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Press Release -
October 15, 2007
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Class Counsel Announce Patients File Class
Action Lawsuits Against Medtronic For Manufacturing
Faulty Defibrillator Lead Wires |
-- Plaintiffs Seek to Hold Medtronic Responsible
for the Injuries They Suffered and to Reimburse
All Patients with the Defective Leads for the
Medical Care and Surgical Expenses Arising out
of the Medtronic Recall |
October 15, 2007, Minneapolis, MN and San Juan,
PR - Class counsel announced today that heart
patients nationwide implanted with recalled defibrillator
leads filed separate lawsuits in Minneapolis,
Minnesota, and San Juan, Puerto Rico, against
the manufacturer Medtronic Inc., and related
companies. Each plaintiff received a cardiac
pacemaker/defibrillator combination that was
attached to their hearts with a lead wire system
manufactured by Medtronic and sold under the
brand name Sprint Fidelis. In the case of three
of the patients, the Sprint Fidelis lead fractured
or frayed, necessitating additional surgery to
remove the device and implant a new lead system.
The plaintiffs are residents of California, Massachusetts,
North Carolina, New York and Oregon. |
"The complaints charge that Medtronic
has misrepresented the safety of the Sprint Fidelis
leads and a large proportion may fracture," stated
class counsel Elizabeth J. Cabraser of the national
plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein,
LLP. "As a result, patients may receive
massive, unnecessary electrical shocks or the
device may fail to function during a life-threatening
cardiac event." |
"The Medtronic Sprint Fidelis lead, compared
to competing products, has a significantly higher
failure rate that appears in just the first two
years after implantation. We are concerned that
Medtronic is minimizing the likelihood that patients
may need to have their lead surgically removed,"
stated Wendy R. Fleishman, a partner at the New
York office of Lieff Cabraser. "It
is critical that patients with the recalled Medtronic
lead promptly meet with their physician and discuss
their options." |
Medtronic has not disclosed the precise mechanism
of the Sprint Fidelis lead fracture failures.
The complaints charge that it appears the defect
is attributable to the small diameter of the
coil and conductors in the lead and because of
this the lead is subject to stress damage both
during and after the implant. Fracture eventually
occurs when the conductor is critically overstressed. |
“The defect is potentially fatal,” explained
class counsel Nick J. Drakulich of The Drakulich
Firm of San Diego, California. “In the
class action lawsuit filed in Minnesota, plaintiffs
seek an order from the Court requiring that Medtronic
create a treatment fund to monitor the health
of all patients with the recalled lead and reimburse
patients for all diagnostic and corrective medical
and surgical expenses attributable to their faulty
leads.” |
"Both the patients who have had to undergo
unnecessary and invasive surgeries as a result
of Medtronic's actions -- which Medtronic has
only now begun to admit but has not accepted
responsibility for - and those who now fear that
their life-saving devices may not save their
lives, should have their opportunity to obtain
justice," added Seth R. Lesser of the Locks Law
Firm in New York, New York. |
Plaintiffs’ Experiences and Allegations |
In January 2006, Kelly Luisi of San Diego,
California, a plaintiff in the class action lawsuit
filed in Minnesota, was implanted with a defibrillator
with a Sprint Fidelis lead. As alleged in the
complaint, in March 2007, Ms. Luisi experienced
frightening episodes of unnecessary shocks. She
went to the hospital and was admitted in the
emergency department. The Medtronic Representative
was present, and when he used his device to interrogate
the device, Ms. Luisi’s defibrillator began
delivering unnecessary shocks over and over again.
The Medtronic Representative did not have a magnet
to de-energize the leads, and could not immediately
deactivate the device. Ms. Luisi experienced
several additional inappropriate and frightening
shocks at the emergency room. |
Ms. Luisi’s lead was removed in April
2007 as it has fractured. Ms. Luisi was required
to undergo additional and complicated surgery
to remove and replace the faulty lead. |
In the lawsuit filed in Puerto Rico, plaintiff
Russell Nelson of Portland, Oregon, received
a defibrillator heart with a Sprint Fidelis lead
in March 2005. The lead was found to have “frayed” in
the nature of a fracture and was replaced in
an emergency surgery in January of 2007. |
In October 2005, George Anastas, a resident
of Westminister, Massachusetts, and also a plaintiff
in the lawsuit filed in Puerto Rico, received
a defibrillator with a Sprint Fidelis lead. |
The complaint charges that in May 2006, Mr.
Anastas experienced frightening episodes of unnecessary
shocks. He went to the hospital and was admitted
in the emergency department. A Medtronic representative
was present, and when he used his device to interrogate
the defibrillator, it began delivering repetitive
unnecessary shocks. The Medtronic representative
did not have a magnet to de-energize the leads,
and could not immediately deactivate the device.
Mr. Anastas experienced several additional inappropriate
and frightening shocks at the emergency room. |
As was the case with Ms. Luisi, the Medtronic
lead system inside Mr. Anastas had fractured.
Mr. Anastas was therefore forced to undergo additional
and complicated surgery to remove and replace
the faulty lead. |
Information for Heart Patients |
On October 15, 2007, due to reports of adverse
events and at least five patient deaths with
defibrillator leads sold under the brand name
Sprint Fidelis, Medtronic issued a recall of
the product. |
Leads are the thin insulated
wires connected to a defibrillator that carry
electric impulses to the heart. Your wallet
card will specify the manufacturer of your
defibrillator leads. |
If you would like to learn more about the Medtronic
recall and your legal rights,
please visit http://www.medtronicheartleadrecall.com. |
Patients who have had to undergo surgery
to replace a faulty lead or have been advised
by a physician their lead may be defective
are also welcome to call class counsel toll
free at 1-800-541-7358 and ask to speak to
attorney Heather A. Foster at Lieff Cabraser
Heimann & Bernstein, LLP. |
Resources for Reporters |
Reporters that wish to receive a copy of the
class action complaint are welcome to contact
Stephen Cassidy at Lieff Cabraser at scassidy@lchb.com or
(415) 956-1000. |
About Plaintiffs' Counsel |
Representing plaintiffs in the Minnesota
class action lawsuit are Daniel E. Gustafson,
Gustafson Gluek PLLC; Elizabeth J. Cabraser
,Wendy R. Fleishman and Rebecca Bedwell-Coll,
Lieff, Cabraser, Heimann & Bernstein,
LLP; Silvija A. Strikis, Kellogg, Huber, Hansen,
Todd, Evans & Figel, PLLC; Nicholas J. Drakulich,
The Drakulich Firm; Jennings & Drakulich,
LLP; Richard J. Arsenault, Neblett, Beard & Arsenault;
Hunter J. Shkolnik, Rheingold, Valet, Rheingold,
Shkolnik & Mccartney LLP; and Seth R. Lesser,
Locks Law Firm. |
Representing plaintiffs in the Puerto Rico
lawsuit are John F. Nevares, Smith & Nevares;
Camillo K. Salas, III, Salas & Co.; Richard
J. Arsenault, Neblett, Beard & Arsenault;
Elizabeth J. Cabraser, Wendy R. Fleishman and
Rebecca Bedwell-Coll, Lieff, Cabraser, Heimann & Bernstein,
LLP; Nicholas A. Drakulich, The Drakulich Firm;
Jennings & Drakulich, LLP; Daniel E. Gustafson,
Gustafson Gluek PLLC; Seth R. Lesser, Locks Law
Firm; Hunter J. Shkolnik, Rheingold, Valet, Rheingold,
Shkolnik & Mccartney LLP; and Silvija A.
Strikis, Kellogg, Huber, Hansen, Todd, Evans & Figel,
PLLC. |
Source/Contact for Media Inquiries Only |
Wendy Fleishman
Lieff Cabraser Heimann & Bernstein, LLP
(212) 355-9500 (office) |
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TRADEMARK NOTICE: "Sprint Fidelis" is
a trademark of Medtronic, Inc. Lieff Cabraser
is in no way affiliated with Medtronic, Inc. The use of this
mark is solely for informational and product identification purposes. |
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