Joseph Mink v. Smith & Nephew, Inc.
2017 U.S. App. LEXIS 11288
| 11th Cir. | 2017Background
- Joseph Mink underwent implantation of Smith & Nephew’s Birmingham Hip Resurfacing (BHR) metal-on-metal Class III device after being recruited into S&N’s FDA‑required 10‑year post‑approval study and signing a consent form promising monitoring and tests.
- Shortly after surgery, his local S&N representative surgeon (Dr. Weisstein) moved and arrangements to continue study monitoring failed; S&N later terminated Mink from the study.
- Mink developed elevated chromium and cobalt blood levels, eye problems, enlarged lymph node (removed surgically), and ultimately required revision surgery to remove the BHR device.
- Mink sued S&N in Florida state court (removed) asserting four state‑law claims: negligence (three theories: manufacturing defect, improper training, failure to report), strict product liability (manufacturing defect), breach of contract (study/consent form), and fraudulent misrepresentation (inducement to choose BHR and promised monitoring).
- The district court dismissed all claims as either failing under Florida law or preempted (expressly or impliedly) by federal law; the Eleventh Circuit affirmed dismissal of negligence claims based on improper training and failure‑to‑report, and breach of contract, but reversed dismissal of negligence and strict liability claims based on manufacturing defect and the misrepresentation claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether negligence claim premised on manufacturing defect is viable and preempted | Mink: device was manufactured outside FDA‑approved specs causing metal ion toxicity; federal violations can establish state negligence (parallel claim) | S&N: federal preemption (express/implied) bars state tort claims against PMA devices | Held: Manufacturing‑defect negligence survives under Florida law and is not expressly or impliedly preempted when pled as a parallel federal violation |
| Whether negligence claim premised on improper training (failure to train surgeon) is viable | Mink: S&N failed to train physicians properly, causing harm | S&N: learned‑intermediary doctrine and Florida law bar duty to patient for training physicians; preemption arguments | Held: Dismissed — Florida law (learned‑intermediary) bars failure‑to‑train claim |
| Whether negligence claim premised on failure to report adverse events is preempted | Mink: S&N failed to investigate/report adverse events to FDA, supporting negligence | S&N: such claims seek to enforce duties owed to FDA and are preempted | Held: Dismissed — impliedly preempted under Buckman as a fraud‑on‑the‑FDA type claim |
| Whether strict product liability (manufacturing defect) and fraudulent misrepresentation claims are preempted | Mink: strict liability parallels federal manufacturing requirements; misrepresentation induced reliance and is a state‑law contract/tort matter | S&N: claims either impose extra requirements on device safety/effectiveness (express preemption) or attempt to privately enforce FDA duties (implied preemption) | Held: Both claims survive — strict liability manufacturing claim not preempted (parallel duty); misrepresentation not preempted because it alleges fraudulent inducement by S&N, not private enforcement of FDA duties |
| Whether breach of contract (consent/study promises) was properly pleaded | Mink: consent form and surgeon’s statements created contractual obligations by S&N | S&N: no sufficient allegation of breach of the written consent; any oral contract claim conceded withdrawn | Held: Dismissed — Mink conceded oral contract and failed to plead breach of the written consent form |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (federal premarket approval can expressly preempt state requirements that add to or differ from federal ones)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (state common‑law claims may survive preemption if they parallel federal requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (state claims that seek to enforce duties owed to FDA or constitute fraud‑on‑the‑agency are impliedly preempted)
- Wolicki‑Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir.) (discusses pleading requirements and parallel‑requirements test under § 360k)