Burke v. Mentor Worldwide LLC et al
Filing
51
ORDER granting 47 Motion for Partial Summary Judgment. Ordered by US DISTRICT JUDGE CLAY D LAND on 09/02/2016. (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 No.
4:13-cv-229 (Burke)
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
Vivian Burke was implanted with ObTape and asserts that she
suffered injuries caused by ObTape.
liability
action
against
Mentor,
Burke brought a product
contending
that
ObTape
had
design and/or manufacturing defects that proximately caused her
injuries.
warn
her
Burke also asserts that Mentor did not adequately
physician
about
the
risks
associated
with
ObTape.
Mentor seeks summary judgment on several of Burke’s claims.
For
the reasons set forth below, Mentor’s partial summary judgment
motion (ECF No. 47 in 4:13-cv-229) is granted.
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
On
Burke
February
with
2,
ObTape
2005,
to
Dr.
treat
Bernhardt
her
stress
Rothschild
urinary
implanted
incontinence.
Burke did not review any materials from Mentor in deciding to
undergo the sling procedure, and she did not speak to Mentor
representatives about the procedure.
Burke did speak with Dr.
Rothschild before she decided to undergo the procedure.
contends
that
she
suffered
adverse
symptoms
ObTape, including chronic vaginal pain.
related
Burke
to
her
Her ObTape has never
been removed, although Dr. E. Stanton Shoemaker did diagnose her
with a small mesh extrusion in 2012.
Burke is a Texas resident,
and her ObTape related medical treatment occurred in Texas.
In her Complaint, Burke asserted the following Counts: I negligence; II - strict liability – design defect; III - strict
liability
–
manufacturing
defect;
IV
-
strict
liability
–
failure to warn; V - strict liability – defective product; VI -
2
breach of express warranty; VII - breach of implied warranty;
VIII - fraudulent concealment; IX - constructive fraud; X discovery
rule,
tolling
negligent
misrepresentation;
emotional
distress;
XIII
and
-
fraudulent
XII
-
concealment;
negligent
violation
of
XI
infliction
consumer
of
protection
laws; XIV - gross negligence; XV - unjust enrichment; and XVII punitive damages.
Mentor seeks summary judgment on all Counts
except for counts I, II, III, XIV, and XVII.
Burke does not
oppose summary judgment as to Counts V, VI, VII, VIII, IX, X,
XI, XII, XIII, and XV.
Mentor is therefore entitled to summary
judgment on those claims.
The only issue remaining is whether
Burke presented enough evidence to create a genuine fact dispute
on Count IV, Burke’s strict liability – failure to warn claim.
DISCUSSION
Burke filed this action on June 4, 2013 by filing a short
form complaint in In Re: Coloplast Corp. Pelvic Support System
Products Liability Litigation, MDL No. 2387.
In that Complaint,
Burke stated that the proper venue for her action is the U.S.
District Court for the Southern District of Texas.
ECF No. 1 in 4:13-cv-229.
Compl. ¶ 5,
The Judicial Panel on Multidistrict
Litigation transferred the action to this Court for pretrial
proceedings.
The
parties
agree
that
Texas
law
applies
to
Burke’s claims because Burke is a Texas resident and all of her
ObTape-related medical treatment took place in Texas.
3
Burke asserts that Mentor did not provide Dr. Rothschild
accurate
true
information
risks
inadequate
of
ObTape’s
complications
tissue
intermediary
regarding
ingrowth.
doctrine
like
erosion,
Under
requires
a
risks,
Texas
including
the
infection,
and
law,
prescription
the
learned
medical
device
manufacturer to provide an adequate warning about the device’s
risks
to
directly.
the
prescribing
physician
and
not
to
the
patient
Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 157 (Tex.
2012) (holding “that a prescription drug manufacturer fulfills
its duty to warn end users of its product’s risks by providing
adequate warnings to the intermediaries who prescribe the drug
and, once fulfilled, it has no further duty to warn the end
users directly”).
To establish her failure to warn claim, Burke must show
that Mentor did not adequately warn Dr. Rothschild about the
true risks of ObTape and that the inadequate warning caused
Burke’s
injuries.
requirements).
In
See
other
id.
at
words,
170
(explaining
Burke
must
show
causation
that
her
prescribing physician “would have acted differently had [Mentor]
provided a different warning” about ObTape.
Id. at 171; accord
Ackermann v. Wyeth Pharm., 526 F.3d 203, 208 (5th Cir. 2008)
(“[T]he plaintiff must show that a proper warning would have
changed the decision of the treating physician, i.e., that but
for the inadequate warning, the treating physician would have
4
not used or prescribed the product.” (quoting
Dyer v. Danek
Med., Inc., 115 F. Supp. 2d 732, 741 (N.D. Tex. 2000)); McNeil
v. Wyeth, 462 F.3d 364, 372 (5th Cir. 2006) (“Under Texas law, a
plaintiff who complains ‘that a prescription drug warning is
inadequate must also show that the alleged inadequacy caused her
doctor to prescribe the drug for her.’” (quoting Porterfield v.
Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999)).
Burke’s implanting physician, Dr. Rothschild, died before
he could testify in this action, and there is no direct evidence
that different warnings would have changed how Dr. Rothschild
treated Burke.
Burke tries to establish causation in two other
ways.
Burke
First,
argues
that
if
Dr.
Rothschild
had
been
provided with additional information about ObTape’s risks, then
Dr. Rothschild likely would have told Burke about those risks.
In support of this assertion, Burke argues that a “read and
heed”
presumption
applies
here;
under
this
presumption,
causation may be established “by the rebuttable presumption that
the user would have read and heeded the warnings had they been
given.”
Guzman v. Synthes (USA), 20 S.W.3d 717, 720 (Tex. App.
1999).
The Fifth Circuit Court of Appeals has expressed doubt
that Texas courts would hold that this presumption applies in
cases involving prescription drugs or devices.
Ackermann, 526
F.3d
federal
at
212
(noting
that
“neither
Texas
nor
courts
applying Texas law have applied the read-and-heed presumption to
5
pharmaceutical
cases
involving
learned
intermediaries”).
In
Guzman, the Court of Appeals of Texas did address the “read and
heed” presumption in the context of a medical device case where
there was undisputed evidence that the doctor would not have
changed his treatment if he had been given a different warning;
the court concluded that the “read and heed” presumption could
not establish causation in such a case.
720.
Guzman, 20 S.W.3d at
The Guzman court did not hold that the “read and heed”
presumption can establish causation in medical device cases.
Even if the “read and heed” presumption does apply in the
medical device context, it would simply permit the Court to
presume
that
Dr.
Rothschild
would
have
considered
ObTape’s
tissue ingrowth risks and the infection and erosion rates—among
other considerations—in determining which product to select for
Burke. The presumption does not, however, permit the Court to
speculate
additional
about
how
Dr.
warnings.
To
Rothschild
fill
the
would
gap,
have
Burke
weighed
points
to
the
the
expert report of Dr. Bruce Rosenzweig, who opines that: (1) Dr.
Rothschild likely did not know that ObTape had certain risks
that were not disclosed in the product insert data sheet and (2)
a reasonable physician in Dr. Rothschild’s position would have
told his patients about all of these additional risks had he
known of them.
6
Burke did not point to any Texas authority to establish
that she can rely on Dr. Rosenzweig’s opinion to establish that
Dr. Rothschild would have given her different warnings.
The
cases
Dr.
Burke
cited
in
support
of
her
contention
that
Rosenzweig’s affidavit establishes causation do not explicitly
state
that
a
plaintiff
may
rely
on
evidence
of
what
other
doctors might have done to establish that a different warning to
the plaintiff’s doctor would have made a difference.
In McNeil,
for example, there was a fact question on causation because the
plaintiff’s own doctor testified that he would have alerted the
plaintiff to the significant risks associated with a drug had he
known of them. 462 F.3d at 372.
The Court is aware that in
Centocor, the Supreme Court of Texas noted in dicta that the
plaintiffs had not only failed to point to “subjective evidence,
but
they
presented
no
objective
evidence
that
a
different
warning would have affected the decision of a reasonable doctor
to
prescribe
[the
drug]
for
Centocor, 372 S.W.3d at 171.
[the
plaintiff’s]
condition.”
But the Centocor court’s holding
was based on the plaintiff’s failure to present evidence that a
different warning would have caused the plaintiff’s own doctors
to stop prescribing the drug.
Id. at 172-73.
Even if Burke could rely on Dr. Rosenzweig’s opinion to
establish that Dr. Rothschild would have given her different
warnings had he known of them, she did not point to any evidence
7
of what she would have done differently if she had been given a
different warning.
would
have
In her response brief, Burke stated that she
declined
ObTape
if
Dr.
Rothschild
accurate complication rates for ObTape.
had
given
her
Pl.’s Br. in Resp. to
Def.’s Mot. for Summ. J. 9, ECF No. 49 in 4:13-cv-229.
In
support of this statement, Burke cites Dr. Rosenzweig’s opinion
that a reasonable physician in Dr. Rothschild’s position would
have
passed
material
all
does
differently
warnings
not
had
to
his
establish
she
received
patients.
what
a
Burke
different
But
would
warning
the
cited
have
done
from
Dr.
Rothschild, and Burke did not point to any evidence of how she
would have weighed an additional warning.
Thus, Burke failed to
establish that a different warning from Dr. Rothschild would
have resulted in a different outcome.
Burke asserts that even if she cannot establish that a
different warning from Dr. Rothschild would have changed her
outcome, she can establish causation based on Dr. Rosenzweig’s
opinion that Dr. Rothschild “[m]ore likely than not . . . would
have altered his clinical practice in treating [stress urinary
incontinence]”
if
he
had
received
additional
warnings
about
ObTape “in that he would have not offered [ObTape] as option to
Ms. Burke, would have offered additional options to Ms. Burke
and/or
would
have
relayed
Mentor to Ms. Burke.”
additional
safety
information
from
Rosenzweig Aff. ¶ 8, ECF No. 49-6 in
8
4:13-cv-229.
Burke
did
not
point
to
any
Texas
authority
suggesting that she may establish causation by having an expert
opine
about
warnings.
what
her
doctor
might
have
done
with
different
Even if she had, Dr. Rosenzweig’s affidavit does not
explain how he reached this conclusion.
Dr. Rosenzweig cannot
offer an expert opinion unless it is based on “sufficient facts
or data,” Fed. R. Evid. 702(b), and Burke did not point to
anything in the present record to suggest that Dr. Rosenzweig’s
opinion on this point is supported by any facts or data about
Dr.
Rothschild’s
practices,
including
how
Dr.
Rothschild
evaluated the risks and benefits of the products he implanted in
his patients.
Dr.
For all of these reasons, the Court finds that
Rosenzweig’s
affidavit
does
Burke’s failure to warn claim.
not
establish
causation
on
Burke did not point to any other
evidence of causation, so Mentor is entitled to summary judgment
on this claim.
CONCLUSION
For
the
reasons
set
forth
above,
Mentor’s
Motion
for
Partial Summary Judgment (ECF No. 47 in 4:13-cv-229) is granted.
Mentor
is
entitled
to
judgment
as
a
matter
of
law
on
the
following counts: IV - strict liability – failure to warn; V strict liability – defective product; VI - breach of express
warranty; VII - breach of implied warranty; VIII - fraudulent
concealment;
IX
-
constructive
9
fraud;
X
-
discovery
rule,
tolling
and
fraudulent
misrepresentation;
XII
-
concealment;
negligent
XI
infliction
-
negligent
of
emotional
distress; XIII - violation of consumer protection laws; and XV unjust enrichment.
The following counts remain pending: I -
negligence; II - strict liability – design defect; III - strict
liability – manufacturing defect; XIV - gross negligence; and
XVII - punitive damages.
This action is now ready for trial.
the
date
of
this
Order,
the
parties
Within seven days of
shall
notify
the
Court
whether they agree to a Lexecon waiver.
IT IS SO ORDERED, this 2nd day of September, 2016.
s/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA
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