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Krumpelbeck v. Breg, Inc.

United States Court of Appeals for the Sixth Circuit

August 10, 2012, Filed

File Name: 12a0874n.06

No. 11-3726

Opinion

 [*715]  BERNICE BOUIE DONALD, Circuit Judge. This appeal arises from a product liability action against medical device manufacturer Breg, Inc., for injuries allegedly resulting from Rachel Krumpelbeck's use of a Breg pain pump. Krumpelbeck's complaint asserted seven claims against Breg: (1) strict liability - design defect; (2) strict liability - warning defect; (3) strict liability - nonconformance with representations; (4) negligence; (5) breach of express warranty; (6) breach of implied warranty; and (7) negligent misrepresentation and fraud. Breg filed a motion for summary judgment in which it argued that it was reasonably unaware of the risk  [**2] of injury that Krumpelbeck sustained, and therefore, that it had no duty to warn. Alternatively, Breg argued that Krumpelbeck could not show that a failure to warn caused her injury. The district court granted Breg's motion for summary judgment and dismissed Krumpelbeck's complaint. Krumpelbeck timely appealed. While we find no error in the district court's dismissal of Krumpelbeck's common law claims and her statutory claim of nonconformance with representations, we find that, construing the evidence in the light most favorable to Krumpelbeck, there are genuine disputes of fact that could allow a reasonable jury to find in her favor on her statutory claims of defective design and inadequate warning or instruction. Accordingly, we AFFIRM in part, REVERSE in part, and REMAND for further proceedings.

I. BACKGROUND

On March 3, 2005, Plaintiff-Appellant Rachel Krumpelbeck, then seventeen years old, underwent arthroscopic surgery on her shoulder. Her surgeon, Dr. Paul Favorito, used a Breg pain pump device to administer a local anesthetic to Krumpelbeck's shoulder for four days following her surgery. Dr. Favorito inserted the pain pump catheter directly into Krumpelbeck's shoulder joint to  [**3] deliver the prescribed pain medication. In the months following her surgery, Krumpelbeck experienced extreme pain, and worsening stiffness, clicking, and popping in her shoulder joint. In December 2007, Krumpelbeck was diagnosed with glenohumeral chondrolysis, a painful condition involving the permanent destruction of articular cartilage in the shoulder joint. According to her doctor, Krumpelbeck's prognosis is poor, and she will likely require several complete shoulder replacements during her lifetime.

On February 6, 2009, Krumpelbeck filed a seven-count complaint against Breg, the manufacturer of the pain pump; Orthofix International NV, Breg's parent corporation; and Advanced Technology, a wholesale distributer of medical equipment, including the Breg pain pump.2 The complaint alleged strict liability for defective design, inadequate warnings, and failure of the pump to conform to representations. The complaint also asserted claims for negligence, breach of express and implied warranty, negligent misrepresentation, and fraud.

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491 Fed. Appx. 713 *; 2012 U.S. App. LEXIS 16809 **; 2012 FED App. 0874N (6th Cir.); CCH Prod. Liab. Rep. P18,971; 2012 WL 3241587

RACHEL KRUMPELBECK, Plaintiff-Appellant, v. BREG, INC., et al., Defendants-Appellees.

Notice: NOT RECOMMENDED FOR FULL-TEXT PUBLICATION. SIXTH CIRCUIT RULE 28 LIMITS CITATION TO SPECIFIC SITUATIONS. PLEASE SEE RULE 28 BEFORE CITING IN A PROCEEDING IN A COURT IN THE SIXTH CIRCUIT. IF CITED, A COPY MUST BE SERVED ON OTHER PARTIES AND THE COURT. THIS NOTICE IS TO BE PROMINENTLY DISPLAYED IF THIS DECISION IS REPRODUCED.

Prior History:  [**1] ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF OHIO.

Krumpelbeck v. Breg, Inc., 759 F. Supp. 2d 958, 2010 U.S. Dist. LEXIS 138888 (S.D. Ohio, 2010)

CORE TERMS

pump, pain, district court, intra-articular, manufacturer, representations, warning, notice, orthopedic, surgery, summary judgment motion, design defect, shoulder, summary judgment, space, strict liability, chondrolysis, promoted, common law claim, foreseeable risk, nonconformance, anesthetic, risk of harm, indications, deposition, off-label, infusion, testing, argues, negligent misrepresentation

Civil Procedure, Appeals, Standards of Review, De Novo Review, Summary Judgment Review, Standards of Review, Summary Judgment, Entitlement as Matter of Law, General Overview, Governments, Legislation, Statutory Remedies & Rights, Torts, Products Liability, Types of Defects, Design Defects, Marketing & Warning Defects, Healthcare Law, Medical Treatment, Medical Devices, Premarket Approval