Kildow v. BREG, INC.
796 F. Supp. 2d 1295
D. Or.2011Background
- Plaintiff alleges injuries from a pain pump used to deliver local anesthetics after shoulder arthroscopy, seeking economic, non-economic, and punitive damages.
- Breg, Inc. is the alleged manufacturer/distributor; the pain pumps are Class II devices marketed via 510(k) clearance.
- The FDA permitted general intra-operative use; no FDA clearance existed for intra-articular/shoulder joint space use for the specific indication.
- Plaintiff underwent surgeries on July 23, 2003 and March 22, 2004; chondrolysis developed in the shoulder joint thereafter.
- Plaintiff filed suit on January 6, 2010; Breg moves for summary judgment arguing statute of limitations, knowledge, causation, and punitive damages issues.
- Court denies summary judgment on all grounds, finding factual questions regarding discovery, knowledge, and causation remain.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| accrual/discovery rule timing | Kildow lacked timely discovery; discovery rule tolls accrual. | Plaintiff should have discovered injury-source earlier; statute barred. | Denial of summary judgment; issues of fact remain regarding discovery. |
| Breg's knowledge of risk before surgery | Breg knew or should have known risks of intra-articular pain pump use. | Breg had no knowledge/reason to know of such risks as of 2003–2004. | Issue of fact exists; summary judgment denied. |
| Duty to warn and causation | Breg's failure to warn contributed to plaintiff's injuries. | Cannot prove Breg's lack of warning caused plaintiff's injuries. | Genuine issues of material fact preclude summary judgment on causation. |
| Punitive damages | Breg acted with malice or conscious indifference given marketing despite risks. | Lacks clear knowledge of harm as of 2003–2004; punitive damages inappropriate at this stage. | Not granted; factual questions remain; summary judgment denied. |
Key Cases Cited
- Photo-Medex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010) (510(k) process, substantial equivalence guidance)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. Supreme Court 1996) (FDA regulatory framework for medical devices; PMA vs 510(k))
- McEwen v. Ortho. Pharm. Corp., 270 Or. 375 (1974) (drug manufacturer duty to warn the medical profession of dangers)
- Benjamin v. Wal-Mart Stores, Inc., 185 Or.App. 444 (2002) (duty to warn evidence: knowledge or reasonable foreseeability of danger)
- T.R. v. Boy Scouts of America, 344 Or. 282 (2008) (discovery accrual standard: when knowledge/investigation would reveal role in injury)