United States District Court, N.D. Texas, Dallas Division
MEMORANDUM OPINION AND ORDER
Lindsay, United States District Judge.
the court are Defendant Boston Scientific Corporation's
(“Defendant” or “Boston Scientific”)
Motion to Dismiss for Failure to State a Claim (Doc. 5),
filed September 11, 2018; Plaintiff Carolyn Carpenter's
(“Plaintiff” or “Carpenter”) Response
(Doc. 10), filed October 2, 2018; and Defendant's Reply
(Doc. 11), filed October 16, 2018.
careful consideration of the motion, briefs, pleadings, and
applicable law, the court grants
Defendant's Motion to Dismiss for Failure to State a
Claim (Doc. 5); dismisses with prejudice
Plaintiff's breach of implied and express warranty claims
as being barred by the statute of limitations; and
dismisses without prejudice Plaintiff's
negligence and strict liability claims but allows her to file
an amended pleading.
Factual and Procedural Background
27, 2018, Carpenter filed Plaintiff's Original Petition
(the “Petition”) in the 68th Judicial District
Court of Dallas County, Texas, asserting the following state
law claims against Boston Scientific: (1) negligence; (2)
strict liability for a design defect; (3) strict liability
for a manufacturing defect; (4) strict liability for failure
to warn; (5) breach of implied warranty; and (6) breach of
express warranty. Def.'s Notice of Removal, Doc. 1 at 1;
Pl.'s Pet., Doc. 1-3 at 11-15. Boston Scientific was
served on August 13, 2018, and removed this action to federal
court on September 4, 2018, on the basis of diversity
jurisdiction. Def.'s Notice of Removal, Doc. 1 at 1-3;
Ex. B., Doc. 1-2 at 3.
asserts that these claims arise based on her being surgically
implanted with Boston Scientific's medical device, the
Advantage Fit Transvaginal Mid-Urethral Sling System (the
“Advantage Fit”). The Advantage Fit is a device
composed of polypropylene mesh that is implanted onto a
woman's vaginal wall and secured in place by two arms
that extend through the pelvis. Pl.'s Pet., Doc. 1-3,
¶ 7. The purpose of the device is to correct and restore
the normal vaginal structure of women who suffer from pain,
discomfort, and urinary incontinence. Id.
April 5, 2012, Carpenter underwent surgery at Texas Health
Presbyterian Hospital Plano and was implanted with the
Advantage Fit to treat her urinary incontinence. Pl.'s
Pet., Doc. 1-3, ¶ 32. Carpenter alleges that, as a
result of the implantation of the device, she suffered
complications that required corrective surgeries.
Specifically, she contends that, in January 2017, she had
surgery to remove stones from her bladder; in May 2017, she
had surgery to remove mesh that had eroded into her bladder;
and in May 2018, she had surgery to remove additional mesh
that had eroded into her bladder and treat bladder lesions.
Pl.'s Pet., Doc. 1-3, ¶¶ 33-35. Carpenter
alleges that she will continue to suffer injury as a result
of being implanted with the Advantage Fit device, including
pain, discomfort, chronic infections, surgeries, and erosion
of the device into her surrounding organs and tissues.
Pl.'s Pet., Doc. 1-3, ¶ 36.
asserts that scientific evidence shows that “this
material is biologically incompatible with human tissue and
promotes an immune response, ” which causes the mesh
material to degrade, leading to “the formation of
severe adverse reactions.” Pl.'s Pet., Doc. 1-3,
¶ 9. Carpenter asserts that Boston Scientific, in
promoting the Advantage Fit, has made exaggerated and
misleading representations regarding the safety, utility, and
efficacy of the device. Pl.'s Pet., Doc. 1-3, ¶ 11.
Carpenter asserts that, in addition to her, a significant
number of women who were implanted with the Advantage Fit
have subsequently experienced severe and irreversible
injuries as a result of the device and have required frequent
and often debilitating revision surgeries. Pl.'s Pet.,
Doc. 1-3, ¶ 12. Some of the resulting injuries, she
contends, include: mesh erosion, infection, inflammation,
scar tissue, organ perforation, blood loss, acute and chronic
nerve damage and pain, and urinary and fecal incontinence.
Pl.'s Pet., Doc. 1-3, ¶ 26. Carpenter contends that
the medical and scientific literature studying the effects of
polypropylene mesh, the material used in the Advantage Fit,
has concluded that “each of these injuries, conditions,
and complications . . . are in fact causally related to the
mesh itself and do not often implicate errors related to the
implantation of the devices.” Pl.'s Pet., Doc. 1-3,
¶ 27. Carpenter contends that the FDA issued warnings in
2008 and 2011, regarding the use of transvaginal mesh
products. Pl.'s Pet., Doc. 1-3, ¶ 7.
September 11, 2018, Boston Scientific filed its Motion to
Dismiss. Boston Scientific argues that Carpenter's claims
are barred by the applicable statutes of limitations, that
her Petition fails to state a claim upon which relief can be
granted, and that it should be dismissed pursuant to Federal
Rule of Civil Procedure 12(b)(6) (“Rule
12(b)(6)”). For the reasons that follow, the court
determines that Carpenter's breach of implied and express
warranty claims are barred by the statute of limitations;
that the pleadings do not support Defendant's arguments
that her negligence and strict liability claims are
time-barred; and that, although the Petition has factual
deficiencies with respect to the negligence and strict
liability claims, Carpenter will be permitted to replead her
claims in an amended complaint.
Rule 12(b)(6) - Failure to State a Claim
defeat a motion to dismiss filed pursuant to Rule 12(b)(6) of
the Federal Rules of Civil Procedure, a plaintiff must plead
“enough facts to state a claim to relief that is
plausible on its face.” Bell Atlantic Corp. v.
Twombly, 550 U.S. 544, 570 (2007); Reliable
Consultants, Inc. v. Earle, 517 F.3d 738, 742 (5th Cir.
2008); Guidry v. American Pub. Life Ins. Co., 512
F.3d 177, 180 (5th Cir. 2007). A claim meets the plausibility
test “when the plaintiff pleads factual content that
allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged. The
plausibility standard is not akin to a ‘probability
requirement,' but it asks for more than a sheer
possibility that a defendant has acted unlawfully.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)
(internal citations omitted). While a complaint need not
contain detailed factual allegations, it must set forth
“more than labels and conclusions, and a formulaic
recitation of the elements of a cause of action will not
do.” Twombly, 550 U.S. at 555 (citation
omitted). The “[f]actual allegations of [a complaint]
must be enough to raise a right to relief above the
speculative level . . . on the assumption that all the
allegations in the complaint are true (even if doubtful in
fact).” Id. (quotation marks, citations, and
footnote omitted). When the allegations of the pleading do
not allow the court to infer more than the mere possibility
of wrongdoing, they fall short of showing that the pleader is
entitled to relief. Iqbal, 556 U.S. at 679.
reviewing a Rule 12(b)(6) motion, the court must accept all
well-pleaded facts in the complaint as true and view them in
the light most favorable to the plaintiff. Sonnier v.
State Farm Mutual Auto. Ins. Co., 509 F.3d 673, 675 (5th
Cir. 2007); Martin K. Eby Constr. Co. v. Dallas Area
Rapid Transit, 369 F.3d 464, 467 (5th Cir. 2004);
Baker v. Putnal, 75 F.3d 190, 196 (5th Cir. 1996).
In ruling on such a motion, the court cannot look beyond the
pleadings. Id.; Spivey v. Robertson, 197
F.3d 772, 774 (5th Cir. 1999). The pleadings include the
complaint and any documents attached to it. Collins v.
Morgan Stanley Dean Witter, 224 F.3d 496, 498-99 (5th
Cir. 2000). Likewise, “‘[d]ocuments that a
defendant attaches to a motion to dismiss are considered part
of the pleadings if they are referred to in the
plaintiff's complaint and are central to [the
plaintiff's] claims.'” Id. (quoting
Venture Assocs. Corp. v. Zenith Data Sys. Corp., 987
F.2d 429, 431 (7th Cir. 1993)). In this regard, a document
that is part of the record but not referred to in a
plaintiff's complaint and not attached to a motion to
dismiss may not be considered by the court in ruling on a
12(b)(6) motion. Gines v. D.R. Horton, Inc., 699
F.3d 812, 820 & n.9 (5th Cir. 2012) (citation omitted).
ultimate question in a Rule 12(b)(6) motion is whether the
complaint states a valid claim when it is viewed in the light
most favorable to the plaintiff. Great Plains Trust Co.
v. Morgan Stanley Dean Witter, 313 F.3d 305, 312 (5th
Cir. 2002). While well-pleaded facts of a complaint are to be
accepted as true, legal conclusions are not “entitled
to the assumption of truth.” Iqbal, 556 U.S.
at 679 (citation omitted). Further, a court is not to strain
to find inferences favorable to the plaintiff and is not to
accept conclusory allegations, unwarranted deductions, or
legal conclusions. R2 Invs. LDC v. Phillips, 401
F.3d 638, 642 (5th Cir. 2005) (citations omitted). The court
does not evaluate the plaintiff's likelihood of success;
instead, it only determines whether the plaintiff has pleaded
a legally cognizable claim. United States ex rel. Riley
v. St. Luke's Episcopal Hosp., 355 F.3d 370, 376
(5th Cir. 2004). Stated another way, when a court deals with
a Rule 12(b)(6) motion, its task is to test the sufficiency
of the allegations contained in the pleadings to determine
whether they are adequate enough to state a claim upon which
relief can be granted. Mann v. Adams Realty Co., 556
F.2d 288, 293 (5th Cir. 1977); Doe v. Hillsboro Indep.
Sch. Dist., 81 F.3d 1395, 1401 (5th Cir. 1996),
rev'd on other grounds, 113 F.3d 1412 (5th Cir.
1997) (en banc). Accordingly, denial of a 12(b)(6) motion has
no bearing on whether a plaintiff ultimately establishes the
necessary proof to prevail on a claim that withstands a
12(b)(6) challenge. Adams, 556 F.2d at 293.
statute of limitations may support dismissal pursuant to Rule
12(b)(6) when it is evident from a plaintiff's pleadings
that the action is time-barred and the pleadings fail to set
forth or raise some basis for tolling the statute. Jones
v. Alcoa, Inc., 339 F.3d 359, 366 (5th Cir. 2003)
Statute of Limitations
Plaintiff's Breach of Implied and ...