Opinion
CV 20-1466 (GRB)
2021-09-29
Hans KAEMMLEIN, Plaintiff, v. ABBOTT LABORATORIES, an Illinois Corporation, St. Jude Medical, Inc., a Minnesota Corporation, and St. Jude Medical, LLC, a Delaware Corporation, Defendants.
Jay Joseph Massaro, Joseph G. Dell, Dell & Dean, PLLC, Garden City, NY, for Plaintiff. Shana Eve Russo, Reed Smith LLP, Princeton, NJ, Lisa Marie Baird, Pro Hac Vice, Reed Smith LLP, Miami, FL, Michael K. Brown, Pro Hac Vice, Reed Smith LLP, Los Angeles, CA, for Defendants Abbott Laboratories, St. Jude Medical, LLC. Shana Eve Russo, Reed Smith LLP, Princeton, NJ, for Defendant St. Jude Medical, Inc.
Jay Joseph Massaro, Joseph G. Dell, Dell & Dean, PLLC, Garden City, NY, for Plaintiff.
Shana Eve Russo, Reed Smith LLP, Princeton, NJ, Lisa Marie Baird, Pro Hac Vice, Reed Smith LLP, Miami, FL, Michael K. Brown, Pro Hac Vice, Reed Smith LLP, Los Angeles, CA, for Defendants Abbott Laboratories, St. Jude Medical, LLC.
Shana Eve Russo, Reed Smith LLP, Princeton, NJ, for Defendant St. Jude Medical, Inc.
MEMORANDUM & ORDER
GARY R. BROWN, United States District Judge:
In 2015, doctors operated on plaintiff Hans Kaemmlein to upgrade his pacemaker, replacing a unit installed years earlier with the defendants’ Unify Assura defibrillator. About a year later, a physician contacted plaintiff with terrible news: the Unify Assura had a defect leading to undetectable premature battery depletion. After weighing his options, plaintiff decided to undergo surgery, once again, in 2017, to remove defendants’ unit and replace it with another device.
According to the complaint and supporting United States Food and Drug Administration ("FDA") documents, defendants were aware, long before plaintiff's initial surgery, about the defective battery issue. First Amended Compl., Docket Entry ("DE") 6. This issue resulted from defendants’ failure to maintain proper procedures and facilities to correct and prevent manufacturing defects in violation of federal regulations. Id. Worse still, in obtaining premarket approval ("PMA") from the FDA, defendants had concealed this problem: in 2011, defendants had received evidence from its battery supplier that a phenomenon known as "lithium cluster bridging" was causing premature battery depletion, yet defendants failed or refused to investigate or properly report the problem. Id. ¶ 85. Defendants reviewed repeated reports of cluster bridging depletion, yet "concluded" that the cause remained elusive. Id. After a 2017 review, the FDA documented numerous, extraordinary findings, including the following:
A review of 42 Product Analysis Reports produced between 2011 and 2014 showed that the firm repeatedly concluded that the cause of premature depletion of the Greatbatch QHR2850 battery could not be determined in instances when the analysis provided ample evidence that lithium cluster bridging had prematurely drained the battery. [ ]
Failure investigations were not timely. [ ]
[I]ncomplete information was provided to the management review and medical advisory boards relative to the premature battery depletion issue. [ ]
[I]n 2014, St. Jude Medical formally requested Greatbatch to implement a design improvement to eliminate lithium cluster bridging in the 2850 battery header. [ ] Despite the fact that this
design change was made to reduce a serious risk to health posed by the device, St. Jude Medical failed to notify FDA of a correction until August 2016.
Id. , Ex. B at 41-42.
In this action, plaintiff seeks recovery for the unnecessary surgery based on several state law theories, including breach of implied warranty, negligence, failure to warn, misrepresentation by omission and strict products liability. Notwithstanding this remarkable history, defendants seek dismissal on the ground of preemption – arguing that the rigorous FDA approval process, the very process which defendants thwarted through failure to disclose information and comply with requisites, preempts all state law causes of action. DE 23-1 and 23-8. In other words, defendants seek the legal benefit of the comprehensive federal regulatory scheme after failing to properly submit to that scheme. In a second, marginal argument, defendants incorrectly contend that plaintiff has failed to satisfy the pleading standards of Rule 9(b) of the Federal Rules of Civil Procedure.
FACTS
The following facts, drawn from the first amended complaint and official documents appended thereto, are assumed to be true and for purposes of the pending motion to dismiss, and are viewed in the light most favorable to plaintiff, the non-moving party.
1. History of St. Jude Medical's Implantable Cardioverter Defibrillator
The Unify Assura Model 3357-40 ("Unify Assura") manufactured by St. Jude Medical provides pacing therapy for slow heart rhythms as well as electrical impulses to stop dangerously fast heart rhythms. The unit is powered by a lithium-based battery. DE 6, ¶¶ 2-3. As early as 2011, St. Jude Medical received evidence from its battery supplier that lithium cluster bridging was causing its batteries to prematurely deplete, but defendants neither reported nor investigated the issue and instead represented that the cause could not be confirmed. Id. ¶ 10.
Plaintiff has named both St. Jude Medical, Inc. and St. Jude Medical, LLC as defendants. St. Jude Medical Inc. is now known as St. Jude Medical, LLC. St. Jude Medical, LLC is a wholly-owned subsidiary of defendant Abbott Laboratories. (collectively "defendants"). See DE 6 ¶¶ 23-34.
The FDA approved the Unify Assura device for sale on May 8, 2012 through the PMA process, which requires a device manufacturer to provide the FDA with vast amounts of data and information to ensure that its device is safe and effective. Id. ¶¶ 48, 54. Following PMA approval, the FDCA requires medical device manufacturers to comply with all device specific regulations and standards in the device's PMA. Id. ¶ 49. In addition, medical device manufacturers are required to report to the FDA adverse events associated with the use of the approved product. Id. ¶¶ 57-64.
The Court grants defendants’ application for judicial notice of documents from the FDA reflecting the PMA for the device at issue. See Request for Judicial Notice, DE 23-2. Exs. 1-2.
From 2011 through 2014, St. Jude Medical reviewed 42 product reports of battery depletion caused by lithium cluster bridging in various recalled devices that had similar battery designs, including the Unify Assura, but concluded that the cause of premature battery depletion could not be determined. Id. ¶ 85. In October 2016, the FDA issued a recall of certain St. Jude Medical defibrillators, including the Unify Assura, due to the battery manufacturing defect. Id. ¶ 4. According to the recall notice, patients would not be able to detect when the lithium-ion battery was low on charge or drained. Id. ¶ 6. On October 11, 2016, St. Jude Medical sent a "Dear Doctor" letter to physicians warning them of the manufacturing defect in the device. Id. ¶ 5. The FDA conducted an inspection of defendants’ facility and concluded that defendants had failed to establish and maintain procedures for implementing corrective and preventative actions, as required by 21 C.F.R. § 820.I00(a), and violated defendants’ Quality Management Review Standard Operating Procedure. Id. ¶¶ 84, 89-90. Several of the documents generated by the FDA are attached to the complaint.
2. Plaintiff's Surgery
On May 25, 2012, plaintiff underwent the surgical implantation of the Accent DR, PM2110 pacemaker ICD. Id. ¶ 17. On July 29, 2015, plaintiff underwent a laser lead extraction, biventricular ICD upgrade, which included the implantation of a Unify Assura defibrillator. Id. ¶ 18. Thereafter, on October 27, 2016, a physician advised plaintiff that the St. Jude Medical ICD implanted in him was subject to a recall due to the possibility of early battery depletion. Id. ¶ 19. Although his device was properly functioning, plaintiff decided "to have a surgical procedure instead of surveillance of battery life." Id. Plaintiff underwent a surgical removal of the Unify Assura defibrillator and the insertion of a new biventricular ICD on March 30, 2017. Id. ¶ 21. Plaintiff claims that he suffered physical injury due to the manufacturing defect in the battery of the Unify Assura, to wit, the necessity to undergo a replacement surgery. Id. ¶ 22.
3. Procedural Background
On March 19, 2020, plaintiff commenced the instant action. DE 1. Plaintiff filed a first amended complaint, DE 6, alleging six causes of action against defendants under New York Law: (1) breach of express warranty, id. ¶¶ 91-99 ; (2) breach of implied warranty, id. ¶¶ 100-105; (3) negligence, id. ¶¶ 106-111; (4) failure to warn, id. ¶¶ 112-131; (5) misrepresentation by omission, id. ¶¶ 132-140; and (6) strict products liability, id. ¶¶ 141-156. On October 5, 2020, defendants moved to dismiss the complaint for failure to state a claim pursuant to Rule 12(b)(6) of the Federal Rule of Civil Procedure, arguing principally that plaintiff's claims are entirely preempted by the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 360k(a), and the United States Supreme Court decision in Riegel v. Medtronic, Inc. , 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). DE 23-1 and DE 23-8.
In his opposition papers, plaintiff states that he does not oppose the dismissal of his breach of express warranty claims. DE 23-5 at 40. Accordingly, the Court dismisses plaintiff's claims for breach of express warranty.
DISCUSSION
Standard of Review
Generally, motions to dismiss are decided under the well-established standard of review for such matters, as discussed in Burris v. Nassau County District Attorney , No. 14-5540 (JFB) (GRB), 2017 WL 9485714, at *3-4 (E.D.N.Y.), adopted by 2017 WL 1187709 (E.D.N.Y. 2017), incorporated by reference herein. The gravamen of that standard, of course, is the question of whether, assuming the allegations of the complaint to be true solely for the purposes of the motion, the complaint sets forth factual material to render the claims plausible. Preemption
In 1976, Congress enacted the Medical Device Amendments, 21 U.S.C. § 360c, et seq. , to the FDA which granted exclusive authority to the FDA to regulate medical devices and created a "regime of detailed federal oversight." Riegel , 552 U.S. at 316-17, 128 S.Ct. 999. The regulatory scheme established three categories of medical devices, identified as Class I, II, or III, "depending on the risks they present." 21 U.S.C. § 360c(a) ; see Riegel , 552 U.S. at 317, 128 S.Ct. 999. Unify Assura is a Class III device, which is one that "is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," or "presents a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C). Class III medical devices are subject to the most extensive federal oversight. See Riegel , 552 U.S. at 316, 128 S.Ct. 999.
Before marketing a Class III medical device, the manufacturer must seek FDA premarket approval, a process which "typically requires submission of a multivolume application including reports of safety and efficacy studies, an explanation of the device's components, and details regarding its manufacturing, packaging, and installation." Riegel , 552 U.S. at 317-18, 128 S.Ct. 999 (citing 21 U.S.C. § 360e). "Premarket approval is a rigorous process." Id. "The FDA spends an average of 1,200 hours reviewing each application ... and grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device's ‘safety and effectiveness[.]’ " Id. at 318, 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d) ). After premarket approval, a manufacturer is required to (i) seek FDA approval to make any changes in the design specifications, manufacturing processes, or labeling of the medical device that would impact the safety or effectiveness of the medical device; (ii) inform the FDA of new clinical studies or investigations; and (iii) report any incidents of injury or death, or malfunctioning that may cause injury or death. Id. at 319, 128 S.Ct. 999.
The MDA includes an explicit preemption provision, which prevents any "State or political subdivision of a State" from establishing or continuing 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).
As the Supreme Court observed, preemption is predicated upon the demanding review process which requires significant submissions by the manufacturer:
Premarket approval is a "rigorous" process. Lohr, supra , at 477, 116 S. Ct. 2240. A manufacturer must submit what is typically a multivolume application. FDA, Device Advice—Premarket Approval (PMA) 18, http://www.fda.gov/cdrh/devadvice/pma/printer.html. It includes, 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. § 360e(c)(1). Before deciding whether to approve the application, the agency may
refer it to a panel of outside experts, 21 CFR § 814.44(a) (2007), and may request additional data from the manufacturer, § 360e(c)(1)(G).
Riegel, 552 U.S. at 317–18, 128 S.Ct. 999. Those obligations on the part of the manufacturer extend well beyond premarket approval:
After premarket approval, the devices are subject to reporting requirements. § 360i. These include 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, 21 CFR § 814.84(b)(2), 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, § 803.50(a).
Id. at 319, 128 S.Ct. 999. This motion raises the curious question of the applicability of this doctrine where a manufacturer fails or refuses to hold up its end of the process. In other words, where the agency has made the determination that the manufacturer did not supply complete and accurate information during and subsequent to the manufacturing process, can that manufacturer benefit from the legal protections afforded by Congress?
A private litigant cannot file suit solely to enforce violations of the relevant federal regulations. In Buckman Co. v. Plaintiffs’ Legal Comm. , the Supreme Court construed § 337(a) as barring suits by private litigants "for noncompliance with the medical device provisions." 531 U.S. 341, 349 n.4, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) ; see Pearsall v. Medtronics, Inc. , 147 F. Supp. 3d 188, 193 (E.D.N.Y. 2015) (noting state law claims based entirely on violations of the MDA have been construed by the courts as impliedly preempted because they were solely dependent on federal law obligations of disclosure to the FDA). In some circumstances, private plaintiffs may pursue state remedies for injuries related to failures to comply with the FDA's protocols. In Riegel , the Court noted that § 360k "does not prevent a State from providing 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." 552 U.S. at 330, 128 S.Ct. 999. Read together
Reigel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a) ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman ).
In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig. , 623 F.3d 1200, 1204 (8th Cir. 2010) (internal quotation marks and citation omitted); see Franzese v. St. Jude Medical, Inc. , No. 13-CV-3203(JS), 2014 WL 2863087, at *3 (E.D.N.Y. June 23, 2014) (same). Thus, "to state a plausible product liability claim that avoids federal preemption, a plaintiff must set forth facts pointing to specific premarket approval requirements that have been violated and link those violations to his injuries. " Cordova v. Smith & Nephew, Inc. , No. 14-CV-351 (JFB), 2014 WL 3749421, at *5 (E.D.N.Y. July 30, 2014) (emphasis in original); see Franzese , 2014 WL 2863087, at *3.
Here, the link could not be any clearer: defendants’ improper concealment of the defects in the unit led to (1) plaintiff's undergoing surgery to have the potentially defective unit installed in the first instance and (2) the quite reasonable and foreseeable result that, a short time later, plaintiff would need to undergo a second, entirely avoidable surgery to replace the suspect pacemaker.
With jaw-dropping obliviousness, defendants’ counsel charges that "although his device was ‘properly functioning,’ [plaintiff] decided to have a prophylactic replacement when he learned that his ICD model had been subject to a voluntary recall due to possible early battery depletion." DE 23-1 at 10. While counsel's implication remains unclear, plaintiff's decision at that time can hardly be described as unreasonable or extravagant.
The Second Circuit's recent decision in Glover v. Bausch & Lomb, Inc. , 6 F.4th 229 (2d Cir. 2021), while factually distinguishable from the instant case, provides useful guidance in resolving the motion. Decided by a two-member panel, Glover reviewed a district court dismissal of negligence and failure to warn claims brought under Connecticut law arising from complications suffered by a plaintiff from a Class III medical device. In Glover , the Court grappled with "the scope of federal preemption of state tort law claims based on injuries caused by a medical device." Id. at 232.
The Glover decision provides a detailed exegesis of Supreme Court decisions on MDA preemption. Beginning with Medtronic, Inc. v. Lohr , the Circuit reiterated the Supreme Court's holding regarding express preemption that that "§ 360(k) simply was not intended to pre-empt most, let alone all, general common-law duties enforced by damages actions," and that "[n]othing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." 6 F.4th at 237 (quoting Medtronic, Inc. v. Lohr , 518 U.S. 470, 495-97, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ). Thus, in Lohr , the Supreme Court upheld a plaintiff's rights to proceed with "manufacturing and labeling claims to the extent that they rest on claims that [the manufacturer] negligently failed to comply with duties equal to, or substantially identical to, requirements imposed under federal law." Id.
To "avoid implied preemption, the Court explained, claims must be based not on the FDCA, but on ‘traditional state tort law which ... predated the federal enactments in question[ ].’ " Id. (quoting Buckman , 531 U.S. at 352-53, 121 S.Ct. 1012 ). Finally, the Circuit cautioned that, in Riegel , "the device in question ‘violated state tort law notwithstanding compliance with the relevant federal requirements’ and accordingly, imposed requirements in addition to those imposed by federal law, contravening § 360(k).’ " Id. (quoting Riegel , 552 U.S. at 330, 128 S.Ct. 999 ).
Here, the allegations set forth claims that fall squarely within these parameters. Plaintiff seeks recovery consistent with traditional state tort law doctrines that predate the MDA, but given the facts here, are substantially identical to the federal regulatory requirements, without exceeding those requirements. Based on the facts set forth, no one, not the FDA, common law courts, doctors, patients or, for that matter, any rational individual or institution would authorize the manufacture, sale, distribution, purchase or implantation of the device at issue: a pacemaker that could – based on concealed design or manufacturing flaws – unpredictably and catastrophically fail. Defendants’ arguments to the contrary demonstrate confusion or disingenuity.
Indeed, the factual differences between this case and Glover – in which the panel referred the matter to the state court for clarification as to whether state law created a duty to the FDA – further demonstrate the point. In Glover , plaintiffs alleged that the defendant "downplay[ed]" risks of the device[ ] ... fail[ing]to alert the FDA to the extent of the risk" of certain postoperative conditions. Id. at 234. Here, by contrast, the allegations rise to the level of misrepresentation: concealing knowledge of a potentially fatal defect based upon a design or implementation that deviated in function from that approved by the FDA. The Glover court's reliance on Bausch v. Stryker Corp. , 630 F.3d 546 (7th Cir. 2010) proves instructive. Just as in this case, in Bausch , the FDA "conducted an inspection at the defendants’ [ ] manufacturing facility" and informed the defendants of "numerous deficiencies [in the] manufacturing and inspection processes" and ultimately "issued a letter to defendants on March 15, 2007 warning that the [device] was "adulterated due to manufacturing methods ... not in conformity with industry and regulatory standards." 630 F.3d at 559 (internal quotation marks omitted). The Seventh Circuit concluded that " Section 360k provides immunity for manufacturers of new Class III medical devices to the extent that they comply with federal law, but it does not protect them if they have violated federal law. " Id. at 553 (emphasis added). The Bausch court also rejected a defense of implied preemption, holding that those "claims, like those in Lohr , and unlike those in Buckman , are tort law claims based on manufacturing defects, not fraud on a federal agency." Id. at 557. The analysis in Bausch is fully applicable to the instant case.
Notably, many cases analyzing MDA preemption struggle with peculiarities of individual state laws. See, e.g., Glover , 6 F.4th at 236, 244 (certifying questions to the Connecticut Supreme Court concerning the state law implications of failure to comply with the FDA's post-approval requirements). The theories raised by plaintiff here, by contrast, involve paradigmatically "traditional damages remedy for violations of common-law duties." Lohr, 518 U.S. at 495, 116 S.Ct. 2240. New York law offers seminal cases underlying the common law theories pled. For example, plaintiff seeks recovery based upon negligence, which developed in New York common law nearly a century ago. See Palsgraf v. Long Island R.R. Co., 248 N.Y. 339, 351, 162 N.E. 99 (1928) ("[W]hen injuries do result from our unlawful act, we are liable for the consequences."). Fraudulently concealing the defects in a manufactured item has been actionable under New York law from time out of mind. See Kuelling v. Roderick Lean Mfg. Co., 183 N.Y. 78, 89, 75 N.E. 1098 (1905) ("[O]ne who sells an article, knowing it to be dangerous by reason of concealed defects, is ... liable in damages to any person ... who suffers an injury by reason of his willful and fraudulent deceit and concealment."). The storied history of liability for defective and mislabeled products under New York law – particularly those that endanger human life – can be traced back at least to the mid-19th Century. See MacPherson v. Buick Motor Co., 217 N.Y. 382, 384, 111 N.E. 1050 (1916) (discussing liability of manufacturer producing items with defective components); Thomas v. Winchester, 6 N.Y. 397, 405 (1852) (imposing liability for the mislabeling of poisonous extract of belladonna as innocuous extract of dandelion). Implied warranty of merchantability has even deeper roots. See Gallagher & Mason v. Waring, 1832 WL 2859 (N.Y. Sup. Ct. 1832), aff'd sub nom. Waring v. Mason , 1837 WL 2892 (N.Y. 1837) ("no implied warranty arises as to the fineness or particular degree of quality of the article, except that it is of a merchantable quality and condition"). In short, New York law clearly provides traditional – if not venerable – tort remedies for the acts complained of herein.
Additionally, in applying the law to this particular set of facts, the Court is not writing upon a completely blank slate. First, at least two district courts have ruled upon this precise product (though examining claims under other state law), determining that preemption did not require dismissal of certain state law claims related to the Unify Assura pacemaker. See Hill v. Abbott Laboratories, No. 6:19-cv-01011-DCC, 2020 WL 4820243, at *5 (D. S.C. Aug. 19, 2020) (plaintiff provided "ample factual information to support a plausible inference that the St. Jude Defendants violated the PMA and federal law [and] should have the opportunity to conduct discovery to determine what the PMA's requirements are and whether the St. Jude Defendants complied with those requirements"); Lewis v. Abbott Laboratories , No. 6:19-cv-909-Orl, 2020 WL 8254280, at *4 (M.D. Fla. Feb. 24, 2020) ("Plaintiff's state law claims fit within the ‘narrow gap’ between express preemption and implied preemption because she sufficiently claims ‘the breach of a well-recognized duty owed to her under state law and ... can show that she was harmed by a violation of applicable federal law’ "). In addition, another suit, filed by the Justice Department in conjunction with the FDA's Criminal Investigation Division and settled for $27 million, alleged that defendants "failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall." "St. Jude Agrees To Pay $27 Million For Allegedly Selling Defective Heart Devices," 30 No. 6 FDA Enforcement Manual News. 1, DOJ 21-634, (August 2021) (hereinafter "DOJ 21-634").
This settlement was publicly announced in August 2021, after the briefs had been filed, though it seems certain that defendants were aware of the litigation well before that time. Yet, counsel never mentioned it. While the Court recognizes that liability was not conceded, information associated with the case provides useful background for this decision, and is cited for those purposes only.
Plaintiff has interposed claims of negligence, products liability (including theories of design defect, manufacturing defect, and failure to warn), breach of implied warranty and misrepresentation. Following briefing and argument, the Court ruled that these claims were sufficiently pled at this juncture to survive a motion to dismiss. DE 17. The only remaining issue, at this time, is the question of preemption.
Plaintiff's Negligence and Strict Liability Claims are Not Preempted by the MDA
Plaintiff has interposed claims of negligence and strict products liability based on theories of design defect, manufacturing defect, and failure to warn. Plaintiff's claims based upon an alleged design defect or manufacturing defect sounding in either negligence or strict liability are functionally equivalent under New York law and will be examined concurrently. See Jarvis v. Ford Motor Co. , 283 F.3d 33, 62-63 (2d Cir. 2002) ("In general ... the strict liability concept of defective design is functionally synonymous with the earlier negligence concept of unreasonable designing") (citing Denny v. Ford Motor Co. , 87 N.Y.2d 248, 639 N.Y.S.2d 250, 662 N.E.2d 730 (1995) ); see also Cowan v. Costco Wholesale Corp. , No. 15-CV-05552, 2017 WL 59080, at *4 (E.D.N.Y. Jan. 5, 2017) ("Under New York law, the elements of negligence claims based on design defect [and] manufacturing defect ... theories are the same as those under strict liability."). Moreover, it is well-established that "[w]here liability is predicated on a failure to warn, New York views negligence and strict liability claims as equivalent." Estrada v. Berkel Inc. , 14 A.D.3d 529, 789 N.Y.S.2d 172, 174 (2005) (internal quotation marks and citation omitted). Accordingly, the Court considers plaintiff's negligence and strict liability claims together.
a. Design Defect and Manufacturing Defect
Under New York law, "there are three distinct claims for strict products liability: (1) a manufacturing defect, which results when a mistake in manufacturing renders a product that is ordinarily safe dangerous so that it causes harm; (2) a warning defect, which occurs when the inadequacy or failure to warn of a reasonably foreseeable risk accompanying a product causes harm; and (3) a design defect, which results when the product as designed is unreasonably dangerous for its intended use." McCarthy v. Olin Corp. , 119 F.3d 148, 155-56 (2d Cir. 1997). Plaintiff maintains that design defects, manufacturing defects and a failure to provide adequate warnings in connection with the Unify Assura caused his injuries.
Whether this matter is properly categorized as a design defect or manufacturing defect case, that is, whether the alleged defect arose from the unit's design or whether the entire "batch" of pacemakers released constitute a manufacturing defect, remains unclear on this record. Plaintiff alleges that the device was defectively designed and included defective materials, "namely a defective lithium-ion battery that could create lithium clusters and prematurely lose its charge." DE 6 ¶ 148. Plaintiff further contends that the device was adulterated in violation of Section 501(h) of the FDCA in that "the methods used in, or the facilities or controls used for, their manufacturing, packaging, storage, or installation" were not in conformity with current good manufacturing practice requirements. DE 6 ¶ 150. The Government has contended both that "by 2013, St. Jude knew that lithium clusters formed on the batteries of the devices, causing some of the batteries to short and, in turn, suffer a premature power drain," and that "in late 2014, St. Jude submitted a request to the FDA to approve a change to prevent lithium clusters from draining the battery," referring to the latter as a "new design." DOJ 21-634. Irrespective of its classification, though, the Government announced that
St. Jude failed to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices, which are implantable defibrillators used in patients at risk of cardiac arrest due to an irregular heartbeat. [ ]
St. Jude submitted a request to the FDA to approve a change to prevent lithium clusters from draining the battery and told the FDA, "no serious injury, permanent harm or deaths have been reported associated with this" issue. However, according to the government's allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with premature battery depletion (PBD) induced by lithium clusters.
Id. Under either theory, plaintiff has sufficiently alleged that the conduct constituting a documented failure to comply with federal disclosure requirements simultaneously gives rise to a state law defective product claim. These claims, therefore, are not preempted. See Lewis , 2020 WL 8254280 at *3-4 (finding that strict liability claims not preempted).
b. Strict Liability for Failure to Warn
Plaintiff alleges that St. Jude Medical failed to (1) conduct adequate risk analyses and provide ongoing instructions regarding safety hazards of the device to the FDA; (2) timely report adverse events and potential premature battery risks to the FDA; and (3) warn physicians and the medical community of relevant information and known risks of the device. Under New York law, a plaintiff may prevail on a failure to warn claim where "(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 the failure to do so was the proximate cause of the harm." Reed v. Pfizer , 839 F. Supp. 2d 571, 575 (E.D.N.Y. 2012) (internal citation omitted); see Bertini v. Smith & Nephew , 8 F. Supp. 3d 246, 256 (E.D.N.Y. 2014) (holding a medical device manufacturer has a duty "to warn of all potential dangers which it knows or should know, and must take such steps as are reasonably necessary to bring that knowledge to the attention of the medical profession") (citation omitted). Relying upon New York's "learned intermediary doctrine," which requires manufacturers to notify physicians rather than patients directly, defendants urge this Court to find that plaintiff's failure to warn claim is expressly preempted. DE 23-1 at 17.
Plaintiff alleges that defendants failed "to conduct adequate risk analyses and investigations required by federal law and regulations regarding any potential safety defects associated with the battery design utilized in the Unify Assura." DE 6 ¶ 126. Plaintiff states that defendants had "a continuing duty to provide ongoing warnings and instructions regarding safety hazards associated with its ICDs, which includes obligations under the FCTA and FDA regulations, to investigate and report adverse events and potential device risks to the FDA." Id. ¶ 114.
Plaintiff alleges that defendants "breached their duty by failing to timely and adequately report potential defective battery issues associated with the Unify Assura ... to the FDA in violation of New York law, including the learned intermediary doctrine." DE 6 ¶ 116. Plaintiffs further maintains that defendants’ "breach of their duty to warn includes that between 2011 and 2014, St. Jude Medical Inc. reviewed 42 product reports showing evidence of premature battery depletion due to lithium cluster bridging; yet failed to take action commensurate with this risk and failed to timely advise the medical community or the FDA." Id. ¶ 120.
Plaintiff alleges that defendants "failed to warn the medical community about the risk of lithium-battery bridging and/or failed to warn the medical community about the risks of early battery depletion." DE 6 ¶ 122. For example,--the 2013 Unify Assura product manual that was created by St. Jude Medical "does not address the lithium-battery bridging nor premature battery depletion" in the "warnings and precautions section." Id. And the "potential adverse events" section does not state that a possible adverse [e]vent was lithium-battery bridging or premature battery depletion. Id. In addition, plaintiff asserts that defendants’ failure to warn "is reflected in the fact that defendants sent out an October 11, 2016 ‘Dear Doctor’ letter, which is reflective of the fact that prior to October 11, 2016, the medical community was not sufficiently informed of the risks." Id. ¶ 123.
This argument, though, plainly fails given the factual record developed even at this preliminary stage. Plaintiff's case is not solely dependent on alleged violations of federal regulations but is premised on traditional duties between a manufacturer of a product and a consumer, or in the case of the learned intermediary doctrine, a consumer's physician. See Desiano v. Warner-Lambert & Co. , 467 F.3d 85, 94-95 (2d Cir. 2006) ("Significantly, all of the claims advanced by Appellants in this case are premised on traditional duties between a product manufacturer and [ ] consumers. None of them derives from, or is based on, a newly concocted duty between a manufacturer and a federal agency"), aff'd 552 U.S. 440, 128 S. Ct. 1168, 170 L.Ed.2d 51 (2008). The FDA findings annexed to the complaint specifically reference the defendants’ failure to provide warnings to "Medical Advisory Boards" in support of violations of federal regulations. See, e.g., DE 6 at 38, 42. Such failures appear to run afoul of both FDA regulations and the learned intermediary doctrine. As in Hill , defendants
Of course, these documents may be considered on a Rule 12(b) motion. See Newman & Schwartz v. Asplundh Tree Expert Co., 102 F.3d 660, 662 (2d Cir. 1996) ("In considering a motion to dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6), a district court must limit itself to facts stated in the complaint or in documents attached to the complaint as exhibits.").
had continuing obligations under the PMA Supplement and federal regulations, which the FDA found it violated; and its failure to comply with the regulations resulted in its failure to warn the recipients of the ICD of the hazardous situation." Again, the Court finds that Plaintiff has alleged a sufficient factual basis to lead to the plausible inference that the St. Jude Defendants violated state law in a manner that did not impose requirements in addition to or different from federal law.
Hill , 2020 WL 4820243, at *6 (citation omitted). Thus, this Court fully agrees with the determination in Hill that plaintiff's strict liability and negligence claims based on failure to warn are not preempted by federal law. Id.
Any lingering doubt as to whether New York's failure to warn claims are preempted under the MDA are banished by Judge Ramos's fine analysis of this problem:
[T]he core of Plaintiffs’ failure-to-warn claim is that Defendants failed to timely and properly report information to the FDA concerning adverse effects of the product in violation of FDA requirements. See, e.g., Compl. ¶¶ 10, 89 (alleging that Defendants delayed production of adverse event reports to the FDA, failed to follow up on many adverse event reports that they received, erroneously blamed most adverse events on other causes, and submitted insufficiently detailed annual reports that minimized problems); 21 C.F.R. §§ 814.82, 814.84 (providing that the FDA may require such reports). Numerous courts have held that state claims for violations of FDA reporting requirements are "parallel" to and thus not preempted by the MDA. See Stengel [v. Medtronic Inc.], 704 F.3d [1224] at 1232–33 [ (9th Cir. 2013) ] (holding that a state claim for "failure to warn the FDA," "insofar as the state-law duty parallels a federal-law duty under the MDA, is not preempted"); Hughes v. Bos. Sci. Corp., 631 F.3d 762, 776 (5th Cir. 2011) ("[Plaintiff's] failure to warn claim is neither expressly nor impliedly preempted by the MDA to the extent that this claim is premised on [defendant's] violation of FDA regulations with respect to reporting [adverse events] caused by the [device]."); Plourde [v. Sorin Group USA, Inc.], 2018 WL 1542361, at *7 (holding, with respect to the same Valve product, that "a state-law claim for failure to report information to the FDA is not preempted"); Gale [v. Smith & Nephew, Inc.], 989 F.Supp.2d [243] at 251 [ (S.D.N.Y. 2013) ] (holding that a state tort claim based on a failure to comply with a premarket approval's monitoring and reporting requirements is not preempted).
Since a state claim for failure to warn the FDA is not preempted, the next question is whether, under New York law, the duty to warn may include warning the FDA. See Plourde , 2018 WL 1542361, at *7 ("[T]he preemption analysis in this area turns on whether a particular state's common law requires the manufacturer to report information to the FDA...."). [ ]
Under New York common law, a "manufacturer of a product used by the medical community has a duty to warn the medical community ‘of all potential dangers which it knows or should know, and must take such steps as are reasonably necessary to bring that knowledge to the attention of the medical [community].’ " Clar v. Riegler, 46 A.D.3d 1465, 849 N.Y.S.2d 739, 740 (4th Dep't 2007) (quoting Glucksman v. Halsey Drug Co. , 160 A.D.2d 305, 553 N.Y.S.2d 724, 726 (1st Dep't 1990) ). "This duty is a continuous one, and requires that the manufacturer be aware of the current information concerning the safety of its product." Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342, 1345–46 (E.D.N.Y. 1992) (citing Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 91 (2d Cir. 1980) ). Moreover, New York courts have long recognized that the violation of a regulation mandating a standard of conduct is some evidence of negligence and probative of whether the conduct is reasonable and adequate under the circumstances. E.g., Rizzuto v. L.A. Wenger Contracting Co. , 91 N.Y.2d 343, 670 N.Y.S.2d 816, 693 N.E.2d 1068, 1072 (1998). Courts have also recognized that the violation of MDA requirements can support claims for negligence and strict liability for a manufacturing defect. Gelber [v. Stryker Corp.] , 788 F. Supp. 2d [145] at 155–57 [ (S.D.N.Y. 2011) ]. Accordingly, the Court holds that a manufacturer's duty to take steps that are reasonably necessary to warn the medical community may include warning the FDA as required by the MDA. To the extent Plaintiffs assert a claim for failure to warn the FDA, that claim is not preempted.
Nor is this claim impliedly preempted under Buckman . This claim does not "exist solely by virtue of the FDCA disclosure requirements," but rather "rel[ies] on traditional state tort law." Buckman , 531 U.S. at 352–53, 121 S.Ct. 1012. Plaintiffs’ claim is "based on the underlying state duty to warn about the dangers or risks of [the] product" and thus survives Buckman preemption. Hughes, 631 F.3d at 775.
A.F. by & Through Fogel v. Sorin Grp. USA, Inc., 346 F. Supp. 3d 534, 542-44 (S.D.N.Y. 2018).
c. Misrepresentation
Likewise, plaintiff's misrepresentation by omission claims are not preempted because the claims are not premised solely upon fraudulent statements made to a federal agency but rather are premised upon traditional state law torts. Plaintiff asserts that defendants had "a continuing duty to monitor the device after premarket approval and to discover and report to the FDA any complaints or potential risks concerning the device's performance, and any adverse health consequences," DE 6 ¶ 133, but violated its duty by failing "to investigate and report evidence that the Greatbatch batteries used in its ICD devices were defective and could prematurely deplete as a result of the defect." Id. at ¶ 135. Plaintiff further alleges that "[h]ad [d]efendants timely ... reported adverse events and potential risks associated with a defective battery to the FDA, they would have appeared on the FDA's MAUDE internet database and in medical journals, and/or the FDA would have investigated the reports and issued Safety Communications and a Class I recall prior to October 10, 2016 .... [and] physicians would have ceased recommending the specific device be implanted." Id. at ¶ 138. According to plaintiff, defendants "fraudulently, negligently, or recklessly concealed from or failed to disclose to the FDA the [b]attery [d]epletion [d]efect in violation of the FDCA and federal regulations." Id. at ¶ 137. As discussed above, the FDA findings annexed to the complaint describe defendants’ withholding material information regarding the Unify Assura Defibrillator to "Medical Advisory Boards" in support of violations of federal regulations, which omissions were relied upon not only by the FDA, but by the medical community. See, e.g., DE 6 at 38, 42. Here, the misrepresentations by omission to the FDA were relevant to the defects present in the ICD that were foreseeable and were justifiably relied upon by the medical community in recommending the device to patients. Cf. Desiano , 467 F.3d at 97 (observing that suit depending on traditional and preexisting tort sources and only incidentally on evidence of FDA fraud was not preempted). Hence, the Court finds that plaintiff has alleged a plausible inference that defendants failed to disclose material foreseeable risks which were relied upon by the FDA and the medical community. As plaintiff notes, had defendants not concealed the dangerous battery defect, plaintiff's physicians would not have recommended the Unify Assura defibrillator. Accordingly, as plead the misrepresentation by omission claims are not preempted.
Negligent misrepresentation claims are subject to the heightened pleading standard set for in Rule 9 of the Federal Rules of Civil Procedure. See Nakahata v. New York-Presbyterian Healthcare System, Inc., 723 F.3d 192, 197-98 (2d Cir. 2013) (holding "[a]llegations of fraud are subject to a heightened pleading standard"). To state a claim of fraudulent misrepresentation under New York law, a plaintiff must set forth facts alleging "[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. , 583 F.3d 103, 108 (2d Cir. 2009) (citation omitted); see Burkett v. Smith & Nephew Gmbh , No. 12-CV-4895 (LDW), 2014 WL 1315315, at *7 (E.D.N.Y. Mar. 31, 2104) (holding a misrepresentation by omission claim requires a plaintiff to allege "(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") (internal quotation marks and citation omitted). Due to the detailed FDA findings annexed to the complaint, plaintiff easily satisfies these requisites, and defendants’ arguments in this regard are meritless.
d. Implied Warranty
Under New York law, "the implied warranty of merchantability is a guarantee by the seller that its goods are fit for the intended purpose for which they are used and that they will pass in the trade without objection." Caronia v. Philip Morris USA, Inc. , 715 F.3d 417, 433 (2d Cir. 2013). "This standard does not require that the goods be perfect, or that they fulfill [a] buyer's every expectation; it requires only that the goods sold be of a minimal level of quality." Id. at 433-34 (internal quotation marks and citations omitted). The inquiry:
focuses on the expectations for the performance of the product when used in the customary, usual and reasonably foreseeable manners. The cause of action is one involving true strict liability, since recovery may be had upon a showing that the product was not minimally safe for its expected purpose—without regard to the feasibility of alternative designs or the manufacturer's reasonableness in marketing it in that unsafe condition.
Id. at 434 (internal quotation marks and italics omitted). Upon a showing that a product is not minimally safe for its expected purpose, a plaintiff may recover under New York law for a breach of implied warranty. See Porrazzo v. Bumble Bee Foods, LLC , 822 F. Supp. 2d 406, 417 (S.D.N.Y. 2011). In order for Plaintiff to set forth a breach of implied warranty claim based on design defect, he must allege the following three elements: "(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 v. Ford Motor Co. , No. 13 CV 4584 (JS), 2014 WL 2048571, at *4 (E.D.N.Y. May 19, 2014) (citations omitted).
Here, plaintiff alleges that defendants established an implied warranty that the Unify Assura device was safe and effective for its intended use when implanted in plaintiff. Significantly, 21 C.F.R. § 808.1(d)(1) specifically provides that § 521(a) of the Act [ 21 U.S.C. § 360k(a) ] "does not preempt State or local requirements of general applicability where the purpose of the requirement relates ... to other products in addition to devices (e.g., requirements such as ... the Uniform Commercial Code (warranty of fitness))." Thus, plaintiff's implied warranty claims are not preempted. See, e.g., Berger v. Medtronic, Inc. , 164 Misc.2d 378, 623 N.Y.S.2d 985, 990 (Sup. Ct.1995) ; Fogal v. Steinfeld , 163 Misc.2d 497, 620 N.Y.S.2d 875, 883 (Sup. Ct.1994) ; Ministry of Health v. Shiley, Inc. , 858 F. Supp. 1426, 1440 (C.D. Cal. 1994) ; cf. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 525, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (holding an express warranty was not preempted since it was not " ‘imposed under State law,’ but rather [was] imposed by the warrantor ") (emphasis in original).
CONCLUSION
Based on the foregoing, defendants’ motion to dismiss is denied. The parties are directed to proceed with discovery with the assigned Magistrate Judge.