Mack v. Stryker Corp.
893 F. Supp. 2d 976
D. Minnesota2012Background
- Mack underwent arthroscopic shoulder surgery on August 1, 2002, with a Stryker pain pump implanted in the intra-articular joint space.
- Mack alleges the pump’s continuous infusion caused glenohumeral chondrolysis and that Stryker knew or should have known of this risk.
- FDA denied clearance for joint-space use due to lack of a substantially equivalent predicate device; device approved only for intraoperative, intra-articular infusion.
- Stryker marketed the pump for joint-space use; marketing materials described placement directly into the shoulder joint.
- There was no pre-2002 literature linking intra-articular pain pump use to chondrolysis; related literature prior to 2005 did not establish a clear causal link.
- Court analyzes whether Mack can show foreseeability of harm pre-surgery, and whether Stryker had a duty to test or warn under O’Hare.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Mack may recover for failure to warn/test. | Mack: foreseeability existed from literature; duty to test and warn applies. | Stryker: no pre-2002 knowledge; FDA denial not safety-related; no duty to test or warn. | No genuine duty to test or warn; no liability pre-2002. |
| Effect of FDA 510(k) denial on duty to warn. | FDA denial signals potential risk; triggers duty to test and warn. | FDA denial was predicate-based; not evidence of safety concern or duty. | FDA denial not probative of duty to test or warn. |
| Whether pre-2002 literature put Stryker on notice of cartilage risk. | Twelve articles, including Nole and Jaureguito, foresee risk. | Articles do not show link between intra-articular pump use and chondrolysis in 2002. | No constructively known risk in 2002; not enough to trigger liability. |
| Whether the law requires Stryker to be the medical pioneer to discover risk. | Stryker should have tested given available literature. | Not obligated to discover; lack of demonstrable pre-2002 warning data. | No liability due to hindsight and lack of preexisting warning data. |
| Appropriate standard for products-liability duties (strict liability vs negligence) under Minnesota law. | Duty and foreseeability analysis support failure-to-warn/defect claims. | Merged tests under O’Hare; foreseeability controls; no duty to test or warn here. | O’Hare framework applied; no foreseeability before Mack's surgery. |
Key Cases Cited
- O’Hare v. Merck & Co., 381 F.2d 286 (8th Cir. 1967) (duty to test/warn based on foreseeability and available data)
- Rodriguez v. Stryker Corp., 680 F.3d 568 (6th Cir. 2012) (FDA denial not evidence of safety; cannot trigger duty)
- Lee v. Crookston, Coca-Cola Bottling Co., 290 Minn. 321 (Minn. 1971) (elements of product liability: defect, causation, proximate cause)
- Bilotta v. Kelley Co., 346 N.W.2d 616 (Minn. 1984) (negligence and strict liability concepts merge in design/failure-to-warn)
- Pio(t)rowski v. Southworth Prods. Corp., 15 F.3d 748 (8th Cir. 1994) (merger of negligence and strict liability in product design/warning)