Bellew v. Ethicon, Inc. et al

Filing 287

MEMORANDUM OPINION AND ORDER (Motions in Limine) For the reasons stated herein, the following motions in limine are GRANTED in part and DENIED in part: Ethicon's 206 Omnibus Motion in Limine; Plaintiff's 188 Omnibus Motions in Limine No s. 1-3 Limiting Defense Medical Experts; Plaintiff's 194 Omnibus Motions in Limine Nos. 14-20 Regarding General Issues; and the Plaintiff's 202 Omnibus Motions in Limine Nos. 32-34 Limiting FDA Related Evidence; the following motions a re GRANTED: Ethicon's 184 Motion in Limine to Exclude Evidence of Plaintiff's Allegations of Spoliation and the Plaintiff's 277 Motion to Strike; the following motion is DENIED: Plaintiff's 200 Omnibus Motions in Limine Nos. 26-31 to Exclude Improper Opinion Testimony From Treating Physicians; the ruling on the following motion is RESERVED: Plaintiff's 185 Motion in Limine to Preclude Improper Deposition Designations. Signed by Judge Joseph R. Goodwin on 11/25/2014. (cc: attys; any unrepresented party) (ras)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
DIANNE M. BELLEW,
Plaintiff,
v.

CIVIL ACTION NO. 2:13-cv-22473

ETHICON, INC., et al.,
Defendants.
MEMORANDUM OPINION AND ORDER
(Motions in Limine)
Pending before the court are the following motions in limine brought by the plaintiff,
Dianne M. Bellew, and by the defendants, Ethicon, Inc. and Johnson & Johnson (collectively,
“Ethicon”): Ethicon’s Motion in Limine to Exclude Evidence of Plaintiff’s Allegations of
Spoliation [Docket 184], Ethicon’s Omnibus Motion in Limine [Docket 206], the plaintiff’s
Motion to Preclude Improper Deposition Designations [Docket 185], the plaintiff’s Omnibus
Motions in Limine Nos. 1–3 Limiting Defense Medical Experts [Docket 188], the plaintiff’s
Motion in Limine No. 4 to Preclude Defendants from Defending Based on a Long History of Use
of Polypropylene in the Human Body [Docket 190], the plaintiff’s Omnibus Motions in Limine
Nos. 5–13 Precluding Improper Case Specific Arguments or Evidence [Docket 192], the
plaintiff’s Omnibus Motions in Limine Nos. 14–20 Regarding General Issues [Docket 194], the
plaintiff’s Omnibus Motions in Limine Nos. 21–24 to Preclude Improper Liability Defenses
[Docket 196], the plaintiff’s Motion in Limine No. 25 Establishing the Admissibility of Ethicon’s
Decision to Discontinue the Sale and Marketing of the Prolift [Docket 198], the plaintiff’s
Omnibus Motions in Limine Nos. 26–31 to Exclude Improper Opinion Testimony From Treating

Physicians [Docket 200], the plaintiff’s Omnibus Motions in Limine Nos. 32–34 Limiting FDA
Related Evidence [Docket 202], and the plaintiff’s Motion to Strike [Docket 277].
The court conducted a pretrial conference on November 24, 2014. At the time of filing,
the transcript from this conference was not yet available. As stated in the record and for reasons
appearing to the court, the following motions are DENIED: Plaintiff’s Motion in Limine No. 4 to
Preclude Defendants from Defending Based on a Long History of Use of Polypropylene in the
Human Body [Docket 190]; Plaintiff’s Omnibus Motions in Limine Nos. 5–13 Precluding
Improper Case Specific Arguments or Evidence [Docket 192]; Plaintiff’s Omnibus Motions in
Limine Nos. 14–20 Regarding General Issues [Docket 194] with respect to No. 16: To Exclude
Statements Regarding the Number of Randomized Controlled Trials that Allegedly Support the
Safety of Prolift and Similar Products and No. 17: To Exclude Statements About Counsel;
Plaintiff’s Omnibus Motions in Limine Nos. 21–24 to Preclude Improper Liability Defenses
[Docket 196]; Plaintiff’s Motion in Limine No. 25 Establishing the Admissibility of Ethicon’s
Decision to Discontinue the Sale and Marketing of the Prolift [Docket 198]; Ethicon’s Omnibus
Motion in Limine No. 1 Concerning Evidence of Failure to Warn of Complications Not Alleged
by Ms. Bellew, Including Cancer, Erosion, Infection, or Other Adverse Conditions [Docket 206];
Ethicon’s Omnibus Motion in Limine No. 5 Concerning Photographic or Video Depiction of
Actual Prolift Surgery [Docket 206].
As stated in the record and for reasons appearing to the court, the following motions are
GRANTED: Ethicon’s Omnibus Motion in Limine No. 6 concerning two irrelevant off-color
email strings [Docket 206]; Ethicon’s Omnibus Motion in Limine No. 14 concerning the use of
deposition videos or testimony in opening statements [Docket 206]; Ethicon’s Omnibus Motion
in Limine No. 15 on the Heniford DVD concerning Kugel Composix hernia mesh [Docket 206];

2

Ethicon’s Omnibus Motion in Limine No. 16 to exclude any argument, testimony, or other
evidence of Ethicon’s marketing Prolift prior to obtaining FDA clearance [Docket 206];
Ethicon’s Omnibus Motion in Limine No. 17 to exclude evidence or argument criticizing the
FDA’s 510(k) clearance process or the effectiveness of the FDA’s monitoring of medical devices
[Docket 206]; Ethicon’s Omnibus Motion in Limine No. 18 to exclude the evidence submitted by
third parties to the FDA for the 2011 FDA Advisory Committee Meeting, as well as the
transcript of the meeting and conclusions stated by the FDA at the meeting as to POP products
[Docket 206]; Ethicon’s Omnibus Motion in Limine No. 19 to exclude the 2012 FDA 522 orders
and additional information letters [Docket 206]; Ethicon’s Omnibus Motion in Limine No. 20 to
exclude reference to the 1 May 2014 FDA proposed administrative orders regarding the
reclassification of surgical mesh for transvaginal pelvic organ prolapse repair and the
requirement of premarket approval regarding same [Docket 206]; Ethicon’s Omnibus Motion in
Limine No. 21 to exclude evidence of the FDA’s 2005 483 action [Docket 206].
Finally, as stated in the record, I GRANT in part and DENY in part Ethicon’s Omnibus
Motion in Limine No. 2 concerning the February 19, 2009 email of Dr. Leong and any
questioning or argument related to a “mutilated” or “permanently destroyed” vagina [Docket
206].
This Order explains the court’s rulings on the remaining motions in limine.
The following motions in limine by the plaintiff are GRANTED because Ethicon does
not oppose the exclusion: No. 18: To Exclude States Referencing Tort Reform or a Litigation
Crisis and Otherwise Critical Comments About Lawsuits in General [Docket 194]; and No. 19:
To Exclude Any Reference to Increases in the Costs of Health Care or Health Products [Docket
194]. Additionally, Ethicon’s Motion in Limine No. 4 Evidence of Other Lawsuits [Docket 206]

3

is GRANTED because the plaintiff does not oppose the exclusion of evidence regarding other
mesh lawsuits.1
For the reasons set forth below, the following motions by Ethicon are DENIED: Motion
in Limine No. 3 to exclude evidence of anecdotal case reports or case series [Docket 206];
Motion in Limine No. 7 to exclude a 2008 physician survey conducted by a consulting group
[Docket 206]; Motion in Limine No. 8 to exclude evidence of allegations regarding Johnson &
Johnson or Ethicon products other than pelvic mesh products [Docket 206]; and Motion in
Limine No. 9 to exclude evidence related to the accuracy of the New England Journal of
Medicine’s conflict-of-interest disclosures regarding the Altman study [Docket 206]. The
following motions by Ethicon are GRANTED: Motion in Limine No. 11 to exclude evidence
that Ethicon no longer sells Prolift [Docket 206]; Unopposed Motion in Limine No. 12 to exclude
evidence concerning any Material Safety Data Sheets, including any suggestion that
polypropylene causes or may cause cancer [Docket 206]; Unopposed Motion in Limine No. 13 to
exclude reference to the designation of documents as confidential for purposes of discovery or to
refer to the documents as “secret” documents or similar suggestion that because they were
designated as confidential in connection with this litigation Ethicon was somehow hiding
information [Docket 206]; and Motion in Limine to Exclude Evidence of Plaintiff’s Allegations
of Spoliation [Docket 184].
The following motions by the plaintiff are DENIED: Motion in Limine No. 1: To Limit
Dr. Elser’s Testimony [Docket 188]; Motion in Limine No. 2: To Limit Dr. Pramudji’s
Testimony [Docket 188]; Motion in Limine No. 15: To Exclude Testimony and Evidence
Relating to Personal Experiences (and Personal Preferences) of Defendant’s Employees and

1

In the Pretrial Conference record, I mistakenly indicated that Ethicon’s Motion in Limine No. 4 was “denied.” To
clarify, neither party may introduce evidence regarding other pelvic mesh lawsuits.

4

Expert Witnesses With Implanted TVM Devices [Docket 194]; and Motions in Limine Nos. 26–
31 to Exclude Improper Opinion Testimony From Treating Physicians [Docket 200]. The
following motions by the plaintiff are GRANTED: Motion in Limine No. 3: To Exclude the
“Time to Rethink” Article [Docket 188]; Motion in Limine No. 32: Ethicon Cannot Defend
Based on 510(k) Clearance or Compliance [Docket 202]; Motion in Limine No. 34: Ethicon and
its Experts and Other Witnesses Should Be Barred From Commenting on or Discussing the
Morgan Liscinsky Email [Docket 202]; and Plaintiff’s Motion to Strike [Docket 277]. The
following motions by the plaintiff are GRANTED in part and DENIED in part: Motion in
Limine No. 14: To Exclude Evidence of Defendant’s Prior or Unrelated “Good Acts” or “Good
Reputation” [Docket 194]; Motion in Limine No. 20: To Exclude Any Evidence of Payments
Which Have Been or May Have Be [sic] Made by Health Insurers or Others [Docket 194]; and
Motion in Limine No. 33: Ethicon’s Regulatory Expert, Timothy Ulatowski, Should be Barred or
Limited in Testifying at Trial [Docket 202].
I RESERVE ruling on the plaintiff’s Motion in Limine to Preclude Improper Deposition
Designations [Docket 185].
I.

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

on Multidistrict Litigation 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 67,000 cases currently pending, approximately 22,000 of which are in the Ethicon, Inc.
MDL, MDL 2327. In this particular case, the plaintiff was surgically implanted with the Prolift
Anterior Pelvic Floor Repair System (“Prolift”), a mesh product manufactured by Ethicon and
Johnson & Johnson (collectively, “Ethicon”) to treat POP. (See Short Form Compl. [Docket 1],

5

at 2).2 The plaintiff received her surgery in Arizona. (Id. at 3). The plaintiff claims that as a result
of implantation of the Prolift, she has experienced multiple complications, including mesh
erosion, mesh contraction, inflammation, dyspareunia (pain during sexual intercourse), urinary
incontinence, chronic pain, and recurring prolapse of organs. (Master Compl. ¶ 49). In addition,
she had four subsequent operations to remove and revise the implanted mesh. (Pl. Fact Sheet
[Docket 206-1], at 7). The plaintiff alleges negligence, failure to warn, design defect, common
law fraud, fraudulent concealment, negligent misrepresentation, breach of express warranty,
violation of consumer protection laws, gross negligence, and punitive damages. (Short Form
Compl. [Docket 1], at 4).3 The instant Motions in Limine involve the parties’ efforts to exclude
or limit certain evidence, arguments, and testimony at trial.
II.

Ethicon’s Motions
a. Motion in Limine to Exclude Evidence of Plaintiff’s Allegations of Spoliation
[Docket 184]
Ethicon has separately filed a motion in limine to exclude evidence of the plaintiff’s

allegations of spoliation [Docket 184]. I have previously reviewed allegations that Ethicon lost or
destroyed documents relevant to this multidistrict litigation. See Huskey v. Ethicon, Inc., No.
2:12-cv-05201, 2014 WL 3861778, at *5–6 (S.D. W. Va. Aug. 6, 2014). The parties in this case
assert the same arguments regarding spoliation that I addressed in Huskey. To the extent that
there are differences in fact or exhibits, the court does not find them sufficiently material. In
Huskey, I ruled as follows:

2

I have selected this case as a Prolift bellwether case in the Ethicon MDL. (See Pretrial Order # 98 [Docket 29], at
1).
3
Since filing her short form complaint, the plaintiff has dropped several causes of action from her lawsuit. (See Pl.’s
Opp’n to Defs.’ Mot. for Summ. J. [Docket 153], at 1 n.1 (“Ms. Bellew will not pursue any causes of action for
manufacturing defect, breach of implied warranty, constructive fraud, unjust enrichment, negligent infliction of
emotional distress, or ‘strict liability—product defect’ (except to the extent the latter encompasses design defect and
failure to warn).”)).

6

On February 4, 2014, Magistrate Judge Eifert held that Ethicon’s actions were
negligent, not willful or deliberate, and denied the plaintiffs’ motions for severe
sanctions, such as default judgment, striking of defenses, or offering an adverse
instruction in every case. (See In re Ethicon, Inc., Pelvic Repair System Prods.
Liab. Litig., MDL No. 2327, Pretrial Order #100 [Docket 1069]). However,
Judge Eifert recommended that I allow the plaintiffs “the opportunity to introduce
evidence regarding Ethicon’s loss of relevant documents on a case-by-case basis,
and, when appropriate, to tender an adverse inference instruction.” (Id. at 42–43).
The plaintiffs have since asked Judge Eifert to reconsider Pretrial Order #100,
claiming that they have discovered new evidence that establishes that Ethicon’s
duty to preserve evidence began earlier than previously thought. (See Pls.’
Request for Clarification and Reconsideration, In re Ethicon, Inc., Pelvic Repair
System Prods. Liab. Litig., MDL No. 2327 [Docket 1099]).
While a motion for reconsideration is pending before Judge Eifert, the parties
have indicated that they do not desire a ruling on the motion at this time. If and
until Judge Eifert rules on the motion to reconsider, her original ruling remains in
force and effect. Moreover, the plaintiffs have offered no evidence or argument
that evidence of spoliation will be relevant in this case. Therefore, Ethicon’s
motion in limine on the issue of spoliation is GRANTED.
Huskey, 2014 WL 3861778, at *5–6. Accordingly, Ethicon’s motion in limine with regard to
spoliation is GRANTED.
b. Defendants’ Omnibus Motions in Limine [Docket 206]
i. No. 3: To Exclude Evidence of Anecdotal Case Reports or Case Series
Ethicon seeks to exclude anecdotal case reports or case series, which “describe a single
patient’s experience or outcome with a particular drug or medical device.” (Defs. Mem. in Supp.
of Omnibus Mot. in Limine (“Defs.’ Mem. in Supp.”) [Docket 207], at 8). Ethicon argues that
these case reports are impermissible hearsay, irrelevant, and violate Rule 403. Ethicon also
contends that this evidence will likely be offered by the plaintiffs “to suggest that harmful
outcomes are widespread[.]” (Id. at 9).
Consistent with my rulings on similar motions in limine in prior cases, I DENY Ethicon’s
motion here. See Eghnayem, et al. v. Boston Scientific Corp., No. 2:13-cv-07965, 2014 WL
5465741, at *13 (S.D. W. Va. Oct. 28, 2014); see also Lewis, et al. v. Ethicon, Inc., No. 2:12-cv-

7

4301, 2014 WL 505234, at *5 (S.D. W. Va. Feb. 5, 2014). I lack the context needed to make a
substantive ruling on this matter at this time.
ii. No. 4: To Exclude Evidence of Other Lawsuits
At the pretrial conference, I DENIED this motion. To clarify, this motion is moot
because, in her response, the “plaintiff agrees she will not introduce evidence of other lawsuits in
her case-in-chief.” (Pl.’s Res. In Opp’n to Defs.’ Omnibus Mot. in Limine (“Pl.’s Resp.”)
[Docket 232], at 7). Therefore, Ethicon’s motion here is, in fact, GRANTED.
iii. No. 6: To Exclude Two Irrelevant Off-Color Email Strings
At the pretrial conference, I GRANTED Ethicon’s motion in limine concerning two
irrelevant off-color email strings. I clarify here that this motion is numbered Ethicon’s Omnibus
Motion in Limine No. 6.
iv. No. 7: To Exclude a 2008 Physician Survey Conducted by a
Consulting Group
Ethicon moves to exclude evidence or argument concerning a 2008 physician survey
report entitled “May 16-21, 2008 Physician IDPs.” The study involved a consulting firm
conducting 20 phone interviews with “top customers” at Ethicon’s direction. (Pl.’s Resp.
[Docket 232], at 11; see Defs.’ Mem. in Supp. [Docket 207], at 16). Ethicon argues that the
report is impermissible hearsay and violates Rule 403. Fed. R. Evid. 403. The plaintiff argues
that the report falls within the business records exception to hearsay and, regardless, is
admissible to prove that Ethicon had notice of complications associated with the Prolift.
As I explained in the pretrial conference with respect to several other motions in limine,
this motion is an attempt to obtain a premature ruling which calls simply for the application of
the rules of evidence. If this evidence is presented at trial, the defendant should object at that
time. Therefore, I DENY this motion.
8

v. No. 8: To Exclude Evidence of Allegations Regarding Johnson &
Johnson or Ethicon Products Other than Pelvic Mesh Products
Ethicon seeks to exclude evidence of alleged “bad acts” of Johnson & Johnson and
Ethicon with regard to their non-pelvic mesh products. Ethicon argues that this evidence is
irrelevant, unfairly prejudicial, and impermissible character evidence.
In this court’s rulings in Lewis, I did not admit evidence of unrelated “(1) criminal guilty
pleas and fines . . . (2) state attorney general actions . . . (3) consent decrees with the U.S.
Department of Justice or FDA . . . (4) settlements or fines with the U.S. Department of Justice or
Securities and Exchange Commission . . . and (5) any investigations or proceedings by any
political bodies or enforcement agencies . . .” See Lewis, 2014 WL 505234, at * 4–5. However, I
stated that:
[S]ome other “bad acts” evidence may be relevant to the punitive damages claim
or the negligence claim. At this stage, without knowing the precise evidence at
issue and how the parties intend to use it, I cannot rule on the admissibility of all
“bad acts” evidence. However, the plaintiffs are cautioned to tread carefully when
introducing this kind of evidence. Accordingly, Ethicon’s motion on this issue is
DENIED without prejudice.
Id. at *4. I ADOPT this reasoning here. Therefore, I DENY Ethicon’s motion on this matter.
vi. No. 9: To Exclude Evidence Related to the Accuracy of the New
England Journal of Medicine’s Conflict-of-Interest Disclosures
Regarding the Altman Study
Ethicon seeks to exclude evidence or argument “related to conflict-of-interest disclosures
published by the New England Journal of Medicine regarding a study of the Prolift product
conducted by Dr. Daniel Altman and numerous other surgeons.” (Defs.’ Mem. in Supp. [Docket
207], at 20). It is premature for me to rule on this matter at this time. This motion is an attempt to
obtain an advisory ruling which calls simply for the application of the rules of evidence. I do not
know the context in which this evidence is to be admitted. Therefore, I DENY this motion.

9

vii. No. 11: To Exclude Evidence that Ethicon No Longer Sells Prolift
Ethicon seeks to exclude evidence that Ethicon no longer sells the Prolift product under
Federal Rules of Evidence 401, 402, and 403. The plaintiff contends that she seeks to admit this
evidence for impeachment purposes and that, therefore, it is admissible.
I GRANT this motion. Even if this evidence is admissible for impeachment purposes,
Federal Rule of Evidence 403 precludes its admission. The probative value of this evidence is
substantially outweighed by the risk of unfair prejudice. Fed. R. Evid. 403. Furthermore, this
evidence is closely related to evidence concerning the FDA, and I will not risk the occurrence of
a mistrial such as in Cisson. (See Defs.’ Exhibit Q [Docket 206-17] (Trial Transcript for Cisson
discussing mistrial)). Therefore, this motion is GRANTED.
viii. No. 12: To Exclude Evidence Concerning Any Material Safety Data
Sheets, Including Any Suggestion that Polypropylene Causes or May
Cause Cancer
Ethicon moves to exclude three specific Material Safety Data Sheets (“MSDS”) and “any
MSDS sheets that contain any suggestion that polypropylene causes or may cause cancer[.]”
(Defs.’ Mem. in Supp. [Docket 207], at 24). In her response, the plaintiff concedes that she
“respects the Court’s [previous] ruling [on this matter] and will not contest the motion except to
say plaintiff may approach the Court and seek to introduce this evidence” in rebuttal. (Pl.’s Resp.
[Docket 232], at 18). Therefore, this motion is GRANTED.
ix. No. 13: To Exclude Reference to the Designation of Documents As
Confidential for Purposes of Discovery or to Refer the Documents As
“Secret” Documents or Similar Suggestion that Because They Were
Designated As Confidential in Connection With This Litigation
Ethicon Was Somehow Hiding Information
Ethicon moves to exclude any reference to the designation of documents as confidential.
The plaintiff concedes that she “will not make reference to the litigation stamp of ‘confidential’

10

during the litigation for the discovery process.” (Pl.’s Resp. [Docket 232], at 19–20). As I
explained in Tyree, “‘[w]hether a party designates a document as confidential during the
litigation process is absolutely irrelevant.’ Lewis, 2014 WL 505234, at *7. The jury will be
instructed at trial to disregard the confidential marking on documents.” Tyree v. Boston Scientific
Corp., No. 2:12-cv-08633, 2014 WL 5445769, at *9 (S.D. W. Va. Oct. 22, 2014). I ADOPT this
reasoning here. Therefore, I GRANT Ethicon’s motion in limine with respect to this issue.
III.

The Plaintiff’s Motions
a. Motion to Preclude Improper Deposition Designations [Docket 185]
The plaintiff seeks to preclude Ethicon from (1) affirmatively designating deposition

testimony of available witnesses; and (2) counter-designating deposition testimony, unless
narrowly limited to testimony necessary for completeness and context of the plaintiff’s
affirmative designations. (Pl.’s Mot. to Preclude Improper Dep. Designations [Docket 185], at 1).
Ethicon has failed to respond to the plaintiff’s motion on this issue. Objections regarding
deposition designations will be addressed by Magistrate Judge Eifert as a part of pre-trial
discovery. It is my intent to adopt Judge Eifert’s rulings. Accordingly, I RESERVE ruling on the
plaintiff’s motion in limine with regard to improper deposition designations.
b. Plaintiff’s Omnibus Motions in Limine Nos. 1–3 Limiting Defense Medical
Experts [Docket 188]
i. No. 1: To Limit Dr. Elser’s Testimony; No. 2: To Limit Dr.
Pramudji’s Testimony
The plaintiff seeks to limit the testimony of Ethicon’s expert witnesses, Dr. Denise Elser
and Dr. Christina Pramudji. (Pl.’s Mem. of Law in Supp. of Omnibus Mots. in Limine Nos. 1–3
Limiting Def. Medical Experts (“Pl.’s Mem. in Limine Nos. 1-3”) [Docket 189], at 2–5). I have
previously reviewed the expert opinions of Dr. Elser and Dr. Pramudji under Daubert. (See

11

Mem. Op. & Order re: Daubert Mots. [Docket 265], at 32–37). I agree with Ethicon that this
motion in limine is an attempt to “belatedly challeng[e] the credentials” of Dr. Elser and Dr.
Pramudji. (Defs.’ Resp. in Opp’n to Pl.’s Mots. in Limine Nos. 1–3 [Docket 220], at 1). My
Daubert ruling on these two experts stands, and I will not consider any matters that should have
been addressed in a prior motion. To the extent the plaintiff has further objections to Dr. Elser
and Dr. Pramudji’s expert opinions, which have not yet been ruled on, she is free to raise those
objections at trial. Accordingly, the plaintiff’s motion in limine with regard to Dr. Elser and Dr.
Pramudji is DENIED.
ii. No. 3: To Exclude the “Time to Rethink” Article
The plaintiff also seeks to exclude reference to an article written by Ethicon and Boston
Scientific consultants which was published in the International Urogynecology Journal because it
“is an unscientific propaganda opinion piece[.]” (Pl.’s Mem. in Limine Nos. 1-3 [Docket 189], at
5–6). See Miles Murphy, et al., Time to Rethink: An Evidence-Based Response from Pelvic
Surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated
with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”, Int. Urogynecol. J.
(Jan. 23, 2012). This article discusses a safety communication released by the FDA in July of
2011. Throughout these MDLs, I have held that the probative value of evidence related to the
FDA is substantially outweighed by the risk of jury confusion. Accordingly, the plaintiff’s
motion in limine with regard to the “Time to Rethink” article is GRANTED, and the parties are
precluded from referencing this article at trial.
In sum, the plaintiff’s Omnibus Motions in Limine Nos. 1–3 Limiting Defense Medical
Experts [Docket 188] is DENIED in part and GRANTED in part.
c. Plaintiff’s Omnibus Motions in Limine Nos. 14–20 Regarding General Issues
[Docket 194]
12

i. No. 14: To Exclude Evidence of Defendant’s Prior or Unrelated
“Good Acts” or “Good Reputation”
The plaintiff moves to exclude evidence regarding “prior acts of public benefit that are
unrelated to the device in this case (e.g. community employment, charitable donations of money
and medicine and medical contributions such as the development of new products) in order to
convey a general ‘good company’ reputation.” (Mem. in Supp. of Pl.’s Omnibus Mot. in Limine
Nos. 14–20 Regarding General Issues (“Mem. in Limine Nos. 14–20”) [Docket 195], at 1). The
plaintiff contends that such evidence is irrelevant, unduly prejudicial, and improper propensity
evidence. Ethicon represents that it will not offer evidence about community jobs, charitable
donations, or its good reputation. (Defs.’ Resp. in Opp’n to Pl.’s Mot. in Limine No. 14–20
(“Resp. Nos. 14–20”) [Docket 223], at 1). In these respects, therefore, the plaintiff’s motion in
limine is GRANTED.
Ethicon states, however, that it will seek to prove that it develops new products, to the
extent such evidence is relevant to this case, and complete exclusion of this subject matter at this
time would be “too broad.” (Id.) Given that I cannot presently discern the manner in which
Ethicon will use evidence of new products—to prove a pertinent character trait or otherwise—I
agree with Ethicon. I cannot properly rule on this issue prior to trial. Accordingly, the plaintiff’s
motion is DENIED in this respect.
For these reasons, the plaintiff’s motion in limine No. 14 is GRANTED in part and
DENIED in part.
ii. No. 15: To Exclude Testimony and Evidence Relating to Personal
Experiences (and Personal Preferences) of Defendant’s Employees
and Expert Witnesses with Implanted TVM Devices
The plaintiff next requests exclusion of “any retrospective or hypothetical testimony

13

regarding Defendants’ [witnesses’] willingness to have a pelvic mesh device implanted in
themselves (or their family members).” (Mem. in Limine Nos. 14–20 [Docket 195], at 4). In the
plaintiff’s view, this evidence is irrelevant, confusing to the jury, and improper testimony from a
lay witness or an expert witness. (Id. at 4–7). Ethicon responds that it does not intend to
introduce evidence of this nature at trial unless the plaintiff “open[s] the door” to it. (Resp. Nos.
14–20 [Docket 223], at 2). Because a dispute does not seem to exist at this time regarding
Motion in Limine No. 15, I DENY the plaintiff’s motion and reserve judgment on this issue until
trial, should it arise.
iii. No. 20: To Exclude Any Evidence of Payments Which Have Been or
May Have Be [sic] Made by Health Insurers or Others
Relying on the collateral source rule, the plaintiff moves to exclude any evidence of
payments made to Ms. Bellew through Medicare or Medicaid; health insurance companies; and
Ms. Bellew’s disability status. (Mem. in Limine Nos. 14–20 [Docket 195], at 11–12). Ethicon
agrees not to present evidence regarding money or benefits received from collateral sources as
compensation for Ms. Bellew’s injuries alleged in this case. (Resp. Nos. 14–20 [Docket 223], at
4). Therefore, as to collateral compensation received by the plaintiff for her alleged injuries from
the Prolift, the motion is GRANTED.
Ethicon maintains, however, that Ms. Bellew’s disability compensation, which she has
received since 2007 (two years before her Prolift surgery), relates to preexisting injuries, not
injuries allegedly arising from the Prolift, and as a result, evidence of Ms. Bellew’s disability
status does not violate the collateral source rule. (Id.). The collateral source rule provides that
“when an injured plaintiff has been compensated for his injuries from a source other than the
defendant, the latter cannot benefit from the recovery.” Olivas v. United States, 506 F.2d 1158,
1163 (9th Cir. 1978) (citing United States v. Price, 288 F.2d 448, 449 (4th Cir. 1961) (“[W]here
14

the injured plaintiff’s compensation comes from a ‘collateral source,’ it should not be offset
against the sum awarded for the tort nor considered in determining that award.”)). Because the
disability payments at issue are not intended to compensate Ms. Bellew for her alleged injuries
arising from the Prolift and instead concern unrelated injuries she received in 2007, the collateral
source rule does not apply to the disability payments. Therefore, the plaintiff’s motion in limine
on this point is DENIED.
In sum, the plaintiff’s motion in limine No. 20 is GRANTED in part and DENIED in
part.
d. Plaintiff’s Omnibus Motions in Limine Nos. 26–31 to Exclude Improper
Opinion Testimony From Treating Physicians [Docket 200]
The plaintiff next moves to exclude the opinion testimony of six treating physicians: (1)
Dr. Terry Huff, one of Ms. Bellew’s gynecologists who ultimately referred Ms. Bellew to a
specialist after a short consultation; (2) Dr. Matthew Holland, a pain management doctor who
treated Ms. Bellew for neck and back pain in 2010 and 2012; (3) Dr. Toure Knighton, a pain
management doctor who treated Ms. Bellew’s neck and back pain from June 2013 through
August 2014; (4) Dr. Joseph Leano, a family medicine doctor who treated Ms. Bellew for
various conditions from October 31, 2008, through August 7, 2012; (5) Dr. Javier Amadeo, a
neurosurgeon who performed Ms. Bellew’s cervical disk surgery in 2007; and (6) Dr. Mitar
Vranic, a vascular surgeon who treated Ms. Bellew for varicose veins in 2013 and 2014. The
plaintiff’s arguments in support of exclusion are largely the same for each treating physician, and
I can therefore address the motion in summary fashion.
The plaintiff first contends that Ethicon has not submitted a Rule 26 expert report for
these physicians, and as such, any opinions offered that go beyond the scope of their treatment of
the plaintiff is improper and should be excluded. This court has held that a Rule 26 report is not
15

required for treating physicians who testify solely about their treatment of the plaintiff. See In re
C. R. Bard, Inc., 948 F. Supp. 2d 589, 615 (S.D. W. Va. 2013) (“[A]bsent evidence that a
plaintiff’s treating physician or surgeon is retained or specially employed to provide expert
testimony, a Rule 26(a)(2)(B) written report will not be required.” (internal quotations omitted)).
And Ethicon has represented that it offers these physicians solely for this purpose. (Defs.’ Resp.
in Opp’n to Pl.’s Mot. in Limine No. 26–31 (“Resp. Nos. 26–31) [Docket 226], at 1 (stating that
the defendants offer the treating physicians only to provide “opinions based on observed facts
rendered for the course of treatment”). Rather than parsing through the deposition transcripts of
each treating physician at issue, I simply reemphasize my prior ruling—absent an expert
designation, a treating physician may only offer testimony that “addresses knowledge gained and
opinions formed during the course of treatment.” In re C. R. Bard, Inc., 948 F. Supp. 2d at 615
(emphasis added). The parties are represented by able counsel, and I trust they can abide by this
rule and establish the proper content for these six physicians’ trial testimony.4
Another consistent theme throughout the plaintiff’s motion is relevancy. Specifically, the
plaintiff asserts that testimony about Ms. Bellew’s other medical conditions unrelated to the
Prolift are irrelevant, confusing to the jury, and a waste of judicial time. (See, e.g., Pl.’s Omnibus
Mots. in Limine Nos. 26–31 to Exclude Improper Op. Test. from Treating Physicians (“Mem. in
Limine Nos. 26–31”) [Docket 201], at 7 (contending that the “defendants seek to defend
themselves by overwhelming the jury with evidence of unrelated medical conditions,” which the
court should exclude as “irrelevant,” “confusing and misleading,” and a “waste of valuable

4

The plaintiff continuously objects to the treating physicians’ testimony as it relates to Ms. Bellew’s smoking
history. (See, e.g., Mem. in Limine Nos. 26–31 [Docket 201], at 10 (moving to exclude Dr. Knighton’s “irrelevant
and highly prejudicial” testimony concerning Ms. Bellew’s smoking history). I simply apply the same rule to this
argument—if a treating physician took Ms. Bellew’s smoking history into account when treating Ms. Bellew, then
the opinion testimony on the topic is admissible. Note, however, that like all of this court’s rulings denying a motion
in limine, this allowance of testimony on Ms. Bellew’s smoking history could change at trial, depending on the
context and the merit of a proper objection.

16

judicial resources”)). I disagree. Evidence about preexisting injuries, including neck and back
pain, can conceivably serve various roles in Ethicon’s case, such as demonstrating Ms. Bellew’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. While the plaintiff argues that
these preexisting medical conditions are “wholly unrelated” to the plaintiff’s claims, (id. at 10),
the province of weighing the testimony and determining the relationship, if any, among Ms.
Bellew’s injuries belongs to the jury. Accordingly, the plaintiff’s Motions in Limine Nos. 26–31
[Docket 200] are DENIED.
e. Plaintiff’s Omnibus Motions in Limine Nos. 32–34 Limiting FDA Related
Evidence [Docket 202]
i. No. 32: Ethicon Cannot Defend Based on 510(k) Clearance or
Compliance
The plaintiff seeks to exclude any evidence related to the FDA’s 510(k) clearance of the
Prolift. In every previous case in these MDLs, this court has excluded evidence regarding the
510(k) clearance process of the product at issue.5 I see no reason to depart from this position,
which I succinctly described in In re C. R. Bard, Inc.:

5

See Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 756 (S.D. W. Va. 2014) (granting a motion to exclude
evidence of the 510(k) process because 510(k) clearance “does not go to whether the [mesh] products are safe and
effective”) (internal quotations omitted); Eghnayem, et al. v. Boston Scientific Corp., No. 2:13-cv-07965, 2014 WL
5461991, at *60 (S.D. W. Va. Oct. 27, 2014) (“I have 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.”);
Tyree, et al. v. Boston Scientific Corp., No. 2:12-cv-08633, 2014 WL 5320566, at *64 (S.D. W. Va. Oct. 17, 2014)
(same); Sanchez, et al. v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 WL 4851989, at *37 (S.D. W. Va. Sept.
29, 2014) (same); Edwards v. Ethicon, Inc., No. 2:12-cv-09972, 2014 WL 3882186, at *3 (S.D. W. Va. Aug. 7,
2014) (“I now hold that the evidence of the FDA’s 510(k) process is inadmissible in this case.”); Huskey v. Ethicon,
Inc., No. 2:12-cv-05201, 2014 WL 1883784, at *1 (S.D. W. Va. May 12, 2014) (same); Cisson, et al. v. C. R. Bard,
Inc., No. 2:11-cv-00195, 2013 WL 3821280, at *7 (S.D. W. Va. July 23, 2013) (“The FDA 510(k) process does not
go to safety and effectiveness and does not provide any requirements on its own. Basically, it has no operative
interaction with state tort laws.”) (internal citation omitted). (See also Mem. Op. & Order [Docket 280], at 12
(concluding that the plaintiff’s claims are not preempted by the 510(k) clearance of the Prolift because 510(k)
clearance does not speak to the safety or effectiveness of a product)).

17

After reviewing the motions, responses, and exhibits thereto, I FIND that
evidence as to the FDA’s 510(k) process and lack of enforcement action should
be excluded under Federal Rule of Evidence 403 because of the danger of
misleading the jury, confusing the issues, and unfair prejudice. Given the parties’
filings throughout this case, it is abundantly clear that there would be a substantial
mini-trial on the 510(k) process and enforcement should it be allowed. In short,
this evidence poses a substantial risk of misleading the jury to believe that FDA
510(k) clearance might be dispositive of the plaintiffs’ state law claims, and if
such evidence comes in via expert testimony, the expert would effectively be
offering a legal conclusion.
No. 2:10-CV-01224, 2013 WL 3282926, at *2 (S.D. W. Va. June 27, 2013), motion to certify
appeal denied sub nom., No. 2:10-CV-01224, 2013 WL 4508339 (S.D. W. Va. Aug. 22, 2013).
On these grounds, I GRANT the plaintiff’s Motion in Limine No. 32.
ii. No. 33: Ethicon’s Regulatory Expert, Timothy Ulatowski, Should be
Barred or Limited in Testifying at Trial
The plaintiff also moves to bar or limit the testimony of Ethicon’s regulatory expert,
Timothy Ulatowski. The plaintiff maintains that Mr. Ulatowski’s opinions “are based on
speculation and/or net opinions, and/or are completely irrelevant to the issues in this trial.” (Pl.’s
Mem. in Supp. of Omnibus Mots. in Limine Nos. 32–34 Limiting FDA Related Evidence
(“Mem. in Limine Nos. 32–34) [Docket 203], at 5). Ethicon responds that this motion in limine is
actually an untimely Daubert motion and that Mr. Ulatowski’s opinions “are highly relevant, and
supported by knowledge and training about the 510(k) process, post-market surveillance,
enforcement action, and design controls.” (Defs.’ Resp. in Opp’n to Pl.’s Mots. in Limine No.
32–34 [Docket 227], at 5).
To the extent that Mr. Ulatowski’s opinions implicate the 510(k) clearance process in
general or with respect to the Prolift specifically, his opinion is improper and therefore
EXCLUDED. As explained above, this court will not tolerate the presentation of evidence that
touches on or in any way alludes to the 510(k) clearance process. Furthermore, insofar as Mr.
Ulatowski’s opinions relate to FDA regulations or procedures, FDA decision-making, FDA
18

communications, or Ethicon’s compliance with such, they are EXCLUDED. I have previously
expressed concern with the risks of leading the jury into the confusing domain of the FDA. See
Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 WL 4851989, at *35–36 (S.D. W.
Va. Sept. 29, 2014) (“Given that the probative value of expert testimony on FDA requirements is
substantially outweighed by the risk of jury confusion, I cannot admit Dr. Pence’s testimony as it
relates to the FDCA or FDA regulations.”). Particularly, I emphasized that “expert testimony
about the requirements of the FDCA, which are not at issue in this case, could lead to more
confusion . . . than enlightenment.” Id. at *35. I have these same concerns about Mr. Ulatowski’s
opinions, which appear to entirely focus on FDA regulations, FDA procedures (the 510(k)
clearance process as well as others), FDA communications, and Ethicon’s compliance with FDA
law. (See Ulatowski Report [Docket 202-4], at 6–38 (discussing FDA provisions “relevant to the
subject case,” in addition to other FDA requirements)). Thus, any opinion testimony on matters
of the FDA is EXCLUDED, and the plaintiff’s motion on this issue is GRANTED.
The plaintiff requests entire exclusion of Mr. Ulatowski’s opinion. The plaintiff,
however, failed to file a timely Daubert motion challenging Mr. Ulatowski as an expert.
Accordingly, with respect to the portions of Mr. Ulatowski’s opinion unrelated to the 510(k)
process or the FDA, the plaintiff’s motion in limine is DENIED.6
iii. No. 34: Ethicon and its Experts and Other Witnesses Should be
Barred From Commenting on or Discussing the Morgan Liscinsky
Email
Finally, the plaintiff asks this court to exclude reference to an email between FDA
spokesperson Morgan Liscinsky and a reporter at Bloomberg News regarding Ethicon’s failure
to obtain 510(k) clearance before marketing the Prolift (“FDA email”). The plaintiff asserts that

6

I note that based on my review of Mr. Ulatowski’s expert report, very little of it, if any, provides permissible
opinions unrelated to the FDA. Thus, it is quite possible that my ruling has indeed resulted in the entire exclusion of
Mr. Ulatowski’s opinion.

19

this email improperly relates to 510(k) clearance and “is pure hearsay.” (Mem. in Limine Nos.
32–34 [Docket 203], at 7). Ethicon, on the other hand, argues that the FDA email is relevant
because “it explains that Ethicon acted in a good faith belief that it was in compliance when it
did not seek new 510(k) clearance for Prolift until 2008.” (Resp. Nos. 32–34 [Docket 227], at 6).
Because the email concerns the 510(k) process, which I have ruled as inadmissible under Federal
Rule of Evidence 403, I similarly exclude the FDA email without addressing the hearsay
arguments. The plaintiff’s motion in limine on this point is therefore GRANTED.
In conclusion, I GRANT in part and DENY in part Plaintiff’s Omnibus Motions in
Limine Nos. 32–34 Limiting FDA Related Evidence [Docket 202].
f. Plaintiff’s Motion to Strike [Docket 277]
Lastly, the plaintiff moves to strike Ethicon’s Bench Memorandum Regarding the
Admissibility of Plaintiff’s Prior Medical History (“Ethicon’s Bench Memorandum”). I have
already rejected the plaintiff’s objections to the admissibility of Ms. Bellew’s prior medical
history at this stage. Therefore, further argument on this issue, as stated in Ethicon’s Bench
Memorandum [Docket 276], is unnecessary. Accordingly, the plaintiff’s Motion to Strike
[Docket 277] is GRANTED.
IV.

Conclusion
For the reasons stated above, the following motions in limine are GRANTED in part

and DENIED in part: Ethicon’s Omnibus Motion in Limine [Docket 206]; Plaintiff’s Omnibus
Motions in Limine Nos. 1–3 Limiting Defense Medical Experts [Docket 188]; Plaintiff’s
Omnibus Motions in Limine Nos. 14–20 Regarding General Issues [Docket 194]; Plaintiff’s
Omnibus Motions in Limine Nos. 32–34 Limiting FDA Related Evidence [Docket 202].
The following motions are GRANTED: Ethicon’s Motion in Limine to Exclude

20

Evidence of Plaintiff’s Allegations of Spoliation [Docket 184]; Plaintiff’s Motion to Strike
[Docket 277].
Plaintiff’s Omnibus Motions in Limine Nos. 26–31 to Exclude Improper Opinion
Testimony From Treating Physicians [Docket 200] is DENIED.
I RESERVE ruling on the plaintiff’s Motion in Limine to Preclude Improper Deposition
Designations [Docket 185].
The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER:

21

November 25, 2014