McClelland v. Medtronic, Inc.
944 F. Supp. 2d 1193
M.D. Fla.2013Background
- Decedent BrEanne A. McClelland, resident of Florida, died August 11, 2011; plaintiff is her mother and estate representative.
- Defendant Medtronic, Inc. is a Minnesota corporation manufacturing implantable cardiac devices, including the EnPulse E1DR21 PMA device.
- E1DR21 implanted April 30, 2004; plaintiff alleges device defects caused failure to regulate rhythm leading to death.
- Plaintiff asserts knowledge of device defects prior to 2009 and alleges a duty to notify FDA and to warn patients.
- Defendant issued a recall of many devices eighteen months after death and later released a software update addressing recalled devices.
- Plaintiff filed state-law negligence claims in Florida (2011); case removed to federal court; prior dismissal in 2012 found preemption; plaintiff was granted leave to amend, resulting in Second Amended Complaint alleging negligence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the SAC claim is expressly preempted by the MDA | SAC alleges duty to warn patients paralleling PMA conditions | Claim imposes requirements different from federal ones | Express preemption applies; claim dismissed |
| Whether the SAC claim is impliedly preempted under Buckman | Claim targets FDA reporting duties; not merely FDCA violation | Private suit cannot enforce FDCA; implied preemption applies | Implied preemption applies; claim barred |
| Whether the SAC could survive as a parallel claim under Wolicki-Gables | Claims are genuinely equivalent to federal PMA duties | Not genuinely equivalent; broader state duty to warn patients | Not a parallel claim; preempted |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMAs impose device-specific requirements; preemption analysis set)
- Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (parallel claim principle; genuinely equivalent standards)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (implied preemption; private actions cannot enforce FDCA)
- Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (claims to enforce FDCA are impliedly preempted)
- Linder v. Portocarrero, 963 F.2d 332 (11th Cir. 1992) (foundation for accepting factual allegations on motion to dismiss)