846 F. Supp. 2d 1085
C.D. Cal.2011Background
- Plaintiff Robert Erickson has had four pacemakers implanted between 1997 and 2005 and a fifth implanted in 2005 that remains in place but is alleged to be suspect.
- The first pacemaker, VIGOR DR Model 1232, was implanted in 1997 and allegedly failed after four years and nine months, requiring removal.
- The second pacemaker, INSIGNIA Plus DR Model 1298, was implanted in 2002 and removed in 2005 after failing before a ten-year expected lifespan.
- The third pacemaker, INSIGNIA Ultra DR Model 1290, was implanted after 2002 and allegedly failed in less than five years.
- The fourth pacemaker, ALTRUA 60 DDR Model S606, was implanted in 2005 and remains in Erickson’s body, though its operation is described as suspect.
- Erickson alleges Defendants misrepresented safety and quality and actively concealed defects, asserting five claims: strict liability for failure to warn, strict liability for design/manufacturing defect, negligence, fraud, and gross negligence malice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| MDA preemption scope for the pacemakers | Erickson argues claims may escape preemption | Preemption applies because devices are Class III with PMA/PDP approvals | Preemption applies; state-law claims are preempted |
| Parallel claims under preemption | Parallel claims survive if they allege FDA regulation violations | Plaintiff failed to plead specific FDA requirements or causal link | Parallel claims insufficient to defeat preemption |
| FDA review process (PMA/PDP) and preemption | Some pacemakers may have entered market via PDP or §501(k)RA process | Documents show PMA/PDP processes; §501(k) not shown | PMA/PDP processes govern preemption; §501(k) not shown to apply |
| Fraud claim sufficiency under Rule 9(b) | Misrepresentations about safety, longevity induced implantation | Conclusory; lacks time, place, content, and actor details | Fraud claim deficient under Rule 9(b) |
| Statute of limitations on two pacemakers (Vigor 1232 and Insignia 1298) | Two-year clock not started until 2009 due to warranty discussion | Clock began earlier; discovery rule cannot toll beyond 2007 | Partial summary judgment granted; limitations bar claims on Vigor 1232 and Insignia 1298 |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption where federal requirements apply and state claim adds new standard of care)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (parallel claims concept under MDA preemption)
- Edwards v. Marin Park, Inc., 356 F.3d 1058 (9th Cir. 2004) (Rule 9(b) specificity requirements for fraud claims)
- Jolly v. Eli Lilly & Co., 44 Cal.3d 1103 (Cal. 1988) (discovery rule for statute of limitations in dismissed claims)