Edwards et al v. Ethicon, Inc. et al
Filing
180
AMENDED MEMORANDUM OPINION AND ORDER (Motions in Limine) for the reasons set forth herein, denying 142 MOTIONS by Gary Edwards, Tonya Edwards in Limine; denying in part and granting in part 147 OMNIBUS MOTION by Ethicon, Inc., Johnson & Johnson in Limine; granting 141 MOTION by Ethicon, Inc., Johnson & Johnson in Limine to Exclude Evidence of Plaintiffs' Allegations of Spoliation. Signed by Judge Joseph R. Goodwin on 8/7/2014. (cc: attys; any unrepresented party) (skh)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
TONYA EDWARDS, et al.,
Plaintiffs,
v.
CIVIL ACTION NO. 2:12-CV-09972
ETHICON, INC., et al.,
Defendants.
AMENDED MEMORANDUM OPINION AND ORDER
(Motions in Limine)
Pending before the court are the Plaintiffs’ Motions in Limine [Docket 142], the
Defendants’ Omnibus Motion in Limine [Docket 147], and the Defendants’ Motion in Limine to
Exclude Evidence of Plaintiffs’ Allegations of Spoliation [Docket 141]. In accordance with this
opinion, the Plaintiffs’ Motions in Limine [Docket 142] are DENIED, the Defendants’ Omnibus
Motion in Limine [Docket 147] is DENIED in part and GRANTED in part, and the Defendants’
Motion in Limine to Exclude Evidence of Plaintiffs’ Allegations of Spoliation [Docket 141] is
GRANTED.
I.
Background
This case is one of more than 60,000 that have been assigned to me by the Judicial Panel
on Multidistrict Litigation in seven MDLs involving pelvic mesh products. Approximately 20,000
of these cases reside in the In re Ethicon, Inc. MDL, MDL No. 2327. The device at issue in this
case is the Gynecare TVT Obturator (“TVT-O”), manufactured by the defendants, Ethicon, Inc.
and Johnson & Johnson, Inc. (collectively, “Ethicon”). The TVT-O is a medical device that
includes a mechanism used to place a mesh tape, or sling, under the urethra to provide support to
the urethra to treat stress urinary incontinence. Having resolved the parties’ motions for summary
judgment, the following claims remain for trial: negligence, strict liability for design defect, strict
liability for failure to warn, negligent infliction of emotional distress, gross negligence, and
punitive damages. (See Short Form Compl. [Docket 1], at 4-5; see generally Mem. Op. & Order
[Docket 272]).
II.
Motions in Limine
The plaintiffs filed 21 motions in limine and Ethicon filed 19. Many of these motions are
silly. For the vast majority of them, I simply cannot make a substantive ruling at this time without
knowing the particular piece of evidence that a party seeks to introduce or argument that a party
seeks to make. Nor can I make a ruling without knowing the context in which that party seeks to
introduce such evidence or argument. In short, a blanket exclusion of such evidence or argument
is premature at this time. For instance, Ethicon asks that I exclude “all evidence and argument”
related to “off-color” emails that are irrelevant, unfairly prejudicial, and inadmissible hearsay.
(Ethicon’s Mem. in Supp. of Omnibus Mot. in Limine [Docket 148], at 29-30). Ethicon points to
a few emails, but asks me to rule on many that I have not seen. It is probable that some of the
emails are inadmissible, but I need not make a ruling at this stage. The plaintiffs filed several
motions in limine that the defendants do not oppose, but that are devoid of any argument regarding
why the court should exclude the evidence at issue. As a result, it is unnecessary that I rule at this
time. For example, the plaintiffs include a motion in limine asking the court to exclude “[a]ny
reference to or suggestion that Plaintiffs would possibly be able to obtain free medical treatment
and/or other types of assistance from any governmental or charitable organization, based upon
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either age or condition.” (Pls.’ Mots. in Limine [Docket 142], at 16). That is the entirety of the
plaintiffs’ motion.
Many of the pending motions in limine are unopposed. There is no need for me to rule on
such motions. The parties are expected to abide by these concessions.
Where evidence is not admissible pursuant to the Federal Rules of Evidence, it will not be
admitted. Otherwise, it will be admitted. The parties are represented by able counsel, and I trust
they can distinguish the difference. I expect counsel to know the rules of evidence and for only
matters which they believe in good faith to be admissible, I expect objection only where the
opposing part believes in good faith that the evidence is inadmissible. I expect lawyers to make
informed decisions about the proof of their case without asking me elementary questions.
For these reasons, the following motions are DENIED without prejudice: Ethicon’s
Motions in Limine Nos. 1, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 16, 17; and the plaintiffs’ Motions in
Limine Nos. 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 22.1 My denial of these
motions without prejudice is not an invitation for the parties to relitigate these matters at trial. The
parties are cautioned to use their best judgment in offering and objecting to evidence.
Having denied the majority of the motions in limine without prejudice, several remaining
motions in limine nevertheless merit rulings at this time. I discuss those motions below.
-
Plaintiffs’ Motion 1: To Exclude TVT-O Complication Rates
The plaintiffs seek to exclude information regarding the TVT-O’s complication rates. The
plaintiffs argue that Ethicon cannot accurately calculate complication rates because it does not
1
The only addition to this amended order is the inclusion of a denial of the plaintiffs’ motion in limine number 22
without prejudice.
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know the number of TVT-O devices that have been implanted. This is the same argument that the
plaintiffs raised in Lewis v. Ethicon. In that case, I stated:
I will not admit anecdotal evidence of complication rates because that evidence has
little probative value and it is highly misleading. However, evidence of
complication rates may be admitted where it is based on reliable, scientific
statistics, peer-reviewed literature, or where it has been or may be tested. At this
stage, I cannot determine which particular complication rate evidence Ethicon seeks
to introduce.
Lewis v. Ethicon, No. 2:12-cv-4301, 2014 U.S. Dist. LEXIS 14971, at *4-5 (S.D. W. Va. Feb. 5,
2014). The same is true here. Anecdotal evidence regarding complication rates will not be
admitted, but evidence of complications may be admitted where it is based on reliable, scientific
statistics, or where it has been tested. Therefore, the plaintiffs’ motion is DENIED without
prejudice.
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Plaintiffs’ Motion 3: Motion to Exclude Evidence of 510(k) Clearance of the
Ethicon Mesh Products by the United States Food and Drug Administration
(“FDA”), or Lack of FDA Enforcement Action
The plaintiffs seek to exclude any evidence or testimony related to the FDA’s 510(k)
clearance of Ethicon products and/or the FDA’s lack of enforcement action related to these
products. As I held in Lewis:
In sum, the parties may not present evidence regarding the 510(k) clearance process
or subsequent FDA enforcement actions. This is consistent with prior rulings by
this court. See, e.g., Cisson v. C.R. Bard, Inc., No. 2:11-cv-00195, 2013 U.S. Dist.
LEXIS 102699, at *22 (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
reference omitted); Order, Cisson v. C.R. Bard, Inc., No. 2:11-cv-00195, 2013 U.S.
Dist. LEXIS 183718 (S.D. W. Va. July 1, 2013), [Docket 309], at 3-4 ("Under
United States Supreme Court precedent, the FDA 510(k) process does not go to
whether the product is safe and effective . . . . Because the FDA 510(k) process
does not go to whether the [mesh] products are safe and effective and the 510(k)
process does not impose any requirements on its own, the 510(k) process is
inapplicable to this case. This evidence is excluded under Federal Rule of Evidence
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402 as irrelevant, and under Rule 403 for the reasons previously stated, including
the very substantial dangers of misleading the jury and confusing the issues.");
Mem. Op. & Order, Cisson v. C.R. Bard, Inc., No. 2:11-cv-00195, 2013 U.S. Dist.
LEXIS 90210 (S.D. W. Va. June 27, 2013) [Docket 302], at 3-4 (holding that
evidence regarding the 510(k) process and enforcement should be excluded under
Rule 403).
Lewis v. Johnson & Johnson, No. 2:12-cv-04301, 2014 U.S. Dist. LEXIS 4985, at *17-18 (S.D.
W. Va. Jan. 15, 2014). This reasoning is equally applicable here. The plaintiffs’ motion on this
issue is GRANTED.
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Plaintiffs’ Motion 17: To Exclude Any Statement or Opinion Published by Any
Professional Organization Regarding the Safety and/or Efficacy of
Transvaginal Mesh products
The plaintiffs, without any elaboration or discussion of what evidence they are specifically
referring to, seek to exclude all statements or opinions published by professional organizations
regarding the safety of transvaginal mesh products. This evidence may be admissible for several
reasons. First, to the extent that the Position Statement is relied upon by an expert witness, it may
be admissible under the learned treatise exception to the hearsay rule. See Fed. R. Evid. 803(18).
Second, under Rule 703, experts are permitted to rely on otherwise inadmissible information
provided that they “would reasonably rely on those kinds of facts or data in forming an opinion on
the subject.” Fed. R. Evid. 703. Third, Ethicon’s state of mind is relevant to the punitive damages
claim, and “[a]n out-of-court statement that is offered to show its effect on the hearer’s state of
mind is not hearsay under Rule 801(c).” United States v. Thompson, 279 F.3d 1043, 1047 (D.C.
Cir. 2002). Provided that Ethicon properly introduces this evidence, the plaintiffs’ motion on this
issue is DENIED.
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-
Ethicon’s Motion 2: To Exclude Brian Luscombe’s Internal Marketing
Presentation
Ethicon moves to exclude an internal marketing presentation mimicking David
Letterman’s “Top Ten” lists. The presentation is styled as the “Top Ten Reasons to Pursue
Gynecare TVT Obturator Approach.” (Presentation [Docket 147-2]). It then lists ten sarcastic
reasons that surgeons should use the TVT-O, including:
10: For the surgeon who likes to point their needles too far lateral (and hit things
like the external iliac), this gives them something new to go after!!!!
9: Since the needles don’t enter the retropubic space, bladder perforations
SHOULD be reduced
...
7: Small Bowel . . . when things just aren’t in the right place . . . enough said
...
1: MAMA NEEDS A NEW PAIR OF SHOES!!!!
(Id.). Ethicon contends that the presentation was intended as a “sarcastic, lighthearted ‘ice breaker’
for Ethicon’s sales force, rather than a serious presentation.” (Ethicon’s Mem. in Supp. of Omnibus
Mot. in Limine [Docket 148], at 3). According to Ethicon, the employee who created it designed
it as a joke to lighten up training events for sales representatives. (See id.). Ethicon asserts that it
will have to explain this context to the jury, as well as David Letterman’s “Top Ten” list, if this
evidence is admitted. Ethicon therefore contends that the presentation is irrelevant, unfairly
prejudicial, and risks confusing the jury and wasting time during trial.
The plaintiffs argue that the presentation is probative because it demonstrates the potential
benefits that Ethicon claimed the TVT-O provided and because it shows why Ethicon developed
the TVT-O. I disagree. The presentation is a poor attempt at humor. It is not probative to any
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claims in this case. Even if it were probative, I would exclude it under Rule 403 for its risk of
unfair prejudice and its potential to waste time in trial. Accordingly, Ethicon’s motion on this issue
is GRANTED.
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Ethicon’s Motion 10: To Exclude Evidence of PA Consulting Group Report
Ethicon argues that the PA Consulting Group report titled “Investigating Mesh Erosion in
Pelvic Floor Repair” should be excluded as irrelevant. It argues that the report was created to aid
in producing a new mesh product for the treatment of pelvic organ prolapse, not stress urinary
incontinence. It also argues that the erosion rates used in the report are irrelevant and unfairly
prejudicial because they are not specifically related to the TVT-O, but rather to many other
polypropylene mesh products. I denied this same motion in Lewis v. Johnson & Johnson:
Ethicon’s arguments are misleading. While Ethicon argues that the report was
written only to address issues related to pelvic organ prolapse, the report itself states
that Ethicon asked PA Consulting Group “to conduct a broad analysis of the
problem of mesh erosion[.]” . . . The report does not state anywhere that it was
examining erosion only as it relates to pelvic organ prolapse; rather, it discusses
mesh erosion generally, in line with the broad analysis requested by Ethicon.
Although the overall purpose of the report may have been to aid Ethicon in
developing a next-generation device for pelvic organ prolapse, its discussion of
general mesh erosion is relevant to the plaintiffs’ claims. It also contains erosion
rates of mesh, which have probative value.
In re Ethicon, Inc., Pelvic Repair Sys. Prods. Liab. Litig., No. 2:12-cv-4201, 2014 WL 505234, at
*11 (S.D. W. Va. Feb. 5, 2014). This reasoning applies with equal force here. Accordingly,
Ethicon’s motion on this issue is DENIED.
-
Ethicon’s Motion 15: To Exclude Evidence Regarding Alleged Problems with
TVT-O Sheath Removal
Ethicon moves to exclude evidence or argument that physicians have encountered
problems removing the sheath from the TVT-O before implantation. According to one of the
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plaintiffs’ experts, physicians experienced difficulty removing the sheath, which can potentially
cause roping and curling of the mesh. (See Rosenzweig Report [Docket 106-3], at 64-67). Ethicon
argues that this evidence is irrelevant, overly prejudicial, and a waste of time because no witness
will testify that there was a problem with the removal of the sheath attached to Ms. Edwards’s
TVT-O, or that Ms. Edwards sustained any injury as a result of sheath removal. (See Ethicon’s
Mem. in Supp. of Omnibus Mot. in Limine [Docket 148], at 26).
Contrary to Ethicon’s suggestions, this evidence is relevant. As I held in Huskey v. Ethicon,
“the TVT-O’s potential to rope and fray . . . and complications associated with small pore mesh
are” relevant to the plaintiffs’ failure-to-warn claim. Huskey v. Ethicon, Inc., No. 2:12-cv-05201,
2014 WL 3362287, at *5 (S.D. W. Va. July 8, 2014). Thus, hearing this evidence will not be a
waste of time or unfairly prejudicial. Accordingly, this motion is DENIED.
III.
Spoliation
Ethicon has separately filed a motion in limine to exclude evidence related to spoliation
[Docket 141]. The plaintiffs have repeatedly alleged that Ethicon lost or destroyed documents
relevant to this multidistrict litigation. 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 caseby-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
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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.
IV.
Conclusion
For the reasons discussed above, Plaintiffs’ Motions in Limine [Docket 142] are DENIED,
the Defendants’ Omnibus Motion in Limine [Docket 147] is DENIED in part and GRANTED
in part, and the Defendants’ Motion in Limine to Exclude Evidence of Plaintiffs’ Allegations of
Spoliation [Docket 141] is GRANTED.
ENTER: August 7, 2014
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