40 F.4th 1329
11th Cir.2022Background
- Plaintiff Lalitha Jacob received Mentor MemoryGel breast implants (Class III, FDA PMA-approved) in 2007 and later discovered a rupture; she alleges systemic injury from silicone leakage.
- Jacob sued Mentor pro se raising negligence (including negligent manufacturing and failure to warn), strict liability failure-to-warn, and strict liability manufacturing-defect claims.
- Mentor moved to dismiss under Rule 12(b)(6), arguing both express and implied preemption under the Medical Device Amendments; the district court dismissed failure-to-warn claims as preempted and manufacturing-defect claims for pleading defects (Rules 8 and 10), then granted leave to amend.
- Jacob filed an amended complaint asserting additional counts; the district court dismissed the amended complaint (some with prejudice) on preemption and other grounds; Jacob appealed.
- The Eleventh Circuit reviewed de novo, construed Jacob’s pro se filings liberally, held she did not waive challenge to the original manufacturing-defect claims, and concluded those claims were plausibly pleaded and not preempted at the motion-to-dismiss stage.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Waiver of omitted claims after amendment | Jacob contends she need not replead claims the court previously rejected where repleading would be futile | Mentor argues omission from the amended complaint waived the original claims | Court: No waiver — plaintiff may appeal original dismissal when repleading would have been futile and dismissal was on merits/preemption grounds |
| Express preemption under 21 U.S.C. § 360k (PMA devices) | Jacob argues her manufacturing-defect claims allege parallel state and federal violations (failure to follow FDA-approved specifications), so they are not different or additional requirements | Mentor contends state claims would impose requirements different from federal requirements and thus are expressly preempted | Court: Jacob plausibly alleged parallel (genuinely equivalent) violations; claims survive express preemption at pleading stage |
| Implied preemption (fraud-on-FDA / private enforcement of federal duties) | Jacob asserts her claims enforce traditional state duties to consumers, not duties owed solely to FDA | Mentor argues alleged violations are only actionable because of federal regulatory duties (thus impliedly preempted) | Court: Manufacturing-defect claims fall within traditional state tort duties (not duties owed to FDA) and avoid implied preemption |
| Pleading sufficiency under Rule 12(b)(6) | Jacob alleges Mentor used nonconforming materials/processes, violated FDA-approved manufacturing controls, and that defects (porous shell) caused rupture and injury | Mentor asserts allegations lack device-specific regulatory references and factual detail (relying on Wolicki‑Gables) | Court: Liberally construing pro se pleadings, allegations are sufficiently specific to state a plausible manufacturing-defect claim at the pleading stage |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (framework for preemption under Medical Device Amendments; parallel-state-law claims may survive)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (express preemption applies to PMA-approved devices unless state duties are genuinely equivalent)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (fraud-on-the-FDA claims are impliedly preempted because they conflict with federal enforcement scheme)
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (state liability ordinarily not equivalent where a manufacturer could be liable under state law without violating federal law)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility standard for Rule 12(b)(6) dismissals)
- Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (plaintiff’s failure to identify specific FDA regulation violations supports preemption dismissal at later stages)
- Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017) (Florida manufacturing-defect negligence/strict-liability claims are traditional state duties and can avoid implied preemption)
- Godelia v. Doe 1, 881 F.3d 1309 (11th Cir. 2018) (discussion of limits of implied preemption and when state claims rely solely on federal duties)
- Reynolds v. Behrman Cap. IV L.P., 988 F.3d 1314 (11th Cir. 2021) (amended complaint does not necessarily waive right to appeal dismissed original claims where repleading would be futile)