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 Motions in Limine
[ECF Nos. 90, 94] and the defendants' Motion in Limine
[ECF No. 92].
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. 94]
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. Pl.'s Mem. Supp. Mot. Lim. 1-4
[ECF No. 95].
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. 94] as to Motion in Limine No. 1 and in any instance
where the defendants conceded to the plaintiff's Motion.
The remainder of the plaintiff's Motion in Limine [ECF
No. 94] 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. 92]
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 and would
require presentation of evidence on a collateral issue.
Defs.' Mem. Supp. Mot. Lim. 3-6 [ECF No. 93]. The
plaintiff does not contest this Motion. Pl.'s Mem.
Response to Mot. Lim. 4 [ECF No. 102]. 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. 92] on this point and in any
instance where the plaintiff conceded to the defendants'
Motion; the remainder of the Motion is DENIED without
remaining Motion in Limine [ECF No. 90] does not comport with
PTO 234's requirement to focus 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” and are
more appropriately handled by the trial court judge following
remand or transfer at or before trial. PTO 234 at 5.
Accordingly, the plaintiffs Motion in Limine Regarding IVS
Tunneler [ECF No. 90] is GRANTED insofar as the defendants
conceded to the plaintiffs Motion and is otherwise DENIED
court DIRECTS the Clerk to send a copy of this Order to
counsel of ...