Mink v. Smith & Nephew, Inc.
169 F. Supp. 3d 1321
S.D. Fla.2016Background
- Plaintiff Joseph Mink received a Birmingham Hip Resurfacing (BHR) metal-on-metal hip implant on June 6, 2011 and later developed elevated chromium and cobalt blood levels and related injuries, ultimately undergoing revision surgery in November 2014.
- Smith & Nephew (S&N) marketed the BHR under an FDA premarket approval (PMA) granted May 9, 2006, which imposed device-specific post-approval study, reporting, and manufacturing obligations.
- Mink was recruited into S&N’s 10-year post-approval study (the BHR Study) via Dr. Weisstein, signed a consent form, but was later terminated from the Study when S&N could not locate a follow-up site; Mink alleges monitoring then became his financial burden.
- Mink’s Second Amended Complaint (SAC) pleads four claims: negligence, strict products liability, breach of contract (based on the consent/study promises), and negligent misrepresentation (promises of 10-year monitoring and no out-of-pocket cost).
- S&N moved to dismiss, arguing the claims are preempted by the Medical Device Amendments (MDA) to the FDCA and/or otherwise barred under Florida law; the court granted dismissal with prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether negligence claim survives MDA preemption | Mink alleges S&N violated PMA conditions and specific FDA regs and thus states a parallel negligence claim | S&N contends claims seek to enforce federal FDCA/PMA duties (expressly or impliedly preempted) and Florida law provides no private remedy to enforce FDA requirements | Dismissed: plaintiff’s claims effectively seek to enforce PMA/FDCA duties and are impliedly and/or expressly preempted under controlling precedent; dismissal with prejudice |
| Whether strict products liability claim survives preemption | Mink alleges manufacturing deviations from PMA specifications caused metal toxicity | S&N argues manufacturing/noncompliance claims are attempts to privately enforce FDCA and are preempted | Dismissed: impliedly preempted because private actions to enforce FDCA/PMA requirements are barred |
| Whether breach of contract claim (Study termination) is viable | Mink contends consent/study created contractual obligations (10-year monitoring, transfer to other sites) and termination breached that contract | S&N argues Mink fails to identify contract terms breached and such a state-law duty would conflict with PMA/federal scheme (preempted) | Dismissed: plaintiff fails to plead a contractual provision and the claim is expressly preempted if it would impose requirements different from or additional to federal law |
| Whether negligent misrepresentation claim survives | Mink alleges inducement to choose BHR based on representation of 10-year monitoring at no cost | S&N argues the claim is grounded in promised PMA/study obligations and therefore preempted | Dismissed: same preemption principles bar the claim; dismissal with prejudice |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (PMA preemption: state requirements that are different from or in addition to federal PMA requirements are preempted)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (private suits to enforce FDA requirements are impliedly preempted)
- Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296 (11th Cir.) (plaintiff must plead a parallel claim by identifying specific PMA/federal requirements violated)
- In re Medtronic, Inc., 623 F.3d 1200 (8th Cir.) (describing narrow gap between Riegel and Buckman and explaining nearly all claims about FDA-approved devices are preempted)