# Hosbrook v. Ethicon, Inc.

> District Court, S.D. Ohio · September 29, 2021

URL: https://www.frixlaw.com/law-library/cases/10378899

## Case

- **Court:** District Court, S.D. Ohio
- **Decided:** September 29, 2021
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10378899

## How later opinions describe it (automated extraction)

- explaining that premarket approval imposes requirements and the § 510(k) process is an “exemption from federal safety review”
- concluding in explosion of 26 acetylene cylinder that “foreign legal standards have been found excludable by the 11th Circuit, and we now follow that holding”

## Opinion text

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION

PATRICIA HOSBROOK, :
Plaintiff,
Case No. 3:20-cv-88
V. :
JUDGE WALTER H. RICE
ETHICON, INC., et al.,
Defendants. :

DECISION AND ENTRY SUSTAINING IN PART AND OVERRULING
IN PART PLAINTIFF'S OMNIBUS MOTION IN LIMINE (DOC. #127)
AND SUSTAINING IN PART AND OVERRULING IN PART
DEFENDANTS’ MOTIONS IN LIMINE (DOC. ##101, 102, 103, 104,
105, 106, 107, 108, 109, 110, 111, 112, 113 and 126)

Plaintiff, Patricia Hosbrook (Plaintiff) has filed an Omnibus Motion /n Limine,
Doc. #127, consisting of eight motions (“Plaintiff's MIL”), and Defendants, Ethicon,
Inc., and Johnson & Johnson (collectively “Ethicon” or “Defendants) have filed
14 Motions /n Limine, Doc. ##101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111,
112, 113 and 126 (Defendants’ Motions). Responses to these motions have been
filed by Defendants, Doc. #139, and by Plaintiff, Doc. ##147, 148, 149, 150, 151,
152, 153, 154, 155, 156, 157, 158 and 159. Defendants have also filed replies, Doc.
##164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174 and 175. Oral argument
before the Court was held on September 17, 2021. Following oral argument,
Plaintiff filed a Notice of Supplemental Authority. Doc. # 180. For the reasons set

forth below, Plaintiff's MIL and Defendants’ Motions are sustained in part and
overruled in part.

|. Procedural Background
Ethicon, a subsidiary of Johnson & Johnson, designed and manufactured
Prolift, a mesh product used to treat pelvic organ prolapse (“POP”) and stress
urinary incontinence (“SUI”). On March 27, 2007, the Prolift was surgically
implanted in Plaintiff in Livingston, Tennessee, and on May 14, 2012, she
underwent surgery in Dayton, Ohio, for the “excision of extruded vaginal mesh
and rectocele repair.” Doc. #33-1. On November 16, 2012, Plaintiff filed a “Short
Form Complaint” against Defendants in certain multidistrict litigation pending in
the United States District Court for the Southern District of West Virginia entitled
“In re Ethicon Inc., Pelvic Repair System Products Liability Litigation, MDL No.
2327." Doc. #1. Her case was remanded to this Court’s docket on March 9, 2020,
for trial.
On April 23, 2021, the Court sustained Defendants’ Motion for Partial
Summary Judgment. Doc. #120. As a result of this Decision and Entry, Plaintiff's
sole claim is for design defect under Tennessee law, as codified in the Tennessee
Products Liability Act of 1978, Tennessee Code Annotated § 29-28-101, et seq.
(“TPLA”). Doc. #120.'

' The Court also sustained in part and overruled in part Defendants’ Motion to Dismiss the
Case-Specific Opinions of Bruce Rosenzweig, M.D. Doc. #120.

ll. Standard of Review
Although neither the Federal Rules of Evidence nor the Federal Rules of
Civil Procedure explicitly authorize the Court to rule on an evidentiary motion jn
limine, the Supreme Court has noted that the practice of ruling on such motions
“has developed pursuant to the district court's inherent authority to manage the
course of trials.” Luce v. United States, 469 U.S. 38, 41 n.4 (1984). The purpose of
a motion /n /imine is to allow the Court to rule on issues pertaining to evidence in
advance of trial in order to both avoid delay and ensure an evenhanded and
expeditious trial. See Indiana Ins. Co. v. Gen. Elec. Co., 326 F. Supp.2d 844, 846
(N.D. Ohio 2004) (citing Jonasson v. Lutheran Child & Family Servs., 115 F.3d 436,
440 (7th Cir. 1997)). Pretrial orders also often save the parties time and cost in
preparing for trial and presenting their cases.
Courts are generally reluctant to grant broad exclusions of evidence jn
limine, however, because “a court is almost always better situated during the
actual trial to assess the value and utility of evidence.” Koch v. Koch Indus., Inc., 2
F. Supp.2d 1385, 1388 (D. Kan. 1998); accord Sperberg v. Goodyear Tire & Rubber
Co., 519 F.2d 708, 712 (6th Cir. 1975). A court should not make a ruling jn /imine
unless the moving party meets its burden of showing that the evidence in
question is clearly inadmissible. /ndiana Ins. Co., 326 F. Supp.2d at 846; Koch, 2 F.
Supp.2d at 1388. If this high standard is not met, evidentiary rulings should be
deferred so that the issues may be resolved in the context of the trial. /na/ana □□□□
Co., 326 F. Supp.2d at 846.

ll. Law of the Case Doctrine
The law of the case doctrine exists to prevent re-litigation of issues in a case
that have already been decided. “[W]hen a court decides upon a rule of law, that
decision should continue to govern the same issues in subsequent stages in the
same case.” Arizona v. California, 460 U.S. 605, 618 (1983). Although the Sixth
Circuit has noted that the “‘law of the case’ doctrine is ‘directed to a court's
common sense’ and is not an ‘inexorable command,’"” Hanover Ins. Co. v. Am.
Eng’g Co., 105 F.3d 306, 312 (6th Cir. 1997) (quoting Petition of U.S. Steel Corp.,
479 F.2d 489, 494 (6th Cir. 1973)), the Supreme Court has held that “courts should
be loathe” to “revisit prior decisions of its own or a coordinate court in the
absence of extraordinary circumstances.” Christianson v. Colt Indus. Operating
Corp., 486 U.S. 800, 817 (1988) (quoting Arizona, 460 U.S. at 618 n.8). Three
reasons exist to reconsider a prior ruling of the court: “(1) where substantially
different evidence is raised on subsequent trial; (2) where a subsequent contrary
view of the law is decided by the controlling authority; or (3) where a decision is
clearly erroneous and would work a manifest injustice.” Hanover Ins. Co., 105
F.3d at 312 (citations omitted).
In the Ethicon Pelvic Mesh Multidistrict Litigation (“MDL”), the cases were
divided into “waves” with this case being included in the “Ethicon Wave 5 cases.”
Doc. #20. Judge Goodwin of the MDL Court ruled on all pretrial matters in the
waves, including discovery and evidentiary issues. Here, the Court will adopt all

of the MDL opinions unless it determines that “extraordinary circumstances”
exist.?

IV. Plaintiff’s Omnibus Motion (Doc. #127)
A. Motion in Limine No. 1: Exclude Evidence, Argument or Reference to
the FDA’s § 510(k) Clearance Process (PagelD#25797)
In her first MIL, Plaintiff seeks to exclude any “evidence, argument or
reference” by Defendants to the Food and Drug Administration’s (“FDA’s”)
“[§]510(k) mesh product process.” She asserts that this process is only a
“clearance process” for marketing purposes as opposed to one of “approval” of
safety.’ In further support of her argument, she states that the MDL Court has

? Although the Sixth Circuit has not addressed the applicability of the doctrine of the law
of the case after remand from an MDL court, the Fifth Circuit in /n re Ford Motor Co., 591
F.3d 406, 411 (5th Cir. 2009) and the D.C. Circuit in, /n re Multi Piece Rim Prods. Liab.
Litig., 653 F.2d 671, 678 (D.C. Cir. 1981), as well as other courts within this circuit,
Mathews v. Novartis Pharmaceuticals Corp., No. 3: 12-cv-314, 2013 WL 5780415, at *16
(S.D. Ohio Oct. 25, 2013)(Rice, J.), Smith v. Pfizer, Inc., 688 F. Supp. 2d 735, 752 (M.D.
Tenn. 2010) and /n re Welding Fume Prods. Liability Litig., 1: 03-CV-17000, 2010 WL
7699456, at *2 (N.D. Ohio June 4, 2010), have found that the doctrine applies to rulings
rendered by an MDL court. See, Cutter v. Ethicon, Inc., No. 5:19-443-DCR, 2020 WL
2060342, at *2 (E.D. Ky. Apr. 29, 2020).
“Submission of a premarket notification in accordance with this subpart, and a
subsequent determination by the Commissioner that the device intended for introduction
into commercial distribution is substantially equivalent to a device in commercial
distribution before May 28, 1976, or is substantially equivalent to a device introduced into
commercial distribution after May 28, 1976, that has subsequently been reclassified into
class | or Il, does not in any way denote official approval of the device. Any representation
that creates an impression of official approval of a device because of complying with the
premarket notification regulations is misleading and constitutes misbranding.” 21 C.F.R. §
807.97.

“consistently and unequivocally” excluded evidence of the FDA’s § 510(k) process
in the vaginal mesh cases pursuant to Fed. R. Evid. 401, 402 and 403.4 Sanchez v.
Boston Scientific Corp., 38 F. Supp. 3d 727, 744 (S.D. W. Va. 2014) (“[a]s | have
repeatedly ruled in relation to this multidistrict litigation, and as | now hold in this
case, no party will be permitted to introduce evidence relating to the FDA or the
[8]510(k) clearance process”). In Sanchez, the MDL Court cited to its earlier
decision in Lewis v. Johnson & Johnson, 991 F.Supp.2d 748, 754 (S.D. W.Va.
2014), stating that such evidence “poses a substantial risk of misleading the jury
and confusing the issues,” is “not relevant to state tort law” and “runs the risk of
misleading the jury to believe that [the] FDA [8] 510(k) clearance might be
dispositive of the plaintiffs' state law claims.” The MDL Court further noted that
“[T]he prejudicial value of evidence regarding the § 510(k) process far outweighs
its probative value.” See Hovey v. Cook, Inc., No. 2:13-cv-18900, 2015 WL 1405558,

“Rule 401. Test for Relevant Evidence. Evidence is relevant if: (a) it has any tendency to
make a fact more or less probable than it would be without the evidence; and (b) the fact
is of consequence in determining the action.
Rule 402. General Admissibility of Relevant Evidence. Relevant evidence is admissible
unless any of the following provides otherwise: ¢ the United States Constitution; ¢ a
federal statute; ¢ these rules; or ® other rules prescribed by the Supreme Court. Irrelevant
evidence is not admissible.
Rule 403. Excluding Relevant Evidence for Prejudice, Confusion, Waste of Time, or Other
Reasons. The court may exclude relevant evidence if its probative value is substantially
outweighed by a danger of one or more of the following: unfair prejudice, confusing the
issues, misleading the jury, undue delay, wasting time, or needlessly presenting
cumulative evidence.

at *2 (S.D. W. Va. Mar. 26, 2015) (“[T]his court has excluded FDA evidence in
every MDL trial to date based on [Federal Rules of Evidence 401, 402, and 403]”).
Plaintiff asserts that the exclusion of this evidence pursuant to Fed. R. Evid. 401,
402 and 403 has been upheld by the Eleventh Circuit, Eghnayem v. Boston
Scientific Corp., 873 F.3d 1304, 1317-18 (11th Cir. 2017), the Fourth Circuit, Huskey
v. Ethicon, Inc., 848 F.3d 151 (4th Cir. 2017) and Campbel/ v. Boston Scientific
Corp., 882 F.3d 70 (4th Cir. 2018) and the Seventh Circuit, Kaiser v. Johnson &
Johnson, 947 F.3d 996 (7th Cir. 2020).
In response, Defendants acknowledge that “the MDL Court and other courts

... have excluded all evidence of the FDA’s regulation of pelvic mesh products on
the ground that it does not speak to a device's ‘safety’ or ‘efficacy.’” Doc. #139,
PagelD#29164. They “respectfully disagree for purposes of appeal.” /d.
The Court finds that admission of evidence, argument or reference to the
FDA’s § 510(k) process concerns “equivalence, not safety.” Medtronic, Inc. v. Lohr,
518 U.S. 470, 478-79 (1996); Riegel v. Medtronic, Inc., 552 U.S. 312, 322 (2008)
(explaining that premarket approval imposes requirements and the § 510(k)
process is an “exemption from federal safety review”). Accordingly, evidence of
the 8 510(k) process concerning Prolift is excluded based on the law of the case
doctrine as well as Fed. R. Evid. 401, 402 and 403. Under Rule 401, evidence of
this process is not relevant since it does not establish that the Prolift is safe and
effective; therefore, it has no “tendency to make a fact more or less probable than
it would be without the evidence.” Because evidence of this FDA process does not

go to the Prolift’s safety and efficacy, it is irrelevant evidence and not admissible
pursuant to Rule 402. Even assuming that evidence of compliance with the FDA
regulations is relevant, the Court finds that its probative value is substantially
outweighed by the danger of unfair prejudice, confusion of the issues and/or
misleading the jury. Plaintiff's MIL No. 1 is SUSTAINED.

B. Motion in Limine No. 2: Preclude any Evidence, Argument or Reference
by Ethicon that Plaintiff's Claims are Federally Preempted
(PagelD#25801)
Plaintiff's second MIL asserts that Defendants should be precluded from
arguing that Plaintiff's claims are “preempted” by federal law. Defendants
respond that preemption is not the proper subject of a MIL and state they do not
intend to offer any such evidence. Accordingly, the Court OVERRULES as moot
Plaintiff's MIL No. 2.

C. Motion in Limine No. 3: Preclude any Evidence, Argument, or Reference
by Ethicon that Plaintiff's Claims are Barred as a Result of “Compliance
with all Applicable Federal Statutes and Regulations” (PagelD#25802)
Although Plaintiff's third MIL is similar to her first MIL, the present motion is
not strictly limited to the FDA’s 8 510(k) mesh product clearance process. Instead,
this MIL includes Defendants alleged compliance “with all applicable federal
statutes and regulations.” She contends that such evidence, argument or
reference violates Fed. R. Evid. 403, since it misleads the jury and is unfairly
prejudicial. Doc. #127 PagelD#25802. She further asserts that such evidence is

routinely excluded by the MDL Court as well as other courts on remand.
Defendants disagree “for the purpose of preserving the issue for appeal,” citing
§ 29-28-104(a) of the TPLA which raises a presumption of no defect if compliance
with all applicable federal and state regulations exist. They acknowledged in oral
argument, however, that they are bound by the MDL rulings “as the law of the
case.”
Neither party cites the Court to any specific federal statute or regulation
that Defendants have allegedly complied with other than § 510(k) process which
the Court excluded earlier in this Decision and Entry pursuant to the law of the
case doctrine and Fed. R. Evid. 401, 402 and 403. Accordingly, for the same
reasons stated in MIL No. 1, pursuant to the law of the case doctrine and Fed. R.
Evid. 401, 402 and 403, Plaintiff's MIL No. 3 is SUSTAINED.

D. Motion fn Limine No. 4: Exclude any Evidence or Argument that this
Lawsuit or Transvaginal Mesh Litigation is Attorney Driven Litigation
(PagelD#25803)
Plaintiff argues that evidence or argument by Defendants that the suit or
“transvaginal mesh litigation” is “attorney driven” should be excluded as
irrelevant pursuant to Fed. R. Evid. 401 and is unfairly prejudicial pursuant to Rule
403. Defendants state that they do not intend to make any such argument. Doc.
#139, PagelD#29166. Accordingly, Plaintiff's MIL No. 4is OVERRULED as moot.

E. Motion jn Limine No. 5: Exclude Evidence, Argument or Reference to
the Number of Women Allegedly Treated with Pelvic Mesh for SUI or
POP (PagelD#25803)
Plaintiff seeks to exclude any evidence, argument or reference concerning
“the number of women allegedly treated with pelvic mesh” for stress urinary
incontinence (“SUI”) or pelvic organ prolapse (“POP”). She argues that evidence
from Defendants that the Prolift has been “implanted in millions of women
around the world,” or claims of satisfaction by women treated with transvaginal
mesh products is irrelevant under Fed. R. Evid. 401. Additionally, Plaintiff argues
that the evidence is unfairly prejudicial under Rule 403, in part, because these
women are unidentified, their medical records have not been examined and they
have not been deposed.
In response, Defendants argue that “[t]he fact that millions of women have
been treated with pelvic mesh and have not had major complications is directly
relevant” and admissible for two reasons. They first argue that Plaintiff must
show under 8 29-28-105(a) that the Prolift was in a “defective condition or
unreasonably dangerous” when it left Ethicon’s control,® and that here
“unreasonably dangerous” is determined under the “prudent manufacturer test”

§ 29-28-105. Defective or dangerous conditions; determination
(a) A manufacturer or seller of a product shall not be liable for any injury to a person or
property caused by the product unless the product is determined to be in a defective
condition or unreasonably dangerous at the time it left the control of the manufacturer or
seller.

10

and not the “ordinary consumer test.” ® They contend that only the “prudent
manufacturer test” applies because the Prolift is a “complex product” and “an
ordinary consumer would have no reasonable expectation” of it. In support of
their argument, Defendants cite to Ray by Holman v. BIC Corp., 925 S.W.2d 527,
532 (Tenn. 1996). They argue that this case lists the relevant factors under the
“prudent manufacturer test” as including “the usefulness and desirability of the
product,” “the user's ability to avoid danger’” and “awareness of the danger,” /a.
at 532, making evidence that the Prolift has been “implanted in millions of women
around the world” without major complications relevant. Ethicon also argues that
evidence of Prolift’s use by “millions of women” without major complications is
relevant to its state-of-the-art defense in § 29-28-105(b).8”
Under Tennessee law, the “prudent manufacturer test” and the “ordinary
consumer test” are not mutually exclusive.” Jackson v. Gen. Motors Corp., 60
S.W.3d 800, 806 (Tenn. 2001). Additionally, “[e]ven a technically complex failure

° § 29-28-102 (8) defines an “unreasonably dangerous” product as one that is “dangerous
to an extent beyond that which would be contemplated by the ordinary consumer who
purchases it, with the ordinary knowledge common to the community as to its
characteristics, or that the product because of its dangerous condition would not be put
on the market by a reasonably prudent manufacturer or seller, assuming that the
manufacturer or seller knew of its dangerous condition.”
’ Ethicon contends that the “intended users” of the Prolift are pelvic floor surgeons.
*(b) In making this determination, the state of scientific and technological knowledge
available to the manufacturer or seller at the time the product was placed on the market,
rather than at the time of injury, is applicable. Consideration is given also to the
customary designs, methods, standards and techniques of manufacturing, inspecting and
testing by other manufacturers or sellers of similar products.

1]

may involve a subject about which an ordinary consumer may have an
expectation|[,]” as the expectation “’does not depend necessarily on a product's
complexity in technology or use’ but, instead, relies on the common knowledge of
consumers as to a product's characteristics and performance.” Coffey v. Dowley
Mfg., Inc., 187 F. Supp. 2d 958, 968-69, 972 (M.D. Tenn. 2002) (quoting Jackson, 60
S.W.3d at 805).
Although the “state of the art defense” is permitted under § 29-28-105(b),
the blanket statement of the use of Prolift by “millions of women” without major
complications, does not establish what “scientific and technological knowledge”
was available to Ethicon as the manufacturer at the time Prolift was placed on the
market, nor does it show “the customary designs, methods, standards and
techniques of manufacturing, inspecting and testing by other manufacturers or
sellers of similar products.” Ray by Holman 925 S.W.2d at 532.
At this early stage in the proceedings, the Court is unable to determine
whether evidence, argument or reference concerning “the number of women
allegedly treated with pelvic mesh” for stress urinary incontinence (“SUI”) or
pelvic organ prolapse (“POP”) or that the Prolift has been “implanted in millions
of women around the world” without major complications, or with complications,
generally, is admissible. Therefore, the Court reserves any ruling on this motion
until trial. Until the Court hears more evidence, neither party may refer to the
number of women who have undergone Prolift surgery, without major
complications or with complications, in either vo/r dire or opening statement. If

12

counsel for Plaintiff and/or Defendants wishes to introduce evidence concerning
this subject, this motion can be argued to the Court outside of the presence of the
jury based on evidence that has been introduced thus far in the case.
Accordingly, Plaintiff's MIL No.5 is OVERRULED, without prejudice to
renewal at trial.

F. Motion jn Limine No. 6: Exclude Evidence, Argument or Reference to
Ethicon’s Prior or Unrelated “Good Acts” or “Reputation” (PagelD#25805)
In her sixth MIL, Plaintiff moves the Court to exclude evidence of
Defendants’ prior or “unrelated good acts or reputation.” In this motion, she
specifically references any evidence from Defendants of the “beneficial nature” of
other products that they manufacture or market, monies donated to women’s
health or charitable issues and other “good acts.” Defendants assert that
Plaintiff's motion is “overbroad” because it seeks to preclude all evidence of their
“good product development story” and that this evidence should not be excluded
at the pretrial stage.
At this early stage in the proceedings, the Court is unable to determine
whether “evidence argument or reference concerning Defendants’ “prior or
unrelated good acts or reputation” is admissible. Therefore, the Court reserves
any ruling on this motion until trial. Until the Court hears more evidence, neither
party may refer to this subject in either vo/r dire or opening statement. If counsel
for Defendants wish to introduce evidence concerning this subject, this motion

13

can be argued to the Court outside of the presence of the jury based on evidence
that has been introduced thus far in the case.
Accordingly, Plaintiff's MIL No. 6 is OVERRULED, without prejudice to
renewal at trial.

G. Motion in Limine No. 7: Exclude any Evidence or Testimony Concerning
Collateral Sources (PagelD#25806)
Although Plaintiff mistakenly argues that Florida law, as opposed to that of
Tennessee, applies to bar evidence of certain collateral source payments,
Tennessee also precludes evidence of collateral source payments. Dedmon v.
Stee/man, 535 S.W. 3d 431, 434 (2017) (defendants in a personal injury case are
precluded from submitting evidence of discounted rates accepted by medical
providers from the insurer to rebut the plaintiffs’ proof that the full, undiscounted
charges are reasonable medical expenses); Tenn. Code Ann.§ 24-5-113 (procedure
for evidence of bills for health care and treatment). Defendants state that they do
not “intend to offer any evidence that would violate this rule,” and “reserve the
right to present relevant evidence regarding necessity, reasonableness, and
whether a claimed service was actually paid.” Doc. #139, PagelD#29168-29169. In
support, they cite to Fye v. Kennedy, 991 S.W.2d 754, 764, 1998 WL 338198 (Tenn.
Ct. App. 1998). Fye, however, held that “a defendant is permitted to introduce
relevant evidence regarding necessity, reasonableness, and whether a claimed

14

service was actually rendered,” as opposed to whether it was “actually paid.” /d.
at 764.
Accordingly, Plaintiff's MIL No. 7 is SUSTAINED.

H. Motion /n Limine No. 8: Exclude Evidence and Testimony Regarding
Personal Experiences and/or Preferences of Witnesses as to
Transvaginal Mesh Implants (PagelD#25807)
In this MIL, Plaintiff seeks to exclude testimony from Defendants’
employees, lay witnesses or experts concerning their “personal experiences with
pelvic mesh devices” or those of a friend or family member. She also includes in
this motion exclusion of any “retrospective or hypothetical testimony” that these
women would “be willing to (or prefer to) have a sling implanted” if they were
“suffering from SUI.” Doc. #127, PagelD#25807. She argues that such evidence
is irrelevant pursuant to Fed. R. Evid. 401 and is more prejudicial than probative
pursuant to Fed. R. Evid. 403. Defendants contend that this exclusion of evidence
is overbroad since it potentially excludes all of Defendants’ testimony, including
from their medical directors and licensed physicians employed to assess the
safety and efficacy of the Prolift, as well as testimony from their expert witnesses
who are qualified to render opinions pursuant to Fed. R. Evid. 702, based on their
“knowledge, skill, experience, training or education.” Finally, Defendants state
that they do not intend to elicit testimony from their witnesses as to any
recommendations of the product and request that Plaintiff's witnesses be barred
from testimony that they would not recommend use of the products.

15

Because the parties agree that there will be no testimony from any lay
witness concerning the recommendations of the use or non-use of the Prolift
product, the Court OVERRULES as moot this portion of Plaintiff's MIL No. 8.
Concerning the exclusion of testimony from Defendants’ medical directors and
expert witnesses of their experiences with the product, the Court reserves ruling
on this motion until trial. Until the Court hears more evidence, neither party may
refer to this subject in either vo/r dire or opening statement. If counsel for Plaintiff
or Defendants wishes to introduce evidence concerning this subject, this motion
can be argued to the Court outside of the presence of the jury based on evidence
that has been introduced thus far in the case.
Accordingly, Plaintiff's MIL No. 8 is OVERRULED, without prejudice to
renewal at trial.

V. DEFENDANTS’ MOTIONS
A. Motion in Limine No. 1: to Exclude Evidence or Argument in Support of
Plaintiff's Non-Existent Failure to Warn Claims (Doc. #101)
Defendants’ first Motion moves to exclude all evidence or argument in
support of Plaintiff's dismissed claim of failure to warn. They argue that this
includes the Prolift “Instructions for Use” (“IFU”) document, patient brochure, all
revisions to these documents after Plaintiff's 2007 implantation surgery and any
expert testimony that Defendants failed to warn physicians of certain risks
associated with the use of the Prolift. They argue that this Motion should be

16

sustained since the Court has dismissed Plaintiff's failure to warn claim in its
Decision and Entry on their Partial Motion for Partial Summary Judgment. Doc.
#120. Because of the Court's ruling, they contend that “warning evidence” is
irrelevant pursuant to Fed. R. Evid. 401 and is not admissible under Rule 402.
Additionally, Defendants argue that some of the warning related evidence is
inadmissible as a subsequent remedial measure pursuant to Fed. R. Evid 407.2
Plaintiff argues that this evidence is relevant since it “shows what Ethicon was
communicating about its products to the medical field and potential patients.”
Doc. #147, PagelD#29794. Finally, she asserts that this evidence is admissible
since Defendants “will offer this type of evidence touting certain benefits” to
prove their “state-of-the-art defense” and that evidence concerning warnings and
instructions is relevant to prove punitive damages.” /d. at PagelD#29795.

Fed. R. Evid. 407, provides that if measures “are taken that would have made an earlier
injury or harm less likely to occur, evidence of the subsequent measures is not admissible
to prove:
® negligence;
¢ culpable conduct;
a defect in a product or its design; or
* a need for a warning or instruction.” Such evidence is admissible, however, if itis “for
another purpose, such as impeachment or--if disputed--proving ownership, control, or the
feasibility of precautionary measures.”
Plaintiff has filed a motion to apply New Jersey law to her claim for punitive damages.
Doc. #135. Defendants do not object. Doc. #137. N.J. S. A. 2A:58C-5 c. reads as follows:
“Punitive damages shall not be awarded if a... device... which caused the claimant's
harm was subject to premarket approval or licensure by the federal Food and Drug
Administration . .. and was approved or licensed: or is generally recognized as safe and
effective pursuant to conditions established by the federal Food and Drug Administration
and applicable regulations, including packaging and labeling regulations. However,
where the product manufacturer knowingly withheld or misrepresented information
17

Plaintiff's claim of failure to warn has been dismissed from this case. Doc.
#120. Accordingly, Defendants’ Motion No. 1, barring any testimony, evidence or
opinions regarding warnings or of Plaintiff's lack of informed consent from any
witness, including her expert, Dr. Rosenzweig, as well as testimony or evidence of
the Prolift “Instructions for Use” (“IFU”) document, patient brochure or revisions
to these documents is SUSTAINED.

B. Motion in Limine No. 2: to Exclude Evidence of Alleged
Complications Associated with the Device other than those
Alleged by Plaintiff (Doc. #102)
In this Motion, Defendants argue that because Plaintiff has alleged
complaints of pain, bleeding, mesh erosion and mesh extrusion and a recurrent
rectocele, there should be no evidence of other possible complications such as
“pain with intercourse.” They contend that any complication that Plaintiff has not
claimed, including complications experienced by others, have no connection to
this case and are irrelevant and would confuse the jury. They cite to numerous
cases involving Ethicon as well as a transcript from the Ethicon Pelvic Mesh MDL
in which Magistrate Judge Eifert stated “If there was an injury in that product but
it wasn’t suffered or claimed by the plaintiff in the case, [the MDL Court] wasn’t
letting any evidence in about it.” Doc. #102, PagelD#18075. Defendants also cite
to the MDL Court's holding in Bellew v. Ethicon, Inc., No. 2:13-CV-22473, Order at

required to be submitted under the agency's regulations, which information was material
and relevant to the harm in question, punitive damages may be awarded. . .
18

19-20 (S.D. W. Va. Nov. 20, 2014) that “[E]vidence of complications that the
plaintiff did not experience is irrelevant and lacking in probative value.”" In
response, Plaintiff argues that such evidence is relevant and cites to three Sixth
Circuit cases concerning aircraft accidents, accidents at railroad crossings and
automobile accidents in which the Court deemed such evidence admissible.
The Court finds that any evidence of injuries that Plaintiff has not sustained
are excluded under the law of the case doctrine and is also not relevant pursuant
to Fed. Rule 401. Accordingly, Defendants’ Motion No. 2 is SUSTAINED.

C. Motion in Limine No. 3: to Exclude Evidence Concerning the
Decommercialization of Prolift (Doc. #103)
In 2012, five years after Plaintiff's implantation of the Prolift, Ethicon
removed this product and several other pelvic mesh products from the
marketplace. Defendants seek to exclude from evidence the
“decommercialization of the product.” They contend that removal of the product
was not mandated by the FDA but was done because of the “complexities of
clinical study requirements, adverse publicity, the litigation environment, the size
and competitiveness of the marketplace and the availability of other treatment
options.” Doc. #103, PagelD#18185. Based on this, they argue that admitting
evidence of the withdrawal of the product is irrelevant pursuant to Fed. R. Evid.

'' Bellew was selected by Judge Goodwin “as a Prolift bellweather case in the Ethicon
MDL case.” Bellew v. Ethicon, Inc., No. 2:13-cv-22473, 2014 WL 12685965 *1 (S.D. W.Va.
Nov. 20, 2014
19

401 and 402 and that, even if relevant, any probative value is substantially
outweighed by being unfairly prejudicial pursuant to Fed. R. Evid. 403, since it will
be seen by the jury as an admission of liability. Finally, Defendants assert that if
this evidence is offered by Plaintiff as proof of a design defect, it should be
excluded as a “subsequent remedial measure” pursuant to Fed. R. Evid. 407.72
Plaintiff argues that removal of the product is evidence of Defendants’ recognition
that “the failure rate of the product warranted removal.” Marion v Smith &
Nephew Inc., 2016 Dist. LEXIS 9949, at * 12 (D. Utah July 27, 2016). She also
contends that although it may be inadmissible pursuant to Fed. R. Evid. Rule 407,
it may be admissible for other purposes “such as impeachment or--if disputed--
proving ownership, control, or the feasibility of precautionary measures.” /d.
Defendants’ Motion No. 3, is SUSTAINED. The Court finds that the
decommercialization of the Prolift is a subsequent remedial measure pursuant to
Fed. R. Evid. 407 and is not admissible to prove a defect in the design of the
product. Unless Plaintiff can show that evidence of decommercialization is
permissible for purposes of impeachment or, if disputed, to prove ownership,
control or the feasibility of precautionary measures, as set forth in Rule 407, any
evidence of the decommenrcialization of the Prolift is excluded. Should counsel for
Plaintiff wish to examine a witness on this subject, he must make any arguments
to the Court, outside of the presence of the jury.

12 See n. 10, infra

20

D. Motion in Limine No. 4: to Exclude Post-Implant Company
Documents (Doc. #104)
Defendants seek to exclude all company documents after 2007, the date of
Plaintiff's surgery. They argue that because these documents are dated after her
Prolift implantation, they are irrelevant since § 29-28-105(a) requires the product
must to be in a defective or unreasonably dangerous condition at the time it left
Ethicon’s control. They further assert that, in this case, “unreasonably
dangerous” is proven by whether a “prudent manufacturer” would put the
product on the market “assuming the manufacturer . . . knew of its dangerous
condition.” TPLA § 29-28-102(8)."° If, however, the Court finds that the company
documents after 2007 are relevant, Defendants contend the “limited probative
value” is outweighed by the danger of unfair prejudice requiring exclusion under
Fed. R. Evid. 403. Defendants specifically argue for the exclusion of two
documents: (1) the 2008 Prolift Physicians In-Depth Interviews (“IDIs”) and (2) the
PA Consulting Group Report, published in 2011, entitled “Investigating Mesh
Erosion in Pelvic Floor Repair.” Defendants assert that the Prolift IDlis were
conducted by a consulting group and are “replete with the hearsay statements of
20 anonymous physicians.” Doc. #104, PagelD#18209. Concerning the PA
Consulting Group’s Report, they argue that it discusses potential causes for pelvic
mesh erosion generally and reviews existing data for multiple Ethicon products as

Seen. 6, infra.
2]

well as those of other manufacturers. /d. In response, Plaintiff argues that the
date of publication of company documents should not contro! whether the Prolift
was in a defective condition and unreasonably dangerous when it left Ethicon’s
control and that these documents are relevant to show evidence of design defect,
causation and are relevant to punitive damages. She further asserts that the PA
Consulting Group Report interviewed Ethicon employees who designed and
tested its mesh products. Doc. #150, PagelD#29805. Finally, Plaintiff argues that
Defendants may make certain arguments at trial that are directly rebutted by the
Prolift Physicians IDIs and the PA Consulting Group Report.
The Court does not find that the date of any company document necessarily
controls its admissibility or use at trial in this strict liability design defect case. To
succeed in a TPLA action, a plaintiff must establish that “(1) the product was
defective and/or unreasonably dangerous, (2) the defect existed at the time the
product left the manufacturer's control, and (3) the plaintiff's injury was
proximately caused by the defective product.” Sigler v. Am. Honda Motor Co., 532
F.3d 469, 483 (6th Cir. 2008). Although, under § 29-28-105(a), the relevant inquiry
is whether the product was in a defective condition or unreasonably dangerous at
the time it left the control of the manufacturer or seller, exclusion is not
necessarily determined by the date of the company documents, since statements,
findings and research contained therein may show that Ethicon knew that the
Prolift was “unreasonably dangerous” at the time that it put the Prolift on the
market and, thus, Ethicon was not acting as a “reasonably prudent manufacturer”
22

pursuant to § 29-28-102 (8)."* However, because at this early stage in the
proceedings the Court is unable to determine whether these documents and “all
post-implant company documents should be excluded, the Court OVERRULES
this motion, without prejudice to renewal at trial. Until the Court hears more
evidence, neither party may refer to this subject in either vo/r dire or opening
statement. If counsel for Plaintiff wishes wish to introduce evidence concerning
this subject, this motion can be argued to the Court outside of the presence of the
jury based on evidence that has been introduced thus far in the case.

E. Motion in Limine No. 5: to Exclude Evidence of Post-2011 FDA
Regulatory Actions and Other Related Issues (Doc. #105)
Defendants move to exclude evidence of the FDA’s regulatory actions
concerning transvaginal prolapse mesh products issued “years after Plaintiff's
implantation of the Prolift Posterior.” They specifically move to exclude three FDA
regulatory actions: (1) third-party submissions, transcripts and FDA statements
from a 2011 FDA Advisory Committee meeting; (2) the FDA’s 2012 “522 letters;”
and (3) the FDA’s 2014, 2016 and 2019 orders concerning the classification of
transvaginal prolapse mesh. They argue that all three of the FDA regulatory
actions are irrelevant under Fed. R. Evid. 401 and that, even if the 2011 FDA
Advisory Committee meeting submissions, transcripts and statements and the
2014, 2016 and 2019 FDA orders are relevant, their probative value is substantially

4 See n.5, infra.
23

outweighed by the danger of unfair prejudice. Finally, they argue that the 2011
FDA Advisory Committee meeting contains inadmissible hearsay.
Plaintiff argues that it is immaterial whether the dates of the FDA
publications are after Plaintiff's 2007 surgery and that the FDA public health
notifications for 2008, 2011 and 2019 concerning the surgical mesh products “bear
directly on Plaintiff's design defect claims demonstrating that the risks
(particularly for POP mesh products like the Prolift) outweigh the benefits.” Doc.
#151, Page ID#29820. She further argues that this evidence is admissible to prove
causation, punitive damages and to rebut Ethicon’s claims that the Prolift was safe
and effective under its state-of-the-art defense. /d
Several reasons exist requiring exclusion of this evidence. First, pursuant to
§ 28-29-105(b) of the TPLA, the relevant date to determine whether a product is in
a defective condition or unreasonably dangerous is “at the time it left the control
of the manufacturer or seller.” Here, that date is 2007, the date of Plaintiff's
implantation. Additionally, in Be/lew v. Ethicon, Inc., No. 2:13-cv-22473, 2014 WL
6680356, at *1 (S.D. W. Va. Nov. 25, 2014), a Prolift bellweather case in the Ethicon
Pelvic Mesh MDL, Judge Goodwin excluded all evidence of the 2011 FDA
Advisory Committee meeting including submission made by third parties to the
FDA, the transcript of the meeting and conclusions stated at the meeting by the
FDA as to POP products. He also excluded all evidence of the “522 Orders” sent
by the FDA to Ethicon and other pelvic mesh manufacturers in 2012, as well as
references to the FDA’s 2014 proposed administrative orders regarding the
24

reclassification of surgical mesh for transvaginal pelvic organ prolapse repair and
the requirement of premarket approval. Additionally, this Court further finds that
the 2011 FDA Advisory Committee third-party submissions, transcripts and FDA
statements, are out of court statements and are inadmissible hearsay pursuant to
Fed. R. Evid. 802, and that this evidence from the 2011 FDA Advisory Committee
meeting, the “522 letters” and the FDA’s 2014 orders concerning the classification
of transvaginal prolapse mesh, are irrelevant under Fed. R. Evid 401. Even
assuming relevance, the Court finds that this evidence is excluded under Rule 403
since its probative value is outweighed by the danger of unfair prejudice,
confusion of the issues and/or misleading the jury. Finally, as to the FDA’s Public
Health Notifications and 2016 and 2019 enforcement action, which were not at
issue in Bellew, the Court finds this evidence to be irrelevant under Rule 401 for
the reasons stated earlier and because Ethicon stopped selling the Prolift in 2012.
The probative value of such information, even if relevant, is outweighed by the
danger of unfair prejudice, confusion of the issues and/or misleading the jury.
Simply stated, these three regulatory actions do not show whether the Prolift was
defectively designed under the TPLA, and that admission of these three regulatory
actions will require an explanation of the FDA’s decision-making operations and a
“mini-trial” on the FDA process causing both undue delay and wasting the jury’s
time.
For the reasons stated above, Defendants’ Motion No. 5 is SUSTAINED.

25

F. Motion én Limine No. 6: to Exclude Foreign Regulatory Issues
and other Foreign Evidence (Doc. #106)
Defendants move to exclude evidence of foreign regulatory issues including
websites, labels or other documents as well as suspensions of product sales
and/or types of pelvic floor surgeries in other countries. They argue that any
regulatory evidence from foreign countries, like that of the FDA, is irrelevant
pursuant to Fed. R. Evid. 401 and 402 and that even if relevant, the probative value
is outweighed by the danger of unfair prejudice and confusion of the issues and/or
misleading the jury and must be excluded under Rule 403. Plaintiff responds to
this Motion by requesting that the Court reserve ruling on this issue until trial and
argues, despite Defendants’ arguments, that this evidence “raises no question
regarding the interpretation of foreign law” and instead “discusses health
complications” with the mesh products making it “relevant and admissible for
establishing knowledge, notice” and Defendants’ state-of-the-art defense. Doc.
#152, PagelD#29866.
The Court finds, for the reasons set forth in its ruling excluding the FDA
regulatory actions in Defendants’ Motion No. 5, that evidence of foreign
regulatory issues and other foreign evidence are irrelevant as to whether the
Prolift was defectively designed under the TPLA. Even if relevant, under Rule 403,
the probative value of this evidence is outweighed by the danger of unfair
prejudice, confusion of the issues and/or misleading the jury. See also, Hurt v.
Coyne Cylinder Co., 956 F.2d 1319, 1327 (6th Cir. 1992) (concluding in explosion of

26

acetylene cylinder that “foreign legal standards have been found excludable by
the 11th Circuit, and we now follow that holding”) (citation omitted)).
Accordingly, Defendants’ Motion No. 6 is SUSTAINED.

G. Motion in Limine No. 7: to Exclude Certain Irrelevant and Unfairly
Prejudicial Company Documents, Emails and Argument (Doc. #107)
Defendants move to exclude two email chains: (1) an email string between
Terry Courtney, an Ethicon salesman and Martin Weisberg, a surgeon, (the
“Courtney-Weisberg email chain”);'> and (2) an email chain between Ethicon
employees and European surgeons (the “TVM Group”), discussing potential
follow-up questions directed towards the Prolift surgical patients."° Defendants
also move to bar Plaintiff from referring to any document produced in discovery
as “secret” or “confidential.” They assert that both email chains should be
excluded because they are irrelevant under Fed. R. Evid. 401 and that even if the
Court determines them relevant, they must be excluded pursuant to Rule 403,

Defendants summarize the string as follows: “an email string between Terry Courtney
and Dr. Martin Weisberg where, in the course of a discussion regarding a woman’s
complaint about the erosion of a TVT product and her husband's remark that ‘sex felt like
screwing a wire brush,’ Dr. Weisberg made the comment that the situation ‘[s]ounds like
a buttonhole. It can be locally excised. I’ve never tried the wire brush thing so | won’t
comment.’ Ex, 1, July 9, 2003 email.” Doc. #107, PagelD#18369; Doc. #107-1.
Defendants summarize this email string as follows: “An email chain between Ethicon
employees and European surgeons discussing potential follow-up questions directed
towards Prolift surgical patients, including commentary from one surgeon regarding
questions directed towards “fellatio, sodomy, [etc.]” Ex. 2, Sept. 2005-Oct. 2005 email
chain. In response, another surgeon commented on the complexity of human sexuality,
and stated “[i]sn’t it this concern that has lead [sic] me to say (and | don’t think I'll be the
only [sic] for a while ...) that | would not like for my wife to undergo this procedure.” Doc.
#107, PagelD#18370, Doc. #107-2.
27

since the probative value is substantially outweighed by the danger of unfair
prejudice, confusion of the issues and/or misleading the jury. Defendants also
assert that these email chains contain inadmissible hearsay.
The “Courtney-Weisberg” email chain concerns an email that Courtney,
identified in the email chain as “Sales Representative for Gynecare, a Division of
Ethicon, Inc.,” forwarded to Weisberg, an Ethicon medical director. The
forwarded email from Courtney concerned a report from a doctor regarding a
patient's issue with mesh erosion, the statement from the patient’s husband and
how the doctor surgically corrected the erosion the patient was experiencing. The
patient, her husband and the doctor are not identified and the product is not the
Prolift, but the Gynecare TVT, a different product used to treat stress urinary
incontinence and not pelvic organ prolapse. Defendants argue for exclusion of
this email chain since the product is not the Prolift and the unidentified patient is
experiencing dyspareunia, pain with sexual intercourse, which is a condition that
Plaintiff does not allege. Plaintiff argues that this email chain is not hearsay since
it is an admission by a party-opponent and admissible pursuant to Fed. R. Evid.
801(d)(2). She asserts that because the Courtney-Weisberg email chain was
written in 2003, before Plaintiff's implantation surgery, Ethicon had notice of
Plaintiff's design defect. Finally, she argues it supports her claim for punitive
damages.
The second TVM Group email chain is characterized by Defendants as
between “Ethicon employees and European surgeons” and ranges in dates from
28

September 20, 2005, through October 10, 2005. Ethicon does not state who in this
email chain is an Ethicon employee and who is a European surgeon. Also, it is
unknown how this email chain came into Ethicon’s possession. Included in this
chain is an email from Claude Rosenthal concerning “a quick word about
sexuality” including "fellatio, sodomy, [etc.]," and possible questions to “surgical
patients” concerning intercourse before and after the surgery. Doc. #107-2,
PagelD#18384. A response to Rosenthal’s email is from Dr. Jacquetin Bernard,
who is identified by Plaintiff as “the inventor of the Prolift and its procedure.” In
response to Rosenthal’s email, Bernard states "[i]sn't it this concern that has lead
me to say (and | don't think I'll be the only [one] for a while ...) that | would not like
for my wife to undergo this procedure." /d., at 18383. She further asserts that the
surgeons in this email chain are a French “group of physicians who helped
develop the Prolift and performed the original study for the product.” Doc. # 153,
PagelD#29870. Plaintiff argues that this email chain is admissible because it
concerns the Prolift, was written two years prior to Plaintiff's surgery and is from
the inventor of the product.
Finally, Plaintiff states that she does not intend to comment on the
confidential or secretive nature of Ethicon’s documents, but will refer to them as
“internal.”
The Court SUSTAINS Defendants’ Motion No. 7 as it pertains to the
Courtney-Weisberg email. This email is irrelevant under Fed. R. Evid. 401, since it
concerns the TVT product and not the Prolift, as well as a complaint that Plaintiff
29

does not allege. Even if this email chain is relevant, any probative value is
substantially outweighed by the danger of causing unfair prejudice to Ethicon or
confusion of the issues under Fed. R. Evid. 403.
As to the TVM Group email chain, without additional evidence, the Court is
unable to determine whether it is admissible. Accordingly, the Court OVERRULES
this motion without prejudice to renewal at trial. Until the Court hears more
evidence, neither party may refer to this email chain in either vo/r dire or opening
statement. If counsel for Plaintiff wishes to introduce evidence concerning this
subject, this motion can be argued to the Court outside of the presence of the jury
based on evidence that has been introduced thus far in the case.
Defendants also move to exclude Plaintiff's counsel or her witnesses from
referring to the confidential status of documents produced in discovery and
Ethicon documents not disseminated publicly as “secret” or “confidential”
company documents. In response, Plaintiff's counsel states that he “does not
intend to comment on the confidential designations of Ethicon’s internal
documents” and will, instead, refer to these documents as “Ethicon internal
documents.” He will also argue that the information contained in these internal
company documents was not shared with physicians. Based on this
representation, Defendants’ Motion concerning Plaintiff or her witnesses
commenting on the confidential or secretive nature of Ethicon’s documents is
OVERRULED as moot.

30

H. Motion in Limine No. 8: to Exclude Other Lawsuits, Claims, and
Investigations (Doc. #108)
In Defendants Motion No. 8, they move to exclude evidence of other
lawsuits and claims relating to pelvic mesh products manufactured by Ethicon, as
well as unrelated governmental or other investigations involving other Johnson &
Johnson companies. They argue that such evidence is “irrelevant and unfairly
prejudicial, amounts to improper ‘bad acts’ evidence, and constitutes inadmissible
hearsay.” They cite to two MDL cases, Lewis v. Ethicon, Inc., 2:12-cv-4301, 2014
WL 505234, at *6 (S.D. W. Va. Feb. 5, 2014) and Bellew v. Ethicon, Inc., 2014 WL
6680356, at *2 (S.D. W. Va. Nov. 25, 2014), as well as several other cases, and
argue that evidence of other lawsuits and claims are inadmissible, given that
Plaintiff's case is not “substantially similar” to other mesh cases. Croskey v. BMW
of North Am., Inc., 532 F.3d 511, 518 (6th Cir. 2008) (other accidents must have
occurred under “substantially similar circumstances or share the same cause” to
be admitted into evidence). They assert that such testimony is also irrelevant
under Fed. R. Evid. 401 and that, even if relevant, the probative value under Rule
403 is outweighed by confusion of the issues and would result in a waste of the
jury’s time since it would create a “mini-trial” of the other cases. Defendants also
argue that testimony of other pelvic mesh lawsuits or claims is inadmissible
hearsay. As for unrelated investigations, Defendants move to exclude evidence of
fines, consent decrees, recalls and misdemeanor guilty pleas as irrelevant and

31

unfairly prejudicial pursuant to Fed. R. Evid. 401 and 403, and also pursuant to
404(b)(1), since it constitutes inadmissible character evidence.
In response, Plaintiff argues that this evidence is admissible because
Ethicon “imitated other pelvic mesh products to create Prolift and TVT” and that
all cases share the “common characteristic of monofilament polypropylene
material,” an issue that Defendants dispute. She further contends that such cases
constitute “notice” to Defendants of problems and that evidence of lawsuits and
claims are needed so Plaintiff can “impeach and rebut” Defendants “averments
that vaginal mesh is safe and has been in use for years without any significant
problems” or that Plaintiff's physical problems are “unique.” Finally, Plaintiff
requests that the Court wait until trial before ruling on this Motion.
Because at this early stage in the proceedings the Court is unable to
determine whether evidence of other lawsuits, claims, and investigations of other
Johnson & Johnson companies should be excluded, the Court OVERRULES this
motion without prejudice to renewal at trial. Until the Court hears more evidence,
neither party may refer to this subject in either vo/r dire or opening statement. If
counsel for Plaintiff wishes to introduce evidence concerning this subject, this
motion can be argued to the Court outside of the presence of the jury based on
evidence that has been introduced thus far in the case.

Je

I. Defendants’ Motion jn Limine No. 9: to Exclude Material Safety Data
Sheets (Doc. #109)
Defendants move to exclude any attempt by Plaintiff to introduce or refer to
the following Material Safety Data Sheets (“MSDS”): (1) the Chevron-Phillips
MSDS for Marlex® Polypropylene Mesh (1/28/2014): (2) the Sunoco MSDS for
C4001 Polypropylene Homopolymer (4/13/2005); and (3) the Braskem MSDS. They
argue the following: (1) all the MSDSs should be excluded as irrelevant under Fed.
R. Evid. 401, since they concern raw polypropylene and are intended only for
workplace use and not finished products regulated by the FDA; (2) even if not
excluded because they are intended only for workplace use, the MSDSs for
Chevron-Philips and Braskem must be excluded, since Ethicon does not use their
polypropolene; and (3) the Sunoco MSDS should be excluded since it warns of
cancer, a condition that Plaintiff is not alleging as an injury. Defendants also argue
that, even if relevant, any probative value that might exist in these documents is
outweighed by the danger of unfair prejudice and misleading the jury, making
them excludable under Fed. R. Evid. R. 403. Finally, Defendants argue that the
documents are hearsay.
At oral argument, Plaintiff conceded that because Sunoco was the only
supplier to Ethicon it is the only MSDS at issue. She argues, however, that it is
admissible because its MSDS warns users that polypropylene is incompatible
with “strong oxidizers,” Doc. #109-2, PagelD#18474, and that “[A]s Plaintiff's
expert Dr. Rosenzweig notes, the vagina is a ready source of oxidizing agents. The

33

application of those oxidizing agents to Ethicon’s polypropylene mesh contributes
to causing the mesh to degrade /n vivo, which causes pain and the need for
revision surgery.” Doc. #155, PagelD#29952.
Although the Court OVERRULES as moot Defendants’ Motion No. 9
concerning the Chevron-Phillips MSDS for Marlex® Polypropylene Mesh
(1/28/2014) and the Braskem MSDS, since only the Sunoco polypropolene was
used by Defendants in the manufacture of the Prolift, the Court will not exclude
the Sunoco MSDS in its entirety. /n re Davol, 2:18-cv-01509, Case No. 2:18-md-
2846, 2020 WL 6603657 at *4, Oct. 20, 2020 (Sargus, J) (admitting MSDS for
Chevron-Phillips Marlex Polypropolene, with limiting instruction in polypropylene
hernia mesh products finding that “[T]he allegedly dangerous characteristics of a
component of a device are certainly relevant to the question of whether a finished
device has dangerous characteristics.”). The Court SUSTAINS Defendants’ Motion
to exclude the Sunoco MSDS, excepting the portion on “Section 10, Stability and
Reactivity, Incompatibility,” Doc. #109-2, PagelD#18474, warning that
polypropylene is incompatible with “strong oxidizers” Doc. #109-2, PagelD#18474.
As to this issue, until the Court hears more evidence, presumably from Plaintiff's
expert witness, Dr. Rosenzweig, neither party may refer to this subject in either
voir dire or opening statement. If counsel for Plaintiff wishes to introduce
evidence concerning this portion of the Sunoco MSDS and her expert witness,
counsel for Plaintiff and Defendants can argue this motion further to the Court

34

outside of the presence of the jury, including objections based on hearsay and the
danger of unfair prejudice and confusion of the issues under Fed. R. Evid 403.

J. Defendants’ Motion in Limine No. 10: to Preclude Plaintiff's
Experts from Acting as Conduits for Corporate Information and Improper
Opinions (Doc. #110)
In this Motion, Defendants move to exclude Plaintiff's expert witnesses
from “reading corporate documents” to the jury and, then, interpreting what the
documents mean and inferring the author's state of mind or intent. They contend
that this is a “narrative summary” and an “abuse of Fed. R. Evid. 703,” since it
permits Plaintiff's experts to “invade the province of the jury” instead of letting
the documents speak for themselves. Doc. #110, PagelD#18506. In support,
Defendants cite to Judge Goodwin's order concerning one of Plaintiff's expert
witness, Dr. Daniel Elliott.
[Mlany of the motions seek to prohibit an expert from parroting facts
found in corporate documents and the like. | caution the parties
against introducing corporate evidence through expert witnesses.
Although an expert may testify about his review of internal corporate
documents solely for the purpose of explaining the basis for his or
her expert opinions - assuming the expert opinions are otherwise
admissible-he or she may not offer testimony that is solely a conduit
for corporate information.
In re Ethicon Inc. Pelvic Repair Sys. Prod. Liab. Litig., 2018 U.S. Dist. LEXIS
130869, *15 (S.D.W. Va. Aug. 1, 2018)
Plaintiff has indicated that she will abide by Judge Goodwin’s order.
Accordingly, Defendants’ Motion No. 110 is OVERRULED as moot. If at trial
counsel believes that an expert witness is acting as a “conduit for corporate
35

information” and simply reading company documents to the jury, an objection
can be made at that time.

K. Defendants’ Motion /n Limine No. 11: to Preclude the Use of Video
Deposition Testimony or other Videos during Opening Statement (Doc.
#111)
Defendants move to prevent Plaintiff from showing any video deposition or
other videos during opening statements. Plaintiff states that he does not intend to
play any video clips at that time. Defendants’ Motion No. 11 is OVERRULED as
moot.

L. Defendants’ Motion jn Limine No. 12: to Exclude Surgical Videos and
Photographs (Doc. #112)
Defendants’ Motion No. 12 moves to exclude Plaintiff from offering into
evidence surgical training videos depicting a Prolift implantation surgery. They
contend that it is a video designed for surgeons, not lay people, contains graphic
images and will not assist the jury in finding that the Prolift is a dangerous device.
Accordingly, they assert that it has “no tendency to make any fact of consequence
in this case more probable” and should be excluded pursuant to Fed. R. Evid. 401.
Additionally, they argue that its “marginal probative value” is “substantially
outweighed by the significant danger of unfair prejudice to Ethicon,” requiring
exclusion under Fed. R. Evid. 403. Defendants propose that animations can be
used to explain the process to the jury and further argue that, if the Court is
inclined to permit these surgical training videos, it should first view them. Plaintiff

36

responds to this Motion by stating that she intends to use only “direct relevant
video depictions of the exact procedure performed on Plaintiff that have been
produced by Ethicon and performed by Ethicon key opinion leaders.” She asserts
that this will assist the jury in understanding the evidence and that the Court can
give a “warning” to the jury prior to showing them. Animations, she contends,
“falsely depict” portions of the surgery since it shows the mesh arms “coming
through the cannulas and lying flat in perfect position, contrary to live surgery.”
The result, Plaintiff argues, is misleading to the jury. Finally, she states that she
would be “judicious” in her use of videos and argues that the videos are
necessary to counter Defendants’ defense that the Prolift surgery “was an easy,
low risk non -invasive procedure” and/or that other procedures were more
invasive.
Because of the Court's concern with the unfairly prejudicial effect of these
surgical training videos on the jury, the Court will need to view the video prior to
it being shown to the jury or before any testimony concerning it and defers ruling
on this Motion at this time. Accordingly, this motion is OVERRULED, without
prejudice to renewal at trial. Until the Court is able to view the surgical video(s) to
determine their admissibility, counsel for Defendants and Plaintiff are not
permitted to characterize the Prolift surgery as an “easy, low risk non-invasive
procedure” or that itis a “difficult, risky or invasive procedure.”

37

M. Defendants’ Motion jn Limine No. 13: to Exclude Evidence of
Plaintiff's Allegations of Spoliation (Doc. #113)
Defendants move to exclude testimony from Plaintiff that Defendants
engaged in spoiliation of evidence. In particular, they contend that Plaintiff will
use Ethicon’s corporate representative, “Mr. Mittenthal,” who was retained to
testify about Ethicon’s document retention policies and to investigate plaintiffs’
allegations of spoilation, to insinuate that relevant documents are missing. They
contend that these arguments are irrelevant under Fed. R. Evid. 401 and should
also be excluded under Fed. R. Evid. 403, since the probative value is substantially
outweighed by unfair prejudice, unfair prejudice, confusion of the issues and/or
misleading the jury. Finally, it states that the MDL Court has rejected motions for
litigation sanctions, /n re Ethicon, Ine. Pelvic Repair Sys. Prod. Liab. Litig., 299
F.R.D. 502, 507 (S.W. W. Va. 2014), and that over 60 federal courts have also
considered and rejected this issue. Doc. #113, PagelD#18545. Plaintiff states that,
consistent with several MDL Court's rulings, she does not intend to argue to the
jury that Ethicon “spoiiated evidence,” but that “it may indeed be relevant for the
jury to know that there are relevant documents that are unaccounted for.” She
requests that the Court defer ruling on this issue until trial.
Because Plaintiff does not intend to argue spoiliation but, instead, will state
that “there are relevant documents that are unaccounted for,” the Court
OVERRULES as moot Defendants’ Motion No. 13, without prejudice to renewal at
trial.

38

N. Defendants’ Motion én Limine No. 14: to Preclude Improper Arguments by
Plaintiff's Counsel (Doc. #126)
Defendants have filed a motion to prevent Plaintiffs counsel from making
improper arguments that are “unfairly prejudicial” and that have “no purpose
other than to inflame the passions and prejudices of the jury.” They assert that
“these tactics are a part of the Schlesinger firm’s ‘closing argument template.’”
They include with their Motion nine different trial transcripts in support. Plaintiff
filed no response, but has argued that whether an argument is improper depends
on the context. Because there is no evidence at this time that Plaintiff will make
an “unfairly prejudicial” closing argument with no purpose but to “inflame the
passions and prejudices of the jury,” the Court OVERRULES Defendants Motion
No. 14.

VI. Conclusion
Accordingly, for the reasons stated above, Plaintiff's Omnibus Motion jn
Limine, Doc. #127, are SUSTAINED in part and OVERRULED in part. Defendants’
Motions /n Limine, Doc. ##101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111,
112, 113 and 126, are SUSTAINED in part and OVERRULED in part.

Date: September 29, 2021 LAr wy wo
WALTER H. RICE
UNITED STATES DISTRICT JUDGE

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10378899. Public record. Not legal advice.