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Rosen v. St. Jude Medical, Inc.

United States District Court, N.D. New York

August 28, 2014

SUSAN ROSEN, Plaintiff,

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For Susan Rosen, Plaintiff: Amanda M. Williams, Daniel E. Gustafson, LEAD ATTORNEYS, PRO HAC VICE, Gustafson, Gluek Law Firm, Minneapolis, MN; Joseph C. Berger, LEAD ATTORNEY, Thomas M. Kernan, Berger, Kernan Law Firm, Clifton Park, NY; Yvonne M. Flaherty, LEAD ATTORNEYS, PRO HAC VICE, Lockridge, Grindal Law Firm, Minneapolis, MN.

For St. Jude Medical, Inc., Pacesetter, Inc., Defendants: Daniel J. Hurteau, LEAD ATTORNEY, Nixon, Peabody Law Firm - Albany Office, Albany, NY; Maja C. Eaton, LEAD ATTORNEY, PRO HAC VICE, Sidley, Austin Law Firm - Chicago Office, Chicago, IL; Rebecca K. Wood, LEAD ATTORNEY, PRO HAC VICE, Sidley, Austin Law Firm - DC Office, Washington, DC.

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Lawrence E. Kahn, United States District Judge.


In this medical device case, Plaintiff Susan Rosen (" Plaintiff" ) alleges that she

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suffered injuries as a result of manufacturing defects and failure to warn by Defendants St. Jude Medical, Inc. and Pacesetter, Inc. (collectively, " Defendants" ). Dkt. No. 1 (" Complaint" ). Defendants filed a Motion to dismiss, and Plaintiff responded with an Amended Complaint. Dkt. Nos. 8; 19 (" Amended Complaint" ). Defendants then filed a Motion to Dismiss the Amended Complaint for failure to state a claim upon which relief may be granted. Dkt. No. 25 (" Motion" ). For the following reasons, Defendants' Motions to dismiss are denied.


A. Statutory and Regulatory Background

The Medical Device Amendments (" MDA" ) to the Food, Drug, and Cosmetic Act (" FDCA" ), 21 U.S.C. § 301 et. seq., require certain medical devices to undergo a stringent Pre-Market Approval (" PMA" ) process by the Food and Drug Administration (" FDA" ) before they may be marketed and sold to the public. 21 U.S.C. § 360e; Riegel v. Medtronic, Inc., 552 U.S. 312, 317, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Class III medical devices, which are used " in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" or " present[] a potential unreasonable risk of illness or injury," are subject to the greatest level of scrutiny. Riegel, 552 U.S. at 316; 21 U.S.C. § 360c(a)(1)(C).

Even after a device is FDA-approved and marketed to the public, " all PMA-approved devices are subject to the same federal device-specific regulation[, including] complying with the standards set forth in their individual approved PMA applications." Riegel v. Medtronic, Inc., 451 F.3d 104, 119 (2d Cir. 2006), aff'd, 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). A manufacturer is not permitted to, inter alia, make changes to design specifications or manufacturing processes without FDA approval. 21 U.S.C. § 360e(d)(6)(A)(i); Riegel, 552 U.S. at 319. Device manufacturers are also subject to continued reporting requirements, " including the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device of which the manufacturer knows or reasonably should know, and the obligation 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 were it to reoccur." McConologue v. Smith & Nephew, Inc., No. 13-CV-0880, 8 F.Supp.3d 93, 2014 WL 1246834, at *4 (D. Conn. Mar. 24, 2014); 21 U.S.C. § 360i; 21 C.F.R. § § 814.84(b)(2), 803.50(a); Riegel, 552 U.S. at 319.

B. Riata Leads

Defendants[2] manufacture a variety of medical devices to treat heart conditions, including implantable cardiac defibrillators (" ICD" ) and wires, called " leads," which attach the ICD to the heart. Am. Compl. ¶ 2.

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The leads serve to monitor the heartbeat and correct any irregular rhythms. Id. In 1996, Defendants received approval from the FDA to market and distribute the Ventritex TVI Lead, a Class III medical device. Am. Compl. ¶ ¶ 3, 20. From 1996 to 2002, Defendants submitted, and the FDA approved, fourteen PMA Supplements, which altered various aspects of the design and manufacturing process. Id. ¶ 29. Based on the original and supplemental PMAs, in 2002, Defendants formally introduced its Riata Leads to replace the Ventritex TVI Lead. Id. ¶ 3. Over the next several years, Defendants submitted and received approval for numerous modifications to the manufacturing and design processes for the Riata Leads. Id. ¶ ¶ 30-35.

C. Plaintiff's Implantation and Removal of Riata Lead

Plaintiff was implanted with a Riata Lead in 2004. Am. Compl. ¶ 8. On or around September 25, 2012, Plaintiff's treating physician determined that the lead was not operating properly and suspected that it may have fractured. Id. On or around October 8, 2012, Plaintiff's Riata Lead was surgically extracted; the surgeon found that it had indeed fractured, and the conductor coils had " externalized." [3] Id. ¶ 9.

D. FDA Inspections and Reports

1. 2009

In 2009, the FDA conducted a for-cause Quality Systems Inspection Technique (" QSIT" ) of one of Defendants' manufacturing facilities in California. Am. Compl. ¶ 50. The inspection required Defendants to provide a list of all Corrective and Preventative Action (" CAPA" ) and Product Improvement Requests (" PIR" ) opened since 2002. Id. ¶ 50. Defendants' list included PIRs, such as, " cable fracture," " Riata coil fracture," " Missing DF-1 crimps," " Riata Lead with incorrect conduction paths," " Riata Lead abrasion," " Insufficient crimp," " Riata perforation," and " Riata Lead cable coating abrasion." Id. The FDA's inspection also revealed deficiencies in Defendants' " handling of complaints, making Medical Device Reporting (" MDR" )[4] determinations, CAPA procedures, and receiving protocols." Id. ¶ 51.

As part of the 2009 QSIT, the FDA interviewed Defendants' Director of Regulatory Compliance, who provided the FDA with a spreadsheet of all complaints for the Riata Leads dating back to 2002, when the Riata Leads entered the U.S. market. Am. Compl. ¶ 54. The spreadsheet indicated that since 2002, a total of 8,463 complaints had been filed; however, the FDA " adverse event database" showed only 3,689 MDRs reported. Id. Following the inspection, the FDA's review revealed that " in some cases Defendants failed to submit MDR reports containing all information reasonably known to them in accordance with the provisions of 21 C.F.R. § 803.50(b)." Id. ¶ 56. " Specifically, the complaint files show that the complainants reported perforation adverse events for the Riata [Leads], . . . but these events were not reported as 'perforations' in the associated MDRs submitted to the FDA by [Defendants]." Id.

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The FDA also produced an Establishment Inspection Report (" EIR" ), which noted that " complaints representing events that are MDR reportable were not promptly reviewed, evaluated and investigated by [Defendants] per 21 C.F.R. § 820.198(d), and MDRs were not submitted within the mandatory reporting timeframes required by 21 C.F.R. § 803.50 for device manufacturers." Am. Compl. ¶ 58. Specifically, two " perforation events" from 2003 and 2004 were not submitted until 2008, and were submitted " without explanation." Id.

On July 8, 2009, the FDA issued an eight-item FDA-483 report,[5] which cited deficiencies including, inter alia : failure to include all information reasonably known to [Defendants] on an MDR report in violation of 21 C.F.R. § 803 et. seq.; failure to timely submit MDRs to the FDA in violation of 21 C.F.R. § 803 et. seq.; failure to define and implement procedures for corrective and preventative actions in violation of 21 C.F.R. § 820 et. seq.; and failure to properly monitor and review adequately a number of " critical" component parts in violation of 21 C.F.R. § 820 et. seq. Am. Compl. ¶ 72.

2. 2011

A 2011 FDA report indicated that Defendants' CAPAs limited their analysis to " externalized cables and [did] not include exposed cables or all other forms of abrasion, which FDA considers important contributors to the published rate of all abrasion presented in [Defendants'] November 2011 Product Performance Report (" PPR" )." Am. Compl. ¶ 60. The FDA's report also noted " numerous instances of underreporting and . . . that the terms 'externalized cable' or even 'abrasion' may not be employed when it is a contributing cause." Id. ¶ 62. It further indicated that Defendants may have failed to report " the diagnosis of the lead mechanical failure," and that Defendants may have been under-reporting " inappropriate high voltage shock delivery" " due to their limiting terminology." [6] Id. ¶ ¶ 62-63.

E. Dear Doctor Letters and Recall

On December 15, 2010, Defendants published a " Dear Doctor" letter indicating " issues with defects in the insulation" of several Riata Leads models. Am. Compl. ¶ 91. The letter addressed vulnerability of the Leads' insulation to " abrasion," which may prevent the Leads from performing properly, and it also published the Leads' current abrasion rate. Id. ¶ ¶ 92-93. Defendants did not recall the Leads, but rather noted that they were " phasing out" all Riata Leads by the end of 2010. Id. ¶ 94. On Nov 28, 2011, Defendants published a second Dear Doctor letter, which indicated that the previously published abrasion rate in 2010 had increased. Id. ¶ ¶ 95-96.

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On December 21, 2011, the FDA " reclassified [Defendants'] Dear Doctor letters as a Class I Recall," which is " the most serious level of recall and is defined as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." Am. Compl. ¶ ¶ 97-98. The FDA warned that " failures associated with lead insulation abrasion on the [Riata Leads] . . . may cause the conductors to become externalized. If this occurs, this product may cause serious adverse health causes, including death." Id. ¶ 99.

F. Review of the Complaint

Plaintiff asserts that her Riata Lead was defective due to Defendants' failure to comply with the " specifications, requirements, federal regulations, and/or the PMAs," in the following ways: (1) failure to manufacture the internal conductors, or cables, at sizes consistent with applicable requirements; (2) inconsistent insulation diameters and/or thickness surrounding the electric conductors; (3) failure to comply with approved methods and/or specifications and requirements of curing and sterilization during the manufacture process; (4) processing the leads in a solution which caused the cables and/or conductors to stretch and then vibrate when exposed to electrical charge through the silicone; and (5) failure to crimp the leads with a controlled, uniform degree of force, which resulted in insecure crimps over the length of the Leads. Am. Compl. ¶ ¶ 82-86. These defects resulted in " increased tension, bending and/or movement of the internal conductors, or cables, within the insulation thereby causing inside-out abrasion." Id. Ultimately, these defects caused the cables to protrude through the insulation and come in contact with materials and body fluids, which can produce painful shocks and fracture, or otherwise prevent the device from functioning properly. Id. ¶ ¶ 87-88.

In the Complaint, Plaintiff asserts three causes of action under New York common law: (1) strict liability for manufacturing defect; (2) negligent manufacturing defect; and (3) failure to warn. Am. Compl. ¶ ¶ 109-124. Plaintiff alleges that she suffered physical, emotional, and economic damages resulting from " extrusion of the conductor, compromised lead insulation, increased lead impedence, and ...

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