Reddick v. Medtronic
21-30169
| 5th Cir. | Mar 10, 2022Background
- In 2013 Reddick was implanted with five Medtronic devices (Evera SVR ICD, Sprint Quattro lead, MyCareLink — Class III; Reveal LINQ and WireX — Class I/II) after a Brugada diagnosis; he later experienced repeated inappropriate shocks and alarms.
- Reddick was later found not to have Brugada syndrome and had the ICD removed in 2017.
- He sued Medtronic under the Louisiana Products Liability Act (LPLA) for defective construction, defective design, failure to warn, and breach of express warranty, and also alleged breach of contract (24/7 service support).
- The district court: dismissed LPLA claims as to Class III devices as preempted by 21 U.S.C. § 360k(a); dismissed LPLA claims as to Class I/II devices under Rule 12(b)(6) for failure to state a claim; and granted summary judgment to Medtronic on the breach-of-contract claim for lack of any contract evidence.
- The Fifth Circuit reviewed de novo and affirmed: it found many appellate arguments forfeited, held the Class III claims impermissibly conclusory (thus preempted), found the Class I/II design claims lacked pleaded alternative designs, and held there was no triable issue on the existence of a contract.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether LPLA claims against Class III (PMA) devices are preempted under 21 U.S.C. § 360k(a) | Reddick: claims are not preempted; alleges defects, recalls, FDA warnings and warranties | Medtronic: PMA establishes federal requirements that preempt state-law requirements; plaintiff’s allegations are conclusory | Held: Preemption applies; plaintiff’s LPLA claims were not pleaded with the factual particularity needed to qualify as non‑preempted parallel claims and are dismissed |
| Whether plaintiff pleaded a parallel claim with adequate factual detail (Funk/Naquin standard) | Reddick: alleges recalls, FDA action, res ipsa, and on appeal cites a 2021 recall | Medtronic: pleadings are conclusory, lack device‑specific linkage to FDA requirements or to plaintiff’s devices | Held: Claims are "impermissibly conclusory and vague" under Funk and Naquin; dismissal affirmed; court will not consider new evidence raised only on appeal |
| Sufficiency of design‑defect pleadings for Class I/II devices (LINQ, WireX) | Reddick: asserts defective software/security for LINQ/WireX | Medtronic: complaint fails to identify a reasonable, feasible alternative design as LPLA requires | Held: Dismissed under Rule 12(b)(6) — plaintiff failed to plead an alternative design or facts supporting one |
| Breach of contract (including alleged oral contract/third‑party beneficiary) | Reddick: contends website/advertisements or oral promises created a contract or implied warranty; claims third‑party beneficiary status | Medtronic: no written contract, no evidence of an oral agreement, and no intent to benefit plaintiff in clinic contracts | Held: Summary judgment for Medtronic — no record evidence of any contract or third‑party beneficiary intent |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (establishes two‑prong preemption test under § 360k for PMA devices)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (distinguishes PMA devices and § 510(k) process for preemption analysis)
- Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) (parallel‑claim pleading must specify how federal requirements were violated; conclusory pleadings insufficient)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard — courts disregard conclusory allegations)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility standard for pleadings)
- Wildman v. Medtronic, Inc., 874 F.3d 862 (5th Cir. 2017) (LPLA warranty claims require particularity)
- Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006) (design, warning, and warranty LPLA claims implicated federal preemption)
- Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (PMA devices automatically satisfy Riegel’s first prong)
- Nola Spice Designs, L.L.C. v. Haydel Enters., Inc., 783 F.3d 527 (5th Cir. 2015) (summary judgment standard and burden to produce evidence to create genuine issue of material fact)