766 F. Supp. 2d 1012
E.D. Cal.2011Background
- Monroe sues Zimmer US, Inc. and Zimmer, Inc. alleging negligence and negligent/strict products liability from intra-articular use of a ZAP pain pump causing glenohumeral chondrolysis.
- Plaintiff asserts general negligence, negligent products liability, and strict products liability; claims target design, manufacture, distribution, and inadequate warnings.
- Facts: ZAP inserted post shoulder surgery; subsequent deterioration of glenohumeral cartilage leading to chondrolysis; Cross treated Monroe and performed further procedures; ZAP remained in shoulder for days; plaintiff underwent corticosteroid injections and additional surgery.
- Plaintiff offers two general causation experts (Dragoo and Wells) and a treating physician for specific causation (Cross); defendant challenges Wells under Rule 702 and Daubert.
- Court grants in part and denies in part defendants’ summary judgment and denies exclusion of Wells’ testimony; outcome hinges on whether intra-articular pain pumps can cause chondrolysis and whether ZAP caused Monroe’s injury.
- Procedural posture: motion for summary judgment under Rule 56 and motion to exclude Wells’ testimony; court acts as gatekeeper on admissibility of causation evidence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is Wells' general causation testimony admissible? | Wells uses Hill criteria to establish association. | Wells lacks medical/epidemiological expertise and reliability. | DENIED; Wells is qualified and his methods admissible. |
| Can Monroe prove general causation that intra-articular pain pumps can cause chondrolysis? | Multiple studies show association; no epidemiology needed. | Reliance on case series; insufficient epidemiological proof. | DENIED; triable issue for general causation remains. |
| Can Monroe prove specific causation that ZAP caused her injury? | Cross’s differential-diagnosis method yields a basis to attribute causation to ZAP. | Cross admits opinions are not science and evolving; lacks factual basis. | DENIED; factual questions exist as to whether ZAP caused Monroe’s chondrolysis. |
| Did defendants owe a duty to warn based on medical literature or FDA testing? | Existing literature and FDA testing requirements should have triggered a duty to warn. | Evidence insufficient to establish a duty to warn based on literature or testing. | GRANTED; no duty to warn based on literature or FDA testing shown by plaintiff. |
| Does strict products liability require proof of duty/breach here, given causation issues? | Even without definitive causation, design or warning defects may survive. | Without causation, strict liability lacks basis. | DENIED as to issues; strict liability claim survives given material issues on causation. |
Key Cases Cited
- McClellan v. I-Flow Corp., 710 F. Supp. 2d 1092 (D. Or. 2010) (gateskeeping and reliance on non-epidemiological evidence in causation analyses)
- Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010) (rejects reliance on undefined error rate in Hansen study for causation)
- Grace v. Grace, 504 F.3d 745 (9th Cir. 2007) (associational studies informing expert causation opinions permissible)
- U.S. v. Grace, 504 F.3d 745 (9th Cir. 2007) (contextual reference for epidemiological evidence admissibility)
- Primiano v. Cook, 598 F.3d 558 (9th Cir. 2010) (gatekeeping and admissibility of expert testimony under Daubert)