Henson v. Wright Medical Technology, Inc. et al

Filing 22

MEMORANDUM-DECISION and ORDER granting in part and denying in part 13 Motion to Dismiss for Failure to State a Claim. Defendants' Motion to dismiss is GRANTED and the third, fourth, seventh and eighth causes of action are DISMISSED WITH PREJU DICE; Defendants' motion to dismiss is GRANTED and the first, fifth and sixth causes of action are DISMISSED WITHOUT PREJUDICE WITH LEAVE TO AMEND; the Defendants' motion to dismiss is DENIED with regard to the second cause of action; Plai ntiff shall file and serve his amended complaint within TEN (10) days of the date of this Memorandum-Decision and Order. The matter is referred to Magistrate Judge Dancks for all further pretrial matters. Signed by Senior Judge Frederick J. Scullin, Jr on 3/28/2013. (lah, )

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF NEW YORK
_____________________________________________
JOSEPH HENSON,
Plaintiff,

v.

5:12-CV-805
(FJS/TWD)

WRIGHT MEDICAL TECHNOLOGY,
INC., a Delaware corporation; and WRIGHT
MEDICAL GROUP, INC., a Delaware
Corporation,
Defendants.
_____________________________________________
APPEARANCES

OF COUNSEL

WILLIAMS & RUDDEROW, PLLC
250 Harrison Street
Suite 302
Syracuse, New York 13202
Attorneys for Plaintiff

MICHELLE E. RUDDEROW, ESQ.
S. ROBERT WILLIAMS, ESQ.

HOWARD & HOWARD
ATTORNEYS, PLLC
450 West Fourth Street
Royal Oak, Michigan 48067
Attorneys for Defendants

MICHAEL O. FAWAZ, ESQ.

HANCOCK ESTABROOK, LLP
100 Madison Street
Suite 1500
Syracuse, New York 13202
Attorneys for Defendants

ASHLEY D. HAYES, ESQ.
JOHN L. MURAD, JR., ESQ.

SCULLIN, Senior Judge

MEMORANDUM-DECISION AND ORDER
I. INTRODUCTION
Currently before the Court is Defendants' motion to dismiss under Rule 12(b)(6) of the
Federal Rules of Civil Procedure. See Dkt. No. 16.1

II. BACKGROUND2
On May 27, 2003, Plaintiff Joseph Henson underwent hip replacement surgery at
Pennsylvania Hospital in Philadelphia, Pennsylvania. See Dkt. No. 1 at ¶ 12. During the
operation, the surgical team implanted a Wright ProFemur Total Hip System (hereinafter the
"Prosthesis") that Defendants designed, manufactured, tested, labeled, marketed, distributed,
and/or sold. See id. at ¶¶ 11, 13. Dr. Jonathan Garino performed the surgery. See id. at ¶ 12.
The Prosthesis included a Wright ProFemur Z size 3 titanium modular femoral neck (the
"Femoral Neck"). Approximately eight years later, the Femoral Neck "suddenly and without
warning failed, broke, and/or fractured," causing Plaintiff to have emergency surgery for a total
hip replacement on May 18, 2011. See id. at ¶¶ 14-15.
Plaintiff thereafter filed this action, asserting various product liability causes of action
arising from his alleged injury. See generally Dkt. No. 1. Reading the complaint broadly,
Plaintiff appears to claim that Defendants (1) failed to warn and/or provide adequate warnings
about the Prosthesis' true risks; (2) defectively designed the Prosthesis; (3) misrepresented the
Prosthesis' qualities and characteristics; (4) breached their duty of care to provide a safely
manufactured product, to notify the Food and Drug Administration ("FDA") of flaws, and to
1

To avoid confusion, the Court's citations to specific page numbers reference the page
numbers that the Court's electronic filing system automatically generates.
2

For purposes of ruling on the instant motion to dismiss, the Court accepts as true all
well-pleaded allegations in the complaint.
2

warn the FDA and Plaintiff of the Prosthesis' defective nature; and (5) are negligent per se for
violations of the Food, Drug, and Cosmetic Act ("FDCA").3 See Dkt. No. 1 at ¶¶ 60-120. On
July 27, 2012, Defendants brought this motion to dismiss the complaint. See Dkt. No. 16

III. DISCUSSION
A.

Standard of review
1. Motion to dismiss
"A motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6) of the Federal

Rules of Civil Procedure tests the legal sufficiency of the party's claim for relief." Lyman v. NYS
OASAS, No. 1:12-CV-530, 2013 U.S. Dist. LEXIS 25828, *7 (N.D.N.Y. Feb. 26, 2013) (citing
Patane v. Clark, 508 F.3d 106, 111-12 (2d Cir. 2007)). In considering the legal sufficiency, a
court must accept all well-pleaded factual allegations in the complaint as true and draw all
reasonable inferences in the plaintiff's favor. See Bell Atlantic Corp. v. Twombly, 550 U.S. 544,
555-56 (2007) (citation omitted). This presumption of truth, however, does not extend to legal
conclusions or "[t]hreadbare recitals of the elements of a cause of action, supported by mere
conclusory statements[.]" Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citation omitted).
To survive a motion to dismiss, the plaintiff need only plead "a short and plain statement
of the claim," see Fed. R. Civ. P. 8(a)(2), with sufficient factual "heft to 'sho[w] that the pleader
is entitled to relief.'" Twombly, 550 U.S. at 557 (quotation omitted). Under this standard, the

3

Plaintiff also alleges that Defendants (1) breached an express warranty in the third cause
of action, see Dkt. No. 1 at ¶¶ 80-87; and (2) defrauded medical personnel and the public to
avoid recalling the Prosthesis and incurring liability in the fifth cause of action, see id. at ¶¶ 94104. In his opposition to this motion, however, Plaintiff concedes that the Court should dismiss
both claims, with the fifth cause of action being dismissed without prejudice. See Dkt. No. 18 at
6, 15-16. The Court, therefore, dismisses the third cause of action with prejudice and the fifth
cause of action without prejudice and grants Plaintiff leave to amend accordingly.
3

pleading's "[f]actual allegations must be enough to raise a right of relief above the speculative
level," id. at 555 (citation omitted), and present "enough facts to state a claim to relief that is
plausible on its face[,]" id. at 570. "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." Iqbal, 556 U.S. at 678 (citation omitted). Indeed, "[w]here 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.'" Id. (quotation omitted).
Ultimately, "when the allegations in a complaint, however true, could not raise a claim of
entitlement to relief," Twombly, 550 U.S. at 558, or where a plaintiff has "not nudged [its] claims
across the line from conceivable to plausible, the[] complaint must be dismissed[,]" id. at 570.

B.

Failure to warn claim (first cause of action)
1. Sufficiency of the pleading
Under New York law, a plaintiff advancing a failure to warn claim must demonstrate that

"'(1) a manufacturer has a duty to warn (2) against dangers resulting from foreseeable uses about
which it knew or should have known, and (3) that failure to do so was the proximate cause of the
harm.'" Reed v. Pfizer, Inc., 839 F. Supp. 2d 571, 575 (E.D.N.Y. 2012) (quoting State Farm Fire
& Cas. Co. v. Nutone, Inc., 426 F. App'x 8, 10 (2d Cir. 2011)) (other citation omitted); see also
Tompkins v. R.J. Reynolds Tobacco Co., 92 F. Supp. 2d 70, 90 (N.D.N.Y. 2000) (stating "New
York courts consider a negligence claim for failure to warn and a strict liability claim for failure
to warn to be equivalent" (citation omitted)). "[A] failure to warn cause of action is
appropriately dismissed if a plaintiff does not plead facts indicating how the provided warnings
were inadequate." Reed, 839 F. Supp. 2d at 575 (citations omitted).

4

At the outset, the Court notes Plaintiff's misguided claim that, "[a]t this early stage of the
litigation, all [he] is required to plead in his failure to warn claim is that the defendants had a
duty to warn the plaintiff, that the defendants breached its duty to warn the plaintiff, and that the
breach of duty was a substantial factor or proximate cause of plaintiff's injury." See Dkt. No. 18
at 10 (citations omitted). The Supreme Court has clearly declared that "[t]hreadbare recitals of
the elements of a cause of action, supported by mere conclusory statements, do not suffice[;]"
and "[w]here 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."'" Iqbal, 556
U.S. at 678 (quotation omitted).
It follows that Plaintiff has insufficiently pled a failure to warn claim because his
allegations lack facts as to "how or why the acknowledged warning was inadequate, that is, about
what risk of harm, or in what way, the acknowledged warning failed to warn." Reed, 839 F.
Supp. 2d at 577; see also Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75 (2d Cir. 1993)
(stating that "[a] plaintiff proceeding under a failure-to-warn theory in New York must
demonstrate that the failure to warn adequately of the dangers of a product was a proximate
cause of his or her injuries" (citation omitted)). Plaintiff alleges, in part, that Defendants failed
to (1) warn health care professionals and the public of the risks associated with the Prosthesis,
including fretting and fracturing; and (2) provide adequate warnings about the Prosthesis' safe
and effective use. See Dkt. No. 1 at ¶¶ 62, 64; see also Reed, 839 F. Supp. 2d at 576 (dismissing
a failure to warn claim where the plaintiff merely alleged, "(1) 'the drug was not accompanied by
adequate warnings;' and (2) the drug was promoted 'without sufficient disclosure of its dangerous
propensities'" (quotation omitted)). Not only are these allegations merely legal conclusions

5

unsupported by factual content, but they also demonstrate nothing more than "a sheer possibility
that [D]efendant[s] ha[ve] acted unlawfully." Ashcroft, 556 U.S. at 678 (citation omitted).
Accordingly, the Court grants Defendants' motion to dismiss this claim but grants
Plaintiff leave to amend.4

2. "Learned intermediary" doctrine
Given Plaintiff's claims that Defendants failed to provide adequate warnings, and this
case involves a medical product, the learned intermediary doctrine applies. See Sita v. Danek
Med., Inc., 43 F. Supp. 2d 245, 259 (E.D.N.Y. 1999) (finding that "plaintiff's 'failure to warn'
claim, whether sounding in negligence or strict liability, is barred under the informed
intermediary doctrine" (citation omitted)). Under the learned intermediary doctrine, a defendant
manufacturer has an obligation to inform the treating physician of the risks of a medical device.
See Glucksman v. Halsey Drug Co., Inc., 553 N.Y.S.2d 724, 726 (1st Dep't 1990) (citation
omitted); see also Steinman v. Spinal Concepts, Inc., No. 05-CV-774S, 2011 U.S. Dist. LEXIS
107286, *26 (W.D.N.Y. Sept. 22, 2011) (stating that "[i]t is well settled with respect to
prescription drugs and medical devices that a manufacturer's duty to warn is owed not [to] the
patient, but to the treating physician as the 'learned intermediary'" (quotation and other citation
omitted)). This doctrine is based on the notion that a physician serves as a learned intermediary
"between the manufacturer and the patient, evaluating the patient's needs, assessing the risks and
benefits of available drugs, and prescribing and supervising their use." Glucksman, 160 A.D.2d

4

To the extent Plaintiff also asserts his failure to warn claim under the theory of
negligence, the Court dismisses such a claim because, "[w]here liability is predicated on a failure
to warn, New York views negligence and strict liability claims as equivalent." Martin v. Hecker,
8 N.Y.2d 1, 8 n.1 (1993) (citation omitted).
6

305, 307 (1st Dep't 1990) (citations omitted). A manufacturer's liability, therefore, is related
directly to the adequacy of the warning provided. See id.
In this case, the Prosthesis is a medical device that only physicians may implant and that
is only available to the public via a prescription, meaning that Defendants distribute information
about the Prosthesis to physicians, not to patients. Although Plaintiff does not appear to deny
that Defendants provided a warning to physicians, he disputes the warnings' adequacy in
conveying the Prosthesis' known or knowable risks. See Dkt. No. 18 at 6. The Court, however,
cannot determine the adequacy of the warnings on a motion to dismiss. Thus, at this pleading
stage, Defendants have not proven that the learned intermediary doctrine bars Plaintiff's claim.
See Smith v. St. Luke's Roosevelt Hosp., No. 08 Civ. 4710, 2009 U.S. Dist. LEXIS 69995, *30
(S.D.N.Y. Aug. 11, 2009) (stating that, in deciding a motion to dismiss, the court's role "'"is
merely to assess the legal feasibility of the complaint, not to assay the weight of the evidence
which might be offered in support thereof"'" (quotation and other citation omitted)).

C.

Misrepresentation claim (fourth cause of action)
New York General Business Law ("GBL") §§ 349 and 350 make unlawful deceptive acts,

practices, and false advertising "in the conduct of any business, trade or commerce or in the
furnishing of any service[.]" N.Y. Gen. Bus. Law §§ 349(a), 350. Although Plaintiff does not
cite to GBL §§ 349 and 350 in the complaint, he does so in his memorandum of law in
opposition to Defendants' motion to dismiss. Compare Dkt. No. 1 with Dkt. No. 18. Even if the
Court were to construe Plaintiff's complaint as alleging causes of action pursuant to §§ 349 and
350, it is clear that these claims are meritless.

7

To state a claim under §§ 349 and 350, the plaintiff must show that the act, practice, or
advertisement was (1) consumer-oriented; (2) misleading in a material respect; and (3) caused
his injury. See Levine v. Landy, 832 F. Supp. 2d 176, 192 (N.D.N.Y. 2011) (quotation omitted).
In addition, for § 350, "'the plaintiff must "point to [a] specific advertisement or public
pronouncement" upon which [the consumer] relied.'" Medisim Ltd. v. BestMed LLC, No. 10 Civ.
2463, 2012 U.S. Dist. LEXIS 169042, *22 (S.D.N.Y. Nov. 28, 2012) (footnote omitted).
In the present matter, Plaintiff neglects to plead the necessary elements of §§ 349 and 350
violations, let alone allege sufficient factual allegations "to raise a right of relief above the
speculative level." Twombly, 550 U.S. at 555 (citation and footnote omitted). Indeed, Plaintiff
merely alleges that (1) Defendants represented the Prosthesis as safe for its intended uses but
knew it was defective and caused "dozens of similar injuries," see Dkt. No. 1 at ¶ 90; (2) they
knew the falsity of their representations about the Prosthesis' safety, which Plaintiff justifiably
relied upon to his detriment, see id. at ¶ 91; and (3) their misrepresentations proximately caused
his injuries, see id. at ¶¶ 92-93. Beyond these flat assertions and conclusory statements, Plaintiff
advances no sufficient allegations regarding how Defendants' alleged deceptive or misleading
business practices harmed consumers. See Stadt v. Fox News Network LLC, 719 F. Supp. 2d
312, 324 (S.D.N.Y. 2010) (finding no GBL § 349 violation where the complaint lacked
allegations that the defendant "harmed consumers or the public interest in any material respect"
(footnote omitted)). He also neglects to identify any specific advertisement or public
pronouncement on which he relied. See N.Y. Gen. Bus. Law § 350.
Accordingly, the Court finds that Plaintiff has failed to state a cause of action for
violations of GBL §§ 349 and 350 and grants Defendants' motion to dismiss this claim.

8

D.

Negligence claim (sixth cause of action)5
In the sixth cause of action Plaintiff alleges that Defendants (1) "had a duty and continue

to owe a duty to plaintiff to provide a safely manufactured product, to notify the FDA of flaws,
and to warn the FDA and plaintiff of the defective nature" of the Prosthesis, see Dkt. No. 1 at
¶ 106; and (2) "breached their duty of reasonable care to [him] by failing to promptly and
adequately notify the FDA . . . of known deficits" with the Prosthesis, id. at ¶ 109. Defendants
argue that, to the extent Plaintiff is stating a negligence claim related to wrongdoings on the
FDA, federal law preempts such a claim. See Dkt. No. 16 at 17-18.
Section 360k(a) of the Medical Device Amendments Act ("MDA") to the FDCA states,
[N]o 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 Act 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
Act.
21 U.S.C. § 360k(a). However, "[t]he MDA does not preempt state-law claims based on medical
devices that received pre-market approval through the FDA's 'substantial-equivalence' review
under § 510(k)." Aaronson v. Am. Med. Sys., Inc., No. 09-CV-2487, 2010 U.S. Dist. LEXIS
92879, *5 n.2 (E.D.N.Y. Sept. 7, 2010) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 492-94,
116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996)); see also Sita, 43 F. Supp. 2d at 261 (explaining that
the § 510(k) clearance process allows "[a] manufacturer [to] circumvent the lengthy pre-market
approval process by establishing that the medical device sought to be marketed is 'substantially

5

Defendants contend that the Court should dismiss the eighth cause of action, which
alleges that they breached their duty to Plaintiff, causing him emotional and physical harm,
because it is merely a claim for damages and is duplicative of the sixth cause of action. See Dkt.
No. 16 at 10; Dkt. No. 1 at ¶¶ 119-20. The Court agrees and, therefore, dismisses the eighth
cause of action.
9

equivalent' to a device that existed on the market prior to the enactment of the FDCA in 1976"
(citing 21 U.S.C. § 360e(b)(1)(B)). Consequently, because the Prosthesis in this case received
§ 510(k) clearance from the FDA on December 13, 2000, the MDA does not preempt Plaintiff's
negligence claim. See Dkt. No. 1 at ¶¶ 21, 23.
Accordingly, the Court denies Defendants' motion to dismiss this claim.

E.

Negligence per se claim (seventh cause of action)
Plaintiff alleges that Defendants are negligent per se for violating §§ 331(a) and

333(a)(1) of the FDCA. See Dkt. No. 1 at ¶ 115. Specifically, Plaintiff contends that Defendants
unlawfully adulterated and/or misbranded the Prosthesis by advertising, marketing, and selling
its product as safe and similar to those on the market without providing warnings about its
known risk of fracturing. See Dkt. No. 18 at 17.
Section 331(a) prohibits, in relevant part, "[t]he introduction or delivery for introduction
into interstate commerce of any . . . device . . . that is adulterated or misbranded." 21 U.S.C.
§ 331(a). Second, § 333(a)(2) sets forth criminal consequences for misbranding. See 21 U.S.C.
§ 333(a)(2) (providing, in relevant part, that "if any person commits [] a violation [of section
301] after a conviction of him under this section has become final, or commits such a violation
with the intent to defraud or mislead, such person shall be imprisoned for not more than three
year or fined not more than $10,000 or both"); see also United States v. Caronia, 703 F.3d 149,
154 (2d Cir. 2012) (stating that "[p]harmaceutical manufacturers and their representatives can
face misdemeanor charges for misbranding or felony charges for fraudulent misbranding"
(citations omitted)). Additionally, although the FDCA does not provide an express or implied
private cause of action, "the Second Circuit has expressly recognized that a private cause of

10

action for per se negligence arises under New York State law upon violation of the FDCA." Sita,
43 F. Supp. 2d at 262 (citing Ezagui v. Dow Chemical Corp., 598 F.2d 727, 733 (2d Cir. 1979))
(other citations omitted). Thus, Plaintiff is entitled to recovery under a theory of per se
negligence, despite Defendants' contention otherwise. See id.
In addition, a defendant is negligent per se if the plaintiff establishes that "(1) [he] is
among the class of people for whose particular benefit a statute had been enacted; (2) recognition
of a private right of action would promote the legislative purpose behind the statute; and (3)
creation of the right would be consistent with the overall legislative scheme. See Prohaska v.
Sofamor, S.N.C., 138 F. Supp. 2d 422, 448 (W.D.N.Y. 2001) (citation omitted).
The Court finds that, although Plaintiff is plainly a member of the class for whose benefit
Congress passed the FDCA, his bare allegations do not plausibly set forth violations of §§ 331(a)
and 333(a)(2). First, Plaintiff's factual allegation that the Prosthesis received § 510(k) clearance
from the FDA on December 13, 2000, contradicts his claim that it is adulterated. See Dkt. No. 1
at ¶ 23; see also 21 U.S.C. § 351 (stating, "[a] . . . device shall be deemed adulterated . . . if it is a
class III device" which, with respect to an intended use, has not received premarket approval or
§ 510(k) clearance). Second, with respect to misbranding, the complaint is void of allegations
that Defendants provided inadequate directions for the Prosthesis' intended use, "including
relevant hazards, effects and side effects, indications and contraindications, and warnings to
medical practitioners cautioning them on how to make use of the device safely and in the manner
in which it is intended to be used." Sita, 43 F. Supp. 2d at 261 (citing 21 U.S.C. § 352(f); 21
C.F.R. §§ 801.4, 801.109 (1993)). Third, it follows that Plaintiff's failure to allege plausible
facts that Defendants violated § 333(a)(2) is fatal to any claim of criminal misbranding in
violation of § 333(a)(1). See 21 U.S.C. § 333(a)(2).

11

Accordingly, the Court grants Defendants' motion to dismiss this claim.

F.

Unavoidably unsafe exception to strict liability
Restatement (Second) of Torts § 402A, comment k ("Comment k"), as adopted in New

York, imposes strict liability on manufacturers of unreasonably dangerous products. See
Restatement (Second) of Torts § 402A, cmt. K. However, it also provides an exception to the
imposition of strict liability for "unavoidably unsafe products." Id. Per the unavoidably unsafe
exception, a manufacturer is not strictly liable for injurious side effects from properly
manufactured prescription drugs, provided they include adequate warnings about potential side
effects and proper directions for use. See Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 61 (4th Dep't
1979).
In this case, Defendants argue that the unavoidably unsafe defense enumerated above
bars all of Plaintiff's non-negligence claims. See Dkt. No. 16 at 1, 3, 5-6. Although Comment k
traditionally applies to prescription medication, Defendants assert that the Prosthesis is
unavoidably unsafe because it is a sophisticated, prescription medical device available only to
physicians. See id. at 5; Dkt. No. 21 at 1-2. To the contrary, Plaintiff argues that Defendants
have insufficiently demonstrated that the unavoidably unsafe exception applies to medical
devices, as they fail to provide supporting legal authority.6 See Dkt. No. 18 at 5.

6

The Court notes the Second Circuit's decision in Bravman v. Baxter Healthcare Corp.,
984 F.2d 71 (2d Cir. 1993). In Bravman, the plaintiffs appealed the district court's decision to
dismiss his claim that his heart valve implant, which the defendant manufactured, suffered
product and design defects and that the defendant violated its duty to warn. See id. at 76.
Contrary to the plaintiffs' arguments, the Second Circuit found that the heart valve "may be
treated, at least at the time of [the plaintiff's] surgery, as an unavoidably unsafe product." Id.
(citing McPheron v. Searle Lab., Inc., 888 F.2d 31, 33 (5th Cir. 1989) (listing courts following
majority rule that medical devices that must be prescribed and inserted by a physician are
unavoidable unsafe products)). Although the Second Circuit ultimately affirmed the dismissal, it
12

Notably, "[t]he fact that a product is sold only to physicians or by prescription is
significant only insofar as it may qualify a product as 'unavoidably unsafe. . .[.]' The
manufacturer still must show that the warning provided specific and detailed information on the
potential hazards of the product . . . [.]" Varveris v. Orthopaedic & Sports Assocs. of Long Is.,
P.C., No. 023193/10, 2011 N.Y. Misc. LEXIS 5042, *6-*7 (N.Y. Sup. Ct. Oct. 21, 2011)
(internal and other citation omitted). Consequently, assuming, without deciding, that the
Prosthesis is an unavoidably unsafe product, Defendants' defense hinges on the adequacy of the
warnings it provided to the medical community, including Plaintiff's physician. See id. at *6
(stating that, "a manufacturer of an 'unavoidably unsafe' product cannot escape liability without
demonstrating that its product was accompanied by proper directions and adequate warnings").
For the reasons previously set forth, the Court cannot determine the adequacy of such warnings
at this stage of the proceedings.
Accordingly, the Court denies Defendants' motion to dismiss on this ground.

IV. CONCLUSION
After carefully reviewing the entire record in this matter, the parties' submissions, and the
applicable law, and for the above-stated reasons, the Court hereby
ORDERS that Defendants' motion to dismiss is GRANTED and the third, fourth,
seventh and eighth causes of action are DISMISSED WITH PREJUDICE; and the Court
further

stated that "the district court findings on the product and design defect claims did not depend
upon th[e] determination" of the heart valve being an unavoidably unsafe product. Id.
13

ORDERS that Defendants' motion to dismiss is GRANTED and the first, fifth, and sixth
causes of action are DISMISSED WITHOUT PREJUDICE and WITH LEAVE TO
AMEND; and the Court further
ORDERS that Defendants' motion to dismiss is DENIED with regard to the second
cause of action;7 and the Court further
ORDERS that Plaintiff shall file and serve his amended complaint within ten (10) days
of the date of this Memorandum-Decision and Order;8 and the Court further
ORDERS that this matter is referred to Magistrate Judge Dancks for all further pretrial
matters.

IT IS SO ORDERED.

Dated: March 28, 2013
Syracuse, New York

7

To the extent that Defendants assert the unavoidably unsafe defense to Plaintiff's first
and second causes of action, the Court denies their motion to dismiss those claims on that
ground.
8

Consistent with this Memorandum-Decision and Order, any amended complaint that
Plaintiff files shall include only those causes of action that he enumerated as the first, second,
fifth, and sixth causes of action in his original complaint.
14