Kapps v. Biosense Webster, Inc., 2011 U.S. Dist. LEXIS 111105

Kapps suffered heart injury when a Biosense LASSO catheter, reprocessed by Ascent, broke off in a Mayo Clinic procedure in June 2005.
Multiple cross-motions were filed: Kapps and Biosense on summary judgment, Ascent on multiple summary-judgment motions, and Daubert motions; a day-long hearing occurred March 17, 2011.
The court denied Kapps’s summary-judgment motions and granted in part and denied in part various motions to exclude expert testimony, including Barkalow’s testimony.
FDA regulatory context discussed: Biosense obtained 510(k) clearance for the Lasso in 2000; Ascent filed 510(k) clearance for reprocessing in 2001, approved in 2002/2004, with an internal line-extension determination for the Lasso in 2002.
Court denied punitive damages relief; the order resolved Daubert and summary-judgment issues but left other claims for trial.
The final order granted Biosense summary judgment on all claims; Ascent’s Daubert-related challenges were granted in part; Ascent’s partial summary judgment requests were denied in part; punitive-damages amendment was denied.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Manufacturing defect evidence against Biosense	Barkalow shows defect in Biosense catheter.	Barkalow’s methods are unreliable; no pre-reprocessing defect proven.	Barkalow’s testimony excludes as to Biosense.
Ascent as a manufacturer and liability theory	Ascent’s reprocessing caused defect; manufacturer status supports liability.	Ascent not a traditional manufacturer; limited liability.	Barkalow/Benditt admissible on key res ipsa theory; Ascent not barred as manufacturer for all claims.
Warning defect and causation	Warning deficiencies caused injuries; Dear Doctor letter could have changed outcomes.	No causation; warnings unlikely to change physician behavior; Buckman preemption concerns.	Warning-defect claim dismissed for lack of causation; Buckman not allowing implied FDCA-based claims.
Design defect, breach of warranty, and negligence	Lasso design defect and warranty breaches supported by experts.	No viable design defect; warranty claims superseded by strict liability; negligence unpersuasive.	Biosense design-defect claim dismissed; implied warranty preempted or subsumed by strict liability; negligence claims rejected; punitive damages denied.

Lee v. Crookston Coca-Cola Bottling Co., 188 N.W.2d 426 (Minn. 1971) (core manufacturing defect framework in Minnesota product liability)
Bilotta v. Kelley Co., 346 N.W.2d 616 (Minn. 1984) (design-defect and res ipsa balancing framework; negligence vs. strict liability merged)
Holkestad v. Coca-Cola Bottling Co. of Minnesota, 180 N.W.2d 860 (Minn. 1970) (res ipsa loquitur support for manufacturing defect cases)
Schafer v. JLC Food Systems, Inc., 695 N.W.2d 570 (Minn. 2005) (restatement approach; circumstantial evidence in defective-food product liability applied to products generally)
Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (U.S. 2001) (FDCA preemption of private claims; learned intermediary considerations)
Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (preemption framework for medical-device regulation)
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (U.S. 1993) (standards for admissibility of expert testimony)
Joiner v. General Electric Co., 522 U.S. 136 (U.S. 1997) (gatekeeping and reliability gaps in expert testimony)