Lewis v. Johnson & Johnson
991 F. Supp. 2d 748
S.D.W. Va2014Background
- MDL involving Ethicon surgical mesh products for pelvic organ prolapse and incontinence; TVT device implanted in plaintiff Lewis; first bellwether trial set for Feb. 2014.
- Motions: (1) 510(k) FDA clearance/enforcement evidence; (2) preemption of certain claims; (3) Texas affirmative defenses (82.007, 82.008).
- TVT is a Class II device cleared via FDA 510(k); 510(k) focuses on equivalence, not safety/efficacy; premarket approval (PMA) is safety-focused.
- Court applies Texas substantive law for tort claims, New Jersey for punitive damages, and Fourth Circuit law for federal questions.
- 510(k) evidence excluded under Rules 402/403 due to risk of misleading jury and irrelevance to state tort claims.
- Plaintiffs’ claims about polypropylene use not preempted because device as a whole underwent 510(k) clearance, not PMA appeal; component-part preemption rejected.
- FDA 510(k) clearance does not denote safety/efficacy; TVT differs from Prolene suture; preemption analysis treats device as a whole.
- Texas Secs. 82.007, 82.008(a), 82.008(c) deemed inapplicable; thus partial summary judgment in plaintiffs’ favor granted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| 510(k) evidence admissibility | Lewis argues 510(k) clearance/review isn’t relevant. | Ethicon argues relevance to safety/efficacy and post-clearance regulation. | 510(k) evidence excluded (irrelevant/misleading). |
| Preemption of polypropylene claims | Claims related to TVT materials not preempted by PMA framework. | Arguments hinge on components vs device; PMA preemption applies to PMA devices. | Use of polypropylene not preempted; device as a whole governs analysis. |
| Texas defenses applicability | 82.007/82.008 defenses should apply to certain claims. | Some defenses may shield liability under Texas law. | Sections 82.007 and 82.008(c) inapplicable; 82.008(a) inapplicable; partial summary judgment for plaintiffs. |
Key Cases Cited
- Lohr v. Medtronic, Inc., 518 U.S. 470 (1996) (510(k) focus on equivalence, not safety; PMA safety focus)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA preemption; PMA creates federal requirements)
- Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012) (PMA preemption scope in Fourth Circuit)
- In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig., 97 F.3d 1050 (8th Cir. 1996) (Choice-of-law governs pretrial motions in MDLs)