Mullins v. Ethicon, Inc.
147 F. Supp. 3d 478
S.D.W. Va2015Background
- Consolidated action of 37 West Virginia plaintiffs implanted with Ethicon’s TVT mesh for stress urinary incontinence; cases limited to design-defect claims (strict liability and negligent design).
- Defendants (Ethicon/Johnson & Johnson) moved for summary judgment arguing state-law design-defect claims are impliedly preempted by federal law via impossibility/conflict preemption tied to the FDA 510(k) clearance process.
- Defendants’ theory: complying with a state-law design duty would force product changes requiring FDA 510(k) clearance (i.e., federal permission), so it is impossible to comply with both regimes.
- Plaintiffs relied on Supreme Court precedent (notably Medtronic v. Lohr) arguing the 510(k) process focuses on substantial equivalence, not safety, and does not preempt state-law design claims.
- The court framed the issue as whether impossibility preemption (implied conflict preemption) alters the Lohr result and concluded it does not.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law design-defect claims are preempted by federal law (impossibility/conflict preemption) | State-law duty to make products reasonably safe does not conflict with 510(k); Lohr shows Congress did not intend preemption. | 510(k) clearance means design changes require FDA review/permission; defendants cannot independently satisfy state duties without federal permission, so impossibility preemption applies. | Denied — no impossibility preemption; state claims not preempted. |
| Whether Mensing/Bartlett drug-labeling impossibility logic applies to devices | Lohr and the lack of a statutory ban on device changes mean manufacturers can pursue safety improvements; state law complements federal scheme. | Mensing/Bartlett’s ‘‘special permission’’ rationale should control: FDA discretion to deny clearance makes compliance impossible. | Court rejects transplanting Mensing/Bartlett; Mensing’s duty-of-sameness is not analogous. |
| Whether the 510(k) process frustrates congressional purpose by allowing state tort claims | Congress intended 510(k) to preserve market status quo and rapid improvements; not to preempt state tort law. | 510(k) discretion to refuse changes means state duties would interfere with federal regulatory authority. | Court finds congressional purpose disfavors preemption; 510(k) focuses on equivalence, not safety. |
| Whether the presumption against preemption is overcome | State police powers over health/safety weigh against preemption; defendants did not show clear and manifest congressional intent to preempt. | Federal regulatory scheme should displace conflicting state duties when FDA discretion is implicated. | Presumption against preemption stands; defendants failed the demanding impossibility standard. |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) clearance focuses on substantial equivalence, does not preempt state-law design-defect claims)
- Wyeth v. Levine, 555 U.S. 555 (2009) (impossibility preemption is demanding; manufacturer may avoid preemption if it can unilaterally comply with state duty)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic-drug duty-of-sameness produced impossibility preemption where federal law barred independent label changes)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) (applies Mensing to find preemption for generic drugs; stopping sales does not avoid impossibility in that context)