Kampe v. Mentor Worldwide LLC

Filing 8

ORDER granting in part and denying in part 5 Motion for Summary Judgment; transferring this action to the U.S. District Court for the Northern District of Illinois. Ordered by US DISTRICT JUDGE CLAY D LAND on 10/20/2017. (CCL) [Transferred from Georgia Middle on 10/20/2017.]

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.
4:16-cv-300 (G. KAMPE)

O R D E R
Defendant Mentor Worldwide LLC developed a suburethral sling
product

called

ObTape

Transobturator

Tape,

which

treat women with stress urinary incontinence.

was

used

to

Plaintiff Gayle

Kampe was implanted with ObTape and asserts that she suffered
injuries caused by ObTape.

Kampe brought this product liability

action against Mentor, contending that ObTape had design and/or
manufacturing
Kampe

also

physicians

defects

asserts
about

that

that

the

proximately

Mentor

risks

did

caused

not

associated

her

adequately

with

ObTape.

injuries.
warn

her

Mentor

contends that Kampe’s claims are barred by the applicable statute
of limitations.

For the reasons set forth below, Mentor’s Motion

for Summary Judgment (ECF No. 5 in 4:16-cv-300) is granted as to
Kampe’s breach of warranty claims but denied as to her other
claims.
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.”
P. 56(a).

Fed. R. Civ.

In determining whether a genuine dispute of material

fact exists to defeat a motion for summary judgment, the evidence
is

viewed

summary

in

the

judgment,

light

most

drawing

opposing party’s favor.
U.S. 242, 255 (1986).

favorable

all

to

the

justifiable

party

opposing

inferences

in

the

Anderson v. Liberty Lobby, Inc., 477
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
Viewed in the light most favorable to
reveals the following.

Kampe, the record

Kampe sought treatment for stress urinary

incontinence from Dr. Francisco Garcini.

Dr. Garcini recommended

ObTape, and he implanted Kampe with ObTape on December 29, 2004.
After the procedure, Kampe could not urinate but was released
from the hospital with a self-catheter.

On January 4, 2005,

Kampe presented to Dr. Garcini complaining of pelvic pain and
difficulty moving her legs.
of these problems.

A few days later, Kampe went to the emergency

room with similar symptoms.
weeks

after

the

Dr. Garcini did not find the source

implant

And on January 9, 2005—less than two
surgery—Dr.

induration consistent with infection.
and drained an abscess.

Garcini

found

a

vulvar

He removed Kampe’s ObTape

Although Dr. Garcini testified that he

2

told Kampe her ObTape was removed due to an infection, Kampe does
not remember Dr. Garnici telling her that the ObTape had been
removed.

All of Kampe’s ObTape-related treatment occurred in

Illinois, and Kampe was a citizen of Illinois when she filed this
action.
Kampe filed her Complaint on August 30, 2016.
Compl.,

ECF

No.

1

in

4:16-cv-300.

Kampe

See generally

asserts

claims

for

personal injury under the following theories: negligence, strict
liability design defect, strict liability manufacturing defect,
strict liability failure to warn, breach of express and implied
warranties, fraudulent misrepresentation, fraudulent concealment,
and

negligent

claims

in

misrepresentation.

response

to

Mentor’s

Kampe
summary

withdrew

her

judgment

warranty

motion,

so

Mentor’s summary judgment motion is granted on those claims.
DISCUSSION
Kampe

filed

her

direct filing order.

action

in

this

Court

under

the

Court’s

The parties agree 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 § II(E), ECF No. 446

in 4:08-md-2004.

The Illinois choice-of-law rules thus apply,

and the parties agree that Illinois law applies to Kampe’s claims
because

Kampe

is

an

Illinois

treatment took place in Illinois.

3

resident

whose

ObTape-related

Kampe’s tort claims “are governed by the two-year statute of
limitations applicable to personal injury claims.”

Curtis v.

Mentor Worldwide, LLC, 543 F. App’x 901, 903 (11th Cir. 2013)
(per

curiam)

‘discovery

(citing

rule’

in

735

Ill.

Illinois

Comp.

delays

Stat.
the

5/13–202).

commencement

“The
of

the

applicable statute of limitations until the plaintiff knows or
reasonably should know that he has been injured and that his
injury was wrongfully caused.”

Id. (citing Hermitage Corp. v.

Contractors Adjustment Co., 651 N.E.2d 1132, 1137 (Ill. 1995)).
“The phrase ‘wrongfully caused’ does not mean knowledge of a
specific

defendant’s

negligent

conduct

existence of a cause of action.”

or

knowledge

of

the

Id. (quoting Castello v. Kalis,

816 N.E.2d 782, 789 (Ill. App. Ct. 2004)).

Rather, the phrase

means that the injured party “becomes possessed of sufficient
information
reasonable

concerning
person

on

his

injury

inquiry

to

and

its

determine

cause
whether

to

put

a

actionable

conduct is involved.” Id. (quoting Castello, 816 N.E.2d at 789).
Here, Mentor contends that Kampe knew her injury may have
been wrongfully caused less than two weeks after her implant
surgery because her doctor had to remove the ObTape due to an
infection.

But there is no evidence in the present record that

the removal surgery was necessitated by an erosion or infection
of the ObTape as opposed to some other surgical complication that
caused Kampe to be unable to urinate after the implant surgery

4

and

ultimately

genuine

factual

caused

an

dispute

abscess
exists

near

as

to

the

incision

whether

site.

A

was

the

ObTape

mechanism that contributed to the complications Kampe suffered
almost immediately after the implant surgery.
The Court’s decision in Curtis v. Mentor Worldwide, LLC,
which was affirmed by the Eleventh Circuit, is distinguishable.
In that case, the plaintiff suffered a vaginal erosion several
months after her implant surgery, and she underwent a partial
excision of her sling.

Curtis, 543 F. App’x at 902.

Months

later, the plaintiff developed a deep infection in her leg and
had to have her entire ObTape removed.

She knew at the time that

“her infection and related problems had something to do with the
ObTape sling, and she had the sling removed.”

Id. at 903-04.

At

that time, the plaintiff “was obligated to begin her inquiry as
to who manufactured her sling and whether her complications were
due to a problem with the surgery or a defective sling.”
Here,

unlike

in

Curtis,

there

is

a

fact

Id.

question

as

to

whether Kampe’s infection had something to do with her ObTape.
If a reasonable jury could only conclude from the present record
that the infection near the incision site shortly after Kampe’s
surgery was connected to ObTape, then the Court would likely find
as a matter of law that Kampe’s claim accrued on the date of the
excision

surgery.

establishes.

But

that

is

not

what

the

present

record

A reasonable jury could conclude that ObTape caused

5

the infection near the surgical site.

But Mentor did not point

to sufficient evidence for the Court to exclude the reasonable
possibility that the infection was unrelated to the ObTape, or
that the surgical procedure itself contributed to the problems
Kampe suffered.
exists

as

to

injury

that

For these reasons, a genuine factual dispute
when

Kampe

would

suffered

commence

the

limitations under Illinois law.
matter

of

law

that

Kampe’s

excision surgery in 2005.1

an

ObTape-related

running

of

the

physical

statute

of

Thus, the Court cannot find as a

claim

accrued

when

Kampe

had

the

Mentor is therefore not entitled to

summary judgment on statute of limitations grounds.
CONCLUSION
For the reasons set forth above, Mentor’s Motion for Summary
Judgment (ECF No. 5 in 4:16-cv-300) is granted as to Kampe’s
breach of warranty claims but denied as to her other claims.
TRANSFER OF ACTION
Kampe

filed

this

action

Filing Order in MDL No. 2004.

pursuant

to

the

Court’s

Direct

See Order Regarding Direct Filing

§ II(A), ECF No. 446 in 4:08-md-2004 (permitting plaintiffs from
outside the Middle District of Georgia whose cases “would be
subject

to

“directly

in

transfer
the

MDL

to

MDL

No.

proceedings

1

2004”
in

to

the

file
Middle

their

cases

District

of

This ruling does not mean that Mentor may not eventually prevail on
its statute of limitations defense, but it is not entitled to prevail
as a matter of law based on the present record.

6

Georgia”).

The action was “filed in MDL No. 2004 for pretrial

proceedings

only,

consistent

with

December

the
3,

Judicial

2008,

Panel

Transfer

on

Multidistrict

Litigation’s

Order.”

Id. § II(B).

All discovery has been completed, and this case is

ready for trial.
Given

that

Mentor

has

not

elected

to

waive

venue

under

Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26
(1998)

since

early

2016,

the

Court

finds

it

appropriate

to

transfer this action to the court where venue is proper, the U.S.
District Court for the Northern District of Illinois.

See Compl.

¶ 1, ECF No. 1 (“Plaintiff is now and was at all times herein
mentioned

a

citizen

and

resident

residing in Plainfield, Illinois.”).

of

the

State

of

Illinois,

For the convenience of that

court, the appendix to this Order contains a brief chronicle of
the coordinated proceedings, as well as a list of significant
filings and orders in MDL No. 2004.
The Clerk of Court is directed to provide a copy of this
Order

to

the

Clerk

of

the

Judicial

Panel

on

Multidistrict

Litigation.
IT IS SO ORDERED, this 20th day of October, 2017.
S/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA

7

APPENDIX
I.

Brief Background of the Mentor ObTape MDL
Mentor Worldwide LLC manufactured and sold a polypropylene

mesh suburethral sling product called ObTape Transobturator Tape,
which was used to treat women with stress urinary incontinence.
The United States Food and Drug Administration cleared ObTape for
sale

in

2003

via

its

510(k)

regulatory

process,

and

ObTape

remained on the market in the United States until March 2006.
About ten years ago, women who had been surgically implanted
with ObTape began filing lawsuits against Mentor, alleging that
they

had

been

infections

injured

caused

by

by

ObTape—primarily

ObTape

and

that

they

ObTape eroded through their bodily tissues.

that

they

were

suffered

injured

when

In December 2008,

the Judicial Panel on Multidistrict Litigation created MDL No.
2004 and transferred seventeen actions involving alleged injuries
resulting

from

ObTape

to

this

coordinated pretrial proceedings.

Court

for

consolidated

and

See In re Mentor Corp. ObTape

Transobturator Sling Products Liability Litigation, 588 F. Supp.
2d

1374

(J.P.M.L.

2008).

After

pretrial

proceedings

and

a

bellwether trial that settled mid-trial, the original cases and
approximately

forty

additional

tag-along

cases

this Court were resolved through settlement.

transferred

to

Since then, MDL No.

2004 has grown to include more than 800 additional tag-along
cases,

although

only

a

few

remain

8

open.

The

litigation

was

divided

into

phases,

and

cases

from

phase

IV-10

are

still

pending.

In 2013, the Court tried a Phase III bellwether case to

verdict.

In 2016, the Court tried a Phase IV-1 bellwether case

to verdict.
II.

Significant Filings in MDL No. 2004
These filings are, for the most part, evidentiary rulings
that were made in the context of the bellwether cases that
were tried in this Court; these issues may arise again.
1.

Order Denying Motion to Disqualify Expert Witness Dr.
Catherine Ortuno, Apr. 1, 2010.
ECF No. 231 in 4:08md-2004; 2010 WL 1416548.
Summary: Mentor sought to exclude the testimony of Dr.
Catherine Ortuno, who was an employee of a French
Mentor subsidiary called Porges.
While she was
employed by Porges, Dr. Ortuno and a colleague
developed concerns about the safety of ObTape and
ultimately recommended that sales of ObTape be stopped.
The Court concluded that Dr. Ortuno would be permitted
to serve as an expert witness for Plaintiffs but that
she would not be permitted to offer any testimony that
would
divulge
privileged,
attorney-client
communications.

2.

Order
on
Phase
I
Summary
Judgment
Motions
and
Admissibility of Plaintiffs’ Experts, Apr. 22, 2010.
ECF No. 241 in 4:08-md-2004; 711 F. Supp. 2d 1348.
Summary: Mentor sought to exclude Plaintiffs’ experts
under Federal Rule of Evidence 702.
Dr. Catherine Ortuno – motion denied; the Court found
that
Dr.
Ortuno’s
methodology
was
sufficiently
reliable.
General Causation Witnesses (Dr. Linda Brubaker, Dr.
Suzanne Bush, Dr. Michel Cosson, Dr. John Davis, Dr.
James Hiller, Dr. Mickey Karram, Dr. Kenneth Mitchell,
Dr. Donald Ostergard, Dr. William Porter, and Dr.
Andrew Siegel) – motion denied; the Court found that
these experts’ methodology was sufficiently reliable.
Specific Causation Witnesses (Dr. Linda Brubaker, Dr.
Suzanne Bush, Dr. John Davis, Dr. James Hiller, Dr.
Mickey Karram, Dr. Kenneth Mitchell, and Dr. Mark

9

Slack) – motion denied; the Court found that these
experts’ methodology was sufficiently reliable.
Dr. George Samaras – motion granted in part and denied
in part; based on then-existing Rule 26 Report, the
Court concluded that Dr. Samaras would be permitted to
testify
on
general
causation
but
not
specific
causation.
Dr. Ahmed El-Ghannam – motion denied; the Court found
that
Dr.
El-Ghannam’s
opinions
were
sufficiently
reliable.
Dr. Paul Ducheyne – motion granted in part and denied
in part; based on then-existing Rule 26 Report, the
Court concluded that Dr. Ducheyne could not testify
regarding what caused degradation in ObTape but could
testify that Mentor should have done more testing based
on Mentor’s awareness that ObTape could degrade.
Dr. Arnold Lentnek – motion deferred pending Daubert
hearing. On May 12, 2010, the Court decided to permit
Dr. Lentnek’s testimony (ECF No. 301 in 4:08-md-2004).
3.

Order re Evidence Related to FDA Regulatory Process,
Apr. 23, 2010.
ECF No. 242 in 4:08-md-2004; 2010 WL
1734638.
Summary: Plaintiffs sought to exclude evidence related
to the FDA regulatory process.
Discussed basic rules
regarding evidence of FDA regulatory process. Deferred
ruling until pretrial conference.
At the pretrial
conference on May 3, 2010, the Court granted the motion
in limine but stated that if Plaintiffs opened the door
to the FDA evidence, it could come in. (ECF No. 299 –
Transcript 174:9-175:16).
Note: the Court admitted 510(k) evidence during the
2013 trial of Morey v. Mentor, 4:11-cv-5065 but gave a
limiting instruction on this issue.
Morey, Jury
Instructions Charge No. 11, ECF No. 183 in 4:11-cv5065.
But the Court reconsidered its ruling on the
admissibility of FDA 510(k) evidence in its order on
Phase IV-1 motions in limine dated December 3, 2015.

4.

Order re Phase I Plaintiffs’ Experts, Apr. 27, 2010.
ECF No. 246 in 4:08-md-2004; 2010 WL 1727828.
Summary: Mentor sought to exclude the testimony of
Plaintiffs’ experts under Federal Rule of Evidence 702
and based on relevance. The motion was granted in part
and denied in part.
Dr. Ann Buchholtz – testimony not permitted.

10

Rabbit Study – testimony explaining rabbit study
permitted,
but
not
testimony
that
rabbit
study
establishes that ObTape is capable of causing similar
conditions in humans.
Mentor’s Warnings to Physicians and the FDA – testimony
may be relevant to failure to warn claim, but Plaintiff
must
establish
relevance
before
eliciting
this
testimony.
5.

Order re Phase I Experts, Apr. 29, 2010.
ECF No. 282
in 4:08-md-2004; 2010 WL 1782272.
Summary: The parties sought to exclude expert testimony
of each other’s experts under Federal Rule of Evidence
702. The motions were denied.
Dr. Michael Chernick (Plaintiffs’ statistician) –
testimony permitted.
Mentor’s Specific Causation Rebuttal Witnesses (Dr.
Marta Villarraga, Dr. Charles L. Secrest, Dr. A.W.
Karchmer, Dr. James M. Anderson) – testimony permitted.
Dr. Marta Villarraga (Mentor’s expert re Mentor’s
conduct in bringing ObTape to Market) – testimony
permitted.
Mentor’s Experts regarding Pore Distribution (Drs.
Villarraga and Clevenger) – testimony permitted.

6.

Phase I Bellwether Pretrial Conference Transcript (Day
1), May 3, 2010.
ECF No. 299 in 4:08-md-2004.
Ruled
from
the
bench
on
several
motions
in
limine.
Significant Issues:
 Cross Motions to Exclude Evidence re FDA Regulatory
Process (ECF Nos. 249 & 259) – Granted.
Hr’g Tr.
164:11-175:16.
Written opinion on this issue
December 3, 2015. See infra § III.18.i.
 Plaintiffs’ Motion to Exclude “Complication Rates”
(ECF Nos. 250 & 251) – Denied.
Hr’g Tr. 175:20178:19.

7.

Phase I Bellwether Pretrial Conference Transcript (Day
2), May 4, 2010.
ECF No. 300 in 4:08-md-2004.
Ruled
from
the
bench
on
several
motions
in
limine.
Significant Issue:
Mentor’s Motion to Exclude Evidence Adverse Event
Reports (ECF No. 273) – Denied, but reports must be
redacted. Hr’g Tr. 42:7-47:8.

8.

Order re Dr. Arnold Lentnek, May 12, 2010.
in 4:08-md-2004.
11

ECF No. 301

Summary: Denied Mentor’s motion to exclude Dr. Lentnek,
concluding
that
Dr.
Lentnek’s
methodology
was
sufficiently reliable.
9.

Order to “Tie Up Some Loose Ends” after Pretrial
Conference, May 18, 2010. ECF No. 335 in 4:08-md-2004,
2010 WL 1998166.
Summary: addressed several issues.
Significantly, the
Court stated that it would permit recording of the
testimony of European witnesses so the recordings could
be used in later trials of MDL No. 2004 cases.
Also
addressed the trial structure and concluded that trial
should
be
bifurcated
(Phase
1:
compensatory
damages/punitive damages entitlement; Phase 2: punitive
damages amount).
Note: part of this Order was later vacated (see ECF 350
re continuing duty to warn under Georgia law).

10.

Order re Subsequent Remedial Measure, May 20, 2010.
ECF No. 341 in 4:08-md-2004, 2010 WL 2015146.
Summary: Concluded that Mentor’s decision to stop
selling ObTape is a subsequent remedial measure under
Federal Rule of Evidence 407, so evidence of this
decision is not admissible “to prove negligence,
culpable conduct, a defect in a product, a defect in a
product's design, or a need for a warning or
instruction” but may be admitted for another purpose.
Also concluded that Mentor’s introduction of a new
sling product, Aris, was not a subsequent remedial
measure under Federal Rule of Evidence 407.

11.

Order re Similar Complications, May 28, 2010. ECF No.
351 in 4:08-md-2004, 2010 WL 2196632.
Summary: Explained rationale for concluding that other
incidents
of
ObTape
complications
proffered
by
Plaintiffs were substantially similar to Plaintiffs’
injuries.

12.

Order Appointing Plaintiffs’ Liaison Counsel and CoLead Counsel, Sept. 21, 2011. ECF No. 422 in 4:08-md2004.

13.

Order Establishing Plaintiffs’ Litigation Expense Fund
and Common Benefit, Aug. 9, 2012. ECF No. 493 in 4:08md-2004. This agreement is between Plaintiffs’ counsel
and addresses the sharing among Plaintiffs of the cost

12

of special services performed and expenses performed
for the common benefit of the Plaintiffs of MDL No.
2004.
14.

Text Order re Dr. Ahmed El-Ghannam, June 4, 2013 in
Morey v. Mentor, 4:11-cv-5065.
Explained that general
causation witness’s must be tied to the Plaintiff: “To
introduce [Dr. El-Ghannam’] testimony regarding ObTape
degradation and/or the release of toxins, the witness
must establish a causal connection between that
degradation and/or release of toxins and Plaintiff’s
infection and extrusion/erosion.”

15.

Order re Post-Injury Evidence/Punitive Damages (in
Morey v. Mentor), June 12, 2013. ECF No. 671 in 4:08md-2004.
Summary: Concluded that, under Minnesota law, certain
post-injury evidence is admissible on the issue of
punitive damages.
Order re Withdrawal of ObTape from the Market (in Morey
v. Mentor), June 12, 2013.
ECF No. 673 in 4:08-md2004.
Summary: Reiterated that the withdrawal of ObTape from
the market was a subsequent remedial measure under
Federal Rule of Evidence 407.

16.

17.

18.

Jury Instructions and verdict form in Morey v. Mentor,
June 13, 2013.
ECF No. 183 in 4:11-cv-5065.
Notes:
Morey asserted a negligence claim under Minnesota law.
The Court reconsidered its ruling on the admissibility
of FDA 510(k) evidence in its order on Phase IV-1
motions in limine dated December 3, 2015.
Order on Motions in Limine, Dec. 3, 2015 (in Taylor,
4:12-cv-176; Sanborn, 4:13-cv-42; and Mack, 4:14-cv117), ECF No. 92 in 4:12-cv-176, 2015 WL 7863032.
Significant issues:
i.
FDA 510(k) Evidence.
Ruled that evidence of
510(k)
preclearance
process
would
not
be
admitted because even if it is relevant, the
probative value is substantially outweighed by
the risk of unfair prejudice and potential to
confuse and mislead the jury.
ii.

Dr. Lentnek.
Ruled that Plaintiffs would have
to establish “fit” prior to admission of Dr.
Lentnek’s testimony.

13

iii.

Dr. El-Ghannam.
Ruled that Plaintiffs would
have to make proffer of specific causation
before Dr. El-Ghannam could testify on certain
issues.

iv.

Post-Implant Evidence.
Ruled that evidence of
Mentor’s conduct and awareness after Plaintiffs’
implant date is admissible.

19.

Order re Similar Complications (in Taylor, 4:12-cv-176;
Sanborn, 4:13-cv-42; and Mack, 4:14-cv-117), Feb. 1,
2016. ECF No. 115 in 4:12-cv-176, 2016 WL 393958.
Summary: Explained rationale for concluding that other
incidents
of
ObTape
complications
proffered
by
Plaintiffs were substantially similar to Plaintiffs’
injuries.

20.

Jury Instructions and verdict form in Taylor v. Mentor,
Feb. 18, 2016.
ECF Nos. 172, 174 in 4:12-cv-176.
Note: Taylor’s claims were under Florida law.

14