United States District Court, M.D. Georgia, Columbus Division
IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION No. 4:08-MD-2004 (CDL) No. 4:14-cv-207 (Luciano)
D. LAND CHIEF U.S. DISTRICT COURT JUDGE.
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 as to Mrs. Luciano's
claims sounding in strict liability, her breach of express
warranty claim, her failure to warn claims, and her punitive
damages claim. Mrs. Luciano does not oppose Mentor's
summary judgment 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
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.”
Fed.R.Civ.P. 56(a). In determining whether a genuine
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. Anderson v. Liberty Lobby, Inc.,
477 U.S. 242, 255 (1986). 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.
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. Dr. Kraus
advised Mrs. Luciano to undergo an ObTape implant procedure,
and he implanted Mrs. Luciano with ObTape on June 21, 2004.
Dr. Kraus does not recall receiving any literature or
training regarding ObTape. Kraus Dep. 23:8-15, 36:13-22, ECF
No. 39-4. 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. Id. at
36:23-3, 69:23-70:25. But Dr. Kraus did recall that he spoke
with a Mentor sales representative about ObTape's pore
size. Id. at 22:10-23:7. Although Dr. Kraus did not
remember the specifics of his discussion with the Mentor
representative regarding 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. Id. at
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. The parties agree that Massachusetts
law applies to this case because Mrs. Luciano was a
Massachusetts resident when her ObTape was implanted, and all
of her ObTape-related treatment took place in Massachusetts.
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, 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.
discussed above, Mentor's partial summary judgment motion
(ECF No. 38 in 4:14-cv-207) is granted as to Mrs.
Luciano's strict liability, breach of express warranty,
continuing duty to warn, and punitive damages 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.
action is 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
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.
Clerk of Court is directed to provide a copy of this Order to
the Clerk of the Judicial Panel on Multidistrict Litigation.
Brief Background of the Mentor ObTape MDL
Worldwide LLC manufactured and sold a polypropylene mesh
suburethral sling product called ObTape Transobturator Tape,
which was used to treat women with stress urinary
incontinence. The United States Food and Drug Administration
cleared ObTape for sale in 2003 via its 510(k) regulatory
process, and ObTape remained on the market in the United
States until March 2006.
ten 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). After
pretrial proceedings and a bellwether trial that settled
mid-trial, 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 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.
Significant Filings in MDL No. 2004
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.
Order Denying Motion to Disqualify Expert Witness Dr.
Catherine Ortuno, Apr. 1, 2010. ECF No. 231 in 4:08-md-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, attorney-client communications.
Order on Phase I Summary Judgment Motions and Admissibility
of Plaintiffs' Experts, Apr. 22, 2010. ECF No. 241 ...