Austin v. Mentor Worldwide LLC 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 12/7/2016. (CCL)
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF GEORGIA
COLUMBUS DIVISION
* MDL Docket No. 2004
4:08-MD-2004 (CDL)
*
Case Nos.
* 4:13-cv-388 (Austin)
IN RE MENTOR CORP. OBTAPE
TRANSOBTURATOR SLING PRODUCTS
LIABILITY LITIGATION
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
Susan Austin was implanted with ObTape and asserts that she
suffered injuries caused by ObTape.
liability
action
against
Mentor,
Austin brought a product
contending
that
ObTape
had
design and/or manufacturing defects that proximately caused her
injuries.
warn
her
Austin also asserts that Mentor did not adequately
physicians
about
the
risks
associated
with
ObTape.
Mentor seeks summary judgment on all of Austin’s claims.
As
discussed below, Mentor’s summary judgment motion (ECF No. 40 in
4:13-cv-388) 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 Susan Austin was diagnosed with stress urinary
incontinence.
Dr. Lillian Decosimo implanted Austin with ObTape
on April 12, 2005.
Austin relied on Dr. Decosimo in deciding to
undergo the ObTape implant surgery; she did not rely on any
information from Mentor in making the decision.
Though Dr.
Decosimo does not remember Austin’s case, she testified that she
counseled all her “patients that come in with urinary issues
that the sling may or may not cure the stress urinary continence
parts of it and could worsen any overactive bladder symptoms.”
Decosimo Dep. 50:7-15, ECF No. 40-6 in 4:13-cv-388.
Dr.
Decosimo
used
products,
including
ObTape,
that
were
selected by a committee of urologists and gynecologists at the
hospital where she practiced; Dr. Decosimo was not part of the
selection committee.
4:13-cv-388.
Decosimo Dep. 16:19-17:20, ECF No. 42-3 in
Although Dr. Decosimo does not recall whether she
2
had
any
conversations
with
a
Mentor
representative
regarding
ObTape, she did testify that Mentor representatives provided her
with information about ObTape at conferences she attended, and
she relied on that information.
Id. at 69:7-21.
Dr. Decosimo
expected product manufacturers to disclose risks associated with
the product; if Dr. Decosimo received information from Mentor
regarding the risks of ObTape, she would have relied on it.
at 67:11-68:16.
Id.
And if the frequency of risks associated with a
product is a level Dr. Decosimo deems to be unacceptable, then
Dr. Decosimo would not recommend that product.
Id. at 107:8-22,
114:16-115:12.
After Austin’s implant surgery, her incontinence improved
for a while.
But then her incontinence worsened, and she had
several urinary tract infections and yeast infections.
Dep.
44:12-21,
ECF
No.
42-4
in
4:13-cv-388.
Over
Austin
the
next
several years, Austin sought treatment from several doctors for
her symptoms.
Before 2012, none of Austin’s doctors told her
that her problems might be related to ObTape.
In 2012, Austin sought treatment from Dr. Cheryl Iglesia
for recurrent incontinence.
with
an
erosion
or
Dr. Iglesia did not diagnose Austin
infection
of
her
ObTape;
the
only
complication Dr. Iglesia found is that Austin’s incontinence had
recurred because her ObTape was no longer working.
26:20-28:9,
ECF
No.
42-6
in
4:13-cv-388.
3
Iglesia Dep.
According
to
Dr.
Iglesia, a recurrence of incontinence is a known complication
that can happen following a sling procedure.
But Dr. Iglesia
also testified that the problem may have been that Austin’s
sling was not tight enough.
Id. at 66:7-12.
According to
Austin, Dr. Iglesia never told her that her ObTape may have been
implanted too loosely.
Austin Dep. 203:5-8, ECF No. 42-4 in
4:13-cv-388.
Austin testified that Dr. Iglesia told her that the ObTape
had become “deformed and wasn’t working anymore” due to its
small pore size.
Id. at 202:11-203:2.
Dr. Iglesia recommended
removing Austin’s ObTape; Austin testified that Dr. Iglesia told
her
that
the
ObTape
“needed
to
be
removed
because
of
the
characteristics of it” and also told her that a “new mesh would
help” her.
Iglesia
Id. at 198:3-7.
planned
potential
for
to
remove
erosion
and
Dr. Iglesia’s notes state that Dr.
Austin’s
ObTape
infection.”
“given
Kuntz
[ObTape’s]
Decl.
Ex.
C,
Iglesia Medical R., ECF No. 42-5 at 4 in 4:13-cv-388.
After Dr.
Iglesia
implanted
removed
a
portion
of
Austin’s
ObTape
and
Austin with a new sling, she gave Austin photographs of the
excised ObTape and told Austin that “ObTape was being recalled
and that it had some mechanical deficiencies.”
35:16-20, ECF No. 42-4 in 4:13-cv-388.
Austin Dep.
Austin understood from
Dr. Iglesia that the ObTape had “rotted in [her] body.”
206:8-17.
4
Id. at
Dr.
Bruce
Rosenzweig,
a
urogynecologist
who
offered
an
expert report on behalf of Austin, opined that ObTape “has many
well-known
characteristics
that
should
have
caused
Mentor
to
avoid its use in a product intended for permanent implantation
into the human vaginal floor[, including]: (1) degradation of
the mesh; (2) chronic foreign body reaction; (3) serious chronic
infections and Bio-films; (4) microporous construction resulting
in
poor
tissue
ingrowth;
bonded laser cut mesh.
4:13-cv-388.
and
(5)
stiff
non
elastic
thermal
Rosenzweig Report 3, ECF No. 42-7 in
Dr. Rosenzweig further opined that ObTape’s “poor
design increased the risk of serious complications and caused
[Austin’s]
specific
complications.”
Rosenzweig
opined,
“[t]o
certainty,”
that
foreign
body
subclinical
“poor
reasonable
tissue
reaction,
infection
a
of
Id.
ingrowth,
chronic
the
at
15.
degree
of
degradation,
inflammation
ObTape
And
caused
and
Ms.
Dr.
medical
chronic
chronic
Austin’s
worsening SUI, worsening urge incontinence and urgency, mixed
urinary incontinence, frequency, nocturia, mild bladder outlet
obstruction,
urinary
retention,
difficulty
initiating
and
stopping stream, dyspareunia, tender and tight left levator ani,
mesh banding, the need for pelvic floor physical therapy and the
need for a mesh removal procedure.”
Id. at 18.
According to
Dr. Rosenzweig, “[b]ut for the ObTape procedure and implantation
of the heat-welded polypropylene mesh in Ms. Austin, the tissue
5
response,
scarring,
subsequent
surgical
intervention,
infections, dyspareunia and urinary dysfunction, as set forth
above, would not have occurred.”
Austin
is
a
Virginia
Id.
resident,
and
nearly
ObTape-related treatment took place in Virginia.
all
of
her
Austin asserts
claims for negligence; strict liability design defect; strict
liability
manufacturing
defect;
strict
liability
failure
to
warn; breach of warranties; fraudulent concealment; constructive
fraud;
discovery
rule,
tolling,
fraudulent
concealment;
negligent misrepresentation; negligent infliction of emotional
distress;
violation
enrichment.
claims.
Mentor
of
consumer
seeks
protection
summary
judgment
laws;
on
and
all
of
unjust
these
Austin does not challenge Mentor’s summary judgment
motion on the following claims: strict liability (Counts II-V);
warranty (Counts VI-VII); discovery rule, tolling, fraudulent
concealment (Count X); negligent misrepresentation (Count XI);
negligent
infliction
of
emotional
distress
(Count
XII);
violation of consumer protection laws (Count XIII); and unjust
enrichment (Count XV).
The Court thus grants Mentor’s summary
judgment motion as to those claims.
DISCUSSION
Austin brought this action on August 8, 2013 by filing a
short form complaint in MDL No. 2387 in the U.S. District Court
for
the
Southern
District
of
West
6
Virginia.
The
case
was
transferred to this Court as part of a multidistrict litigation
proceeding regarding ObTape.
In her Complaint, Austin stated
that if she had not filed her case directly in MDL No. 2387,
then venue would be proper in the U.S. District Court for the
Eastern District of Virginia.
Virginia
law
applies
to
The parties do not dispute that
Austin’s
claims
because
she
is
a
Virginia resident and nearly all of her ObTape-related treatment
took place in Virginia.
I.
Design Defect Claim
Austin
theory.
brings
a
design
defect
claim
under
negligence
She asserts that ObTape was negligently designed and
that the negligent design caused her injuries.
that
a
this
claim
fails
for
lack
of
causation.
Mentor argues
The
Court
disagrees.
Under Virginia law, Austin “bears the burden to produce
evidence showing that the defendant was the proximate cause of
the injury sustained.”
McCauley v. Purdue Pharma L.P., 331 F.
Supp. 2d 449, 461 (W.D. Va. 2004).
“Virginia courts follow the
‘but for’ rule of proximate causation, under which a defendant
is not liable unless the harm would not have occurred but for
the defendant’s act.”
Id.
Mentor contends that Austin did not
point to sufficient evidence to create a genuine fact dispute on
causation.
7
As
discussed
above,
Dr.
Rosenzweig
opined
that
ObTape’s
characteristics and design increased the risk of complications
like degradation and poor tissue ingrowth.
that
the
problems
complications,
with
including
ObTape’s
her
He further opined
design
caused
Austin’s
stress
urinary
worsening
incontinence and the need for the ObTape removal procedure.
And
he opined that but for the ObTape implant, the complications—
including the subsequent surgical intervention—would not have
occurred.
Mentor argues that because Dr. Iglesia believed that
Austin’s sling may not have been tensioned properly when it was
implanted, there is no genuine fact dispute on whether Austin’s
worsening
design.
stress
urinary
incontinence
was
caused
by
ObTape’s
The Court is not convinced, however, that Dr. Iglesia’s
opinion on this point requires exclusion of Dr. Rosenzweig’s
opinion.
Dr. Rosenzweig’s expert report is sufficient to create
a genuine fact dispute on whether Austin’s injuries—including
the worsening stress urinary incontinence and the ObTape removal
surgery—were caused by ObTape’s
design.
For these reasons, the
Court denies Mentor’s summary judgment motion as to Austin’s
design
defect
claim
and
her
derivative
gross
negligence
and
punitive damages claims.
II.
Failure To Warn and Fraud Claims
Austin brings failure to warn claims under a negligence
theory,
contending
that
Mentor
8
did
not
adequately
warn
her
physicians about the true risks of ObTape.
Austin also brings
fraudulent concealment and constructive fraud claims, asserting
that Mentor made fraudulent misrepresentations to her physicians
about the risks of ObTape and that Mentor fraudulently concealed
the
risks
of
ObTape.
Mentor
argues
that
Austin
has
not
presented enough evidence to create a genuine fact dispute on
causation for these claims.
To establish causation on her failure to warn and fraud
claims
under
Virginia
law,
Austin
must
establish
that
a
different warning or an accurate disclosure of the risks of
ObTape would have made a difference in her treatment.
Talley v.
Danek Med., Inc., 7 F. Supp. 2d 725, 730 (E.D. Va. 1998), aff’d,
179 F.3d 154 (4th Cir. 1999) (“[A] plaintiff must not only show
that
a
manufacturer’s
inadequacy
product
and
affected
warning
the
thereby
was
inadequate,
prescribing
injured
the
but
physician’s
plaintiff.”);
that
such
use
of
the
Kling
v.
Key
Pharm., Inc., 35 F.3d 556 (4th Cir. 1994) (table) (concluding
that there was no proof of causation because the plaintiff did
not present evidence that “more explicit warnings would have
altered [the doctor’s] treatment plan”).
Mentor contends that Austin cannot prove causation because
Austin did not suffer an erosion or infection, which are the
risks
she
claims
were
not
adequately
disclosed.
But
Dr.
Decosimo, who relied on information representatives provided to
9
her about ObTape at conferences, testified that if the risks
associated with a product were at a level she deemed to be
unacceptable,
patients.
a
of
infection.
is
would
not
recommend
that
product
for
her
And, one of the reasons Dr. Iglesia elected to excise
portion
there
she
Austin’s
ObTape
was
the
risk
of
erosion
and
Based on this evidence, the Court is satisfied that
a
genuine
fact
dispute
on
causation
negligent failure to warn and fraud claims.
for
Austin’s
Mentor is therefore
not entitled to summary judgment on these claims.
CONCLUSION
As discussed above, Mentor’s summary judgment motion (ECF
No. 40 in 4:13-cv-388) is granted in part and denied in part.
Mentor’s motion is granted as to the following claims: strict
liability
rule,
(Counts
tolling,
II-V);
fraudulent
warranty
(Counts
concealment
VI-VII);
(Count
X);
discovery
negligent
misrepresentation (Count XI); negligent infliction of emotional
distress
(Count
XII);
violation
of
consumer
(Count XIII); and unjust enrichment (Count XV).
protection
laws
Mentor’s motion
is denied as to the following claims: negligence (Count I),
fraudulent concealment (Count VIII), constructive fraud (Count
IX), gross negligence (Count XIV), and punitive damages (Count
XVII).
10
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 7th day of December, 2016.
s/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA
11
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