United States District Court, D. Idaho
RONALD GRUNIG and SHANNON GRUNIG, husband and wife, Plaintiffs,
JOHNSON & JOHNSON, a New Jersey Corporation, and ETHICON, INC., a New Jersey corporation, Defendants.
MEMORANDUM DECISION AND ORDER
Lynn Winmill U.S. District Court Judge
the Court is Defendants' Johnson & Johnson and
Ethicon, Inc. Motion for Summary Judgment. (Dkt. 26.) Also
before the Court is Defendants' Motion to Strike. (Dkt.
31.) Oral argument was held on the fully briefed motions on
October 22, 2019. After careful consideration of the
parties' memoranda, exhibits, and arguments, the Court
will grant both the Motion to Strike and the Motion for
facts below relate to the claims in this action and are not
in dispute, unless otherwise noted.
Ethicon Proceed Surgical Mesh
manufacture and distribute Ethicon Proceed Surgical Mesh,
which “is a sterile, thin, flexible, laminate mesh
designed for the repair of hernias and other fascial
deficiencies.” (Dkt. 30-10 at 6; Dkt. 30-3 at 8.)
Ethicon Surgical Mesh is at the heart of Plaintiffs'
claims in this matter.
mesh is composed of four layers. (Dkt. 30-3 at 8.) Layer one
is oxygenated regenerated cellulose-a plant-based fiber.
(ORC). Id. at 8-9. Layer two is a 0.8 mm sheet of
polymer film. Id. Layer three is a flexible plastic
“Prolene mesh product.” Id. at 8.
Finally, another layer of polymer film, this time 0.2 mm
thick is placed on top of the Prolene mesh. Id. at
8-9. During production, the layers are heated and moved
through a lamination roll. Id. at 8. The process
results in the OCR and the Prolene mesh being securely glued
to one and other by the adjacent layers of polymer film.
layer is a bioabsorbable product. (Dkt. 30-10 at 6; Dkt. 30-3
at 18.) It is designed to “physically separate”
the Prolene mesh “from the underlying tissue and organ
surfaces during the wound healing period to minimize tissue
attachment to the mesh.” (Dkt. 30-10 at 6.) In line
with its function, the ORC layer is designed to be completely
absorbed by the body within four (4) weeks of implantation.
Id. The polymer film also begins to break down and
dissipate after surgery. Id. The polymer film is
designed to be absorbed by the body within six (6) months of
implantation. Id. Thus, approximately 180 days after
a hernia repair surgery, only one layer of the product -the
Prolene mesh- remains in the body. In a surgical setting, the
Prolene side of the mesh is inserted facing the abdominal
wall, thus the OCR side faces the abdominal area and organs.
Id. It is expected that scar tissue will grow into
the Prolene side of the mesh, securing it to abdominal wall
allowing for “adequate stabilization” of the
fascial defect, i.e. the hernia. Id.
2010 Hernia Repair Surgery
October 2010, Ronald Grunig underwent a ventral hernia repair
surgery at Mercy Medical Center in Nampa, Idaho. (Dkt. 1 at
4.) “A hernia is a defect in the connective tissue
called facia, and that defect allows the body to push
intra-abdominal contents through the defect.”
(Ballantyne Dep.; Dkt. 30-4 at 10.) The surgery was performed
by Dr. Richard C. Ballantyne, D.O. Id. According to
Dr. Ballantyne, he used Ethicon Proceed Surgical Mesh to
repair the hernia, given the hernia's relatively large
size. Id. at 10-11. There were no complications
during the surgery. Id. at 11.
Mr. Grunig had undergone one hernia repair surgery and other
abdominal surgeries prior to the October 2010
surgery. (Dkt. 26-2, Ex. A; Dkt. 30-4 at 9.) Dr.
Ballantyne noted that the prior abdominal surgeries were
significant because “with previous repairs and his
surgical repair” Mr. Grunig was “going to have a
lot of scar tissue, a lot of adhesions, ” which would
make it more difficult to repair the hernia. (Dkt. 30-4 at
9.) Dr. Ballantyne testified that, he would have discussed
these risks with Mr. Grunig, including the risk of creating
more adhesions in the performance of another hernia repair.
2017 Bowl Obstruction Surgery
2017, Mr. Grunig experienced several days of nausea,
vomiting, pain, discomfort, and abdominal distension. (Dkt. 1
at ¶ 14.) Around July 16, 2017, Mr. Grunig was diagnosed
with bowel obstruction and was admitted to the hospital.
Id. On July 24, 2017, Dr. Forrest Fredline, D.O.,
performed an exploratory laparotomy. (Fredline Dep.; Dkt.
30-6 at 6.) During the procedure, Dr. Fredline observed that
there were “dense inflammatory attachments between the
loops of small intestine, ” and stated that these
attachments or adhesions “were between the visera
[sic], the small intestine, and the anterior
abdominal wall mesh, and there was dilated bowel prior to the
area of these attachments and decompressed bowel, distal or
after the areas of attachments.” Id.
Fredline testified that inflammation resultant from abdominal
surgery cause bands of tissue -adhesions-to form.
Id. at 6-7. According to Dr. Fredline, because there
was mesh present in Mr. Grunig's abdomen, he had
adhesions to the mesh. Id. Significantly, Dr.
Fredline testified Mr. Grunig “would have had adhesions
to the abdominal wall even if he didn't have mesh.”
Id. In sum, Dr. Fredline determined that Mr.
Grunig's bowel obstruction was caused by the adhesions.
Id. During the laparotomy, Dr. Fredline dissected
Mr. Grunig's bowel “off of the underlying
mesh” and removed “a portion of the mesh”
to clear the bowel obstruction. Id. The removed
portion of the mesh was not retained or
analyzed. (Dkt. 30-9.)
March 2018, Mr. Grunig and his wife Shannon Grunig, filed a
products liability action against Defendants.
(Compl., Dkt. 1.) Therein, Plaintiffs claim
Defendants are strictly liable for the defective manufacture
and design of the surgical mesh removed from Mr. Grunig, and
for failure to warn. Plaintiffs allege also that Defendants
are guilty of negligence in design, testing, inspection,
manufacture, packaging, labeling, marketing, distributing,
and in preparing instructions and warnings regarding the
mesh. Plaintiffs seek damages for Mr. Grunig's past,
present, and future medical expenses, mental and physical
pain and suffering, and for Ms. Grunig's loss of
consortium and services. Plaintiffs additionally seek
2018, Defendants filed their answers to the Complaint.
(Answer, Johnson & Johnson, Dkt. 6;
Answer, Ethicon, Dkt. 7.) After the discovery
period, Defendants filed a joint motion for summary judgment.
(Dkt. 26.) Therein, Defendants argue the undisputed material
facts show Plaintiffs cannot establish any of their claims as
a matter of law, and therefore, this action should be
dismissed in its entirety. By separate motion, Defendants
also ask the Court to strike portions of an affidavit
submitted in support of Plaintiffs' response to the
motion for summary judgment. (Dkt. 31.) Defendants argue the
affidavit contains inadmissible hearsay statements that do
not fall within a recognized hearsay exception. The Court
will set forth the relevant standards of law and analyze the
merits of Defendants' motions below.
Motion for Summary Judgment
judgment is appropriate when the evidence, viewed in the
light most favorable to the non-moving party, demonstrates
“there is no genuine issue of any material fact and
that the movant is entitled to judgment as a matter of
law.” Fed.R.Civ.P. 56(c); Celotex Corp. v.
Catrett, 477 U.S. 317, 322 (1986); Galen v. County
of Los Angeles, 477 F.3d 652, 658 (9th Cir. 2007).
summary judgment purposes, an issue must be both
“material” and “genuine.” An issue is
“material” if it affects the outcome of the
litigation; an issue is “genuine” if it must be
established by “sufficient evidence supporting the
claimed factual dispute ... to require a jury or judge to
resolve the parties' differing versions of the truth at
trial.” Hahn v. Sargent, 523 F.3d 461, 464
(1st Cir. 1975) (quoting First Nat. Bank of Ariz. v.
Cities Serv. Co., 391 U.S. 253, 289 (1968)); see
also British Motor. Car Distrib. v. San Francisco Auto.
Indus. Welfare Fund, 883 F.2d 371, 374 (9th Cir. 1989).
“Only admissible evidence may be considered in ruling
on a motion for summary judgment.” Stimpson v.
Midland Credit Mgmt., Inc., 347 F.Supp.3d 538, 544 (D.
the record taken as a whole could not lead a rational trier
of fact to find for the non-moving party, there is no genuine
issue for trial.” Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 587 (1986). Evidence
includes “the pleadings, depositions, answers to
interrogatories, and admissions on file, together with the
affidavits….” DeVries v. DeLaval, Inc.,
2006 WL 1582179, at *5 (D. Idaho June 1, 2006).
moving party initially bears the burden to show no material
fact is in dispute and a favorable judgment is due as a
matter of law. Celotex, 477 U.S. at 323. If the
moving party meets this initial burden, the non-moving party
must identify facts showing a genuine issue for trial to
defeat the motion for summary judgment. Cline v. Indus.
Maint. Eng'g & Contracting Co., 200 F.3d 1223,
1229 (9th Cir. 2000). The Court must enter summary judgment
if the nonmoving party “fails to make a showing
sufficient to establish the existence of an element essential
to that party's case, and on which that party will bear
the burden of proof at trial.” Celotex Corp. v.
Catrett, 477 U.S. 317, 322 (1986).
considering a motion for summary judgment, a court does not
make findings of fact or determine the credibility of
witnesses. See Anderson, 477 U.S. at 255.
Rather, it must draw all inferences and view all evidence in
the light most favorable to the nonmoving party. See
Matsushita, 475 U.S. at 587-88; Whitman v.
Mineta, 541 F.3d 929, 931 (9th Cir. 2008).