CHOCK et al v. MENTOR WORLDWIDE LLC
ORDER granting in part and denying in part 30 Motion for Summary Judgment; granting 32 Motion to Amend/Correct. Ordered by US DISTRICT JUDGE CLAY D LAND on 12/19/2016. (CCL)
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF GEORGIA
IN RE MENTOR CORP. OBTAPE
* MDL Docket No. 2004
* 4:14-cv-99 (Chock)
TRANSOBTURATOR SLING PRODUCTS
O R D E R
sling product called ObTape Transobturator Tape, which was used
Genevieve Chock was implanted with ObTape and asserts that she
product liability action against Mentor, contending that ObTape
had design and/or manufacturing defects that proximately caused
adequately warn her physicians about the risks associated with
Her husband Roman asserts a loss of consortium claim.
Mentor seeks summary judgment on all of Plaintiffs’ claims.
the reasons set forth below, Mentor’s summary judgment motion
(ECF No. 30 in 4:14-cv-99) is granted in part and denied in
Plaintiffs seek leave to amend their complaint to add a
claim for punitive damages.
99) is granted.
That motion (ECF No. 32 in 4:14-cv-
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
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.
dispute is genuine if the evidence would allow a reasonable jury
to return a verdict for the nonmoving party.
Plaintiff Genevieve Chock experienced symptoms of stress
implanted Mrs. Chock with ObTape to treat her stress urinary
Before he implanted Mrs. Chock with ObTape, Dr.
Keller attended a training seminar on the technique used to
insert data sheet before performing an ObTape implant.
Dep. 34:7-11, ECF No. 33-24 in 4:14-cv-99; see also id. 60:21-23
(testifying that Dr. Keller implanted ObTape in accordance with
the product insert data sheet); id. at 104:6-11 (“I’m sure I
If Mentor had told Dr. Keller that his patients
pelvic pain related to the ObTape, that may have impacted his
decision to implant Mrs. Chock with ObTape; at the least, he
would have sought informed consent from Mrs. Chock.
If Dr. Keller had informed Mrs. Chock
that she could develop chronic pain and recurring urinary tract
undergone the ObTape procedure.
Chock Dep. 87:19-88:13, ECF No.
33-4 in 4:14-cv-99.
Dr. Keller told Mrs. Chock that there was a “9 out of 10”
chance that the ObTape would work to help her stress urinary
Keller Dep. 102:1-5.
For two years following the
implant surgery, Mrs. Chock did not report incontinence or any
other issues with her ObTape.
But starting in 2007, Mrs. Chock
infections, pain, and recurrent incontinence.
Dr. Andrew Siegel, a board certified urologist and Mrs.
properties of ObTape can prevent tissue ingrowth and can cause
Cook Decl. Ex. W, Siegel Report 4, ECF
urogynecologist and Mrs. Chock’s specific causation expert, also
opined that ObTape’s physical properties rendered it “prone to
infection and extrusion.”
Cook Decl. Ex. A, White Report 3, ECF
No. 33-3 in 4:14-cv-99.
Dr. White reviewed Mrs. Chock’s medical records and relied
on her own extensive experience with urethral slings.
her review, Dr. White concluded that “ObTape is a substantial
infections, and nocturia.”
White Report 8.
She also opined
likely caused by the material properties of the ObTape device.”
She also opined that “[t]he material properties of the
ObTape transobturator sling, namely unwoven, thermally bonded
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
The result is an encapsulated graft with acute
and chronic inflammation.”
Id. at 9.
Mrs. Chock asserts claims for strict liability, negligence,
design defect, manufacturing defect, failure to warn, and breach
of express and implied warranties.
Mr. Chock asserts a loss of
Mentor seeks summary judgment on all of these
Mrs. Chock does not challenge Mentor’s summary judgment
motion on her warranty claims, so the Court grants Mentor’s
summary judgment motion as to those claims.
Plaintiffs filed their action in this Court on April 23,
2014 under the Court’s direct filing order.
The parties agreed
that for direct-filed cases, the “Court will apply the choice of
law rules of the state where the plaintiff resides at the time
of the filing of the complaint.”
Order Regarding Direct Filing
Minnesota, and all of Mrs. Chock’s ObTape-related treatment took
applies to the Plaintiffs’ claims.
Design Defect Claims
Mrs. Chock brings design defect claims under negligence and
strict liability theories, asserting that ObTape had a design
Chock’s claims fail for lack of specific causation.
Mentor asserts that Mrs. Chock did not point to sufficient
evidence to establish specific causation: that ObTape actually
caused Mrs. Chock’s injuries.
Again, Dr. White opined that
based on her review of Mrs. Chock’s medical records, ObTape more
likely than not was a substantial contributing cause of Mrs.
infections and pelvic pain.
Dr. White further opined that the
permitted bacteria to enter the graft while preventing defense
Mrs. Chock’s injuries.
Mentor contends that
Court should exclude Dr. White’s opinion because her report does
not detail, to Mentor’s satisfaction, how Dr. White reached this
But Mentor did not file a Daubert motion seeking to
exclude Dr. White’s testimony, and the Court notes that Dr.
White has not been deposed in this action.
The Court declines
to exclude Dr. White’s testimony on this basis.
Mentor does not appear to contend that Mrs. Chock did not point to
enough evidence to establish general causation: that ObTape is capable
of causing the types of injuries Mrs. Chock suffered.
asserts that she suffered chronic infections and pain.
opined that ObTape is capable of causing these types of injuries due
to its physical properties.
This evidence is sufficient to create a
genuine fact dispute on general causation.
physician believes that Mrs. Chock’s urinary tract infections
and chronic pain (at least through 2012) were not caused by
ObTape, the Court should ignore Dr. White’s opinion.
difference in opinion between Mrs. Chock’s treating physician
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.
For these reasons, the Court
summary judgment motion as to Mr. Chock’s loss of consortium
claim, which is derivative of Mrs. Chock’s claims.
v. Fletcher, 442 N.W.2d 169, 173 (Minn. Ct. App. 1989) (noting
that a husband’s loss of consortium claim is derivative of his
wife’s underlying tort claim).
Failure To Warn Claims
liability and negligence theories, contending that Mentor did
Mentor argues that Mrs. Chock has not presented enough
evidence to create a genuine fact dispute on causation for these
Under Minnesota law, a plaintiff claiming a failure to warn
Tuttle v. Lorillard Tobacco Co., 377
F.3d 917, 924 (8th Cir. 2004) (applying Minnesota law).
Minnesota law, Mrs. Chock must 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
Mentor argues that Mrs. Chock cannot establish a failure to
warn claim because Mrs. Chock did not suffer the precise type of
injury she claims Dr. Keller should have been warned about, such
as an erosion or an infection.
But Mrs. Chock does contend that
Dr. Keller was not adequately warned of the risk of recurrent
related to her ObTape.
As discussed above, Mrs. Chock’s expert
witnesses opined that ObTape’s physical characteristics make it
problems; the same characteristics that can cause erosions can
also result in infections like the ones Mrs. Chock experienced.
Mrs. Chock pointed to evidence that Dr. Keller reviewed
sheet, before he began using ObTape.
Mrs. Chock also presented
evidence that if Mentor had provided Dr. Keller with accurate
information about ObTape’s pore size and its risks, Dr. Keller
may have considered a different product for Mrs. Chock and at
least would have sought informed consent from Mrs. Chock.
Mrs. Chock presented evidence if Dr. Keller had sought informed
consent from her based on ObTape’s true risks, Mrs. Chock would
sufficient to create a genuine fact dispute on causation for
Mrs. Chock’s failure to warn claims. Mentor is therefore not
entitled to summary judgment on these claims.
III. Plaintiffs’ Motion to Add Punitive Damages Claim
Plaintiffs seek leave to add a claim for punitive damages.
plaintiff must establish by “clear and convincing evidence that
the acts of the defendant show deliberate disregard for the
rights or safety of others.”
Minn. Stat. Ann. § 549.20 subd.
A plaintiff may not seek punitive damages in her initial
Id. § 549.191.
Rather, “[a]fter filing the suit a
party may make a motion to amend the pleadings to claim punitive
“The motion must allege the applicable legal
[Minn. Stat. Ann. § ]
549.20 . . . for awarding
punitive damages in the action and must be accompanied by one or
more affidavits showing the factual basis for the claim.”
“The Court must give the plaintiff leave to add a claim for
punitive damages if it finds that the plaintiff provides prima
facie evidence in support of the motion [to amend].”
Prestige Capital Markets, Ltd., 944 F. Supp. 2d 702, 711 (D.
Minn. 2013) (citing Swanlund v. Shimano Indus. Corp., 459 N.W.2d
151, 154 (Minn. Ct. App. 1990)).
Based on the Court’s review of Plaintiffs’ motion, which is
supported by an affidavit and eighty-one exhibits—most of which
detail the information that was available to Mentor regarding
motion for leave to file an amended
complaint to add a claim for punitive damages (ECF No. 32 in
4:14-cv-99) is therefore granted.
As discussed above, Mentor’s summary judgment motion (ECF
No. 30 in 4:14-cv-99) is granted as to Mrs. Chock’s warranty
complaint to add a claim for punitive damages (ECF No. 32 in
4:14-cv-99) is granted.
This action is ready for trial.
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 19th day of December, 2016.
S/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA
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