MENDEZ v. SHAH et al

Filing 128

OPINION FILED. Signed by Judge Noel L. Hillman on 6/27/14. (js)

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

:
:
:
Plaintiff,
:
:
v.
:
:
RAHUL V. SHAH, M.D., et al.,
:
:
Defendants.
:
:
______________________________ :
MARIA MENDEZ,

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 second 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 in part and denied in part.

I.

BACKGROUND
Plaintiff, Maria Mendez, suffered from chronic back

pain.

Defendant Dr. Shah performed surgery on her back on March

21, 2011 and implanted various medical devices in her back that
plaintiff alleges failed and caused her injury.

Plaintiff’s

allegations against the Medtronic defendants concern the
implantation of Medtronic’s “Infuse Bone Graft/LT-Cage Lumbar
Fusion” device as well as “the Capstone Spinal System, Infuse
Bone Graft, MasterGraft Matrix, CD Horizon Legacy screws,
Cancellous chips, and surgical putty.”

Plaintiff states that

Capstone cages and Infuse bone graft were inserted into the
spaces between her fourth and fifth lumbar vertebrae (L4/L5) and
between the fifth lumbar vertebra and the sacrum (L5/S1).
Plaintiff asserts that a Medtronic sales representative, “Ken,”
was present in the operating room.
Due to increasing pain and disabili1y over several
weeks post-operatively, films were taken that showed that the
cages had migrated.

A revision surgery was performed on May 18,

2011 and similar products in a smaller size were implanted.
Plaintiff states that the L5/S1 hardware had allegedly failed,
with the L4/L5 implant remaining well fixed.

The second surgery

involved “shav[ing] the space of the L5/S1” joint, “remov[ing]
the loose and migrated Capstone interbody spacer,” and
2

“insert[ing]” a “new larger Capstone spacer.”

Plaintiff alleges

she sustained "drop foot," and other complications resulting
from these surgeries.

She alleges that she is disabled and

suffers excruciating pain every day.

It is not expected that

any further treatment will help her.
Plaintiff brought claims of negligence, medical
malpractice, battery, lack of informed consent, breach of the
implied warranty of fitness for a particular purpose, breach of
express warranty, breach of contract, fraudulent concealment,
fraud and misrepresentation, as well as claims pursuant to the
New Jersey Product Liability Act (“PLA”) and a third party
beneficiary claim.

Plaintiff seeks compensatory and punitive

damages.
The Medtronic defendants argue that claims against one
of the devices, the “Infuse Bone Graft/LT-Cage Lumbar Fusion”
devince, is preempted by federal law because it received
premarket approval from the Food and Drug Administration.

They

also seek to dismiss plaintiff’s claims for implied and express
warranties, third party beneficiary, fraud, and claims brought
pursuant to the PLA.

Finally, they request to have plaintiff’s

request for punitive damages stricken.
II.

JURISDICTION
This Court exercises jurisdiction pursuant to 28
3

U.S.C. § 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
statement of the claim showing that the pleader is entitled to
4

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
applied to federal complaints before Twombly.”).
Following the Twombly/Iqbal standard, the Third
5

Circuit has instructed a two-part analysis in reviewing a
complaint under Rule 12(b)(6).

First, 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.

Fowler, 578 F.3d at 210

(citing Iqbal, 129 S. Ct. at 1950).

Second, 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. (quoting Iqbal, 129 S. Ct. at 1950).

A

complaint must do more than allege the plaintiff's entitlement
to relief.

Id.; see also Phillips v. County 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’
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.
6

Hedges v.

U.S., 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).

B. Premarket Approval of The Device
The parties do not dispute that the device,
Medtronic’s “Infuse Bone Graft/LT-Cage Lumbar Fusion” device
(the “Infuse/LT-Cage device”) is a Class III medical device that
received pre-market approval (“PMA”). 1 Premarket approval

1
The MDA [Medical Device Amendments] separates
devices into three categories: Class I devices are
those that present no unreasonable risk of illness
7

imposes “requirements” under the Medical Device Amendments of
1976 (“MDA”) and is specific to individual devices.

Riegel v.

Medtronic, Inc., 552 U.S. 312, 322-23, 128 S.Ct. 999, 1007
(2008).

“[I]t is federal safety review.”

Id.

552 at 321.

The

MDA “... expressly pre-empts only state requirements ‘different
from, or in addition to, any requirement applicable ... to the
device’ under federal law... .” Id. (citing 21 U.S.C.A. §
360k(a)(1)).
“[T]he FDA requires a device that has received
premarket approval to be made with almost no deviations from the

or injury and therefore require only general
manufacturing controls; Class II devices are those
possessing a greater potential dangerousness and
thus warranting more stringent controls; Class III
devices “presen[t] a potential unreasonable risk
of illness or injury” and therefore incur the
FDA's strictest regulation.
§ 360c(a)(1)(C)(ii)(II).
...
Class III devices must complete a thorough
review process with the FDA before they may be
marketed. This premarket approval (PMA) process
requires the applicant to demonstrate a
“reasonable assurance” that the device is both
“safe ... [and] effective under the conditions
of use prescribed, recommended, or suggested in
the proposed labeling thereof.”
§§ 360e(d)(2)(A), (B).
Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S.
341, 344, 121 S.Ct. 1012, 1015 (2001).
8

specifications in its approval application, for the reason that
the FDA has determined that the approved form provides a
reasonable assurance of safety and effectiveness.” Id.
A Class III medical device presents a “potential
unreasonable risk of illness or injury,” or purports or
represents “to be for a use in supporting or sustaining human
life or for a use which is of substantial importance in
preventing impairment of human health.”
360c(a)(l)(C)(ii).

See 21 U.S.C. §

“Before a new Class III device may be

introduced to the market, the manufacturer must provide the FDA
with a ‘reasonable assurance’ that the device is both safe and
effective.

Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct.

2240 (1996) (citing 21 U.S.C. § 360e(d)(2)).

The Supreme Court

has recognized this process of establishing “reasonable
assurance,” known as the “premarket approval,” or “PMA” process,
to be “rigorous.” 2 Id.; Buckman Co. v. Plaintiffs' Legal

2

Among other information, an application must include
all known reports pertaining to the device's safety
and efficacy; a full statement of the components,
ingredients, and properties and of the principle or
principles of operation of such device; a full
description of the methods used in, and the facilities
and controls used for, the manufacture, processing,
and, when relevant, packing and installation of, such
device; samples of the device (when practicable); and
specimens of the labeling proposed to be used for such
device. The PMA process is ordinarily quite time
9

Committee, 531 U.S. 341, 344, 121 S.Ct. 1012, 1015 (2001).
Medtronic submitted an application for the Infuse/LTCage device to the FDA on January 12, 2001.

The device received

approval under PMA Number P000058 on July 2, 2002.

The Infuse

device’s description states, in part:
The InFUSE™ Bone Graft/LT-CAGE™ Lumbar
Tapered Fusion Device consists of two
components containing three parts-a tapered
metallic spinal fusion cage, a recombinant
human bone morphogenetic protein and a
carrier/scaffold for the bone morphogenetic
protein and resulting bone. The InFUSE™ Bone
Graft component is inserted into the LTCAGE™ Lumbar Tapered Fusion Device component
to form the complete InFUSE™ Bone Graft/LTCAGE™ Lumbar Tapered Fusion Device. These
components must be used as a system. The
InFUSETM Bone Graft component must not be
used without the LT-CAGETM Lumbar Tapered
Fusion Device component.
...
LT-CAGE™ Lumbar Tapered Fusion Device
component is sold separately from the
InFUSE™ Bone Graft component, however, these
two componenets must be used together. The
package labeling for the LT-CAGE™ Lumbar
Tapered Fusion Device contains complete
product information for this component.
(Emphasis in original).

consuming because the FDA's review requires an average
of 1,200 hours [for] each submission.
Buckman, 531 U.S. at 344-45 (internal quotes and citations
omitted).
10

Although the parties agree that the device is a Class
III device that received PMA, the parties disagree on whether
federal law preempts plaintiff’s state law claims.
C. Federal Preemption
Given the extensive regulation by the FDA over medical
devices, certain state law claims are preempted by federal law.
What state law claims are preempted, and under what conditions,
has been the subject of much debate by the courts.
In Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct.
2240 (1996), the Supreme Court found that certain state law
claims were not preempted if those claims imposed duties that
paralleled federal requirements.

The medical device in Lohr, a

pacemaker, received premarket approval as a “substantial
equivalent” of a device already on the market.

518 U.S. at 479

(contrasting the more limited “ § 510(k) process,” for devices
that are substantially equivalent with devices already on the
market, with the more rigorous PMA process).
In Reigel, the Supreme Court ruled that state
common law claims against manufacturers of medical devices that
are approved through §360k premarket approval are subject to
federal preemption.

552 U.S. at 322–25.

The MDA contains an

express preemption clause that “bars common-law claims
challenging the safety and effectiveness of a medical device
11

given premarket approval by the [FDA].”

Id. at 315.

This

express preemption provision is generally applied in a two-step
process in which it must be determined: (1) “whether the Federal
Government has established requirements applicable to” a medical
device; and if so, (2) whether the state law claim asserted
against the manufacturer is based on requirements with respect
to the device that are different from or in addition to federal
requirements, and that relate to safety and effectiveness.
Riegel, 552 U.S. at 321-22; 21 U.S.C. § 360k(a). 3
If the state law claim is expressly preempted, then
the claim is dismissed.

If not expressly preempted, the state

law claim may be still be barred under implied preemption.

See

Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 350,

3

Section 360k(a) states, in part:
(a) General rule
Except as provided in subsection (b) of this section,
no State or political subdivision of a State may
establish or continue in effect with respect to a
device intended for human use 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.
12

121 S.Ct. 1012 (2001) (finding that the FCDA impliedly preempted
state law fraud claims because claims conflicted with federal
law).

The holding in Buckman, however, is often limited to

“fraud-on-the-agency” claims and not extended to claims based on
state law tort principles.

See Bausch v. Stryker Corp., 630

F.3d 546, 557 (7th Cir. 2010) (finding no implied preemption
where state law claims were based on manufacturing defects, not
fraud on a federal agency).
Courts have understood that the general rule that has
emerged from this trio of cases, Lohr, Buckman, and Reigel, is
that “the MDA does not preempt a state-law claim for violating a
state-law duty that parallels a federal-law duty under the MDA.”
Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1117 (9th Cir. 2013)
(citing Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 (9th
Cir. 2013) (en banc)); compare Lohr, 518 U.S. at 495 (finding
common-law claims were not preempted under § 360k because
allegations included claims that Medtronic had violated FDA
regulations) with Riegel, 552 U.S. at 322-23 (finding that §
360k preempted common-law claims challenging the safety and
effectiveness of a medical device that had received premarket
approval from the FDA).
In order to determine if plaintiff’s claims are
expressly preempted, first, it must be determined whether the
13

Federal Government established requirements applicable to
Medtronic’s medical device.

There is no dispute that the

Infuse/LT-Cage device is a Class III device that obtained PMA
approval, and, therefore, is subject to the MDA express
preemption provision. 4
Secondly, it must be determined whether plaintiff’s
state claims are based on requirements that relate to safety and
effectiveness with respect to the Infuse/LT-Cage device that are
different from or in addition to federal requirements.
Plaintiff argues that she was harmed by defendants’ illegal
promotion and sale of a component of the Infuse/LT-Cage device,
the Infuse Bone Graft, for uses not approved by the FDA and,
therefore, her “parallel” claims are not preempted by federal
law.

Particularly, she argues that the PMA was for the Infuse

Bone Graft to be used in combination with the LT-Cage Lumbar
Tapered Fusion Device (“LT-Cage”), employing an anterior
approach.

She argues that the use of the Infuse Bone Graft with

the Capstone Cage employing a posterior approach violated
federal law.

Although plaintiff concedes that a doctor may

prescribe an FDA approved device for non-approved used, she

4 The parties do not address whether any of the other products
listed obtained PMA, or other FDA approval, so the preemption
discussion is limited to the Infuse/LT-Cage device.
14

argues that a manufacturer is barred from marketing or promoting
“off-label” uses.
Plaintiff also argues that the Medtronic defendants,
in order to increase sales, promoted the use of the Infuse Bone
Graft without the LT-Cage, in violation of the FDA approval.
She states that the Infuse Bone Graft was sold separately to
facilitate off-label use and that sales representatives were
placed in operating rooms to promote the separate use.
To the extent that any of plaintiff’s state law claims
assert that the warnings on the Infuse/LT-Cage device were
insufficient because they did not warn of dangers from using the
Infuse Bone Graft without the LT-Cage, or not using an anterior
approach, such claims are expressly preempted.

To require

defendant to add language to the warning would impose an
additional requirement relating the safety or effectiveness of
the device. 5

See Horn v. Thoratec Corp., 376 F.3d 163, 168 (3d

Cir. 2004) (“[W]hen a state law neither imposes requirements nor
differs from or adds to an FDA requirement nor relates to the
safety or effectiveness of the device or to any other matter
included in an FDA requirement, the state law is not pre-empted

5 The Medtronic defendants would be prohibited by federal law
from changing any of the language approved by the FDA in the
PMA. Any change in the label would require the defendants to
submit a supplemental request for approval.
15

by § 360k.”).
What plaintiff is arguing, however, is that defendants
engaged in off-label promotion that was false or misleading.
Plaintiff has argued that defendants through their marketing and
sales representatives promoted the use of the Infuse Bone Graft
in a manner that was contrary to the labeling approved on the
device, and harmful to patients.

Defendants argue that off-

label promotion is not expressly banned by federal law.

They

rely on Buckman in which the Supreme Court noted that “offlabel” usage of medical devices “is an accepted and necessary
corollary of the FDA's mission to regulate in this area without
directly interfering with the practice of medicine.”
at 350.

531 U.S.

However, the Court was referring to off-label use by

physicians, not manufacturers.

See id. (noting an amendment to

the FDCA that expressly states in part that “[n]othing in this
chapter shall be construed to limit or interfere with the
authority of a health care practitioner to prescribe or
administer any legally marketed device to a patient for any
condition or disease within a legitimate health care
practitioner-patient relationship.”)(citing 21 U.S.C. § 396
(1994 ed., Supp. V) (emphasis added).
Certain courts have noted the murkiness of federal
preemption law with regard to medical devices and off-label use.
16

See Schouest v. Medtronic, Inc., --- F.Supp.2d ----, 2014 WL
1213243, at *6 (S.D.Tex. 2014) (noting that federal law does not
expressly ban off-label promotion, but noting the FDA views offlabel promotion to be misbranding and concluding that “federal
law bars off-label promotion when it is false or misleading.”).
Thus, although there is no express provision banning off-label
promotion, it is clear that such practices are not in keeping
with FDA directions and allowing such practices would encourage
manufacturers to promote their products in ways not approved by
the FDA and possibly provide inaccurate or misleading
information to patients.
Therefore, plaintiff’s claims based on a theory of
off-label promotion of the Infuse/LT-Bone Graft device is not
different from or in addition to federal requirements, and
therefore are not preempted by federal law.

See id. at *8

(“[M]aking false or misleading statements about medical devices
is prohibited by federal law[; therefore,]...

state law fraud

claims based on false off-label promotion would, if proven, also
amount to a violation of federal law, and thus such claims could
survive preemption.”).

Likewise, since plaintiff’s theory is

not based on Medtronic defendants committing fraud against the
FDA, their off-label promotion claims are not barred by implied
preemption under Buckman.
17

Further, the Infuse/LT-Cage device received PMA as a
system, not as separate parts.

In plaintiff’s case, the Infuse

Bone Graft was used without the LT-Cage.

The FDA did not give

PMA to the Infuse Bone Graft alone, or to the Infuse Bone Graft
with devices other than the LT-Cage.

Thus, to the extent

Medtronic’s argument is that its Infuse Bone Graft by itself
enjoys PMA, such argument is on shaky ground, particularly here,
where plaintiff has alleged that not only did Medtronic know
about the off-label use, but encouraged it. 6
Having determined generally that claims based on a
theory of off-label marketing and promotion by the manufacturer
would not necessarily be preempted by federal law, we now turn
to the specific state law claims brought by plaintiff to
determine whether they are subject to dismissal. 7

6 The Court does not determine at this early stage in the
proceeding whether there is Federal preemption for a device
knowingly sold and marketed as separate device where the PMA was
for the device to be part of a system. Health care
practitioners use devices off-label. We do not suggest that
such off-label use strips a manufacturer of its PMA status for
the device, particularly if the usage is not promoted by the
manufacturer.
7 In assessing each state law claim, the first inquiry is
whether a state law claim exists. If it does not, then it will
be dismissed pursuant to Fed.R.Civ.P. 12(b)(6). If there is a
valid state law claim, then the inquiry is whether it is barred
by the doctrine of federal preemption.
18

D. Breach of Implied Warranty – Count V
Medtronic seeks dismissal of plaintiff’s breach of
implied warranty claim on grounds that the claim is subsumed
under the PLA and, therefore should be dismissed pursuant to
FedR.Civ.P. 12(b)(6).

Plaintiff responds that her claim is

pursuant to the Uniform Commercial Code (UCC) and that the
warranty of fitness in this case is “express” not “implied”
based on the conduct, representations, and circumstances
surrounding the sale of the Medtronic medical devices to
plaintiff’s surgeon, including the presence of a Medtronic sales
representative in the operating room.
The section of the UCC relied upon by plaintiff,
12A:2-315, pertains to the implied warranty for fitness for
particular purpose.

It states that “[w]here the seller at the

time of contracting has reason to know any particular purpose
for which the goods are required and that the buyer is relying
on the seller's skill or judgment to select or furnish suitable
goods, there is unless excluded or modified under the next
section an implied warranty that the goods shall be fit for such
purpose.”

See N.J.S.A. 12A:2-315.
New Jersey law is clear that the PLA provides one

unified, statutorily defined theory of recovery for harm caused
by a product.

See Calender v. NVR, Inc., No. 10–4277, 2012 WL
19

4482009, at *3–4 (D.N.J. Sept. 26, 2012) (granting summary
judgment to defendant on negligence and implied breach of
warranty claims because they were subsumed by the PLA); Gupta v.
Asha Enterprises, LLC, 422 N.J.Super. 136, 144-45, 27 A.3d 953
(App.Div. 2011) (affirming dismissal of claims for negligence,
violations of the CFA and breach of implied warranty insofar as
they were based upon product defect); Koruba v. Am. Honda Motor
Co., 396 N.J.Super. 517, 935 A.2d 787, 795 (2007) (explaining
that “the PLA ‘no longer recognizes negligence or breach of
warranty (with the exception of an express warranty) as a viable
separate claim for “harm[,]” [including personal injury,] caused
by a defective product’ or an inadequate warning.”) (citation
omitted).
New Jersey courts have not made any exception to this
rule and have adhered strictly to the parameters set out in the
PLA.

See Cornett v. Johnson & Johnson, 998 A.2d 543, 566

(N.J.Super.A.D. 2010) (“This preclusion of breach of implied
warranty ‘as a viable separate claim’ is ‘definitive.’”) (citing
Tirrell v. Navistar Int'l, Inc., 248 N.J.Super. 390, 398, 591
A.2d 643 (App.Div.); Koruba, 935 A.2d at 787).

Plaintiff has

not demonstrated how her claim brought under a statute for
implied warranty could be translated into an express warranty,
and even if it could, plaintiff has not shown why her express
20

warranty claim in Count V is different from the express warranty
claim raised in Count VII.

Further, there is nothing in the UCC

language to suggest that it encompasses express warranties.
Accordingly, plaintiff’s claim for implied warranty is subsumed
under the PLA and not cognizable as a state law claim under New
Jersey law.

Therefore it shall be dismissed.

E. Breach of Express Warranty – Count VII
Medtronic also seeks to dismiss plaintiff’s claim for
breach of express warranty pursuant to Fed.R.Civ.P 12(b)(6).
“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
21

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
(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.A.D.
2012) (citing Realmuto v. Straub Motors, Inc., 65 N.J. 336, 343,
322 A.2d 440 (1974)).
Plaintiff responds generally that Medtronic provided
an express warranty in their conduct and representations
concerning the use of Infuse separately from the "system"
approved by the FDA, and in the aggressive marketing campaign
including incentive payments, kickbacks, and falsifying clinical
trial results.

Plaintiff also argues that the Medtronic

defendants separately packaged and sold the Infuse device and
trained physicians to use it in ways the FDA did not approve and
in direct conflict with the restrictions on the FDA approval
received for the 3-component Infuse system with the LT-cage.
Plaintiff states that in her case Infuse was used with a
different cage and other materials, in a posterior approach,
which was contraindicated.
It not clear, however, what Medtronic expressly
22

warranted.

Even a review of the allegations in plaintiff’s

second amended complaint do not shed any additional light on
what express warranties Medtronic allegedly made.

In her second

amended complaint, plaintiff alleges that the Medtronic
defendants expressly warranted that their product would help and
cure her.

Plaintiff also alleges that statements made by

Medtronic’s sale and marketing personnel in “literature, on-line
and in television or other advertising” constituted express
warranties.

Plaintiff states that Medtronic promoted off-label

experimental uses in public advertising, as well as to
physicians, hospitals or surgical centers.

Plaintiff alleges

that the Medtronic defendants breached the express warranties by
using off-label experimental use of their “spinal surgery
products” in plaintiff’s back without her consent which caused
aggravation of her existing condition, new nerve and muscular
damage and “drop foot.”
Plaintiff’s statements are general averments and do
not allege the specific affirmation, promise or guarantee made
by Medtronic regarding the Infuse device.

See Synder, 792

F.Supp.2d at 722 (“Plaintiffs have pointed to specific
affirmations or promises by Defendants regarding the safety of
the use of their Products on pets, and therefore their breach of
warranty claim survives a motion to dismiss.”); Hemy v. Perdue
23

Farms, Inc., 2013 WL 1338199, at *10 (D.N.J. Mar. 31 2013)
(denying motion to dismiss express warranty claim where
plaintiffs sufficiently pled that a reasonable consumer may have
interpreted the Humanely Raised label to include the processes
to which the chicken is exposed throughout its life, including
slaughter, and fulfilled their obligations under the contract by
paying the purchase price and have alleged damages derived
therefrom).
Although plaintiff refers to advertising and marketing
of Medtronic products off-label, she does not specifically state
what Medtronic expressly warranted.

See Fidelity and Guar. Ins.

Underwriters, Inc. v. Omega Flex, Inc., 936 F.Supp.2d 441, 452
(D.N.J. 2013) (dismissing breach of express warranty claim
because plaintiff asserted only that its insured relied on the
skill and judgment of defendant and its representations and
warranties in the purchase and/or use of product, but failed to
identify any actual representations regarding the product);
Schraeder v. Demilec (USA) LLC, 2013 WL 3654093, at *5 (D.N.J.
July 12, 2013) (“Courts dismiss claims for breach of an express
warranty where plaintiffs fail to specify any factual support as
to the specific language or source of the alleged warranty.”);
Walters v. Carson, 2012 WL 6595732, at *3 (D.N.J. Dec. 17, 2012)
(dismissing express warranty claim because plaintiff did not
24

state how the claims allegedly made by Tylenol that its product
was merchantable, free from defects, and reasonably fit for the
foreseeable use and intended purposes for which it was sold
formed any part of the basis of his decision to purchase the
product).
If plaintiff is alleging that Medtronic made
statements during its promotion and marketing campaigns that
deviated from the device’s labeling and instructions, then
plaintiff must provide a more definite statement regarding what
those statements were regarding which specific devices.
Therefore, plaintiff’s express warranty claims will be dismissed
without prejudice.

Plaintiff is granted leave to amend her

complaint to provide more detail as to what was expressly
warranted by Medtronic and for what device.

8

8 Pursuant to Fed.R.Civ.P. 15(a), “The court should freely give
leave [to amend] when justice so requires.” See Snyder v.
Baxter Healthcare, Inc., 393 Fed.Appx. 905, 909-10 (3d Cir.
2010) (noting the conflict between Phillips v. County of
Allegheny, 515 F.3d 224, 236 (3d Cir. 2008) which held that
“[i]f a complaint is vulnerable to 12(b)(6), a district court
must permit a curative amendment, unless an amendment would be
inequitable or futile[]” and the long standing rule that, to
request leave to amend a complaint, the plaintiff must submit a
draft amended complaint to the court so that it can determine
whether amendment would be futile). Here, the conflict is not
implicated because the Court is not permitting plaintiff to
plead new claims, only permitting plaintiff to provide a clearer
statement of her claims. See Island Green, LLC v. Querrard, 429
Fed.Appx. 90, 92-93 (3d Cir. 2011) (instructing that the
district court should give plaintiff the opportunity to amend
25

F. New Jersey Product Liability Act
The Medtronic defendants also seek to dismiss
plaintiff’s PLA claims pursuant to Fed.R.Civ.P. 12(b)(6).
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.
N.J.S.A. 2A:58C-2.
Three causes of action are established under the PLA,
namely, claims for design defect, manufacturing defect, or
warnings defect.

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.”

Cornett v.

Johnson & Johnson, 414 N.J.Super. 365, 998 A.2d 543 (App.Div.

and re-plead specifically what wrongful conduct was committed
and by whom). Plaintiff has requested leave to amend the
complaint if her allegations concerning violations of Federal
prove insufficient. See Pl. Opp. at 33 n. 8.
26

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., 293 N.J.Super. 129, 142, 679
A.2d 733 (App.Div. 1996)(citing

Jurado v. Western Gear Works,

131 N.J. 375, 385, 619 A.2d 1312 (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, 157 N.J. 84, 723 A.2d 45, 52 (N.J.
1999) (citing Scanlon v. General Motors Corp., 65 N.J. 582, 591,
326 A.2d 673 (1974); Manieri v. Volkswagenwerk A.G., 151
N.J.Super. 422, 430-31, 376 A.2d 1317 (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].”
Scanlon, 65 N.J. at 593-94).
27

Id. at 53 (citing

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., 66 N.J.

454, 458, 332 A.2d 599 (1975)).

“Proof that a product is not

fit for its intended purposes ‘requires only proof ... that
‘something was wrong’ with the product.’”
65 N.J. at 591, 326 A.2d 673).

Id. (citing Scanlon,

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.

Plaintiff asserts manufacturing and design defect
claims, as well as failure to warn claims against Medtronic.
Plaintiff identifies the defective products as the Infuse bone
graft material, Capstone spinal cage, various screws and other
material as listed in the operative reports.

Plaintiff also

points to the operative reports which lists "hardware failure"
as the diagnosis.

Plaintiff has stated that a manufacturing

defect caused overgrowth of bone graft material resulting in
migration of the cages out of position described as "hardware
failure" in the medical records; identified as a design defect
the design of separate packaging for marketing and sale of the
Infuse product without the other components of the "system"
approved by the FDA; and has alleged that the Medtronic
28

defendants failed to include truthful and adequate warnings and
instructions.

Plaintiff does not allege that the FDA warnings

are somehow inadequate on the Infuse itself, but that the
conduct of the Medtronic defendants mitigated or nullified the
warnings in their marketing and distribution scheme and created
inadequate warnings.

Plaintiff also states that the Medtronic

sales representative may have removed or otherwise mitigated the
warnings to encourage the surgeon to use the product in an illadvised, contraindicated, and experimental way in plaintiff’s
surgery.

Plaintiff further alleges that these defects were all

significant causative factors in the harm that plaintiff
sustained.
Although plaintiff jumbled together her analysis of
all three theories of defect under the PLA, the standards of
proof for each theory are not exactly the same and therefore,
are addressed separately.
1. Design Defect
For a design defect, plaintiff must assert that the
product could have been designed more safely and present under a
risk-utility analysis the existence of an alternative design
that is both practical and feasible.
Co., 715 A.2d 967, 980 (N.J. 1998).
29

Lewis v. American Cyanamid
A plaintiff may pursue a

design defect claim by contending that its risk outweighs its
harm, or that an alternate design exists.

See Schraeder v.

Demilec (USA) LLC, No. 12–cv–6074, 2013 WL 5770670, at *2
(D.N.J. Oct. 22, 2013).

Though there is no “per se rule that

Plaintiffs must, under all circumstances, provide a reasonable
alternative design,” a plaintiff must plead either that the
product’s risk outweighs its harm, or that an alternate design
exists, in order to state a claim for a design defect under the
Product Liability–Act.

Id.

Plaintiff has stated that the separate packaging of
the Infuse Bone Graft product without the other components of
the "system" approved by the FDA constituted a design defect.
Presumably, plaintiff is suggesting that the alternative design
would be to package the components together.

Plaintiff has

failed, however, to present a risk-utility analysis on the group
packaging.

Medtronic has stated that the Infuse Bone Graft is

supplied in three kit sizes containing different amounts of
rhBMP protein and that the LT-Cage Lumbar Tapered Fusion Device
component is supplied in seven sizes which must be properly
selected based on a specific patient’s anatomy.

The components

are sold separately to allow physicians to select the

30

appropriate combination based on each patient’s needs. 9
Plaintiff has not presented any allegations to refute
this.

Thus, plaintiff has not sufficiently alleged a design

defect claim under New Jersey law and this claim will be
dismissed pursuant to Fed.R.Civ.P. 12(b)(6).

Moreover, even if

plaintiff properly plead the design defect claim, it would be
preempted under federal law.

The packaging of the components

separately was approved by the FDA during the PMA process.
Allowing a state law claim to proceed that would challenge the
safety and effectiveness of the packaging would run afoul of the
MDA’s express preemption clause barring such claims brought
against a medical device with PMA.

See Reigel, 552 U.S. at 315.

2. Manufacturing Defect
To determine whether a product contains a
manufacturing defect, the “product may be measured against the
same product as manufactured according to the manufacturer's

9 In general, when ruling on a motion to dismiss pursuant to
12(b)(6), a court may only consider the contents of the
pleadings. Pryor v. Nat'l Collegiate Athletic Ass'n, 288 F.3d
548, 560 (3d Cir. 2002) (quoting 62 Fed. Proc. L.Ed. § 62:508).
However, “[d]ocuments that the defendant attaches to the motion
to dismiss are considered part of the pleadings if they are
referred to in the plaintiff’s complaint and are central to the
claim....” Id. Here, the information regarding the device is
from documents submitted for its PMA and, therefore, directly
related to plaintiff’s claim.
31

standards.

Mickens v. Ford Motor Co., No. 10–cv–05842, 2011 WL

3444055, at *3 (D.N.J. 2011) (citing Navarro v. George Koch &
Sons, Inc., 512 A.2d 507, 517 (N.J.Super. App. Div. 1986)).

“If

the particular product used by the plaintiff fails to conform to
those standards or other units of the same kind, it is a
manufacturing defect.”

Id. (internal marks omitted).

Plaintiff has stated that a manufacturing defect
caused overgrowth of bone graft material resulting in migration
of the cages out of position, that the defect was "hardware
failure" in the medical records, and that she was injured as a
result of the product failing.
Although rather sparse, plaintiff has pleaded the
minimum needed to survive a 12(b)(6) challenge.

By alleging

that the medical records indicate that the device had a
“hardware failure” this could suggest a plausible claim that the
device as manufactured did not conform to standards of other
units of the same kind.
Having determined that plaintiff plead a state law
claim for manufacturing defect, it must be determined whether
her claim is preempted by federal law.

To the extent that the

claim is a hardware failure because the device did not conform
to the standards of other units, and also violated federal
32

regulations and procedures in manufacturing, then it would be
parallel claim and would not be preempted.

See Bass v. Stryker

Corp., 669 F.3d 501, 515 (5th Cir. 2012) (finding that
plaintiff’s manufacturing defect claims could proceed because
they were premised on violations of FDA regulations and
therefore parallel claims that were not preempted); Williams v.
Cyberonics, Inc., 654 F.Supp.2d 301, 306 (E.D.Pa. 2009) (“To
avoid federal preemption, a plaintiff must make some showing
that the medical device was not manufactured in accordance with
FDA standards.”), aff’d 388 Fed.Appx. 169 (3d Cir. 2010).
However, if the Infuse device was manufactured in compliance
with its PMA, then any claim of manufacturing defect would not
parallel a federal claim and would be preempted.

See In re

Medtronic, Inc., Sprint Fidelis Leads Products Liability
Litigation, 623 F.3d 1200, 1207 (8th Cir. 2010) (finding
district court properly concluded manufacturing claim preempted
because “as pleaded and argued, the manufacturing defect claims
are not parallel, they are a frontal assault on the FDA's
decision to approve a PMA Supplement after weighing the
product's benefits against its inherent risks.”).
Although plaintiff’s claim of manufacturing defect may
be enough to survive a 12(b)(6) challenge, in order to determine
33

whether the claim is preempted by federal law, additional facts
must be alleged.

It is not clear on the basis of plaintiff’s

complaint or opposition to the motion to dismiss the exact
nature of plaintiff’s manufacturing claim.

Therefore, the claim

will be dismissed without prejudice and plaintiff granted leave
to amend her complaint.

To avoid preemption, plaintiff must be

able to demonstrate that her state law manufacturing defect
claim is parallel to federal law with regard to any PMA approved
device.

With regard to other devices, plaintiff must allege

that the device failed to conform to standards or other units of
the same kind.
3. Failure to Warn
In a failure-to-warn case, “the duty to warn is
premised on the notion that a product is defective absent an
adequate warning for foreseeable users that ‘the product can
potentially cause injury.’”

Clark v. Safety–Kleen Corp., 179

N.J. 318, 336, 845 A.2d 587 (2004) (quoting Coffman v. Keene
Corp., 628 A.2d 710 (N.J. 1993)).

The plaintiff must establish

that the defendant had a duty to warn, and then establish that
an adequate warning was not provided.

James v. Bessemer

Processing Co., 714 A.2d 898, 907 (N.J. 1998).

Plaintiff must

then prove the breach of duty (the absence of a warning) was a
34

proximate cause of the accident.

Coffman, 628 A.2d at 716.

There is no question Medtronic had a duty to warn or
that a warning was placed on the device.

The FDA's PMA approval

includes specific language for Class III device labels and
warnings.

Plaintiff does not allege that Medtronic modified or

failed to include FDA-approved warnings.
Rather, she alleges that defendants did not provide
truthful and adequate warnings and instructions due to the
conduct of the Medtronic defendants who mitigated or nullified
the warnings in their marketing and distribution scheme, or in
their encouragement to use the product separately.

Plaintiff

has alleged that the “nullification” of the warnings caused her
injury in how the product was used during her surgery.
Given the early procedural posture of the case, this
claim will be allowed to proceed.

If defendants had physically

removed the warning label from the device, then it would be
clear that the warnings were no longer adequate since they would
no longer be on the device.

However, if the defendants by their

actions nullified the warning, it could be plausible that the
warning would have been inadequate as if it had been physically
removed.
In addition, plaintiff’s failure to warn claim is not
35

preempted.

Plaintiff’s theory is based on the idea that

Medtronic’s actions modified the warning label so that the
prohibition against using the Infuse Bone Graft with any other
component other than the LT-Cage was nullified.

Plaintiff is

not arguing that Medtronic should have given warnings that were
different from or in addition to the warning provided.

See In

re Medtronic, Inc., Sprint Fidelis Leads Products Liability
Litigation, 623 F.3d 1200, 1205 (8th Cir. 2010) (“Plaintiffs did
not allege that Medtronic modified or failed to include FDAapproved warnings. Rather, they alleged that, by reason of state
law, Medtronic was required to give additional warnings,
precisely the type of state requirement that is ‘different from
or in addition to’ the federal requirement and therefore
preempted.”).

Rather, plaintiff is arguing that Medtronic’s

actions resulted in the warning label being ignored.

What is

not clear, however, is whether plaintiff is asserting that
Medtronic’s actions is a failure to comply with FDA regulations.
See Hughes v. Boston Scientific Corp., 631 F.3d 762, 769 (5th
Cir. 2011) (“To the extent that Hughes asserts a failure to warn
claim based only on Boston Scientific's failure to comply with
FDA regulations, however, such a claim is not expressly
preempted.”).
36

Thus, plaintiff’s failure to warn claim will be
dismissed without prejudice.

Plaintiff must clearly state the

federal regulation that parallels her state law claim.
G. Third Party Beneficiary
The Federal government and Medtronic (formerly known
as Kyphon, Inc.) entered into a “Corporate Integrity Agreement”
(CIA) to “promote Kyphon’s compliance with … Medicare, Medicaid,
and all other Federal health care programs.”

This agreement was

entered into, along with a settlement agreement, to resolve a
lawsuit brought against Medtronic based on the Federal
government’s investigation of Medtronic’s submission of false
claims to Medicare.

Plaintiff asserts that as a Medicare

beneficiary, she is also a third party beneficiary to the CIA.
Under New Jersey law, plaintiff lacks standing to be a
third party beneficiary to the CIA.

See Rieder Communities,

Inc. v. Township of North Brunswick, 546 A.2d 563, 567
(N.J.Super.A.D. 1988).

“The essence of contract liability to a

third party is that the contract be made for the benefit of said
third party within the intent and contemplation of the
contracting parties.”

Id. (quoting Gold Mills, Inc. v. Orbit

Processing Corp., 121 N.J.Super. 370, 373, 297 A.2d 203 (Law
Div. 1972)).

“Unless such a conclusion can be derived from the
37

contract or surrounding facts, a third party has no right of
action under that contract despite the fact that he may derive
an incidental benefit from its performance.”
plaintiff is an “incidental beneficiary.”

Id.

Rather,

See id.

Plaintiff failed to demonstrate that the parties to
the CIA intended Medicare beneficiaries to also be beneficiaries
of the contract, or that they intended Medicare beneficiaries to
enforce such a benefit in a court of law.

A review of the CIA

shows that it was meant to provide terms within which Medtronic
must comply, including reporting and training, and terms for
breach of any of the terms of the agreement by Medtronic.

There

is no indication that the parties contemplated, much less
intended, that third parties be granted a right of action under
the CIA.

Therefore, plaintiff’s claim as a third party

beneficiary will be dismissed.
H. Fraud and Misrepresentation
Plaintiff alleges, in the alternative, that Medtronic
engaged in a false and misleading campaign for advertising,
marketing and promoting the use of Infuse.

Plaintiff states

that her claims are separate from any issue of product defect
and are based entirely upon the improper course of conduct by
Medtronic.

Specifically, plaintiff alleges:
38

•

Defendants made material misrepresentations of past and
presently existing facts including but not limited to:
misrepresenting the use of InFuse® as safe and effective
when it was not; misrepresenting the causation of side
effects when InFuse® was used in spinal surgeries (whether
used in FDA approved ways or not); misrepresenting its
financial arrangements including but not limited to
contracts with researchers, paid consultants, recipients of
royalties, sham study payments, promotional payments to
surgeons and facilities; and other misrepresentations.

•

Defendants knew and believed that such misrepresentations
were false because it had actual and/or constructive
knowledge of the side effects at the very highest levels of
management and (i) designed and conducted the nationwide
and global advertising campaign of falsified data and
studies as a means to satisfy its greed and profit motive
with skyrocketing sales of InFuse® and (ii) “agreed” in a
Corporate Integrity Agreement entered into in July 2008 for
a period of five years as part of its settlement with DOJ
to implement a monitoring program of payments to physicians
and surgeons and other parts of its marketing campaign and
(iii) continues to this day to downplay, minimize, and deny
the catastrophic side effects of InFuse® in spinal
surgeries despite growing reports and disclosures of
adverse events which Medtronic paid handsomely to suppress
from the first trials forward.

•

Defendants specifically intended that surgeons and the
medical community generally would rely on their
misrepresentations so that their sales of InFuse would
increase, as they did—sometimes to the extent of becoming
highly paid Medtronic consultants or “opinion leaders” who
would then convince other surgeons to recommend and use
InFuse®.

•

Defendants specifically intended that patients rely on the
misrepresentations of Medtronic delivered by and through
their physicians and the coercive influence of sales
representatives in the operating rooms, including the
operating rooms in which Plaintiff was surgically implanted
with InFuse and other Medtronic products.

39

•

Such reliance on Medtronic’s misrepresentations and
fraudulent statements was justifiable in the case of this
Plaintiff because she trusted her doctor and had absolutely
no knowledge of the truth about the surgical products used
in her and, whether her doctor was complicit in this scheme
or not, he failed to advise her of what was going on, even
concerning the revelations in various journal articles and
news sources disclosing the falsification of studies and
data by Medtronic agents, servants and employees, or even
the presence of a Medtronic salesman in the OR, or the fact
that her surgeries would be an off-label, experimental use
of InFuse and the other products.

•

Even now, on Medtronic’s website, they misrepresent the
findings of the Yale study and have posted a false and
misleading video to “spin” the true results by CEO Omar
Ishrak in order to continue to perpetrate the fraud against
the public, the medical community, patients, and the
government.

Although plaintiff stresses the representations made
by Medtronic, ultimately, the essence of her claim is that the
misrepresentations resulted in physical harm from the product.
See Schraeder v. Demilec (USA) LLC, 12-6074, 2013 WL 3654093, at
*4 (D.N.J. 2013) (dismissing CFA claim as subsumed under PLA and
concluding that while plaintiffs allege that Demilec promoted
the SPF as “green” and non-toxic, the essence of plaintiffs'
real claim sounds in products liability; “it asserts that
Demilec failed to warn of the potential health issues that could
occur if their product was not mixed correctly, which resulted
in harm from the product.”); Sinclair v. Merck & Co., Inc., 195
N.J. 51, 66, 948 A.2d 587 (2008) (finding that the PLA subsumed
40

plaintiffs' CFA claim because “the heart of plaintiffs' case is
the potential for harm caused by [defendants'] drug.”).
In Indian Brand Farms v. Novartis Crop Protection,
Inc., 890 F.Supp.2d 534, 547 (D.N.J. 2012), this Court was faced
with a similar theory and determined that the essential nature
of plaintiffs’ case was that of a traditional product liability
action and therefore, found that plaintiffs' common law
misrepresentation claim and statutory claim under the CFA were
subsumed by the PLA.

Id. (finding that although plaintiffs

clearly alleged that Novartis misrepresented that product
controlled certain insects without inflicting adverse effects on
plants or soil, and that plaintiffs relied on these
misrepresentations, the heart of plaintiffs' dissatisfaction is
that the product itself caused harm to the blueberry plants).
The Court understands that plaintiff is trying to
navigate her tort claims through the barriers of Federal
preemption and the absorption of common law tort claims by the
PLA.

However, re-packaging her basic argument to argue in the

alternative that Medtronic’s promotion of off-label use of
Infuse, without the LT-Cage, in a posterior approach procedure,
at two levels in the spine is a “conduct” claim rather than a
“product” claim will not work.

See Sinclair, 195 N.J. at 66
41

(the “language of the PLA represents a clear legislative intent
that, despite the broad reach we give to the CFA, the PLA is
paramount when the underlying claim is one for harm caused by a
product”).
Thus, plaintiff’s fraud and misrepresentation claim
against Medtronic shall be dismissed as subsumed under the PLA. 10

10 Plaintiff attempts to come under an exception to the PLA
which permits a CFA claim to stand alone if the harm alleged was
to the product itself. This is not applicable here since
plaintiff is not alleging harm to the Infuse product itself, but
rather the harm is to her physically. The PLA defines the term
“product liability action” as “any claim or action ... for harm
caused by a product, irrespective of the theory underlying the
claim, except actions for harm caused by breach of an express
warranty.” N.J. Stat. Ann. § 2A:58C–1(b)(3). Claims for
“physical damage ... to the product itself” are not “product
liability action[s]” because the PLA specifically excludes such
damage from its definition of “harm.” Estate of Edward W.
Knoster v. Ford Motor Co., 200 Fed.Appx. 106, 115-16 (3d Cir.
2006) (citing N.J. Stat. Ann. § 58C–1(b)(2),(3); Alloway v.
General Marine Ins. L.P., 149 N.J. 620, 695 A.2d 264 (1997)).
In Knoster, the Third Circuit concluded that plaintiffs’
consumer fraud claim was not subsumed by the PLA because they
were seeking only to recover harm to the product, a car, itself.
Id. at 116 (“The PLA cannot subsume that which it explicitly
excludes from its coverage.”). However, in cases where the
plaintiff is seeking to recover for physical injuries caused by
a defective product, such a fraud claim is subsumed by the PLA.
See Rossi v. Innovation Ventures, LLC, No. 13-1870, 2014 WL
1315656, at *5 (D.N.J. 2014) (where the factual allegations in
support of consumer fraud claim relate to a physical injury
caused by the alleged defective product, the PLA subsumes
plaintiff's cause of action under the Consumer Fraud Act).
42

I. Punitive Damages
The PLA provides that:
Punitive damages shall not be awarded if a drug or
device or food or food additive which caused the
claimant's harm was subject to premarket approval or
licensure by the federal Food and Drug
Administration under the “Federal Food, Drug, and
Cosmetic Act,” 52 Stat. 1040, 21 U.S.C. § 301 et
seq. or the “Public Health Service Act,” 58 Stat.
682, 42 U.S.C. § 201 et seq. and was approved or
licensed; or is generally recognized as safe and
effective pursuant to conditions established by the
federal Food and Drug Administration and applicable
regulations, including packaging and labeling
regulations. However, where the product manufacturer
knowingly withheld or misrepresented information
required to be submitted under the agency's
regulations, which information was material and
relevant to the harm in question, punitive damages
may be awarded.

N.J.S.A. 2A:58C–5c.
Plaintiff has argued that Medtronic’s off-label
promotion was not approved by the FDA, and resulted in a
“nullification” of the FDA approved labeling of the device.
Such allegations would come under the exception to the PLA
where the product manufacturer knowingly withheld or
misrepresented information to the FDA.
A determination that plaintiff’s request for punitive
damages comes under an exception to the PLA does not end the
inquiry.

The next question is whether punitive damages are
43

impliedly preempted under Buckman.

In Buckman, plaintiff

alleged that the defendant made fraudulent representations to
the FDA “in the course of obtaining approval to market the
screws.”

531 U.S. at 344.

The defendant sought § 510(k)

approval 11 for its bone screw device, indicating it for use in
spinal surgery.

Id. at 346.

In its third application to the

FDA, defendant “sought clearance to market the plates and screws
for use in the long bones of the arms and legs” rather than
seeking clearance for spinal applications.

Id.

The Supreme

Court found that plaintiffs' state-law fraud-on-the-FDA claims
conflicted with federal law.

Id. at 348.

“The conflict stems

11
An exception to the PMA requirement exists for
devices that were already on the market prior to
the MDA's enactment in 1976. See 21 U.S.C. §
360e(b)(1)(A). The MDA allows these “predicate”
devices to remain available until the FDA
initiates and completes the PMA process. In
order to avoid the potentially monopolistic
consequences of this predicate-device exception,
the MDA allows other manufacturers to distribute
(also pending completion of the predicate
device's PMA review) devices that are shown to
be “substantially equivalent” to a predicate
device. § 360e(b)(1)(B).
Demonstrating that a device qualifies for this
exception is known as the “§ 510(k) process,”
which refers to the section of the original MDA
containing this provision.
Buckman, 531 U.S. at 345.
44

from the fact that the federal statutory scheme amply empowers
the FDA to punish and deter fraud against the Administration,
and that this authority is used by the Administration to achieve
a somewhat delicate balance of statutory objectives.”

Id. 12

Therefore, the issue in Buckman is slightly different
than the issue here.

In Buckman, the Supreme Court found that

plaintiff’s claims that defendant committed fraud on the FDA
during the § 510(k) process was impliedly preempted.

Here, the

issue is whether plaintiff’s claims that Medtronic is committing
fraud, after the PMA process, permits plaintiff to seek punitive
damages.

While it is clear that any claim of fraud during the

§510(k) process, or the more demanding PMA process, would be
preempted, it is not clear whether the holding in Buckman would
extend to fraud committed after the PMA process concluded.
Here, plaintiff alleges that Medtronic engaged in offlabel marketing.

The Supreme Court in Buckman states that

“’off-label’ usage of medical devices (use of a device for some
other purpose than that for which it has been approved by the

12 The Court notes that the FDA has enforcement authority under
the Federal Food, Drug and Cosmetic Act (FDCA). It can seek
injunctive relief, 21 U.S.C. § 332, civil penalties, 21 U.S.C. §
333(f)(1)(A), seizing the device, 21 U.S.C. § 334(a)(2)(D), and
criminal prosecution, 21 U.S.C. § 333(a). The FDCA does not
permit a private right of action.
45

FDA) is an accepted and necessary corollary of the FDA's mission
to regulate in this area without directly interfering with the
practice of medicine.”

Id. at 350.

However, as previously

noted, this statement only refers to off-label usage, not offlabel marketing.

Also, the Supreme Court clarified their intent

by citing to 21 U.S.C. § 396 (1994 ed., Supp. V), which states
in part that “[n]othing in this chapter shall be construed to
limit or interfere with the authority of a health care
practitioner to prescribe or administer any legally marketed
device to a patient for any condition or disease within a
legitimate health care practitioner-patient relationship.”.

The

Supreme Court cited to a statement regarding a health care
practitioner’s authority to engage in off label uses, not a drug
company’s.
Therefore there is nothing in Buckman that would
clearly preempt a plaintiff seeking punitive damages for offlabel marketing by a drug company after the PMA process has
concluded.

Nonetheless, it is important to review the policy

underlying the preemption for “fraud-on-FDA” claims to determine
whether Buckman should be extended in this case.

In Buckman,

the Supreme Court determined that if plaintiffs were to maintain
their fraud-on-the-agency claims, “they would not be relying on
46

traditional state tort law which had predated the federal
enactments in question.

On the contrary, the existence of these

federal enactments is a critical element in their case.”
353.

Id. at

In other words, “but for petitioner's fraud, the allegedly

defective orthopedic bone screws would not have reached the
market.”

Id.
After the approval process, and after the device has

reached the market, the causation element is that but for
defendant’s off label marketing, the medical device would not
have been used in the manner contrary to the FDA approved
labeling on the device.

In their concurrence, Justices Stevens

and Thomas noted that in Buckman, the “fact that the Food and
Drug Administration (FDA) has done nothing to remove the devices
from the market, even though it is aware of the basis for the
fraud allegations, convinces me that this essential element of
the claim cannot be proved.”

The concurring opinion was

concerned with the idea that a plaintiff should not “second
guess” the FDA, and concluded that if the FDA had determined
that fraud occurred during the approval process and required
removal of the product from the market, then “state damages
remedies would not encroach upon, but rather would supplement
and facilitate, the federal enforcement scheme.”
47

Thus, the underlying inquiry is whether allowing
plaintiff to assert a claim would impinge upon the authority of
the FDA to regulate medical devices.

In McDarby v. Merck & Co.,

Inc., 949 A.2d 223, 275 (N.J.Super.A.D. 2008), the New Jersey
appellate court concluded that the PLA’s provision excluding
claims for fraud “is designed to effectuate the State's interest
in punishing unlawful conduct.”

The court determined that “a

plaintiff bringing a product liability action acts in a fashion
akin to a private attorney general, since any damages awarded on
his punitive damage claim do not compensate him for his injury,
but instead vindicate societal interests.”
omitted).

Id. (citations

The court found a distinction between a plaintiff

seeking compensatory damages, and a plaintiff seeking punitive
damages in which the latter “is narrowly drawn upon a
defendant's act of knowingly withholding from or misrepresenting
to the FDA information material to the harm alleged.”

Id.

(“Although there are differences between the fraud-on-the-FDA
claim asserted in Buckman and McDarby's punitive damage claim
premised on the withholding of information regarding the
incidence of myocardial infarctions demonstrated by a metaanalysis, we find the single focus upon fraud on the FDA in each
to be sufficiently similar to warrant the application of Buckman
48

to this case.”).
Based on a review of the Supreme Court’s policy
suspending the presumption against preemption in fraud-on-theFDA claims, and the New Jersey courts’ interpretation of their
PLA statute regarding punitive claims as a vindication of
societal interests, it appears that plaintiff’s punitive damages
claim is impliedly preempted.

Whether Medtronic misrepresented

to the FDA its use of the Infuse device, or whether its off
label marketing actions rendered the FDA approved label a
nullity, the imposition of punitive damages would act as a
punishment against Medtronic.

Any punishment or policing of

Medtronic would fall within the purview of the FDA and encroach
upon “the federal statutory scheme [to] empower[] the FDA to
punish and deter fraud against the Administration... .”
531 U.S. at 348.

Buckman

In other words, the policing power of the FDA

does not stop after a device is approved, but rather the
relationship between the FDA and those subject to its
regulations continues so that any behavior contrary to what was
specifically approved by the FDA is subject to FDA authority.
Indeed, the PMA for the Infuse/LT-Cage device required Medtronic
to perform post-approval studies and provide post-approval
reports.

A punitive damages claim would permit plaintiff to
49

potentially encroach upon duties of the FDA and, therefore,
plaintiff’s punitive damages claim as to the Infuse device is
preempted.
With regard to the other devices, the Court will
permit plaintiff to amend her allegations so that it is clear
what allegations pertain to the other devices that would give
rise to malice or willful disregard in support of a punitive
damages claim, while deleting any allegations specific to the
Infuse/LT-Cage device.
IV.

CONCLUSION
Medtronic’s motion to dismiss shall be granted in part and

denied in part.

Count V (implied warranty), Count VI (design

defect), Count X (third party beneficiary), and Count XII (fraud)
will be dismissed.

Plaintiff’s request for punitive damages will be

denied as to any Medtronic device that received premarket approval.
Count VII (express warranty), and Count VI (manufacturing defect and
failure to warn) will be dismissed without prejudice and plaintiff
will be granted leave to file an amended complaint to provide a more
definite statement of her claims.
An appropriate order will be entered.
s/Noel L. Hillman
NOEL L. HILLMAN, U.S.D.J.

At Camden, New Jersey
Dated:

June 27, 2014
50