United States District Court, S.D. West Virginia, Charleston Division
MEMORANDUM OPINION AND ORDER (Motions in
R. GOODWIN, UNITED STATES DISTRICT JUDGE
before the court are the plaintiff's Motion in Limine
[ECF No. 92], the defendants' Motions in Limine [ECF Nos.
93, 95], and the defendants' Motion for Leave to File a
Reply [ECF No. 101].
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
58, 000 cases currently pending, approximately 28, 000 of
which are in this MDL, which involves defendants Johnson
& Johnson and Ethicon, Inc. (collectively
“Ethicon”), among others.
MDL, the court's tasks include “resolv[ing]
pretrial issues in a timely and expeditious manner” and
“resolv[ing] important evidentiary disputes.”
Barbara J. Rothstein & Catherine R. Borden, Fed. Judicial
Ctr., Managing Multidistrict Litigation in
Products Liability Cases 3 (2011). The court seeks the
assistance of the parties in completing these tasks by asking
the parties to focus on discrete, important, or more relevant
matters. Here, the court expected the parties to focus their
motions in limine on “highly prejudicial statements in
opening or closing statements or questions at trial that,
once heard by the jury, cannot be easily cured by an
instruction to disregard.” Pretrial Order No. 234, at 5
[2:12-md-2327 ECF No. 2314] (“PTO 234”). The
court further cautioned that it would “not provide
advisory opinions on the admissibility of evidence a party
may offer at trial and [would] summarily deny those motions
as premature.” Id.
The Plaintiff's Motion to Preclude Evidence Relating to
the FDA (Motion in Limine No. 1) [ECF No. 92]
plaintiff asks the court to exclude evidence related to the
FDA, including the FDA's 510(k) process, arguing it is
impermissibly irrelevant and prejudicial under Federal Rules
of Evidence 402 and 403.
short, the 510(k) process “does not in any way denote
official approval of [a] device.” 21 C.F.R. §
807.97. The process is not focused on whether a device is
safe; it is concerned with the device's equivalence to
another device. Medtronic, Inc. v. Lohr, 518 U.S.
470, 493 (1996). Because the process does not speak to the
safety or efficacy of any product, whether Ethicon products
were approved through this process is irrelevant. Even if the
510(k) process were relevant, the court would exclude this
evidence under Rule 403. Any kernel of relevance is
outweighed by “the very substantial dangers of
misleading the jury and confusing the issues.” In
re C. R. Bard, 810 F.3d 913, 922 (4th Cir. 2016)
(affirming the court's exclusion of 510(k) evidence).
simply, evidence of this sort is inadmissible and, in any
event, does not survive a Rule 403 analysis. The court will
not belabor the point here as it has already done so on
several occasions. E.g., Lewis v. Johnson &
Johnson, 991 F.Supp.2d 748, 754-56 (S.D. W.Va. 2014).
The court GRANTS in part the plaintiff's
Motion in Limine [ECF No. 92] as to Motion in Limine No. 1
and in any other instance where the defendants conceded to
the plaintiff's Motion. The remainder of the
plaintiff's Motion in Limine [ECF No. 92] is
DENIED without prejudice.
The Defendants' Motion to Exclude the January 2012
“522” Letters and Subsequent FDA
Actions (Motion in Limine No. 2) [ECF No. 93]
defendants ask the court to exclude evidence of the January
2012 “522” letters and subsequent FDA actions
that would have applied to Ethicon devices if they had not
been discontinued, arguing it is prejudicial under Federal
Rules of Evidence 403 and would require presentation of
evidence on a collateral issue. Mem. Supp. Mot. Lim. 3-6 [ECF
No. 94]. The plaintiff does not contest this Motion. Resp. 4
[ECF No. 98]. Indeed, the court has excluded this same
evidence on prior occasions. See, e.g., Be
lew v. Ethicon, Inc., No.
2:13-cv-22473, 2014 WL 6680356, at *1 (S.D. W.Va. Nov. 25,
2014). The court GRANTS in part the
defendants' Motion in Limine [ECF No. 93] on this point
and in any instance where the plaintiff concedes to the
defendants' Motion; the remainder of the Motion is
DENIED without prejudice.
The Defendants' Motion to Exclude Evidence of
Plaintiff's Allegations of Spoliation [ECF No.
defendants have separately filed a motion in limine to
exclude evidence related to spoliation. [ECF No. 95]. The
plaintiff have repeatedly alleged that the defendants lost or
destroyed documents relevant to this multidistrict
litigation. On February 4, 2014, Magistrate Judge Eifert held
that the defendants' 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.
Pretrial Order No. 100, Feb. 4, 2014 [ECF No. 1069]. However,
Judge Eifert recommended that I allow the plaintiffs
“the opportunity to introduce evidence regarding [the
defendants'] 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 the defendants' duty to preserve
evidence began earlier than previously thought. See
Pls.' Request for Clarification and Reconsideration
[2:12-md-2327 ECF No. 1099].
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 plaintiff has offered no
evidence or argument that evidence of spoliation will be
relevant in this ...