51 Cal.App.5th 850
Cal. Ct. App.2020Background
- Plaintiff Rexina Mize received Mentor MemoryGel silicone breast implants as part of an adjunct IDE study; she did not know the implants were investigational. Her husband, Minh Nguyen, sued derivatively.
- Mentor had a 1998 FDA consent decree alleging manufacturing, quality-control, and reporting violations; the decree was later dissolved and Mentor obtained FDA premarket approval in 2006 with six postapproval study/reporting conditions.
- Mize later developed systemic symptoms; an MRI in December 2016 showed implant rupture and removal in January 2017 led to symptom improvement.
- The third amended complaint alleged manufacturing defects, failure to warn (failure to report adverse events to the FDA), negligence per se, and a derivative loss-of-consortium claim.
- The trial court sustained Mentor’s demurrer without leave to amend, finding preemption and inadequate causation; the Court of Appeal reversed and remanded, holding the tort claims survive preemption and that causation was sufficiently pleaded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether manufacturing defect claims are preempted by the MDA | Mize: state tort claims for manufacturing defects parallel federal requirements and are not impliedly preempted; state duties exist independent of FDA | Mentor: claims hinge entirely on violations of federal law and are therefore impliedly preempted | Not preempted; manufacturing defect claims survive (do not seek to enforce an exclusively federal requirement) |
| Whether plaintiff pleaded causation for manufacturing-defect claims | Mize: alleged Mentor’s pre-implant manufacturing violations and subsequent symptoms that improved after removal — the facts permit an inference of causation | Mentor: consent decree and its dissolution sever any causal link; complaint lacks specific facts tying IDE/factory failures to Mize’s implants | Sufficiently pleaded; causal connection may be inferred at pleading stage (demurrer improper) |
| Whether failure-to-warn (failure to report adverse events to FDA) claims are preempted | Mize: California recognizes a duty to report adverse events to FDA; state claim parallels federal reporting duties and is not expressly preempted | Mentor: Coleman/Stengel support preemption or show no parallel state duty; plaintiff failed to allege violation of a specific FDA requirement | Not expressly preempted; claim based on duty to report adverse events survives under California law (Coleman controls) |
| Whether plaintiff pleaded causation for failure-to-warn claims | Mize: alleged that Mentor’s failure to report prevented adverse-event data from reaching MAUDE/doctors, delaying diagnosis/removal, and causing harm | Mentor: speculative that reports would be published, that FDA would include them in MAUDE, or that doctors would have seen them in time | Sufficiently pleaded causal connection at pleading stage; factual disputes are for later proceedings |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (framework for MDA express preemption where PMA imposes federal requirements)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) (federal enforcement scheme can impliedly preempt state-law claims that seek to enforce exclusively federal requirements)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (MDA does not categorically preempt state-law manufacturing defect claims)
- Glennen v. Allergan, Inc., 247 Cal.App.4th 1 (2016) (state claims survive if premised on conduct that (1) violates MDA and (2) would be actionable under state law absent MDA)
- Coleman v. Medtronic, Inc., 223 Cal.App.4th 413 (2014) (California recognizes a manufacturer’s duty to report adverse events to FDA; such failure-to-report claims can avoid express preemption)
- Bockrath v. Aldrich Chemical Co., Inc., 21 Cal.4th 71 (1999) (plaintiff may plead causation/conclusions when defendant has superior access to facts)
- Rannard v. Lockheed Aircraft Corp., 26 Cal.2d 149 (1945) (pleading standard: allegation of a causal connection is sufficient at pleading stage)
- Armstrong v. Optical Radiation Corp., 50 Cal.App.4th 580 (1996) (state tort duties can require manufacturers to meet federal specifications)
- Evraets v. Intermedics Intraocular, Inc., 29 Cal.App.4th 779 (1994) (distinguishes design/testing/failure-to-warn claims; pre-Lohr decision discussed in preemption context)