Warstler v. Medtronic, Inc., 3:16-cv-00385

Background

Plaintiff Randy Warstler sued Medtronic under Ohio law alleging design/manufacturing defects in two SynchroMed II devices and related injuries; diversity jurisdiction applied.
District court previously granted Medtronic’s motion to dismiss, concluding plaintiff’s state-law claims were expressly preempted by the Medical Device Amendments, 21 U.S.C. § 360k(a).
Court applied the Riegel two-step test: (1) whether federal requirements applicable to the device exist; (2) whether state-law claims impose requirements different from or in addition to federal requirements. Court found both satisfied.
Plaintiff moved for reconsideration and sought leave to file a proposed First Amended Complaint asserting he obtained additional detail about the device defect, a Medtronic recall, manufacturing violations, the PMA, and his injuries.
Defendant argued plaintiff failed to meet Rule 59(e) standards and did not cure the preemption defects; court treated the motion as a post-judgment Rule 15 request subject to the heightened Rule 59/60 standards.
Court denied reconsideration/amendment because plaintiff did not show the evidence was newly discovered or otherwise justify failure to seek leave to amend before judgment; finality and expeditious termination weighed against reopening the case.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether § 360k(a) preempts Warstler’s state-law claims	Warstler implicitly contended federal requirements do not preempt his common-law claims or that his claims can parallel FDA requirements	Medtronic argued § 360k(a) and Riegel preempt plaintiff’s state claims because federal PMA requirements apply	Court held § 360k(a) preempts the claims under Riegel; federal requirements applied and state duties would add to/differ from them
Whether proposed amendments plead parallel claims to avoid preemption	The proposed FAC adds detail about defects, recall, manufacturing violations, PMA violations, and injuries that (plaintiff contends) cure pleading defects	Medtronic argued the proposed allegations do not overcome preemption and plaintiff failed to show a basis to amend post-judgment	Court held the proposed amendments did not justify reopening because plaintiff failed to show they represent newly discovered evidence or that he could not have amended earlier
Whether plaintiff met Rule 59(e)/post-judgment Rule 15 standard (newly discovered evidence/intervening law/etc.)	Plaintiff implied the new allegations were obtained after the initial complaint and thus are newly discovered	Medtronic argued plaintiff offered no explanation why the information was previously unavailable and that plaintiff waited too long	Court held plaintiff failed to satisfy Rule 59(e): no showing that evidence was previously unavailable or that any Rule 59(e) ground applied
Whether finality and undue delay bar post-judgment amendment	Plaintiff did not provide a compelling explanation for not amending earlier	Medtronic emphasized finality, prejudice, and the Sixth Circuit’s requirement for a compelling explanation	Court denied amendment, finding undue delay and no compelling explanation to reopen judgment

Key Cases Cited

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (states may allow common-law damages remedies that "parallel" federal requirements)
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (interpreting § 360k preemption and the two-step analysis for PMA devices)
Leisure Caviar, LLC v. U.S. Fish & Wildlife Serv., 616 F.3d 612 (6th Cir. 2010) (post-judgment amendment requires meeting Rule 59/60 standards and a heavier burden)
Benzon v. Morgan Stanley Distribs., Inc., 420 F.3d 598 (6th Cir. 2005) (courts must consider finality and movant’s explanation for failing to amend before judgment)
Wolicki-Gables v. Arrow Intern., Inc., 634 F.3d 1296 (11th Cir. 2011) (discussing preemption and parallel-claims doctrine)
In re Medtronic, Inc. Spring Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (analyzing § 360k preemption for PMA devices)