491 F. App'x 713
6th Cir.2012Background
- Krumpelbeck sues Breg, Inc. for injuries from intra-articular infusion of anesthetic via a Breg pain pump after shoulder arthroscopy in 2005.
- Claims include design defect, inadequate warnings, nonconformance with representations, negligence, breach of express/implied warranty, and negligent misrepresentation/fraud.
- District court granted summary judgment, holding no duty to warn given lack of knowledge of risk in 2005 and abrogation of common law claims by the 2005 OPLA amendment.
- Court declined to consider late expert/deposition materials; Krumpelbeck appealed contending disputes of fact on design and warning and mischaracterization of OPLA.
- This court AFFIRMS in part (common law claims), REVERSES in part (statutory design/warning claims), and REMANDS for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Applicable OPLA version governing claims | Pre-amendment version should apply, preserving common law claims. | Post-amendment version governs; common law claims barred. | Krumpelbeck waived pre-amendment argument; court applied post-amendment framework. |
| Whether genuine disputes exist on design defect and inadequate warning under OPLA | Evidence shows foreseeability and consumer expectations support design/warning defects. | No knowledge of risk as of 2005; no duty to warn; literature/data insufficient. | Genuine disputes of material fact exist; not entitled to summary judgment on these statutory claims. |
| Impact of FDA clearance/marketing on notice and design/warning claims | FDA refusals and off-label marketing evidence put Breg on notice of risks and testing needs. | FDA rejection was about data safety; not evidence of actual risk notice; off-label promotion not dispositive. | Evidence supports jury could infer notice/need for testing; issues for trial on design/warning. |
| Whether misrepresentation-based claims survive under OPLA | Breg made representations about safety/approval; device did not conform to representations. | No proven express representations to Krumpelbeck or doctor; statutory nonconformance claim may apply but need proof. | Common-law misrepresentation/warranty claims barred; no express representations proven; statutory nonconformance claim reviewed. |
Key Cases Cited
- Celotex Corp. v. Catrett, 477 U.S. 317 (Sup. Ct. 1986) (summary judgment burden on movant to show absence of genuine issues of material fact)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (Sup. Ct. 1986) (genuine issues of material fact preclude summary judgment only if evidence is more than a scintilla)
- Miller v. ALZA Corp., 759 F. Supp. 2d 929 (S.D. Ohio 2010) (discusses elements of claims under Ohio's product-liability framework)