United States District Court, E.D. Pennsylvania
KRISTEN A. BULL
ST. JUDE MEDICAL, INC.,
MEMORANDUM RE: MOTION TO DISMISS
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.
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.
Initial and Supplemental Pre-market Approval, and Medical
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.)
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.)
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.)
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.)
2009 FDA Quality Systems Inspection Technique and Resulting
Establishment Inspection Report
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., ¶
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.)
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.)
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
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.)
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