Opinion
Civil Action 21-10241-MLW
03-01-2022
PAUL CUNNINGHAM, Plaintiff, v. ABBOTT VASCULAR, INC., Defendant.
REPORT AND RECOMMENDATION ON DEFENDANT'S MOTION TO DISMISS [DOCKET NO. 12]
JENNIFER C. BOAL, United States Magistrate Judge.
Defendant Abbott Vascular, Inc. (“Abbott”) has moved to dismiss plaintiff Paul Cunningham's complaint pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Docket No. 12. I heard oral argument on December 20, 2021 and February 15, 2022. For the following reasons, I recommend that Judge Wolf grant the motion.
Because this Court has denied Cunningham's motion to amend the complaint, this report and recommendation addresses the original complaint. See Docket No. 1-3.
On October 13,2021, Judge Wolf referred this case to the undersigned for full pretrial management, including report and recommendation on dispositive motions. Docket No. 31.
Because this matter is before the Court on a motion to dismiss for failure to state a claim, the Court “recite[s] the facts as alleged in the plaintiff's] complaint, accepting all well-pleaded facts as true and drawing all reasonable inferences in favor of the non-moving party.” Abdisamad v. City of Lewiston, 960 F.3d 56, 57 (1st Cir. 2020) (quoting Squcri v. Mount Ida Coll., 954 F.3d 56.61 (1st Cir. 2020)).
On or about November 30, 2017, Cunningham suffered a serious heart attack. Complaint at ¶ 3. He was rushed by ambulance to the Beth Israel Hospital in Boston, Massachusetts. Id. At the hospital, doctors discovered that there was a blockage in the artery leading to his heart. Id. at ¶ 4. In order to open the blockage, the doctors performed a percutaneous coronary intervention known as a balloon angioplasty. Id. They inserted a catheter into Cunningham's artery. Id. At the tip of the catheter, there was a balloon. Id. The doctors inflated the balloon inside the artery. Id. As the balloon inflated, it removed the blockage. Id.
After performing the balloon angioplasty, doctors inserted a stent in the artery to keep it open. Id. at ¶ 5. Cunningham alleges that the stent failed to expand properly inside his artery and that it currently remains in an unopened position inside his artery. Id. at ¶ 7. He further alleges that the stent's failure to open has adversely affected the condition of his heart, impacting his quality of life and likely necessitating further medical treatment in the future. Id. at ¶ 8.
Cunningham alleges that the stent placed in his artery was a Xience brand stent that was manufactured by defendant Abbott. Id. at ¶ 6. He alleges that Abbott “negligently and carelessly designed and manufactured the stent so that the stent was defective and unsafe.” Id. at ¶ 9. He further alleges that Abbott failed to warn him about problems with the stent and failed to supply an instruction manual for the stent to warn him of the defective design. Id. at ¶ 10. The Complaint contains three counts: (1) negligence, (2) breach of the implied warranty of merchantability, and (3) strict liability. Id. at ¶¶ 13-23.
Abbott has identified the stent at issue as Abbott's Xience Alpine Everolimus Eluting Coronary Stent System, a Class III medical device approved by the U.S. Food and Drug Administration (“FDA”) as safe and effective through the premarket approval (“PMA”) process. Docket No, 13 at 1-2. In so doing, Abbott relies on the Affidavit of Benjamin W. O'Grady (Docket No. 13-1). This Court, however, may not consider the Grady Affidavit on a motion to dismiss as it does not fall within any of the exceptions to the rule that a court may properly consider only facts and documents that are part of or incorporated into the complaint. See Gustavsen v. Alcon Labs., Inc., 272 F.Supp.3d 241.246 (D. Mass. 2017) (Wolf, J.) (citing Watterson v. Page, 987 F.2d 1.3 (1st Cir. 1993)). Nevertheless, Cunningham himself has identified the product as a Xience brand stent manufactured by Abbott. Complaint at ¶ 6. All Xience brand stents manufactured by Abbott have in fact been approved by the FDA as safe and effective through the PMA process. See generally Premarket Approval Database entry for Xience Prime and Xience Prime LL, FDA, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P 110019. This Court may take judicial notice of documents on the FDA's website. See Gustavsen, 272 F Sup.3d at 252 ; see also Sundaramurthy v. Abbott Vascular, Inc., No. 4:21-cv-40055-TSH, Docket No. 25 at 4, n.l (D. Mass. Dec. 6, 2021).
II. ANALYSIS
A. Standard Of Review
A complaint must contain only “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed, R. Civ. P. 8(a)(2). To survive a motion to dismiss, the complaint “must contain sufficient factual matter... to state a claim to relief that is plausible on its face.” Abdisamad, 960 F.3d at 59 (quoting Saldivar v. Racine, 818 F.3d 14, 18 (1st Cir. 2016)). “If the factual allegations in the complaint are too meager, vague, or conclusory to remove the possibility of relief from the realm of mere conjecture, the complaint is open to dismissal.” Id. (quoting Barchock v. CVS Health Corp., 886 F.3d 43,48 (1 st Cir. 2018)).
In assessing the sufficiency of the complaint, the Court must first “strip away and discard the complaint's conclusory legal allegations.” In re Montreal, Maine & Atlantic Railway, Ltd., 888 F.3d 1,6 (1st Cir. 2018) (quoting Shay v. Walters, 702 F.3d 76, 82 (1st Cir. 2012)). The Court must then “determine whether the remaining facts allow it ‘to draw the reasonable inference that the defendant is liable for the misconduct alleged.'” Id. (quoting Jane Doe No. 1 v. Backpage.com, LLC, 817 F.3d 12,24 (1st Cir. 2016)).
B. Cunningham's Claims Are Preempted By The MDA
In 1976, Congress enacted the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. 360k et seq., to require FDA approval before new medical devices are introduced into the market. Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). This “new regulatory regime established various levels of oversight for medical devices, depending on the risks they present.” Id. at 316. Class I devices are subject to the lowest level of federal scrutiny, while Class III devices receive the greatest oversight. Id. at 316-317.
To obtain permission to sell a new Class III device, a manufacturer must go through the premarket approval process, which is “rigorous.” Id., at 317. The manufacturer must submit what is typically a multivolume application, which the FDA spends an average of 1,200 hours reviewing. Id. at 317-318. The FDA will grant premarket approval “only if it finds there is a ‘reasonable assurance' of the device's ‘safety and effectiveness.'” Id. at 318. The FDA must “weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” Id. (citing 21 U.S.C. 8360c(a)(2)(C)). “It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.” Id.
“Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). If the manufacturer wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application. Id. (citing 21 U.S.C., § 360e(d)(6); 21 C.F.R. 8 814.39(c)). After premarket approval, the devices are subject to reporting requirements, including:
the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of, and to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a
manner that would likely cause or contribute to death or serious injury if it recurred.Id. (internal citations omitted).
Prior to the enactment of the MDA, several states had adopted their own measures to regulate the sales of medical devices. Id. at 315-316. The MDA contains an express preemption provision, however, which provides that:
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 device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.21 U.S.C. § 360k(a). “[T]he express preemption provided by 21 U.S.C. § 360k(a) manifests a decision by Congress to replace the private rights of action usually available under state law with civil and criminal enforcement by the federal government when thoroughly regulated devices ... arc at issue.” Talbott v. C.R. Bard, Inc., 865 F.Supp.37,40 (D. Mass. 1994) (Wolf, J.), aff'd, 63 F.3d 25 (1st Cir. 1995). “This judgment represents a permissible decision by Congress that the public interest will best be served by relying exclusively on the FDA to strike the proper balance between reasonably assuring safety and promoting innovation with regard to new devices that have the potential both to enhance and to injure human health.” Id.
In Riegel, the Supreme Court addressed whether the MDA preemption provision bars state-law tort actions that are based upon negligence, breach of warranty, and strict liability. The Supreme Court held that such claims were preempted by the MDA. Riegel, 552 U.S. at 329. The Supreme Court concluded that the PMA process constitutes a federal safety review for specific medical devices that imposes federal requirements within the meaning of the MDA. Id. at 322-323. As a result, the Supreme Court determined that state-law tort suits would interfere with the strict requirements imposed on Class III device manufacturers via the PMA process. Id. at 330. However, because the MDA preempts state law claims “only to the extent that they are ‘different from, or in addition to' the requirements imposed by federal law,” states may “provid[e] a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case parallel, rather than add to, federal requirements.” Id. at 330. “In other words, a Class III medical device manufacturer is protected from liability to the extent that the manufacturer has complied with federal law.” Carrelo v. Advanced Neuromodulation Sys., Inc. 777 F.Supp.2d 303, 309 (D.P.R. 2011) (citing Bausch v, Stryker Corp. Inc., 630 F.3d 546, 552 (7th Cir. 2010)).
In Riegel, the Supreme Court established a two-step test in order to determine whether or not a state law claim is preempted. First, the court must determine whether a Class III medical device PMA imposes medical requirements. Riegel, 552 U.S. at 322-323. The Riegel decision established that any Class III device receiving PMA approval by the FDA will satisfy this prong of the test because the PMA process itself establishes federal requirements for a particular device. Id. at 322.
Second, the court must determine whether the state law claims would impose requirements that are different from or in addition to the approved device PMA. Id. at 322-323. The Supreme Court has said that common law claims do impose “state requirements” regarding safety and effectiveness. Id. The Supreme Court also attempted to clarify what it means for a state requirement to be “different from or in addition to” an MDA requirement. The Court said that state claims “premised on a violation of FDA regulations” arc “parallel claims,” and do not impose requirements that are different from or in addition to federal requirements. Id. at 330.
“A state-law claim not expressly preempted by the FDCA may be impliedly preempted, however.” Plourde v. Sorin Group USA, Inc., 23 F.4th 29, 33 (1st Cir. 2022) (citing Buckman Co. v. Pls.' Legal Comm., 531 U.S. 341, 352-353 (2001)). The MDA also provides that all actions to enforce FDA requirements “shall be by and in the name of the United States.” 21 U.S.C. § 337(a). “That language shows ‘that Congress intended that the [FDCA] be enforced exclusively by the Federal Government.'” Plourde, 23 F.4th at 33 (quoting Buckman, 531 U.S. at 352). “So § 337(a) preempts any state-law claim that exists ‘solely by virtue' of an FDCA infraction - like, for example, a claim against a manufacturer for violating the FDCA's ban on making false statements to the FDA during the PMA process.” Id. “On the flip side, a state-law claim based on ‘traditional state tort law' that happens to ‘parallel' the FDCA is outside of § 337(a)'s preemptive scope.” Id.
Accordingly,
Working in tandem, § 360k(a) and § 337(a) leave plaintiffs with a narrow gap through which [their] state-law claim must fit if it is to escape express or implied preemption: the plaintiff[s] must be suing for conduct that violates the FDCA (or else [their] claim is expressly preempted by [§ 360k(a)], but [they] must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted [by § 337(a)].Id. (emphasis in original). “Put differently, to survive preemption, a plaintiff must plead conduct that (1) violates the FDCA (because state law may not impose additional or different duties) and (2) would be actionable under state law independently of the FDCA (because a plaintiff may not seek to enforce the FDCA).” Brooks v. Mentor Worldwide LLC, 985 F.3d 1272, 1279 (10th Cir. 2021) (citation omitted).
The Xience Stent is a Class III medical device that received approval through the PMA process. Therefore, the first prong of the Riegel preemption test has been satisfied. See Riegel, 552 U.S, at 322-323. Cunningham brings common law state law claims of negligence and breach of warranties, which impose state requirements regarding safety and effectiveness. See id. at 323-325. Accordingly, the only issue left is whether Cunningham has pled “parallel” claims. See id. at 330.
Cunningham has not pled any parallel claims. He has not alleged that the Xience Stent deviates from any FDA requirements. Rather, each of his claims asserts that Abbott failed duties owed to Cunningham. See, e.g, Complaint at ¶¶ 14 (“Defendant Abbott owed a duty to plaintiff to safely design, manufacture, test, repair, distribute, sell and maintain the stent.”); 18 (“Defendant Abbott impliedly warranted to plaintiff that the stent and its component parts were merchantable, safe and fit for ordinary purposes.”). In other words, Cunningham asserts that Abbott violated state law notwithstanding its compliance with the FDA premarket approval requirements. Thus, the question becomes whether Cunningham's claims impose additional or different requirements. They do.
Manufacturing Defect Claims.
Cunningham brings claims against Abbott on the basis of both negligence and strict liability as a result of a manufacturing defect. See Complaint at ¶¶ 15,22. “Manufacturing defect claims may avoid MDA preemption when the plaintiff alleges that a medical device did not satisfy the FDA's premarket approval standards.” Cooley v. Medtronic, Inc., No. 09-30-ART, 2012 WL 1380265, at *4 (E.D. Ky. Apr. 20, 2012) (citing Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919, 933 (5th Cir. 2006)). However, Cunningham fails to allege that the Xience Stent he received failed to comply with the specifications approved by the FDA. Without such an allegation, Cunningham's manufacturing defect claim simply alleges that Abbott's manufacturing process itself is deficient. The MDA preempts this claim because Cunningham would have to prove that the stent should have been manufactured differently from the manner approved by the FDA. See, e.g., id. Design Defect Claims. In addition, Cunningham alleges that the Xience Stent was defectively designed. See Complaint at ¶¶ 15,23. Absent concrete allegations that the stent was not the product design approved in the PMA supplement, such claims are expressly preempted by the MDA. See Medtronic, 623 F.3d at 1206; see also Carrelo, 777 F.Supp.2d at 314 (“Any allegation by Plaintiffs that challenges the FDA approved design would be expressly preempted because it would impose requirements that are different from, or in addition to, the existing federal regulations.”). Cunningham has not alleged that the Xience Stent was not designed in accordance with the product design approved in the PMA supplement. Accordingly, his design defect claims are expressly preempted by the MDA.
Failure to Warn. Cunningham's claims also appear to be based on a theory that Abbott failed to warn him about various risks. See Complaint at ¶¶ 10, 15. These claims are also preempted by the MDA because success on these claims would require Abbott to have provided different or additional warnings from those approved by the FDA. See, e.g., Cooley, 2012 WL 1380265, at *3; Medtronic, 623 F.3d at 1205 (absent allegations that defendant modified or failed to include FDA approved warnings, failure to warn claims impose requirements that are “different from or in addition to” federal requirements and therefore preempted).
Breach of Warranty Claims. Cunningham alleges that Abbott “impliedly warranted to plaintiff that the stent and its component parts were merchantable, safe and fit for ordinary purposes.” Complaint at ¶ 18. “The MDA preempts these causes of action because a jury would have to find that the devices were ‘not safe and effective, a finding that would be contrary to the FDA's approval.'” Cooley, 2012 WL 1380265. at *4 (citations omitted).
In addition to breach of implied warranties, Cunningham asserts that his strict liability claim “can be evaluated as a claim of breach of express warranty.” Docket No. 16 at 8. While some courts have found that breach of express warranty claims are preempted by the MDA, see, e.g., Medtronic, 623 F.3d at 1208, others have not. See, e.g., Purccl v. Advanced Bionics Corp., No. 3:07-CV-1777-M, 2010 WL 2679988, at *6 (N.D. Tex. June 30, 2010). Those courts finding an absence of preemption for express warranty claims have done so because such claims sound in contract, rather than tort. See Prudhel v. Endologix, Inc., No. CIV. S-09-066, 2009 WL 2045559, at *4 (E.D. Cal. Jul. 9, 2009) (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 526 (1992)). “While tort duties are imposed by the state, contractual obligations are voluntarily assumed by the parties, and such obligations may therefore fall outside preemption clauses.” Id. In any event, as more fully set forth below, Cunningham's complaint fails to state a claim for breach of express warranties.
Accordingly, I find that Cunningham's claims are preempted by the MDA.
C. In Any Event, Cunningham's Complaint Has Failed To State A Claim
Even if Cunningham's claims were not preempted by the MDA, his complaint fails to state a claim. “A plaintiff in a product liability case must demonstrate ‘(1) the defendant produced or sold a defective product and (2) the product caused the plaintiffs injury.'” Bumham v. Wyeth Labs. Inc., 348 F.Supp.3d 109, 111-112 (D. Mass. 2018) (citation omitted). “In order for a product to be deemed defective, a plaintiff must demonstrate ‘a manufacturing defect, a design defect, or a warning defect, that is, a failure reasonably to warn of the product's foreseeable risks of harm.” Id. at 112 (quoting Evans v. Lorillard Tobacco Co., 465 Mass. 411, 422 (2013)).
In order to establish a manufacturing defect, Cunningham must show that there is a “deviation from the design [that] rendered the product unreasonably dangerous and therefore unfit for its ordinary purposes.” Id. (quoting Back v. Wickes Corp., 375 Mass. 633, 641 (1978)). Here, Cunningham has not made any allegations to suggest that the stent deviated from its intended design.
In order to establish a design defect, the plaintiff “must show that there was a feasible alternative design for the product that would have reduced or prevented the harm.” Town of Westport v. Monsanto Co., No. 14-12041, 2017 WL 1347671, at *4 (D. Mass. Apr. 7, 2017); see also Gillespie v. Sears, Roebuck & Co., 386 F.3d 21, 26 (1st Cir. 2004) (“An essential element of ... a design flaw claim is that there be a safer alternative design.”). Because a reasonable alternative design is a required element of design defect, Cunningham must plead in his complaint sufficient facts to show that an alternative design exists. See Ducat v. Ethicon, 534 F.Supp.3d 152, 159 (D. Mass. 2021). But see Taupier v. Pavol, Inc., 490 F.Supp.3d 430,446 (D. Mass. 2020) (holding that “(a]lthough proof of a safer alternative design may ultimately be required, it does not appear that Massachusetts law would require a plaintiff to plead the existence of an alternative design.”). He has failed to do so.
In Ducat, Judge Hillman acknowledged that the First Circuit has not resolved the issue of whether a plaintiff must prove the existence of a reasonable alternative design to prevail on a negligence defective design claim. Ducat, 534 F.Supp.3d at 158-159.
To establish a failure to warn claim, Cunningham must show that a “deficiency in the warnings” proximately caused his injuries. See, e.g., MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 142 (1985). Under Massachusetts law, the learned intermediary doctrine carves out a middleman exception in the context of medical products. See Niedner v. Ortho-McNeill Pharm., Inc., 90 Mass.App.Ct. 306, 309 (2016) (citations omitted). The learned intermediary doctrine “relieves ‘manufacturers of the duty to warn a patient of the possible side effects of a [product] where it has adequately informed the prescribing physician of any associated risks.” Langlois v. Am. Medical Sys., Inc., 462 F.Supp.3d 1, 2 (D. Mass. 2020) (citations omitted). “The immunity conferred by the doctrine is, however, limited: when the manufacturer breaches the duty to warn the doctor, it is directly liable to the patient.” Tersigni v. Wyeth-Ayerst Pharm., Inc., No. 11-10466-RGS, 2013 WL 6531118, at *5 (D. Mass. Dec. 13, 2013) (citing MacDonald, 394 Mass, at 136). Cunningham has made no allegations that Abbott failed to provide adequate warnings to his doctors.
“A plaintiff bringing an implied warranty of merchantability claim must plead facts sufficient to allege that (1) the defendant manufactured or sold the product that eventually injured the plaintiff; (2) the product had a defect or otherwise unreasonably dangerous condition such that it was unsuited for the ordinary use for which it was sold; (3) the plaintiff used the product as intended by the defendant or in a manner that was at least foreseeable to the defendant; and (5) [sic] the defect or unreasonably dangerous condition was a legal cause of the plaintiffs injury.” DaSilva v. Toyota Motor Corp., 474 F.Supp.3d 448, 456 (D. Mass. 2020) (citation omitted). Here, Cunningham has failed to plead any facts to support a defect or otherwise unreasonably dangerous condition in the stent.
Finally, Count III of the Complaint asserts a cause for “strict liability.” Complaint at ¶¶ 20-23. In Massachusetts, however, “there is no strict liability in tort apart from liability for breach of warranty under the Uniform Commercial Code, G.L. c. 106, §§ 2-314-2-318.” Cruickshank v. Clean Seas Co., 346 BR. 571- 577-578 (D. Mass. 2006) (quoting Guzman v. MRM/Elgin, 409 Mass, 563, 569 (1991)). Instead, “‘Massachusetts law of warranty is congruent in nearly all respects' with a strict liability theory of recovery.” Id. at 578. The SJC has been unwilling to hold “that, apart from liability for breach of warranty under our statute, there may be liability without fault for defective products.” Id. (quoting Mason v. General Motors Corp., 221 Mass, 183, 191 (1986)). Therefore, there is not an independent claim of strict liability in tort under Massachusetts law, and the sole remedy for strict liability is provided under the UCC. Id. Cunningham has conceded as much. Docket No- 16 at 7-8. He states that this Court should construe his strict liability claim as a claim for breach of express warranties. Id. at 8.
Under Massachusetts law, “an express warranty claim is and generally has been understood to be an action of contract.” Anthony's Pier Four, Inc, v. Crandall Dry Dock Eng'rs, Inc., 396 Mass. 818, 822 (1986). Pursuant to the Massachusetts version of the Uniform Commercial Code:
(a) Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise.
(b) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description.
(c) Any sample or model which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the sample or model.M.G.L, c, 106, $ 2-313(1). “The theory of such a claim is that the defendants are liable to the plaintiff for failure to provide a design that meets a standard of performance allegedly promised by the defendants.” Anthony's Pier Four, Inc., 396 Mass. at 822. “Because the standard of performance is set by the defendant's express promises to the plaintiff, ‘the plaintiff must demonstrate that the defendant promised a specific result' and that the defendant failed to deliver on his promise and, therefore, breached the express warranty.” Jackson v. Johnson & Johnson & Janssen Pharms., Inc., 330 F.Supp.3d 616,627 (D. Mass. 2018) (quoting Anthony's Pier Four, Inc., 396 Mass. at 823). Cunningham has failed to state a claim for breach of express warranties because he has not alleged any affirmation of fact or promise about the Xience Stent that was made by Abbott or that the stent failed to conform to a particular description, sample, or model.
D. Cunningham Has Failed To Satisfy The Applicable Pleading Requirements
Contrary to Cunningham's suggestion, see Docket No, 16 at 7, & this Court is not subjecting him to a heightened pleading standard. Under Twombly and Iqbal, Cunningham must plead “enough factual matter” that, taken as true, “state[s] a claim to relief that is plausible on its face.” Bell Atlantic Corp, v. Twombly, 550 U.S. 544, 556, 570 (2007). “The plausibility standard is not akin to a ‘probability requirement,' but it asks for more than a sheer possibility” of relief. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In the context of MDA preemption, courts have disagreed upon the precise level of specificity required. See White v. Stryker Corp., 818 F.Supp.2d 1032, 1037-1039 (W.D. Ky. 2011). Regardless of the level of specificity required, however, Cunningham has not met his burden because he has failed to allege any violation of any federal standard that would give rise to a parallel claim.
Similarly, Cunningham has failed to meet the notice pleading requirements with respect to the claims alleged in the Complaint. He alleges, in a conclusory fashion, that the stent was “unsafe and defective” but fails to allege any facts to support that conclusion. For example, he fails to allege what caused the stent not to open or how Abbott's conduct led to the alleged defect. In essence, Cunningham's complaint alleges that because there was a problem with the stent while it was being placed in his artery, the stent must be defective. Such conclusory allegations are insufficient to meet the pleading requirements of Twombly and Iqbal. See Iqbal, 556 U.S. 662. 678 (2009) (citing Twombly, 550 U.S, at 555) (Court is “not bound to accept as true a legal conclusion couched as a factual allegation.”); see also Iannacchino v. Ford Motor Co., 451 Mass. 623, 632-633 (2008) (“Because the term ‘defect' is conclusory and can be subjective as well, a bare assertion that a defendant... has knowingly manufactured and sold a product that is ‘defective,' or suffers from ‘safety-related defects,' docs not suffice to state a viable claim.”).
E. Cunningham's Request For Leave To Amend
Cunningham requests that, should the Court determine that his complaint has not been pled properly, he be allowed leave to amend his complaint to cure any pleading defects. Docket No- 16 at 8- Since this request, Cunningham has moved for leave to amend his complaint. Docket No. 38. As set forth in this Court's order on the motion for leave to amend, Cunningham's proposed amended complaint does not cure the deficiencies in the original complaint. See Docket No, 51. Accordingly, I recommend that Judge Wolf deny Cunningham's request for leave to amend his complaint.
III. RECOMMENDATION
For the foregoing reasons, I recommend that Judge Wolf grant Abbott's motion to dismiss Cunningham's complaint.
IV. REVIEW BY DISTRICT JUDGE
The parties are hereby advised that under the provisions of Fed. R. Civ. P. 72(b), any party who objects to these proposed findings and recommendations must file specific written objections thereto with the Clerk of this Court within 14 days of service of this Report and Recommendation. The written objections must specifically identify the portion of the proposed findings, recommendations, or report to which objection is made, and the basis for such objections. See Fed, R, Civ. P. 72. The parties are further advised that the United States Court of Appeals for this Circuit has repeatedly indicated that failure to comply with Fed, R, Civ. P.72(b) will preclude further appellate review of the District Court's order based on this Report and Recommendation. See Phinney v. Wentworth Douglas Hospital, 199 F.3d 1 (1st Cir. 1999); Sunview Condo. Ass'n v. Flexel Int'l, Ltd., 116 F.3d 962 (1st Cir. 1997); Pagano v. Frank, 281 F.2d 343 (1st Cir. 1993).