Franzese et al v. St. Jude Medical, Inc. et al

Filing 27

MEMORANDUM & ORDER granting 16 Motion to Dismiss for Failure to State a Claim; granting 17 Motion to Compel. For the foregoing reasons, Defendants' motions to dismiss and for judicial notice are both GRANTED. As Plaintiffs have already attempted to amend their Complaint, and such amendment being unsuccessful, the Court finds that further amendment would be futile. Accordingly, the Clerk of the Court is directed to mark this matter CLOSED. So Ordered by Judge Joanna Seybert on 6/23/2014. C/ECF (Valle, Christine)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
----------------------------------------X
GERARD FRANZESE and ROSEMARY
FRANZESE,
Plaintiffs,

MEMORANDUM & ORDER
13-CV-3203(JS)(WDW)

-againstST. JUDE MEDICAL, INC. and ST.
JUDGE MEDICAL S.C., INC.,
Defendants.
----------------------------------------X
APPEARANCES
For Plaintiffs:
Joseph G. Dell, Esq.
Dell & Dean, PLLC
1321 Franklin Avenue, Suite 100
Garden City, NY 11530
For Defendants:

Russell T. McHugh, Esq.
Lawrence, Worden, Rainis & Bard, P.C.
225 Broad Hollow Road, Suite 105E
Melville, NY 11747
Todd M. Malynn, Esq.
Feldman Gale PA
880 W First Street, Suite 315
Promenade West
Los Angeles, CA 90012

SEYBERT, District Judge:
Currently pending before the Court are: (1) defendants
St.

Jude

Medical,

Inc.

and

St.

Jude

Medical

S.C.,

Inc.

(together, “Defendants” or “St. Jude”) motion to dismiss the
Amended Complaint (Docket Entry 16), and (2) Defendants’ motion
to compel judicial notice (Docket Entry 17).
reasons, Defendants’ motions are GRANTED.

For the following

BACKGROUND1
On April 14, 2010, plaintiff Gerard Franzese received
surgery at St. Catherine of Siena Hospital on Long Island, New
York to implant a St. Jude implantable defibrillator (“ICD”)2.
(Am. Compl. ¶ 19; see also Dell Aff., Docket Entry 23, ¶ 3.)
During that procedure, a St. Jude representative was present and
directing the procedure.

(Am. Compl. ¶ 20.)

The ICD that Mr.

Franzese received was ICD Model Number CD3211-36Q; RV lead Model
Number 7121Q/65, which used a Durata SJ4 RV lead (7121Q/65).
(Am.

Compl.

assembled,

¶

19.)

tested,

Defendants

inspected,

designed,

produced,

manufactured,

marketed,

imported,

distributed, marketed and sold the defibrillator and the Durata
lead.

(Am. Compl. ¶ 12.)
Thereafter, the Durata lead wore away and prematurely

deteriorated.

(Am. Compl. ¶¶ 21-22.)

On October 17, 2011, Mr.

Franzese underwent a second ICD surgical procedure during which
the lead was discarded and replaced.
Aff. ¶ 8.)

(Am. Compl. ¶ 25; Dell

The second procedure was unsuccessful, thus causing

a third surgery on October 28, 2011.

(Am. Compl. ¶¶ 26-27.)

A

St. Jude representative informed Mr. Franzese that some of the
The following facts are taken from Plaintiffs’ Amended
Complaint and are presumed to be true for the purposes of this
Memorandum and Order.
1

“ICD’s are designed to be implanted near a patient’s heart,
monitor the heart rhythms and give life-saving electrical shocks
if necessary.” (Dell Aff. ¶ 6.)
2

2

St. Jude’s leads were defective, including the lead he received
on April 14, 2010.

(Am. Compl. ¶¶ 29-30.)

Mr. Franzese and his wife Rosemary Franzese (together
“Plaintiffs”) raise claims in the Amended Complaint for strict
liability,

negligence,

negligent

misrepresentation/failure

to

warn, breach of express and implied warranties, and loss of
consortium.
DISCUSSION
Defendants now seek to dismiss the Amended Complaint
arguing

that

Plaintiffs’

claims

are

preempted

Plaintiffs have otherwise failed to state a claim.

and

that

Defendants

also seek judicial notice of the Food and Drug Association’s
(“FDA”) pre-market approval of St. Jude’s Durata lead and St.
Jude’s implantable cardioverter defibrillator.

The Court will

first address the applicable legal standard before turning to
the substance of Defendants’ motions.
I. Legal Standard
In
Court

deciding

applies

a

Rule

12(b)(6)

“plausibility

“[t]wo working principles.”

motions

standard,”

to

which

dismiss,
is

guided

the
by

Ashcroft v. Iqbal, 556 U.S. 662,

678, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009); accord Harris v.
Mills, 572 F.3d 66, 71-72 (2d Cir. 2009).
Court

must

accept

“inapplicable

to

all

allegations

legal

as

conclusions;”
3

First, although the

true,

this

thus,

“tenet”

is

“[t]hreadbare

recitals of the elements of a cause of action, supported by mere
conclusory statements, do not suffice.”
accord Harris, 572 F.3d at 72.

Iqbal, 556 U.S. at 678;

Second, only complaints that

state a “plausible claim for relief” can survive a Rule 12(b)(6)
motion to dismiss.

Iqbal, 556 U.S. at 679.

Determining whether

a complaint does so is “a context-specific task that requires
the

reviewing

court

common sense.”

to

draw

on

its

judicial

experience

and

Id.; accord Harris, 572 F.3d at 72.

Furthermore, the Court is confined to “the allegations
contained within the four corners of [the] complaint.”

Pani v.

Empire Blue Cross Blue Shield, 152 F.3d 67, 71 (2d Cir. 1998).
This

has

attached

been
to

incorporated
which

the

interpreted
the

in

broadly

Complaint,

the

Complaint

any

Complaint
heavily

by

to

statements
reference,

relies,

judicial notice may be taken.

include

and

any
or

any

document
documents

document

anything

of

on

which

See Chambers v. Time Warner,

Inc., 282 F.3d 147, 152-53 (2d Cir. 2002) (citations omitted);
Kramer v. Time Warner Inc., 937 F.2d 767, 773 (2d Cir. 1991).
II. Analysis
A. Preemption Under the MDA
In

1976,

congress

enacted

the

Medical

Device

Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”),
giving the FDA the authority to regulate medical devices.
generally 21 U.S.C. § 360c et. seq.
4

See

The MDA creates three

levels of scrutiny, depending on the type of medical device,
before pre-market approval (“PMA”) can be obtained.

See Burkett

v. Smith & Nephew Gmbh, No. 12-CV-4895, 2014 WL 1315315, at *1
(E.D.N.Y. Mar. 31, 2014) (citing 21 U.S.C. § 360c(a)(1)).

So-

called “Class III” medical devices are subject to the highest
level of scrutiny.
device

is

a

“The PMA process for a Class III medical

‘rigorous’

process

that

typically

requires

submission of a multivolume application that includes reports of
safety

and

efficacy

studies,

an

explanation

of

the

device’s

components, and details regarding its manufacturing, packaging,
and installation.”

Id. (citing 21 U.S.C. § 360e; Riegel v.

Medtronic, Inc., 552 U.S. 312, 317-18, 128 S. Ct. 999, 1004, 169
L. Ed. 2d 892 (2008)).
Even after receiving PMA, the manufacturer must comply
with reporting and other obligations, including submission of an
application

for

supplemental

premarket

approval

to

make

any

changes in the design specifications, manufacturing processes,
or labeling of the medical device that would affect safety or
effectiveness of the device.
The

MDA

includes

Id.
an

express

preemption

provision,

which provides:
[N]o State or political subdivision of a
State may establish or continue in effect
with respect to [medical devices covered by
the MDA] any requirement--

5

(1) which is different from, or in addition
to, any requirement applicable under [the
MDA] to the device, and
(2)
which
relates
to
the
safety
or
effectiveness of the device or any other
matter included in a requirement applicable
to the device under this chapter.
21 U.S.C. § 360k(a).

The Supreme Court in Riegel shed some

additional light on the “different from, or in addition to”
language.

Riegel, 552 U.S. at 329-30, 128 S. Ct. at 1011.

Specifically, it held that “parallel” claims, are not preempted.
In other words, “[t]he Court observed that the MDA preemption
provision does not bar a state from providing a damages remedy
for claims premised on the violation of FDA regulations, because
‘the state duties in such a case parallel, rather than add to,
federal

requirements.’”

Burkett,

2014

WL

1315315,

(quoting Riegel, 552 U.S. at 330, 128 S. Ct. at 1011).

at

*2

Thus, to

successfully circumvent preemption, a plaintiff must allege a
claim based upon violation of an FDA regulation.
To

complicate

the

preemption

doctrine

further,

however, a plaintiff’s claim cannot be based solely on that
violation.

The FDA regulations themselves do not provide a

private cause of action.

See Buckman Co. v. Plaintiffs’ Legal

Comm., 531 U.S. 341, 348, 349 n.4, 121 S. Ct. 1012, 148 L. Ed.
2d 854 (2001).

Thus, “[t]o shoot this [narrow gap through which

a plaintiff’s state-law claim must fit to escape preemption],
the ‘plaintiff must be suing for conduct that violates [federal
6

law, or Section 360k(a) pre-empts the claim,] . . . but the
plaintiff

must

not

be

suing

because

the

conduct

violates’

federal law, because he has no private right to bring such a
claim.’”

Gale v. Smith & Nephew, Inc., --- F. Supp. 2d ----,

2013 WL 563403, at *3 (S.D.N.Y. Feb. 13, 2013) (quoting In re
Medtronic, Inc. v. Sprint Fidelis Leads Prods. Liab. Litig., 623
F.3d 1200, 1204 (8th Cir. 2010) (emphases and alterations in
original)).

“Stated

differently,

‘section

360k

protects

a

medical device manufacturer from liability to the extent that it
has complied with federal law, but it does not extend protection
from

liability

where

the

[state

violation of federal law.’”
Corp.,

630

F.3d

546,

552

tort]

claim

is

based

on

a

Id. (quoting Bausch v. Stryker
(7th

Cir.

2010)

(alteration

in

original)).
Finally, the plaintiff’s claim must otherwise satisfy
the general Iqbal/Twombly pleading standards, and “cannot simply
make the conclusory allegation that defendant’s conduct violated
FDA regulations.”

Simon v. Smith & Nephew, Inc., --- F. Supp.

2d ----, 2013 WL 6244525, at *4 (S.D.N.Y. Dec. 3, 2013).
Defendants argue that Plaintiffs’ claims are preempted
and fail to state a parallel claim because the Amended Complaint
does not identify the specific federal regulations violated or
how

they

Plaintiffs’

were

violated.

claims

are

Defendants

also

impliedly
7

further
preempted

argue

that

and

that

Plaintiffs have otherwise failed to state a claim for their
breach

of

warranty,

consortium

claims.

negligent
The

misrepresentation,

Court

will

address

and

each

loss
of

of

these

arguments in turn.
B. Judicial Notice
Before

the

Court

can

fully

address

preemption,

however, the Court also notes that Defendants have moved for
judicial notice of: (1) the FDA’s PMA of St. Jude’s Durata lead;
and (2) the FDA’s PMA of St. Jude’s implantable cardioverter
defibrillator.
Entry

17.)

letters.

(See
In

Defs.’

support,

(Defs.’

Br.

Br.

for

Judicial

Defendants

provide

for

Judicial

Notice,
the

Notice,

Docket

FDA’s
Exs.

PMA
1-2.)

Plaintiffs have not opposed this motion and the Court finds that
judicial notice is appropriate here.
A court may judicially notice a fact when the fact(s)
are “(1) generally known within the trial court’s territorial
jurisdiction; or (2) can be accurately and readily determined
from sources whose accuracy cannot reasonably be questioned.”
FED. R. EVID. 201(b).

Here, Defendants provide accurate documents

from the FDA reflecting PMA for the devices at issue.
notice of such facts is consistent with precedent.

Judicial
See, e.g.,

Gale, 2013 WL 563403, at *1 n.2; Desabio v. Howmedia Osteonics
Corp., 817 F. Supp. 2d 197, 201 n.3 (W.D.N.Y. 2011); (Defs.’ Br.
for Judicial Notice at 2-3 (collecting cases)).
8

Accordingly, Defendants’ motion for judicial notice is
GRANTED.
C. Preemption & Claims
The Court thus turns to each of Plaintiffs’ claims.
1. Strict Liability
Plaintiffs assert claims sounding in strict liability
for design defect, manufacturing defect, and failure to warn.
Specifically, they assert that
the
defibrillator
and
Durata
lead
in
question was defective in that, among other
things,
it
was
made
of
improper
and
defective
material;
it
was
improperly
designed; it was improperly manufactured; it
failed to have adequate and proper warnings
or instructions; it was not safe to be used
for the purposes intended; it was inherently
and/or
unreasonably
dangerous;
its
utilization violated FDA regulations; and it
caused severe injuries while being used and
the products were otherwise defective.
(Am. Compl. ¶ 50.)
a. Manufacturing Defect
Plaintiff alleges, among other things, that Defendants
violated 21 U.S.C. § 351(h) by making unsanctioned adulterations
to the Durata lead in violation of CGMPs and that the Durata
lead and/or defibrillator had an impurity, imperfection, and/or
other product defect.

(Am. Compl. ¶¶ 54, 74.)

They further

allege that Defendants violated 21 C.F.R. § 820.75 “by failing
to ensure that the process of manufacturing the Durata lead was

9

validated” and by failing to establish manufacturing procedures
for monitoring the Durata lead, failing to establish procedures
for control of process parameters, and failing to monitor the
flow of the machinery.

(Am. Compl. ¶¶ 56, 59-61.)

Under New York law, “[t]o plead and
prove a manufacturing flaw under either
negligence
or
strict
liability,
the
plaintiff must show that a specific product
unit was defective as a result of some
mishap in the manufacturing process itself,
improper workmanship, or because defective
materials were used in construction, and
that the defect was the cause of plaintiff’s
injury.”
Burkett, 2014 WL 1315315, at *4 (quoting Colon ex rel. Molina v.
BIC USA, Inc., 199 F. Supp. 2d 53, 85 (S.D.N.Y. 2001)).

Here,

similar

Nephew

Gmbh,

was

issued

to

Plaintiffs

the
use

case
an

of

FDA

Burkett
warning

v.

Smith

letter,

&

which

subsequent to Mr. Franzese’s operation, to argue “post[ ] PMA
violation of federal law,” and specifically, violation of the
CGMPs.

Certainly, the FDA warning letter, issued on January 10,

2013--almost three years after Mr. Franzese’s operation--cites
to various CGMP violations, including that the Durata lead was
adulterated because methods were not in conformity with CGMPs.
(See Dell Aff. ¶¶ 11-12 & Ex. D.)
However,

the

law

is

clear

that

Plaintiffs

identify a specific federal regulation allegedly violated.

must
See

Desabio, 817 F. Supp. 2d at 204 (“‘To properly allege parallel

10

claims,

the

complaint

must

set

forth

facts[]

pointing

to

specific PMA requirements that have been violated.’” (quoting
Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th
Cir.

2011)).

Here,

Plaintiffs

identity

the

CGMPs.

Courts

across the country are generally split on this issue.

Compare

Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 159 (S.D.N.Y.
2011)

(finding

that

manufacturing

defect

claims

premised

on

CGMPs were not preempted) with Illaraza v. Medtronnic, Inc., 677
F. Supp. 2d 582, 588 (E.D.N.Y. 2009) and Horowitz v. Stryker
Corp., 613 F. Supp. 2d 271, 283-84 (E.D.N.Y. 2009).

Moreover,

only the Sixth and Seventh Circuits have directly spoken on this
issue, both finding that allegations founded on violations of
CGMPs are sufficient to state a claim.

See Howard v. Sulzer

Orthopedics, 382 F. App’x 437 (6th Cir. 2010); Bausch v. Stryker
Corp., 630 F.3d 546 (7th Cir. 2010).

Despite this precedent,

though, the Eastern District of New York has generally held that
parallel claims may not be predicated on violation of CGMPs.
See Burkett, 2014 WL 1315315, at *5; Ilarraza, 677 F. Supp. 2d
at 588 (“The intentionally vague and open-ended nature of the
[CGMP] regulations relied upon is the precise reason why they
cannot serve as the basis for a parallel claim.”).

Contrary to

Plaintiffs’ argument that there has been a shift toward allowing
such

claims

(Dell

Aff.

¶

26),

Eastern

District

of

New

York

precedent--including Burkett, which was issued just a few months
11

ago and after the parties briefed the current motion--has held
that the CGMPs do not identify a federal law that is specific to
the medical device at issue, thus forming an insufficient basis
for a parallel claim.
(“Because

Burkett’s

See Burkett, 2014 WL 1315315, at *5

manufacturing

defect

claim

is

based

on

violation of generally applicable CGMPs, as opposed to federal
requirements

specific

to

the

R3

liner,

preemption

bars

the

claim.”).
Moreover, Plaintiffs do allege that the Durata lead
was adulterated in violation of Section 501(h) of the FDCA and
that

the

lead

and/or

defibrillator

imperfection, or other product defect.
Even

assuming

violation

of

sufficiently
injuries.

that

such

federal
alleged

Specifically,

“Defendants

violated

assert

regulations,
this
the

violation

law

adulterations” to the Durata lead.

impurity,

a

sufficient

Plaintiffs

Amended

federal

an

(Am. Compl. ¶¶ 54, 74.)

allegations

how

had

caused

Complaint
by

have

not

Plaintiffs’
alleges

making

that

unsanctioned

(Am. Compl. ¶ 54.)

However,

such assertions appear to be based on the FDA warning letter,
which

simply

stated

that

the

Durata

lead

was

considered

adulterated within the meaning of Section 501(h) because “the
methods used in, or the facilities or controls used for, their
manufacture,

packing,

conformity with CGMPs.

storage,

or

installation”

are

not

(Dell Aff. ¶ 12(1) & Ex. D.)
12

in
The

specific

CGMPs

implications

identified,

on

how

or

though,
why

do

the

not

any

lead

Durata

have

direct

prematurely

deteriorated.
Allegations regarding adulterations in particular can
sufficiently state a claim where the violation of CGMPs also
indicate

a

deviation

from

PMA

requirements.

In

Purcel

v.

Advanced Bionics Corp., No. 07-CV-1777, 2008 WL 3874713 (N.D.
Tex.

Aug.

13,

2008),

for

example,

the

plaintiffs

had

sufficiently alleged a non-preempted claim where they asserted
that the defendant, subsequent to PMA, changed its supplier,
altered the device’s mechanical configuration, and changed the
length, composition, and “firing” process for glass used in the
device.

2008 WL 3874713, at *1.

The result was that moisture

levels within the cochlear implants exceeded the maximums set
out by the FDA, causing the device to malfunction.

Id.; see

also Ilarraza, 677 F. Supp. 2d at 589 (citing as examples Purcel
and Rollins v. St. Jude Medical, 583 F. Supp. 2d 790 (W.D. La.
2008), in which “the plaintiff stated a parallel claim where he
was

able

packaging

to

point

to

requirements

the

alleged

applicable

violation
to

the

of

premarketing

particular

medical

device at issue”).
Contrary

to

cases

such

as

Purcel,

Plaintiffs

have

failed to connect a violation of the CGMPs with the violation of
any

federal

regulation

specific
13

to

the

devices

at

issue

or

explain

how

Formulaic

such

violations

recitation

is

Supp. 2d at 588-89.

caused

insufficient.

Mr.
See

Franzese’s
Ilarraza,

injury.
677

F.

This is true, even though courts have

recognized that PMA documents are often confidential, making it
difficult for a plaintiff to plead the exact violation.

See

Burgos v. Satiety, Inc., No. 10-CV-2680, 2011 WL 1327684, at *34 (E.D.N.Y. Apr. 5, 2011).

Nonetheless, alleging that a device

was

explaining

adulterated,

without

how

that

adulteration

contravened federal law specific to the device fails to state a
claim.

Gale, 2013 WL 563403, at *3.
Accordingly, Plaintiffs’ claim for strict liability-

manufacturing defect is preempted and otherwise fails to state a
claim.
b. Design Defect
Next, Plaintiffs allege a claim under strict liability
for design defect.
violated

various

They allege, inter alia, that Defendants

CGMPs

by

failing

to

establish

and

maintain

adequate procedures for verifying the design of the Durata lead;
failing

to

Durata

lead

validate
design

the

test

methods

verification

implemented

testing;

during

implementing

the
test

methods that did not follow a national standard; failing to
follow

established

test

procedures;

and

performing

design

verification of the Durata lead prior to it establishing design
inputs.

(Am. Compl. ¶¶ 62-69.)
14

“‘Under
actionable

under

New
a

York

strict

law,

‘a

products

product is not reasonably safe.’”

design

defect

liability

may

theory

if

be
the

Burkett, 2014 WL 1315315, at

*4 (quoting Denny v. Ford Motor Co., 87 N.Y.2d 248, 256-57, 639
N.Y.S.2d 250, 662 N.E.2d 730 (1995)); see also Bertini v. Smith
& Nephew, Inc., --- F. Supp. 2d ----, 2014 WL 1028950, at *5
(E.D.N.Y. Mar. 17, 2014) (listing the relevant factors as “the
product as designed posed a substantial likelihood of harm,” “it
was feasible to design the product in a safer manner,” and “the
defective design was a substantial factor in causing plaintiff’s
injury” (internal quotation marks and citation omitted)).

“‘[A]

defectively designed product is one which, at the time it leaves
the

seller’s

contemplated

hands,
by

the

is

in

a

ultimate

condition

consumer

and

dangerous for its intended use . . . .’”
1315315,

at

*4

(quoting

Robinson

v.

not
is

reasonably
unreasonably

Burkett, 2014 WL

Reed-Prentice

Div.

of

Package Mach. Co., 49 N.Y.2d 471, 479, 426 N.Y.S.2d 717, 403
N.E. 2d 400 (1980)).
Again, similar to the claims in Burkett, Plaintiffs
assert that Defendants failed to comply with federal law in
designing the Durata lead after its PMA approval.
Compl. ¶¶ 62-69.)

(See Am.

In Burkett, as here, Plaintiffs point to an

FDA warning letter relating primarily to manufacturing issues,
and have not alleged that Defendants strayed from the design
15

approved by the FDA.

See 2014 WL 1315315, at *4.

this claim is preempted.

Accordingly,

See Bertini, 2014 WL 1028950, at *6

(finding strict liability design defect claim preempted where
the plaintiffs did not allege that the design failed to meet the
FDA requirements, but rather that the device could have been
designed safer); Simon, 2013 WL 6244525, at *7 (“[D]esign defect
claims regarding a PMA-approved device are squarely preempted by
the MDA.”).
c. Failure to Warn
Next, Plaintiffs assert a claim for strict liability
based upon Defendants’ alleged failure to warn.

Specifically,

they assert that Defendants violated 21 U.S.C. § 352(t)(2) by
misbranding

the

Durata

lead

and/or

refusing

or

failing

to

furnish material or information and by failing to report to the
FDA no later than thirty days after receipt of information that
the Durata lead malfunctioned.
To

prevail

on

this

claim,

Plaintiffs

must

“‘demonstrate that (1) a manufacturer has a duty to warn (2)
against dangers resulting from foreseeable uses about which it
knew or should have known, and (3) that failure to do so was the
proximate cause of the harm.’”

Burkett, 2014 WL 1315315, at *6

(quoting State Farm Fire & Cas. Co. v. Nutone, Inc., 426 F.
App’x 8, 10 (2d Cir. 2011)).

Plaintiffs’ allegations cite to 21

U.S.C. § 352(t)(2), following the assertions in the FDA warning
16

letter, that the Durata lead was misbranded and that Defendants
failed to report to the FDA no later than 30 calendar days after
receipt of information that the Durata lead malfunctioned.
Compl. ¶¶ 70-71.)

The FDA warning letter was issued nearly

three years after Mr. Franzese’s initial surgery.
have

not

alleged

how

any

shortcomings

specifically

failed

to

Plaintiffs

identified

letter relate to the state of affairs in 2010.
have

(Am.

allege

in

a

2013

Thus, Plaintiffs

proximate

cause.

Accordingly, even if Plaintiffs’ claim for failure to warn is
not preempted, they have otherwise failed to state a claim in
this regard.
2. Breach of Warranty (Express and Implied)
Plaintiffs also assert claims for breach of express
warranty and breach of implied warranty.

They allege that Mr.

Franzese and his treating doctors relied on Defendants’ express
representations

set

forth

in

the

defibrillator

and

lead’s

packaging materials and on an implied warranty that the products
were

safe

addition,

and

merchantable.

they

assert

that

(Am.

Compl.

Defendants’

¶¶

102-04.)

In

representatives

made

personal representations to Mr. Franzese and/or his doctors that
the

devices

erode,

and

intervention.

were

safe,

would

not

long

lasting,

require

(Am. Compl. ¶¶ 108-09.)

17

any

would

not

prematurely

additional

surgical

“Under New York law, ‘[t]o state a claim for breach of
express warranty, the plaintiff must show that there was an
affirmation

of

fact

or

promise

by

the

seller,

the

natural

tendency of which [was] to induce the buyer to purchase, and
that the warranty was relied upon.’”

Burkett, 2014 WL 1315315,

at *8 (quoting Gelber, 788 F. Supp. 2d at 165 (alterations in
original)).

To state a claim for breach of implied warranty,

Plaintiffs must sufficiently allege “‘that the [product] was not
reasonably

fit

intended.’”

for

Id.

the

ordinary

(quoting

purpose

Horowitz,

613

for
F.

which

it

was

2d

at

284

rest

on

the

Supp.

(alteration in original)).
To

the

extent

packaging

materials,

preempted.

See id.

representatives

that

which

Plaintiffs’

were

approved

claims
by

the

FDA,

it

is

To the extent that Plaintiffs allege that

made

specific

representations

beyond

those

contained in the packaging materials, Plaintiffs fail to state a
claim.
providing

Plaintiffs make only a conclusory allegation without
any

factual

support

alleged representations.
(“Without

sufficient

for

the

context

of

any

such

See Horowitz, 613 F. Supp. 2d at 286

allegations

identifying

the

conduct

at

issue, plaintiff has failed to give the defendants notice of the
grounds of her claim.”).
Moreover, “Plaintiffs must show [Defendants’] product
‘was not minimally safe for its expected purpose’ to maintain
18

their

breach

of

implied

warranty

claim.”

Bertini,

2014

WL

1028950, at *11 (quoting Caronia v. Philip Morris USA, Inc., 715
F.3d

417,

434

plaintiffs

(2d

cannot

Cir.

2013)).

demand

that

However,

defendant

“[u]nder

design

the

the

MDA,

[medical

device] in a safer manner, when the FDA has already approved the
safety and effectiveness of defendant’s design.”
warning letter does not save this claim.

Id.

The FDA

Though the letter

identifies potential issues, it does not equate to a finding
that

the

devices

purpose.
letters

were

unsafe

or

unfit

for

their

ordinary

See Horowitz, 613 F. Supp. 2d at 284 (“The FDA warning
never

imply,

and

plaintiff

never

alleges,

that

defendants’ federal violations caused the Trident System to be
unfit in assisting patients in walking, which is the purpose for
which the Trident System was created.”).
3. Negligence
Plaintiffs also assert a claim for negligence.

(See

Am. Compl. ¶ 86 (“Defendants breached their duties in that they
failed

to

exercise

reasonable

care

in

the

design,

testing,

manufacture, packaging, labeling, warnings, quality assurance,
marketing,

p[o]st-market

monitoring

and/or

surveillance,

advertising, promotion, distribution and sale of the Plaintiff’s
implantable

defibrillator

and

Durata

lead.”);

Compl. ¶ 87.)
To state a claim for negligence,
19

see

also

Am.

a
plaintiff
must
show
“(1)
that
the
manufacturer
owed
plaintiff
a
duty
to
exercise reasonable care; (2) a breach of
that duty by failure to use reasonable care
so that a product is rendered defective,
i.e. reasonably certain to be dangerous; (3)
that the defect was the proximate cause of
the plaintiff’s injury; and (4) loss or
damage.”
Burkett, 2014 WL 1315315, at *7 (quoting Colon ex rel. Molina,
199 F. Supp. 2d at 82)).
To the extent that Plaintiffs base their negligence
claims on design defect, manufacturing defect, or failure to
warn, these claims are preempted or otherwise fail to state a
claim, and therefore Plaintiffs’ negligence claim fails for the
same reason.

See id.; Bertini, 2014 WL 1028950, at *10.

4. Negligent Misrepresentation
Plaintiffs allege negligent misrepresentation because
they assert that Defendants misbranded the Durata lead and/or
failed to furnish material or information respecting the device
as required, in violation of 21 U.S.C. § 352(t)(2).
¶ 94.)

(Am. Compl.

They further assert that “Defendants were negligent in

that they did not disclose manufacturing flaws to the FDA or
treating

doctors

although

said

manufacturing

flaws

increased

risk of injury to patients receiving the Promote Plus ICD and/or
the Durata lead.”

(Am. Compl. ¶ 95.)

Negligent misrepresentation claims are subject to the
heightened pleading standard set forth by Federal Rule of Civil
20

Procedure 9.

See Burkett, 2014 WL 1315315, at *7.

Accordingly,

Plaintiffs must allege “‘(1) what the omissions were (2) the
person responsible for the failure to disclose; (3) the context
of

the

omissions

plaintiff;
fraud.’”

and

and

(4)

the

what

manner

the

in

which

defendant

they

the

through

obtained

misled

the

Id. (quoting Woods v. Maytag Co., 807 F. Supp. 2d 112,

119 (E.D.N.Y. 2011)).
Plaintiffs have not done so here.
that

[Mr.

Franzese]

defibrillator]
physician[s]

does

actually

misrepresentations
proceed

with

not

[Mr.

and

purchased
show

the

that

relied
omissions

Franzese’s]

[Durata

[Mr.

on

“[T]he mere fact
lead

Franzese]

defendant[s’]

when

deciding

surgery.”

or

his

alleged

whether

Bertini,

and

2014

to
WL

1028950, at *10.
Accordingly, Plaintiffs have failed to state a claim
for negligent misrepresentation.
5. Loss of Consortium
Finally, Mrs. Franzese’s loss of consortium claim is a
derivative

claim,

Franzese’s claims.

which

does

not

exist

See id. at *12.

independently

of

Mr.

Given that his claims fail,

so must the loss of consortium claim as well.
CONCLUSION
For

the

foregoing

reasons,

Defendants’

dismiss and for judicial notice are both GRANTED.
21

motions

to

As Plaintiffs

have

already

amendment

attempted

being

to

amend

unsuccessful,

the

their
Court

Complaint,
finds

that

and

such

further

amendment would be futile.
Accordingly, the Clerk of the Court is directed to
mark this matter CLOSED.

SO ORDERED.

/s/ JOANNA SEYBERT______
Joanna Seybert, U.S.D.J.
Dated:

June
23 , 2014
Central Islip, NY

22