Luciano et al v. Mentor Worldwide LLC
Filing
43
ORDER granting in part and denying in part 38 Motion for Partial Summary Judgment; suggesting remand to the U.S. District Court for the District of Massachusetts. Ordered by US DISTRICT JUDGE CLAY D LAND on 02/22/2017. (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 No.
* 4:14-cv-207 (Luciano)
O R D E R
Defendant
Mentor
Worldwide
LLC
developed
a
suburethral
sling product called ObTape Transobturator Tape, which was used
to
treat
women
with
stress
urinary
incontinence.
Plaintiff
Juana Luciano was implanted with ObTape and asserts that she
suffered injuries caused by ObTape.
Mrs. Luciano brought a
product liability action against Mentor, contending that ObTape
had design defects that proximately caused her injuries.
Mrs.
Luciano also asserts that Mentor did not adequately warn her
physicians about the risks associated with ObTape.
Her husband
Ronald brought a loss of consortium claim.
Mentor seeks summary
judgment
sounding
as
to
Mrs.
Luciano’s
claims
in
strict
liability, her breach of express warranty claim, her failure to
warn claims, and her punitive damages claim.
not
oppose
Mentor’s
summary
judgment
Mrs. Luciano does
motion
on
her
strict
liability, breach of express warranty, continuing duty to warn,
and punitive damages claims.
Mentor’s summary judgment motion
is therefore granted as to these claims.
Mrs. Luciano does
oppose
summary
judgment
on
her
claim
that
Mentor
did
not
adequately warn her physician of the risks of ObTape before her
implant surgery.
As discussed below, the Court denies Mentor’s
summary judgment motion as to Mrs. Luciano’s pre-implant failure
to warn claim (ECF No. 38 in 4:14-cv-207).
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.”
Civ. P. 56(a).
In determining whether a
genuine
Fed. R.
dispute of
material fact exists to defeat a motion for summary judgment,
the evidence is viewed in the light most favorable to the party
opposing summary judgment, drawing all justifiable inferences in
the opposing party’s favor.
477 U.S. 242, 255 (1986).
Anderson v. Liberty Lobby, Inc.,
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 the Lucianos, the
record reveals the following.
Juana Luciano sought treatment
from Dr. Stanley Kraus for stress urinary incontinence.
Kraus
advised
Mrs.
Luciano
to
undergo
an
ObTape
Dr.
implant
procedure, and he implanted Mrs. Luciano with ObTape on June 21,
2
2004.
Dr. Kraus does not recall receiving any literature or
training regarding ObTape.
No. 39-4.
Kraus Dep. 23:8-15, 36:13-22, ECF
Dr. Kraus could not identify any specific statements
Mentor made that played a role in his decision to implant Mrs.
Luciano with ObTape, and he does not recall reading the ObTape
product insert data sheet.
Dr.
Kraus
did
recall
that
Id. at 36:23-3, 69:23-70:25.
he
spoke
with
representative about ObTape’s pore size.
Although
discussion
Dr.
Kraus
with
the
did
not
Mentor
remember
the
representative
a
Mentor
But
sales
Id. at 22:10-23:7.
specifics
regarding
of
his
ObTape’s
pore size, he did understand that it was important for a mesh
product to have large pores.
Id. at 22:23-23:15.
Dr. Kraus
also testified that if he had known that ObTape had a greater
risk of erosion (a complication associated with smaller pore
size) than other slings, that information could have altered his
decision to use ObTape to treat Mrs. Luciano.1
Id. at 116:18-
117:15.
1
Mentor argued for the first time in its reply brief that the Court
should ignore Dr. Kraus’s testimony in response to a hypothetical
question suggesting that ObTape had a higher rate of erosion than
other mesh slings because Plaintiffs did not present Dr. Kraus with
evidence to support the hypothetical.
Based on the Court’s
experience, which includes presiding over three trials regarding
ObTape and deciding more than 100 summary judgment motions, the Court
is satisfied that the common evidence regarding ObTape is sufficient
to create a genuine fact dispute on whether ObTape had smaller pores
and a higher erosion rate than other mesh sling products used to treat
stress urinary incontinence.
3
DISCUSSION
The
Lucianos
filed
this
action
in
the
United
States
District Court for the District of Massachusetts on July 8,
2014,
and
the
Judicial
Panel
on
Multidistrict
Litigation
transferred the case to this multidistrict litigation proceeding
for pretrial proceedings.
law
applies
to
this
The parties agree that Massachusetts
case
because
Mrs.
Luciano
was
a
Massachusetts resident when her ObTape was implanted, and all of
her ObTape-related treatment took place in Massachusetts.
Under
Massachusetts
law,
a
prescription
medical
device
manufacturer must adequately inform a patient’s physician of the
foreseeable risks associated with the device.
E.g., Albright v.
Boston Sci. Corp., 58 N.E.3d 360, 368 (Mass. App. Ct. 2016).
Here, Mentor argues that Mrs. Luciano cannot establish causation
on her pre-implant failure to warn claim because she did not
present enough evidence to show that (1) Dr. Kraus relied on any
representations from Mentor when he selected ObTape for Mrs.
Luciano and (2) Dr. Kraus would not have recommended ObTape for
Mrs. Luciano had he received a different warning from Mentor.
But, as discussed above, Mrs. Luciano pointed to evidence that
Dr. Kraus discussed ObTape—including its pore size—with a Mentor
representative and that if Dr. Kraus had known that ObTape had a
greater risk of erosion (a complication associated with smaller
pore
size)
than
other
slings,
4
that
information
could
have
altered his decision to use ObTape to treat Mrs. Luciano.
Based
on this evidence, the Court finds that there is a genuine fact
dispute on Mrs. Luciano’s pre-implant failure to warn claim, and
Mentor’s summary judgment motion on this claims is denied.
CONCLUSION
As
motion
discussed
(ECF
No.
above,
38
Luciano’s
strict
continuing
duty
in
Mentor’s
4:14-cv-207)
liability,
to
partial
warn,
is
breach
and
granted
of
punitive
summary
as
express
damages
judgment
to
Mrs.
warranty,
claims.
The
motion is denied as to Mrs. Luciano’s pre-implant failure to
warn
claims.
That
claim,
along
with
the
following
claims,
remain pending for trial: Mrs. Luciano’s claims for negligence
and
breach
of
implied
warranty
and
Mr.
Luciano’s
loss
of
consortium claim.
SUGGESTION OF REMAND
This action is ready for trial.
elected
to
waive
venue
under
Given that Mentor has not
Lexecon
Inc.
v.
Milberg
Weiss
Bershad Hynes & Lerach, 523 U.S. 26 (1998) since Phase IV-1, the
Court
finds
it
appropriate
to
suggest
that
this
action
be
remanded to the transferor court, the U.S. District Court for
the District of Massachusetts.
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.
5
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 22nd day of February, 2017.
s/Clay D. Land
CLAY D. LAND
CHIEF U.S. DISTRICT COURT JUDGE
MIDDLE DISTRICT OF GEORGIA
6
APPENDIX
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
began
filing
who
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
Products
(J.P.M.L.
Court
for
See In re
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 has grown to include more
7
than 800 additional tag-along cases, more than eighty of which
remain open.
The litigation was divided into phases, and cases
from phases IV-8 through 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, 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.
8
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).
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.
9
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.
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.
10
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.
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
11
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.
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.
12
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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