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Bull v. St. Jude Medical, Inc.

United States District Court, E.D. Pennsylvania

July 12, 2018



          BAYLSON, J.

         I. Introduction

         In this case, Plaintiff Kristen Bull alleges that Defendant St. Jude Medical, Inc. committed negligence by failing to warn her physicians about risks inherent in a medical device it manufactured, the Riata ST Lead, a component part of a medical device that was implanted in Plaintiff's heart. Plaintiff asserts that St. Jude was aware of instances in which the Riata ST Lead malfunctioned, creating danger to patients, and that it did not inform the FDA about all of these instances in violation of its specific duty to do so under relevant federal regulations. Plaintiff brings one common law tort cause of action against St. Jude. Presently before the Court is a Motion to Dismiss the Amended Complaint for failure to state a claim for which relief can be granted, filed by St. Jude. For the reasons discussed below, Defendants' motion is denied.

         II. Factual History

         Taking Plaintiff's allegations as true, the factual background is as follows. Defendant St. Jude manufactures a medical device known as an implantable cardiac defibrillator (“ICD”), which is used to treat heart conditions. (Amended Complaint, ¶ 7.) Specifically, an ICD can correct slow heart rates, pace rapid heart rates, and administer a shock to stabilize the heart and allow for a return to an appropriate rhythm. (Id., ¶ 11.) Wires, called leads, connect an ICD to the muscle on the inside of the heart. (Id., ¶ 7.) Leads conduct electrical impulses between the heart and the ICD. (Id., ¶ 12.) High voltage leads are inserted through a major vessel and attached directly to the muscle on the inside of the heart. (Id.) Electrodes that sense the heart's rhythm are built into the leads via cables and conductors, and are positioned in the heart for the purpose of monitoring the heartbeat and correcting any irregular rhythms by transmitting electric shocks from the ICD when necessary. (Id., ¶¶ 7, 12.) If the ability of the lead to sense or transmit electrical signals is compromised, the ICD will fail to perform properly. (Id., ¶ 13.) Types of lead failures include externalization of the conductors, abrasion, fractured wires, cables, or conductors, insulation loss, loss of ability to capture changes in electrical characteristics in the ventricle chamber, abnormal lead impedance, sensing failure, and changes in tissue conductor interface. (Id.)

         A. Initial and Supplemental Pre-market Approval, and Medical Device Reporting

         St. Jude Riata Leads are Class III medical devices. (Am. Compl., ¶ 16.) A pre-market approval application (“PMA”) must be submitted to the FDA for any Class III medical device. (Id., ¶ 14.) A PMA must contain particular information that is reviewed by the FDA to determine the safety and efficacy of the device. (Id.) PMA Supplements are supplemental applications to an approved PMA seeking approval of a change or modification in a Class III medical device. (Id., ¶ 21.) Pursuant to 21 C.F.R. § 814.3(g), PMA supplements include “all information submitted with [the PMA Supplement] or incorporated by reference therein.” (Id., ¶ 22.)

         In 1996 the FDA approved St. Jude's PMA for the Ventritex TVI Lead, the predecessor of the Riata and Riata ST Leads. (Id., ¶¶ 8, 16.) St. Jude was required to, and did, “establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met” consistent with 21 C.F.R. § 820.30. (Id., ¶ 18.) Pursuant to 21 U.S.C. § 360(h), St. Jude was required to be, and was, inspected by the FDA “at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter.” (Id., ¶ 20.)

         The Riata Leads were introduced to the U.S. market in 2002. (Id., ¶ 8.) FDA approval for these leads was based on fourteen supplements to St. Jude's 1996 submission for approval of the Ventritex TVI Lead, submitted between 1996 and 2002. (Id., ¶¶ 8, 22.) These supplements altered various aspects of the design and manufacture of the leads. In March 2006, the FDA approved changes to the Riata Leads. (Id., ¶ 23.) The devices as modified are marketed under different trade names, one of which is Riata ST Model 7042, the model used in the ICD implanted in Plaintiff's heart. (Id.)

         The FDA relies on Medical Device Reporting (“MDR”) to receive information about significant medical device adverse events from manufacturers, importers, and user facilities, so that problems can be corrected quickly. (Id., ¶ 49.) The FDA publishes the adverse events and MDRs in a public, searchable database called MAUDE which is updated monthly. (Id., ¶ 50.) The general public, including physicians and patients, uses the MAUDE database to obtain safety data on medical devices. (Id.) Full and complete reporting of adverse events is required of all manufacturers by the FDA. (Id., ¶ 51.) This reporting serves to notify the public that a potential problem with a device exists, and can prompt an informed person or organization to develop a solution. (Id.)

         B. 2009 FDA Quality Systems Inspection Technique and Resulting Establishment Inspection Report

         In 2009 the FDA conducted a for-cause Quality Systems Inspection Technique (“QSIT”) of St. Jude's manufacturing facility in Sylmar, California. (Am. Compl., ¶ 24.) As part of this inspection, the FDA required St. Jude to provide a list of all Corrective and Preventive Action (“CAPA”) and Product Improvement Requests (“PIRs”) opened since 2002, and St. Jude reported fourteen PIRs regarding High Voltage Leads. (Id.) The inspection revealed that St. Jude had deficiencies in the handling of complaints, making MDR determinations, CAPA procedures, and receiving protocols. (Id., ¶ 25.)

         St. Jude provided a spreadsheet during the investigation indicating that between 2002 and 2009, the company had received 8, 463 complaints regarding the Riata and Durata lead models, and that for all complaints identified as “perforation, patient, ” an MDR was submitted. (Id., ¶ 28.) However, the FDA adverse event database contained only 3, 689 MDRs from St. Jude for the Riata and Durata lead models during this same time period. (Id.) The inspection revealed that in some cases in which complainants reported perforation adverse events associated with the Riata and Durata devices, St. Jude did not report “perforations” in the associated MDRs submitted to the FDA, and did not identify “perforation” in Form 3540A submissions in either the patient or device problem codes. (Id., ¶ 31.) Eight complaints from the MAUDE database, that were identified by St. Jude as “capture anomaly, ” “dislodgment, ” or “patient discomfort, ” were reviewed and the investigation concluded that six of these eight “in fact described a suspected perforation and it could not be ruled out as possible for the other two events.” (Id., ¶ 32.)

         The 2009 Establishment Inspection Report also notes that “complaints representing events that are MDR reportable were not promptly reviewed, evaluated and investigated by the designated individual 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 manufacturer.” (Id., ¶ 33.) The report also states that review of the MDRs submitted from 2007 through June 2009 concluded that there was no evidence that the perforation events described in the medical or scientific literature were submitted to the FDA as required by regulations and company procedures. (Id., ¶¶ 34, 40.) The 2009 inspection also revealed that St. Jude failed to follow their procedure for product design developments of the Leads. (Id., ¶ 35.)

         As a result of these deficiencies the FDA issued an eight-item FDA-483 report on July 8, 2009. (Id., ¶ 36.) An FDA Form 483 is issued to management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic Act and related Acts. (Id.) The eight deficiencies identified in the report are as follows:

1. St. Jude failed to include all information that was reasonably known to the manufacturer on an MDR report in violation of 21 C.F.R. § et seq.
2. St. Jude failed to timely submit MDRs to the FDA and such submissions were significantly past the mandatory reporting timeframes without written explanation in violation of 21 C.F.R. § 803 et seq.
3. St. Jude failed to define the procedures for implementing corrective and preventative actions in violation of 21 C.F.R. § 820 et seq.
4. St. Jude failed to review their sampling methods for adequacy of their intended use in violation of 21 C.F.R. § 820 et seq.
5. St. Jude failed to perform design reviews at appropriate times in violation of 21 C.F.R. § 820 et seq.
6. St. Jude failed to perform a complete risk analysis in violation of 21 C.F.R. § 820 et seq.
7. St. Jude failed to establish procedures for the validation or verification review, and approval of design changes before their implementation in violation of 21 C.F.R. § 820 et seq.
8. St. Jude failed to resolve discrepancies noted at the completion of design verification in violation of 21 C.F.R. § 820 et seq.

(Id., ¶ 37.) The Establishment Inspection Report states that “complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by the designated individual per 21 C.F.R. § 820.198(d).” (Id., ¶ 38.)

         The report also states that St. Jude's Standard Operating Procedure for Global Risk Management was inadequate as it related to “clinical risk in new product development and throughout the product life cycle, and [was] inadequate in that the procedure did not establish a methodology for ...

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