Kaemmlein v. Abbott Laboratories

Decision Date29 September 2021
Docket NumberCV 20-1466 (GRB)
Citation564 F.Supp.3d 58
Parties 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.
CourtU.S. District Court — Eastern District of New York

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 Medical1 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.

The FDA approved the Unify Assura device for sale on May 8, 2012 through the PMA process,2 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.

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. ¶¶ 91-993 ; (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.

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....

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