Kordek v. Becton
921 F. Supp. 2d 422
E.D. Pa.2013Background
- Plaintiff Diane Kordek, a surgical technician, was injured removing the shield from a Becton, Dickinson scalpel, resulting in permanent disability (RSD/CRPS).
- Two scalpel designs at issue: conventional disposable scalpel with fully removable vinyl shield and a protected disposable (retractable shield) scalpel with a shield that can be retracted and re-shielded.
- Removing the conventional shield requires two hands; the retractable shield allows shield retraction and exposure with one hand.
- BD marketed retractable shield scalpels as safer and nearly the same size/weight as conventional scalpels, but adoption was uneven among facilities.
- Regulatory and professional opinions (OSHA, American College of Surgeons) acknowledged safety benefits but warned safety must not compromise surgical technique or patient safety.
- BD moved for summary judgment, seeking to exclude plaintiff’s expert and to defeat strict liability and negligence claims; the court granted in part and denied in part.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Dr. Benda’s testimony should be excluded | Dr. Benda’s methods are reliable and fit the design defect theory. | Dr. Benda’s opinion on a reasonable alternative design is unreliable and improperly scoped. | Dr. Benda's opinion admitted; reliability established for key aspects. |
| Whether a reasonable alternative design exists under Restatement (Third) | Retractable shield scalpel is a reasonable alternative reducing risk. | Retractable designs create new hazards and are not safer overall. | No reasonable alternative design; retractable shield not a safer overall design. |
| Whether plaintiff can sustain a strict liability claim | Design defect exists via reasonable alternative design. | No reasonable alternative design; claim fails. | Summary judgment for defendant on strict liability claim. |
| Whether plaintiff can sustain a negligence claim | Manufacturer owed duty and breached it by designing with a dangerous shield. | No breach; conventional scalpel design is not defective. | Summary judgment for defendant on negligence claim. |
Key Cases Cited
- In re Paoli R.R. Yard PCB Litig., 35 F.3d 717 (3d Cir. 1994) (three-factor Daubert reliability and fit framework for expert testimony)
- Covell v. Bell Sports, Inc., 651 F.3d 357 (3d Cir. 2011) (applies Restatement (Third) to PA design-defect cases)
- Beard v. Johnson & Johnson, Inc., 41 A.3d 823 (Pa. 2012) (Beard acknowledged Covell but declined to resolve Restatement choice)
- Sansom v. Crown Equip. Corp., 880 F. Supp. 2d 648 (W.D. Pa. 2012) (discusses Restatement (Third) application and design defect issues)
- Lynn v. Yamaha Golf-Car Co., 894 F. Supp. 2d 606 (W.D. Pa. 2012) (extends Restatement (Third) framework to design defect analysis)
- Riley v. Becton Dickinson Vascular Access, Inc., 913 F. Supp. 879 (E.D. Pa. 1995) (considered substitute safety design and overall safety of alternatives)