Monday, August 01, 2011


No. 10-12578
D.C. Docket No. 7:08-cv-00114-HL
a wholly owned subsidiary of Mast
Biosurgery AG, the parent company,
Appeal from the United States District Court
for the Middle District of Georgia
(June 30, 2011)
Before TJOFLAT, WILSON and RIPPLE,* Circuit Judges.
* Honorable Kenneth F. Ripple, United States Circuit Judge for the Seventh Circuit,
sitting by designation.
RIPPLE, Circuit Judge:
Wanda Williams brought this diversity action in the United States District
Court for the Middle District of Georgia against Mast Biosurgery USA, Inc.
(“Mast”), a medical device manufacturer. She sought relief under Georgia
products liability law. After barring certain testimony that Ms. Williams had
attempted to offer in order to establish an element of her claim, the district court
entered summary judgment for Mast. We conclude that the district court did not
err in its evidentiary rulings and that Ms. Williams has failed to introduce
evidence sufficient to establish the manufacturing defect that she alleged.
Accordingly, we affirm the judgment of the district court.
A. Facts
In 2006, Ms. Williams sought treatment for a painful, undiagnosed
gynecological condition that was suspected to contribute to infertility. An
ultrasound revealed a large ovarian cyst. Ms. Williams underwent a laproscopic
procedure to drain the cyst. During the procedure, Dr. Adcock, her gynecologist,
observed within Ms. Williams’s abdomen significant dense adhesions that had
resulted from a prior surgery some years before. He further observed that these
adhesions “were suspicious for malignancy or something to that effect.” R.37,
Ex. 1 at 48.
To address further these observations, Dr. Adcock performed an exploratory
laparotomy on August 22, 2006. During this second procedure, he biopsied Ms.
Williams’s peritoneum and both ovaries and removed “extensive adhesions of
[the] sigmoid and rectum to the posterior uterine fundus.” Id. at 49 (internal
quotation marks omitted). To prevent new adhesions from forming, Dr. Adcock
placed four pieces of SurgiWrap in Ms. Williams’s abdomen. SurgiWrap is a
product designed and produced by Mast. It is marketed as a bioresorbable barrier
used to prevent post-surgical adhesions. Dr. Adcock believed that preventing
further adhesions between Ms. Williams’s organs could have a positive effect on
her fertility.
One month after the August 22 procedure, Ms. Williams returned to
Dr. Adcock’s office. She presented a number of symptoms, including persistent
diarrhea, fever and pain in the lower left quadrant of her abdomen. Observing that
she “looked really sick,” Dr. Adcock admitted her to the hospital and ordered tests
to ascertain the reason for her distress. Id. at 81. After ruling out various causes
of her symptoms, he referred her to Dr. George Yared, a gastroenterologist, for a
colonoscopy. During the colonoscopy, Dr. Yared observed what he described as
several stiff, hard and brittle pieces of plastic in Ms. Williams’s colon, some as
large as fourteen to eighteen millimeters. He removed two large pieces, but was
unable to remove other pieces embedded in the wall of the colon. He suspected
the material was the SurgiWrap used by Dr. Adcock during the August 22
procedure. The day following the colonoscopy, Ms. Williams underwent, at Dr.
Yared’s recommendation, a further exploratory procedure by Dr. Robert Brown, a
general surgeon. In addition to cleaning out the significant infection in her pelvis,
Dr. Brown performed a partial sigmoid colectomy to remove a damaged section of
her colon, an appendectomy and a colostomy formation. He found and removed
multiple small pieces that he believed were a foreign, clear, plastic-like substance.
A pathologist, Dr. Robert Nelms, Jr., examined the specimens and described the
material as stiff and thick.

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