Freitas et al v. Johnson & Johnson et al

Filing 109

AMENDED MEMORANDUM OPINION AND ORDER (Motions in Limine) The court's 108 Memorandum Opinion and Order entered on 2/02/2017 is amended to GRANT the 88 MOTION by Ethicon, Inc., Johnson & Johnson in Limine to Exclude Evidence of Plaintiffs' Allegations of Spoliation, as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 2/3/2017. (cc: counsel of record; any unrepresented party) (ts)

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

CIVIL ACTION NO. 2:12-cv-1146

ETHICON, INC., et al.,
Defendants.
AMENDED MEMORANDUM OPINION AND ORDER
(Motions in Limine)
The court’s Memorandum Opinion and Order [ECF No. 108] entered February
2, 2017, is hereby amended to correct the disposition of the Motion in Limine [ECF
No. 88] in the conclusion paragraph.
Pending before the court are the plaintiffs’ Motions in Limine [ECF No. 90, 91],
the defendants’ Motions in Limine [ECF Nos. 86, 88], and the defendants’ Motion for
Leave to File a Reply [ECF No. 96].
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. 90]
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.’ Mot. Lim. 1–4 [ECF No. 90].
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

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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).
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. 90] as to Motion in Limine No. 1 and in any other instance where the
defendants conceded to the plaintiffs’ Motion. The remainder of the plaintiffs’ Motion
in Limine [ECF No. 90] is DENIED without prejudice.
b. The Defendants’ Motion to Exclude the January 2012 “522” Letters and
Subsequent FDA Actions (Motion in Limine No. 2) [ECF No. 86]
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 under Federal Rules of
Evidence 403 and would require presentation of evidence on a collateral issue. Mem.
Supp. Mot. Lim. 3–6 [ECF No. 87]. The plaintiffs do not contest this Motion. Resp. 4
[ECF No. 95]. 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 *1 (S.D. W.
Va. Nov. 25, 2014). The court GRANTS in part the defendants’ Motion in Limine [ECF

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No. 86] on this point and in any instance where the plaintiffs concede to the
defendants’ Motion; the remainder of the Motion is DENIED without prejudice.
c. The Defendants’ Motion to Exclude Evidence of Plaintiffs’ Allegations of
Spoliation [ECF No. 88]
The defendants have separately filed a motion in limine to exclude evidence
related to spoliation. [ECF No. 88]. 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 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 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].
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

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evidence of spoliation will be relevant in this case. Therefore, the defendants’ Motion
in Limine [ECF No. 88] on the issue of spoliation is GRANTED.
Accordingly, the defendants’ Motion for Leave to File a Reply [ECF No. 96] is
DENIED as moot.
d. Remaining Motions
The remaining Motion in Limine [ECF No. 91] 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 is more appropriately handled by the trial court
judge following remand or transfer at or before trial. PTO 234 at 5. Accordingly, the
Motion in Limine [ECF No. 91] is GRANTED insofar as it is are conceded and is
otherwise DENIED without prejudice.
e. Conclusion
The plaintiffs’ Motion in Limine [ECF No. 90] is GRANTED in part as to
Motion in Limine No. 1 and any other conceded motion therein; the remainder of the
Motion is DENIED without prejudice. The defendants’ Motion in Limine [ECF No.
86] is GRANTED in part as to Motion in Limine No. 2 and any other conceded motion
therein; the remainder of the Motion is DENIED without prejudice. The defendants’
Motion to Exclude Evidence of Plaintiffs’ Allegations of Spoliation [ECF No. 88] is
GRANTED. The defendants’ Motion for Leave to File a Reply [ECF No. 96] is
DENIED. The Motion in Limine [ECF No. 91] is GRANTED insofar as it is conceded
and is otherwise DENIED without prejudice.

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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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February 3, 2017