Cole v. Mentor Corporation et al
Filing
43
ORDER suggesting remand to the U.S. District Court for the District of Minnesota. Ordered by US DISTRICT JUDGE CLAY D LAND on 10/30/2015. (CGC)
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.
4:13-cv-195 (M. Cole)
O R D E R
Plaintiff
Melanie
Grubbs
Cole
filed
this
action
against
Defendant Mentor Worldwide LLC in the United States District
Court for the District of Minnesota.
The Judicial Panel on
Multidistrict
her
multidistrict
Litigation
litigation
transferred
proceeding.
Upon
action
to
completion
of
this
the
pretrial proceedings in this action, 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 Plaintiff Melanie Grubbs Cole’s action against Mentor be
remanded to the United States District Court for the District of
Minnesota.
This
Order
contains
a
brief
chronicle
of
the
coordinated proceedings to provide guidance to the transferor
court after remand.
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.
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
Since
then,
trial
that
approximately
to
this
MDL
No.
Court
2004
After pretrial proceedings
settled
forty
were
has
mid-trial,
additional
resolved
grown
to
the
original
tag-along
cases
through
settlement.
include
nearly
800
additional tag-along cases, almost 400 of which remain open.
2
The litigation was divided into separate phases, and cases from
phases IV and V are still pending.
In 2013, the Court tried a
Phase III bellwether case to verdict, and a Phase IV bellwether
trial is scheduled to begin on November 30, 2015.
II.
Overview of Cole’s Case
Plaintiff
various
Melanie
injuries
that
Grubbs
she
Cole
alleges
attributes
to
that
she
ObTape,
recurrent incontinence, infections, and pain.
suffered
including
Cole filed her
Complaint in the United States District Court for the District
of Minnesota on June 5, 2013.
She is a North Carolina resident.
Cole’s case was designated as a Phase IV-1 case.
closed in April 2015.
Discovery
Mentor filed a partial summary judgment
motion, which the Court granted, applying Minnesota law.
In re
Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig.,
MDL Docket No. 2004, 2015 WL 6126829, at *3 (M.D. Ga. Oct. 16,
2015); ECF No. 41 in 4:13-cv-195.
All common discovery and
coordinated pretrial proceedings in Cole’s case are complete,
and the case is ready for trial.
The only claim that remains
pending for trial is Cole’s claim for negligence.
Id.
CONCLUSION
As discussed above, the Court suggests that this action 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 the Cole
3
case and in MDL No. 2004.
That list appears as an appendix to
this Order.
The Clerk of the Court shall provide a copy of this Order
to the Clerk of the Judicial Panel on Multidistrict Litigation.
IT IS SO ORDERED, this 30th day of October, 2015.
S/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA
4
APPENDIX
The Court compiled a list of significant filings and orders
in this case and in MDL No. 2004:
I.
Significant Filings Specific to Melanie Grubbs Cole
1.
2.
Certified Copy of Conditional Transfer Order No. 74,
June 24, 2013. ECF No. 5 in 4:13-cv-195.
3.
Answer to Plaintiff
Demand, July 15, 2013.
4.
Scheduling/Discovery Order Designating Cole as a Phase
IV-1 Case, Nov. 24, 2014. ECF No. 19 in 4:13-cv-195;
ECF No. 877 in 4:08-md-2004.
See also Amended
Scheduling/Discovery Order, March 16, 2014.
ECF No.
23 in 4:13-cv-195; ECF No. 905 in 4:08-md-2004
(modifying deadlines).
5.
Order Granting Mentor’s Motion for Partial Summary
Judgment, Oct. 16, 2015.
ECF No. 41 in 4:13-cv-195;
2015 WL 6134397.
Granted summary judgment as to
Cole’s claims for breach of warranty, strict liability
design defect, and strict liability failure to warn.
The only claim that remains pending for trial is
Cole’s negligence claim.
6.
II.
Plaintiff Melanie Grubbs Cole’s
2013. ECF No. 1 in 4:13-cv-195.
Complaint,
June
5,
Notice Regarding Lexecon, Oct. 23, 2015. ECF No. 42 in
4:13-cv-195.
States that Mentor does not agree to
waive Lexecon.
Cole’s Complaint, with Jury
ECF No. 10 in 4:13-cv-195.
Other Documents Relevant to Cole’s Action
These documents 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 in
Cole’s case.
1.
Order Denying Motion to Disqualify Expert Witness Dr.
Catherine Ortuno, Apr. 1, 2010. ECF No. 231 in 4:08md-2004; 2010 WL 1416548.
5
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.
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.
6
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: this ruling was in the context of a strict
liability claim under Georgia law, not a negligence
claim.
During the 2013 trial of Morey v. Mentor,
4:11-cv-5065, the Court admitted FDA 510k clearance
evidence because the plaintiff in that case asserted a
negligence claim under Minnesota law, and the evidence
was relevant on that claim. The Court gave a limiting
instruction on this issue.
Morey, Jury Instructions
Charge No. 11, ECF No. 183 in 4:11-cv-5065.
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.
7
5.
Order re Phase I Experts, Apr. 29, 2010.
in 4:08-md-2004; 2010 WL 1782272.
ECF No. 282
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. But see supra § III(B)(3).
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.
301 in 4:08-md-2004.
ECF No.
Summary: Denied Mentor’s motion to exclude Dr.
Lentnek, concluding that Dr. Lentnek’s methodology was
sufficiently reliable.
8
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
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.
351 in 4:08-md-2004, 2010 WL 2196632.
ECF No.
Summary: Explained rationale for concluding
Plaintiffs’
evidence
of
other
incidents
substantially similar to Plaintiffs’ injuries.
that
were
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
9
performed for the common benefit of the Plaintiffs of
MDL No. 2004.
14.
Order re application of Minnesota law to non-Minnesota
plaintiffs who file their actions in Minnesota. In re
Mentor Corp. ObTape Transobturator Sling Prods. Liab.
Litig., No. 4:08-md-2004, 2013 WL 286276, at *7 (M.D.
Ga. Jan. 24, 2013).
15.
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.”
16.
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.
17.
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.
18.
Jury Instructions and verdict form in Morey v. Mentor,
June 13, 2013.
ECF No. 183 in 4:11-cv-5065.
Note:
Morey asserted a negligence claim under Minnesota law.
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