HART v. MEDTRONIC, INC et al
OPINION. Signed by Judge Jerome B. Simandle on 11/30/2017. (tf, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
HONORABLE JEROME B. SIMANDLE
No. 1:16-cv-05403 (JBS-AMD)
MEDTRONIC MINIMED, INC.,
JOHN DOES #1-10,
ABC CORPS. #1-10,
Joseph D. Cronin, Esq.
CRONIN LAW FIRM LLC
1500 John F. Kennedy Boulevard
Philadelphia, PA 19102
Attorney for Plaintiff
Aaron Van Nostrand, Esq.
GREENBERG TRAURIG LLP
500 Campus Drive
P.O. Box 677
Florham Park, NJ 079321
Attorney for Defendants
SIMANDLE, District Judge:
Plaintiff Kevin Hart (hereinafter, “Plaintiff”) brought
this suit against Defendants Medtronic, Inc., Medtronic
International1, and Medtronic Minimed, Inc.2, alleging that an
insulin pump, designed, manufactured and sold by Defendants,
caused serious injuries to Plaintiff. This matter comes before
the Court upon the Defendant’s motion to dismiss Plaintiff’s
Amended Complaint under Rule 12(b)(6), Fed. R. Civ. P..
Item 12.] The primary issue is whether Plaintiff’s common law
tort claims arising from use of a medical device that obtained
premarket approval from the U.S. Food and Drug Administration
(“FDA”) are preempted by federal law, namely, 21 U.S.C. §
360k(a). For the following reasons, the motion to dismiss will
be granted without prejudice to allow Plaintiff one final
opportunity to propose a Second Amended Complaint setting forth
a non-preempted claim, consistent with this Opinion.
A. Factual Background
Kevin Hart, is an adult male residing in New Jersey. (Am.
Comp. ¶ 1.)
Plaintiff suffers from Type I diabetes. (Id. at ¶
Defendants contend that there is no entity named “Medtronic
International.” (Def. Br. at 1, n. 1.)
2 Plaintiff also lists an undetermined amount of fictitious
persons and entities that are unknown at this time.
3 For purposes of the pending motions, the Court accepts as true
the version of events set forth in Plaintiff’s Complaint,
documents explicitly relied upon in the Complaint, and matters
of public record. See Schmidt v. Skolas, 770 F.3d 241, 249 (3d
Cir. 2014). The Court may consider these documents on a motion
to dismiss without converting the motion to one for summary
To help control his diabetes, Plaintiff used the MiniMed
530G insulin pump (the “Pump”) designed, sold, and manufactured
by Medtronic, Inc. and Medtronic MiniMed, Inc. (“Defendants”).
(Id. at ¶ 17.) On April 24, 2014, while Plaintiff was asleep,
his Pump administered a potentially lethal dose of insulin. (Id.
at ¶ 18.) When Plaintiff woke up and realized that he had been
administered too much insulin, he went to the bathroom to
attempt to remedy the situation. (Id. at ¶ 19.) Plaintiff
ultimately lost consciousness, fell to the floor, and entered
into a prolonged seizure. (Id. at ¶ 20.) As a result, Plaintiff
sustained a series of injuries including head lacerations,
severe bruising, severe muscle aches, hearing loss, tinnitus,
chronic headaches, neck pain, nerve pain in the right arm,
cracked teeth, diminished mental acuity and depression, as well
as resulting “extreme economic hardship.” (Id. at ¶¶ 21–22.) To
treat the physical and mental injuries, Plaintiff alleges he
sought the treatment of various specialists, underwent various
diagnostic testing and physical therapy and received a root
canal. (Id. at ¶ 22.)
B. FDA Premarket Approval Process
The medical device at issue is a Class III product that has
gone through the rigorous “Premarket Approval Process” (“PMA)”
before obtaining the FDA’s approval for use, as now described.
The FDA regulates medical devices pursuant to the Medical Device
Amendments (“MDA”) of 1976 to the Food, Drug and Cosmetic Act
(“FDCA”). There are three classes of medical devices intended
for human use -- Class I, Class II and Class III. 21 U.S.C. §
360c. The separate classes represent the different levels of
oversight required by the FDA “depending on the risk [the
device] presents.” Riegel v. Medtronic, Inc., 552 U.S. 312, 316
Class I devices –- elasticbandages, examination gloves,
etc. -- are subject to the lowest level of oversight, for
example, “labeling requirements.” Id.; see also 360c(a)(1)(A).
Class II devices -- powered wheelchairs, surgical drapes, etc. - are subject to more rigorous oversight, such as “performance
standards and post market surveillance measures.” Riegel, 552
U.S. at 316; see also 360c(a)(1)(B). Class III devices -replacement heart valves, pacemakers, etc.—receive the most
Class III devices need to go through a Premarket Approval
that includes manufacturers submitting, 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.”
Riegel, 552 at 318 (citing § 360e(c)(1)).
PMA does not end the oversight process for Class III
devices. If the manufacturer wants to make any changes to the
product it must apply for additional approval from the FDA,
which is evaluated under similar criteria to the premarket
approval. Id. at 319 (citing § 360e(d)(6)). Even if the
manufacturer decides not to make any changes, it is still
subject to reporting requirements such as needing to inform the
FDA of any new clinical investigations concerning the device, or
reporting incidents where the device may have caused death or
serious injury or malfunctioned in a way that would likely
contribute to death or serious injury if the malfunction
occurred again. Id. (citing 21 C.F.R. §§ 814.84(b)(2);
C. MiniMed 530G Insulin Pump
The Pump is classified as a Class III product that has gone
through the PMA approval process, and was approved on September
26, 2014. (Def. Br. at 5.) Since receiving the preapproval,
Defendants have submitted and received approval for multiple
changes to the original device. (Id.)
D. Procedural History
Plaintiff initially filed a Complaint before the Superior
Court of New Jersey, Camden County, on April 18, 2016. (Docket
Item 1 ¶ 1.) On September 6, 2016, Defendant timely removed the
case to federal court alleging diversity jurisdiction pursuant
to 28 U.S. C. § 1332. (Id. at ¶ 6). On November 10, 2016,
Plaintiff filed an Amended Complaint, alleging six causes of
action: (1) Strict Product Liability; (2) Negligent Design and
Manufacture; (3) Post-Sale Negligence; (4) Failure to Test/Warn;
(5) Breach of Warranty; and (6) Punitive Damages. [Docket Item
12.] Defendants filed a Motion to Dismiss, Plaintiff filed his
Opposition, and Defendants filed their Reply. [Docket Items 18;
19; 20.] The motion is decided without oral argument pursuant to
Rule 78, Fed. R. Civ. P..
STANDARD OF REVIEW
Pursuant to Rule 8(a)(2), Fed. R. Civ. P., a complaint need
only contain “a short and plain statement of the claim showing
that the pleader is entitled to relief.” Specific facts are not
required, and “the statement need only ‘give the defendant fair
notice of what the . . . claim is and the grounds upon which it
rests.’” Erickson v. Pardus, 551 U.S. 89, 93 (2007) (citations
omitted). While a complaint is not required to contain detailed
factual allegations, the plaintiff must provide the “grounds” of
her “entitle[ment] to relief,” which requires more than mere
labels and conclusions. Bell Atlantic Corp. v. Twombly, 550 U.S.
544, 555 (2007).
A motion to dismiss under Rule 12(b)(6), Fed. R. Civ. P.,
may be granted only if, accepting all well-pleaded allegations
in the complaint as true and viewing them in the light most
favorable to the plaintiff, a court concludes that the plaintiff
failed to set forth fair notice of what the claim is and the
grounds upon which it rests. Id. A complaint will survive a
motion to dismiss if it contains sufficient factual matter to
“state a claim to relief that is plausible on its face.”
Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009). Although a court
must accept as true all factual allegations in a complaint, that
tenet is “inapplicable to legal conclusions,” and “[a] pleading
that offers labels and conclusions or a formulaic recitation of
the elements of a cause of action will not do.” Id. at 678.
A. Subsumption by the Products Liability Act
First, Plaintiff’s claims for negligent design and
manufacturing (Count Two), post-sale negligence (Count Three)
and failure to test/warn (Count Four) are subsumed by the New
Jersey Products Liability Act (PLA). See N.J.S.A. § 2A:58C1(b)(3). Because they do not constitute viable separate claims
under New Jersey law, they must be dismissed as a matter of law.
The PLA "established the sole method to prosecute a product
liability action" such that "only a single product liability
action remains." Tirrell v. Navistar Int'l, Inc., 248 N.J.
Super. 390, 398-99 (App. Div. 1991). "The language chosen by the
Legislature in enacting the PLA is both expansive and inclusive,
encompassing virtually all possible causes of action relating to
harms caused by consumer and other products." In re Lead Paint
Litig., 191 N.J. 405, 436-47, 924 A.2d 484 (2007). It
"effectively creates an exclusive statutory cause of action for
claims falling within its purview." Repola v. Morbark Indus.,
Inc., 934 F.2d 483, 492 (3d Cir. 1991). It subsumes any cause of
action "for harm caused by a product, irrespective of the theory
underlying the claim, except actions for harm caused by breach
of an express warranty." N.J.S.A. § 2A:58C-1(b)(3). In short,
those former common-law causes of action (with the exception of
breach of express warranty) have merged into a single cause of
action under the PLA.
Because New Jersey law no longer recognizes negligence,
failure to test/warn, and breach of implied warranty as viable
separate claims for harm derived from a defective product, the
Court will dismiss Count Two, Count Three and Count Four of
Plaintiff’s Amended Complaint as a matter of law. What remains
is a single strict product liability claim under the PLA (Count
One), breach of express warranty (Count Five) and a claim for
punitive damages (Count Six). The Court will address such below.
B. FDCA § 360k(a) Preemption
Defendant argues that Plaintiff’s claims, though pled as
state-law claims, are preempted by § 360k(a) of the FDCA. The
Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. (the
"MDA"), expressly preempts certain state law requirements,
Except as provided in subsection (b) of this
section, no State or political subdivision of a
State may establish or continue in effect with
respect to a device intended for human use any
requirement - (1) which is different from, or in addition to, any
requirement applicable under this chapter to the
(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
21 U.S.C. § 360k(a).
In Riegel v. Medtronic, Inc., the Supreme Court provided a
two-step analysis for determining whether a claim is expressly
preempted pursuant to the MDA. 552 U.S. 312, 321-22 (2008).
First, the Court must determine whether the FDA has established
requirements applicable to the medical device at issue. As
relevant here, the Supreme Court has concluded that all Class
III devices are subject to requirements that satisfy this first
step in the analysis. Id. at 322 (“Premarket approval . . .
imposes 'requirements' under the MDA . . . .”); see also Hughes
v. Boston Sci. Corp., 631 F.3d 762, 768 (5th Cir. 2011) ("Riegel
established that any Class III device receiving PMA approval
from the FDA will satisfy this first prong of the test . . . ."
(citing Riegel, 552 U.S. at 322)); Dunstan v. Bayer Essure,
Inc., No. 16-1458, 2017 U.S. Dist. LEXIS 163865, at *40 (E.D.
Pa. Oct. 3, 2017).
Thus, the Court’s express preemption inquiry will focus on
the second step, which dictates that the Court determine whether
Plaintiff’s remaining state common law claims relate to safety
and effectiveness and impose requirements that are "different
from, or in addition to" those imposed by federal law. Riegel,
552 U.S. at 321 (quoting 21 U.S.C. § 360k(a)(1)). Where the
state requirements do relate to safety and effectiveness and are
"different from, or in addition to" the requirements imposed by
federal law, any claims for violation of those state
requirements are expressly preempted. Id. at 330 (quoting and
citing 21 U.S.C. § 360k(a)(1)).
“Since the U.S. Supreme Court's decision in Riegel
addressing preemption of claims involving medical devices,
courts across the country [including the Third Circuit] have
applied 21 U.S.C.S. § 360k(a) broadly, preempting all manner of
claims from strict products liability to negligence.” Millman v.
Medtronic, Civil Action No. 14-cv-1465, 2015 U.S. Dist. LEXIS
21750, at *15 (D.N.J. Feb. 24, 2015)(citing In re Medtronic,
Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d
1147, 1152 (D. Minn. 2009), aff'd, 623 F.3d 1200 (8th Cir.
2010)); see also Williams v. Cyberonics, Inc., 388 F. App'x 169,
171 (3d Cir. 2010) ("Appellants' allegations of strict products
liability based on manufacturing defect and breach of warranty
are pre-empted by the MDA."); Desai v. Sorin CRM USA, Inc., No.
12-2995, 2013 U.S. Dist. LEXIS 5795, 2013 WL 163298, at *4-6
(D.N.J. Jan. 15, 2013)(finding that the plaintiffs' claims under
the N.J. Products Liability Act were preempted); Hayes v.
Howmedica Osteonics Corp., No. 08-6104, 2009 U.S. Dist. LEXIS
131984, 2009 WL 6841859, at *6 (D.N.J. Dec. 15, 2009)(finding
that a failure to warn claim is preempted); Delaney v. Stryker
Orthopaedics, No. 08-03210, 2009 U.S. Dist. LEXIS 16865, 2009 WL
564243, at *3 (D.N.J. Mar. 5, 2009) (holding that "the MDA
preempts products liability claims, including" failure to warn,
defective design, negligence and breach of implied warranty);
Gross v. Stryker, 858 F. Supp. 2d 466, 490 (W.D. Pa.
2012)(stating that breach of implied warranty is a state claim
"that imposes requirements that are different [from], or in
addition to, specific federal requirements"); Bentzley v.
Medtronic, Inc., 827 F. Supp. 2d 443, 453 (E.D. Pa.
2011)(deciding that design defect claims are preempted); Mayen
v. Tigges, 36 Misc. 3d 1231[A], 959 N.Y.S.2d 90, 2012 NY Slip Op
51565[U], 2012 WL 3553378, at *1 (N.Y. Sup. Ct. Aug. 17,
2012)(holding that the plaintiff's state law claims for design
and manufacturing defect, negligent design, failure to warn and
breach of warranties were preempted by the FDA through the PMA
process for Class III medical devices).
However, not all state claims are expressly preempted by
the MDA. Riegel recognized that claims alleging that a
manufacturer failed to adhere to the specifications imposed by a
device's premarket approval are not preempted. Such claims are
not preempted because they merely parallel federal requirements
-- that is, they do not add to or differ from federal
requirements, which is the cornerstone of Food, Drug, and
Cosmetic Act (FDCA) medical device preemption. Riegel, 552 U.S.
at 330(citing 21 U.S.C. § 360k(a)(1)).4
Plaintiff’s reliance upon Medtronic, Inc. v. Lohr, 518 U.S.
470, 502 (1996), for the proposition that “the Supreme Court
held that a plaintiff’s manufacturing and warning defects claims
survived preemption because they were outside of the category of
requirements under § 360(k) [sic]” is incorrect. Lohr involved a
device approved through the FDA’s § 510(k) process, in which the
FDA’s requirements were not specific to the device in question,
Riegel, 552 U.S. at 322, which is inapplicable to the present
pump device that has premarket approval with specific
requirements. Id. at 322-23. Further, Plaintiff’s reliance upon
various prescription drug preemption cases -– namely, Wyeth v.
Levin, 555 U.S. 555 (2009); McDarby v. Merck & Co., 949 A.2d 223
(N.J. App. Div. 2008); and Feldman v. Lederle Labs., 479 A.2d
374 (N.J. 1984) -- for the concept that the MDA does not preempt
state-law remedies for failure to warn in this case is also
misplaced. Each of these cases involves prescription drugs -not medical appliances -- for which Congress has not enacted an
Nevertheless, the parallel claim exception to preemption
requires more than just a change of terminology; a plaintiff
"cannot simply incant the magic words '[Defendant] violated FDA
regulations' in order to avoid preemption." Clements v. SanofiAventis, U.S., Inc., 111 F. Supp. 3d 586, 598 (D.N.J. 2015)
(citing In re Medtronic, 592 F. Supp. 2d 1147, 1158 (D. Minn.
2009)); see also Smith v. Depuy Orthopaedics, Inc., 2013 U.S.
Dist. LEXIS 36776, 2013 WL 1108555, at *12 (D.N.J. Mar. 18,
2013)("[B]road references to federal regulations in pleadings
are insufficient" to properly plead a parallel claim). Rather,
the plaintiff must plead "facts showing action or inaction in
[the] defendants' efforts to take part in the PMA process or
implement its results." Smith, 2013 U.S. Dist. LEXIS 36776, 2013
WL 1108555, at *12 (citations omitted). In short, a "parallel
claim," like any other, is subject to the pleading standards of
Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 167 L. Ed. 2d 929
1. Plaintiff’s strict product liability claim is
preempted by § 360k(a) of the FDCA
In Count One of his Amended Complaint, Plaintiff alleges
that Defendants distributed a product, the pump that “was
defective and negligently designed in that it was not reasonably
express preemption provision. See Wyeth, 555 U.S. at 574-75;
Riegel, 552 U.S. at 327.
fit, suitable or safe for its intended and reasonably
foreseeable purposes and uses.” (Am. Compl. ¶ 32.) Plaintiff
further alleges that the pump “failed to include safe and
appropriate guards or other safeguards to protect Plaintiff and
others from foreseeable risk of injury.” (Id. at ¶ 33.)
Additionally, Plaintiff alleges that the pump was defective “due
to [Defendants’] failure to provide adequate warnings and/or
instructions regarding the risks and dangers of the pump during
intended and reasonably foreseeable uses, and by failing to
adequately test the design from a safety standpoint.” (Id. at ¶
34.) Lastly, Plaintiff alleges that Defendants should be held
strictly liable because the pump “was defective from a
manufacturing standpoint in that it failed to conform to
customer specifications and/or omitted expected safety features
required by the stand of reasonable care.” (Id. at ¶ 35.)
As noted above, since the insulin pump was cleared for sale
through the PMA process, it is subject to federal requirements
within the meaning of § 360k(a) of the MDA. See Riegel, 552 U.S.
at 322. In alleging that the pump was defective for failing to
contain sufficient safeguards, for failing to offer adequate
warnings or instructions, or for failing to have undergone
adequate testing of the design for safety, Plaintiff is bringing
into question the testing, design, manufacturing and warning
specifications that the FDA approved and requires for this Class
III medical device. To permit such state law causes of action
would impose requirements different from, or in addition to, the
FDA requirements for this very device. This is precisely what §
360k(a) preempts. Accordingly, Plaintiff’s PLA strict product
liability claims are expressly preempted by § 360k(a). Id.
As noted above, there is a narrow exception for a
"parallel" claim, e.g., "a damages remedy for claims premised on
a violation of FDA regulations." Riegel, 552 U.S. at 330. Thus,
in order to hold Defendants liable, Plaintiffs must plead "facts
showing action or inaction in [the] defendants' efforts to take
part in the PMA process or implement its results." Smith, 2013
U.S. Dist. LEXIS 36776, 2013 WL 1108555, at *12 (citations
omitted). The Court finds that Plaintiff has failed to do so. In
fact, with regard to the PMA process, Plaintiff merely pleads
that “[t]he mere fact [that] there was ‘pre-market approval’
does not mean that the specific device was not defective and
this is not enough to overcome this claim.” (Am. Compl. ¶ 29.)
Nowhere in Plaintiff’s Amended Complaint does Plaintiff set
forth facts that can be construed as alleging that Defendants
violated the FDA regulations. Moreover, the Court finds that
Plaintiff’s brief in opposition to Defendants’ motion to dismiss
is also void of such facts that could support a claim for
violating the FDA regulations pertaining to the warnings,
manufacture or sale of this device. Therefore, the Court finds
that Plaintiff’s PLA strict product liability claim fails to
attempt to set forth a “parallel claim” and it must be
dismissed, as it is expressly preempted by § 360k(a) of the
2. Plaintiff’s breach of express warranty claim is
preempted by § 360k(a) of the FDCA
An express warranty claim is not preempted under the MDA if
a Plaintiff can show that Defendants made "voluntary statements"
that were "not approved by the FDA or mandated by the FDA about
the use or effectiveness" of a medical device. See Cornett v.
Johnson & Johnson, 211 N.J. 362, 392 (2012). At this juncture,
Plaintiff need only meet the minimal pleading standards of Fed.
R. Civ. P. 8 and Twombly. The Court finds that Plaintiff has
failed to do so.
Under New Jersey law, a claim for breach of express
warranty has three essential elements: "(1) that Defendant made
an affirmation, promise or description about the product; (2)
Similarly, the Court has searched Plaintiff’s Opposition Brief
for some elaboration of claims set forth in the Amended
Complaint. Plaintiff’s argument focuses upon failure to warn of
the risks and danger of users “injecting themselves with an
overdose of insulin.” (Pl. Br. at 4.) Thus, Plaintiff argues
that Defendants failed to warn him of dangers and risks
associated with using the MiniMed 530G insulin pump. (Id. at 5.)
Plaintiff does not allege that Defendant failed to provide the
instructions and warnings approved and required by the FDA for
this device. To allege that the FDA’s instructions and warnings
on this Class III medical device emerging from the PMA process
were inadequate or failed to balance safety and efficacy is to
allege a claim that is preempted by 21 U.S.C. § 360k(a).
that this affirmation, promise or description became part of the
basis of the bargain for the product; and (3) that the product
ultimately did not conform to the affirmation, promise or
description." Snyder v. Farnam Companies, Inc., 792 F. Supp. 2d
712, 721 (D.N.J.2011) (citing N.J. Stat. Ann. § 12A:2-313).
In a rather boiler plate fashion, Plaintiff merely alleges
that Defendants “expressly and impliedly represented to
Plaintiff that [the pump] was safe and proper for its intended
use and purpose, and guaranteed to the ultimate consumer or user
that [the pump] was of merchantable quality.” (Am. Compl. ¶ 53.)
Most notably, Plaintiff’s Amended Complaint is void of any
factual allegation that Defendants made any identifiable
voluntary statements that were unapproved by the FDA regarding
the safety or use of the pump.6 Thus, in the absence of claiming
a breach of the representations required by the FDA for this
device (a “parallel claim”) or an assertion that Defendants made
Likewise, Plaintiff’s Opposition Brief does not argue that
Defendants made promises to the user that were beyond those
appearing in the FDA-approved instructions and warnings.
Instead, Plaintiff asserts that those instructions and warnings
contained in the “User Safety” sections of Defendants’ MiniMed
530G System User Guide, attached to Pl. Br. at Ex. B, were
themselves inadequate or incomplete, because there was “no
warning that the pump could deliver a fatal dose of insulin.”
(Pl. Br. at 6.) Again, such a claim does not sound in express
warranty because it is based on an omission but even if it did,
this claim is preempted because it takes issue with the adequacy
of the FDA-approved warning on this Class III medical device
issued under the PMA process. Therefore, the “warranty” claim is
preempted by § 360k(a).
voluntary promises not required by the FDA and breached them,
imposing liability on Defendants would amount to the improper
imposition of safety requirements "different from, or in
addition to” the requirements imposed by federal law. Riegel,
552 U.S. at 330. For this reason, the Court finds that
Plaintiff’s expressed warranty claim must be dismissed, as it is
preempted by § 360k(a)of the FDCA.
3. Plaintiff’s punitive damages claim must be
A request for punitive damages is "similar to a derivative
claim," and thus a "separate but dependent claim for relief." In
re Collins, 233 F.3d 809, 811 (3d Cir. 2000). Because all of
Plaintiff's substantive claims are dismissed, his claim for
punitive damages must be dismissed as well.
For the foregoing reasons, the Court will dismiss
Plaintiff’s claims without prejudice.7 An appropriate Order shall
issue on this date.
November 30, 2017
s/ Jerome B. Simandle
JEROME B. SIMANDLE
U.S. District Judge
Plaintiff has not sought leave to further amend the Amended
Complaint. However, the Court does not rule out that Plaintiff
may be able to cure these pleading deficiencies. Plaintiff, who
claims significant and permanent injuries, will be given one
final opportunity to state a claim that is not preempted by §
360k(a). If Plaintiff seeks to amend a non-preempted claim -such as a parallel claim for breach of the FDA’s requirements
for this medical device, see, e.g., Riegel, 552 U.S. at 330 -then Plaintiff shall file a motion to amend the Amended
Complaint within twenty-one(21) days hereof. While the Court
does not find that any further attempt to amend would be futile,
counsel shall be mindful that any proposed Second Amended
Complaint must be consistent with this Opinion and must conform
to the requirements of Rule 11, Fed. R. Civ. P., containing a
reasonable basis in fact and law formed after due investigation.
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