Shively v. Johnson & Johnson
2:12-cv-00379
S.D.W. VaMar 6, 2017Background
- This multidistrict litigation concerns transvaginal surgical mesh used for POP and SUI; this MDL (No. 2:12-md-2327) includes Ethicon among defendants and thousands of cases.
- The court required motions in limine to focus on highly prejudicial trial statements or questions that could not be cured by instructions (PTO 234).
- Plaintiffs sought to exclude evidence about the FDA and its 510(k) clearance process as irrelevant and prejudicial.
- Defendants sought to exclude evidence of January 2012 FDA "522" letters and subsequent FDA actions, and separately moved to exclude spoliation-related evidence.
- Magistrate Judge Eifert previously found defendants’ document loss negligent (not willful) and denied extreme sanctions, allowing spoliation evidence and adverse-inference instructions only on a case-by-case basis; no new showing altered that ruling here.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of FDA 510(k) evidence | 510(k) process should be excluded as irrelevant and prejudicial | 510(k) clearance may be probative of regulatory treatment of devices | Court: Exclude such evidence; 510(k) does not indicate safety/efficacy and is prejudicial under Rule 403 (GRANTED in part) |
| Admissibility of Jan 2012 FDA 522 letters / subsequent FDA actions | Plaintiffs did not oppose excluding this evidence | Defendants: 522 letters and subsequent actions would be prejudicial and collateral | Court: Exclude this evidence (GRANTED in part) |
| Evidence of spoliation (lost/destroyed documents) | Plaintiffs sought to present spoliation allegations and potentially adverse inference | Defendants sought to exclude spoliation evidence given prior rulings | Court: Exclude spoliation evidence here; Magistrate Judge’s prior order stands and plaintiffs offered no case-specific proof (GRANTED) |
| Numerous other motions in limine | Plaintiffs sought many rulings but some were duplicative or beyond PTO 234 scope | Defendants sought exclusion on various grounds; many motions conceded or premature | Court: Motions that were conceded were granted; other motions denied without prejudice as premature or denied as moot if duplicative |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) clearance concerns equivalence, not safety or efficacy)
- In re C. R. Bard, 810 F.3d 913 (4th Cir. 2016) (affirming exclusion of 510(k)-related evidence under Rule 403)
- Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748 (S.D. W. Va. 2014) (prior local ruling excluding similar FDA 510(k) evidence)