Davis et al 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
* MDL Docket No. 2004
4:08-MD-2004 (CDL)
*
Case Nos.
* 4:13-cv-335 (Davis)

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

Patricia Davis was implanted with ObTape and asserts that she
suffered

injuries

caused

by

ObTape.

Mrs.

Davis

brought

a

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

injuries.

Mrs.

Davis

also

asserts

that

Mentor

did

not

adequately warn her physicians about the risks associated with
ObTape.

Her husband Patrick brought a loss of consortium claim.

Mentor seeks summary judgment on all of Plaintiffs’ claims.

As

discussed below, Mentor’s summary judgment motion (ECF No. 40 in
4:13-cv-335) 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.”

Fed. R.

Civ. P. 56(a).

In determining whether a

genuine

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 Patricia Davis was diagnosed with stress urinary
incontinence.

On October 10, 2005, Dr. Michael Stever implanted

Mrs. Davis with ObTape to treat her stress urinary incontinence.
Before Dr. Stever implanted Mrs. Davis with ObTape, he reviewed
the

product

insert

data

sheet

for

ObTape,

certain risks associated with the product.
23, ECF No. 42-4 in 4:13-cv-335.

which

disclosed

Stever Dep. 182:14-

Dr. Stever also testified that

he probably spoke with a Mentor representative regarding the
risks of ObTape.
After
became

Dr.

aware

Id. at 155:10-19.
Stever

certain

Mrs.

Davis

complications

with

related

ObTape,

he

to

ObTape,

including frequency of infections and other symptoms.

Id. at

164:9-165:22.

of

implanted

Dr. Stever testified that he would “like to know”

such information and that it would have been a factor in his

2

decision to use ObTape in Mrs. Davis.

Id. at 165:19-166:2.

Had

someone from Mentor told Dr. Stever about these issues with
ObTape, he “possibly” would have considered using a different
product for Mrs. Davis.

Id. at 166:16-20.

And, had someone

from Mentor told Dr. Stever about these issues, he would have
passed that information along to Mrs. Davis.

Id. at 166:3-15.

If

these

Dr.

Stever

had

told

Mrs.

Davis

about

potential

complications, she would not have gone forward with the ObTape
implant.

Davis Dep. 132:20-133:20, ECF No. 42-5.

After the ObTape implant, Mrs. Davis experienced chronic
urinary

tract

infections,

chronic

genitourinary

pain,

dysuria
and

(pain

other

while

urinating),

symptoms;

she

treatment from a number of doctors for these symptoms.

sought

She also

experienced incomplete emptying of her bladder and was told that
her

ObTape

had

not

been

tensioned

properly.

Mrs.

Davis

underwent several procedures to treat her symptoms, including
partial excision of her ObTape in 2008.
the

excised

reaction.”

ObTape

and

diagnosed

A pathologist analyzed

“foreign

body

giant

cell

Cook Decl. Ex. T, Surgical Pathology Report (Jan.

30, 2008), ECF No. 42-22 in 4:13-cv-335.

After that procedure,

Mrs. Davis underwent several other procedures to address her
symptoms.
Dr. Andrew Siegel, a board certified urologist who is Mrs.
Davis’s

general

causation

expert,

3

opined

that

the

physical

properties of ObTape can prevent tissue ingrowth and can cause
chronic inflammation.
No.

42-24

in

physical

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

4:13-cv-335.

properties

dysfunction.

of

Id.

Dr.

Siegel

ObTape

Dr.

can

Amanda

also

cause

White,

opined
pain

a

that
and

board

the

organ

certified

urogynecologist who is Mrs. Davis’s specific causation expert,
also opined that ObTape’s physical properties rendered it “prone
to infection and extrusion.”

Cook Decl. Ex. A, White Report 4,

ECF No. 42-3 in 4:13-cv-335.
Dr. White reviewed Mrs. Davis’s medical records.

She also

relied on her extensive experience with urethral slings.

Based

on her review, Dr. White concluded that “Mentor ObTape is a
substantial contributing cause of Ms. Davis’s chronic bladder
symptoms,

including

recurrent

urinary

tract

infections,

incomplete emptying, pelvic pain, vaginal pain, dyspareunia, and
need for subsequent surgeries and treatments.”
She

also

opined

that

Mrs.

Davis’s

“recurrent

White Report 7.
urinary

tract

infections were likely caused by the material properties of the
ObTape device.”

Id. at 8.

Finally, she opined that “[t]he

material properties of the ObTape transobturator sling, namely
unwoven,
such

thermally

that

tissue

bonded

polypropylene

in-growth

with

microporous

capillary

mesh

penetration

are
is

prohibited. While bacteria are able to enter the graft, host
defense

mechanisms

are

unable

to

4

respond

within

the

device

secondary to the size of leukocytes and macrophages. The result
is an encapsulated graft with acute and chronic inflammation.”
Id.
In addition to Dr. White’s opinion, Mrs. Davis relies on
the expert opinion of Dr. Kimberly Allison, a board certified
pathologist

who

is

an

Associate

Professor

Stanford University Medical Center.

of

Pathology

at

Dr. Allison reviewed the

pathology slides and pathology report from Mrs. Davis’s January
2008

ObTape

partial

excision.

Dr.

Allison

observed

“mild

chronic inflammation in the mucosa and foreign body giant cell
reaction to the mesh fibers.”

Cook Decl. Ex. W, Dr. Allison

Report 8, ECF No. 42-25 in 4:13-cv-335.

She also noted that

“[d]ense scar was present around and in between the mesh fibers”
and

that

“[t]here

(treebarking).”

was

evidence

of

mesh

degradation

Id.

Mrs. Davis asserts claims for negligence, strict liability
design

defect,

warranties,

strict

unjust

misrepresentation.
claim.

liability

failure

enrichment,
Mr.

Davis

to

fraud,

asserts

a

warn,
and

loss

of

breach

of

negligent
consortium

Mentor seeks summary judgment on all of these claims.

Mrs. Davis does not challenge Mentor’s summary judgment motion
on

her

warranty

and

unjust

enrichment

claims,

so

the

grants Mentor’s summary judgment motion as to those claims.

5

Court

DISCUSSION
Plaintiffs filed this action on July 9, 2013 in the United
States District Court for the District of Minnesota.
was

transferred

to

this

Court

as

part

litigation proceeding regarding ObTape.

of

a

The case

multidistrict

The parties agree for

purposes of summary judgment that Minnesota law applies to Mrs.
Davis’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).
I.

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

strict liability theories.
defect

that

caused

her

She asserts that ObTape had a design

injuries.

claims fail for lack of causation.

Mentor

argues

that

these

The Court disagrees.

First, Mentor contends that Mrs. Davis did not point to any
evidence to establish general causation: that ObTape is capable
of causing the types of injuries Mrs. Davis suffered.
Siegel

testified

prevent

tissue

Siegel Report 4.

that

the

ingrowth

physical

and

can

properties

cause

chronic

of

But Dr.

ObTape

can

inflammation.

He also opined that the physical properties of

ObTape can cause pain and organ dysfunction.

Id.

And Dr. White

opined that ObTape’s physical properties rendered it “prone to
infection and extrusion.”

White Report 4.

6

Mrs. Davis asserts

that she suffered chronic infections and pain, along with other
symptoms.

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 Mrs. Davis did not point to
sufficient evidence to establish specific causation: that ObTape
actually caused Mrs. Davis’s injuries.

Again, Dr. White opined

that based on her review of Mrs. Davis’s medical records, ObTape
more likely than not was a substantial contributing cause of
Mrs.

Davis’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

leading to Mrs. Davis’s injuries.

macrophages

from

responding—

Mentor contends that because

Mrs. Davis’s treating physicians did not diagnose her with poor
tissue ingrowth, the Court should ignore Dr. White’s opinion.
But

based

on

the

present

record,

including

Dr.

Allison’s

pathology analysis finding inflammation and foreign body giant
cell reaction in Mrs. Davis’s excised ObTape, the Court finds
that Mrs. Davis has submitted evidence sufficient to create a
genuine fact dispute on specific causation.
Mentor’s

summary

judgment

motion

7

as

to

For these reasons,
Mrs.

Davis’s

design

defect claims is denied.

Mentor’s motion as to Mr. Davis’s

derivative loss of consortium claim is likewise denied.
II.

Failure To Warn, Fraud, and Misrepresentation Claims
Mrs. Davis brings failure to warn claims under a strict

liability theory, contending that Mentor did not adequately warn
her physicians about the true risks of ObTape.

Mrs. Davis also

brings fraud and negligent misrepresentation claims, asserting
that Mentor made fraudulent and negligent misrepresentations to
her physicians about the risks of ObTape.

Mentor argues that

Mrs. Davis 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

the

on

claims

her

failure

under

to

Minnesota

Thus,

warn,

fraud,

law,

Cole

and
must

establish that a different warning or an accurate disclosure of
the

risks

treatment.
(or,

in

of

ObTape

would

have

made

a

difference

in

her

There must be some evidence that the product user

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.

8

Mrs. Davis pointed to evidence that Dr. Stever read the
ObTape product data insert sheet before using ObTape.

She also

pointed to evidence suggesting that Dr. Stever relied on the
representations of a Mentor representative when he began using
ObTape.

Mrs. Davis further pointed to evidence that if Dr.

Stever had received information from Mentor regarding the true
risks

of

ObTape—including

information

about

complications

related to ObTape—he possibly would have selected a different
product for Mrs. Davis.

And Mrs. Davis pointed to evidence that

if Dr. Stever had received information regarding the true risks
of ObTape, he would have passed that information to her and she
would have declined to proceed with the ObTape implant.

Based

on this evidence, the Court is satisfied that there is a genuine
fact dispute on causation for Mrs. Davis’s failure to warn,
fraud, and misrepresentation claims.

Mentor is therefore not

entitled to summary judgment on these claims.1
CONCLUSION
As discussed above, Mentor’s summary judgment motion (ECF
No. 40 in 4:13-cv-335) is granted as to Mrs. Davis’s warranty
and unjust enrichment claims, as well any claims Mrs. Davis
1

Mrs. Davis 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 as to her continuing duty to warn claim or
point to any evidence to support such a claim, such as evidence that
her post-implant treatment would have been different had her doctors
received different post-implant information from Mentor.
Thus, if
Mrs. Davis did assert a continuing duty to warn claim, Mentor is
entitled to summary judgment on it.

9

asserted

under

a

continuing

duty

to

warn

theory.

Mentor’s

motion is denied as to Mrs. Davis’s design defect claims and her
failure to warn, fraud, and misrepresentation claims based on
pre-implant warnings and representations.

And Mentor’s motion

is denied as to Mr. Davis’s loss of consortium claim.
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

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