United States District Court, D. New Jersey
MCNULTY UNITED STATES DISTRICT JUDGE
the Court are two motions to dismiss the complaint: one filed
by defendants Atrium Medical Corporation ("AMC")
and Maquet Cardiovascular, LLC ("Maquet") (DE 25),
and the other filed by Getinge AB, a Swedish corporation. (DE
March of 2013, the plaintiff, Latiese Mills, who is a citizen
of Pennsylvania, underwent an abdominal hernia repair
surgery, and was implanted with a hernia mesh device. In
November of 2015, she went to the hospital to repair a
recurrent ventral hernia. During that procedure, it was
revealed that Mills "had developed a seroma" and
that the mesh implant device had "adhered to her
bowels," resulting in significant injuries. Mills's
six-count complaint alleges various products liability claims
related to the hernia mesh device.
Maquet seek dismissal of the complaint pursuant to Federal
Rule 12(b)(6) on the grounds that the complaint fails to meet
pleading standards for statement of a claim. They also
contend that Pennsylvania law applies to the complaint, and
that Pennsylvania law does not recognize strict liability or
warranty claims in medical device products liability cases.
AB, the Swedish corporate parent of AMC and Maquet, joins in
AMC and Maquet's motion. Getinge AB also contends that
service was defective and that it is not subject to personal
jurisdiction in New Jersey. Specifically, it objects that
Mills mailed a copy of the complaint and summons to Maquet,
Getinge AB's domestic subsidiary, and did not translate
the complaint into Swedish as required by the Hague
reasons provided below, the following claims are dismissed
with prejudice as to all defendants because they are invalid
as a matter of law: strict liability for defective design
(second count); strict liability for failure to warn (third
count); breach of the implied warranty of fitness for a
particular purpose (fifth count); and breach of the warranty
of merchantability (sixth count). The remaining counts,
negligence and breach of an express warranty, are dismissed
without prejudice for failure to state a claim.
conclude that service on Getinge AB by mailing a copy of the
summons and complaint to Maquet (Getinge AB's in-state
subsidiary) was deficient. Accordingly, dismissal of the
complaint as to Getinge AB is warranted for this additional
reason. This dismissal is without prejudice.
Factual Background 
March of 2013, Mills underwent an abdominal hernia repair
surgery at Pennsylvania Hospital in Philadelphia and was
implanted with "a hernia mesh device." (Compl
¶36). The hernia mesh is a "medical device"
that is made out of polypropylene and is marketed "by
Defendants as mesh used in repairing hernias and chest wall
defects." (Compl ¶¶44-46). Hernia meshes are
designed and are used for permanent implantation in the human
body. (Compl ¶48).
November of 2015, Mills was admitted to the hospital for
repair of a recurrent ventral hernia. At that time, "it
was revealed that she had developed a seroma, and that the
mesh had adhered to her bowels." (Compl ¶37). Mills
claims that had the hernia mesh device "not failed, she
would not have suffered a recurrence of her hernia, adhesions
and seroma." (Compl ¶38).
alleges that the hernia mesh device "was designed and is
manufactured and distributed by the Defendants, who own the
patent on the device that was inserted into Plaintiffs
body." (Compl ¶41). Mills claims that "a
substantial body of scientific evidence" shows that the
polypropylene mesh "is biologically incompatible with
human tissue and promotes an immune response" in a
"large subset of the population receiving these
products." (Compl ¶46). That immune response
degrades the mesh, as well as the surrounding tissue, and can
contribute to the "severe adverse reactions to the
mesh." (Compl ¶46).
further claims that the suppliers of the polypropylene
"cautioned all users in their United States Material
Safety Data Sheet" that polypropylene "was not to
be used for medical applications involving permanent
implantation in the human body or permanent contact with
internal body fluids or tissues." (Compl ¶49).
Mills asserts that the polypropylene mesh is not suited for
implantation into the human body "due to its small pore
size and weave, high volume of material used, selection of
polypropylene resin, and other design features." (Compl
claims that the "Defendants failed to warn or notify
doctors, regulatory agencies, and consumers of the severe and
life-threatening risks associated with polypropylene."
Indeed, she says, they marketed the hernia mesh device to the
medical community and patients "as safe, effective"
and reliable. (Compl ¶¶50, 64). She also claims
that "Defendants paid doctors, surgeons, physicians
and/or clinicians to promote the hernia mesh device."
asserts that "Defendants failed to comply with the FDA
application and reporting requirements" and that
"defendants" misrepresented "and/or falsified
pre-clinical and/or clinical studies to bolster the perceived
performance of the hernia mesh device." (Compl
¶¶56, 60). She further claims that the mesh is
"unreasonably dangerous, defective, and negligently
designed" in a number of ways. (Compl ¶54). A
malfunction of the mesh "can lead to nerve entrapment
and damage, fistulae formation, and chronic pain."
November 30, 2017, Mills filed a complaint in New Jersey
state court, alleging the following claims: (1) negligence;
(2) strict products liability - defective design; (3) strict
products liability - failure to warn; (4) breach of an
express warranty; (5) breach of an implied warranty for a
particular purpose; and (6) breach of an implied warranty of
merchantability. On December 5, 2017, the Covidien
defendants removed the action to this Court, based on
complete diversity. (DE 1).
December 15, 2017, Mills voluntarily dismissed the following
•A defendants: Ethicon Inc; Johnson 6& Johnson; C.R.
Bard Inc.; Davol Inc.; Covidien, Inc.; Covidien LLC; Covidien
PLC; Covidien AG; Sofradim Production; and John Doe
Corporations 1-100. (DE 2).
the Court are two motions to dismiss the complaint filed by
the remaining defendants: (1) AMC and Maquet (DE 25); and (2)
Getinge AB (DE 26).
Rule of Civil Procedure 8(a) does not require that a
complaint contain detailed factual allegations. Nevertheless,
"a plaintiffs obligation to provide the
'grounds' of his 'entitlement to relief requires
more than labels and conclusions, and a formulaic recitation
of the elements of a cause of action will not do."
BellAtl Corp. v. Twombly, 550 U.S. 544, 555 (2007);
See Phillips v. Cnty. of Allegheny, 515 F.3d 224,
232 (3d Cir. 2008) (Rule 8 "requires a 'showing'
rather than a blanket assertion of an entitlement to
relief." (citation omitted)). Thus, the complaint's
factual allegations must be sufficient to raise a plaintiffs
right to relief above a speculative level, so that a claim is
"plausible on its face." Twombly, 550 U.S.
at 570; see also West Run Student Hous. Assocs., LLC u.
Huntington Nat. Bank, 712 F.3d 165, 169 (3d Cir. 2013).
That facial-plausibility standard is met "when the
plaintiff pleads factual content that allows the court to
draw the reasonable inference that the defendant is liable
for the misconduct alleged." Ashcroft v. Iqbal,
556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S.
at 556). While "[t]he plausibility standard is not akin
to a 'probability requirement'... it asks for more
than a sheer possibility." Id.
12(b)(6) provides for the dismissal of a complaint if it
fails to state a claim upon which relief can be granted. The
defendant, as the moving party, bears the burden of showing
that no claim has been stated. Animal Science Products,
Inc. v. China Minmetals Corp., 654 F.3d 462, 469 n.9 (3d
Cir. 2011). For the purposes of a motion to dismiss, the
facts alleged in the complaint are accepted as true and all
reasonable inferences are drawn in favor of the plaintiff.
New Jersey Carpenters & the Trustees Thereof v.
Tishman Const. Corp. of New Jersey, 760 F.3d 297, 302
(3d Cir. 2014).
deciding a motion to dismiss, a court typically does not
consider matters outside the pleadings. However, a court may
consider documents that are "integral to or explicitly
relied upon in the complaint" or any "undisputedly
authentic document that a defendant attaches as an exhibit to
a motion to dismiss if the plaintiffs claims are based on the
document." In re Rockefeller Ctr. Props.,
Inc. Sec. Litig., 184 F.3d 280, 287 (3d Cir. 1999)
(emphasis and citations omitted); see In re Asbestos
Prods. Liab. Litig. (No. VI), 822 F.3d 125, 133 n.7 (3d
Cir. 2016); Schmidt v. Skolas, 770 F.3d 241, 249 (3d
Cir. 2014) (on motion to dismiss, court may consider,
inter alia, "exhibits attached to the
complaint"); Arcand v. Brother Int'l Corp.,
673 F.Supp.2d 282, 292 (D.N.J. 2009) (court may consider
documents referenced in complaint that are essential to
on these types of documents does not convert a motion to
dismiss into a motion for summary judgment. "When a
complaint relies on a document. . . the plaintiff obviously
is on notice of the contents the document, and the need for a
chance to refute evidence is greatly diminished."
Pension Benefit Guar. Corp. v. White Consol. Indus.,
Inc., 998 F.2d 1192, 1196-97 (3d Cir. 1993).
Choice of Law
AMC, and Maquet all agree that Pennsylvania law applies to
Mills's claims. (PABr at 7; DABr at 4-8). Getinge AB does
not address the issue. (See generally DGBr). AMC and
Maquet suggest that New Jersey could apply to this action, as
this litigation was filed in New Jersey, but they ultimately
contend that Pennsylvania law should apply.
noted above, Mills is a resident of Pennsylvania, and the
surgeries took place in Pennsylvania. Mills's injuries
also occurred in Pennsylvania. AMC is incorporated under the
laws of Delaware. (DE 26-3). Maquet is the "sister
corporation" of AMC. (DGBr at 3 n.l). The complaint
alleges that Maquet is a New Jersey corporation; the
statement of corporate status submitted by Mills in
opposition to Getinge AB's motion to dismiss, however,
provides that Maquet is a Delaware LLC. (Compl ¶18; DE
30-2). Getinge AB is a Swedish corporation, with a principal
place of business in Sweden. (Compl ¶19).
a diversity action, a district court must apply the choice of
law rules of the forum state to determine what law will
govern the substantive issues of a case." Warriner
v. Stanton, 475 F.3d 497, 499-500 (3d Cir. 2007) (citing
Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487,
496 (1941)). New Jersey uses the
most-significant-relationship test, which consists of two
prongs. Maniscalco v. Brother Int'l Corp. (USA),
793 F.Supp.2d 696, 704 (D.N.J. 2011), affd, 709 F.3d
202 (3d Cir. 2013); see also Yocham v. Novartis Pharm.
Corp., 736 F.Supp.2d 875, 880 (D.N.J. 2010)
("Although the New Jersey Supreme Court has not
explicitly adopted the Restatement's test for contract
claims, New Jersey courts have regularly applied the
'most significant relationship' test to such
claims." (citing cases)); Agostino v. Quest
Diagnostics Inc., 256 F.R.D. 437, 461 (D.N.J. 2009)
(applying New Jersey's most significant relationship test
to tort and breach of contract claims).
the court must determine whether a conflict actually exists
between the potentially applicable laws. P.V. v. Camp
Jaycee, 197 N.J. 132, 143 (2008) ("Procedurally,
the first step is to determine whether an actual conflict
exists. That is done by examining the substance of the
potentially applicable laws to determine whether there is a
distinction between them.") (internal quotations
omitted). "[I]f no conflict exists, the law of the forum
state applies." Snyder v. Farnam Companies,
Inc., 792 F.Supp.2d 712, 717 (D.N.J. 2011) (quoting
P.V., 197 N.J. at 143). However, if a conflict
exists, the court goes to the second step of the analysis and
must determine "which state has the 'most
significant relationship' to the claim at issue by
weighing the factors" in the applicable section of the
Restatement (Second) of Conflict of Laws. Agostino,
256 F.R.D. at 462; see also P.V., 197 N.J. at 144.
tort claims, the Restatement provides that the case will be
"determined by the local law of the state which, with
respect to that issue, has the most significant relationship
to the occurrence and the parties under the principles stated
in § 6." Restatement (Second) of Conflict of Laws,
§ 145 (1988); see Yocham, 736 F.Supp.2d at 880.
Section 146 of the Restatement provides a "default"
rule for personal injury cases, and provides that "the
local law of the state where the injury occurred determines
the rights and liabilities of the parties, unless, with
respect to the particular issue, some other state has a more
significant relationship under the principles stated in
§ 6 to the occurrence and the parties." Restatement
(Second) of Conflict of Laws, § 146 (1988);
Yocham, 736 F.Supp.2d at 880 (citing P.V.,
197 N.J. at 147).
contract claims, the applicable Restatement section is §
188. Gilbert Spruance Co. v. Pennsylvania Mfrs.
Ass'nlns. Co., 134 N.J. 96, 102 (1993). "The
standard for contract claims is identical [to the § 145
tort standard], except the word 'transaction' is
substituted for 'occurrence,' § 188, and there
is no similar default rule regarding the location of the
injury." Yocham, 736 F.Supp. at 880.
in determining which substantive law to apply, the evaluation
of both the contract and tort claims "involve[s] the
significance of the states' relations to the parties and
events in light of the principles contained in § 6 of
the Restatement, which lists several factors relevant to the
choice of law analysis that when 'reduced to their
essence . . . are: (1) the interests of interstate comity;
(2) the interests of the parties; (3) the interests
underlying the field of tort law; (4) the interests of
judicial administration; and (5) the competing interests of
the states." Yocham, 736 F.Supp.2d at 880-81
(alteration added) (citing P.V., 197 N.J. at 148).
Actual conflict between Pennsylvania and New Jersey law
first step of the choice of law analysis requires that the
Court determine whether the potentially applicable state laws
are in conflict.
products liability context, there is a conflict between New
Jersey and Pennsylvania law. Unlike Pennsylvania, New Jersey
has enacted the New Jersey Product Liability Act
("NJPLA") to codify its products liability law.
Kallman v. Aronchick, 981 F.Supp.2d 372, 378 (E.D.
Pa. 2013) (citing N.J. Stat. Ann. § 2A:58C-1, et
seq.). As a result, "Pennsylvania law allows
negligence and breach of warranty claims, but New Jersey only
allows one statutory cause of action for strict
liability." Torres v. Lucca's Bakery, 487
F.Supp.2d 507, 513 (D.N.J. 2007) (citing N.J. Stat. Ann.
§ 2A:58C-2; Green v. Gen. Motors Corp., 310
N.J.Super. 507, 517 (App. Div. 1998) ("Under the New
Jersey Products Liability Act ... the causes of action for
negligence, strict liability and implied warranty have been
consolidated into a single product liability cause of action,
the essence of which is strict liability."); Oquendo
v. Bettcherlndust, 939 F.Supp. 357, 361 (D.N.J. 1996);
13 Pa. Cons. Stat. §§ 2314, 2315 (creating causes
of action for breach of implied warranties); Soufflas v.
Zimmer, 474 F.Supp.2d 737, 751-54 (E.D. Pa. 2007)
(discussing product liability claims based on implied
warranties and negligence under Pennsylvania law)); see
also Kallman, 981 F.Supp. at 378 (noting that NJPLA
"subsumes common law products liability claims into one
statutory cause of action for strict liability."). In
addition, Pennsylvania bars strict liability claims that are
brought for injuries related to a medical device, while New
Jersey does not. See Section IV, A, infra.
NJPLA is the "sole basis of relief under New Jersey law
available to consumers injured by a defective product."
Repola v. Morbark Industries, Inc., 934 F.2d 483,
492 (3d Cir. 1991). The NJPLA, therefore, does not permit
negligence or implied breach of warranty claims as separate
claims for injuries caused by defective
products. Kallman, 981 F.Supp. at 378
(citing Torres, 487 F.Supp.2d at 513); see also
Knipe v. Smithkline Beecham, 583 F.Supp.2d 602, 614
(E.D. Pa. 2008) ("Pennsylvania courts allow claims of
negligence and breach of implied warranty to be brought in
conjunction with a products liability claim.");
Borelli v. Everland, 2006 U.S. Dist. LEXIS 6506, at
*9 (E.D. Pa. Feb. 21, 2006) ("[U]nder the NJPLA,
negligence and breach of warranty are not permitted as
separate claims for injuries caused by defective
products." (citations omitted)).
"New Jersey applies a reasonableness standard to the
manufacturer's design in strict liability cases and
insulates a non-manufacturing seller from liability, where
Pennsylvania does not." Coppola v. Ferrellgas,
250 F.R.D. 195, 202 (E.D. Pa. 2008) (citation omitted); see
also N.J. Stat. Ann. § 2A:58C-9(b) ("Upon
filing the affidavit... the product seller shall be relieved
of all strict liability claims.").
dealing with liability based on negligence, strict liability,
products liability or the like, differing rules as to
liability or damages generally represent genuine conflicts
since the laws covering these issues take into account both
the needs of the injured plaintiffs and the economic
viability of the defendants." Torres, 487
F.Supp.2d at 513 (internal quotation omitted) (citing
Boyes v. Greenwich Boat Works, Inc., 27 F.Supp.2d
543, 548 (D.N.J. 1998)).
two states authorize different causes of action arising out
of the same set of facts, a conflict exists between the laws
of the two states. See Torres, 487 F.Supp.2d at 513.
I therefore conclude that a conflict exists between the
products liability laws of New Jersey and Pennsylvania and
turn to the second step of the choice of law analysis.
See Kallman, 981 F.Supp.2d at 379 (concluding that
conflict exists between products liability laws of
Pennsylvania and New Jersey); Knipe, 583 F.Supp.2d
at 614 (holding same); Torres, 487 F.Supp.2d at 513
policies underlying products liability law in New Jersey and
Pennsylvania "are generally the same: both states seek
to compensate people injured by defective products and
regulate the conduct of manufacturers and distributors (i.e.,
ensure production of safe products) within the state."
Torres, 487 F.Supp.2d at 513. Each of the
states' respective interests would therefore be impaired
by the application of the other state's law. Because the
policies are in equipoise, the quality of each state's
contacts to the underlying action is determinative.
quality of the contacts with Pennsylvania leads the Court to
conclude that Pennsylvania law should apply. In making this
determination, the Court must look to a number of factors:
"(a) the place where the injury occurred, (b) the place
where the conduct causing the injury occurred, (c) the
domicil, residence, nationality, place of incorporation and
place of business of the parties, and (d) the place where the
relationship, if any, between the parties is centered."
Restatement (Second) of Conflict of Laws § 145 (1988);
see also Knipe, 583 F.Supp.2d at 614.
events essential to this litigation occurred in Pennsylvania.
Mills is a resident of Pennsylvania, and the allegedly
defective product was used and caused harm in the state of
Pennsylvania. Mills's surgeries, during which the product
was implanted, also occurred in Pennsylvania. Only Maquet,
which is incorporated in this state, has a connection to New
Jersey. See Knipe, 583 F.Supp.2d at 616 (applying
New Jersey law where "[t]he sole contact Pennsylvania
maintains with this litigation is as the situs of
Defendant's headquarters and principal place of
Jersey has a tenuous connection to the harm caused to Mills,
and therefore has little interest in having its products
liability law enforced to protect the rights and interests of
a non-resident. See Deemer v. Silk City Textile Mach.
Co., 193 N.J.Super. 643, 649 (App. Div. 1984) ("New
Jersey has no interest in protecting the compensation rights
of a non-domiciliary resident. Indeed, our Supreme Court . .
. appears to evidence a policy of discouraging forum shopping
where, as here, the contacts with the State are at best
tenuous." (citations omitted)). Accordingly, I conclude
that Pennsylvania law applies to the substantive claims in
Discussion The complaint contains six counts:
Count One: Negligence;
Count Two: Strict Products Liability - Defective Design;
Count Three: Strict Products Liability - Failure to Warn;
Count Four: Breach of Express Warranties;
Count Five: Breach of Implied Warranty of Fitness for
Count Six: Breach of Implied Warranty of Merchantability.
Viability of Causes of Action under Pennsylvania law
addressing the sufficiency of the factual allegations in the
complaint, I consider which causes of action are viable under
Pennsylvania law. Maquet and AMC argue that Pennsylvania law
does not recognize products liability claims for strict
liability or breach of warranty relating to a medical device.
Court's "role in diversity cases is to apply state
law as announced by the state's highest court."
LaBarre v. Bristol-Myers Squibb Co., 544 Fed.Appx.
120, 125 (3d Cir. 2013) (citing Sheridan v. NGK Metals
Corp., 609 F.3d 239, 253 (3d Cir. 2010) ("A federal
court under Erie is bound to follow state law as
announced by the highest state court." (internal
citations omitted)). "In the absence of a controlling
decision by the Pennsylvania Supreme Court, we must predict
how it would decide the questions of law presented in this
case." Wolfe v. Allstate Prop, & Cas. Ins.
Co., 790 F.3d 487, 492 (3d Cir. 2015) (citing
Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 45-46
(3d Cir. 2009)); Leonard v. Tractor Supply Co., 88
F.Supp.3d 459, 461 (W.D. Pa. 2015). A federal district court
in this position should consider "relevant state
precedents, analogous decisions, considered dicta, scholarly
works, and any other reliable data tending convincingly to
show how the highest court in the state would decide the
issue at hand." Berrier, 563 F.3d at 46
(quotation and citation omitted).
Strict liability claims
second count of Mills's complaint alleges strict
liability based on defective design, and the third count
alleges strict liability based on a failure to warn. As many
courts have recognized, the Pennsylvania Supreme Court has
not yet decided whether Pennsylvania law recognizes strict
liability claims related to medical devices. That court has,
however, barred such claims in the analogous context of