I. INTRODUCTION
Plaintiff, Furnie Oden ("Plaintiff"), brings the instant action seeking monetary damages against Defendant, Boston Scientific Corporation ("Defendant"), based upon claims of negligence, strict liability (based upon theories of defective design, defective manufacture and failure to warn), breach of express and implied warranties, fraudulent misrepresentation and concealment, negligent misrepresentation, violation of New York General Business Law ("GBL") Sections 349 and 350 and punitive damages. See generally Complaint ("Compl.") [DE 1]. Presently before the Court is Defendant's motion to dismiss the Complaint in its entirety in accordance with Fed. R. Civ. P. 12(b)(6) for failure to state a claim upon which relief may be granted. See Notice of Motion [DE 6]. Plaintiff opposes the motion. For the reasons that follow, Defendant's motion is GRANTED.
II. FACTUAL BACKGROUND
The following factual allegations have been taken from the Complaint. All facts alleged by the Plaintiff are assumed to be true for purposes of deciding the motion to dismiss and are construed in a light most favorable to the Plaintiff as the non-moving party. See, e.g., LaFaro v. N.Y. Cardiothoracic Grp. ,
On January 1, 2008, after being hospitalized for deep vein thrombosis and pulmonary embolisms, Plaintiff underwent a surgical procedure involving the implantation of an Inferior Vena Cava ("IVC") filter.
According to Plaintiff, "Defendant state[s] on different sources that [its] filters were 'Trusted Performance, Timeless Design' and emphasizes [its] filter's design in protection against certain complications." Id. ¶ 67. However, Plaintiff asserts that "Defendant knew its IVC filters were defective in design and knew that the defect was attributable to the design's failure" but that "Defendant failed to disclose to physicians, patients, or Plaintiff in detail that its permanent IVC filter, the Greenfield Filters, were subject to breakage, collapse, migration, causing thrombus and/or the appropriate degree of risk of damage to the vena cava wall and other complications." Id. ¶¶ 68-69. In addition, Plaintiff claims that "Defendant concealed the known risks and failed to warn of known or scientifically knowable dangers and risks associated with the ... Greenfield Filter." Id. ¶ 71. Moreover, "Defendant failed to provide sufficient warnings and instructions that would have put Plaintiff ... on notice of the dangers and adverse effects caused by implantation of the Greenfield Filter." Id. ¶ 72. Specifically, Plaintiff states that Defendant's "brochure and instructions for us[e], lacked any notable warnings or indication to the full extent of risks and hazards related to [the] Greenfield Filter." Id. ¶ 73.
According to Plaintiff, "the complications [he is experiencing] can be attributable to the Greenfield Filter [and include] the increased risk of DVT despite the implanted device, constant pains in the abdominal region, the risk of the filter migrating to [ ] other parts of the vena cava, heart, lungs or other organs, DVT, fracture or breakage of the filter, perforation of the vena cava or other soft tissue...." Id. ¶ 75.
III. DEFENDANT'S MOTION TO DISMISS
A. Standard of Review
In deciding a motion to dismiss pursuant to Rule 12(b)(6), the Court must liberally construe the claims, accept all factual allegations in the complaint as true, and draw all reasonable inferences in favor of the plaintiff. See Aegis Ins. Servs., Inc. v. 7 World Trade Co., L.P. ,
The Supreme Court clarified the appropriate pleading standard in Ashcroft v. Iqbal ,
In adjudicating a Rule 12(b)(6) motion to dismiss, the Court must limit itself to facts alleged in the complaint, which are accepted as true; to documents attached to the complaint as exhibits or incorporated in the complaint by reference; to matters of which judicial notice may be taken; or to documents whose terms and effect are relied heavily upon in the complaint and, thus, are rendered "integral" to the complaint. Chambers v. Time Warner, Inc. ,
B. Preliminary Issues
1. Consideration of Additional Materials
As an initial matter, Defendant has appended extrinsic documentation to its motion papers for the Court's consideration. However, as the Court is only permitted to consider a narrow universe of documents outside of or otherwise attached to the Complaint, see ASARCO LLC ,
C. Discussion
1. Negligence & Strict Products Liability Claims
Plaintiff has interposed claims based upon theories of negligence and strict liability. Under New York law, a Plaintiff's claim based upon an alleged design defect or manufacturing defect sounding in either negligence or strict liability are functionally equivalent and will be analyzed concurrently. See Jarvis v. Ford Motor Co. ,
Applying New York law, there are four theories under which a plaintiff may pursue a recovery based upon a claim of products liability: (1) strict liability; (2) negligence; (3) express warranty and (4) implied warranty. Hilaire v. DeWalt Indus. Tool Co. ,
There are three types of defects recognized under New York law: (1) design defects; (2) manufacturing defects; and (3) defective or inadequate warnings. Voss ,
a. Design Defect
"A defectively designed product is one which, at the time it leaves the seller's hands, is in a condition not reasonably contemplated by the ultimate consumer and is unreasonably dangerous for its intended use; that is one whose utility does not outweigh the danger inherent in its introduction into the stream of commerce." Scarangella v. Thomas Built Buses, Inc. ,
Plaintiff's design defect claim fails since he has not pleaded sufficient facts satisfying the first and second elements of this cause of action. Turning to the first element, Plaintiff fails to "identify a particular problem in the design of [the Greenfield Filter]" and his attempts to merely plead that the Greenfield Filter is "defective" are insufficient to meet the required plausibility standard as set forth in Iqbal and Twombly. Guariglia ,
Plaintiff's design defect claim also fails on the independent ground that the Complaint does not plead the existence of a feasible alternative design. See Cowan ,
Based upon the foregoing, Plaintiff's negligence and strict liability claims premised upon a design defect theory are dismissed.
b. Manufacturing Defect
"To plead and prove a manufacturing flaw under either negligence or strict liability, the plaintiff must show that a specific product unit was defective as a result of 'some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction,' and that the defect was the cause of plaintiff's injury." Colon ex rel. Molina v. BIC USA, Inc. ,
In support of this claim, Plaintiff pleads that the "Greenfield Filter... contained a condition or conditions, which Defendant did not intend, at the time it left Defendant's control and possession" and that a "malfunction of the Defendant's IVC filter, while implanted in Plaintiff, resulted in his subsequent injuries and health problems." Compl. ¶¶ 107, 109; see also id. ¶ 110 (stating that "as a result of the condition or these conditions, the product injured Plaintiff and failed to perform as safely as the ordinary consumer would expect...."). These claims are conclusory since they fail to allege a specific manufacturing defect affecting the Greenfield Filter implanted in Plaintiff as compared to other Greenfield Filters that were produced by Defendant. Rather, the Complaint merely alleges that some "condition or conditions" existed that ultimately caused Plaintiff's injuries. However, this vague assertion fails to place Defendant on notice as to what the particular error in the manufacturing process was or, at the very least, what component or components of the Greenfield Filter deviated from Defendant's manufacturing standards when compared with a other Greenfield Filters. See Cowan ,
Based upon the foregoing analysis, Plaintiff's negligence and strict liability claims premised upon a manufacturing defect theory are dismissed.
c. Failure to Warn
Pursuant to New York law, "a plaintiff may assert that a product is defective because the manufacturer failed to provide adequate warnings regarding the risks and dangers associated with the use, or foreseeable misuse, of its product." Sorto-Romero ,
Plaintiff's Complaint contains numerous conclusory allegations in support of this claim, including that "Defendant failed to provide sufficient warnings and instructions," Compl. ¶ 72, that "Defendant knew or should have known, and adequately warned that its product created a risk of serious and dangerous side effects, including but not limited to, the migration of the filter to the other parts of the vena cava, heart or other organs, DVT, blood clots, facture or breakage of the filter and other complications," id. ¶ 116, that "[t]he warnings given did not accurately reflect the risk, incidence, symptoms, scope or severity of such injuries to the consumer," id. ¶ 117, that the product brochure differs from the instructions for use since it "only provides limited information [concerning] possible complications from the use of the IVC filter," id. ¶¶ 126-27, and that "Defendant's warnings page on their website which possibly reflects the warning given in their [instructions for use lists only] general complications and adverse events
The "Instructions for Use" included with the Greenfield Filter contain a section entitled "Potential Complications" which sets forth "[p]otential complications associated with the use of vena cava Filters." Vicari Decl., Ex. B at 9; Ex. C at 8. The list of complications include many of the same risks alleged in the Complaint. Compare id. Ex. B at 9; Ex. C at 8 with Compl. ¶¶ 75, 123, 235. Indeed, while Plaintiff alleges that Defendant "failed to properly warn consumers properly of the increased risks of fracture or migration of the IVC filter, perforation of the heart, lungs, other vital organs, the wall of the vena cava tissue, cardiac or pericardial tamponade, chest pain, shortness of breath, severe recurrent pulmonary embolism and DVT, occlusion or clogging on the IVC filter, subsequent revision surgeries, difficultly or impossibility of removal, and possibly death," Compl. ¶ 135, the "Potential Complications" place the physician on notice of many of these potential risks. See Vicari Decl., Ex. B at 9; Ex. C at 8 (setting forth risks associated with use of the device including: placement of the Filter, movement or migration of the Filter, formation of clots which "could result in complete blockage of blood flow," Hematoma or bleeding, infection, potential migration of the Filter, perforation of the vena cava, adjacent blood vessels or organs, pulmonary embolism, air embolism, thrombosis and death). In addition, contrary to Plaintiff's allegations, the product brochure contains a nearly identical section entitled "Potential Adverse Events" which includes many of the same complications as set forth in the Instructions for Use. See Vicari Decl., Ex. F (product brochure). Although the web page for the Greenfield Filter does not set forth the above potential complications directly, there is a clearly delineated link to a "Key Resources" section which includes relevant "Indications, Safety, and Warnings." Id. , Ex. G (Greenfield Filter Webpage).
Notwithstanding these warnings, the Complaint fails to provide facts identifying how or why the included warnings were inadequate. Although Plaintiff claims that Defendant failed to warn or otherwise provided inadequate warnings of all of the aforementioned risks, the Complaint is silent as to how the warnings that were indisputably provided, both in Defendant's Instructions for Use as well as the product brochure, were inadequate. Moreover, Plaintiff has failed to provide the necessary factual nexus showing how the warnings that were provided were insufficient since merely "asserti[ng] that warnings were not 'adequate' or 'sufficient' are nothing more than legal conclusions...." Reed ,
Nor does the Complaint contain any nonconclusory allegations that Plaintiff's treating physician was not adequately informed or apprised of the potential risks associated with the Greenfield Filter especially in light of the printed warnings contained in the Directions for Use and product brochure. See Compl. ¶¶ 118, 121, 133 (setting forth conclusory assertion that "Defendant failed to adequately warn the medical community and consumers of the defective product"); Banker v. Hoehn ,
Based upon the foregoing, Plaintiff's negligence and strict liability claims premised upon a failure to warn theory are dismissed.
2. Breach of Express Warranty
"For a breach of express warranty claim to survive a motion to dismiss, Plaintiff must allege that 'there was an affirmation of fact or promise by the seller, the natural tendency of which was to induce the buyer to purchase and that the warranty was relied upon to [Plaintiff's] detriment.' " Cowan ,
Plaintiff alleges that "Defendant expressed in [its] literature, advertisements, [ ] promotions and through representations by their marketing team and sales agents that Greenfield Filters were safe, effective and fit for implantation into the IVC to prevent PE and DVT for which they were designed, manufactured and marketed." Compl. ¶ 140. According to Plaintiff, "Defendant's webpage makes claims about the filter such as it[s] [ ] 'Proven Stability,' 'Established Filter Performance' and 'Filter Design promotes Clot Lysis.' " The available product brochure,
Assuming these statements, as contained in Defendant's brochure and website, rose to the level of material statements amounting to a warranty, Plaintiff's allegations insufficiently plead his reliance either directly or through his physician intermediary on this warranty as a basis for the contract with the immediate seller. See Goldemberg ,
In light of the fact that Plaintiff has failed to sufficiently plead facts permitting the inference that he or his physicians relied on the statements set forth on Defendant's website and/or product brochure, Plaintiff's breach of express warranty claim is dismissed.
3. Breach of Implied Warranty of Merchantability
In order for a plaintiff to plead a claim based upon breach of an implied warranty, the following elements must be alleged: (1) that the product was defectively designed or manufactured; (2) that the defect existed when the manufacturer delivered it to the purchaser or user; and (3) that the defect was the proximate cause of the injury. Cavanagh ,
As a breach of implied warranty claim requires that Plaintiff plead sufficient factual allegations that the Greenfield Filter was defectively designed or manufactured, and as the Court has previously found that Plaintiff has failed to plead the necessary predicate elements to support his design and manufacturing defect claims, see supra at 889-91, Plaintiff's
In light of the foregoing analysis, Plaintiff's claim premised upon the breach of implied warranty of merchantability is dismissed.
4. Breach of Implied Warranty of Fitness
"[T]he implied warranty of fitness for a particular purpose does not arise in every consumer sale, but only when a seller knows or has reason to know the particular purpose for which a buyer requires goods, and also knows or should know that the buyer is relying on his special knowledge." Catalano v. BMW of N. Am., LLC ,
Having reviewed the allegations underlying this claim, see Compl. ¶¶ 166-173, it is evident that this cause of action does not satisfy the flexible plausibility standard required by Iqbal . Apart from the fact that the allegations are altogether conclusory, the Complaint fails to plead that the Defendant was made aware of the particular purpose for which Plaintiff purchased the Greenfield Filter. See Guariglia ,
Since Plaintiff has failed to plead that Defendant knew of a particular purpose for which Plaintiff purchased the Greenfield Filter or that Plaintiff and/or his physicians were relying upon Defendant's specialized skill and judgment, Plaintiff's claim premised upon this theory fails as a matter of law.
5. Fraudulent Misrepresentation
In order to state a claim sounding in fraud under New York law, a plaintiff must set forth facts illustrating "[1] a misrepresentation or a material omission of fact which was false and known to be false by defendant, [2] made for the purpose of inducing the other party to rely upon it, [3] justifiable reliance of the other party on the misrepresentation or material omission, and [4] injury." Premium Mortg. Corp. v. Equifax, Inc. ,
The Second Circuit has clarified that "[a]llegations of fraud are subject to a heightened pleading standard. When alleging fraud, 'a party must state with particularity the circumstances constituting fraud,' Fed. R. Civ. P. 9(b), which we have repeatedly held requires the plaintiff to '(1) specify the statements that the plaintiff contends were fraudulent, (2) identify the speaker, (3) state where and when the statements were made, and (4) explain why the statements were fraudulent.' " Nakahata v. New York-Presbyterian Healthcare System, Inc. ,
Although Plaintiff's Complaint contains numerous generalized allegations of Defendant's purported fraudulent misrepresentations, see Compl. ¶¶ 174-191, these statements fail to adequately "identify the speaker, state where and when the statements were made (or were viewed), and explain why the statements were fraudulent." Nakahata ,
In any event, even had the Complaint adequately pleaded the alleged fraudulent misrepresentations in accordance with Rule 9(b), Plaintiff's claim would still fail to pass muster given that Plaintiff has not sufficiently alleged the requisite justifiable reliance on the Defendant's published statements. While the Complaint states that "Defendant knew and expected that recipients of that information would rely on the information[,] that the recipients would take action based upon the information" and that the "misrepresentations or omissions were made to Plaintiff [ ], to Plaintiff's physicians and the medical community, all of whom justifiably and foreseeably relied on those representations or missions," Compl. ¶¶ 186, 190, these allegations are no more than conclusory statements asserted as fact. Indeed, they provide no indication as to whether and, if so, when Plaintiff actually read either the statements on the website and brochure and, if he did, whether he justifiably relied on those specific statements to his detriment. Likewise, the allegations contain no facts setting forth whether Plaintiff's physicians ever reviewed and directly relied upon these same materials prior to making the decision to implant Defendant's Greenfield Filter inside Plaintiff. Without such facts, Plaintiff's fraudulent misrepresentation claim cannot proceed. See Lazard Freres & Co. v. Protective Life Ins. Co.,
Based upon the foregoing analysis, Plaintiff's claim of fraudulent misrepresentation is dismissed.
6. Fraudulent Concealment
"The elements of a fraudulent concealment claim under New York law are: (1) a duty to disclose material facts; (2) knowledge of material facts by a party bound to make such disclosures; (3) failure to discharge a duty to disclose; (4) scienter; (5) reliance; and (6) damages." De Sole v. Knoedler Gallery, LLC ,
"[L]ike a claim for fraud, a 'claim of fraudulent concealment must be [pleaded] with particularity, in accordance with the heightened pleading standards of Fed. R. Civ. P. 9(b).' " Warren v. John Wiley & Sons, Inc. ,
In support of his claim of fraudulent concealment, Plaintiff alleges that "Defendant fraudulently concealed and intentionally omitted [certain] material information," Compl. ¶ 204 (setting forth subparts a-k which consist of alleged omissions), and that Defendant "was under a duty to disclose [that information] to Plaintiff [ ], and Plaintiff's physicians...." Id. ¶ 205. However, Plaintiff has failed to plead, with particularity, "(1) what the omissions were; (2) the person responsible for the failure to disclose; (3) the context of the omissions and the manner in which they misled the plaintiff; and (4) what the defendant obtained through the fraud." Woods ,
Plaintiff also does not adequately plead that Defendant had a duty to disclose material facts. See De Sole ,
The Complaint states only that "Defendant was under a duty to disclose to Plaintiff [ ], and Plaintiff's physicians" and that "Defendant had sole access to material facts concerning the defective nature of the product and its propensity to cause serious and dangerous side effects." Compl. ¶¶ 205-206. Thus, it appears Plaintiff is attempting to plead the existence of
For the foregoing reasons, Plaintiff's claim premised upon a theory of fraudulent concealment is dismissed.
7. Negligent Misrepresentation
In order to state a claim for negligent misrepresentation arising under New York law, a plaintiff must put forth facts sufficient to illustrate that "(1) the defendant had a duty, as a result of a special relationship, to give correct information; (2) the defendant made a false representation that he or she should have known was incorrect; (3) the information supplied in the representation was known by the defendant to be desired by the plaintiff for a serious purpose; (4) the plaintiff intended to rely and act upon it; and (5) the plaintiff reasonably relied on it to his or her detriment." Hydro Inv'rs, Inc. v. Trafalgar Power Inc. ,
In addition, "[l]ike fraud, negligent misrepresentation claims must comport with Rule 9(b)." Boco v. Argent Mortg. Co., LLC , No. 13-CV-1165,
Plaintiff has failed to allege these claims with the specificity required by Rule 9(b). See Nakahata ,
Thus, Plaintiff's claim premised upon a theory of negligent misrepresentation is dismissed.
8. Claims Premised Upon GBL §§ 349 and 350
Section 349 of New York's General Business Law ("GBL") prohibits "[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service in this state." GBL § 349(a). Likewise, GBL Section 350 prohibits "[f]alse advertising in the conduct of any business, trade or commerce or in the furnishing of any service in this state." GBL § 350. In order to state a claim pursuant to either statutory section, a plaintiff must allege that "a defendant has engaged in (1) consumer-oriented conduct that is (2) materially misleading and that (3) [the] plaintiff suffered injury as a result of the allegedly deceptive act or practice." Daniel v. Mondelez Int'l, Inc. ,
The rationale behind these statutes is to prevent " 'wrongs against the consuming public' and 'halt[ ] consumer frauds at their incipiency without the necessity to wait for the development of persistent frauds[.]' " Saggio ,
"Claims under GBL sections 349 and 350 are not subject to the pleading-with-particularity requirements of Rule 9(b)." Daniel ,
Assuming, arguendo , that Plaintiff has adequately pleaded the first and second elements, this cause of action fails because Plaintiff has not sufficiently pleaded causation. Although Plaintiff sets forth certain statements contained on Defendant's website and in its product brochure, see Compl. ¶¶ 126-132, 141-147, 177-184, 204, these allegations neither explicitly state nor permit the plausible inference that Plaintiff actually saw these statements prior to making the determination (in conjunction with his physicians) to purchase the Greenfield Filter. See, e.g., id. ¶ 73 ("Defendant's brochure and instructions for us[e], lacked any notable warnings ..."); ¶ 127 ("Defendant's product brochure provides limited information [concerning] possible complications from the use of the IVC filter."); ¶ 128 ("Defendant's warnings on their website ... only list general complications and adverse events but fail to warn and state the actual extent of potential injuries...."); ¶ 141 ("Defendant's relevant webpage pertaining to the IVC filter ... includes a PDF brochure available for public download that assures the Greenfield Filter of its intended functions ... [and] explicitly warrants Defendant's device as having 'Trusted Performance, Timeless Design.' "); ¶ 209 ("Plaintiff and Plaintiff's physicians, prior to the date of Plaintiff's implant surgery, relied on the Defendant's representations about the product...."). None of these allegations provides any indication that Plaintiff ever saw these statements and, to the extent he did, where, when and how Plaintiff came to view either the website or the product brochure. In other words, the relevant factual background to support the above statements is simply lacking. As a result, Plaintiff has failed to sufficiently plead the third element of this claim. See Goldemberg ,
Based upon the foregoing analysis, Plaintiff's claims premised upon GBL §§ 349 and 350 are dismissed.
9. Punitive Damages Claim
Under New York law, "a demand for punitive damages does not amount to a separate cause of action for pleading purposes." Mahar v. U.S. Xpress Enterprises, Inc. ,
10. Leave to Replead
Plaintiff seeks leave to amend the Complaint. Pl.'s Opp'n at 19. "Under Rule 15(a), leave to amend shall be freely given when justice so requires." TechnoMarine SA v. Giftports, Inc. ,
Here, Plaintiff has failed to provide the Court with any indication as to how leave to amend would cure the deficiencies in the Complaint. See Pl.'s Opp'n at 19 (requesting leave to amend but failing to articulate how further amendment would cure deficiencies); TechnoMarine SA ,
For these reasons, Plaintiff's request to amend his Complaint is denied.
IV. CONCLUSION
Based upon the foregoing analysis, Defendant's motion to dismiss the Complaint is GRANTED in its entirety. The Clerk of the Court is directed to close this case.
SO ORDERED.
Notes
According to the Complaint, the Inferior Vena Cava "is a vein that returns blood to the heart from the lower extremities" and that certain individuals can experience "blood clots or thrombi [that] travel from the blood vessels in the leg and pelvis, through the IVC and into the lungs, causing a pulmonary embolism ("PE")." In addition, "these thrombi also can develop in the deep leg veins and are referred to a[s] deep vein thrombosis ("DVT")." At risk individuals are generally prescribed anticoagulants but for "individuals who are at a high risk for PE and/or DVT or for whom anticoagulants are contraindicated, doctors may recommend implantation of an IVC filter to reduce the risk of a thrombotic event." An IVC filter is a device which is "designed to prevent blood clots from traveling from the lower extremities to the hear and lungs. It is inserted in the IVC and works by trapping and filtering clots that form in the lower portions of the body. Compl. ¶¶ 29-32; see ¶ 36 ("The Greenfield Filter, which was designed, manufactured, distributed, marketed, and/or sold by the Defendant "is a permanently implanted medical device designed to prevent pulmonary embolism and DVT, and is designed to protect from perforation of the vena cava wall, and to protect from filter migration.").
Plaintiff concedes that the brochure "might not be the same brochure given to Plaintiff at the time of his implant...." Compl. ¶ 142.
"A 'particular purpose' differs from the ordinary purpose for which the goods are used in that it envisages a specific use by the buyer which is peculiar to the nature of his business whereas the ordinary purposes for which goods are used are those envisaged in the concept of merchantability and go to uses which are customarily made of the goods in question." For example, shoes are generally used for the purpose of walking upon ordinary ground, but a seller may know that a particular pair was selected to be used for climbing mountains.
In any event, Plaintiff's request to amend, contained solely in his opposition memorandum, is procedurally defective since "a bare request to amend a pleading contained in a brief, which does not also attach the proposed amended pleading, is improper under Fed. R. Civ. P. 15." Koehler v. Metro. Transportation Auth. ,
