Loustaunau v. Ethicon, Inc., 2:17-cv-07596

This is a Southern District of West Virginia MDL matter involving transvaginal mesh devices for POP/SUI, with Ethicon, Johnson & Johnson among defendants.
Plaintiffs in this MDL seek to exclude certain evidence via Motions in Limine; defendants also move in limine and seek permission to file a reply.
Court directs focus on discrete, highly prejudicial or easily curable evidentiary issues as per PTO 234 in MDL practice.
Key contested issues concern FDA-related evidence and the regulatory status of the devices, spoliation allegations, and related evidentiary impacts.
Judge issues rulings: partial grant/denial of plaintiffs’ and defendants’ motions in limine; spoliation motion granted; motion for leave to file a reply denied as moot.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of FDA/510(k) evidence	Loustauanu argues 510(k) relevance and prejudice warrant exclusion.	Ethicon contends 510(k) evidence is probative or at least not highly prejudicial.	GRANTED in part for 510(k) exclusion; remaining aspects denied without prejudice.
Exclusion of January 2012 522 letters and FDA actions	Not applicable; plaintiffs concede this point.	Evidence should be excluded as prejudicial collateral issues.	GRANTED in part; remaining aspects denied without prejudice.
Admissibility of evidence of spoliation	Defendants lost/destroyed relevant documents; adverse inference warranted in some cases.	No willful spoliation; evidence should be limited or excluded at partial level.	GRANTED; spoliation evidence excluded at this stage.
Leave to file a reply			DENIED as moot

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) relevance does not denote device safety; not dispositive)
In re C. R. Bard, Inc., 810 F.3d 913 (4th Cir. 2016) (510(k) evidence can be excluded to avoid confusion and prejudice)
Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748 (S.D. W. Va. 2014) (repeated rulings on exclusion of 510(k) evidence)