297 F. Supp. 3d 1288
M.D. Fla.2018Background
- In April 2015 Colleen Rowe received Mentor Worldwide, LLC MemoryGel silicone breast implants; the left implant ruptured within seven months and was replaced; Rowe alleges ongoing symptoms and intends removal.
- MemoryGel implants are Class III devices approved via an FDA premarket approval (PMA) in 2006 with post-approval study conditions; Rowe alleges Mentor failed to conduct required post‑approval studies and failed to warn/ report risks.
- Rowe sued in Florida state law for negligence (Sixories: failure to warn, failure to report, failure to comply with federal requirements, negligent misrepresentation, negligence per se, manufacturing defect), strict liability (failure to warn; manufacturing defect), and breach of implied warranty.
- Mentor moved to dismiss under Rule 12(b)(6), principally arguing federal preemption (express and implied) under the Medical Device Amendments and that several state-law theories are legally deficient.
- The Court dismissed all claims with prejudice except Rowe’s negligent manufacturing-defect theory; the Court ordered Rowe to replead that sole remaining claim within 14 days.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Negligent failure to warn | Mentor failed to warn physicians/consumers of risks and that caused Rowe’s injuries | Claims conflict with FDA-mandated labeling and are preempted if different from federal requirements | Recognized under Florida law but expressly preempted and dismissed |
| Negligent failure to report | Mentor failed to report adverse events to FDA as required, causing harm | Claims are effectively suits to enforce federal reporting duties and thus preempted | Recognized as a parallel theory but impliedly preempted as a "fraud-on-the-FDA" claim and dismissed |
| Negligent manufacturing defect | Implant deviated from PMA/specifications and cGMPs causing rupture and injury | Mentor argued pleadings lack device‑specific violations and thus fail to plead a parallel claim | Claim pleaded sufficiently under Eleventh Circuit precedent and survives; Court permitted repleading to clarify allegations |
| Strict liability manufacturing defect & breach of implied warranty | Implant defective in manufacture; warranty breached | Strict liability claim lacked specific regulatory violations; implied warranty fails for lack of privity | Strict liability manufacturing defect expressly preempted and dismissed; implied warranty dismissed for lack of privity |
Key Cases Cited
- Riegel v. Medtronic, Inc., [citation="552 U.S. 312"] (PMA preemption; changes affecting safety/effectiveness require FDA approval)
- Buckman Co. v. Plaintiffs' Legal Comm., [citation="531 U.S. 341"] (fraud-on-the-FDA theory is impliedly preempted)
- Mink v. Smith & Nephew, Inc., [citation="860 F.3d 1319"] (11th Cir.) (explains MDA express/implied preemption framework and recognizes negligent failure-to-warn/report and distinguishes parallel manufacturing claims)
- Godelia v. Doe 1, [citation="881 F.3d 1309"] (11th Cir.) (parallel state-law manufacturing claims need not cite device-specific regulations to survive dismissal)
- Wolicki-Gables v. Arrow Int'l, Inc., [citation="634 F.3d 1296"] (11th Cir.) (discusses requirement to allege specific federal specifications violated; court contrasted by later Eleventh Circuit decisions)