Cole v. Mentor Corporation et al
Filing
44
ORDER granting in part and denying in part 40 Motion for Summary Judgment. Ordered by US DISTRICT JUDGE CLAY D LAND on 11/28/2016. (CCL)
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF GEORGIA
COLUMBUS DIVISION
IN RE MENTOR CORP. OBTAPE
TRANSOBTURATOR SLING PRODUCTS
LIABILITY LITIGATION
* MDL Docket No. 2004
4:08-MD-2004 (CDL)
*
Case Nos.
* 4:13-cv-321 (Cole)
O R D E R
Defendant
Mentor
Worldwide
LLC
developed
a
suburethral
sling product called ObTape Transobturator Tape, which was used
to
treat
women
with
stress
urinary
incontinence.
Plaintiff
Linda Faye Cole was implanted with ObTape and asserts that she
suffered injuries caused by ObTape.
liability
action
against
Mentor,
Cole brought a product
contending
that
ObTape
had
design and/or manufacturing defects that proximately caused her
injuries.
Cole also asserts that Mentor did not adequately warn
her physicians about the risks associated with ObTape.
seeks summary judgment on all of Cole’s claims.
Mentor
For the reasons
set forth below, Mentor’s summary judgment motion (ECF No. 40 in
4:13-cv-321) is granted in part and denied in part.
SUMMARY JUDGMENT STANDARD
Summary judgment may be granted only “if the movant shows
that there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.”
Civ. P. 56(a).
In determining whether a
genuine
Fed. R.
dispute of
material fact exists to defeat a motion for summary judgment,
the evidence is viewed in the light most favorable to the party
opposing summary judgment, drawing all justifiable inferences in
the opposing party’s favor.
477 U.S. 242, 255 (1986).
Anderson v. Liberty Lobby, Inc.,
A fact is material if it is relevant
or necessary to the outcome of the suit.
Id. at 248.
A factual
dispute is genuine if the evidence would allow a reasonable jury
to return a verdict for the nonmoving party.
Id.
FACTUAL BACKGROUND
Plaintiff
Linda
Faye
Cole
developed
stress
urinary
incontinence and sought treatment from Dr. John Peacock.
Peacock implanted Cole with ObTape on July 30, 2004.
Dr.
When Dr.
Peacock implanted Cole with ObTape, Dr. Peacock had “significant
clinical experience” with ObTape “that had been overwhelmingly
positive.”
Peacock Dep. (Cole) 192:11-15, ECF No. 40-7 in 4:13-
cv-321.
When deciding whether to use a medical device, Dr. Peacock
wants as much clinically relevant information as possible; if
relevant
information
informed decision.
is
withheld,
he
cannot
make
a
fully
Peacock Dep. (Burch) 153:24-154:8, ECF No.
42-10 in 4:13-cv-321.1
When Dr. Peacock implanted Cole with
1
Dr. Peacock implanted Barbara Burch, another plaintiff
with ObTape on July 2, 2004. Burch v. Mentor Corp., No.
2004-CDL, 2015 WL 5722799, at *1 (M.D. Ga. Sept. 29,
relies on the deposition testimony Dr. Peacock gave
addition to the testimony he gave in this case.
2
in this MDL,
2004 4:08-MD2015).
Cole
in Burch in
ObTape, he understood that the risks of certain adverse events
with ObTape were fairly low.
No. 42-3.
Peacock Dep. (Cole) 25:2-9, ECF
He reached that understanding based on his discussion
with a Mentor representative and his review.
Id. at 25:11-13.
Dr. Peacock was aware of both “short and potentially long-term
complications.”
Mentor
Id. at 25:14-20.
representative
that
ObTape
He also understood from the
“was
a
woven
polypropylene
mesh” that was less elastic than the material Dr. Peacock had
been using.
Peacock Dep. (Burch) 29:19-30:4.
Dr. Peacock does
not recall whether he reviewed the ObTape product insert data
sheet.
Id. at 63:20-23.
Dr. Peacock testified that he would
have wanted to know if ObTape could cause chronic inflammation,
as well as the clinical relevance of ObTape’s pore size.
114:2-11, 121:14-20, 123:14-124:7.
Id. at
Before he implanted ObTape
in Cole, Dr. Peacock was not aware of “any differences in pore
size other than [he] knew [ObTape] was smaller than the very
coarse product that [he] was accustomed to using.”
(Cole) 32:11-24, ECF No. 42-3.
Peacock Dep.
Dr. Peacock knew that a larger
pore size would promote more tissue ingrowth than a small pore
size, but he did not know (and still does not know) “the pore
size at which that cutoff is critical.”
Id. at 32:23-34:3.
He
also knew that if a pore did not go all the way through the
ObTape,
that
could
prevent
macrophages
from
infiltrating
the
pore, but he did not know the clinical implications of some
3
blind pores and would not be surprised if some pores did not go
all the way through ObTape.
Id. at 34:14-35:12.
According to
Dr. Peacock, Mentor did not inform him that other doctors had
reported a high erosion rate with ObTape.
172:1-5.
Though
Dr.
Peacock
testified
Peacock Dep. (Burch)
that
he
already
had
extensive experience with ObTape by July 2004 and had not seen
such erosion rates, he also testified that he would want to know
if other doctors were experiencing problems.
Id. at 172:8-15.
If he knew about the complications other doctors reported, that
“might” impact his decision to continue using ObTape.
Id. at
172:16-18.
After
chronic
her
urinary
ObTape
implant
tract
antibiotic prophylaxis.
No. 42-5 in 4:13-cv-321.
surgery,
infections
and
Cole
was
began
placed
to
on
suffer
chronic
Cook Decl. Ex. C, White Report 5-6, ECF
She also began to experience recurrent
urinary incontinence and pelvic pain.
Id. at 6.
Cole has never
been diagnosed with an erosion or infection of her ObTape, and
her entire ObTape is still in her body.
Cole claims that ObTape
caused recurrent incontinence, voiding problems, urinary tract
infections, dyspareunia, vaginal and pelvic pain, and thigh and
back pain.
Two of Cole’s treating physicians—Dr. Peacock and
Dr. Bryant Williams—testified that there is nothing in Cole’s
medical records to suggest that she had complications associated
4
with her ObTape or that she had issues with poor tissue ingrowth
of her ObTape.
Dr. Andrew Siegel, a board certified urologist and Cole’s
general causation expert, opined that the physical properties of
ObTape
can
prevent
inflammation.
in
tissue
ingrowth
and
can
cause
chronic
Cook Decl. Ex. G, Siegel Report 4, ECF No. 42-9
4:13-cv-321.
Dr.
Siegel
also
opined
that
the
physical
properties of ObTape can cause pain and organ dysfunction.
Id.
Dr. Amanda White, a board certified urogynecologist and Cole’s
specific causation expert, also opined that ObTape’s physical
properties
rendered
it
“prone
to
infection
and
extrusion.”
White Report 4.
Dr.
White
reviewed
Cole’s
medical
depositions of Cole’s treating physicians.
records
Dr.
White
concluded
contributing
cause
of
including
urgency
and
Ms.
Based on her
that
“ObTape
is
Cole’s
chronic
bladder
frequency,
the
She also relied on
her extensive experience with urethral slings.
review,
and
recurrent
a
substantial
symptoms,
urinary
tract
infections, nocturia, pelvic pain, and dyspareunia, and need for
subsequent procedures and treatments.”
White Report 7.
She
also opined that Cole’s “recurrent urinary tract infections were
likely caused by the material properties of the ObTape device.”
Id.
Finally, she opined that “[t]he material properties of the
ObTape transobturator sling, namely unwoven, thermally bonded
5
polypropylene microporous mesh are such that tissue in-growth
with capillary penetration is prohibited.
While bacteria are
able to enter the graft, host defense mechanisms are unable to
respond within the device secondary to the size of leukocytes
and macrophages.
The result is an encapsulated graft with acute
and chronic inflammation.”
Id.
Cole asserts claims for negligence, strict liability design
defect, strict liability failure to warn, breach of warranties,
unjust
enrichment,
fraud,
and
negligent
misrepresentation.
Mentor seeks summary judgment on all of these claims.
Cole does
not challenge Mentor’s summary judgment motion on her warranty
and
unjust
enrichment
claims,
so
the
Court
grants
Mentor’s
summary judgment motion as to those claims.
DISCUSSION
Cole filed this action on July 9, 2013 in the United States
District Court for the District of Minnesota.
The case was
transferred to this Court as part of a multidistrict litigation
proceeding regarding ObTape.
The parties agree for purposes of
summary judgment that Minnesota law applies to Cole’s claims.
See Cline v. Mentor Corp., No. 4:10-cv-5060, 2013 WL 286276, at
*7
(M.D.
Ga.
Jan.
24,
2013)
(concluding
that
Minnesota
law
applied to claims of non-Minnesota ObTape plaintiffs who brought
their actions in Minnesota).
6
I.
Design Defect Claims
Cole
brings
design
defect
claims
under
negligence
and
strict liability theories, asserting that ObTape had a design
defect that caused her injuries.
claims fail for lack of causation.
First,
Mentor
contends
that
Mentor argues that Cole’s
The Court disagrees.
Cole
did
not
point
to
any
evidence to establish general causation: that ObTape is capable
of causing the types of injuries Cole suffered.
But Dr. Siegel
testified that the physical properties of ObTape can prevent
tissue
ingrowth
Report 4.
and
can
cause
chronic
inflammation.
He also opined that the physical properties of ObTape
can cause pain and organ dysfunction.
Id.
that
rendered
ObTape’s
physical
infection and extrusion.”
she
suffered
symptoms.
Siegel
chronic
properties
And Dr. White opined
White Report 4.
infections
and
it
“prone
to
Cole asserts that
pain,
along
with
other
Drs. Siegel and White opine that ObTape is capable of
causing these types of injuries, so the Court is satisfied that
the evidence from Drs. Siegel and White is sufficient to create
a genuine fact dispute on general causation.
Second,
Mentor
asserts
that
Cole
did
not
point
to
sufficient evidence to establish specific causation: that ObTape
actually caused Cole’s injuries.
based
on
her
review
of
Cole’s
Again, Dr. White opined that
medical
records,
ObTape
more
likely than not was a substantial contributing cause of Cole’s
7
injuries, including her recurrent urinary tract infections and
pelvic
pain.
properties
of
Dr.
White
ObTape
further
inhibited
opined
tissue
that
ingrowth
the
and
material
permitted
bacteria to enter the graft while preventing defense mechanisms
like
leukocytes
and
Cole’s injuries.
physician
macrophages
from
responding—leading
to
Mentor contends that because Cole’s treating
believes
that
Cole
did
not
experience
poor
tissue
ingrowth or an encapsulated graft, the Court should ignore Dr.
White’s opinion.
Based on the present record, the Court is not
convinced that the difference in opinion between Dr. Peacock and
Dr. White is a valid basis for excluding Dr. White’s opinion at
this
time.
The
Court
thus
declines
to
ignore
Dr.
White’s
opinion and finds that it is sufficient to create a genuine fact
dispute on specific causation.
denies
Mentor’s
summary
For these reasons, the Court
judgment
motion
as
to
Cole’s
design
defect claims.
II.
Failure To Warn, Fraud, and Misrepresentation Claims
Cole brings failure to warn claims under a strict liability
theory,
contending
that
Mentor
did
not
adequately
physicians about the true risks of ObTape.
fraud
and
negligent
misrepresentation
warn
her
Cole also brings
claims,
asserting
that
Mentor made fraudulent and negligent misrepresentations to her
physicians about the risks of ObTape.
8
Mentor argues that Cole
has
not
presented
enough
evidence
to
create
a
genuine
fact
dispute on causation for these claims.
Under Minnesota law, a plaintiff claiming a failure to warn
must
show
that
“the
lack
plaintiff’s injuries.”
of
an
adequate
warning
caused
Tuttle v. Lorillard Tobacco Co., 377
F.3d 917, 924 (8th Cir. 2004) (applying Minnesota law).
to
establish
causation
misrepresentation
claims
the
on
her
under
failure
Minnesota
to
warn,
law,
Cole
Thus,
fraud,
must
and
show
that a different warning or an accurate disclosure of the risks
of ObTape would have made a difference in her treatment.
There
must be some evidence that the product user (or, in cases like
this one where the learned intermediary doctrine applies, the
product user’s doctor) “would have acted differently had the
manufacturers provided adequate warnings.”
Id.
Cole pointed to evidence that Dr. Peacock relied on the
representations of a Mentor representative when he began using
ObTape.
She also pointed to evidence that if Dr. Peacock had
received information from Mentor regarding the true risks of
ObTape—including the clinical relevance of the small pore size
and the complications other doctors experienced with ObTape—that
might have impacted his decision to use ObTape in July 2004.
Based on this evidence, the Court is satisfied that there is a
genuine fact dispute on causation for Cole’s failure to warn,
9
fraud, and misrepresentation claims.
Mentor is therefore not
entitled to summary judgment on these claims.2
CONCLUSION
As discussed above, Mentor’s summary judgment motion (ECF
No. 40 in 4:13-cv-321) is granted as to Cole’s warranty and
unjust enrichment claims but denied as to Cole’s design defect
claims and her failure to warn, fraud, and misrepresentation
claims
based
on
pre-implant
warnings
and
representations.
Mentor’s motion is granted as to any claims Cole asserted under
a continuing duty to warn theory.
This action is ready for trial.
Within seven days of the
date of this Order, the parties shall notify the Court whether
they agree to a Lexecon waiver.
IT IS SO ORDERED, this 28th day of November, 2016.
S/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA
2
Cole focuses on her argument that a different pre-implant warning
would have made a difference. She did not respond to Mentor’s summary
judgment motion on her continuing duty to warn claim or point to any
evidence to support such a claim, such as evidence that her postimplant treatment would have been different had her doctors received
different post-implant information from Mentor.
Thus, if Cole did
assert a continuing duty to warn claim, Mentor is entitled to summary
judgment on it.
10
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