United States District Court, M.D. Pennsylvania
the Court is Defendant Covidien, LP
(“Defendant”)'s motion to dismiss Plaintiffs
Ronald Soutner and Janelle Soutner's
(“Plaintiffs”) second amended complaint (Doc. No.
24), pursuant to Federal Rule of Civil Procedure 12(b)(6)
(Doc. No. 25). For the reasons provided herein, the Court
will grant Defendant's motion.
is a Delaware limited partnership headquartered in Mansfield,
Massachusetts, engaged in the design, manufacture, and sale
of medical devices, including various surgical meshes. (Doc.
No. 24 ¶¶ 3-5.) One such mesh, Parietex ProGrip
Mesh, used in hernia repair surgeries, was implanted in
Plaintiff Ronald Soutner (“Soutner”) during a
surgical procedure on December 20, 2011, and is the subject
of the instant action. (Id. ¶ 4.)
are caused by the “penetration of fatty tissue,
intestine, or organs through a weakened or compromised
location in muscle of [sic] connective tissue.”
(Id. ¶ 13.) As stated in the second amended
complaint, hernia repairs are “common surgeries”
- they are performed in the United States more than one
million times each year - and inguinal hernia repairs make up
approximately 80% of those procedures. (Id. ¶
17.) Surgical mesh, including Defendant's Parietex
ProGrip Mesh, is used during hernia repair surgeries to
“strengthen the repair.” (Id. ¶
19.) Defendant's Parietex ProGrip Mesh is intended for
permanent implantation in a patient's body. (Id.
to Plaintiffs, unlike most hernia mesh products, which are
polypropylene based, Defendant's Parietex ProGrip Mesh is
made of monofilament polyester, which Plaintiffs allege is
“flimsy” compared to polypropylene. (Id.
¶¶ 31, 42.) Plaintiffs aver that, as a result,
surgeons reported difficulty in handling Defendant's
Parietex ProGrip Mesh during hernia repair surgeries.
(Id. ¶ 43.) Plaintiffs state that to remedy
this issue, Defendant added a layer of collagen to the
Parietex ProGrip Mesh, which was intended to make the mesh
easier to handle during surgeries. (Id. ¶ 44.)
In addition, Plaintiffs allege that Defendant attached
micro-grips to the Parietex ProGrip Mesh to prevent the mesh
from tearing. (Id. ¶¶ 46-47.) Plaintiffs
further aver that the micro-grips have caused patients who
have been implanted with the Parietex ProGrip Mesh to
experience “debilitating pain” due to the
Parietex ProGrip Mesh “contracting and pulling on all
of the tissues and nerves upon which it is attached.”
(Id. ¶ 48.)
December 20, 2011, Soutner underwent surgery to repair an
inguinal hernia on the left side of his groin. (Id.
¶ 50.) During this procedure, Defendant's Parietex
ProGrip Mesh was implanted into Soutner to “reinforce
tissue affected by the hernia.” (Id.
¶¶ 50, 52.) At some point following the procedure,
Soutner experienced severe inflammation in the region where
the procedure was performed. (Id. ¶ 55.)
According to Plaintiffs, the inflammation was so severe that
Soutner's vas deferens was “destroyed.”
(Id.) On October 7, 2013, Soutner underwent an
additional surgical procedure, at which time Defendant's
Parietex ProGrip Mesh was removed. (Id. ¶ 53.)
During the second procedure, it was determined that
“Defendant's Parietex ProGrip Mesh integrated to
the surrounding muscles where it had to be dissected
off.” (Id. ¶¶ 53-54.) During this
second procedure, Soutner's vas deferens was removed.
(Id. ¶ 55.) Plaintiffs allege that, following
the second procedure, Soutner has experienced and continues
to experience groin pain and life without his vas deferens.
(Id. ¶ 57.) Plaintiffs further allege that as a
direct and proximate result of the implanted mesh products,
Soutner “suffered, is suffering, and/or will continue
to suffer the abovementioned injuries, including the risk of
malfunction, decreased efficacy, recurrent hernia,
perforation of tissue and/or organs, adherence to
tissue/organs, infection, nerve damage, subsequent surgeries,
and other complications.” (Id. ¶ 65.)
allege that Soutner, through the exercise of reasonable
diligence, could not have discovered his injury was caused by
Defendant's mesh product because his physicians
“were not informed by Defendant that these injuries
could result from the implantation of Defendant[']s
faulty mesh product.” (Id. ¶ 59.)
Plaintiffs further allege that Soutner “did not know
and could not have known that he was injured and that his
injuries were caused by Defendant's defective product
until he saw a commercial in 2017 which enlightened him to
the fact that he was, in fact, injured and that his injuries
could have been caused by the conduct of another.”
(Id. ¶ 62.) Plaintiffs also allege that Soutner
is “not employed in the medical field and was not privy
to the same sophisticated medical information as Defendant,
who negligently and fraudulently concealed the fact that
these injuries could, and did in fact, result from its
defective mesh product.” (Id. ¶ 61.)
experiencing the injuries described supra, Soutner
commenced this action by filing a complaint against Defendant
on October 27, 2017, in the Court of Common Pleas of Dauphin
County, Pennsylvania. (Doc. No. 1 at 10.) In his initial
complaint, Soutner asserted the following ten claims against
Defendant: strict liability based on defective design and
manufacture (Count I); strict liability due to a failure to
warn (Count II); negligence (Count III); breach of warranty
(Count IV); fraudulent misrepresentation (Count V); negligent
misrepresentation (Count VI); unjust enrichment (Count VII);
breach of express warranty (Count VIII); breach of implied
warranty of merchantability (Count IX); and breach of implied
warranty of fitness (Count X). (Id. at 21-36.) On
November 28, 2017, Defendant removed the action to this Court
pursuant to 28 U.S.C. §§ 1441 and 1446.
(Id. at 2.) Soutner filed an amended complaint on
January 12, 2018, adding his wife Janelle Soutner as a
plaintiff and asserting additional claims for punitive
damages (Count XI), and loss of consortium (Count XII). (Doc.
No. 8 at 25-27.) On February 26, 2018, Defendant filed a
motion to dismiss all of the aforementioned claims pursuant
to Federal Rule of Civil Procedure 12(b)(6) (Doc. No. 12),
and filed a brief in support thereof on March 12, 2018 (Doc.
No. 15). Plaintiffs filed their brief in opposition to
Defendant's motion to dismiss on March 27, 2018 (Doc. No.
18), to which Defendants filed a brief in reply on April 10,
2018 (Doc. No. 19). The Court issued an Order and
accompanying Memorandum on October 26, 2018, denying
Defendant's motion and giving Plaintiff's leave to
amend their complaint for a second time. (Doc. Nos. 22, 23.)
November 21, 2018, Plaintiffs filed a second amended
complaint, adding new allegations related to the applicable
statutes of limitations. (Doc. No. 24.) On December 5, 2018,
Defendant filed a motion to dismiss Plaintiffs' second
amended complaint (Doc. No. 25), and a filed a brief in
support thereof on December 19, 2018 (Doc. No. 30). On
January 10, 2019, Plaintiffs filed a brief in opposition
(Doc. No. 37), to which Defendant filed a reply on January
24, 2019 (Doc. No. 39). Having been fully briefed,
Defendant's motion to dismiss is ripe for disposition.
12(b)(6) of the Federal Rules of Civil Procedure permits a
defendant to move to dismiss a complaint for “failure
to state a claim upon which relief can be granted.”
Fed.R.Civ.P. 12(b)(6). The legal standards governing pleading
practice in federal court have shifted to a “more
heightened form of pleading, requiring a plaintiff to plead
more than the possibility of relief to survive a motion to
dismiss.” See Fowler v. UPMC Shadyside, 578
F.3d 203, 210 (3d Cir. 2009). To avoid dismissal, all civil
complaints must set out “sufficient factual
matter” to show that the claim is facially plausible.
Id. The plausibility standard requires more than a
mere possibility that the defendant is liable for the alleged
misconduct. Indeed, “where the well-pleaded facts do
not permit the court to infer more than the mere possibility
of misconduct, the complaint has alleged - but it has not
‘show[n]' - ‘that the pleader is entitled to
relief.'” Ashcroft v. Iqbal, 556 U.S. 662,
679 (2009) (citing Fed.R.Civ.P. 8(a)(2)). “Factual
allegations must be enough to raise a right to relief above
the speculative level.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 555 (2007).
United States Court of Appeals for the Third Circuit has
identified the following steps a district court must take
when evaluating the sufficiency of a complaint's
allegations as tested against a Rule 12(b)(6) motion: (1)
identify the elements a plaintiff must plead to state a
claim; (2) discard any conclusory allegations contained in
the complaint “not entitled” to the assumption of
truth; and (3) determine whether any “well-pleaded
factual allegations” contained in the complaint
“plausibly give rise to an entitlement to
relief.” See Santiago v. Warminster Twp., 629
F.3d 121, 130 (3d Cir. 2010) (citation and quotation marks
evaluating whether a complaint fails to state a claim upon
which relief may be granted, the court must accept as true
all factual allegations in the complaint, and construe all
reasonable inferences to be drawn therefrom in the light most
favorable to the plaintiff. See In re Ins. Brokerage
Antitrust Litig., 618 F.3d 300, 314 (3d Cir. 2010). A
court “need not credit a complaint's ‘bald
assertions' or ‘legal conclusions' when
deciding a motion to dismiss, ” Morse v. Lower
Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir. 1997), and
must disregard any “formulaic recitation of the
elements of a cause of action.” Twombly, 550
U.S. at 555. Additionally, a court may not assume that a
plaintiff can prove facts that the plaintiff has not alleged.
Associated Gen. Contractors of Cal. v. Cal. State Council
of Carpenters, 459 U.S. 519, 526 (1983). In deciding a
Rule 12(b)(6) motion, a court may consider, in addition to
the facts alleged on the face of the complaint, any exhibits
attached to the complaint, “any matters incorporated by
reference or integral to the claim, items subject to judicial
notice, [and] matters of public record.” Buck v.
Hampton Twp. Sch. Dist., 452 F.3d 256, 260 (3d Cir.
2006) (citation and quotation marks omitted).
Federal Rules of Civil Procedure require that affirmative
defenses be pleaded in the answer. Robinson v.
Johnson, 313 F.3d 128, 135 (3d Cir. 2002) (citing
Fed.R.Civ.P. 8(c)). The Third Circuit, however,
“permits a limitations defense to be raised by a motion
under Rule 12(b)(6), but only if ‘the time alleged in
the statement of a claim shows that the cause of action has
not been brought within the statute of
limitations.'” Id. (quoting Hanna v.
U.S. Veterans' Admin. Hosp., 514 F.2d 1092 (3d Cir.
1975)). Where a complaint “is vulnerable to 12(b)(6)
dismissal, a district court must permit a curative amendment
unless such an amendment would inequitable or futile.”
Phillips v. Cty. of Allegheny, 515 F.3d 224, 245 (3d
argues that Plaintiffs' six tort-based
claims and five contract-based
claimsare barred by operation of the applicable
statutes of limitations (Doc. No. 30 at 1), and
Plaintiffs' claim for punitive damages should be
dismissed because Plaintiffs have not sufficiently alleged
that Defendant acted with reckless indifference (id.
at 53). Defendant further argues that even if Plaintiffs'
claims were not time-barred, all of the claims should be
dismissed because they are either precluded by Pennsylvania
law or pleaded inadequately. (Id. at 1.) Plaintiffs
argue that either Pennsylvania's discovery rule or the
doctrine of fraudulent concealment tolls the applicable
limitations period and renders their claims timely. (Doc. No.
37 at 1.) Plaintiffs also state that they have sufficiently
pleaded their claims against Defendant. (Id.)