147 F. Supp. 3d 1017
C.D. Cal.2015Background
- Plaintiff Kevin Funke received a Sorin Mitroflow tissue aortic valve (PMA-approved Class III device) in 2008; the valve failed about five years later and was removed and returned to Sorin for investigation.
- Funke alleges Sorin knew of early valve failures and identified manufacturing process and material issues (cross-stitches, Dacron fabric abrasion) contributing to failures.
- Claims pleaded: negligence, strict products liability — failure to warn, strict products liability — manufacturing defect, negligent misrepresentation, and punitive damages under Cal. Civ. Code § 3294.
- Sorin moved to dismiss all claims as preempted by the Medical Device Amendments (MDA) to the FDCA and Riegel v. Medtronic framework; Sorin submitted FDA PMA materials and MAUDE adverse event reports.
- Court accepted PMA status and FDA post‑market regulation as satisfying Riegel’s threshold; dismissed plaintiff’s complaint but granted leave to amend to clarify non‑preempted theories (manufacturing / FDA‑reporting / parallel-state duties).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Strict liability — failure to warn | Sorin failed to warn physicians, patient, and FDA about known early failures and did not report adverse events to FDA | MDA/Riegel preempts state duties that would require warnings different from FDA‑approved labeling; MAUDE shows AERs filed since 2008 | Claim preempted to the extent it seeks warnings different from FDA requirements; failure‑to‑warn‑FDA theory may survive but Complaint lacks adequate factual/legal detail — dismissed with leave to amend |
| Strict liability — manufacturing defect | Valve was defectively manufactured (deviations from CGMP/QS regs) causing deterioration/erosion | Device design was approved by PMA; design‑based defect claims are preempted; defendant contests sufficiency of manufacturing‑specific allegations | Manufacturing‑defect theory not categorically preempted if pleaded as deviation from FDA‑approved manufacturing; court dismissed claim with leave to amend to clarify manufacturing (vs design) allegations |
| Negligence (design, warnings, manufacturing, postmarket surveillance) | Sorin negligent in design, testing, manufacturing, marketing, post‑market surveillance, and failing to warn/submit reports | Design and labeling claims are preempted under Riegel; warning allegations implicating FDA reporting must be specifically pleaded | Negligence claims premised on design/labeling are preempted; warning/manufacturing allegations dismissed with leave to amend to plead viable, parallel (non‑preempted) theories |
| Negligent misrepresentation & punitive damages | Sorin’s marketing/representations touted long‑term outcomes while concealing early failure risk; seeks punitive damages for malice/conscious disregard | Representations consistent with FDA‑approved labeling are preempted; punitive damages tied to dismissed claims fail | Misrepresentation claim and related punitive damages dismissed with leave to amend (plaintiff must plead how statements deviate from or create duties parallel to federal requirements) |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (establishes MDA express‑preemption framework for PMA devices)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. en banc) (post‑market FDA reporting/failure‑to‑warn‑FDA theory can avoid preemption)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (implied preemption bars private enforcement of exclusively federal duties)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (pleading plausibility standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading plausibility and conclusions not accepted)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.) (discusses need for discovery to distinguish manufacturing vs design defect)
- Coleman v. Medtronic, Inc., 223 Cal.App.4th 413 (California duty to warn parallels FDA reporting duties)
- Barker v. Lull Engineering Co., 20 Cal.3d 413 (definition of manufacturing defect under California law)