McBrayer et al v. Johnson & Johnson et al

Filing 184

MEMORANDUM OPINION AND ORDER (Motions in Limine) The 126 OMNIBUS MOTION by Ethicon, Inc., Johnson & Johnson in Limine is GRANTED in part as to Exclude the January 2012 "522" Letters and Subsequent FDA Actions and DENIED without prejud ice as to the remainder of the Motion. The 132 MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 18 Precluding Improper Arguments or Evidence of Dee McBrayer's Unrelated Medical Conditions and Unrelated Family Medical History, 134 MOTI ON by Dee McBrayer, Timothy McBrayer in Limine No. 19 to Preclude Defendants From Defending Based on a Long History of Use of Polypropylene in the Human Body, 136 MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 20 Precluding Defendants From Improperly Arguing or Introducing Evidence Regarding Plaintiff Dee McBrayer's Pre-Existing Medical Conditions, 138 MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 21 Precluding Improper Arguments or Evidence Regarding the Risks of Alter nate Procedures Which Plaintiff Did Not Undergo, 140 MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 22 Precluding Arguments or Evidence From Defendants From Telling the Jury About Symptoms of Prolapse, 142 MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 23 to Exclude Reference to Dee McBrayer's Difficult Childbirth, 146 MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 26 Establishing the Admissibility of Ethicon's Decision to Discontinue the Sale and Marketin g of the Prolift, 148 OMNIBUS MOTIONS by Dee McBrayer, Timothy McBrayer in Limine Nos. 27-30 to Preclude Improper Liability Defenses, and 150 OMNIBUS MOTIONS by Dee McBrayer, Timothy McBrayer in Limine Nos. 31-32 to Preclude Introduction of or Arguments Regarding This Court's Prior Judicial Opinions Regarding Plaintiffs' Experts and Treatment Plaintiff Did Not Undergo are GRANTED insofar as the defendants conceded and are otherwise DENIED without prejudice. Signed by Judge Joseph R. Goodwin on 12/22/2016. (cc: counsel of record; any unrepresented party) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
DEE MCBRAYER, et al.,
Plaintiffs,
v.

CIVIL ACTION NO. 2:12-cv-779

ETHICON, INC., et al.,
Defendants.
MEMORANDUM OPINION AND ORDER
(Motions in Limine)
Pending before the court are the plaintiffs’ Motions in Limine [ECF Nos. 130,
132, 134, 136, 138, 140, 142, 144, 146, 148, 150] and the defendants’ Motion in Limine
[ECF No. 126].
This 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.
In this 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.
a. The Plaintiffs’ Motion to Preclude Evidence Relating to the FDA (Motion in
Limine No. 1) [ECF No. 130] & Motion in Limine Limiting FDA Related
Evidence [ECF No. 144]
The plaintiffs ask 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. Pls.’ Mem. Supp. Mot. Lim. 1–4 [ECF No.
131].
In 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
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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).
Put 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 plaintiffs’ Motion in Limine
[ECF No. 130] as to Motion in Limine No. 1 and in any instance where the defendants
conceded to the plaintiffs’ Motion. The remainder of the plaintiffs’ Motion in Limine
[ECF No. 130] is DENIED without prejudice.
The plaintiffs’ Motion in Limine Limiting FDA Related Evidence [ECF No. 144]
is DENIED as moot and duplicative. See supra part (a); Mem. Op. & Order, Aug. 25,
2016, 6–8 [ECF No. 174].
b. The Defendants’ Motion to Exclude the January 2012 “522” Letters and
Subsequent FDA Actions (Motion in Limine No. 2) [ECF No. 126]
The 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. 3–5 [ECF
No. 127]. The plaintiffs do not contest this Motion. Pl.’s Mem. Response Defs.’ Mot.
Lim. 3–4 [ECF No. 168]. Indeed, the court has excluded this same evidence on prior
occasions. See, e.g., Bellew v. Ethicon, Inc., No. 2:13-cv-22473, 2014 WL 6680356, at
3

*1 (S.D. W. Va. Nov. 25, 2014). The court GRANTS in part the defendants’ Motion in
Limine [ECF No. 126] on this point and in any instance where the plaintiffs conceded
to the defendants’ Motion; the remainder of the Motion is DENIED without prejudice.
c. Remaining Motions
The remaining Motions do 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 following are GRANTED insofar as the defendants conceded
and are otherwise DENIED without prejudice:
ECF Motion
No.
132

MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 18 Precluding

134

MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 19 to Preclude

136

MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 20 Precluding

Improper Arguments or Evidence of Dee McBrayer's Unrelated Medical
Conditions and Unrelated Family Medical History

Defendants From Defending Based on a Long History of Use of Polypropylene
in the Human Body

Defendants From Improperly Arguing or Introducing Evidence Regarding
Plaintiff Dee McBrayer's Pre-Existing Medical Conditions

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138

MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 21 Precluding

140

MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 22 Precluding

142

MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 23 to Exclude

146

MOTION by Dee McBrayer, Timothy McBrayer in Limine No. 26

148

OMNIBUS MOTIONS by Dee McBrayer, Timothy McBrayer in Limine Nos.

150

OMNIBUS MOTIONS by Dee McBrayer, Timothy McBrayer in Limine Nos.

Improper Arguments or Evidence Regarding the Risks of Alternate
Procedures Which Plaintiff Did Not Undergo

Arguments or Evidence From Defendants From Telling the Jury About
Symptoms of Prolapse

Reference to Dee McBrayer’s Difficult Childbirth

Establishing the Admissibility of Ethicon's Decision to Discontinue the Sale
and Marketing of the Prolift

27-30 to Preclude Improper Liability Defenses

31-32 to Preclude Introduction of or Arguments Regarding This Court's Prior
Judicial Opinions Regarding Plaintiffs' Experts and Treatment Plaintiff Did
Not Undergo
The court DIRECTS the Clerk to send a copy of this Order to counsel of record

and any unrepresented party.
ENTER:

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December 22, 2016