IN THE UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA 

 

CHARLESTON DIVISION

HOLLY JONES, et al., 

Plaintiffs,

v. CIVIL ACTION NO. 2:12-cv-443

ETHICON, INC., et al., 

Defendants.

MEMORANDUM OPINION AND ORDER 

(Motions in Limine) 

Pending before the court are the plaintiffs’ Motion in Limine [ECF No. 110] 

and the defendants’ Motion in Limine [ECF No. 106].

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 

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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. 110] 

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. Pl.’s Mot. Lim. 1–4 [ECF No. 110].

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 

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).

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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. 105] as to Motion in Limine No. 1 and any other instance where the 

defendants concede to the plaintiff’s Motion. 

b. The Defendants’ Motion to Exclude the January 2012 “522” Letters and 

Subsequent FDA Actions (Motion in Limine No. 2) [ECF No. 106] 

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 irrelevant, prejudicial, and would 

require presentation of evidence on a collateral issue. Defs.’ Mem. Supp. Mot. Lim. 2–

5 [ECF No. 107]. The plaintiffs do not contest this Motion. Pl.’s Responses to Defs.’

Mot. Lim. 3 [ECF No. 113]. 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 the defendants’ Motion in Limine 

[ECF No. 106] on this point and any other instance where the plaintiff concedes to 

the defendants’ Motion.

c. Remaining Motions in ECF Nos. 106, 110 

The remaining individual 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 

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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 plaintiff’s Motion 

in Limine [ECF No. 110] and the defendants’ Motion in Limine [ECF No. 106] are 

GRANTED in part and DENIED without prejudice in part. The plaintiffs’ Motion in 

Limine No. 1, the defendants’ Motion in Limine No. 2, and any conceded individual 

motion are GRANTED. All other Motions in Limine in ECF Nos. 106 and 110 are 

DENIED without prejudice.

The court DIRECTS the Clerk to send a copy of this Order to counsel of record 

and any unrepresented party.

ENTER: December 21, 2016

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