United States District Court, D. New Jersey
ALEXANDRA COLELLA MARC J. BERN & PARTNERS, LLP On behalf
STEPHEN C. MATTHEWS DLA PIPER LLP (US) On behalf of Defendant
L. HILLMAN, U.S.D.J.
matter concerns claims by Plaintiff arising from injuries she
allegedly sustained from Defendant's surgical mesh used
to repair Plaintiff's hernia. For the reasons stated
below, Defendant's motion will be granted in part and
denied in part.
November 11, 2016, Plaintiff, Sharon Smith, underwent a
laparoscopic incarcerated incisional and umbilical hernia
repair procedure using Symbotex Mesh in Plaintiff's
abdomen to reinforce tissue affected by a hernia. Symbotex
Mesh is manufactured and sold by Defendant Covidien LP.
claims that within a few weeks of surgery, she suffered from
abdominal pain, swelling, drainage from the wound site, and
other complications, which required three subsequent
surgeries on December 1, 3, and 5, 2016. The surgeries
included removal of infected mesh, drainage of abscess,
abdominal washout, and necrotic tissue debridement. She was
also found to have ischemic (restricted blood flow) tissue as
well as purulent drainage from the right lateral edge of the
wound. Plaintiff claims that she has experienced, and
continues to experience, debilitating abdominal pain since
the implant of the Symbotex Mesh and the multiple surgeries
since the implantation of the Symbotex Mesh.
has advanced claims under the New Jersey Product Liability
Act (“PLA”) for defective design, defective
manufacture, and failure-to-warn. Plaintiff has also brought
claims under New Jersey common law for negligence, breach of
the implied warranty of fitness for a particular purpose,
breach of express warranty, as well as a claim for punitive
has moved to dismiss Plaintiff's complaint in its
entirety. Defendant argues that Plaintiff's common law
claims for negligence and breach of the implied warranty are
subsumed within the PLA and must be dismissed. Defendant also
argues that Plaintiff has failed to properly plead her claims
brought under the PLA and for breach of the express warranty.
Finally, Defendant argues that Plaintiff's count for
punitive damages is derivative and cannot survive where the
substantive claims fail as a matter of law. Plaintiff has
opposed Defendant's motion.
Court exercises jurisdiction pursuant to 28 U.S.C. §
1332(a), diversity of citizenship. Plaintiff is a citizen of
New Jersey. Defendant is a limited partnership with limited
liability companies and corporations as its members, none of
which are citizens of New Jersey. (See Docket No. 6 at 2-3.)
The amount in controversy exceeds $75, 000 exclusive of
interest and costs.
Standard for Motion to Dismiss
considering a motion to dismiss a complaint for failure to
state a claim upon which relief can be granted pursuant to
Federal Rule of Civil Procedure 12(b)(6), a court must accept
all well-pleaded allegations in the complaint as true and
view them in the light most favorable to the plaintiff.
Evancho v. Fisher, 423 F.3d 347, 351 (3d Cir. 2005).
It is well settled that a pleading is sufficient if it
contains “a short and plain statement of the claim
showing that the pleader is entitled to relief.”
a complaint attacked by a Rule 12(b)(6) motion to dismiss
does not need detailed factual allegations, a plaintiff's
obligation to provide the ‘grounds' of his
‘entitle[ment] to relief' requires more than labels
and conclusions, and a formulaic recitation of the elements
of a cause of action will not do . . . .” Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555 (2007) (alteration
in original) (citations omitted) (first citing Conley v.
Gibson, 355 U.S. 41, 47 (1957); Sanjuan v. Am. Bd.
of Psychiatry & Neurology, Inc., 40 F.3d 247, 251
(7th Cir. 1994); and then citing Papasan v. Allain,
478 U.S. 265, 286 (1986)).
determine the sufficiency of a complaint, a court must take
three steps: (1) the court must take note of the elements a
plaintiff must plead to state a claim; (2) the court should
identify allegations that, because they are no more than
conclusions, are not entitled to the assumption of truth; and
(3) when there are well-pleaded factual allegations, a court
should assume their veracity and then determine whether they
plausibly give rise to an entitlement for relief. Malleus
v. George, 641 F.3d 560, 563 (3d Cir. 2011) (quoting
Ashcroft v. Iqbal, 556 U.S. 662, 664, 675, 679
(2009) (alterations, quotations, and other citations
district court, in weighing a motion to dismiss, asks
“not whether a plaintiff will ultimately prevail but
whether the claimant is entitled to offer evidence to support
the claim.” Twombly, 550 U.S. at 563 n.8
(quoting Scheuer v. Rhoades, 416 U.S. 232, 236
(1974)); see also Iqbal, 556 U.S. at 684 (“Our
decision in Twombly expounded the pleading standard
for ‘all civil actions' . . . .”); Fowler
v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009)
(“Iqbal . . . provides the final nail in the
coffin for the ‘no set of facts' standard that
applied to federal complaints before
Twombly.”). “A motion to dismiss should
be granted if the plaintiff is unable to plead ‘enough
facts to state a claim to relief that is plausible on its
face.'” Malleus, 641 F.3d at 563 (quoting
Twombly, 550 U.S. at 570).
in reviewing a Rule 12(b)(6) motion must only consider the
facts alleged in the pleadings, the documents attached
thereto as exhibits, and matters of judicial notice. S.
Cross Overseas Agencies, Inc. v. Kwong Shipping Grp.
Ltd., 181 F.3d 410, 426 (3d Cir. 1999). A court may
consider, however, “an undisputedly authentic document
that a defendant attaches as an exhibit to a motion to
dismiss if the plaintiff's claims are based on the
document.” Pension Benefit Guar. Corp. v. White
Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir.
1993). If any other matters outside the pleadings are
presented to the court, and the court does not exclude those
matters, a Rule 12(b)(6) motion will be treated as a summary
judgment motion pursuant to Rule 56. Fed.R.Civ.P. 12(b).
Plaintiff's claims under the PLA
Under the New Jersey Product Liability Act (PLA), A
manufacturer or seller of a product shall be liable in a
product liability action only if the claimant proves by a
preponderance of the evidence that the product causing the
harm was not reasonably fit, suitable or safe for its
intended purpose because it: a. deviated from the design
specifications, formulae, or performance standards of the
manufacturer or from otherwise identical units manufactured
to the same manufacturing specifications or formulae, or b.
failed to contain adequate warnings or instructions, or c.
was designed in a defective manner.
cited statutory text establishes three causes of action under
the PLA: (1) design defect, (2) manufacturing defect, or (3)
warnings defect. Mendez v. Shah, 28 F.Supp.3d 282,
296 (D.N.J. 2014) (citing Roberts v. Rich Foods,
Inc., 139 N.J. 365, 375, 654 A.2d 1365 (N.J. 1995);
Dziewiecki v. Bakula, 361 N.J.Super. 90, 97-98, 824
A.2d 241 (App. Div. 2003)). The standard of liability is that
the product “was not reasonably fit, suitable or safe
for its intended purpose.” Id. (citing
Cornett v. Johnson & Johnson, 414 N.J.Super.
365, 998 A.2d 543 (App. Div. 2010)). The “mere
occurrence of an accident and the mere fact that someone was
injured are not sufficient to demonstrate the existence of a
defect.” Id. (citation omitted).
takes the position that hernia mesh products are generally
reliable and have been used successfully for many years in
hundreds of thousands of surgeries. Moreover, it contends
that the Symbotex mesh product at issue has not been subject
to any recalls, withdrawals, or adverse regulatory action,
and that the alleged complications from Plaintiff's
surgery are common side-effects disclosed in the
product's Instructions for Use. Under these
circumstances, Defendant contends, Plaintiff cannot maintain
her claims that the Symbotex mesh was defectively designed,
improperly manufactured, or Defendant should have warned her
of the product's dangers. In short, Defendant argues that
Plaintiff has not, and cannot, plead any facts to support her
claims that the Symbotex mesh used to repair Plaintiff's
hernia was not “reasonably fit, suitable or
to Defendant's view of Plaintiff's claims, while
Plaintiff's complaint is admittedly thin it does not
assert in conclusory fashion that simply because Plaintiff
suffered complications from the surgical use of Symbotex mesh
it must be because the product was defective in some fashion.
The Court concludes that, at this pleading stage, Plaintiff
has alleged enough facts to establish the plausibility of her
three claims under the PLA.
determining whether a product was defectively designed,
courts apply a risk-utility analysis. Lopez v. Borough of
Sayreville, 2008 WL 2663423, at *25 (
N.J.Super.Ct.App.Div. 2008), cert. denied, 960 A.2d
395 (N.J. 2008) (citing Cavanaugh v. Skil Corp., 164
N.J. 1, 8, 751 A.2d 518 (2000); Lewis v. American
Cyanamid Co., 715 A.2d 967, 980 (N.J. 1998)). “A
plaintiff must prove either that the product's risks
outweighed its utility or that the product could have been
designed in an alternative manner so as to minimize or
eliminate the risk of harm.” Id. (citing
Lewis, 715 A.2d at 980).
are seven listed factors in the classical statement of the
risk-utility analysis,  but the prevalent view is that unless
one or more of the other factors might be relevant in a
particular case, the issue upon which most claims will turn
is the proof by plaintiff of a reasonable alternative design,
the omission of which renders the product not reasonably
safe. Cavanaugh v. Skil Corp., 751 A.2d 518, 522
(N.J. 2000) (citation omitted). The burden is on the
plaintiff to prove “the existence of an alternative
design that is both practical and feasible” and
“safer” than that used by the manufacturer.
Lopez, 2008 WL 2663423 at *25 (citing
Lewis, 715 A.2d at 980) (“Plaintiffs who
assert that the product could have been designed more safely
must prove under a risk-utility analysis the existence of an
alternative design that is both practical and
the factfinder is required to perform a risk-utility analysis
in order to determine whether a product is defective in its
design, and in performing a risk-utility analysis, an expert
opinion is ordinarily relied upon to establish a reasonable
alternative design. Rocco v. New Jersey Transit Rail
Operations, Inc., 749 A.2d 868, 879 (
N.J.Super.Ct.App.Div. 2000). “Except in the rare case
when the risk-utility analysis points to the appropriate
result as a matter of law, the jury, not the court,
ultimately resolves factual issues arising from a
risk-utility analysis.” Lewis, 715 A.2d at 979
(citing Dreier et al., Current N.J. Products Liability
and Toxic Torts Law, § 5.2 at 29 (1998)); see
also Toms v. J.C. Penney Co., Inc., 304 Fed.Appx. 121');">304 Fed.Appx. 121,
124 (3d Cir. 2008) (citations omitted) (“[T]he
existence of a design defect is frequently proven through the
testimony of an expert who has examined the product and
offers an opinion on its design.”).
Plaintiff alleges in her complaint:
• Symbotex mesh is a “three-dimensional textile
non-absorbable monofilament polyester mesh with absorbable
collagen film and marking.”
• Issues with polyester concern “the terminal
product in a chain of very reactive and toxic precursors.
Most are carcinogens; all are poisonous, ” and
polyester is increasingly toxic because it is often treated
with a flame retardant.
• These components are alleged to cause issues where:
“the collagen film fails to mitigate the body's
adverse reaction to the non-absorbable polyester mesh”;
“polyester is prone to tearing, ripping, and/or
fraying” and “once the polyester fibers unravel,
they become detached from the mesh and migrate to other
regions of the body, ” which cause imbedding and an
inflammatory response; and “polyester mesh contracts
over time, causing tension to increase.”
• The collagen barrier dissolves, and when it does,
internal organs are left unprotected from the dangers
associated with the synthetic polyester textile.
• Both polycarbonate and polystyrene are reasonable
alternative designs which are less dangerous and equally, if
not more, effective than polyester.
• The defective design was a proximate cause of
(Docket No. at 20-22.)
argues that these allegations are not sufficient to state a
design defect claim because Plaintiff fails to plead any
facts to answer the questions of “What is it about
collagen that causes it to ‘fail to mitigate the
body's adverse reaction'?” or “[W]hat is
it about polyester that causes an ‘adverse
reaction,' and what type of ‘adverse reaction'
does it cause?” or “What are the characteristics
of polyester that make it ‘prone to tearing and ripping
and/or fraying'?” (Docket No. 16 at 9-10.)
Additionally, Defendants argue that Plaintiff has not alleged
that these defects caused her injuries, particularly because
her alleged injuries can be suffered with any mesh product.
Defendant further argues that Plaintiff has ...