SIDES et al v. MENTOR CORPORATION et al

Filing 44

ORDER suggesting remand to the United States District Court for the District of Minnesota. Ordered by US DISTRICT JUDGE CLAY D LAND on 02/14/2017. (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 Nos.
4:14-cv-118 (Sides)
4:14-cv-201 (Yandle)

*
O R D E R
Plaintiffs Gail and Henry Sides filed an action against
Defendant Mentor Worldwide, LLC in the U.S. District Court for
the District of Minnesota on April 25, 2014.

Plaintiffs Pamela

and Chris Yandle filed an action against Mentor in the U.S.
District Court for the District of Minnesota on July 9, 2014.
The Judicial Panel on Multidistrict Litigation transferred both
cases to this MDL for pretrial proceedings.

Upon completion of

the pretrial proceedings in these actions, 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, and the Court
suggests that the actions be remanded to the U.S. District Court
for the District of Minnesota.

This Order contains a brief

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

I.

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

mesh

suburethral

Tape,

which

was

incontinence.
cleared

sling
used

product
to

called

treat

ObTape

women

with

Transobturator
stress

urinary

The United States Food and Drug Administration

ObTape

for

sale

in

2003

via

its

510(k)

regulatory

process, and ObTape remained on the market in the United States
until March 2006.
Nearly
implanted

ten

with

years
ObTape

ago,

women

who

began

filing

had

lawsuits

been

surgically

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

consolidated and coordinated pretrial proceedings.
Mentor

Corp.

Litigation,

ObTape

588

F.

Transobturator
Supp.

2d

1374

Sling

Court

See In re

Products

(J.P.M.L.

for

Liability

2008).

After

pretrial proceedings and a bellwether trial that settled midtrial,

the

original

cases

and

approximately

forty

additional

tag-along cases transferred to this Court were resolved through
settlement.
than

800

Since then, MDL No. 2004 has grown to include more

additional

tag-along

cases,

2

more

than

80

of

which

remain open.

The litigation was divided into phases, and cases

from phases IV-8 to 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.

Overview of the Plaintiffs’ Cases
Plaintiffs Gail Sides and Pamela Yandle allege that they

suffered various injuries that they attribute to ObTape.

Their

husbands Henry Sides and Chris Yandle assert loss of consortium
claims.
The

Sideses

filed

their

Complaint

in

the

U.S.

District

Court for the District of Minnesota on April 25, 2014.
action was designated as a Phase IV-8 case.
December 2016.

This

Discovery closed in

On February 7, 2017, the Court granted Mentor’s

unopposed partial summary judgment motion as to Mrs. Sides’s
breach of warranty and post-sale duty to warn claims.
Sides’s
(Count

strict
II),

liability

and

failure

claims
to

(Count

warn

I),

claims

negligence
(Count

IV)

Mrs.
claims
remain

pending, as does her husband Henry’s loss of consortium claim
(Count

V).

All

common

discovery

and

coordinated

pretrial

proceedings in this case are complete, and the case is ready for
trial.

Mentor

declined

to

consent

to

trial

in

the

Middle

District of Georgia.
The

Yandles

filed

their

Complaint

in

the

U.S.

District

Court for the District of Minnesota on July 9, 2014.

3

This

action was designated as a Phase IV-8 case.
December 2016.

Discovery closed in

On February 7, 2017, the Court granted Mentor’s

unopposed partial summary judgment motion as to Mrs. Yandle’s
breach of warranty and post-sale duty to warn claims.

Mrs.

Yandle’s strict liability claims (Count I), negligence claims
(Count

II),

and

failure

to

warn

claims

(Count

IV)

remain

pending, as does her husband Chris’s loss of consortium claim
(Count

V).

All

common

discovery

and

coordinated

pretrial

proceedings in this case are complete, and the case is ready for
trial.

Mentor

declined

to

consent

to

trial

in

the

Middle

District of Georgia.
CONCLUSION
As discussed above, the Court suggests that these actions
be remanded to the United States District Court for the District
of Minnesota.

For the convenience of that court, the Court

compiled a list of significant filings and orders in these cases
and in MDL No. 2004.
Order.
Order

That list appears as an appendix to this

The Clerk of Court is directed to provide a copy of this
to

the

Clerk

of

the

Judicial

Panel

on

Multidistrict

Litigation.
IT IS SO ORDERED, this 14th day of February, 2017.
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 Gail and Henry Sides
1.
2.

Answer to Gail and Henry Sides’s Complaint, with Jury
Demand, May 27, 2014. ECF No. 6 in 4:14-cv-118.

3.

Order granting Mentor’s partial summary judgment
motion. Feb. 7, 2017. ECF No. 42 in 4:14-cv-118.

4.

II.

Gail and Henry Sides’s Complaint, Apr. 25, 2014. ECF
No. 1 in 4:14-cv-118.

Notice Regarding Lexecon, Feb. 13, 2017. ECF No. 43 in
4:14-cv-118.
States that Mentor does not agree to
waive Lexecon.

Significant Filings Specific to Pamela and Chris Yandle
5.

Pamela and Chris Yandle’s Complaint, July 9, 2014. ECF
No. 1 in 4:14-cv-201.

6.

Answer to Pamela and Chris Yandle’s Complaint, with
Jury Demand, Aug. 12, 2014. ECF No. 9 in 4:14-cv-201.

7.

Order granting Mentor’s partial summary judgment
motion. Feb. 7, 2017. ECF No. 42 in 4:14-cv-201.

8.

Notice Regarding Lexecon, Feb. 13, 2017. ECF No. 43 in
4:14-cv-201.
States that Mentor does not agree to
waive Lexecon.

III. 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
5

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.
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).

6

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.
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.

7

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.
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).

8

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
4:08-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.

9

16.

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.

17.

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.

18.

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.

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.

19.

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

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

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.

10

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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