SAN FRANCISCO, Feb. 10, 2015 /PRNewswire/ -- Shareholder
and consumer rights law firm Schubert Jonckheer & Kolbe LLP has
launched an investigation into whether certain officers and
directors of St. Jude Medical, Inc. (NYSE: STJ) breached their
fiduciary duties to St. Jude and its shareholders.
A class action brought on behalf of purchasers or St. Jude
shares during the period February 5,
2010 to November 20, 2012,
pending in the United States District Court for the District of
Minnesota, seeks to obtain damages
from St. Jude. The District Court denied St. Jude's motion to
dismiss the case, and the case is now proceeding toward trial.
The class action concerns public statements and material
omissions made by key St. Jude executives, including St. Jude's
President and Chairman of the Board, Daniel
J. Starks, regarding the safety and reliability of two
generations of its leads, which were used to connect pacemakers or
implantable cardioverter defibrillators to patients' hearts. The
defibrillation leads at issue included St. Jude's Riata, Riata ST,
and Riata St Optim (later renamed "Durata"). The pacing leads at
issue included the Quick Site, Quick Flex, QuickFlex µ and Quartet
models.
Defibrillation and pacing leads provide "life-supporting or
life-sustaining therapy, and thus are classified as Class III
medical devices by the Food and Drug Administration per 21 C.F.R.
§ 860.93. As such, these leads are subject to the most
stringent regulatory controls, including premarket approval and
post-market surveillance. See 21 C.F.R.
§ 360.3(c)(2).
The class action alleges that defendants failed to inform the
public that St. Jude's quality controls of over the design,
production and post-market monitoring of its leads were chronically
deficient and were the subject of scrutiny and repeated criticism
from the FDA. The class action alleges that the defendants made
actionably misleading statements and omissions of material facts
regarding these issues in its Form 10-K annual reports for 2009,
2010 and 2011, and quarterly reports for the first and second
quarters of 2012, as well as in an investor call and certain "Dear
Doctor" advisory letters issued during the February 2010 through November 20, 2012 period.
The Schubert Law Firm's investigation concerns whether current
St. Jude shareholders may be able to bring derivative claims on
behalf of St. Jude itself against certain of its officers and
directors for their actions in causing St. Jude to incur liability
in the class action.
If you currently own St. Jude stock and wish to obtain
additional information about the Schubert Law Firm's investigation
and your legal rights, please contact Miranda Kolbe either via email at
mkolbe@schubertlawfirm.com or by telephone at (415) 788-4220, or
fill out the form on our website at
http://classactionlawyers.com/stjude
About Schubert Jonckheer & Kolbe
Schubert Jonckheer & Kolbe has extensive experience in
prosecuting securities claims, representing investors throughout
the nation in securities and shareholder lawsuits. Attorney
advertising. Prior results do not guarantee similar outcomes.
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SOURCE Schubert Jonckheer & Kolbe LLP