Webb v. Ethicon Endo-Surgery, Inc.
Filing
247
MEMORANDUM OPINION AND ORDER denying plaintiff's 39 Motion for Partial Summary Judgment (Written Opinion). Signed by Judge John R. Tunheim on December 17, 2014. (DML)
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
SUSAN WEBB,
Civil No. 13-1947 (JRT/JJK)
Plaintiff,
v.
ETHICON ENDO-SURGERY, INC.,
MEMORANDUM OPINION AND
ORDER DENYING PLAINTIFF’S
MOTION FOR PARTIAL
SUMMARY JUDGMENT
Defendant.
William L. Tilton, Michael J. Gross, George R. Dunn, and Grace Davies,
TILTON & DUNN, P.L.L.P., 101 Fifth Street East, Suite 2220, St. Paul,
MN 55101, for plaintiff.
David R. Noteware and Timothy E. Hudson, THOMPSON & KNIGHT
LLP, One Arts Plaza, 1722 Routh Street, Suite 1500, Dallas, TX 75201,
and Kim M. Schmid and Sheryl A. Bjork, BOWMAN & BROOKE LLP,
150 South Fifth Street, Suite 3000, Minneapolis, MN 55402, for
defendant.1
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
1
John Sear, Bowman & Brooke LLP, represented defendant Ethicon Endo-Surgery, Inc.
and provided argument for the motion at the August 5, 2014, hearing. On September 3, 2014, a
Notice of Withdrawal and Substitution of Counsel was filed. (Docket No. 169.)
29
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.
BACKGROUND
I.
SUSAN WEBB’S SURGERY
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.
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¶ 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.)
2
All page numbers refer to the CM/ECF pagination unless otherwise noted.
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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
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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) secondary to her critical illness caused by the GI leak,”
which have “persisted and are permanent.” (Compl. ¶¶ 35-36, July 19, 2013, Docket
No. 1.)
II.
THE DISAPPEARANCE OF WEBB’S STAPLER
Sometime between the end of Webb’s surgery and the filing of her claim, the
TX60B stapler used during Webb’s surgery was lost or discarded. United Hospital’s
standard procedure following surgeries is to discard one-time use equipment, such as a
TX60B stapler. (Henderson Aff. ¶ 10; Lindquist Aff. ¶ 8.) In this case, Dr. Rupp
testified that he instructed a member of the surgical team to return the stapler to Ethicon
for evaluation. (Rupp Dep. at 4.) When asked by counsel at what time he gave that
instruction, Dr. Rupp testified that he did so “[i]mmediately after [he] used it and saw
that it didn’t function correctly.” (Id.) Dr. Rupp did not recall to whom he gave this
instruction. (Id.)
In a 2013 affidavit, Nurse Henderson stated that she did not remember the details
of Webb’s surgery and did not know what happened to the stapler. (Henderson Aff. ¶¶ 1,
10.) In a July 2014 deposition, however, Nurse Henderson described placing the stapler
in a red bag and setting it on the counter in the equipment room, along with a note stating,
“Per M.D., stapler didn’t fire.” (Decl. of John D. Sear, Ex. 1 (Dep. of Robin Henderson)
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at 10, Aug. 11, 2014, Docket No. 146.) Nurse Henderson does not know whether the
stapler was ever returned to Ethicon. (Henderson Aff. ¶ 10.) She and Tyler Lindquist,
the Business Manager at United Hospital’s Surgical Care Center, both agree, however,
that the stapler was not given to Webb or any member of her family. (Id. ¶ 11; Lindquist
Aff. ¶ 10.) There is no record of United Hospital actually sending the stapler to Ethicon
nor is there a record of Ethicon receiving the stapler. The stapler is now unavailable for
inspection.
III.
TX60B STAPLER MANUFACTURING PROCESS
TX60B staplers are manufactured at Ethicon’s facilities in Juarez, Mexico. (Decl.
of Michael D. Cronin ¶ 10, June 9, 2014, Docket No. 73.) The staple cartridges are
manufactured by a third-party and delivered to Ethicon’s Juarez manufacturing facility to
be loaded with staples and assembled as part of the final stapler product. (Id. ¶ 10.)
At the Juarez facility, each stapler goes through four of what Ethicon refers to as
“quality assurance processes or checks.” (Id. ¶ 25.) First, each new, unloaded staple
cartridge is visually inspected by a Staple Maker Loader (“SML”) machine operator. (Id.
¶ 12.) The operator places each staple cartridge individually into the automated SML.
(Id. ¶ 13.) The SML prepares each cartridge to receive the staples and then loads staples
into the cartridge. (Id.)
Second, the cartridges are then removed by the operator who performs a second
visual inspection to ensure that the staples are in the cartridge. (Id. ¶ 14.) In addition to
the operator’s visual inspection, Ethicon’s facility selects samples from each batch of
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cartridges and conducts a test on the ejection of the staples and their conformity to the
correct dimensions and shape. (Id. ¶ 15.)
Third, the operator presents the cartridges to Ethicon’s “Staple Presence vision
system,” which “takes a picture of each individual staple pocket and compares those
pictures to known pictures of staple pockets which do and do not have staples inside
them.” (Id. ¶ 16.) If the system detects an empty cartridge, it automatically “ejects the
unacceptable cartridge into a locked scrap bin.” (Id. ¶ 17.)
The fourth “quality assurance process” is for each staple cartridge to be fitted with
a red retaining cap, which prevents the staples from moving or dislodging during
transport. (Id. ¶ 18.) The cap remains in place until the nurse or surgical technician
removes the cap in the operating room. (Id.)
Finally, each stapler cartridge is visually inspected and photographed with another
vision system to ensure that each cartridge has the correct type of staple in it and a red
retaining cap. (Id. ¶ 20.) The staplers are then sent to New Mexico for sterilization,
packaged in sterilized pouches, and shipped to hospitals. (Id. ¶ 22.) Michael D. Cronin,
the Project Director for Ethicon’s Research and Development department, asserts that in
twenty-seven years of working at Ethicon, he is “unaware of any time that an empty or
defective [stapler] cartridge left the manufacturing facility.” (Id. ¶ 26.)
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ANALYSIS
I.
STANDARD OF REVIEW
Summary judgment is appropriate where there are no genuine issues of material
fact and the moving party can demonstrate that it is entitled to judgment as a matter of
law. Fed. R. Civ. P. 56(a). A fact is material if it might affect the outcome of the suit,
and a dispute is genuine if the evidence is such that it could lead a reasonable jury to
return a verdict for either party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248
(1986). A court considering a motion for summary judgment must view the facts in the
light most favorable to the non-moving party and give that party the benefit of all
reasonable inferences to be drawn from those facts. Matsushita Elec. Indus. Co. v. Zenith
Radio Corp., 475 U.S. 574, 587 (1986).
II.
RES IPSA LOQUITUR
Webb seeks relief from Ethicon on three grounds: strict products liability,
negligence with respect to manufacturing, and breach of warranty of merchantability.
With respect to the strict liability claim, Webb alleges that the TX60B stapler used during
her surgery was unreasonably dangerous due to a manufacturing defect at the time it left
Ethicon’s control. (Compl. ¶¶ 9-10, 41.) She now seeks summary judgment only on her
strict liability claim.
A.
Res Ipsa Loquitur in Minnesota Strict Products Liability Actions
As a federal court sitting in diversity, the Court applies the substantive law of the
state in which it sits. Fogelbach v. Wal-Mart Stores, Inc., 270 F.3d 696, 698 (8th Cir.
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2001). To recover on a strict liability claim brought under Minnesota products liability
law, “the plaintiff must establish (1) that the defendant’s product was in a defective
condition unreasonably dangerous for its intended use, (2) that the defect existed when
the product left the defendant’s control, and (3) that the defect was the proximate cause of
the injury sustained.” Bilotta v. Kelly Co., Inc., 346 N.W.2d 616, 623 n.3 (Minn. 1984);
Mack v. Stryker Corp., 748 F.3d 845, 849 (8th Cir. 2014). A manufacturing defect exists
when a product is “physically flawed, damaged, or incorrectly assembled . . . [and] such a
defect existed in the product when it left the hands of the manufacturer.” Restatement
(Third) of Torts: Prod. Liab. § 2, cmt. c (1998). Even if a product’s design encompasses
certain known risks, “‘where individual products within a product line are improperly
constructed’” such that the product bears risks not reasonably anticipated by a consumer,
the improperly-constructed products are considered unreasonably dangerous. Rynders v.
E.I. Du Pont, De Nemours & Co., 21 F.3d 835, 842 (8th Cir. 1994) (quoting Peterson v.
Safway Steel Scaffolds Co., 400 N.W.2d 909, 912 (S.D. 1987)).
Where the product is missing or the plaintiff is unable to determine the exact
defect in the product, a plaintiff may still reach the jury by employing a theory of res ipsa
loquitur. Lee v. Crookston Coca-Cola Bottling Co., 188 N.W.2d 426, 434-35 (Minn.
1971). Under a res ipsa loquitur theory, the plaintiff may rely on circumstantial evidence
to demonstrate the dangerously defective nature of a product.
Kapps v. Biosense
Webster, Inc., 813 F. Supp. 2d 1128, 1147-48 (D. Minn. 2011). Once a plaintiff has
shown injury from an allegedly defective product, if:
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the claimed defect is such that there is circumstantial evidence from which
it can be inferred that it is more probable than not that the product was
defective when it left defendant’s hands, absent plaintiff’s own want of care
or misuse of the product, there is an evidentiary basis for submitting the
issue of liability to the jury on both the theory of negligence and strict
liability in tort.
Id. at 1147 (quoting Holkestad v. Coca-Cola Bottling Co. of Minn., Inc., 180 N.W.2d
860, 865-66 (Minn. 1970)).
In Minnesota, however, “res ipsa loquitur alone cannot make out a products
liability case.” Trost v. Trek Bicycle Corp., 162 F.3d 1004, 1009 (8th Cir. 1998). Trost
allows plaintiffs to proceed to the jury on a theory of res ipsa loquitur in products liability
cases, but plaintiffs must be able to show “‘something more’” than that an accident or
injury occurred. Id. (quoting Peterson v. Crown Zellerbach Corp., 209 N.W.2d 922, 924
(Minn. 1973)); Bhd. Mut. Ins. Co. v. ADT, LLC, No. 13-1870, 2014 WL 2993728, at *5
(D. Minn. July 2, 2014) (quoting Rohwer v. Fed. Cartridge Co., No. 03-2872, 2004 WL
2677200, at *3 (D. Minn. Nov. 18, 2004)).
A plaintiff must also introduce some
additional evidence supporting a finding that the product was defective when it left the
manufacturer and that the defect caused the plaintiff’s injury. Peterson, 209 N.W.2d at
924.
B.
Webb’s Claim
Because the stapler used during Webb’s surgery is now missing, Webb relies on a
theory of res ipsa loquitur to make out her strict liability claim. She argues that evidence
of previous reports of similarly defective staplers, along with the lack of any testimony
contradicting Dr. Rupp’s account of the stapler malfunction during Webb’s surgery,
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entitles her to partial summary judgment.
Webb bases this claim largely on the
Minnesota Supreme Court’s analysis in Lee v. Crookston Coca-Cola Bottling Co. In Lee,
the court explained that when a plaintiff relies on a res ipsa loquitur theory to prove a
strict liability manufacturing defect claim, “a finding that the [product] was defective
when defendant put it on the market would compel a verdict for plaintiffs . . . .” 188
N.W.2d at 435.
Ethicon, in contrast, contends that the reports of other alleged stapler defects are
inadmissible because they are hearsay and because Webb has not shown that the other
incidents were “substantially similar” to this case. See Katzenmeier v. Blackpowder
Prods., Inc., 628 F.3d 948, 951 (8th Cir. 2010). As such, Ethicon asserts that the reports
are insufficient to satisfy the “something more” requirement under Trost and Peterson.
Further, Ethicon argues that the theory of res ipsa loquitur, as described in Lee, is
designed to enable a plaintiff to reach the jury when circumstantial evidence of a defect is
all that is available. At most, it can compel a verdict for the plaintiff at trial when the
defendant fails to introduce admissible evidence to combat the plaintiff’s claims.
Although Webb has produced some circumstantial evidence, the Court finds that
summary judgment is not appropriate for Webb’s strict liability claim. Webb is unable to
point to any Minnesota case – and this Court has found no case – in which a court has
entered summary judgment for the plaintiff in a strict products liability action under a
theory of res ipsa loquitur. Rather, when courts have found in favor of the plaintiff under
such a theory, it has been to allow the plaintiff to survive a defendant’s summary
judgment motion and proceed to the jury. See, e.g., Lee, 188 N.W.2d at 432-33 (“The
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narrow question presented here . . . is whether circumstantial evidence, the core of the
res ipsa loquitur doctrine, is sufficient to take the case to the jury on the theory of strict
liability . . . .”); Hammes v. Yamaha Motor Corp. U.S.A., Inc., No. 03-6456, 2006 WL
1195907, at *12 (D. Minn. 2006) (“The court determines that [Plaintiff] has presented
sufficient evidence of causation to survive summary judgment.”); Schafer v. JLC Food
Sys., Inc., 695 N.W.2d 570, 576 (Minn. 2005) (“[W]hen the specific harm-causing object
is not known[,] circumstantial evidence should be available . . . for purposes of
submitting the issue of liability to the jury in defective food product cases.”); Holkestad,
180 N.W.2d at 862 (“The dispositive question presented is whether circumstantial
evidence . . . is sufficient to justify the trial court’s submission of the issue of defendantappellant’s liability to the jury under the theory of res ipsa loquitur . . . .”).
While the Court does not rule out the possibility that there could be a case wellsuited to summary judgment for a plaintiff under a theory of res ipsa loquitur, the Court
finds that in this case, there remains a genuine issue of material fact as to whether the
stapler was defective and proximately caused Webb’s injuries. Although Dr. Rupp has
provided a detailed account of his recollection of the surgery, there were very few people
present in the operating room during Webb’s surgery, and other witnesses are less certain
about the events that transpired. Accordingly, the Court finds that it is appropriate for
Ethicon to have an opportunity to cross-examine Dr. Rupp, Nurse Henderson, and other
witnesses.
Additionally, to obtain summary judgment, Webb must prove that that “the defect
was the proximate cause of the injury sustained.” Lee, 188 N.W.2d at 329. Ethicon has
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offered the testimony of Dr. William G. Hawkins and several scientific studies as
evidence that postoperative leaks are an inherent risk of gastroesophageal surgery,
regardless of whether the surgeon uses a surgical stapler or hand-sewn sutures. (Hawkins
Decl. ¶¶ 4-7, Exs. B-D.)
The rates of postoperative leaks, Ethicon asserts, are not
significantly higher with hand-sewn closures than with stapled closures. Webb disputes
the relevance of Dr. Hawkins’s testimony in light of the unplanned nature of Webb’s
hand-sewn sutures. The Court finds, however, that Webb’s objections are best addressed
on cross-examination. Thus, Ethicon’s evidence raises a genuine issue of material fact
for the jury to decide.
Based on the evidence presented by both parties, a reasonable jury could find that
a defect in an Ethicon stapler was not the proximate cause of Webb’s injuries from a
postoperative leak. Therefore, the Court finds that partial summary judgment is not
appropriate for Webb’s strict liability claim.
ORDER
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
HEREBY ORDERED that Plaintiff’s Motion for Partial Summary Judgment [Docket
No. 39] is DENIED.
DATED: December 17, 2014
at Minneapolis, Minnesota.
____s/
____
JOHN R. TUNHEIM
United States District Judge
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