Krumpelbeck v. Breg, Inc.
759 F. Supp. 2d 958
S.D. Ohio2010Background
- Plaintiff underwent shoulder arthroscopy with a Breg Pain Care 4200 infusion pump administered postoperatively, alleged to cause chondrolysis.
- Plaintiff asserts seven claims including strict liability, negligence, breach of warranties, and misrepresentation; argues Breg had a duty to warn despite alleged lack of knowledge.
- FDA cleared Pain Care 4200 for continuous infusion of local anesthetic for postoperative pain, not specifically for intra-articular/orthopedic use.
- Plaintiff contends Breg promoted joint-space/intra-articular use and failed to warn of risks evidenced by pre-2005 literature and internal communications.
- Defendant moves for summary judgment, arguing no duty to warn existed before knowledge of risk, and testing/foreseeability issues negate liability.
- Court analyzes foreseeability under Ohio law (OPLA) and distinguishes relevant literature, internal emails, and FDA regulatory context.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether defendant owed a warning duty under OPLA | Krumpelek contends knowledge of risk existed pre-2005, creating duty to warn. | Breg had no duty to warn absent known/knowable risk at use time. | No duty found; no genuine fact issue on foreseeability at time of surgery. |
| Effect of FDA clearance on liability for warnings | General clearance and subsequent promotion for orthopedic use imply misrepresentation of FDA status. | FDA clearance for general use does not establish a private Ohio liability; FDA issues are immaterial to OPLA claims. | FDA regulatory issues immaterial; summary judgment granted on warnings claims. |
| If pre-litigation literature and internal emails put Breg on notice before 2005 | Articles and internal memos before March 2005 suggested possible chondrolysis risk from intra-articular infusion. | Literature and emails do not establish a known/knowable risk prior to surgery; not enough to create duty. | Insufficient to establish foreseeability pre-2005; no duty found. |
Key Cases Cited
- Schott v. I-Flow Corp., 696 F.Supp.2d 898 (S.D. Ohio 2010) (summary judgment issues in pain-pump case; considerations of expert reliability and knowledge of risk)
- Miles v. Kohli & Kaliher Assocs., Ltd., 917 F.2d 235 (6th Cir. 1990) (duty to warn under Ohio law tied to what manufacturer knew or should have known)
- Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010) (external authority on timing of knowledge of risks in pain-pump chondrolysis disputes)