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

Filing 49

-CLERK TO FOLLOW UP- DECISION AND ORDER ADOPTING REPORT AND RECOMMENDATIONS ; adopting in part Report and Recommendations re 26 Report and Recommendation; finding as moot 41 Motion to Withdraw as Attorney ; finding as moot 46 Motion to Appoint Counsel. (Clerk to close case.) Copy of Decision and Order sent to Plaintiff by first class mail.) Signed by Hon. Michael A. Telesca on 6/30/16. (JMC)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NEW YORK

JOHN J. TEIXERIA,
Plaintiff,
DECISION AND ORDER
No. 1:14-cv-00789-MAT-HBS

-vsST. JUDE MEDICAL S.C., INC., ST
JUDE MEDICAL, INC., and
PACESETTER, INC., D/B/A ST. JUDE
MEDICAL CARDIAC RHYTHM MANAGEMENT
DIVISION,
Defendants.

INTRODUCTION
Represented

by

counsel,

John

J.

Teixeria

(“Teixeria”

“Plaintiff”) instituted this product liability action in New
State Supreme

or

York

Court (Erie County) against St. Jude Medical S.C.,

Inc., St. Jude Medical, Inc., and Pacesetter, Inc., d/b/a St. Jude
Medical

Cardiac

Rhythm

“Defendants” or “St. Jude”).

Management

Division

(collectively,

Defendants removed the matter to this

Court on September 17, 2014, and subsequently filed a Motion to
Dismiss or in the Alternative for Summary Judgment (Dkt #4), a
Motion to Dismiss for Failure to State a Claim (Dkt #16) (“Motion
to Dismiss”) and a Motion for Sanctions and to Strike Amended
Complaint (Dkt #18) (“Motion to Strike”).

On July 15, 2015,

Magistrate Judge Hugh B. Scott issued a Report and Recommendation
(“Report”) (Dkt #26) on the Motion to Dismiss and the Motion to
Strike. With regard to the Motion to Dismiss, Magistrate Judge

Scott recommended (1) allowing the first cause of action based on
strict

liability

for

a

manufacturing

defect

to

proceed;

(2) allowing the second cause of action for negligent manufacturing
to proceed; (3) dismissing the third and fourth causes of action
for failure-to-warn claims based on negligence and strict liability
in their entirety; (4) dismissing the fifth cause of action for
negligent representation based on St. Jude’s failure to provide
Plaintiff, his doctors, and the FDA with accurate information about
the reliability and safety of the Durata lead; (5) dismissing the
claim for breach of implied warranty asserted in the sixth cause of
action, to the extent that Teixeira alleges anything other than a
deviation from FDA standards that equates to a lack of fitness for
intended purposes; (6) dismissing the claim for breach of express
warranty asserted in the sixth cause of action, with respect to any
allegations

other

than

explicit,

personal

representations

by

St. Jude; and (7) denying the motion in all other respects.
Magistrate Judge Scott denied the Motion for Sanctions and to
Strike the Amended Complaint in its entirety, without prejudice to
future

motions

that

may

be

required

to

address

allegations

maintained despite pretrial discovery to the contrary. See Report,
pp. 35-36.
Defendants filed partial Objections (Dkt #27)

to the Report

and Recommendation, and Plaintiff filed a Reply/Response (Dkt #28)
to

Defendants’

objections,

to

-2-

which

Defendants

filed

a

Reply/Response

(Dkt

#30).

The

matter

was

transferred

to

the

undersigned on May 6, 2016 (Dkt #48).
FACTUAL BACKGROUND
The underlying facts are set out comprehensively in the
Report. Briefly, however, Teixeira had surgery on September 6,
2011, to place an implantable cardioverter-defibrillator (“ICD”)
(Durata Model CD1231-40Q) and lead (Durata Model 7121Q/65),1 which
were designed, manufactured, and sold by St. Jude.2 On September
20, 2011, Teixeria underwent a second surgery to replace the lead
for reasons not articulated in the Amended Complaint. Although the
Amended Complaint contains no allegations indicating that anyone
has

ever

examined

the

Durata

device

that

was

explanted

and

replaced, Plaintiff theorizes that the lead insulation became
abraded in situ and resulted in an “externalization” of the lead,

1

An ICD is implanted in patients to help treat certain heart conditions and
symptoms of heart failure. A lead is a thin, insulated wire that delivers
electronic pulses from the ICD to the heart. Premature lead abrasion is a known
and disclosed risk of harm. See Amended Complaint (“Am. Compl.”) ¶ 72; Viserta
v. St. Jude Med. Inc., C.A. No. 8:11–cv–00505–JMC, 2012 WL 667814, at *4 (D. S.C.
Feb. 29, 2012).
2

The Durata ICD and lead are categorized in the highest risk classification
level (Class III) under the 1976 Medical Device Act (“MDA”), which “imposed a
regime of detailed federal oversight” over medical devices. Riegel v. Medtronic,
Inc., 552 U.S. 312, 316-17 (2008); see also 21 U.S.C. § 360c(a)(1)(C)(ii). As a
Class III device, the Durata was required to undergo the FDA’s rigorous Premarket
Approval (“PMA”) process, which involves an extensive application, disclosure of
all investigations related to the device’s safety and effectiveness, disclosure
of all ingredients or device components, review of manufacturing processes and
facilities, submission of device samples, and submission of device labeling. See
21 U.S.C. § 360e(c)(1). The Durata’s completion of the PMA process means that the
FDA has approved the design, manufacturing method, and labeling of the ICD and
lead as appropriate and reasonably safe. The FDA continues to oversee Class III
devices after the grant of PMA. See 21 U.S.C. § 360i.

-3-

i.e., the lead wires began protruding through the insulation.
According to Plaintiff, this caused the wires to come into contact
with bodily substances that prevented the ICD from functioning
properly. Defendants argue that Plaintiff’s theory is based on
issues that occurred with a different model of lead, the Riata, a
predecessor to the Durata that differs from it in several respects.
Moreover, Defendants contend, when “externalization” has occurred,
it has been many months, if not years, after implantation of the
device. Therefore, Defendants argue, externalization could not have
happened here, since Plaintiff had his device replaced only 14 days
after

implantation.

Complaint,

Defendants

asserting

that

urge

Plaintiff

dismissal
has

of

failed

the
to

Amended

allege

a

violation of federal requirements specific to the Durata lead and
has failed to

plausibly allege a causal link between any alleged

violation of federal law and his purported injuries.
GENERAL LEGAL PRINCIPLES
I.

Review of Reports and Recommendations
Where no objection is made to a report and recommendation, or

the parties make frivolous, conclusive, or general objections, only
“clear error” review is required by the district court. See FED. R.
CIV. P. 72(b), Advisory Comm. Notes (1983); Camardo v. General
Motors Hourly–Rate Employees Pension Plan, 806 F. Supp. 380, 382
(W.D.N.Y. 1992)). In such case, the district court “need only
satisfy itself that there is no clear error on the face of the

-4-

record in order to accept the recommendation.” FED. R. CIV. P. 72(b),
Advisory Comm. Notes (1983).
However, a district court must review de novo those portions
of the magistrate judge’s findings and recommendations to which a
party has made specific and timely objections. See 28 U.S.C.
§ 636(b)(1)(C); FED. R. CIV. P. 72(b). The de novo standard requires
that the district court “‘give fresh consideration to those issues
to which specific objections have been made’” and “examine the
entire record,” and “mak[ing] an independent assessment of the
magistrate judge’s factual and legal conclusions.” United States v.
Raddatz, 447 U.S. 667, 675 (1980) (quoting legislative history).
After conducting the appropriate review, the district judge may
“accept, reject, or modify, in whole or in part, the findings or
recommendations

made

by

the

magistrate

judge.”

28

U.S.C.

§ 636(b)(1)(C).
II.

Rule 12(b)(6) Motions to Dismiss
When deciding motions to dismiss under Rule 12(b)(6), the

court must apply a “plausibility standard,” guided by “[t]wo
working principles.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
First, although the court must accept all factual allegations as
true, this tenet is “inapplicable to legal conclusions[.]” Id.
Second, only complaints that state a “plausible claim for relief”
can survive a Rule 12(b)(6) motion to dismiss. Id. at 679.

A

plaintiff must provide “factual content that allows the court to

-5-

draw the reasonable inference that the defendant is liable for the
misconduct alleged[,]” a standard that requires “more than a sheer
possibility that a defendant has acted unlawfully.” Id. at 678. If
the plaintiff has not “nudged [his] claims across the line from
conceivable to plausible,” they “must be dismissed.” Bell Atlantic
Corp. v. Twombly, 550 U.S. 544, 570 (2007); accord Iqbal, 556 U.S.
at 669.
DEFENDANTS’ MOTION TO DISMISS
I.

Review of the Portions of the Report to Which the Parties Have
Not Objected
Plaintiff

requests

that

indicates
the

Court

that

he

accept

agrees
in

with

full

the

the

Report

and

findings

and

recommendations therein. Thus, Plaintiff does not object to the
dismissal of the third (negligent failure to warn), fourth (failure
to warn under a theory of strict liability), and fifth (negligent
misrepresentation) causes of action. Defendants likewise do not
object to these portions of the Report. Because the Court finds
that the Report’s recommendations as to these causes of action are
not clearly erroneous, the Court adopts them and dismisses the
third, fourth, and fifth causes of action with prejudice.
II.

Review of Defendants’ Objections
In their Objections, Defendants discuss four issues that they

assert were

not

resolved

or

considered in the

Report, i.e.,

“(1) [w]hether Plaintiff has stated a claim for breach of express
warranty;

(2) whether

the FDA’s
-6-

2013

Warning

Letter

has

any

applicability

in

this

case;

(3)

whether

to

state

a

parallel[ ]claim3 under Twombly a plaintiff must plead facts based
on a device inspection or medical records that put the plaintiff
within the alleged zone of danger; and (4) whether Twombly requires
that any allegations made on ‘information or belief’ not be made
up,

but

rather,

be

supported

by

a

reasonable

and

plausible

inference from well-pled facts.” Objections (Dkt #27), p. 2. In his
Response, Plaintiff contends that he has provided well-pled factual
allegations, sufficient to substantiate plausible causes of action.
A.

First Objection: Whether Plaintiff Has Stated a NonPreempted Claim for Breach of Express Warranty

St. Jude agrees with the Report’s recommendation that the
breach of express warranty claim is preempted to the extent it is
based on St. Jude’s packaging and labeling, which were approved by
the FDA in the PMA process. St. Jude objects to the Report’s
recommended finding that the claim is not preempted to the extent

3

“The MDA’s pre-emption clause provides that no State ‘“may establish
or continue in effect with respect to a device . . . any requirement”’ relating
to safety or effectiveness that is different from, or in addition to, federal
requirements.”’” Altria Grp., Inc. v. Good, 555 U.S. 70, 86 (2008) (quoting
Riegel, 552 U.S. at 328 (quoting 21 U.S.C. § 360k(a)); emphasis deleted in
original; ellipsis in original). In Riegel, the Supreme Court held that state-law
design and manufacturing defect claims are preempted under the MDA where they
impose safety requirements on medical device manufacturers that are different
from, or in addition to federal requirements, but allowed a narrow exception for
state-law claims based on state-law duties that merely “‘parallel,’ rather than
add to, federal requirements.” 552 U.S. at 330 (dismissing as preempted state
common-law claims related to the safety and effectiveness of a medical device
approved by FDA where plaintiffs alleged that the device violated state tort law
notwithstanding compliance with the federal requirements, the state claims were
preempted).

-7-

that it is based on “explicit, personal representations,” Report,
p. 29, that were “volunteered,” id., by St. Jude, and in which
St. Jude “stepped outside,” id., of the FDA-approved labeling for
the Durata lead.
The Court agrees with St. Jude that the first rationale, i.e.,
that the representations were “volunteered,” is not a basis to deny
the

motion

to

dismiss

because,

whether

volunteered

by

the

manufacturer or required by law, claims based on written or oral
statements

whose

content

falls

within

the

parameters

of

FDA-approved labeling are expressly preempted under the MDA. See
Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 285 (E.D.N.Y. 2009)
(“Plaintiff’s breach of express warranty claim is preempted to the
extent that it is premised on FDA approved representations made by
the manufacturer.”) (citing Lake v. Kardjian, 874 N.Y.S.2d 751, 754
(Sup. Ct. 2008) (finding that “a breach of express warranty claim
based

upon

FDA

approved

statements

in

product

labeling

and

advertising is preempted . . . , because such a claim would impose
requirements

different

from,

or

in

addition

to,

the

federal

requirements, potentially resulting in the imposition of liability
on a manufacturer who has fully complied with federal law”)).
The Court turns next to the Report’s recommendation that
Plaintiff’s breach of express warranty claim should survive to the
extent it is based on “explicit, personal representations,” in
which St. Jude allegedly “stepped outside,” Report, p. 29, of the

-8-

FDA-approved labeling for the Durata lead. Under New York state
law, “representations which are the subject of breach of express
warranty claims are considered to be requirements imposed by the
warrantor, not by the state.” Horowitz, 613 F. Supp.2d at 285-86
(citing Wallace v. Parks Corp., 629 N.Y.S.2d 570, 574 (4th Dep’t
1995) (finding that liability under “[b]reach of express warranty
claims . . . arises . . . from a promise voluntarily made by the
manufacturer”) (citing Cipollone v. Liggett Group, Inc., 505 U.S.
504, 525 & n.23 (1992)). An express warranty is an “affirmation of
fact or promise made by the seller to the buyer which . . . becomes
part of the basis of the bargain.” N.Y. UNIFORM COMMERCIAL CODE
§ 2–313(1)(a). Thus, “an action for breach of express warranty
requires both the existence of an express promise or representation
and reliance on that promise or representation.” Horowitz, 613 F.
Supp.2d at 286 (citing CBS Inc. v. Ziff–Davis Publ’g Co., 75 N.Y.2d
496, 503 (1990)).
Defendants argue that Plaintiff has not specifically pled any
explicit, personal representation made by an agent or employee of
St. Jude, much less a representation the substance of which was not
approved by the FDA. After independently examining Plaintiff’s
allegations in the Amended Complaint regarding the representations
by St. Jude, contained in Paragraphs 169, 173, and 174, the Court
agrees, as discussed further below.

-9-

First, in Paragraph 169, Plaintiff alleges that St. Jude
expressly or impliedly warranted and represented to the
Plaintiff that the aforesaid defibrillator and Durata
lead were safe, proper, merchantable and fixable,
foreseeable [sic] and intended uses [sic] for which it
[sic] were designed, manufactured and assembled; were not
a danger to the user; would not be dangerous or present
a risk of injury; were free from defects, were reasonably
safe, were of merchantable quality and reasonably fit for
the purposes for which it was designed, manufactured,
assembled, inspected, tested, sold and purchased and
intended to be used.
. . .
Am. Compl. ¶ 169. These bare-bones allegations are too generic to
set forth a claim for breach of an express warranty. See, e.g.,
Fisher, 783 F. Supp.2d at 431-32 (dismissing breach of express
warranty where complaint merely stated that “[d]efendants expressly
warranted to [the plaintiff] and his physicians that the product
was of merchantable quality and safe for the use for which it was
intended”; stating that the “failure to allege any specific words,
promises or statements made by [the defendants] to [the plaintiff]
or his physicians that would create an express warranty is fatal to
the claim”).
Next, Plaintiff asserts that
[r]epresentatives
of
Defendants
made
personal
representations to Plaintiff and/or his treating medical
providers that the devices utilized on Plaintiff were
safe, long lasting, and would not prematurely erode.
Am. Compl. ¶ 173. While courts have held that “[a]ffirmations of
fact regarding the safety of a product are actionable on a claim
for breach of express warranty[,]” Williamson v. Stryker Corp.,
-10-

No. 12 CIV. 7083 CM, 2013 WL 3833081, at *9 (S.D.N.Y. July 23,
2013) (citations omitted),4 the plaintiff nevertheless “must allege
where, when or how the alleged promise or statement was provided to
[himself] or his physicians.” Fisher v. APP Pharm., LLC, 783 F.
Supp.2d 424, 431 (S.D.N.Y. 2011). Here, Plaintiff has not pleaded
any facts regarding where, when, and how the alleged statements and
promises

regarding

the

Durata

lead

were

made

to

him

or

his

physicians by a representative of St. Jude. See Gelber v. Stryker
Corp., 788 F. Supp.2d 145, 166 (S.D.N.Y. 2011) (complaint alleging
that manufacturers of artificial hip prosthesis represented that
prosthesis was safe and effective for its intended purpose, and
that manufacturers complied with manufacturing specifications set
forth in PMA application submitted to FDA, failed to state claim
for

breach

of

express

warranty

under

New

York

law,

absent

allegations of where alleged representations appeared or to whom
they were made); Cordova v. Smith & Nephew, Inc., No. 14-CV-351 JFB
ARL, 2014 WL 3749421, at *8 (E.D.N.Y. July 30, 2014) (finding that
complaint did not state a breach of warranty claim where plaintiff
alleged in a “wholly conclusory fashion” that defendant “breached
express warranties ‘regarding the performance of the [R3 Ceramic
System]’ including warranties ‘that it would be safe to use’, and

4

See, e.g., Rice v. Kawasaki Heavy Indus., Ltd., No. CV–07–4031(SJF)(ARL),
2008 WL 4646184, at *10 (E.D.N.Y. Oct. 17, 2008); Spiegel v. Saks 34th St., 252
N.Y.S.2d 852, 857–58 (N.Y. Sup. App. Term. 1964), aff’d, 272 N.Y.S.2d 972 (2d
Dept’ 1966).

-11-

that it

was

‘inspected and

accepted

in

accordance

with

this

defendant’s own and other recognized safety standards’”).
Finally, Plaintiff asserts that
[u]pon information and belief, Representatives of
Defendants made personal representations to Plaintiff
and/or his treating medical providers that the devices
utilized on Plaintiff would not require a surgical
intervention.
Am. Compl. ¶ 174. The Second Circuit has explained that the
Twombly/Iqbal plausibility standard “does not prevent a plaintiff
from “pleading facts alleged ‘upon information and belief’” where
the facts are peculiarly within the possession and control of the
defendant,” Arista Records, LLC v. Doe 3, 604 F.3d 110, 120
(2d Cir. 2010) (citation omitted), “or where the belief is based on
factual

information

that

makes

the

inference

of

culpability

plausible,” id. (citing Iqbal, 129 S. Ct. at 1949). However,
whether representations were made to Plaintiff or his medical
providers are factual matters that are peculiarly within the
possession of Plaintiff himself, or could be obtained by Plaintiff
simply asking his doctors or reviewing his own medical records. For
Plaintiff to make an allegation “on information and belief” in such
circumstances is an improper use of this pleading device.

This

speculative allegation does not assist Plaintiff in stating a claim
for breach of express warranty.
Finally, the Court must address the Report’s finding that
“Teixeira

will

have

to

conform

-12-

through

discovery

what

representations St. Jude explicitly made, but for now, explicit
personal representations from a manufacturer eager to sell a device
plausibly could have happened.” Report, p. 29 (emphasis supplied).
The Court respectfully must disagree with this recommendation,
given the clear statement by the Supreme Court in Iqbal that Rule 8
of the Federal Rules of Civil Procedure “does not unlock the doors
of discovery for a plaintiff[,]” such as Teixeria, “armed with
nothing more than conclusions.” 556 U.S. at 678-79.
Because the Court finds that Plaintiff has failed to plead,
under Twombly/Iqbal, a plausible claim for breach of express
warranty, it need not decide whether such a claim, if well-pled,
would be expressly or impliedly preempted by federal law. The claim
for breach of express warranty, asserted in the sixth cause of
action, is dismissed for failure to state a claim.
B.

Objections Two and Three: The Relevance of the FDA’s 2013
Warning Letter and the Lack of
Factual Allegations
Specific to Plaintiff’s Durata Device

St. Jude objects to Plaintiff’s reliance on the FDA’s 2013
Warning letter

and

argues

that

its

issuance

does

not

assist

Plaintiff in articulating plausible parallel, non-preempted claims
for

strict

liability,

negligent

manufacturing,

and

breach

of

implied warranty.
“To

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

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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.” Colon ex rel. Molina v. BIC
USA,

Inc.,

199

F.

Supp.2d

53,

85

(S.D.N.Y.

2001)

(emphasis

supplied; quoting Caprara v. Chrysler Corp., 52 N.Y.2d 114, 129
(1981)). “A breach of implied warranty claim requires proof . . .
(1) that the product was defectively designed or manufactured;
(2) that the defect existed when the manufacturer delivered it to
the purchaser or user; and (3) that the defect is the proximate
cause of the accident.” Plemmons v. Steelcase Inc., No. 04 CV
4023(LAP), 2007 WL 950137, at *3 (S.D.N.Y. Mar. 29, 2007) (internal
quotation marks and citation omitted; emphasis supplied). As the
Second Circuit has observed, “[t]here is . . . no older requirement
in

th[e]

area

[causative]

of

link

[tort]

law

between

than

the

the

need

defendant’s

to

show

actions

such
and

a

the

plaintiff’s loss.” Zuchowicz v. United States, 140 F.3d 381, 383
(2d

Cir.

1998).

In

the

context

of

product

liability

claims

involving FDA-regulated devices, showing a “causal connection is ‘a
critical

element’

of

a

properly

pled

parallel

claim

because

premarket approval does not mean that a medical device will never
result in injuries, only that the benefits outweighs the risks of
probable

injuries.”

Leonard

v.

Medtronic,

Inc.,

No. 1:10-CV-03787-JEC, 2011 WL 3652311, at *6 (N.D. Ga. Aug. 19,
2011) (quoting Franklin v. Medtronic, Inc., No. 09-CV-02301REBKMT,

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2010 WL 2543579, at *10 (D. Colo. May 12, 2010), report and
recommendation adopted, No. 09-CV-02301-REB-KMT, 2010 WL 2543570
(D. Colo. June 22, 2010); citing Reigel, 552 U.S. at 319).
With these general principles in mind, the Court evaluates
St. Jude’s objection regarding Plaintiff’s reliance on the Warning
Letter issued by the FDA in 2013, following an inspection of St.
Jude’s

production

facility

located

in

Sylmar,

California,

on

September 25, 2012, through October 17, 2012. The FDA’s inspection
revealed that the Durata devices manufactured at the facility “are
adulturated within the meaning of Section 501(h) of the [FDCA], 21
U.S.C. § 351(h), in that the methods used in, or the facilities or
controls

used

installation
manufacturing

for,
are

their

not

practice

in

manufacture,
conformity

[(“CGMP”)]

packing,

with

the

requirements

of

storage,
current
the

or
good

Quality

System regulation found at [21 C.F.R. Pt. 820]. . . .” Am. Compl.
¶ 15.

St. Jude argues, inter alia, the Amended Complaint does not

factually link the Warning Letter to the alleged defect, namely,
the supposed externalization of a conductor in Plaintiff’s lead,
given that the FDA inspection that led to the Warning Letter took
place more than two years after Plaintiff’s first surgery to
implant the Durata ICD and lead. Plaintiff has set forth no
allegations regarding how his Durata ICD and lead, implanted in
September 2011, could have been affected by FDA investigations that
occurred a year later. See Horowitz, 613 F. Supp.2d at 282-83

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(dismissing complaint where “Plaintiff provide[d] no explanation as
to how her Trident System, which was implanted in her body in 2005,
relates to investigations conducted by the FDA in 2006 and 2007.
Her complaint also fail[ed] to specify in which of defendants’
facilities her hip replacement device, or any components included
in the device, was manufactured, making it unclear which, if
either, of the two letters she [was] using to substantiate her
claims.”)

(citation

omitted).

The

Court

agrees

that

specific

allegations of a plausible causal connection between the 2013
Warning Letter and Plaintiff’s device are entirely lacking. See,
e.g., Franzese v. St. Jude Med., Inc., No. 13-CV-3203 JS WDW, 2014
WL 2863087 (E.D.N.Y. June 23, 2014).
In Franzese, the district court found that a plaintiff who had
been implanted with a Durata device failed to state a parallel
claim where he incorporated the same FDA Warning Letter relied on
by Teixeria, and urged the same theory of product defect, i.e.,
that the Durata lead suffered premature deterioration. See 2014 WL
2863087, at *5 (plaintiff alleged that Durata lead was adulterated
in violation of Section 501(h) of the FDCA and that the lead and/or
defibrillator had an impurity, imperfection, or other product
defect). The district court in Franzese found that “[e]ven assuming
that such allegations [based on the Warning Letter] assert a
sufficient violation of federal regulations,” the plaintiffs had
“not

sufficiently

alleged

how

this

-16-

violation

caused

[their]

injuries.” Franzese, 2014 WL 2863087, at *5. In Franzese, similar
to the present case, the plaintiff alleged that St. Jude “‘violated
federal law by making unsanctioned adulterations’ to the Durata
lead[,]’” but, as the district court noted, “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,

storage,

or

installation’ are not in conformity with CGMPs.” Id. The specific
CGMPs identified in the 2013 Warning Letter, however, “do not have
any direct implications on how or why the Durata lead prematurely
deteriorated.” Franzese, 2014 WL 2863087, at *5 (internal citations
to record omitted). As in Franzese, Plaintiff here has not alleged
any facts connecting the 2013 Warning Letter to his case; nor has
he attempted to articulate how or why the product defect he alleges
(externalization of the lead) could have been caused by any of the
regulatory violations cited in the Warning Letter.
Relatedly, St. Jude objects to the Report’s reference to
unspecified “red flags” regarding the Durata lead. The Amended
Complaint

contains

page

after

page

of

allegations

concerning

problems with the Riata lead, an earlier model of lead manufactured
by St. Jude, such as the fact that it was the subject of a Class I
Recall by the FDA in December 2011. However, the FDA has not
instituted a recall of the Durata lead, which has a different

-17-

design and structure than the Riata lead.5 Given these differences,
Plaintiff’s allegations regarding Riata leads are irrelevant and do
not assist Plaintiff in stating plausible parallel claims in
connection with the Durata lead. See, e.g., Horowitz, 613 F.
Supp.2d at 282 (finding that the plaintiff failed to “demonstrate
a cognizable link between the defendant’s federal violations and
plaintiff’s injury”; noting that “[a]lthough plaintiff cites to
recalls instituted by defendants [for other devices], such recalls
did not include the Trident System or any of its components” with
which she was implanted).
The Court further finds that Plaintiff’s reliance on Rosen v.
St.

Jude

Med.,

Inc.,

41

F.

Supp.3d

170

(N.D.N.Y.

2014),

is

misplaced. First, Rosen involved a different device manufactured by
St. Jude, a Riata lead. Second, unlike the Durata, the Riata lead
was the subject of a recall by the FDA. Third, the plaintiff in
Rosen pled specific facts regarding an inspection of his particular
device, namely, that his surgeon examined the lead after it was
removed, finding

that

it had

indeed

fractured,

and

that the

conductor coils had “externalized[,]” Rosen, 41 F. Supp.3d at 174.

5

St. Jude, in connection with the Motion to Strike, submitted a screenshot
from the FDA’s website showing the PMA of St. Jude’s Riata ST Optim leads, which
were created by placing a second, additional layer of insulation consisting of
Optim, a proprietary material, over the silicon lead body of the Riata ST leads.
Malynn Decl. ¶ 5 & Ex. 4. In 2008, the FDA approved St. Jude’s request to change
the tradename for the Riata ST Optim lead to Durata. Id. ¶ 6 (citing
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfPMA/pma.cfm (enter “P950022” in the PMA Number field and “1/10/2008” as both
the “from” and “to” dates in the Decision Date fields; execute “Search”) (last
visited June 29, 2016)).

-18-

Although Teixeria urges the same theory as the plaintiff in Rosen
regarding how and why his device malfunctioned, Teixeria does not
allege

any

facts

supporting

his

theory

that

externalization

actually occurred. The Amended Complaint contains no allegations
regarding an examination of Teixeria’s explanted Durata lead, no
allegations regarding statements or observations made by Teixeria’s
physicians, and no allegations referencing notes from Teixeria’s
medical records—which the Report acknowledges. See Report, p. 3
(“The record contains no allegation or other information about
where the replaced lead is and whether anyone has examined it.”).6
Moreover, Plaintiff’s theory of liability—that premature lead
abrasions resulted in externalization of the lead wires shortly
after implantation—is undermined by documentation he has submitted
in

connection

with

his

Amended

Complaint.

Where,

as

here,

a

plaintiff has “reli[ed] on the terms and effect of a document in
drafting the complaint,’” and that document is thus “‘integral to
the complaint,’” the court “may consider its contents even if it is
not formally incorporated by reference.” Broder v. Cablevision Sys.
Corp., 418

F.3d

187,

196

(2d

Cir. 2005)

(quotation

omitted;

6

For essentially the same reasons, the other two cases based on Riata
devices that Plaintiff cites are unhelpful to his argument. First, they involved
Riata leads, and second, the plaintiff in those cases pled facts regarding the
results of actual testing or examination of the explanted, defective leads. See
Waltenburg v. St. Jude Med, Inc., No. 3:13-CV-01106, 2014 WL 3586471, at * 1
(W.D. Ky. July 21, 2014) (complaint alleged externalization shown from diagnostic
testing of recalled Riata lead); O’Neil v. St. Jude Med., Inc., No. C13-0661,
2013 WL 6173803, at *1 (W.D. Wash. Nov. 22, 2013) (allegations that plaintiff’s
surgeon confirmed Riata lead was defective).

-19-

brackets in original). As noted above, the Durata has an additional
layer of insulation made of a proprietary material called OPTIM®.
Plaintiff has submitted a 2012 article published in the journal,
HeartRhythm, authored by Dr. Robert G. Hauser, who has performed
several studies on ICDs and leads manufactured by St. Jude. In that
article, Dr. Hauser acknowledged that “there are no reports in the
medical literature of inside-out abrasions involving St. Jude
Medical leads that employ Optim insulation.” Exhibit (“Ex.”) F,
p. 9 (Dkt #20-6), attached to Declaration of Joseph Manna, Esq.
(“Manna

Decl.”)

(Dkt

#20),

referenced

in

Am.

Compl.

¶

105.

Moreover, the results of this study indicate that externalization
of a Riata lead (which does not have the extra layer of OPTIM®
insulation), takes at least a year to occur. See Ex. F (Dkt #20-6),
p. 4 (“The average age of the 105 analyzed [Riata] leads was 62.1
± 18.6 months (range 15-108 months). . . .”) to Manna Decl.
(Dkt #20). These factors render Plaintiff’s claims concerning the
Durata even less plausible.
It bears noting that allegations which are “merely consistent
with” a plaintiff’s theory of liability are insufficient to meet
the “plausibility” standard. See Iqbal, 556 U.S. at 678
complaint

pleads

defendant’s

facts

liability,

that
it

are

‘stops

‘merely
short

(“Where a

consistent
of

the

line

with’

a

between

possibility and plausibility of ‘entitlement to relief.’” (quoting
Twombly, 550 U.S. at 557; brackets omitted in original). Based on

-20-

his own documentary submissions, Plaintiff’s theory of liability is
not even consistent with the facts he has alleged.
C.

Objection Four: Whether the Allegations Made “On
Information and Belief” Are Sufficiently Supported

St. Jude objects to the Report’s acceptance of Plaintiff’s
allegations that are made “on information and belief,” see Report,
pp. 31-33. According to St. Jude, Plaintiff has not properly used
this pleading device, and the Report ignored the principle that
allegations based “on information and belief” cannot be wholly
unsupported. Cf. Arista Records, LLC, 604 F.3d at 121 (rejecting
defendant’s assertion that complaint’s allegations were too vague
and conclusory to state a plausible claim where, “[t]o the extent
that

.

.

.

allegations

are

made

on

information

and

belief,

virtually all of them are supported by factual assertions in [the
attached] [e]xhibit”).
The Court notes that the allegations Plaintiff makes “on
information and belief” were also the subject of the Motion to
Strike, in which St. Jude argued that Plaintiff copied them, more
or less verbatim, from a case out of the District of Minnesota,
Pinsonneault

v.

St.

Jude

Med.,

Inc.,

No.

12-CV-1717

PJS/JSM

(D. Minn. June 24, 2014), which involved a Riata lead (not a Durata
lead). As Defendants noted in their Motion to Strike, Plaintiff’s
initial 4-page Complaint failed to identify which medical device
(the ICD or the lead) was allegedly defective and also failed to

-21-

identify the name of the device. However, a mere 21 days after
Defendants’ Motion to Dismiss was filed, Plaintiff filed a 44-page
Amended

Complaint

containing

numerous

allegations

that

are

identical, or nearly identical, to allegations in the Pinsonneault
complaint. See Declaration of Todd Malynn, Esq. (“Malynn Decl.”)
(Dkt #18-2), Ex. 2 (Pinsonneault complaint); Ex. 3 (comparison of
excerpts from Teixeria’s Amended Complaint and the Pinsonneault
complaint). For instance, a review of the paragraphs under the
heading, “Manufacturing Defects with Regard to Riata and Durata
Leads,” in Teixeria’s Amended Complaint reveals that counsel simply
inserted the word “Durata” into that heading and copied it into the
Amended Complaint; apparently the same cutting-and-pasting was done
with many of the paragraphs from the Pinsonneault complaint, either
without making any changes or just altering the verbiage slightly
in Teixeria’s Amended Complaint. In the representative sample set
forth below, the struck-through words and numerals were in the
Pinsonneault complant; the italicized words and numerals were added
in Teixeria’s Amended Complaint:

4767. From 2005-2010 St. Jude applied for over 27
several manufacturing or process changes to the Riata
Leads. and Durata lead family. The FDA approved these
changes in a PMA and multiple supplements. Upon
information and belief, Defendants St. Jude failed to
manufacture the Riata and Durata Leads consistent with
design specifications and/or these approved changes,
thereby creating a defective products.
. . .
5073. The breach of insulation and externalization of the
lead wires on the Riata and Durata Leads can cause the
-22-

Lleads to short, and to transmit incorrect information or
noise to the pacemaker/defibrillator thereby causing it
to produce unnecessary and very painful shocks of
electricity, or alternatively, to fail to communicate
with the pacemaker/defibrillator at which point the lifesaving therapies of the device are unavailable.
. . .
5274. Additionally, St. Jude applied and received
approval for multiple changes to the cure and
sterilization processes used in the manufacture of the
Riata and Durata Leads. Upon information and belief, St.
Jude, failed to comply with the approved methods and/or
specifications of curing and sterilization during the
manufacture of the Leads. Upon information and belief,
failure to follow the approved cure and sterilization
processes resulted in reduced tensile strength of the
silicone insulation.
75. 53. Finally, St. Jude applied and received approval
for numerous modifications to the welding and crimping
procedures in the manufacture of the Riata and Durata
Leads. Upon information and belief, the PMA and
Conditions of Approval required the application of a
controlled, uniform degree of force was required when
applying the crimp. Upon information and belief, failure
to crimp with a controlled, uniform, degree of force,
resulted in insecure crimps over, lead wire length
differences both longer and/or shorter than specification
for the length of the Lead.
. . .
Dkt #18-2, Ex. 3.
The factual similarities between Teixeria’s Amended Complaint
and the Pinsonneault complaint are striking and impossible to
ignore.7 Plaintiff’s attorney, however, denies copying allegations

7

Courts in this Circuit have dismissed complaints when presented with such
similarities. See Grimes v. Fremont Gen. Corp., 933 F. Supp.2d 584, 601 (S.D.N.Y.
2013) (“The fact that so many of Plaintiff’s factual allegations are copied from
pleadings in unrelated cases is an independent basis for the Court to dismiss
Plaintiffs’ Civil Rights Act claims.”) (citing Triano v. Town of Harrison, 895

-23-

from Pinsonneault, and states that his office was not aware either
of the complaint in that case or the decision granting summary
judgment to St. Jude. In Pinsonneault, the plaintiffs asserted
state-law

claims

of

strict

liability/manufacturing

defect,

negligent manufacturing, negligence per se, and negligence res ipsa
loquitur

based

on

St.

Jude’s

violation

of

alleged

federal

requirements with respect to insulation thickness, crimp force,8
curing,

and

lubricious

2879754, at *4, *8.

interface.

See

Pinsonneault,

2014

WL

The district court noted that if there were no

such federal requirements, then the state-law claims would be
preempted under the MDA because they would impose requirements “in
addition to” the requirements imposed on the device by virtue of
the PMA process. See Pinsonneault, 2014 WL 2879754, at *8. The
district court found that St. Jude had “come forward with evidence
that, standing alone, prove[d] by a preponderance of the evidence
that there are no federal requirements with respect to insulation
thickness, crimp force, curing, or lubricious interface.” Id. The

F. Supp.2d 526, 537 (S.D.N.Y. 2012) (dismissing municipal liability claim;
plaintiff’s allegations were “troubling,” because he had “copied [a] list of
‘systematic flaws’ in his Amended Complaint—which he claim[ed] support[ed] the
existence of a municipal custom of tolerating and covering up police abuse—almost
verbatim from the allegations made by another plaintiff” in a case in which the
Monell claim had survived a motion to dismiss); other citations omitted).
8

Here, Plaintiff alleges, inter alia, that “[u]pon information and belief,
failure to crimp with a controlled, uniform, degree of force, resulted in
insecure crimps, lead wire length differences both longer and/or shorter than
specification for the length of the Lead.” The plaintiff in Pinsonneault
similarly alleged that “[u]pon information and belief, failure to crimp with a
controlled, uniform, degree of force, resulted in insecure crimps over, the
length of the Lead[.]” See Dkt #18-2, Ex. 3.

-24-

plaintiff, however, failed to rebut that evidence. See 2014 WL
2879754, at *10 (“[T]here is no evidence of any requirement for a
controlled, uniform degree of force when crimping, plaintiffs’
claims that the leads were defective . . . .”); see also id. at *810.
Where, as here, the Court is evaluating the sufficiency of
“information and belief” allegations, its “task is to determine
whether-viewing all of the Amended Complaint’s factual allegations
in the light most favorable to Plaintiff-the pleadings made on
“information and belief” “‘raise a reasonable expectation that
discovery will reveal evidence’ proving . . . Plaintiff’s claim.”
Installed Bldg. Products, LLC v. Cottrell, No. 13-CV-1112-ASC,
2014 WL 3729369, at *4 (W.D.N.Y. July 25, 2014) (quoting Twombly,
550

U.S.

at

556

(“Asking

for

plausible

grounds

to

infer

an

agreement does not impose a probability requirement at the pleading
stage; it simply calls for enough fact to raise a reasonable
expectation

that

discovery

will

reveal

evidence

of

illegal

agreement.”)). Contrary to Plaintiff’s attorney’s suggestion, the
Court is not invoking collateral estoppel based on Pinsonneault.
However, the Court believes that the summary judgment decision in
that case drastically decreases the reasonableness of Teixeria’s
expectation that discovery will reveal evidence proving his claims.
The manufacturing standards for the Riata lead which the plaintiff
in Pinsonneault claimed were violated by St. Jude violated, were

-25-

found—after extensive discovery—to lack a factual basis in any
federal requirements. See Pinsonneault, 2014 WL 2879754, at *10
(“Plaintiffs allege that St. Jude failed to apply a ‘controlled,
uniform degree of force’ when crimping the lead wires, which
resulted in insecure crimps over the length of the leads. To
support their claim that the FDA imposed such a requirement,
plaintiffs offer a ‘crimp schedule’ which refers to crimp depth
‘[r]equirement[s].’ Plaintiffs cite no evidence that this document
is part of the PMA, however. . . . Plaintiffs’ claims could only be
viable, however, if the crimp had to be a particular depth. But
that is not the case; the crimp schedule allows for a range of
permissible
omitted).9
involved
asserting

depths.
Moreover,

a

Riata
the

.
it

lead,

same

.

.”)
bears

not

theory

a
of

(internal

citations

emphasizing
Durata

lead.

manufacturing

that
Yet

to

record

Pinsonneault
Plaintiff

defect

urged

is
in

Pinsonneault with regard to an entirely different model of lead,
the Durata.
Plaintiff’s attorney asserts that in performing research in
connection with the Amended Complaint, his “office found other
cases involving either the Durata or Riata leads that had not been

9

See also Pinsonneault, 2014 WL 2879754, at *8, *9-11 (finding that there
was no evidence that the FDA required the Riata leads be made with uniform
insulation thickness and no evidence of any federal requirements as to curing or
inclusion of a lubricious interface). Teixeria also has included allegations that
St. Jude failed to follow federal requirements regarding insulation thickness,
curing of the materials, and necessity of a lubricious interface.

-26-

dismissed[.]” Manna Decl. (Dkt #20) ¶ 11 (emphasis omitted). Again,
the Court questions why cases involving Riata leads are even
relevant to this inquiry. Nonetheless, the Court reviewed them and
found that they do not help Plaintiff’s cause. First, as noted,
Waltenburg v. St. Jude Med., Inc., No. 3:13-CV-01106-TBR, 2014 WL
3586471 (W.D. Ky. July 21, 2014), involved a Riata lead, not a
Durata lead. Plaintiff’s attorney asserts, without citation, that
the medical research cited in the Waltenburg complaint “indicated”
that the Durata lead “may suffer from the same complications that
plagued the . . . Riata lead, given their similarities in design.”
Manna Decl. ¶ 12. In the Waltenburg complaint (Dkt #20-3), the only
allegations

regarding

medical

research

bear

the

heading,

“Physicians Expose the Riata Lead Defects.” Dkt #20-3, ¶¶ 89-84,
p. 24 of 46 (emphasis supplied). The word “Durata” does not appear
in any of the paragraphs under that heading. Furthermore, the
medical research articles cited in the Waltenburg complaint studied
defects in the Riata and Riata ST leads—not the Durata leads. See
id.
Plaintiff also has submitted a copy of the complaint filed in
Robert and Margaret Loiseau v. St. Jude Medical, Inc., et al.,
No. 2:14-1391-JVS(ANx) (C.D. Cal. Feb. 24, 2014). Plaintiff states
that St. Jude did not file a Rule 11 motion for sanctions in that
case “despite several nearly identical paragraphs between” that
complaint and the Waltenburg complaint. See Manna Decl. ¶ 15.

-27-

Although the complaint in Loiseau purports to seek damages for
“injuries caused by manufacturing defects in the St. Jude Riata and
Durata family of cardiac defibrillator leads,” Mr. Loiseau only was
“implanted with a defective Rialta [sic] Lead and suffered a
related injury first discovered several years later when the device
failed and had to be surgically removed in April 2012.” Dkt. #20-3,
¶ 3. Thus, the Loiseau complaint adds nothing to the reasonableness
of Teixeria’s expectation that discovery will reveal evidence
proving his claims regarding the Durata lead.
Next, Plaintiff’s attorney has submitted voluminous exhibits
containing

“information

.

.

.

found

from

publicly

available

sources,” see Manna Decl. ¶ 12, that allegedly supports Plaintiff’s
theory of liability. However, again, the vast majority of these
documents relate to studies conducted on the Riata lead, not the
Durata lead. See Id. ¶¶ 13-40 & Exs. D-BB.

As an initial matter,

with regard to the exhibits Plaintiff submitted that include
regulatory notices and warning issued by the FDA, and news articles
regarding such notices and warnings, the Court notes that they have
been addressed in the portion of this Decision and Order discussing
Plaintiff’s failure to allege causation. Thus, they will not be
discussed again here. The remaining exhibits that mention the
Durata lead are as follows: Ex. H (Dkt #20-8), a copy of the
New York Times article dated August 16, 2012; Ex. I (Dkt #20-9), a
copy of a New York Times article, published on August 21, 2012; and

-28-

Ex. J (Dkt #20-10), an article from the New York Times dated
September 7, 2012. Turning first to Ex. H, the article merely
states that the FDA has “called for studies of other types of
leads, including a new model called the Durata.” See Ex. H,
Dkt. #20-8. This fact does not make Plaintiff’s claims plausible.
Although the FDA is actively monitoring the Durata lead,10 Plaintiff
has not alleged that the FDA has taken any corrective action with
regard to the Durata lead for any regulatory violation connected to
lead

abrasions

or

externalization,

the

defected

alleged

by

Plaintiff here. Next, Ex. I, references a study published by
Dr. Robert G. Hauser in EP Europace, an British cardiology journal,
“suggest[ing] that a proprietary material used by St. Jude to coat
wires that connect an implanted defibrillator to a patient’s heart
is breaking down prematurely and, in some cases, leading to failure
of the device.” Dkt. #20-9, p. 1. The article goes on to state that
Dr. Hauser “focused on reports that suggested an abrasion problem
with both the Durata and another model that also carries the newer
coating, the Riata ST Optim[,]” and “found 15 such reports for the
Riata ST Optim and 37 for the Durata[,]” in which “the abrasion had
occurred within four years of being implanted.” Id., p. 3. The
article later quotes a financial services analyst from CreditSuisse

10

See Ex. I (Dkt #20-9) to Manna Decl. (Dkt #20) (article dated August 21,
2012, noting that the FDA has “ordered St. Jude Medical to conduct additional
studies on both the older generation of leads, called the Riata, and the new
generation of Durata leads”).

-29-

who said that “Dr. Hauser’s most recent article didn’t provide any
conclusive evidence of flaws with the Durata lead” and failed to
uncover any “smoking guns[.]” Dkt #20-9, p. 4. The Court finds it
significant that Plaintiff has not provided a copy of this study by
Dr. Hauser or attempted to plead a theory of liability based on any
findings

from

this

study

by

Dr.

Hauser,

instead

relying

on

allegations from unrelated lawsuits involving an entirely different
model of St. Jude lead. Finally, Ex. J adds nothing to Plaintiff’s
argument, since it merely references in passing an unnamed study,
which the Court presumes is the Hauser study that was the subject
of Ex. I. In sum, like the rest of the exhibits submitted by
Plaintiff, these New York Times articles do not provide any factual
support so as to make his “information and belief” allegations
plausible. See, e.g., Williams v. Calderoni, No. 11–3020, 2012 WL
691832, at *7 (S.D.N.Y. Mar. 1, 2012) (finding pleadings based upon
information and belief insufficient where plaintiff pointed to no
information that would render his statements anything more than
speculative claims or conclusory assertions).

At most, these

articles intimate “a sheer possibility that [St. Jude] has acted
unlawfully.” Iqbal, 556 U.S. at 678. The pleadings, however, “must
contain something more than . . . a statement of facts that merely
creates a suspicion [of] a legally cognizable right of action.”
Twombly, 550 U.S. at 555 (quoting 5 Charles Alan Wright & Arthur R.
Miller, Federal Practice and Procedure § 1216 (3d ed. 2004)). To

-30-

paraphrase Judge Cardozo, “proof of [product liability] in the air,
so to speak, will not do.”

Palsgraf v. Long Island R. Co., 248

N.Y. 339, 341 (1928).
DEFENDANTS’ MOTION TO STRIKE AND FOR SANCTIONS
Because the Court is dismissing the Amended Complaint in its
entirety, the branch of the motion seeking to strike certain
allegations is moot.
The request for sanctions presents a closer question. Where,
as here, “a plaintiff sets out allegations on information and
belief, he is representing that he has a good-faith reason for
believing what he is saying, but acknowledging that his allegations
are ‘based on secondhand information that [he] believes to be
true.’” Pirelli Armstrong Tire Corp. Retiree Med. Benefits Trust v.
Walgreen Co., 631 F.3d 436, 442 (7th Cir. 2011) (quoting BLACK’S LAW
DICTIONARY 783 (7th ed. 1999)) (alteration in original; citations
omitted). The Court has its concerns about the good faith basis for
the “information and belief” pleadings, but it is mindful that
“[i]n determining whether a pleading lacked a good faith basis the
court must be mindful of the fine ‘line between zealous advocacy
and frivolous conduct.’” Knipe v. Skinner, 146 F.R.D. 58, 60
(N.D.N.Y. 1993) (quoting United States v. International Bhd. of
Teamsters, 948 F.2d 1338, 1343 (2d Cir. 1991)). “Only where it is
‘patently clear’ at the time of the signing that a claim has no
chance of success under existing law, and where no reasonable

-31-

argument can be advanced to modify existing law are sanctions
warranted.” Knipe, 146 F.R.D. at 60. The Court is only reviewing
this portion of the Report for clear error, since Defendants did
not lodge specific objections to it. Upon careful consideration,
the Court cannot find that the Report clearly erred in denying
sanctions without prejudice to renew after discovery. Since this
Decision and Order is terminating this case short of discovery, the
Court adopts the Report’s recommendation to dismiss the request for
sanctions, but with prejudice.
CONCLUSION
For the foregoing reasons, the Court adopts the Report and
Recommendation (Dkt #26) in part and rejects it in part. The Motion
to Dismiss for Failure to State a Claim (Dkt #16) is granted, and
the Amended Complaint (Dkt #8) is dismissed in its entirety. The
joint Motion for Sanctions and to Strike Amended Complaint (Dkt
#18) is dismissed; specifically, the Motion to Strike is dismissed
as moot, and the Motion for Sanctions is dismissed with prejudice.
The Clerk of the Court is directed to close this case.
SO ORDERED.
S/Michael A. Telesca
______________________________
HON. MICHAEL A. TELESCA
United States District Judge
Dated:

June 30, 2016
Rochester, New York.

-32-