MENDEZ v. SHAH et al

Filing 170

OPINION FILED. Signed by Judge Noel L. Hillman on 3/30/15. (js)

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
:
MARIA MENDEZ,
:
:
Plaintiff,
:
:
v.
:
:
RAHUL V. SHAH, M.D., et al.,
:
:
Defendants.
:
:
______________________________ :

Civil Action No.
13-1585

OPINION

Appearances:
MICHAEL T. ROONEY
ROONEY & ROONEY
TWO PENN CENTER PLAZA
1500 JFK BLVD., SUITE 200
PHILADELPHIA, PA 19102
Attorney for Plaintiff
JOHN F. BRENNER
MELISSA ANNE CHUDEREWICZ
PEPPER HAMILTON, LLP
301 CARNEGIE CENTER
SUITE 400
PRINCETON, NJ 08543-5276
Attorneys for defendants Medtronic Sofamaor Danesk USA Inc.,
Medtronic Spine LLC, Medtronic USA Inc., and Medtronic Inc.

HILLMAN, District Judge:
Before the Court is a motion to dismiss the third amended
complaint filed by defendants Medtronic Sofamaor Danesk USA
Inc., Medtronic Spine LLC, Medtronic USA Inc., and Medtronic
Inc. (collectively “Medtronic”).

For the reasons stated below,

the motion will be granted.
I.

BACKGROUND

The factual background was summarized in the Court’s
earlier Opinion, Mendez v. Shah, 28 F.Supp.3d 282 (D.N.J. 2014),
and will not be repeated here.
Procedurally, the Court previously granted Medtronic’s
motion to dismiss plaintiff’s second amended complaint in part.
The Court dismissed Count V (implied warranty), Count VI (design
defect), Count X (third party beneficiary), and Count XII
(fraud).

The Court also dismissed plaintiff’s request for

punitive damages as to any Medtronic device which had received
premarket approval.

The Court dismissed Count VII (express

warranty), and Count VI (manufacturing defect and failure to
warn), but without prejudice, and granted plaintiff leave to
file an amended complaint to provide a more definite statement
of her claims.
Plaintiff filed a third amended complaint which Medtronic
now seeks to dismiss.
II.

JURISDICTION

This Court exercises jurisdiction pursuant to 28 U.S.C. §
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1332(a), diversity of citizenship.

Plaintiff is a citizen of

the Commonwealth of Pennsylvania and the defendants, are
citizens of either the States of New Jersey, Tennessee,
Delaware, or Minnesota.

The amount in controversy exceeds the

jurisdictional limit exclusive of interest and costs.
A Court exercising diversity jurisdiction must apply the
law of the forum state within which it sits, and therefore, New
Jersey law will apply to plaintiff’s state law claims.

See

Chemical Leaman Tank Lines, Inc. V. Aetna Casualty and Surety
Co., 89 F.3d 976, 983 (3d Cir. 1996) (stating that “[a]s a
federal court sitting in diversity, we must apply the
substantive law of New Jersey.”) (citing Borse v. Piece Goods
Shop, Inc., 963 F.2d 611, 613 (3d Cir. 1992)).
III. DISCUSSION
A.

Standard for Motion to Dismiss

When considering a motion to dismiss a complaint for
failure to state a claim upon which relief can be granted
pursuant to Fed. R. Civ. P. 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.
Fisher, 423 F.3d 347, 351 (3d Cir. 2005).

Evancho v.

It is well settled

that a pleading is sufficient if it contains “a short and plain
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statement of the claim showing that the pleader is entitled to
relief.”

Fed. R. Civ. P. 8(a)(2).

Under the liberal federal

pleading rules, it is not necessary to plead evidence, and it is
not necessary to plead all the facts that serve as a basis for
the claim.

Bogosian v. Gulf Oil Corp., 562 F.2d 434, 446 (3d

Cir. 1977).

However, “[a]lthough the Federal Rules of Civil

Procedure do not require a claimant to set forth an intricately
detailed description of the asserted basis for relief, they do
require that the pleadings give defendant fair notice of what
the plaintiff’s claim is and the grounds upon which it rests.”
Baldwin County Welcome Ctr. v. Brown, 466 U.S. 147, 149-50 n.3
(1984) (quotation and citation omitted).
A 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.’”

Bell Atlantic v. Twombly, 127 S. Ct. 1955, 1969 n.8

(2007) (quoting Scheuer v. Rhoades, 416 U.S. 232, 236 (1974));
see also Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (“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
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applied to federal complaints before Twombly.”).
Following the Twombly/Iqbal standard, the Third Circuit has
outlined a three-part analysis in reviewing a complaint under
Rule 12(b)(6).

First, the Court must take note of the elements

needed for plaintiff to state a claim.

Santiago v. Warminster

Tp., 629 F.3d 121, 130 (3d Cir. 2010).

Second, the factual and

legal elements of a claim should be separated; a district court
must accept all of the complaint's well-pleaded facts as true,
but may disregard any legal conclusions.
at 210 (citing Iqbal, 129 S. Ct. at 1950).

Id.; Fowler, 578 F.3d
Third, a district

court must then determine whether the facts alleged in the
complaint are sufficient to show that the plaintiff has a
plausible claim for relief.

Id.

A complaint must do more than

allege the plaintiff's entitlement to relief.

Fowler, 578 F.3d

at 210; see also Phillips v. Cnty. of Allegheny, 515 F.3d 224,
234 (3d Cir. 2008) (stating that the “Supreme Court’s Twombly
formulation of the pleading standard can be summed up thus:
‘stating . . . a claim requires a complaint with enough factual
matter (taken as true) to suggest’ the required element.

This

‘does not impose a probability requirement at the pleading
stage,’ but instead ‘simply calls for enough facts to raise a
reasonable expectation that discovery will reveal evidence of’
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the necessary element”).

A court need not credit either “bald

assertions” or “legal conclusions” in a complaint when deciding
a motion to dismiss.

In re Burlington Coat Factory Sec. Litig.,

114 F.3d 1410, 1429-30 (3d Cir. 1997).

The defendant bears the

burden of showing that no claim has been presented.

Hedges v.

United States, 404 F.3d 744, 750 (3d Cir. 2005) (citing Kehr
Packages, Inc. v. Fidelcor, Inc., 926 F.2d 1406, 1409 (3d Cir.
1991)).
Finally, a court 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.
Southern Cross Overseas Agencies, Inc. v. Kwong Shipping Group
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).

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B.

Analysis

A summary of the premarket approval process for the Infuse
device, as well as the law regarding federal preemption, was
provided in the Court’s earlier Opinion and will not be repeated
here.

See Mendez, 28 F.Supp.3d at 289-93.

Plaintiff filed a third amended complaint bringing various
claims of negligence and product liability against all
defendants.

This motion concerns only those counts directed at

Medtronic, namely, Count IV (product liability under the New
Jersey Product Liability Act), and Count V (breach of express
warranty).
1. Product Liability
The New Jersey Product Liability Act (“PLA”) 1 recognizes

1 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.
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three claims: design defect, manufacturing defect, or failure to
warn. See Roberts v. Rich Foods, Inc., 654 A.2d 1365 (N.J.
1995); Dziewiecki v. Bakula, 824 A.2d 241 (N.J. Super. Ct. App.
Div. 2003).

The standard of liability is that the product “was

not reasonably fit, suitable or safe for its intended purpose.”
Cornett v. Johnson & Johnson, 998 A.2d 543 (N.J. Super. Ct. App.
Div. 2010).

To prove a defect, a plaintiff must be able to show

that: (1) the product was defective; (2) the defect existed when
product left the hands of the defendant; and (3) the defect
caused the injury to a reasonably foreseeable user.’”

McGarvey

v. G.I. Joe Septic Service, Inc., 679 A.2d 733 (N.J. Super. Ct.
App. Div. 1996)(citing Jurado v. Western Gear Works, 619 A.2d
1312 (N.J. 1993)).

“To prove both the existence of a defect and

that the defect existed while the product was in the control of
the manufacturer, a plaintiff may resort to direct evidence,
such as the testimony of an expert who has examined the product,
or, in the absence of such evidence, to circumstantial proof.”
Myrlak v. Port Authority of New York and New Jersey, 723 A.2d
45, 52 (N.J. 1999) (citing Scanlon v. General Motors Corp., 326
A.2d 673 (N.J. 1974); Manieri v. Volkswagenwerk A.G., 376 A.2d

N.J.S.A. 2A:58C-2.
8

1317 (N.J. Super. Ct. App. Div. 1977)).

A plaintiff may also

establish a defect by “negat[ing] other causes of the failure of
the product for which the defendant would not be responsible, in
order to make it reasonable to infer that a dangerous condition
existed at the time the defendant had control [of the product].”
Id. at 53 (citing Scanlon, 65 N.J. at 593-94).
Under New Jersey product liability law, “the injured
plaintiff is not required to prove a specific manufacturer’s
defect.”

Id. at 52 (citing Moraca v. Ford Motor Co., 332 A.2d

599 (N.J. 1975)).

“Proof that a product is not fit for its

intended purposes ‘requires only proof ... that ‘something was
wrong’ with the product.’”

Id. (citing Scanlon, 326 A.2d 673).

However, 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.

In its earlier Opinion, the Court permitted plaintiff to
amend her complaint and re-plead her manufacturing defect and
failure to warn claim.

Because plaintiff has not adequately

identified the federal law that parallels her state law claims,
her products liability claims will be dismissed.
As stated in the Court’s previous Opinion, the Infuse
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device is a Class III medical device that obtained PMA approval
and is subject to the MDA express preemption provision.

“[T]he

MDA expressly pre-empts only state requirements different from,
or in addition to, any requirement applicable ... to the device
under federal law, § 360k(a)(1) ... .” Riegel v. Medtronic,
Inc., 552 U.S. 312, 321, 128 S.Ct. 999 (2008) (internal
quotation marks omitted).

Thus, the MDA preemption clause does

not apply to a state claim that parallels federal law.
330.

Id. at

Although plaintiff cannot simply state that her state law

claim parallels federal law generally, how specific plaintiff
needs to be varies among courts.

Compare Wolicki-Gables v.

Arrow Intern., Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) with
Bausch v. Stryker Corp., 630 F.3d 546, 555 (7th Cir. 2010).
Here, plaintiff states that “Medtronic failed to comply
with the FDA’s [] Good Manufacturing Practices with regard to
InFuse and the Capstone Spinal System as to misbranding and
adulteration,... .”

Although citing to the FDA’s Current Good

Manufacturing Practices (“CGMP”) could present a parallel
federal claim, 2 plaintiff has not identified what regulations

Medtronic argues that the CGMPs “generally do not constitute
enforceable federal requirements capable of serving as a basis
for a parallel claim[]” because they are too flexible and too
generic. Although some courts have followed this idea, the
10
2

under the CGMPs regarding misbranding and adulteration parallel
her state law claim.

Pursuant to Riegel, it must be determined

whether the plaintiff’s common-law claims based upon New Jersey

Seventh Circuit in Bausch provided sound reasoning for why the
CGMPs are binding on manufacturers. Id. at 555. Specifically,
Section 360k makes preemption a defense if a state
seeks to impose on a manufacturer ‘any requirement—(1)
which is different from, or in addition to, any
requirement applicable under this chapter to the
device, and (2) which relates to the safety or
effectiveness of the device or to any other matter
included in a requirement applicable to the device
under this chapter.’ 21 U.S.C. § 360k(a). We
emphasize the phrase ‘any requirement.’ And federal
law is clear: for manufacturers of Class III medical
devices, the Quality System Regulations and Current
Good Manufacturing Practices adopted by the FDA under
its delegated regulatory authority are legally binding
requirements ‘under this chapter.’ 21 C.F.R. § 820.1.
‘The failure to comply with any applicable provision
in this part [of the regulations] renders a device
adulterated under section 501(h) of the act. Such a
device, as well as any person responsible for the
failure to comply, is subject to regulatory action.’
21 C.F.R. § 820.1(c).
The Court concluded that requiring concrete, product-specific
requirements would leave injured patients without any remedy for
a wide range of harmful violations of federal law. Id. (“The
FDA regulations contain many requirements that are not concrete
or product-specific, yet which are obviously vital to producing
safe and effective medical devices.”). This Court follows the
reasoning of the Seventh Circuit and finds that the CGMPs are
binding regulations imposed on manufacturers. See also, Howard
v. Sulzer Orthopedics, Inc., 382 F. App’x 436, 440 (6th Cir.
2010) (finding plaintiff identified specific GMP that he thought
had been violated, and rejecting defendant’s argument that the
relevant GMP is categorically unenforceable).
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requirements with respect to the device are “different from, or
in addition to,” the federal ones, that relate to safety and
effectiveness.

Riegel, 552 U.S. at 321-22 (citing § 360k(a)).

Without properly identifying the federal requirements, such a
comparison cannot be made.

Thus, plaintiff’s product liability

claims for manufacturing defect and failure to warn will be
dismissed. 3
2. Breach of Express Warranty

In its earlier Opinion, the Court permitted plaintiff to
amend her complaint to provide more detail regarding her claim
for breach of express warranty. 4

Because plaintiff has not

3 Further, it appears that plaintiff has grounded her failure to
warn claim on allegations that Medtronic failed to provide
sufficient warnings on the outside of the Infuse Bone Graft
product. Such a failure to warn claim would be preempted even
if plaintiff had sufficiently alleged the federal requirement
that parallels her state law claim. Medtronic has stated that
the packaging and the warnings insert inside the package were
approved by the FDA. Therefore, any argument that the warnings
should have appeared on the outside of the Infuse Bone Graft
product, a Class III device, is preempted because it would
impose a requirement in addition to what the FDA approved. See
Riegel, 552 U.S. at 321-22.
4 Medtronic does not argue that this claim is preempted and,
indeed, most courts agree that an adequately pleaded claim for
breach of express warranty is not expressly preempted. See,
e.g., Byrnes v. Small, --- F.Supp.3d ----, No. 14-1726, 2015 WL
1243219, at *10 (M.D.Fla. Mar. 18, 2015); Wright v. Medtronic,
Inc., --- F.Supp.3d ----, No. 13-716, 2015 WL 328596, at * 15
(W.D.Mich. Jan. 23, 2015); McPhee v. DePuy Orthopedics, Inc.,
12

pleaded sufficient facts that could suggest each element of her
claim, her breach of express warranty claim will be dismissed.
“Under New Jersey law, in order to state a claim for breach
of express warranty, Plaintiffs must properly allege: (1) that
Defendant made an affirmation, promise or description about the
product; (2) that this affirmation, promise or description
became part of the basis of the bargain for the product; and (3)
that the product ultimately did not conform to the affirmation,
promise or description.”

Snyder v. Farnam Companies, Inc., 792

F.Supp.2d 712, 721 (D.N.J. 2011) (citing N.J. Stat. Ann. §
12A:2–313).

“However, ‘an affirmation merely of the value of

the goods or a statement purporting to be merely the seller's
opinion or commendation of the goods does not create a
warranty.’”

Id. (citing N.J. Stat. Ann. § 12A:2–313(2)).

“Additionally, statements that are nothing more than mere
puffery are not considered specific enough to create an express
warranty.”

Id. (citations omitted).

A plaintiff in a warranty

action “need not establish the existence of a defect; the
failure of the goods to perform as warranted is sufficient.”
Spring Motors Distributors, Inc. v. Ford Motor Co., 489 A.2d 660

989 F.Supp.2d 451, 465 (W.D.Pa. 2012).
13

(N.J. 1985).

However, “[p]roof of causation must still be shown

in a case based on breach of an express warranty”.

Ford Motor

Credit Company, LLC v. Mendola, 48 A.3d 366, 375 (N.J. Super.
Ct. App. Div. 2012) (citing Realmuto v. Straub Motors, Inc., 322
A.2d 440 (N.J. 1974)).
In her third amended complaint, plaintiff alleges that
Medtronic “participated in an aggressive marketing campaign,
including improper incentives, inducements, and kickbacks paid
to physicians, hospitals, surgical centers and others, who would
agree to push Medtronic’s products for use in off-label and
experimental spinal surgeries on patients, which included
statements as to the safety of their products ... which
dismissed or downplayed risks of such use, off-label use, or use
in patients for whom the surgery would be unnecessary,
contraindicated, experimental, or ill-advised.”

Plaintiff also

alleges that “statements in Medtronic’s literature, on-line and
in television or other advertising,” deliberately misrepresented
the “results and outcomes of Medtronic studies and clinical
trials and/or made by sales and marketing personnel, constituted
express warranties.”
Also, plaintiff alleges that employees of Medtronic
14

collaborated with physician authors who had significant
financial relationships with the company to draft articles that
downplayed or minimized the adverse events associated with
InFuse when the product was used in various spinal fusion
procedures.

Plaintiff further alleges that these articles and

their conclusions contained material misstatements of fact
including the minimizing or omission of serious adverse events
when InFuse (rhBMP-2) was used off-label and in unapproved ways.
Plaintiff states that her doctor relied upon the warranties
and that Medtronic’s agents were present in the hospitals and in
the operating rooms for the purpose of illegally promoting offlabel and experimental uses of the medical devices in unapproved
procedures.
Plaintiff has not alleged sufficient facts that could
suggest a claim for breach of express warranty.

Plaintiff has

not identified any examples of a false affirmation or promise
made by Medtronic.

Her reference to certain articles and

studies which downplayed or minimized the adverse events
associated with InFuse were made to the medical community atlarge.

Also, plaintiff has not identified any affirmations made

to her by Medtronic or what affirmations she purportedly relied
15

upon.

Further, plaintiff has not identified what statements in

the articles she cites are allegedly false.

Absent allegations

that false statements made to plaintiff “became the basis of the
bargain for the purchase of the good”, no claim for breach of
express warranty can be sustained.

Liberty Lincoln-Mercury,

Inc. v. Ford Motor Co., 171 F.3d 818, 825 (3d. Cir. 1999).
Therefore, plaintiff’s breach of express warranty claim
will be dismissed.
IV.

CONCLUSION

For the foregoing reasons, Medtronic’s motion to dismiss
will be granted.
An appropriate order will be entered.

s/Noel L. Hillman
NOEL L. HILLMAN, U.S.D.J.

At Camden, New Jersey

Dated:

March 30, 2015

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