Rodriguez v. Stryker Corp.
680 F.3d 568
6th Cir.2012Background
- Rodriguez underwent shoulder arthroscopy in 2004 with a pain pump delivering bupivacaine for two days.
- Rodriguez later developed chondrolysis and sued Stryker for strict liability, negligence, and breach of warranty.
- The district court granted summary judgment to Stryker, finding no duty to warn given the 2004 knowledge state and no causation.
- Plaintiff’s experts' testimony was examined for Daubert reliability, but the court found no duty to warn and no causation support.
- This Sixth Circuit affirmed, holding there was no triable issue on duty to warn or causation under Tennessee law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Duty to warn for non-obvious dangers under Tennessee law | Rodriguez contends Stryker should have warned about joint use risks | Stryker asserts no knowledge of a joint-use danger in 2004; duty to warn not triggered | No duty to warn established; evidence shows no known risk in 2004 |
| Whether literature before 2004 put Stryker on notice of chondrolysis risk | Rodriguez points to pre-2004 articles suggesting cartilage damage from foreign solutions | Articles do not link pain pumps/bupivacaine to permanent cartilage damage; knowledge insufficient | Pre-2004 articles do not demonstrate knowledge that would require warning |
| Causation for failure-to-warn claim | Warning would have prevented injury; Kuhn would have changed use | No evidence showing warning would have reached Kuhn or altered his decisions | No triable causation; failure to warn fails as a matter of law |
| Effect of FDA 510(k) process on duty to warn | FDA denials to joint-use indication should have warned Stryker | 510(k) focuses on equivalence, not safety; approved indication covers intra-operative use | 510(k) denial does not establish a safety warning obligation; no duty to warn |
Key Cases Cited
- Pittman v. Upjohn Co., 890 S.W.2d 425 (Tenn. 1994) (duty to warn for non-obvious dangers)
- Evridge v. Am. Honda Motor Co., 685 S.W.2d 632 (Tenn. 1985) (duty to warn for known or discoverable dangers)
- King v. Danek Med., Inc., 37 S.W.3d 429 (Tenn. Ct. App. 2000) (causation in failure-to-warn claims)
- Kalamazoo River Study Group v. Rockwell Int'l Corp., 171 F.3d 1065 (6th Cir. 1999) (courts review expert reasoning in Daubert-like contexts)
- Tamraz v. Lincoln Elec. Co., 620 F.3d 665 (6th Cir. 2010) (evaluates expert reliance and inference requirements)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (FDA 510(k) safety vs. equivalence focus)
- Nye v. Bayer Cropscience, Inc., 347 S.W.3d 686 (Tenn. 2011) (causation standards in product failure-to-warn)
- Fulton v. Pfizer Hosp. Prods. Group, Inc., 872 S.W.2d 912 (Tenn. Ct. App. 1993) (manufacturer not insurer of injury; no hidden risk requiring testing)