Block v. Woo Young Medical Co.
2013 U.S. Dist. LEXIS 44106
D. Minnesota2013Background
- Block sues Woo Young for negligence, alleging a pain pump placed intra-articularly during June 20, 2003 shoulder arthroscopy caused chondrolysis.
- Woo Young’s Accufuser pump received 510(k) clearance for general infusion but not specifically for intra-articular orthopedic use; no clear orthopedic clearance is shown in record.
- Dr. Speer used the pump post-operatively; he did not independently verify FDA clearance and later stopped using intra-articular pumps after learning of potential risks, around 2006–2008.
- Block contends chondrolysis in Block’s shoulder was caused by intra-articular infusion of local anesthetics via the pump; literature and expert opinions are cited to support risk.
- The parties dispute off-label marketing and whether Woo Young marketed the device for orthopedic use, including an orthopedic kit distributor arrangement.
- Woo Young did not conduct testing on intra-articular anesthetic use and did not have FDA 510(k) clearances for that orthopedic indication; FDA denials of similar clearances are noted in the record.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Failure to warn liability for orthopedic use | Block argues Woo Young promoted/consented to orthopedic use and thus owed a warning. | Woo Young contends no alteration/consent to orthopedic use supports liability. | Genuine issue of material fact; summary judgment denied. |
| Causation and sufficiency of warnings | Block maintains an adequate warning would have changed Dr. Speer’s conduct. | Woo Young argues no proof that warning would have altered Speer’s behavior. | Genuine issue of material fact; summary judgment denied. |
| Foreseeability and duty to test | Block alleges literature, lack of testing, and marketing create foreseeability of risk requiring warnings. | Woo Young asserts risk was not foreseeable; questions about testing duty. | Genuine issue of material fact; summary judgment denied. |
Key Cases Cited
- Hairston v. Alexander Tank and Equip. Co., 310 N.C. 227 (N.C. 1984) (foreseeability not required in exact form of injury; reasonable foreseeability standard)
- Nicholson v. American Safety Utility Corp., 124 N.C.App. 59 (N.C. Ct. App. 1996) (duty to test related to latent hazards and warnings)
- Cockerham v. Ward, 262 S.E.2d 651 (N.C. App. 1980) (manufacturer’s duty to make reasonable tests and inspections)
- Fussell v. N.C. Farm Bureau Mut. Ins. Co., 695 S.E.2d 437 (N.C. 2010) (duty of ordinary care defined as reasonable care, forward-looking foreseeability)
- Rodriguez v. Stryker Corp., 680 F.3d 568 (6th Cir. 2012) (foreseeability and warning considerations in failure-to-warn context (appellate discussion))