-4301, 2014 WL 505234, at *6 (S.D.W. Va. Feb. 5, 2014).

Further, evidence of other lawsuits and the factual allegations therein is inadmissible

under Rule 403. Although other lawsuits may ultimately show that the TVT-O is

defective, the jury must still find that the TVT-O caused Plaintiff’s injuries. Evidence

of other lawsuits is likely to confuse and mislead the jury from that task and is highly

prejudicial. Therefore, I GRANT the Motion [ECF No. 208].

Here, however, Plaintiff argues she should be permitted to introduce evidence

of mesh lawsuits brought by patients of the Ethicon’s experts for other purposes – to

show bias, impeach the expert, and attack the basis of their opinions. Ethicon’s

Motion did not address other possible nonhearsay uses and I need not rule on their

admissibility now. To the extent Ethicon believes Plaintiff attempts to improperly

introduce such evidence for purposes other than the truth of the matter asserted,

Ethicon may object at trial.

C. ECF No. 210 – Motion to Exclude Evidence or Argument Regarding Media

Reports and Documentaries

Similar to the previous Motion regarding the article, Plaintiff

agrees that evidence of media reports and/or documentaries that are critical of pelvic

mesh are also irrelevant and inadmissible. However, in accordance with my previous

ruling regarding the article, I lack the context needed to make a

substantive ruling on this matter at this time and DENY this Motion [ECF. No. 210]

without prejudice.

D. ECF No. 212 – Motion to Preclude Evidence or Argument Regarding

Alternative Non-Mesh Procedures

Ethicon seeks to exclude evidence of non-mesh surgical procedures as feasible

alternative designs to the TVT-O device at issue in this case. In considering the

definition of a feasible alternative design under West Virginia law, I have previously

explained, “I am convinced that an alternative, feasible design must be examined in

the context of products—not surgeries or procedures.” ,

236 F. Supp. 3d 940, 942 (S.D.W. Va. 2017). As I explained in ,

Evidence that a surgical procedure should have been used

in place of a device is not an alternative, feasible design in

relation to the TVT. Whether an alternative procedure

could have been [performed] without the use of the TVT

does nothing to inform the jury on the issue of an

alternative, feasible for the TVT. Instead,

alternative surgeries or procedures raise issues wholly

within the context of what a treating physician has

recommended for patients based on the individual needs

and risk factors associated with individual patients. In

other words, alternative surgeries or procedures concern

the medical judgment of the doctors who use TVT devices

to treat stress urinary incontinence (“SUI”); other

surgeries or procedures do not inform the jury on the

TVT's design could have feasibly been made safer to

eliminate the risks that caused the plaintiffs' injuries.

at 943 (citing , 179 F.3d 154, 162 (4th Cir. 1999); W. Va.

P.J.I. § 411).

However, Plaintiff asserts that she does not intend to introduce non-mesh

surgical procedures as feasible alternative designs in support of her strict products

liability claims. Therefore, I DENY the Motion [ECF No. 212] AS MOOT.

However, Plaintiff asserts that evidence of non-mesh procedures is relevant

and admissible for purposes other than proving a feasible alternative design.

Specifically, Plaintiff claims the evidence is relevant to her failure to warn,

negligence, and punitive damages claims, as well as to rebut Ethicon’s defense that

the TVT-O was the “standard of care” and superior to non-mesh procedures in 2009

when Plaintiff was implanted. Ethicon’s Motion did not address these other possible

uses for evidence concerning non-mesh surgical procedures. To the extent Ethicon

believes Plaintiff attempts to improperly introduce such evidence for purposes other

than a feasible alternative design, Ethicon may object at trial.

E. ECF No. 214 – Motion to Preclude References to Online Patient Reviews of

Defense Experts

Ethicon seeks to exclude any mention or introduction into evidence of online

patient reviews of all defense experts. Ethicon claims that discussion of any such

reviews would be irrelevant, unfairly prejudicial, and a waste of time. Ethicon does

not, however, provide any specific examples of online patient reviews it wishes to

exclude. Plaintiff claims that online patient reviews are highly probative evidence for

cross-examination of expert witnesses in that they may speak to the experts’

qualifications, their patients’ experiences with mesh, their patients’ outcomes, or to

bias or credibility of the experts. While it is difficult to image how an online patient

review could be probative of an expert’s qualifications or otherwise relevant, I cannot

rule on this motion without knowing what specific reviews Plaintiff may seek to

introduce, the context in which each review is offered, and the arguments related to

each piece of evidence. Accordingly, a ruling on this motion is premature. Because I

lack the context needed to make a substantive ruling at this time, I DENY the Motion

[ECF No. 214] without prejudice.

F. ECF No. 216 – Motion to Preclude Evidence or Argument that Ultrapro and

TVT-Abrevvo are Feasible Alternative Designs

Ethicon seeks to preclude Plaintiff from introducing any evidence or arguing

that Ultrapro and TVT-Abbrevo, both Ethicon products, are feasible alternative

designs to the TVT-O at issue in this case. Ethicon argues that evidence related to

Ultrapro and TVT-Abbrevo is irrelevant, misleading, and not helpful to the jury

because there is no reliable, scientific evidence that a sling created with either

product would have eliminated the risk of the injuries allegedly suffered by Plaintiff,

or would have been as efficient. Further, at least as to Ultrapro, Ethicon asserts that

there is no evidence the product was a feasible alternative design in 2009, when

Plaintiff was implanted with the TVT-O because it had (and still has) not been cleared

by the FDA as a treatment for SUI. Plaintiff responds that there is scientific evidence

that both Ultrapro and TVT-Abbrevo were feasible alternative designs, and were just

as efficacious as the TVT-O.

I have previously held that, under West Virginia law, a strict products liability

plaintiff “must prove that there was an alternative, feasible design—existing at the

time of the product’s manufacture—that would have eliminated the risk that injured”

her. , No. 2:12-cv-02952, 2016 WL 7197441, *5 (S.D.W. Va.

Dec. 9, 2016). However, I have also recognized that the feasible alternative may be a

“ existing at the time of the TVT's manufacture.”

, 236 F.Supp.3d 90, 944 (S.D.W. Va. 2017). Thus, contrary to Ethicon’s

argument, the product would not have needed to receive FDA clearance as a specific

SUI treatment before Plaintiff’s surgery. In any event, I have clearly held that a

feasible, alternative design must the risks that injured Plaintiff, rather

than merely them. , No. 2:12-cv-02952, 2016 WL

7197441, *5 (S.D.W. Va. Dec. 9, 2016). Even Plaintiff cannot point to any evidence

that either Ultrapro or TVT-Abbrevo the risks of the injuries she

sustained. Accordingly, I GRANT the Motion [ECF No. 216].

G. ECF No. 218 – Supplement to Ethicon’s Omnibus Motion

In this Motion, Ethicon supplements its second Motion contained in

its Omnibus Motion [ECF NO. 71]. In its initial Motion, Ethicon moved to exclude

magnified, graphic images attached to Plaintiff’s case-specific expert, Dr. Margolis’,

supplemental report. Dr. Margolis has since served another supplemental report,

dated August 5, 2019, that includes additional magnified, graphic images. Ethicon

seeks to exclude these images for the same reasons as in its original Motion. For the

reasons discussed in reference to ECF No. 71 above, I DENY this Motion [ECF No.

218].

H. ECF No. 279 – Motion to Preclude Evidence and Argument Related to

Punitive Damages or Johnson & Johnson

In this Motion, Ethicon first explains that it anticipates that Plaintiff will

attempt to introduce evidence relevant to her remaining punitive damages claim

during her case-in-chief, including evidence related to Ethicon’s state of mind and net

worth. Ethicon argues that any evidence or argument solely related to punitive

damages should be excluded because the court has not allowed punitive damages

claims to reach the jury in related MDL cases , , and .

Ethicon next anticipates that Plaintiff will attempt to offer evidence related to

Ethicon’s parent company, Johnson & Johnson, who, according to Ethicon, Plaintiff

did not name as a party in this case. Ethicon argues that any evidence relating to

Johnson & Johnson should be excluded because it is irrelevant to whether Ethicon is

liable in this case.

As to Ethicon’s motion to preclude evidence relating to punitive damages, I can

find no functional difference between this Motion and a motion for

summary judgment. As noted in the court’s scheduling order [ECF No. 7], dispositive

motions were due in this case by March 1, 2018, with any supplemental dispositive

motions related to Plaintiff’s ongoing medical treatment due by September 27, 2019

[ECF No. 170]. Therefore, I DENY this Motion [ECF No. 279] in part as it relates to

punitive damages. Should Plaintiff fail to present evidence sufficient to support an

award of punitive damages at trial, Ethicon may move for judgment as a matter of

law pursuant to Federal Rule of Civil Procedure 50(a).

As to Ethicon’s motion to preclude any evidence related to Johnson & Johnson,

the court agrees that Johnson & Johnson is not a party to this action. In her Short

Form Complaint filed with the court [ECF No. 1], Plaintiff only identified Ethicon,

Inc. as a defendant in response to question six. She did not identify Johnson &

Johnson as a defendant. Indeed, this court has never recognized the existence of more

than one defendant in this case. The docket and case caption both only reflect one

defendant – Ethicon, Inc. Further, Rule 10(a) of the Federal Rules of Civil Procedure

requires a complaint to name all the parties.

Plaintiff argues Johnson & Johnson should be considered a defendant because

an earlier version of the Short Form Complaint she emailed to Ethicon’s counsel, but

did not file with this court, did check both Ethicon and Johnson & Johnson as

defendants. While, pursuant to Pretrial Order #49, that earlier version may have

been sufficient for purposes of tolling the statute of limitations against Johnson &

Johnson, it was ineffective for purposes of establishing Johnson & Johnson as a party

in this case. Because the operative Complaint [ECF No. 1] does not name Johnson &

Johnson as a party, any evidence related to Johnson & Johnson for purposes of

liability and/or damages is irrelevant. Accordingly, I GRANT the Motion [ECF No.

279] in part.

I. ECF No. 320 — Second Supplement to Defendant’s Omnibus Motion

In this Motion, Ethicon again supplements its second Motion in Limine

contained in its Omnibus Motion [ECF NO. 71] to exclude graphic images of Plaintiff's

vulvar abscess. Now, in addition to the images attached to Dr. Margolis’ expert

reports, Ethicon also seeks to exclude similar images in Plaintiffs July 8, 2020

medical records, Bates numbers SUTPHINA_PSR_01990-1991. For the reasons

discussed in reference to ECF No. 71 above, I also DENY this Motion [ECF No. 320].

II. Conclusion

For the reasons stated above, ECF Nos. 48, 208, and 216 are GRANTED; ECF

Nos. 128, 130, 210, 212, 214, 218, 224, 227, 263, 264, 265, and 320 are DENIED; and

ECF Nos. 71 and 279 are GRANTED in part and DENIED in part.

ENTER: August 27, 2020

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JNITED STATES DISTRICT JUDGE

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