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Webb v. Ethicon Endo-Surgery, Inc.

United States District Court, D. Minnesota

December 17, 2014

SUSAN WEBB, Plaintiff,

William L. Tilton, Michael J. Gross, George R. Dunn, and Grace Davies, TILTON & DUNN, P.L.L.P., for plaintiff.

David R. Noteware and Timothy E. Hudson, THOMPSON & KNIGHT LLP, One Arts Plaza, and Kim M. Schmid and Sheryl A. Bjork, BOWMAN & BROOKE LLP, for defendant.[1]


JOHN R. TUNHEIM, District Judge.

Susan Webb brings this action against Ethicon Endo-Surgery, Inc. ("Ethicon"), alleging that a surgical stapler manufactured by Ethicon failed to fire properly during Webb's gastroesophageal surgery, causing her to sustain injuries from a postoperative leak. She asserts claims sounding in strict products liability, negligence with respect to manufacturing, and breach of warranty of merchantability. This matter is now before the Court on Webb's motion for partial summary judgment with respect to her strict liability claim.

The Court concludes that Webb is not entitled to summary judgment because, considering the record in the light most favorable to the non-moving party, there is sufficient evidence upon which a reasonable jury could conclude that Webb's injuries were not proximately caused by a manufacturing defect. The Court will thus deny Webb's motion for partial summary judgment.



In May 2009, doctors at St. John's Hospital in Maplewood, Minnesota diagnosed a large tumor on the outside of Webb's esophagus, partly encasing the junction between Webb's esophagus and stomach. (Aff. of Michael Gross ("Gross Aff."), Ex. 11 at 800026, 800098, May 19, 2014, Docket No. 42.) Webb experienced a great deal of pain from the tumor. ( Id. at 800025.) Two months later, on July 29, 2009, she underwent surgery at United Hospital in St. Paul, Minnesota, where her case was treated as potentially cancerous. (Gross Aff., Ex. 5 (Aff. of William M. Rupp ("Rupp Aff.")) ¶¶ 7, 23.) Dr. William Rupp was Webb's lead surgeon. ( Id. ¶ 7.) Dr. Peter Kelly assisted Dr. Rupp with the surgery. ( Id. ) Robin Henderson was the circulating nurse on duty. (Gross Aff., Ex. 16 (Aff. of Robin Henderson ("Henderson Aff.")) ¶ 1.)

Nurse Henderson prepared the surgical instruments for Webb's surgery. One of the instruments she readied was a TX60B surgical stapler, manufactured by Ethicon. ( Id. ¶ 3; id., Ex. 4 at 1, 4.)[2] Ethicon produces the TX60B as part of its Proximate Linear Stapler line, designed to reclose internal tissue incisions after surgery. ( Id., Ex. 4 at 1, 4.) The stapler is supplied sterile in a protective pouch. ( Id., Ex. 4 at 8.) It is disposable and intended only for use on a single patient. ( Id. ) The stapler has two triggers. The "closing trigger" is squeezed prior to firing any staples, in order to secure the tissue in the jaws of the stapler. ( Id., Ex. 4 at 5-6.) When a surgeon is ready to reclose the incision, he or she then squeezes the second trigger, also known as the "firing trigger, " which discharges the staples along the incision. ( Id., Ex. 4 at 6.) If staples of the incorrect size are loaded into a TX60B stapler, the stapler will still fire, but the discharged staples will be malformed. (Rupp Aff. ¶ 43.)

United Hospital stores surgical equipment, including TX60B staplers, on shelves in the United Surgical Services department prior to surgery dates. (Gross Aff., Ex. 15 (Aff. of Tyler Lindquist ("Lindquist Aff.")) ¶ 3.) TX60B staplers are sterile instruments. United Hospital stores the staplers and sends them to the Operating Room in their original packaging to preserve sterility. ( Id. ¶¶ 3, 6-7.) Prior to Webb's procedure, Nurse Henderson initialed a "Surgical Checklist" form to indicate that the TX60B stapler was present on the surgical cart. (Henderson Aff. ¶ 3.) During the surgery, Nurse Henderson opened the stapler's sealed sterile packaging and handed the stapler to Dr. Rupp for use during the operation. ( Id. ¶ 6.) She has only a vague memory of Webb's procedure but does not recall any mishandling or misuse of the stapler prior to the surgery. ( Id. ¶ 7.)

Dr. Rupp was the surgeon who actually operated the stapler during Webb's surgery. When he was ready to remove Webb's tumor, Dr. Rupp pulled the "closing trigger" on the stapler to secure it in place. (Rupp Aff. ¶ 22.) The closing trigger appeared to function normally, so he proceeded to pull the "firing trigger." ( Id. ) Because of the position of the stapler in a very narrow space, Dr. Rupp was not able to see whether any staples had been discharged when he pulled the firing trigger. (Gross Aff., Ex. 12 (Dep. of William M. Rupp ("Rupp Dep.")) at 11.) Although he was unable to tell whether any staples had discharged, Dr. Rupp assumed the stapler had fully and properly fired, so he proceeded to remove Webb's tumor without incident. (Rupp Aff. ¶¶ 22-24.)

After Dr. Rupp removed the tumor, he unclamped the stapler and realized that no staples had discharged into Webb's tissue. ( Id. ¶ 25.) He inspected both the gastroesophageal tissue and also the excised tumor mass for staples, but did not find any. ( Id. ¶¶ 25, 40-41.) Because Webb's incision remained open, Dr. Rupp hand stitched a suture line to close the opening. ( Id. ¶ 28.) Dr. Rupp felt that hand stitching was a less desirable option because it could have higher rates of postoperative leaks than stapling. ( Id. ¶¶ 19-20, 28-30.) Ethicon disputes the medical evidence on this point. (Decl. of William G. Hawkins ("Hawkins Decl.") ¶¶ 4-7, June 9, 2014, Docket No. 74.) Ethicon asserts that the risk of postoperative leaks following gastroesophageal surgeries is not significantly different for hand-stitched closures than it is for stapled closures. ( Id. )

Webb did, in fact, develop a postoperative leak at the surgical site. (Rupp Aff. ¶¶ 29, 31.) As a result of complications from the leak, she was rehospitalized one week after her initial surgery. (Gross Aff., Ex. 7 (Records from Susan Webb's July 2009 hospitalizations at United Hospital) at 000136.) During the second hospitalization, Webb underwent an urgent additional surgery to stop the leak, which was performed by Dr. Peter Kelly. ( Id .; see also Rupp Aff. ¶¶ 29, 31.) Webb alleges that she has suffered "cognitive deficits (brain injury) ...

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