The Medtronic Heart Lead Recall: Attorneys
For Patients Provide Answers To Frequently
Asked Questions |
October 22, 2007 -- Attorneys
representing heart patients that filed the
first personal injury and class action lawsuits
against Medtronic Inc., and related companies,
for manufacturing defective defibrillator leads
issued today a list of answers to common questions
on the recall. |
"We wish to educate patients
with defibrillators as to how they can identify
if they received the recalled lead as well
as to provide basic information for injured
patients on hiring an attorney and their legal
rights," stated attorney Wendy R. Fleishman
of the national plaintiffs ’ law firm
Lieff Cabraser Heimann & Bernstein, LLP. "However,
first it is critical that patients with the
recalled Medtronic lead promptly meet with
their physician and discuss their options." |
The following questions and answers
were posted today on the website www.medtronicheartleadrecall.com operated
by Lieff Cabraser: |
1. What is a defibrillator
lead? |
Leads are thin insulated wires
connected to a defibrillator that carry electric
impulses to the heart in patients with a heart
rhythm abnormality. |
2. Why has Medtronic
recalled its defibrillator leads? |
Medtronic actually refuses to
call its actions a recall. Instead, on October
15, 2007, Medtronic issued a "voluntary market
suspension" to remove its line of Sprint Fidelis
defibrillation leads from the market. Medtronic
stated that the leads are prone to fracturing
which can cause the defibrillator to deliver
unnecessary shocks or not operate at all. |
3. What Sprint Fidelis
leads were withdrawn from the market? |
The Sprint Fidelis leads
that have been recalled contain the model numbers
6949, 6948, 6931 and 6930. |
4. I don't have a Medtronic
brand defibrillator. Am I therefore unaffected
by all of this? |
No. The Sprint Fidelis leads were
connected to defibrillators made by Medtronic
as well as other defibrillator manufacturers
such as Guidant and St. Jude, and implanted in
or sold to an estimated 268,000 patients worldwide
since 2004 -- with roughly 235,000 patients still
relying on these implanted leads. |
Check your wallet card for your
defibrillator and see if anywhere on the card
the model numbers 6949, 6948, 6931 and 6930 appear
-- either by themselves or at the beginning of
a longer number. If these numbers do appear,
you most likely received a Medtronic Sprint Fidelis
lead. |
5. How many patients
have suffered an injury? |
Medtronic reported that at least
five patient deaths associated with fractured
Sprint Fidelis leads have occurred and that
a small number of patients have had their lead
fracture. |
However, as listed in an October
16, 2007 letter from Dr. Sidney M. Wolfe of
Public Citizen to the Food and Drug Administration
(FDA), over 1,600 injury reports have been
filed with the agency over the past two years.
More than 750 of these reports listed the patient
as having received "inappropriate shocks." |
6. The Sprint Fidelis
lead to my defibrillator has not fractured.
What should I do? |
The FDA recommends that defibrillator
settings be adjusted at the patient's next
scheduled follow-up visit with their doctor.
Doing so may increase the likelihood that a
fracture will be detected before a patient
is harmed. Unfortunately, no test exists to
accurately predict whether a patient's lead
will fracture. |
The FDA does not recommend
the routine surgical removal of a fractured
lead because removal carries risks. Instead,
physicians should weigh the benefits and risks
of either continuing to use the lead with careful
monitoring or implanting a different lead model
and then capping the old lead so it is no longer
useable. |
7. What is the fracture
rate for patients with the recalled Medtronic
heart lead? |
The FDA has stated: "Current
adverse event information indicates that fractures
have occurred in less than 1 percent of the
approximately 268,000 of these leads implanted
worldwide. We don't know if this rate of adverse
events will remain constant or increase over
the life of these leads." |
The number of injury reports
filed with the FDA for the Sprint Fidelis lead,
however, have been escalating with time suggesting
the fracture rate is increasing. Moreover,
clinical studies have found a much greater
failure rate. In a study of patients at Cornell
University Medical Center, 17% of patients
experienced abnormal right ventricular sensing,
requiring early revision (change out) in 4%
of patients. |
In addition, the recalled Medtronic
heart leads, because of their smaller diameter
than competing products, were often used in
young adults and child heart patients. Medical
researches have reported a higher fracture
rate with this population. It is believed the
leads have come under greater stress in more-active
people, including kids, adolescents and younger
adults. |
8. What exactly is
the defect with the Medtronic heart lead? |
Medtronic has not disclosed the
precise reason why its Sprint Fidelis leads
are fracturing. In a "Dear Doctor" letter from
March 2007 Medtronic claimed surgeons were
responsible for causing the fracturing during
implantation of the device. |
In lawsuits filed by heart
patients represented by plaintiffs' counsel,
the plaintiffs allege that the defect is attributable
to the small diameter of the coil and conductors
in the lead which makes it prone to stress
damage both during and after implant surgery.
Fracture eventually occurs when the conductor
is critically overstressed. |
9. What types of injuries
have patients with fractured defibrillator
leads suffered? |
Many patients have experienced
terrifying and devastating episodes of repeated
electrical shocks due to a fractured lead.
In some cases, the patient has died or the
lead did not operate properly when the patient
experienced abnormal heart rhythms. |
10. Why is Medtronic
legally responsible? |
Manufacturers of medical devices
have a duty to patients to produce safe products.
In lawsuits against Medtronic prepared by plaintiffs'
counsel, our clients allege that Medtronic misrepresented
the safety of the Sprint Fidelis lead. |
Hundreds of injuries linked
to Sprint Fidelis heart defibrillator wires had
been reported as of the end of 2006. The high
and early failure rate of Medtronic Sprint Fidelis
leads was also reported in a medical journal
in 2006. Yet, Medtronic failed to issue a recall
and instead continued to sell the devices. |
11. Has Medtronic agreed
to compensate injured persons for their pain
and suffering and families of loved ones who
died? |
No. Medtronic has not agreed
to compensate patients for their extreme injuries.
Only by filing a lawsuit or otherwise making
a claim against Medtronic can injured patients
and families of loved ones who died obtain justice
and compensation for their injuries. |
12. I was injured.
How quickly must I hire an attorney? |
You should not feel pressured
to make an immediate decision about hiring counsel.
Focusing on restoring your health or mourning
the loss of loved ones should take precedence
over liability issues at this difficult time.
However, keep in mind that each state imposes
a deadline for filing lawsuits. This deadline
is known as the statute of limitations, which
in certain states is one year from the date of
the accident. |
| |
Further Information
On Your Legal Rights |
Answers to additional questions
on the law can be found at www.medtronicheartleadrecall.com/faq.htm. |
Contact Information
for Plaintiffs' Counsel |
If you would like to learn
more about the Medtronic recall and your legal
rights, please visit 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 plaintiffs ’ counsel
toll free at 1-800-948-2181. |
About Plaintiffs ’ Counsel |
Representing plaintiffs across
America in Medtronic recall lawsuits are Daniel
E. Gustafson, Gustafson Gluek PLLC; Elizabeth
J. Cabraser, Wendy R. Fleishman, Rebecca Bedwell-Coll,
Heather A. Foster, 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. |
Plaintiffs counsel has been
investigating Medtronic's alleged misconduct
for months and filed the first personal injury
and class actions lawsuits in the nation against
Medtronic arising from the recall of Medtronic
Sprint Fidelis defibrillator leads. |
Source/Contact for Media Inquiries Only |
Wendy Fleishman
Lieff Cabraser Heimann & Bernstein, LLP
(212) 355-9500 (office) |
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