Austin v. Mentor Worldwide LLC et al

Filing 49

ORDER suggesting remand to the United States District Court for the Southern District of West Virginia. Ordered by US DISTRICT JUDGE CLAY D LAND on 12/15/2016. (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-388 (Austin)

O R D E R
Plaintiff Susan Austin filed this action on August 8, 2013
by

filing

Pelvic

a

short

Support

2387.

form

System

The

complaint

Products

Judicial

Panel

in

In

Liability
on

Re:

Coloplast

Litigation,

Multidistrict

Corp.

MDL

Litigation

transferred the case to this MDL for pretrial proceedings.
completion

of

the

pretrial

proceedings

in

this

No.

action,

Upon
the

parties did not agree to a waiver of venue under Lexecon Inc. v.
Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998).

The

Court thus cannot conduct the trial of this action in the United
States

District

Court

for

the

Middle

District

of

Georgia.

Although the parties request that this action be remanded to the
U.S. District Court for the Eastern District of Virginia, the
Court suggests that this action be
where

the

case

originated:

the

remanded

U.S.

Southern District of West Virginia.

District

to the district
Court

for

the

This Order contains a brief

chronicle of the coordinated proceedings to provide guidance to
that court.

If the parties wish to seek transfer to the U.S.

District Court for the Eastern District of Virginia, they should
do so after this action is remanded.
I.

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

mesh

suburethral

Tape,

which

was

incontinence.
cleared

ObTape

sling
used

product
to

called

treat

ObTape

women

with

Transobturator
stress

urinary

The United States Food and Drug Administration
for

sale

in

2003

via

its

510(k)

regulatory

process, and ObTape remained on the market in the United States
until March 2006.
Several years ago, women who had been surgically implanted
with ObTape began filing lawsuits against Mentor, alleging that
they had been injured by ObTape—primarily that they suffered
infections caused by ObTape and that they were injured when
ObTape eroded through their bodily tissues.

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 Court for consolidated
and coordinated pretrial proceedings.

See In re Mentor Corp.

ObTape Transobturator Sling Products Liability Litigation, 588
F. Supp. 2d 1374 (J.P.M.L. 2008).
and

a

cases

bellwether
and

transferred

trial

that

approximately
to

this

Court

After pretrial proceedings

settled

forty
were

2

mid-trial,

additional
resolved

the

original

tag-along

through

cases

settlement.

Since then, MDL No. 2004 has grown to include more than 800
additional tag-along cases, more than 100 of which remain open.
The litigation was divided into phases, and cases from phases IV
and V 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.

Overview of Austin’s Case
Plaintiff Susan Austin alleges that she suffered various

injuries

that

she

attributes

to

ObTape.

Austin

Complaint in this action on August 8, 2013.
designated as a Phase IV-6 case.

filed

her

This action was

Discovery closed in June 2016.

On December 7, 2016, the Court granted in part and denied in
part Mentor’s motion for summary judgment.
remain

pending:

negligence

(Count

I),

The following claims

fraudulent

concealment

(Count VIII), constructive fraud (Count IX), gross negligence
(Count XIV), and punitive damages (Count XVII).

Mentor

and

Austin declined to consent to trial in the Middle District of
Georgia.
CONCLUSION
As discussed above, the Court suggests that this action be
remanded to the United States District Court for the Southern
District of West Virginia.

For the convenience of that court,

the Court compiled a list of significant filings and orders in

3

this case and in MDL No. 2004.

That list appears as an appendix

to this Order.
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 15th 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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APPENDIX
Significant filings and orders in this case and in MDL No.
2004:
I.

Significant Filings Specific to Austin
1.
2.

Answer to Austin’s Complaint, with Jury Demand, Sept.
11, 2013. ECF No. 6 in 4:13-cv-388.

3.

Order granting in part and denying in part Mentor’s
summary judgment motion. Dec. 7, 2016. ECF No. 44 in
4:13-cv-388.

4.

Notice Regarding Lexecon, Dec. 14, 2016. ECF No. 47 in
4:13-cv-388.
States that Mentor does not agree to
waive Lexecon.

5.

II.

Plaintiff Susan Austin’s
ECF No. 1 in 4:13-cv-388.

Complaint,

August 8, 2013.

Notice Regarding Lexecon, Dec. 14, 2016. ECF No. 48 in
4:13-cv-388.
States that Austin does not agree to
waive Lexecon.

Other Relevant Filings
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, attorneyclient communications.

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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
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

6

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.
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

7

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.
ECF No.
301 in 4:08-md-2004.
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-md2004, 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
8

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
4:08-md-2004.
This agreement is between Plaintiffs’
counsel and addresses the sharing among Plaintiffs of
the cost 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 4:08md-2004.
Summary: Reiterated that the withdrawal of ObTape from
the market was a subsequent remedial measure under
Federal Rule of Evidence 407.

16.

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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.

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-cv176; 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-cv176. Note: Taylor’s claims were under Florida law.

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