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

Filing 26

REPORT AND RECOMMENDATIONS RE: 18 MOTION for Sanctions MOTION to Strike 8 Amended Complaint filed by St. Jude Medical S.C., Inc., Pacesetter, Inc., St. Jude Medical, Inc.; 4 MOTION to Dismiss Plaintif f's Complaint or in the Alternative for Summary Judgment filed by St. Jude Medical S.C., Inc., St. Jude Medical, Inc.; and 16 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM (Amended Complaint) filed by St. Jude Medical S.C., Inc., Pacesetter, Inc., St. Jude Medical, Inc.Objections due per 28 U.S.C. § 636(b) and Fed. R. Civ. P. 72. Signed by Hon. Hugh B. Scott on 3/3/2015. (GAI) Modified on 3/3/2015 to correct phrasing in line 13 of page 21 (GAI).

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NEW YORK

JOHN J. TEIXERIA,
Plaintiff,
REPORT AND
RECOMMENDATION
v.
14-CV-789A
ST. JUDE MEDICAL, INC.,
ST. JUDE MEDICAL S.C., INC., and
PACESETTER, INC. d/b/a St. Jude
Medical Cardiac Rhythm Management
Division,
Defendants.

I.

INTRODUCTION
The Hon. Richard J. Arcara referred this case to this Court under 28 U.S.C.

§ 636. (Dkt. No. 6.) Pending before the Court are two motions by defendants St.
Jude Medical, Inc., St. Jude Medical S.C., Inc., and Pacesetter, Inc. (“St. Jude”
collectively). St. Jude has moved (Dkt. Nos. 4, 16) to dismiss the amended
complaint of plaintiff John Teixeira (“Teixeria”) under Rule 12(b)(6) of the Federal
Rules of Civil Procedure (“FRCP”). St. Jude argues that Teixeira’s claims
regarding his implantable defibrillator and heart lead are preempted by
regulations administered by the U.S. Food and Drug Administration (“FDA”). To
the extent that any of Teixeira’s claims would survive preemption, they would fail
to establish enough of a connection between any alleged regulatory violations by

St. Jude and the injuries that Teixeira suffered. Teixeira opposes this motion by
arguing that he has demonstrated how the regulatory violations led to a defective
device and by arguing that his state-law claims are only parallel to any federal
regulations in question.
Additionally, St. Jude has filed a motion (Dkt. No. 18) to strike a number of
paragraphs from the amended complaint, under Rules 11(b)(3) and 12(f). St.
Jude originally included with this motion a request to impose sanctions on
Teixeira and his counsel for making factual contentions that St. Jude considered
baseless. In its reply papers (Dkt. No. 24), St. Jude withdrew the request for
sanctions but still asked to strike portions of the amended complaint that allegedly
copied complaints from other cases that rejected those same allegations as
unsubstantiated. Teixeira opposes this motion by denying that he copied any
language from any other complaint and by asserting that the allegations in the
amended complaint reflect original research about the history of the defibrillator
and heart lead in question.
The Court has deemed the motions submitted on papers under FRCP
78(b). For the reasons below, the Court respectfully recommends granting the
motion to dismiss in part and denying the motion to strike in its entirety.1
1

Motions to strike material that does not directly foreclose any claims or
defenses generally are non-dispositive, but the reasons to strike here parallel the
reasons to dismiss. Out of caution, the Court will use the Report and
Recommendation format to address both motions. Cf., e.g., Zhao v. Kaleida
Health, No. 04-CV-467, 2008 WL 346205, at *1 n.1 (W.D.N.Y. Feb. 7, 2008).
2

II.

BACKGROUND
This diversity case concerns an implantable cardiac defibrillator whose

heart wire, or lead, had to be replaced just 14 days after implantation. On
September 6, 2011, doctors implanted in Teixeira a defibrillator equipped with a
particular lead called the Durata, Model No. 7121Q/65. On September 20, 2011,
doctors operated on Teixeira again to replace the lead. The record contains no
allegations or other information about where the replaced lead is and whether
anyone has examined it.
St. Jude designed and manufactured the Durata lead and has a history of
making products like it. Briefly, heart leads of any kind run from a defibrillator
planted in the chest wall into the heart itself. The lead sends information to the
defibrillator about irregular heart rhythms. The defibrillator, when needed,
delivers electrical shocks to the heart through the lead. Among other features,
the wires making up the lead are coated with insulation to prevent bodily fluids
from short-circuiting the defibrillator or otherwise disrupting communication
between the lead and the defibrillator. In 2002, St. Jude received FDA approval
to market a predecessor to the Durata lead called the Riata lead. Over the next
few years, St. Jude received FDA approval for modifications to the Riata design
that led to new models and a new line of models called Riata ST. St. Jude later
developed a new material, trademarked Optim, to use as insulation for leads
within the Riata ST family. According to FDA databases, St. Jude initially called
3

leads with the new material the Riata STS Optim leads. On January 10, 2008,
the FDA approved a change in the trade name for this newest lead, from Riata
STS Optim to Durata.
Medical devices such as the Durata lead are subject to significant oversight
from the FDA, by way of the Medical Device Amendments of 1976 (“MDA”), Pub.
L. 94-295, 90 Stat. 539 (1976) (codified as amended at 21 U.S.C. §§ 351–360fff7). The MDA creates three classes of medical devices. 21 U.S.C. § 360c. The
FDA has classified the Durata lead as a Class III device, which means, inter alia,
that it “is to be subject, in accordance with section 360e of this title, to premarket
approval to provide reasonable assurance of its safety and effectiveness.” 21
U.S.C. § 360c(a)(1)(C). “Premarket approval is a rigorous process. A
manufacturer must submit what is typically a multivolume application. It includes,
among other things, full reports of all studies and investigations of the device’s
safety and effectiveness that have been published or should reasonably be
known to the applicant; a full statement of the device’s components, ingredients,
and properties and of the principle or principles of operation; 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
or device components required by the FDA; and a specimen of the proposed
labeling. Before deciding whether to approve the application, the agency may
refer it to a panel of outside experts and may request additional data from the
4

manufacturer.” Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18 (2008) (internal
quotation marks and citations omitted). “FDA further assures the safety and
effectiveness of medical devices by regulating their manufacture. To make sure
that drugs and medical devices are manufactured to the same high standards
that are required for their approval, FDA has developed a set of regulations called
the current Good Manufacturing Practices (GMPs). The ultimate purposes of the
GMPs is enforcement of quality standards. The GMPs contain systems-oriented
requirements for quality control and compliance, which serve the FDA’s
enforcement purposes and give operational ‘guidance’ to FDA-regulated firms.
They govern personnel and organization, facilities and sanitation, equipment,
component control, production and process controls, control of packaging and
labeling materials, distribution and installation of devices, and records.” Charles
S. Zimmerman, 1 Pharm. & Med. Device Litig. § 1:20 (Westlaw 2015).
According to Teixeira’s amended complaint, filed on October 15, 2014, St.
Jude’s Riata leads ran afoul of FDA oversight in ways that raise questions about
their Durata leads. In 2012, the FDA inspected one of St. Jude’s manufacturing
facilities and issued warnings about noncompliance with GMPs that mentioned
the Durata lead by name. (See Dkt. No. 8 at 5.) The warnings prompted media
coverage in late 2012 that raised questions about the Durata lead and about the
Optim insulation. The FDA followed up its warnings with a formal warning letter
to St. Jude in early 2013. In the warning letter, the FDA accused St. Jude of
5

producing adulterated devices by way of manufacturing violations pertaining to
product testing, verifying device design, maintaining design history files,
implementing corrective and preventive actions, and misbranding the Durata
lead. (See id. at 5–10.) This warning letter came a little over a year after the
FDA initiated a recall, on November 28, 2011, of Riata and Riata ST leads. The
recall occurred out of concern that insulation on the Riata and Riata ST leads
would fail and expose the underlying wiring. From here, Teixeira asserts upon
information and belief several factors that led to defective Durata leads. These
factors include: lack of consistent insulation diameters as required by federal
regulations; lack of consistency in the application, preparation, and manufacturing
of wire insulation; failure to follow approved processes for curing and sterilization
of insulation; failure to crimp the leads as required by federal regulations;
inadequate product inspections and calibrations; and inadequate training of
personnel. (See generally id. at 19–26.) Teixeira includes in his amended
complaint a particular theory of how St. Jude’s alleged manufacturing defects and
regulatory violations manifested themselves in a lead that had to be replaced
after 14 days:
A natural process of abrasion occurs in situ with the insulation
surrounding the lead wires or electrical conductors. It is foreseeable
that such abrasion will occur with the insulation surrounding the lead
wires and the bad wires after implantation. As a result, the lead
wires protrude through the insulation, causing them to be in contact
with materials and fluids that can prevent the proper functioning of
the ICD [the defibrillator]. This protrusion is called “externalization.”
6

The breach of insulation and externalization of the lead wires
on the Riata and Durata Leads can cause the leads 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 life-saving therapies of the
device are unavailable.
(Id. at 21 ¶¶ 72–73.)
Teixeira’s amended complaint contains six formal claims for relief. In the
first claim, Teixeira accuses St. Jude of violating numerous particular regulations
and thereby incurring strict liability for a manufacturing defect. In the second
claim, Teixeira accuses St. Jude of negligence in manufacturing by violating its
duty to manufacture the Durata lead in conformance with federal regulations. In
the third and fourth claims, Teixeira asserts negligence and strict-liability theories
of a failure to warn, alleging that St. Jude failed to warn him and his doctors that
his lead was associated with adverse events and was unsuitable for use. In the
fifth claim, Teixeira accuses St. Jude of negligent representation by failing to
provide him, his doctors, and the FDA with accurate information about the
reliability and safety of the Durata lead. Finally, in the sixth claim, Teixeira
accuses St. Jude of breaching express and implied warranties by disseminating
information that the Durata lead was safe for foreseeable and intended uses for
which it was designed, manufactured, and assembled. The sixth claim includes
assertions that representatives of St. Jude made personal representations to

7

Teixeira and/or his doctors that the Durata lead was safe and long-lasting, that it
would not prematurely erode, and that it would not require a surgical intervention.
St. Jude seeks dismissal of the amended complaint for two reasons. First,
St. Jude asserts that Teixeira’s claims are expressly and implicitly preempted.
Specifically, St. Jude argues that the FDA already has approved its design,
manufacturing, and labeling processes. According to St. Jude, most of Teixeira’s
allegations come too close to questioning those processes in themselves, which
means that they improperly would add requirements beyond those in the federal
regulations. To the extent that any of Teixeira’s claims or allegations survive
preemption, St. Jude argues that they do not connect any alleged regulatory
violations to his injuries. In an effort to avoid preemption, Teixeira attempts to link
his allegations of design and manufacturing defects to specific federal
regulations. Citing the regulations, though, requires Teixeira to bridge the gap
between administrative violations in themselves and actual harm to patients like
himself. St. Jude argues that Teixeira has failed to bridge that gap and has only
cribbed language from other complaints that does not address his situation.
Teixeira opposes the motion by citing the specific manufacturing problems that he
stated in his amended complaint and noting how those manufacturing problems
each violated federal regulations. Teixeira also notes his theory of how the
alleged manufacturing defects translated into a particular form of product failure
that caused his injuries. Because Teixeira has linked his allegations of
8

manufacturing defects to specific federal regulations, he asserts that he is not
adding to those regulations and thus does not face preemption.
St. Jude also seeks to strike a number of paragraphs and allegations from
the amended complaint. Principally, St. Jude argues that the allegations about
federal regulations requiring certain manufacturing specifications are plainly false
and copied from another case, Pinsonneault v. St. Jude Med., Inc., No.
12-CV-1717 PJS/JSM, from the District of Minnesota. St. Jude asserts that
Pinsonneault is the case “where the false allegations originated and were
thereafter adjudicated as having no merit.” (Dkt. No. 24 at 8.) St. Jude also
insists that Teixeira is confusing the Riata and Durata leads. St. Jude concludes
that striking the allegations is necessary to protect it from having to defend itself
repeatedly against copied allegations that are fabricated. Teixeira opposes this
motion by denying any knowledge of Pinsonneault when he filed the amended
complaint and by denying that he copied any language from any other case.
Teixeira then asserts that the Durata lead derived from the Riata lead and is not a
completely new device. Finally, Teixeira argues that he has conducted significant
original research showing that the FDA, media outlets, and medical professionals
all have raised questions about both the Durata and Riata leads, meaning that
allegations about each product necessarily will have some features in common.

9

III.

DISCUSSION—MOTION TO DISMISS
A.

Motions to Dismiss Generally

“To survive a motion to dismiss, a complaint must contain sufficient factual
matter, accepted as true, to state a claim to relief that is plausible on its face. A
claim has facial plausibility when the plaintiff pleads factual content that allows
the court to draw the reasonable inference that the defendant is liable for the
misconduct alleged. The plausibility standard is not akin to a probability
requirement, but it asks for more than a sheer possibility that a defendant has
acted unlawfully. Where a complaint pleads facts that are merely consistent with
a defendant’s liability, it stops short of the line between possibility and plausibility
of entitlement to relief.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal
quotation marks and citations omitted). Court assess Rule 12(b)(6) motions
“accepting all factual allegations in the complaint as true, and drawing all
reasonable inferences in the plaintiff’s favor.” Peter F. Gaito Architecture, LLC v.
Simone Dev. Corp., 602 F.3d 57, 61 (2d Cir. 2010) (internal quotation marks and
citation omitted). “On a motion to dismiss, the court may consider any written
instrument attached to the complaint as an exhibit or any statements or
documents incorporated in it by reference.” Yak v. Bank Brussels Lambert, 252
F.3d 127, 130 (2d Cir. 2001) (editorial and internal quotation marks and citation
omitted). “Simply stated, the question under Rule 12(b)(6) is whether the facts
supporting the claims, if established, create legally cognizable theories of
10

recovery.” Cole-Hoover v. Shinseki, No. 10-CV-669, 2011 WL 1793256, at *3
(W.D.N.Y. May 9, 2011) (Arcara, J.) (internal quotation marks and citation
omitted).
B.

General Principles of Medical Device Preemption

With exceptions not relevant here, “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.” 21 U.S.C. § 360k(a).
“In [Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)], five Justices concluded that
common-law causes of action for negligence and strict liability do impose
‘requirement[s]’ and would be pre-empted by federal requirements specific to a
medical device. We adhere to that view. In interpreting two other statutes we
have likewise held that a provision pre-empting state ‘requirements’ pre-empted
common-law duties.” Riegel, 552 U.S. at 323–24 (alteration in the original)
(citations omitted). That said, “State requirements are pre-empted under the
MDA only to the extent that they are ‘different from, or in addition to’ the
requirements imposed by federal law. Thus, § 360k does not prevent a State
from providing a damages remedy for claims premised on a violation of FDA

11

regulations; the state duties in such a case ‘parallel,’ rather than add to, federal
requirements.” Id. at 330 (citations omitted).
“Since Riegel, courts have found that to plead a parallel state law claim, the
plaintiff must allege that the defendant violated a particular federal specification
referring to the device at issue. However, a plaintiff may not sue simply because
the conduct violates federal law, since there is no private right of action. In other
words, 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 tort claim is based on a violation of federal law.” Rosen v.
St. Jude Med., Inc., No. 1:13-CV-1159 LEK/CFH, 2014 WL 4257863, at *5
(N.D.N.Y. Aug. 28, 2014) (editorial and internal quotation marks and citations
omitted).
Preemption also may occur implicitly. “Congress’ intent to preempt state
law in a given field may be stated expressly in a statute, or may be expressed
implicitly by the enactment of a scheme of federal regulation so pervasive as to
make reasonable the inference that Congress left no room for the States to
supplement it. Implied preemption also occurs when compliance with both
federal and state regulations is an impossibility.” Lamontagne v. E.I. Du Pont de
Nemours & Co., 834 F. Supp. 576, 580–81 (D. Conn. 1993) (internal quotation
marks and citations omitted).

12

C.

Strict Liability for a Manufacturing Defect

Having covered the general principles for dismissal and preemption, the
Court now turns to Teixeira’s first claim for strict liability for a manufacturing
defect. A review of New York law will help determine both plausibility and overlap
with federal regulatory requirements. “Manufacturers of defective products may
be held strictly liable for injury caused by their products—meaning that they may
be liable regardless of privity, foreseeability or reasonable care. A product may
be defective because of a mistake in the manufacturing process, because of
defective design or because of inadequate warnings regarding use of the
product.” Sprung v. MTR Ravensburg Inc., 788 N.E.2d 620, 622 (N.Y. 2003)
(citations omitted). Plaintiffs in New York must fulfill three criteria to establish
strict liability against a manufacturer: “(1) that at the time of the occurrence the
product is being used (whether by the person injured of damaged or by a third
person) for the purpose and in the manner normally intended, (2) that if the
person injured or damaged is himself the user of the product he would not by the
exercise of reasonable care have both discovered the defect and perceived its
danger, and (3) that by the exercise of reasonable care the person injured or
damaged would not otherwise have averted his injury or damages.” Codling v.
Paglia, 298 N.E.2d 622, 628–29 (N.Y. 1973).
Here, several factors weigh against dismissal. With respect to plausibility,
the parties do not appear to dispute that Teixeira had a defibrillator with the
13

Durata lead installed on September 6, 2011. The parties also do not appear to
dispute that Teixeira had his Durata lead replaced on September 20, 2011.
Subject to discovery, Teixeira has formed a preliminary theory as to how a heart
lead fails in just 14 days. Teixeira has asserted that federal regulations required
certain manufacturing standards and processes, that St. Jude violated those
regulations, and that the violations in themselves led to a substandard product.
St. Jude objects strenuously to the allegations of federal regulations that have not
yet been specified, and the Court will discuss that issue more below. Also, St.
Jude almost certainly has its own theories about what happened that have
nothing to do with manufacturing, but alternative theories do not detract from the
idea that problems with uncontrolled manufacturing plausibly could happen. “The
choice between two plausible inferences that may be drawn from factual
allegations is not a choice to be made by the court on a Rule 12(b)(6) motion . . . .
A court ruling on such a motion may not properly dismiss a complaint that states
a plausible version of the events merely because the court finds a different
version more plausible.” Anderson News, L.L.C. v. Am. Media, Inc., 680 F.3d
162, 185 (2d Cir. 2012) (citation omitted).
Teixeira’s claim also survives express and implied preemption because his
theory of liability stemming from federal regulatory violations does not add to St.
Jude’s responsibilities. New York’s standard for strict liability in itself removes
privity, foreseeability, and reasonable care from consideration, thus eliminating
14

three common sources of additional duties and requirements that would deviate
from federal requirements. The extensive PMA process would have supplied the
intended purpose and manner for the defibrillator. Cf. McConologue v. Smith &
Nephew, Inc., 8 F. Supp. 3d 93, 109 (D. Conn. 2014) (“[Plaintiff] alleges a
products liability claim predicated on a manufacturing defect, asserting only that
the [product] was manufactured contrary to its federally approved design
specifications, thereby making it unreasonably dangerous.”). Teixeira has been
careful in his amended complaint not to stray from federal standards when
alleging, as noted above, that St. Jude did not monitor its FDA-required
manufacturing process and that St. Jude subsequently violated federal
regulations by using a substandard process. St. Jude might raise affirmative
defenses questioning Teixeira’s health and how he cared for his defibrillator, but
any debate about Teixeira’s duty to mitigate puts responsibility on Teixeira and
not St. Jude.
Under these circumstances, Teixeira has set up his claim for strict liability
as a parallel requirement that survives scrutiny under Rule 12(b)(6). See also 21
C.F.R. § 808.1(d)(6)(ii) (“Generally, section 521(a) does not preempt a State or
local requirement prohibiting the manufacture of adulterated or misbranded
devices.”). The Court thus recommends denying St. Jude’s motion with respect
to the first claim.

15

D.

Negligence in Manufacturing

Teixeira’s second claim requires a minor adjustment compared to his first
claim. “A manufacturer is liable in negligence for injury caused by a defective
product if it failed to exercise due care in the production of such product.
However, the ‘decisive issue’ in a manufacturing defect case is the existence of
the defect without regard to the care exercised by the manufacturer.” Colon ex
rel. Molina v. BIC USA, Inc., 199 F. Supp. 2d 53, 86 (S.D.N.Y. 2001) (internal
quotation marks and citations omitted). As with the strict liability claim, Teixeira
has alleged that St. Jude had to follow federal standards when manufacturing its
leads, that the FDA flagged St. Jude for falling short of those standards, and that
St. Jude’s violations led to a lead that injured him and had to be removed just two
weeks after implantation. So long as Teixeira limits himself to proving that his
Durata lead had a defect that resulted directly from FDA violations, his negligence
claim is plausible and can proceed without concern for preemption. General
negligence theories, though, leave room to allege a variety of duties that a
defendant breached, and that is where the Court needs to make a minor
adjustment. Teixeira’s second claim, while including language about following
federal law in parallel, also includes language that St. Jude had a duty to
manufacturer that was “consistent with” federal requirements and that St. Jude
“caused” Teixeira’s lead to have improper and defective material and to be
improperly designed. The Court needs to narrow that language to preclude any
16

possibility that a jury would be free to impose “consistent duties” and “causes”
that differ from actual violations of FDA requirements.
To the extent that Teixeira’s second claim leaves any room to allege duties
beyond the FDA requirements in themselves, the Court recommends granting St.
Jude’s motion. The Court otherwise recommends denying St. Jude’s motion.
E.

Failure to Warn (Negligence and Strict Liability)

Next, the Court will assess Teixeira’s third and fourth claims, which allege a
failure to warn. The essence of these claims lie in nearly identical paragraphs in
which Teixeira states that St. Jude “negligently failed to adequately warn doctors,
the general public and Plaintiff of their lack of knowledge and/or knowledge of
unsuitability such that Plaintiff, prior to implantation in 2011, would not have had
the leads implanted in his body as alleged.” (Dkt. No. 8 at 36–37, ¶¶ 147, 154.)
To make these claims parallel to federal requirements, Teixeira submits a nonexhaustive list of provisions in Title 21 of the Code of Federal Regulations
(“CFR”) that allegedly defined the standard of care for providing warnings.
The problem with Teixeira’s claims for failure to warn is that the respective
federal and state requirements do not match as closely as Teixeira would like.
The standard under New York law is somewhat expansive and relates directly to
the public at large. “A manufacturer has a duty to warn against latent dangers
resulting from foreseeable uses of its product of which it knew or should have
known. A manufacturer also has a duty to warn of the danger of unintended uses
17

of a product provided these uses are reasonably foreseeable.” Liriano v. Hobart
Corp., 700 N.E.2d 303, 305 (N.Y. 1998) (citations omitted). “A manufacturer is
subject to liability where it has (1) reason to know that the product it markets is
likely to be dangerous for the use for which it is supplied; (2) no reason to believe
the user will realize its dangerous condition; and (3) fails to exercise reasonable
care to inform the user of the facts which make the product dangerous.”
Gonzalez by Gonzalez v. Morflo Indus., Inc., 931 F. Supp. 159, 167–68 (E.D.N.Y.
1996) (citations omitted). Under the New York standard, manufacturers have to
communicate directly with users about intended uses and the associated
dangers; they also have to brainstorm unintended but reasonably foreseeable
uses and to communicate dangers for those uses as well. In contrast, Teixeira
has not cited any federal regulations that impose a similarly broad duty on St.
Jude. Under Title 21 of the CFR, St. Jude provides medical device reports to the
FDA, and the FDA “may disclose to the public any report, including any FDA
record of a telephone report, submitted under this part.” 21 C.F.R. § 803.9(a)
(emphasis added); see also 21 C.F.R. § 806.40(a) (“Any report submitted under
this part is available for public disclosure in accordance with part 20 of this
chapter.”) (emphasis added). Sections 803.10, 803.50, and 803.52 impose no
reporting requirements directly to users and require reporting only of information
concerning actual malfunctions or injuries. Section 803.53(a) comes close with
its reference to the need for “remedial action to prevent an unreasonable risk of
18

substantial harm to the public health,” but that need first requires a reportable
event. Section 814.80 concerns packaging and labeling but says nothing about
intended and unintended uses. Other sections that Teixeira cites concern quality
review.
The above differences between the federal standards that Teixeira cites
and the New York standards for failure to warn mean that the two sets of
standards are not parallel. The federal standards barely involve the public at all
and create a close relationship between a manufacturer and the FDA with respect
to quality review and reporting of adverse events that have occurred. Cf.
McConologue, 8 F. Supp. 3d at 108 (“[Plaintiff] has failed to allege the existence
of any FDA requirements applicable to consumer warnings such that the Court
may determine whether a state failure to warn claim is different from, or in
addition to FDA requirements and thus pre-empted, or contrastly whether the
state duties parallel, rather than add to, federal requirements such that they are
organic to or derivative of the device’s premarket approval and thus not
preempted.”) (internal quotation marks and citation omitted); Horowitz v. Stryker
Corp., 613 F. Supp. 2d 271, 286–87 (E.D.N.Y. 2009) (“Plaintiff’s failure to warn
claim is thus an attack on the Trident System’s federally approved label. Allowing
the claim to proceed would permit a jury to find that defendants were required to
provide warnings above and beyond those on the [Trident System’s] product
label—a label that was specifically approved by the FDA as part of the PMA
19

process.”) (alteration in original) (internal quotation marks and citation omitted).
The New York standards require manufacturers to maintain a close relationship
with potential users about possible future events that are not obvious enough for
them to realize on their own. Cf. Becker v. Optical Radiation Corp., 66 F.3d 18,
20 (2d Cir. 1995) (affirming dismissal of claims including failure to warn, where
“the common law of New York would impermissibly add requirements in the areas
reviewed in the premarket approval process, and thus would impose standards
on the [product] which are different from those of the MDA”) (citations omitted).
Under Section 360k(a) and Riegel, Teixeira cannot add New York’s standards to
St. Jude’s responsibilities. The Court thus recommends dismissing Teixeira’s
third and fourth claims as preempted.
F.

Negligent Representation

The Court now looks at Teixeira’s fifth claim for negligent representation. A
review of the New York standard will help determine whether this claim can
parallel federal regulations governing the Durata lead. “It has long been the law
in New York that a plaintiff in an action for negligent misrepresentation must show
either privity of contract between the plaintiff and the defendant or a relationship
so close as to approach that of privity.” Sykes v. RFD Third Ave. 1 Assocs., LLC,
938 N.E.2d 325, 326 (N.Y. 2010) (internal quotation marks and citations omitted).
“For there to be an actionable claim, the defendant must be under a duty to the
plaintiff to exercise reasonable care in giving the information, and plaintiff’s
20

reliance upon the information must be foreseeable. In elaborating on this test, we
stated: There must be knowledge or its equivalent that the information is desired
for a serious purpose; that he to whom it is given intends to rely and act upon it;
that if false or erroneous he will because of it be injured in person or property.
Finally the relationship of the parties, arising out of contract or otherwise, must be
such that in morals and good conscience the one has the right to rely upon the
other for information, and the other giving the information owes a duty to give it
with care.” Heard v. City of N.Y., 623 N.E.2d 541, 545 (N.Y. 1993) (internal
quotation marks and citations omitted).
Here, Teixeira faces two problems when trying to save his claim for
negligent misrepresentation. Under Rule 12(b)(6) without even considering
preemption, Teixeira has not alleged factually plausible privity between himself
and St. Jude. The word “privity” does not appear at all in the claim. Teixeira has
not alleged sufficient communication with St. Jude to that effect. Teixeira also
has not alleged that St. Jude knew that he in particular would rely on specific
information that it released. Cf. Sykes, 938 N.E.2d at 326 (“While [defendant]
obviously knew in general that prospective purchasers of apartments would rely
on the offering plan, there is no indication that it knew these plaintiffs would be
among them, or indeed that [defendant] knew or had the means of knowing of
plaintiffs’ existence when it made the statements for which it is being sued.”).
Teixeira has alleged only that St. Jude had to provide the FDA with certain
21

information as part of the PMA process. From there, either the FDA would make
the information available to the public, or St. Jude would broadcast the
information generally without knowing which individuals might talk to their doctors
about it. This information pathway does not suffice under New York law.
Secondly, even if Teixeira’s allegations survived scrutiny under Rule 12(b)(6),
New York’s requirement of privity does not match the relevant FDA regulations.
As discussed above with the claims for failure to warn, the FDA does have
extensive regulations requiring St. Jude to report product information to the
agency before final approval. The regulations also require St. Jude to report
adverse events to the agency, after they occur. From what Teixeira has pled and
from what the Court can determine, nothing in the PMA process or other FDA
regulations requires St. Jude to have a direct relationship with specific potential
patients before those patients make a final decision to acquire a defibrillator. Cf.
Franzese v. St. Jude Med., Inc., No. 13-CV-3203 JS WDW, 2014 WL 2863087, at
*8 (E.D.N.Y. June 23, 2014) (“The mere fact that Mr. Franzese purchased the
Durata lead and defibrillator does not show that Mr. Franzese or his physicians
actually relied on defendants’ alleged misrepresentations and omissions when
deciding whether to proceed with Mr. Franzese’s surgery.”) (editorial and internal
quotation marks and citation omitted).
The absence of privity in the federal regulations means that they and the
New York standard for negligent representation are not parallel. A jury could find
22

St. Jude liable for negligent representation only by finding that St. Jude breached
a duty to provide accurate information directly to Teixeira, whose reliance on the
information would be reasonably foreseeable. Such a jury finding would imply
that privity existed between Teixeira and St. Jude. The findings of privity,
foreseeability, and breach of duty all would constitute additions to the federal
regulations. Section 360k(a) and Riegel forbid making those additions. The
Court thus recommends dismissing Teixeira’s fifth claim as both legally
insufficient under Rule 12(b)(6) and preempted.
G.

Breach of Warranties

Finally, the Court will assess Teixeira’s sixth claim for breach of express
and implied warranties. As mentioned above, Teixeira alleges two types of
conduct by St. Jude that created express and implied warranties. The first type of
conduct consists of the packaging materials for the defibrillator, through which St.
Jude allegedly asserted that the defibrillator was safe and reasonably fit for its
foreseeable and intended uses for which it was designed, manufactured, and
assembled. The second type of conduct is more personal in nature. Teixeira
alleges that St. Jude “made personal representations to Plaintiff and/or his
treating medical providers that the devices utilized on Plaintiff were safe, longlasting, and would not prematurely erode.” (Dkt. No. 8 at 39 ¶ 173.) Teixeira
alleges also that “[u]pon information and belief, Representatives of Defendants

23

made personal representations to Plaintiff and/or his treating medical providers
that the devices utilized on Plaintiff would not require a surgical intervention.” (Id.
at 40 ¶ 174.)
As with Teixeira’s other claims, a look at New York’s standard for breach of
warranties will provide some guidance. With respect to express warranties,
plaintiffs need to define the warranties that defendants allegedly made and
breached. See, e.g., Davis v. N.Y.C. Hous. Auth., 668 N.Y.S.2d 391, 393 (N.Y.
App. Div. 1998) (“The cause of action and the cross claim sounding in breach of
express warranty, however, were properly dismissed, since the plaintiffs failed to
set forth the terms of the warranty upon which they relied.”) (citation omitted).
Express warranties in recent years have more of a grounding in contract law than
tort law. “The critical question is not whether the buyer believed in the truth of the
warranted information . . . , but whether it believed it was purchasing the seller’s
promise as to its truth. This view of ‘reliance’—i.e., as requiring no more than
reliance on the express warranty as being a part of the bargain between the
parties—reflects the prevailing perception of an action for breach of express
warranty as one that is no longer grounded in tort, but essentially in contract. The
express warranty is as much a part of the contract as any other term. Once the
express warranty is shown to have been relied on as part of the contract, the right
to be indemnified in damages for its breach does not depend on proof that the
buyer thereafter believed that the assurances of fact made in the warranty would
24

be fulfilled. The right to indemnification depends only on establishing that the
warranty was breached.” CBS Inc. v. Ziff-Davis Pub. Co., 553 N.E.2d 997,
1000–01 (N.Y. 1990) (editorial and internal quotation marks and citations
omitted). While contractual in nature, express warranties do not always require a
direct contract. “It may once have been true that the warranty which really
induced the sale was normally an actual term of the contract of sale. Today,
however, the significant warranty, the one which effectively induces the purchase,
is frequently that given by the manufacturer through mass advertising and
labeling to ultimate business users or to consumers with whom he has no direct
contractual relationship. The world of merchandising is, in brief, no longer a
world of direct contract; it is, rather, a world of advertising and, when
representations expressed and disseminated in the mass communications media
and on labels (attached to the goods themselves) prove false and the user or
consumer is damaged by reason of his reliance on those representations, it is
difficult to justify the manufacturer’s denial of liability on the sole ground of the
absence of technical privity.” Randy Knitwear, Inc. v. Am. Cyanamid Co., 181
N.E.2d 399, 402 (N.Y. 1962).
Breaches of implied warranties also concern buyer disappointment, but the
assessment of the buyer’s disappointment includes an assessment of the
product’s performance, not just the express promises that the seller made.
“While the strict products concept of a product that is ‘not reasonably safe’
25

requires a weighing of the product’s dangers against its over-all advantages, the
UCC’s concept of a ‘defective’ product requires an inquiry only into whether the
product in question was fit for the ordinary purposes for which such goods are
used. The latter inquiry focuses on the expectations for the performance of the
product when used in the customary, usual and reasonably foreseeable manners.
The cause of action is one involving true ‘strict’ liability, since recovery may be
had upon a showing that the product was not minimally safe for its expected
purpose—without regard to the feasibility of alternative designs or the
manufacturer’s ‘reasonableness’ in marketing it in that unsafe condition. This
distinction between the ‘defect’ analysis in breach of implied warranty actions and
the ‘defect’ analysis in strict products liability actions is explained by the differing
etiology and doctrinal underpinnings of the two distinct theories. The former class
of actions originates in contract law, which directs its attention to the purchaser’s
disappointed expectations; the latter originates in tort law, which traditionally has
concerned itself with social policy and risk allocation by means other than those
dictated by the marketplace.” Denny v. Ford Motor Co., 662 N.E.2d 730, 736
(N.Y. 1995) (citation omitted).
The inclusion of design assessment in both Teixeira’s allegations and in
the standard for breach of implied warranty requires narrowing the claim for
breach of implied warranty to keep it parallel with federal law. As noted above
and in the parties’ papers, the FDA requires device manufacturers to expend
26

great effort to bring a product all the way through the PMA process. The PMA
process includes regulations about product design and what the manufacturing
process for a Class III device should be. A state jury cannot be allowed to assess
product fitness in any way that would add design and manufacturing
requirements or that would otherwise second-guess the FDA regulatory scheme.
Teixeira’s claim for breach of implied warranty is preempted to the extent that it
leaves room for second-guessing. That said, though, Teixeira has pled plausibly
that St. Jude deviated from the specific manufacturing standards and procedures
that the FDA prescribed for the defibrillator, and that the deviations in themselves
created a defective product that injured him. The Court allowed the negligence
and strict-liability causes of action to survive on that basis. There is no reason
why the implied-warranty claim cannot survive on the same basis. Cf.
McConologue, 8 F. Supp. 3d at 113–14 (“Indeed, courts have held that, where a
plaintiff has pled a defective manufacturing claim, a state law claim for breach of
implied warranty of merchantability is not preempted. Several courts that have
addressed whether implied warranty claims are preempted after Riegel have
determined that, to the extent the plaintiff relies on the failure to comply with the
FDA’s requirements in asserting his breach of implied warranty claim, such
claims may proceed.”) (citation omitted). So long as an eventual jury in this case
receives instructions that only a deviation from FDA standards can equate to a
lack of fitness for intended purposes, a finding of liability and an award of
27

damages would not add anything to St. Jude’s federal responsibilities. Subject to
this limitation, the Court recommends denying St. Jude’s motion with respect to a
claim for breach of implied warranty.
Returning to the claim for breach of express warranty, that claim also
survives in part in a similar way. Teixeira asserts that one express warranty
came from the defibrillator’s packaging and its failure to indicate, inter alia,
susceptibility to premature deterioration and violation of CGMP requirements.
Teixeira has not pled what federal regulations would require those types of
disclosures in product packaging, and the Court cannot allow a jury to add
product packaging requirements to the requirements that the FDA already has
established. Cf. Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197,
206 (W.D.N.Y. 2011) (Skretny, C.J.) (“[A] finding that a defendant violated state
law by not living up to FDA-approved promises would necessarily conflict with the
FDA’s determination that the label was not false or misleading.”) (citation
omitted). Any of Teixeira’s allegations concerning product packaging thus are
preempted. Teixeira, though, also has alleged that St. Jude made direct,
personal representations to him and his physicians that the defibrillator was safe,
long-lasting, not subject to premature erosion, and not subject to subsequent
surgical intervention. The Court is not aware of any federal regulations that
required St. Jude to make those kinds of representations directly to Teixeira. If
St. Jude stepped outside of the FDA requirements and volunteered to make
28

express, personal representations to Teixeira and his doctors then St. Jude
should not be allowed to hide behind a regulatory scheme that has nothing to with
that voluntary conduct. As for Rule 12(b)(6), Teixeira will have to confirm 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. For these reasons, the Court recommends granting St.
Jude’s motion with respect to express warranty claims based on packaging and
denying the motion with respect to express warranty claims based on explicit,
personal representations.
IV.

DISCUSSION—MOTION TO STRIKE
Finally, the Court turns to St. Jude’s motion to strike. As noted above, St.

Jude initially filed this motion as a motion to sanction Teixeira’s counsel under
Rule 11 or, alternatively, to strike portions of the amended complaint under Rule
12(f). St. Jude subsequently narrowed its motion to only the requests to strike,
under Rule 11(b)(3) and Rule 12(f). The core of this motion is fairly
straightforward. “St. Jude is simply requesting the Court to not accept as true, or
to strike, these made up allegations that St. Jude violated non-existent PMA
requirements related to the manufacture of Riata leads—which allegations
Plaintiff has copied from another case to challenge the Durata lead at issue in this
case.” (Dkt. No. 24 at 2.) St. Jude asserts that the Riata and Durata leads for the
defibrillator are different products approved separately by the FDA and containing
29

different materials. St. Jude asserts further that “there is no evidentiary basis for
Plaintiff’s allegation that his Durata lead suffered from the alleged product defect.
Plaintiff neither includes nor attaches any medical report, device inspection or
testimony from a physician or other expert. Plaintiff has no evidentiary support
that his Durata lead suffered a Riata-like externalization lead failure.” (Id. at 6.)
St. Jude cites the case of Pinsonneault v. St. Jude Med., Inc., No. 12-CV-1717
PJS/JSM, 2014 WL 2879754 (D. Minn. June 24, 2014), which granted summary
judgment to St. Jude against a different plaintiff when that plaintiff could not cite
evidence of federal requirements with respect to factors such as insulation
thickness for defibrillator leads, placement of lumens, and crimp force. St. Jude
concludes that “the fact that St. Jude waited until after receiving a
summary judgment order in Pinsonneault to begin taking steps to stem the tide of
parties copying the false allegations made up in Pinsonneault in no way means
that the allegations have any merit or that St. Jude should be required to
continually litigate groundless allegations devoid of any merit. Indeed, once on
notice of the order in Pinsonneault, and having no independent basis for any
reasonable, good faith belief in trying to force St. Jude to re-litigate the alleged
existence of made-up PMA requirements, Plaintiff should have voluntarily
withdrawn the Amended Complaint or the offending allegations.” (Id. at 8–9.)
Teixeira opposes the motion in all respects. Teixeira asserts that the
amended complaint resulted from extensive original research for both the Riata
30

and Durata defibrillator leads, and that the latter is simply a renamed “progeny” of
the former. Teixeira denies being aware of Pinsonneault when drafting the
amended complaint and denies copying any language from the complaint in that
case. Teixeira concludes that “the Plaintiff in this case is not collaterally estopped
by a finding in another case involving a different plaintiff, different lawyers, a
different district court and what Defendants claim is a different product.” (Dkt. No.
21 at 2.).
Resolving this motion requires revisiting some of the basic rules of
pleading. “A pleading that states a claim for relief must contain . . . a short and
plain statement of the claim showing that the pleader is entitled to relief.” FRCP
8(a)(2). “‘A short and plain statement of the claim’ does not mean ‘a short and
plain statement of the eventual jury charge for that claim’ or ‘a short and plain
recitation of the legal elements for that claim.’ FRCP 8(a)(2) requires a plaintiff to
state, in concise but plausible fashion, what he currently thinks a defendant
actually did to him, subject to revision during later discovery.” Beswick v. Sun
Pharm. Indus., Ltd., No. 10-CV-357A, 2011 WL 1585740, at *5 (W.D.N.Y. Mar. 4,
2011) (Arcara, J.). Just as plaintiffs need not submit evidence at the pleading
stage, they also need not produce an exact list of legal authorities in play,
because “under the Federal Rules of Civil Procedure, a complaint need not pin
plaintiff’s claim for relief to a precise legal theory.” Skinner v. Switzer, 562 U.S.

31

521, 131 S. Ct. 1289, 1296 (2011). When necessary, plaintiffs can submit
pleadings upon information and belief. “How else can a pleader avoid the
appearance of perjury when he is without direct personal knowledge regarding
one or more of the allegations necessary to his claim and therefore must plead on
a less certain footing? Pleading on information and belief is a desirable and
essential expedient when matters that are necessary to complete the statement
of a claim are not within the knowledge of the plaintiff but he has sufficient data to
justify interposing an allegation on the subject.” Arthur R. Miller and Mary Kay
Kane, 5 Fed. Prac. & Proc. Civ. § 1224 (3d ed. and 2014 Supp.). Only where
pleadings will not find evidentiary support after a reasonable opportunity for
further investigation should courts consider striking allegations as either frivolous
or as impertinent and immaterial under Rules 11(b)(3) or 12(f). “Evidentiary
questions, such as the one present in this case, should especially be avoided at
such a preliminary stage of the proceedings. Usually the questions of relevancy
and admissibility in general require the context of an ongoing and unfolding trial in
which to be properly decided. And ordinarily neither a district court nor an
appellate court should decide to strike a portion of the complaint on the grounds
that the material could not possibly be relevant on the sterile field of the pleadings
alone.” Lipsky v. Commonwealth United Corp., 551 F.2d 887, 893 (2d Cir. 1976)
(citations omitted); see also Anderson News, L.L.C. v. Am. Media, Inc., No. 09
CIV. 2227 PAC, 2013 WL 1746062, at *4 (S.D.N.Y. Apr. 23, 2013) (“A court
32

called upon to judge the reasonableness of an attorney’s factual inquiry should
consider how much time the attorney had for the investigation, the feasibility of
verifying facts; the complexity of the factual issues; and the need for additional
discovery to develop the factual claim.”) (internal quotation marks and citation
omitted).
Here, the allegations in the amended complaint reduce to a fairly simple
story. Teixeira had a defibrillator and heart lead implanted in him on September
6, 2011. Just 14 days later, on September 20, 2011, Teixeira had to go back into
surgery to have the lead removed. Presumably, Teixeira did not remove the lead
himself; doctors would have diagnosed the need to do so. Why? For now,
subject to discovery, Teixeira has chosen a particular theory to answer that
question. Teixeira claims to have discovered that the Durata lead implanted in
him was a modification of an existing product with a history of defects. Teixeira
also claims to have found that the FDA flagged St. Jude in the past for violations
of device requirements. From there, Teixeira pleads upon information and belief
that the violations of known requirements and possibly others in themselves led
to problems with the defibrillator lead that required his second surgery. Of
course, Teixeira’s medical records will play a major role in proving his allegations.
Specifying every federal regulation in play would be helpful now and eventually
will be necessary. Teixeira in general still has to expend great effort proving the
connection between any federal violations and his injuries, though some of the
33

necessary information may be in St. Jude’s exclusive control right now. The time
for proof will come later, though. For now, what matters is that Teixeira has set
forth a plausible story that a medical device with some red flags in its history had
something to do with injuries that he suffered within 14 days of its implantation.
St. Jude’s references to the Pinsonneault case merit a brief comment. St.
Jude cites Pinsonneault as proof that Teixeira’s allegations have no evidentiary
basis. In that sense, St. Jude’s request to strike amounts to an attempt at
collateral estoppel. “There are two requirements for the application of collateral
estoppel to an issue: (1) there must be an identity of issue which has necessarily
been decided in the prior action and is decisive of the present action, and (2)
there must have been a full and fair opportunity to contest the decision now said
to be controlling.” Burgos v. Hopkins, 14 F.3d 787, 792 (2d Cir. 1994). None of
the criteria for collateral estoppel exist here. Teixeira was not a plaintiff in
Pinsonneault and had no full and fair opportunity to litigate the issues in that
case. The Pinsonneault decision came after pretrial discovery and the filing of a
summary judgment motion. Cf. Rosen v. St. Jude Med., Inc., No. 1:13-CV-1159
LEK/CFH, 2014 WL 4257863, at *15 n.10 (N.D.N.Y. Aug. 28, 2014) (“Moreover,
the Court rejects Defendants’ attempt to incorporate factual findings from
Pinsonneault v. St. Jude Medical, Inc., No. 12-cv-1717, 2014 WL 2879754, at *6
(D.Minn. June 24, 2014) to establish the absence of alleged PMA violations in
this case. Pinsonneault concerned a motion for summary judgment, which
34

involves a different legal standard than a motion to dismiss, and is submitted after
the parties have conducted discovery. See Pinsonneault, 2014 WL 2879754, at
*3. Therefore, Pinsonneault’s factual findings are irrelevant to the instant
Motion.”). St. Jude is concerned that it defeated what, admittedly, do look like
similar issues to Teixeira’s case and now has to defend against them again.
Without some sort of estoppel effect stretching from Pinsonneault to this case,
however, Teixeira is entitled to explore his claims in pretrial discovery. The Court
thus recommends denying St. Jude’s motion to strike.
While recommending denial of the motion, the Court will send a note of
caution to Teixeira. On the surface, some of the issues that arose in
Pinsonneault do look like some of the issues that are emerging in this case.
While Pinsonneault has no estoppel effect here, the existence of the
Pinsonneault decision means that Teixeira now has notice of evidentiary issues
that he will have to address. As just one example, Teixeira is now on notice that
he will have to substantiate his claims that St. Jude violated federal requirements
regarding insulation thickness for defibrillator leads, placement of lumens, and
crimp force. If Teixeira cannot address the evidentiary issues for which he has
notice and does not withdraw those assertions at some later time then he may
have to compensate St. Jude for the cost of defending against those allegations.
The Court’s denial of the motion to strike, therefore, is without prejudice to future

35

motions that may be required to address allegations maintained despite pretrial
discovery to the contrary.
V.

CONCLUSION
For all of the foregoing reasons, the Court respectfully recommends

granting St. Jude’s motion to dismiss (Dkt. Nos. 4, 16) in part as follows:
1) Dismissing the second claim to the extent that Teixeira alleges
duties beyond the FDA requirements in themselves;
2) Dismissing the third, fourth, and fifth claims in their entirety;
3) Dismissing the sixth claim for breach of implied warranty to the
extent that Teixeira alleges anything other than a deviation
from FDA standards that equates to a lack of fitness for
intended purposes; and
4) Dismissing the sixth claim for breach of express warranty with
respect to any allegations other than explicit, personal
representations.
The Court recommends denying the motion in all other respects.
The Court also recommends denying St. Jude’s motion to strike (Dkt. No.
18) without prejudice.
VI.

OBJECTIONS
A copy of this Report and Recommendation will be sent to counsel for the

parties by electronic filing on the date below. Any objections to this Report and
36

Recommendation must be electronically filed with the Clerk of the Court within 14
days. See 28 U.S.C. § 636(b)(1); FRCP 72. “As a rule, a party’s failure to object
to any purported error or omission in a magistrate judge’s report waives further
judicial review of the point.” Cephas v. Nash, 328 F.3d 98, 107 (2d Cir. 2003)
(citations omitted).
SO ORDERED.
__/s Hugh B. Scott________
HONORABLE HUGH B. SCOTT
UNITED STATES MAGISTRATE JUDGE
DATED: March 3, 2015

37