CHOCK et al v. MENTOR WORLDWIDE LLC

Filing 41

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
COLUMBUS DIVISION
IN RE MENTOR CORP. OBTAPE

* MDL Docket No. 2004
4:08-MD-2004 (CDL)
*
Case Nos.
* 4:14-cv-99 (Chock)

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

Genevieve Chock was implanted with ObTape and asserts that she
suffered

injuries

caused

by

ObTape.

Mrs.

Chock

brought

a

product liability action against Mentor, contending that ObTape
had design and/or manufacturing defects that proximately caused
her

injuries.

Mrs.

Chock

also

asserts

that

Mentor

did

not

adequately warn her physicians about the risks associated with
ObTape.

Her husband Roman asserts a loss of consortium claim.

Mentor seeks summary judgment on all of Plaintiffs’ claims.

For

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
part.

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

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 Genevieve Chock experienced symptoms of stress
urinary

incontinence.

On

May

23,

2005,

Dr.

Curtis

Keller

implanted Mrs. Chock with ObTape to treat her stress urinary
incontinence.

Before he implanted Mrs. Chock with ObTape, Dr.

Keller attended a training seminar on the technique used to
implant

ObTape.

He

would

have

reviewed

the

ObTape

product

insert data sheet before performing an ObTape implant.

Keller

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

2

received

literature

patients.”).
might

from

Mentor

for

myself,

but

not

for

If Mentor had told Dr. Keller that his patients

develop

recurrent

urinary

tract

infections

and

chronic

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.
34:17-36:10; 74:18-75:6.

Id. at

If Dr. Keller had informed Mrs. Chock

that she could develop chronic pain and recurring urinary tract
infections

related

to

ObTape,

undergone the ObTape procedure.

Mrs.

Chock

would

not

have

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
incontinence.

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.
sought

treatment

from

But starting in 2007, Mrs. Chock

multiple

doctors

for

urinary

infections, pain, and recurrent incontinence.
those

symptoms

physicians

have

to

ObTape,

told

her

although

that

the

none

She attributes
of

symptoms

tract

her

are

treating

related

to

ObTape.
Dr. Andrew Siegel, a board certified urologist and Mrs.
Chock’s

general

causation

expert,

opined

that

the

physical

properties of ObTape can prevent tissue ingrowth and can cause

3

chronic inflammation.
No.

33-25

physical

in

Cook Decl. Ex. W, Siegel Report 4, ECF

4:14-cv-99.

properties

dysfunction.

Dr.

of

Id.

Siegel

ObTape

Dr.

can

Amanda

also

opined

cause

White,

pain

a

board

that
and

the

organ

certified

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.

Based on

her review, Dr. White concluded that “ObTape is a substantial
contributing
including

cause

urgency

of

Ms.

and

frequency,

infections, and nocturia.”
that

Mrs.

Chock’s

Chock’s

chronic

bladder

recurrent

White Report 8.

“recurrent

urinary

tract

symptoms,

urinary

tract

She also opined
infections

were

likely caused by the material properties of the ObTape device.”
Id.

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
and macrophages.

The result is an encapsulated graft with acute

and chronic inflammation.”

Id. at 9.

4

Mrs. Chock asserts claims for strict liability, negligence,
design defect, manufacturing defect, failure to warn, and breach
of express and implied warranties.
consortium claim.
claims.

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.
DISCUSSION
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.”
§ II(E),

ECF

No.

446

in

Order Regarding Direct Filing

4:08-md-2004.

Plaintiffs

live

in

Minnesota, and all of Mrs. Chock’s ObTape-related treatment took
place

in

Minnesota.

The

parties

agree

that

Minnesota

law

applies to the Plaintiffs’ claims.
I.

Design Defect Claims
Mrs. Chock brings design defect claims under negligence and

strict liability theories, asserting that ObTape had a design
defect

that

caused

her

injuries.

5

Mentor

argues

that

Mrs.

Chock’s claims fail for lack of specific causation.

The Court

disagrees.1
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.
Chock’s

injuries,

including

infections and pelvic pain.
material

properties

of

her

recurrent

urinary

tract

Dr. White further opined that the

ObTape

inhibited

tissue

ingrowth

and

permitted bacteria to enter the graft while preventing defense
mechanisms

like

leukocytes

and

macrophages

leading to

Mrs. Chock’s injuries.

from

responding—

Mentor contends that

the

Court should exclude Dr. White’s opinion because her report does
not detail, to Mentor’s satisfaction, how Dr. White reached this
conclusion.

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.

1

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.
Mrs. Chock
asserts that she suffered chronic infections and pain.
Dr. Siegel
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.

6

Mentor

also

asserts

that

because

Mrs.

Chock’s

treating

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.
the

present

record,

the

Court

is

not

Based on

convinced

that

the

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.
denies

Mentor’s

design

defect

summary

For these reasons, the Court

judgment

claims.

The

motion

Court

as

to

likewise

Mrs.

denies

Chock’s
Mentor’s

summary judgment motion as to Mr. Chock’s loss of consortium
claim, which is derivative of Mrs. Chock’s claims.

See Kohler

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).
II.

Failure To Warn Claims
Mrs.

Chock

brings

failure

to

warn

claims

under

strict

liability and negligence theories, contending that Mentor did
not

adequately

ObTape.

warn

her

physicians

about

the

true

risks

of

Mentor argues that Mrs. Chock has not presented enough

evidence to create a genuine fact dispute on causation for these
claims.

7

Under Minnesota law, a plaintiff claiming a failure to warn
must

show

that

“the

lack

plaintiff’s injuries.”

of

an

adequate

warning

caused

the

Tuttle v. Lorillard Tobacco Co., 377

F.3d 917, 924 (8th Cir. 2004) (applying Minnesota law).

Thus,

to

under

establish

causation

on

her

failure

to

warn

claims

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
warnings.”

Id.

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
late-onset

infections

related to her ObTape.

and

that

she

suffered

such

infections

As discussed above, Mrs. Chock’s expert

witnesses opined that ObTape’s physical characteristics make it
susceptible

to

a

number

of

complications

that

can

cause

problems; the same characteristics that can cause erosions can
also result in infections like the ones Mrs. Chock experienced.

8

Mrs. Chock pointed to evidence that Dr. Keller reviewed
Mentor

materials,

including

the

ObTape

sheet, before he began using ObTape.

product

insert

data

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.

And

Mrs. Chock presented evidence if Dr. Keller had sought informed
consent from her based on ObTape’s true risks, Mrs. Chock would
not

have

undergone

the

implant

surgery.

This

evidence

is

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.
To

be

entitled

to

punitive

damages

under

Minnesota

law,

a

plaintiff must establish by “clear and convincing evidence that
the acts of the defendant show deliberate disregard for the
rights or safety of others.”
1(a).

Minn. Stat. Ann. § 549.20 subd.

A plaintiff may not seek punitive damages in her initial

complaint.

Id. § 549.191.

Rather, “[a]fter filing the suit a

party may make a motion to amend the pleadings to claim punitive
damages.”
basis under

Id.

“The motion must allege the applicable legal

[Minn. Stat. Ann. § ]

9

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.”

Id.

“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].”

Merry v.

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
ObTape’s

risks—the

presented

prima

amendment.

Court

is

facie

satisfied

evidence

Plaintiffs’

to

that

Plaintiffs

support

the

have

requested

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.
CONCLUSION
As discussed above, Mentor’s summary judgment motion (ECF
No. 30 in 4:14-cv-99) is granted as to Mrs. Chock’s warranty
claims
failure
claim.

but
to

denied
warn

as

to

claims,

Plaintiffs’

Mrs.
and

motion

Chock’s

design

Mr.

Chock’s

for

leave

loss

to

defect
of

file

claims,

consortium
an

amended

complaint to add a claim for punitive damages (ECF No. 32 in
4:14-cv-99) is granted.

This action is ready for trial.

10

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 19th day of December, 2016.
S/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA

11