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Kordek v. Becton, Dickinson and Co.

United States District Court, E.D. Pennsylvania

February 4, 2013


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[Copyrighted Material Omitted]

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Larry Bendesky, Robert J. Mongeluzzi, Brian E. Fritz, Saltz, Mongeluzzi, Barrett & Bendesky, P.C., Philadelphia, PA, for Diane Kordek.

Barbara K. Gotthelf, McCarter & English, Philadelphia, PA, for Becton, Dickinson and Co.


McLAUGHLIN, District Judge.

This case arises out of injuries sustained by a surgical technician while removing a shield from the blade of a scalpel manufactured and sold by the defendant. The plaintiff claims that the scalpel, specifically the scalpel shield, was defectively designed. She brings her suit under both strict products liability and negligence causes of action. The defendant has moved for summary judgment on both counts. First, the defendant argues that the plaintiff's sole expert witness should be excluded under Fed.R.Evid. 702. In the alternative, the defendant argues that even including the expert witness's opinion, the plaintiff's claims fail because she has not demonstrated the existence of a reasonable alternative design. The Court grants the defendant's motion.

I. Factual History [1]

A. The Plaintiff's Injury

Plaintiff Diane Kordek was formerly employed as a surgical technician by Albert Einstein Medical Center in Philadelphia. As a surgical technician, Ms. Kordek was responsible for setting up and preparing the operating rooms in the Labor and Delivery unit of the hospital. This included gathering surgical instruments that were needed for child delivery procedures. Transcript of Deposition of Diane Kordek (" Kordek Dep." ) 115:12-20, 143:23-144:6.

On the evening of September 11, 2008, Ms. Kordek prepared a room for an urgent Cesarean section delivery. One of the surgical instruments she handled was a disposable scalpel with a fully removable shield covering the blade. Id. 124:22-128:9, 252:1-7; 274:12-15; 161:7-21.

The scalpel's shield was difficult to remove, and Ms. Kordek wrapped all of her fingers around the shield and pulled. Ms. Kordek pulled on it several times before it came loose. Id. 315:8-17; 310:15-311:10.

In the course of removing the shield, Ms. Kordek lacerated her hand and arm. She has testified that as a result of the scalpel injury, she now suffers from reflex sympathetic dystrophy (RSD) and complex regional pain syndrome (CRPS), such that she is permanently disabled. Compl. ¶ 29.

B. Defendant's Involvement

The scalpel that injured Ms. Kordek was manufactured and sold by defendant, Becton, Dickinson and Company (BD).[2] At the time of the incident, BD manufactured a range of scalpel products, which included the conventional disposable scalpel and the protected disposable scalpel. Compl. ¶ 23;

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Tr. Dep. Carl Chrisbacher (" Chrisbacher Dep." ) 25:1-24.

1. Conventional Disposable Scalpel

A conventional disposable scalpel (also called a conventional scalpel or a disposable scalpel with a fully removable shield) is a single-use product in which the blade is heat-staked into a plastic handle. BD's conventional scalpel blades are protected by a flexible, tube-like vinyl shield, which is fully removed from the scalpel before use. To remove the shield, the individual holds the scalpel with one hand and uses the fingers of the other hand to pinch the tip of the shield and pull it away from the blade. Thus, a person must use two hands to remove the scalpel shield from a conventional disposable scalpel. This is the type of scalpel that Ms. Kordek handled on the night of the incident. Chrisbacher Dep. 130:3-7; 25:23-26:10, 45:10-46:13, 47:4-8; Kordek Dep. 267:6-16; 161:7-21.

Aside from Ms. Kordek, Mr. Chrisbacher has not heard any complaints from users encountering difficulty in removing the shield from the conventional scalpel. In addition, in 2008-09, BD did not receive any reports of complaints of injuries from a conventional scalpel and received only one complaint about an " unknown" scalpel. Chrisbacher Dep. 180:21-181:2; Def. Mot. Exh. 8, pp. 4, 6.

2. Protected Disposable Scalpel

Beginning in 2000, BD began developing and implementing a new line of safety-engineered reusable blade systems disposable scalpels, which included the protected disposable scalpel. Chrisbacher Dep. 20:23-21:4.

The protected disposable scalpel (also called a retractable shield scalpel) is a single-use product and consists of a plastic handle, blade, and shield. Unlike the conventional disposable scalpel, which has a fully removable vinyl shield, the protected disposable scalpel has a shield that can be retracted for use then pushed back over to protect the blade. Chrisbacher Dep. 24:4-12. This protected disposable scalpel was eventually made available in Albert Einstein Medical Center facilities. Tr. Dep. Karen Horner (" Horner Dep." ) 86:1-87:4.

As a result of the retraction device, a person can " remove" the shield using only one hand. Carl Chrisbacher, BD's manufacturing integrator manager, testified that the ability of the protected disposable scalpel to retract its shield with one hand improved the safety of the scalpel. Chrisbacher Dep. 10:3-10; 36:16-24, 37:21-24, 39:6-20, 41:23-42:1.

BD designed these scalpels to minimize the risk of surgical blade injuries. In subsequent advertising literature regarding the retractable shield products, BD described these products as " [a]llowing clinicians to retract the protective shield easily and safely with one hand." It also stated that the scalpels were " virtually the same size and weight" as conventional scalpels. Id. 37:21-24; Pl. Opp. Exh. K.

BD initially thought that if demand for its scalpels with the retraction capacity was sufficient, it might opt to carry only that line of scalpels and discontinue the manufacture of the products incapable of retraction. ...

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