Franzese et al v. St. Jude Medical, Inc. et al
MEMORANDUM & ORDER granting 16 Motion to Dismiss for Failure to State a Claim; granting 17 Motion to Compel. For the foregoing reasons, Defendants' motions to dismiss and for judicial notice are both GRANTED. As Plaintiffs have already attempted to amend their Complaint, and such amendment being unsuccessful, the Court finds that further amendment would be futile. Accordingly, the Clerk of the Court is directed to mark this matter CLOSED. So Ordered by Judge Joanna Seybert on 6/23/2014. C/ECF (Valle, Christine)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
GERARD FRANZESE and ROSEMARY
MEMORANDUM & ORDER
-againstST. JUDE MEDICAL, INC. and ST.
JUDGE MEDICAL S.C., INC.,
Joseph G. Dell, Esq.
Dell & Dean, PLLC
1321 Franklin Avenue, Suite 100
Garden City, NY 11530
Russell T. McHugh, Esq.
Lawrence, Worden, Rainis & Bard, P.C.
225 Broad Hollow Road, Suite 105E
Melville, NY 11747
Todd M. Malynn, Esq.
Feldman Gale PA
880 W First Street, Suite 315
Los Angeles, CA 90012
SEYBERT, District Judge:
Currently pending before the Court are: (1) defendants
(together, “Defendants” or “St. Jude”) motion to dismiss the
Amended Complaint (Docket Entry 16), and (2) Defendants’ motion
to compel judicial notice (Docket Entry 17).
reasons, Defendants’ motions are GRANTED.
For the following
On April 14, 2010, plaintiff Gerard Franzese received
surgery at St. Catherine of Siena Hospital on Long Island, New
York to implant a St. Jude implantable defibrillator (“ICD”)2.
(Am. Compl. ¶ 19; see also Dell Aff., Docket Entry 23, ¶ 3.)
During that procedure, a St. Jude representative was present and
directing the procedure.
(Am. Compl. ¶ 20.)
The ICD that Mr.
Franzese received was ICD Model Number CD3211-36Q; RV lead Model
Number 7121Q/65, which used a Durata SJ4 RV lead (7121Q/65).
distributed, marketed and sold the defibrillator and the Durata
(Am. Compl. ¶ 12.)
Thereafter, the Durata lead wore away and prematurely
(Am. Compl. ¶¶ 21-22.)
On October 17, 2011, Mr.
Franzese underwent a second ICD surgical procedure during which
the lead was discarded and replaced.
Aff. ¶ 8.)
(Am. Compl. ¶ 25; Dell
The second procedure was unsuccessful, thus causing
a third surgery on October 28, 2011.
(Am. Compl. ¶¶ 26-27.)
St. Jude representative informed Mr. Franzese that some of the
The following facts are taken from Plaintiffs’ Amended
Complaint and are presumed to be true for the purposes of this
Memorandum and Order.
“ICD’s are designed to be implanted near a patient’s heart,
monitor the heart rhythms and give life-saving electrical shocks
if necessary.” (Dell Aff. ¶ 6.)
St. Jude’s leads were defective, including the lead he received
on April 14, 2010.
(Am. Compl. ¶¶ 29-30.)
Mr. Franzese and his wife Rosemary Franzese (together
“Plaintiffs”) raise claims in the Amended Complaint for strict
warn, breach of express and implied warranties, and loss of
Defendants now seek to dismiss the Amended Complaint
Plaintiffs have otherwise failed to state a claim.
also seek judicial notice of the Food and Drug Association’s
(“FDA”) pre-market approval of St. Jude’s Durata lead and St.
Jude’s implantable cardioverter defibrillator.
The Court will
first address the applicable legal standard before turning to
the substance of Defendants’ motions.
I. Legal Standard
“[t]wo working principles.”
Ashcroft v. Iqbal, 556 U.S. 662,
678, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009); accord Harris v.
Mills, 572 F.3d 66, 71-72 (2d Cir. 2009).
First, although the
recitals of the elements of a cause of action, supported by mere
conclusory statements, do not suffice.”
accord Harris, 572 F.3d at 72.
Iqbal, 556 U.S. at 678;
Second, only complaints that
state a “plausible claim for relief” can survive a Rule 12(b)(6)
motion to dismiss.
Iqbal, 556 U.S. at 679.
a complaint does so is “a context-specific task that requires
Id.; accord Harris, 572 F.3d at 72.
Furthermore, the Court is confined to “the allegations
contained within the four corners of [the] complaint.”
Empire Blue Cross Blue Shield, 152 F.3d 67, 71 (2d Cir. 1998).
judicial notice may be taken.
See Chambers v. Time Warner,
Inc., 282 F.3d 147, 152-53 (2d Cir. 2002) (citations omitted);
Kramer v. Time Warner Inc., 937 F.2d 767, 773 (2d Cir. 1991).
A. Preemption Under the MDA
Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”),
giving the FDA the authority to regulate medical devices.
generally 21 U.S.C. § 360c et. seq.
The MDA creates three
levels of scrutiny, depending on the type of medical device,
before pre-market approval (“PMA”) can be obtained.
v. Smith & Nephew Gmbh, No. 12-CV-4895, 2014 WL 1315315, at *1
(E.D.N.Y. Mar. 31, 2014) (citing 21 U.S.C. § 360c(a)(1)).
called “Class III” medical devices are subject to the highest
level of scrutiny.
“The PMA process for a Class III medical
submission of a multivolume application that includes reports of
components, and details regarding its manufacturing, packaging,
Id. (citing 21 U.S.C. § 360e; Riegel v.
Medtronic, Inc., 552 U.S. 312, 317-18, 128 S. Ct. 999, 1004, 169
L. Ed. 2d 892 (2008)).
Even after receiving PMA, the manufacturer must comply
with reporting and other obligations, including submission of an
changes in the design specifications, manufacturing processes,
or labeling of the medical device that would affect safety or
effectiveness of the device.
[N]o State or political subdivision of a
State may establish or continue in effect
with respect to [medical devices covered by
the MDA] any requirement--
(1) which is different from, or in addition
to, any requirement applicable under [the
MDA] to the device, and
effectiveness of the device or any other
matter included in a requirement applicable
to the device under this chapter.
21 U.S.C. § 360k(a).
The Supreme Court in Riegel shed some
additional light on the “different from, or in addition to”
Riegel, 552 U.S. at 329-30, 128 S. Ct. at 1011.
Specifically, it held that “parallel” claims, are not preempted.
In other words, “[t]he Court observed that the MDA preemption
provision does not bar a state from providing a damages remedy
for claims premised on the violation of FDA regulations, because
‘the state duties in such a case parallel, rather than add to,
(quoting Riegel, 552 U.S. at 330, 128 S. Ct. at 1011).
successfully circumvent preemption, a plaintiff must allege a
claim based upon violation of an FDA regulation.
however, a plaintiff’s claim cannot be based solely on that
The FDA regulations themselves do not provide a
private cause of action.
See Buckman Co. v. Plaintiffs’ Legal
Comm., 531 U.S. 341, 348, 349 n.4, 121 S. Ct. 1012, 148 L. Ed.
2d 854 (2001).
Thus, “[t]o shoot this [narrow gap through which
a plaintiff’s state-law claim must fit to escape preemption],
the ‘plaintiff must be suing for conduct that violates [federal
law, or Section 360k(a) pre-empts the claim,] . . . but the
federal law, because he has no private right to bring such a
Gale v. Smith & Nephew, Inc., --- F. Supp. 2d ----,
2013 WL 563403, at *3 (S.D.N.Y. Feb. 13, 2013) (quoting In re
Medtronic, Inc. v. Sprint Fidelis Leads Prods. Liab. Litig., 623
F.3d 1200, 1204 (8th Cir. 2010) (emphases and alterations in
medical device manufacturer from liability to the extent that it
has complied with federal law, but it does not extend protection
violation of federal law.’”
Id. (quoting Bausch v. Stryker
Finally, the plaintiff’s claim must otherwise satisfy
the general Iqbal/Twombly pleading standards, and “cannot simply
make the conclusory allegation that defendant’s conduct violated
Simon v. Smith & Nephew, Inc., --- F. Supp.
2d ----, 2013 WL 6244525, at *4 (S.D.N.Y. Dec. 3, 2013).
Defendants argue that Plaintiffs’ claims are preempted
and fail to state a parallel claim because the Amended Complaint
does not identify the specific federal regulations violated or
Plaintiffs have otherwise failed to state a claim for their
arguments in turn.
B. Judicial Notice
however, the Court also notes that Defendants have moved for
judicial notice of: (1) the FDA’s PMA of St. Jude’s Durata lead;
and (2) the FDA’s PMA of St. Jude’s implantable cardioverter
Plaintiffs have not opposed this motion and the Court finds that
judicial notice is appropriate here.
A court may judicially notice a fact when the fact(s)
are “(1) generally known within the trial court’s territorial
jurisdiction; or (2) can be accurately and readily determined
from sources whose accuracy cannot reasonably be questioned.”
FED. R. EVID. 201(b).
Here, Defendants provide accurate documents
from the FDA reflecting PMA for the devices at issue.
notice of such facts is consistent with precedent.
Gale, 2013 WL 563403, at *1 n.2; Desabio v. Howmedia Osteonics
Corp., 817 F. Supp. 2d 197, 201 n.3 (W.D.N.Y. 2011); (Defs.’ Br.
for Judicial Notice at 2-3 (collecting cases)).
Accordingly, Defendants’ motion for judicial notice is
C. Preemption & Claims
The Court thus turns to each of Plaintiffs’ claims.
1. Strict Liability
Plaintiffs assert claims sounding in strict liability
for design defect, manufacturing defect, and failure to warn.
Specifically, they assert that
question was defective in that, among other
designed; it was improperly manufactured; it
failed to have adequate and proper warnings
or instructions; it was not safe to be used
for the purposes intended; it was inherently
utilization violated FDA regulations; and it
caused severe injuries while being used and
the products were otherwise defective.
(Am. Compl. ¶ 50.)
a. Manufacturing Defect
Plaintiff alleges, among other things, that Defendants
violated 21 U.S.C. § 351(h) by making unsanctioned adulterations
to the Durata lead in violation of CGMPs and that the Durata
lead and/or defibrillator had an impurity, imperfection, and/or
other product defect.
(Am. Compl. ¶¶ 54, 74.)
allege that Defendants violated 21 C.F.R. § 820.75 “by failing
to ensure that the process of manufacturing the Durata lead was
validated” and by failing to establish manufacturing procedures
for monitoring the Durata lead, failing to establish procedures
for control of process parameters, and failing to monitor the
flow of the machinery.
(Am. Compl. ¶¶ 56, 59-61.)
Under New York law, “[t]o plead and
prove a manufacturing flaw under either
plaintiff must show that a specific product
unit was defective as a result of some
mishap in the manufacturing process itself,
improper workmanship, or because defective
materials were used in construction, and
that the defect was the cause of plaintiff’s
Burkett, 2014 WL 1315315, at *4 (quoting Colon ex rel. Molina v.
BIC USA, Inc., 199 F. Supp. 2d 53, 85 (S.D.N.Y. 2001)).
subsequent to Mr. Franzese’s operation, to argue “post[ ] PMA
violation of federal law,” and specifically, violation of the
Certainly, the FDA warning letter, issued on January 10,
2013--almost three years after Mr. Franzese’s operation--cites
to various CGMP violations, including that the Durata lead was
adulterated because methods were not in conformity with CGMPs.
(See Dell Aff. ¶¶ 11-12 & Ex. D.)
identify a specific federal regulation allegedly violated.
Desabio, 817 F. Supp. 2d at 204 (“‘To properly allege parallel
specific PMA requirements that have been violated.’” (quoting
Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th
across the country are generally split on this issue.
Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 159 (S.D.N.Y.
CGMPs were not preempted) with Illaraza v. Medtronnic, Inc., 677
F. Supp. 2d 582, 588 (E.D.N.Y. 2009) and Horowitz v. Stryker
Corp., 613 F. Supp. 2d 271, 283-84 (E.D.N.Y. 2009).
only the Sixth and Seventh Circuits have directly spoken on this
issue, both finding that allegations founded on violations of
CGMPs are sufficient to state a claim.
See Howard v. Sulzer
Orthopedics, 382 F. App’x 437 (6th Cir. 2010); Bausch v. Stryker
Corp., 630 F.3d 546 (7th Cir. 2010).
Despite this precedent,
though, the Eastern District of New York has generally held that
parallel claims may not be predicated on violation of CGMPs.
See Burkett, 2014 WL 1315315, at *5; Ilarraza, 677 F. Supp. 2d
at 588 (“The intentionally vague and open-ended nature of the
[CGMP] regulations relied upon is the precise reason why they
cannot serve as the basis for a parallel claim.”).
Plaintiffs’ argument that there has been a shift toward allowing
precedent--including Burkett, which was issued just a few months
ago and after the parties briefed the current motion--has held
that the CGMPs do not identify a federal law that is specific to
the medical device at issue, thus forming an insufficient basis
for a parallel claim.
See Burkett, 2014 WL 1315315, at *5
violation of generally applicable CGMPs, as opposed to federal
Moreover, Plaintiffs do allege that the Durata lead
was adulterated in violation of Section 501(h) of the FDCA and
imperfection, or other product defect.
adulterations” to the Durata lead.
(Am. Compl. ¶¶ 54, 74.)
(Am. Compl. ¶ 54.)
such assertions appear to be based on the FDA warning letter,
adulterated within the meaning of Section 501(h) because “the
methods used in, or the facilities or controls used for, their
conformity with CGMPs.
(Dell Aff. ¶ 12(1) & Ex. D.)
Allegations regarding adulterations in particular can
sufficiently state a claim where the violation of CGMPs also
Advanced Bionics Corp., No. 07-CV-1777, 2008 WL 3874713 (N.D.
sufficiently alleged a non-preempted claim where they asserted
that the defendant, subsequent to PMA, changed its supplier,
altered the device’s mechanical configuration, and changed the
length, composition, and “firing” process for glass used in the
2008 WL 3874713, at *1.
The result was that moisture
levels within the cochlear implants exceeded the maximums set
out by the FDA, causing the device to malfunction.
also Ilarraza, 677 F. Supp. 2d at 589 (citing as examples Purcel
and Rollins v. St. Jude Medical, 583 F. Supp. 2d 790 (W.D. La.
2008), in which “the plaintiff stated a parallel claim where he
device at issue”).
failed to connect a violation of the CGMPs with the violation of
Supp. 2d at 588-89.
This is true, even though courts have
recognized that PMA documents are often confidential, making it
difficult for a plaintiff to plead the exact violation.
Burgos v. Satiety, Inc., No. 10-CV-2680, 2011 WL 1327684, at *34 (E.D.N.Y. Apr. 5, 2011).
Nonetheless, alleging that a device
contravened federal law specific to the device fails to state a
Gale, 2013 WL 563403, at *3.
Accordingly, Plaintiffs’ claim for strict liability-
manufacturing defect is preempted and otherwise fails to state a
b. Design Defect
Next, Plaintiffs allege a claim under strict liability
for design defect.
They allege, inter alia, that Defendants
adequate procedures for verifying the design of the Durata lead;
methods that did not follow a national standard; failing to
verification of the Durata lead prior to it establishing design
(Am. Compl. ¶¶ 62-69.)
product is not reasonably safe.’”
Burkett, 2014 WL 1315315, at
*4 (quoting Denny v. Ford Motor Co., 87 N.Y.2d 248, 256-57, 639
N.Y.S.2d 250, 662 N.E.2d 730 (1995)); see also Bertini v. Smith
& Nephew, Inc., --- F. Supp. 2d ----, 2014 WL 1028950, at *5
(E.D.N.Y. Mar. 17, 2014) (listing the relevant factors as “the
product as designed posed a substantial likelihood of harm,” “it
was feasible to design the product in a safer manner,” and “the
defective design was a substantial factor in causing plaintiff’s
injury” (internal quotation marks and citation omitted)).
defectively designed product is one which, at the time it leaves
dangerous for its intended use . . . .’”
Burkett, 2014 WL
Package Mach. Co., 49 N.Y.2d 471, 479, 426 N.Y.S.2d 717, 403
N.E. 2d 400 (1980)).
Again, similar to the claims in Burkett, Plaintiffs
assert that Defendants failed to comply with federal law in
designing the Durata lead after its PMA approval.
Compl. ¶¶ 62-69.)
In Burkett, as here, Plaintiffs point to an
FDA warning letter relating primarily to manufacturing issues,
and have not alleged that Defendants strayed from the design
approved by the FDA.
See 2014 WL 1315315, at *4.
this claim is preempted.
See Bertini, 2014 WL 1028950, at *6
(finding strict liability design defect claim preempted where
the plaintiffs did not allege that the design failed to meet the
FDA requirements, but rather that the device could have been
designed safer); Simon, 2013 WL 6244525, at *7 (“[D]esign defect
claims regarding a PMA-approved device are squarely preempted by
c. Failure to Warn
Next, Plaintiffs assert a claim for strict liability
based upon Defendants’ alleged failure to warn.
they assert that Defendants violated 21 U.S.C. § 352(t)(2) by
furnish material or information and by failing to report to the
FDA no later than thirty days after receipt of information that
the Durata lead malfunctioned.
“‘demonstrate that (1) a manufacturer has a duty to warn (2)
against dangers resulting from foreseeable uses about which it
knew or should have known, and (3) that failure to do so was the
proximate cause of the harm.’”
Burkett, 2014 WL 1315315, at *6
(quoting State Farm Fire & Cas. Co. v. Nutone, Inc., 426 F.
App’x 8, 10 (2d Cir. 2011)).
Plaintiffs’ allegations cite to 21
U.S.C. § 352(t)(2), following the assertions in the FDA warning
letter, that the Durata lead was misbranded and that Defendants
failed to report to the FDA no later than 30 calendar days after
receipt of information that the Durata lead malfunctioned.
Compl. ¶¶ 70-71.)
The FDA warning letter was issued nearly
three years after Mr. Franzese’s initial surgery.
letter relate to the state of affairs in 2010.
Accordingly, even if Plaintiffs’ claim for failure to warn is
not preempted, they have otherwise failed to state a claim in
2. Breach of Warranty (Express and Implied)
Plaintiffs also assert claims for breach of express
warranty and breach of implied warranty.
They allege that Mr.
Franzese and his treating doctors relied on Defendants’ express
packaging materials and on an implied warranty that the products
personal representations to Mr. Franzese and/or his doctors that
(Am. Compl. ¶¶ 108-09.)
“Under New York law, ‘[t]o state a claim for breach of
express warranty, the plaintiff must show that there was an
tendency of which [was] to induce the buyer to purchase, and
that the warranty was relied upon.’”
Burkett, 2014 WL 1315315,
at *8 (quoting Gelber, 788 F. Supp. 2d at 165 (alterations in
To state a claim for breach of implied warranty,
Plaintiffs must sufficiently allege “‘that the [product] was not
(alteration in original)).
To the extent that Plaintiffs allege that
contained in the packaging materials, Plaintiffs fail to state a
Plaintiffs make only a conclusory allegation without
See Horowitz, 613 F. Supp. 2d at 286
issue, plaintiff has failed to give the defendants notice of the
grounds of her claim.”).
Moreover, “Plaintiffs must show [Defendants’] product
‘was not minimally safe for its expected purpose’ to maintain
1028950, at *11 (quoting Caronia v. Philip Morris USA, Inc., 715
device] in a safer manner, when the FDA has already approved the
safety and effectiveness of defendant’s design.”
warning letter does not save this claim.
Though the letter
identifies potential issues, it does not equate to a finding
See Horowitz, 613 F. Supp. 2d at 284 (“The FDA warning
defendants’ federal violations caused the Trident System to be
unfit in assisting patients in walking, which is the purpose for
which the Trident System was created.”).
Plaintiffs also assert a claim for negligence.
Am. Compl. ¶ 86 (“Defendants breached their duties in that they
manufacture, packaging, labeling, warnings, quality assurance,
advertising, promotion, distribution and sale of the Plaintiff’s
Compl. ¶ 87.)
To state a claim for negligence,
exercise reasonable care; (2) a breach of
that duty by failure to use reasonable care
so that a product is rendered defective,
i.e. reasonably certain to be dangerous; (3)
that the defect was the proximate cause of
the plaintiff’s injury; and (4) loss or
Burkett, 2014 WL 1315315, at *7 (quoting Colon ex rel. Molina,
199 F. Supp. 2d at 82)).
To the extent that Plaintiffs base their negligence
claims on design defect, manufacturing defect, or failure to
warn, these claims are preempted or otherwise fail to state a
claim, and therefore Plaintiffs’ negligence claim fails for the
See id.; Bertini, 2014 WL 1028950, at *10.
4. Negligent Misrepresentation
Plaintiffs allege negligent misrepresentation because
they assert that Defendants misbranded the Durata lead and/or
failed to furnish material or information respecting the device
as required, in violation of 21 U.S.C. § 352(t)(2).
They further assert that “Defendants were negligent in
that they did not disclose manufacturing flaws to the FDA or
risk of injury to patients receiving the Promote Plus ICD and/or
the Durata lead.”
(Am. Compl. ¶ 95.)
Negligent misrepresentation claims are subject to the
heightened pleading standard set forth by Federal Rule of Civil
See Burkett, 2014 WL 1315315, at *7.
Plaintiffs must allege “‘(1) what the omissions were (2) the
person responsible for the failure to disclose; (3) the context
Id. (quoting Woods v. Maytag Co., 807 F. Supp. 2d 112,
119 (E.D.N.Y. 2011)).
Plaintiffs have not done so here.
“[T]he mere fact
1028950, at *10.
Accordingly, Plaintiffs have failed to state a claim
for negligent misrepresentation.
5. Loss of Consortium
Finally, Mrs. Franzese’s loss of consortium claim is a
See id. at *12.
Given that his claims fail,
so must the loss of consortium claim as well.
dismiss and for judicial notice are both GRANTED.
amendment would be futile.
Accordingly, the Clerk of the Court is directed to
mark this matter CLOSED.
/s/ JOANNA SEYBERT______
Joanna Seybert, U.S.D.J.
23 , 2014
Central Islip, NY
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