HAMPTON V. MENTOR CORPORATION et al
Filing
51
ORDER suggesting remand to the U.S. District Court for the District of Minnesota. Ordered by US DISTRICT JUDGE CLAY D LAND on 04/17/2018. (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.
4:14-cv-078 (Hampton)
O R D E R
Based on its interpretation of Minnesota law, the Eleventh
Circuit Court of Appeals concluded that genuine fact disputes
exist
in
this
case,
thus
precluding
summary
judgment.
See
generally Hampton v. Mentor Corp., No. 17-10160, 2018 WL 1020038
(11th
Cir.
Feb.
22,
2018)
(per
curiam).
This
case
was
transferred from the U.S. District Court for the District of
Minnesota to this MDL for pretrial proceedings.
proceedings
are
complete,
and
the
case
is
The pretrial
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 suggest that
this
action
be
remanded
to
the
U.S.
District
Court
for
the
District of Minnesota.
I.
Brief Background of the Mentor ObTape MDL
Mentor Worldwide LLC manufactured and sold a polypropylene
mesh
Tape,
suburethral
which
was
sling
used
product
to
treat
called
women
ObTape
with
Transobturator
stress
urinary
incontinence.
cleared
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.
About
years
ago,
women
with
implanted
ten
who
ObTape
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.
Since then, MDL No. 2004 grew to include more than
800 additional tag-along cases, although nearly all of them are
now closed.
case
to
In 2013, the Court tried a Phase III bellwether
verdict.
In
2016,
the
bellwether case to verdict.
2
Court
tried
a
Phase
IV-1
II.
Overview of Plaintiff’s Case
Plaintiff
alleges
attributes to ObTape.
that
she
suffered
injuries
that
she
Plaintiff filed her lawsuit in Minnesota
state court, and Mentor removed the action to the U.S. District
Court for the District of Minnesota.
to
this
MDL
proceedings.
for
The action was transferred
consolidated
and
coordinated
pretrial
Plaintiff’s action was designated as a Phase IV-7
case, and plaintiff-specific discovery closed in September 2016.
Mentor
under
contends
Minnesota’s
that
statute
Plaintiff’s
of
claims
limitations.
are
time-barred
Based
on
its
interpretation of Minnesota law, the Eleventh Circuit concluded
that there is a genuine fact dispute on when Plaintiff’s claims
accrued,
thus
precluding
limitations grounds.1
summary
judgment
on
statute
Hampton, 2018 WL 1020038, at *3.
of
All
common discovery and coordinated pretrial proceedings in this
case are complete, and the case is ready for trial.
CONCLUSION
As discussed above, the Court suggests that this action be
remanded
Minnesota.
to
the
U.S.
For
the
District
Court
convenience
of
for
that
the
District
court,
the
of
Court
compiled a list of significant filings and orders in this case
and in MDL No. 2004.
That list appears as an appendix to this
1
Given this decision, Mentor is not a prevailing party in this case,
and the Court thus denies Mentor’s request for taxation of costs (ECF
No. 45 in 4:14-cv-78).
3
Order.
Order
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 17th day of April, 2018.
S/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA
4
APPENDIX
Significant filings and orders in this case and in MDL No.
2004:
I.
Significant Filings Specific to Plaintiff
1.
2.
3.
4.
5.
6.
7.
8.
II.
Complaint, ECF No. 1-1 in 4:14-cv-78.
Answer with Jury Demand, ECF No. 5 in 4:14-cv-78.
Summary Judgment Motion, ECF No. 32 in 4:14-cv-78.
Summary Judgment Response, ECF No. 33 in 4:14-cv-78.
Summary Judgment Reply, ECF No. 34 in 4:14-cv-78.
Order Granting Summary Judgment, ECF No. 36 in 4:14cv-78 (reversed by Eleventh Circuit).
Eleventh Circuit Opinion Reversing Grant of Summary
Judgment, ECF No. 47 in 4:14-cv-78.
Order of Clarification following Eleventh Circuit’s
Opinion in Rogers v. Mentor Corp., No. 16-10119, 2017
WL 928497 (11th Cir. Mar. 9, 2017): In re Mentor Corp.
ObTape Transobturator Sling Prod. Liab. Litig., No.
4:08-MD-2004 (CDL), 2017 WL 987457, at *1 (M.D. Ga.
Mar. 14, 2017).
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.
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.
5
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
opened the door to the FDA evidence, it could come in.
(ECF No. 299 – Transcript 174:9-175:16).
6
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
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.
7
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
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.
8
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.
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
9
18.
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.
10
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?