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GENERAL INFORMATION |
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Frequently Asked Questions about the Medtronic
Heart Lead Recall |
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| Lieff Cabraser Heimann & Bernstein,
LLP represents patients nationwide with the
recalled Sprint Fidelis line of defibrillator
lead wires made by Medtronic Inc. To contact
a medical device defect attorney at Lieff
Cabraser, click
here. |
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| Lieff
Cabraser represents
persons across America
injured by the Medtronic
Sprint Fidelis heart
lead. Click
here to submit
your case. |
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Our
firm has been investigating
Medtronic's alleged
misconduct for months
and filed the first
personal injury lawsuits
in the nation against
Medtronic. |
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Our
attorneys have years
of experience successfully
representing clients
in personal injury
cases. |
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There
is no charge or obligation
for our review of
your case. |
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We
are pleased to visit
you where you live,
at no cost, to discuss
your legal rights
and answer your questions. |
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We
have retained product
safety and medical
experts nationwide
to assist our clients
with their claims. |
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In
addition to a team
of experienced lawyers,
we have dedicated
nurses, legal assistants
and case clerks to
assist our attorneys
in the Medtronic
recall litigation.
Learn more about advantages we
offer our clients. |
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| 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. How
do I determine if I have a recalled Sprint
Fidelis lead? |
Check your patient
ID card. If any of the rows under the column
marked Model #, you see
one of the following four sets of numbers
you have the recalled heart lead: 6949,
6948, 6931, or 6930.
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| 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 it claimed surgeons were responsible
for causing the fracturing during implantation
of the device.
In lawsuits filed by heart patients represented
by Lieff Cabraser, 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 Lieff Cabraser,
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. |
| 13. What
are my legal rights after an injury? |
| In most states,
an injured person may bring a case for
negligence, design defect and other legal
claims for compensation. In wrongful death
cases, most states provide that the decedent's
spouse and children are entitled to sue
for damages. If there is no spouse, then
a child (or guardian of a child) may sue
if there is neither a spouse nor child,
then the decedent's parents are entitled
to sue. After the parents, siblings are
next in line under the law. |
| 14. Will
I have to pay a fee for your review of
my case? |
| No. We do not
charge to review your case. If we
decide we can represent you and you wish
to retain Lieff Cabraser as your attorney,
we will discuss our contingent fees (calculated
as a percentage of the recovery we obtain)
and then provide a written contract to
be agreed upon. |
| 15. How
long will a lawsuit take? |
We cannot give
any guarantees as to when your case will
be resolved. First we must undertake a
thorough investigation of the facts of
each accident. In some instances, a case
will settle to our client's satisfaction
shortly after it is filed, or perhaps even
before. In other cases, a final resolution
may take multiple years.
Rest assured, Lieff Cabraser works swiftly
and efficiently to obtain the maximum compensation
for our clients and to bring each case
to a successful conclusion. We do not charge
our clients hourly fees and earn no compensation
for ourselves until you receive your recovery. |
| 16. How
do I select an attorney to represent
me? |
| You should seek
a lawyer who has substantial experience
in successfully handling similar cases.
It is important to not only verify the
reputation and experience of the law firm
as a whole, but to be sure that your case
will be handled by individuals with appropriate
experience. Finally, in suits involving
defective medical devices, a case can be
expensive to litigate and typically requires
the hiring of experts to assist your case.
You should choose a law firm with substantial
financial resources to conduct the case
through trial and appeal if necessary. |
| 17. What
recovery will I receive? |
In most jurisdictions,
if the defendants are found liable, you
are entitled to a judgment that fully compensates
you for your financial loss. If you suffered
a personal injury, the defendant is responsible
for paying for your medical care, both
past and expected, your past and future
lost earnings, and an amount to compensate
you for pain and suffering. Your spouse
also might be entitled to an award.
If a loved one died, the recovery usually
is based on the amount of economic support
and services that you lost, plus, in some
jurisdictions, an amount designed to compensate
for your grief and mental anguish and loss
of association. We have economists who
specialize in evaluating these injuries
and calculating the lump-sum amount to
determine a monetary compensation for your
loss.
If the conduct that caused the accident
was egregious, you may also be entitled
to an award of punitive damages in certain
states. |
| 18. How
will you handle my case? |
As our client,
you possess the direction and control over
the case. For example, if Medtronic
should make an offer to settle the case,
we will promptly inform you. We will
advise whether or not you should accept
the offer based on the law and facts of
your case. The decision, however,
will be yours alone to make.
If you agree to retain our firm, we will
prosecute your case as a personal injury
lawsuit. You will be assigned an
individual attorney whom will keep you
regularly informed as to the status of
your case. At the same our attorneys
work as a team, sharing evidence and following
a strategic plan for the Medtronic heart
lead litigation. |
| 19. Why
don't I just contact Medtronic and work
out a settlement with the company? |
It is usually
both impossible and inadvisable to try
to resolve a serious accident or wrongful
death case on your own. An accident may
involve multiple parties and questions
concerning what happened, who was legally
responsible, and how the matter should
be resolved. Not only are attorneys but
also medical and product safety specialists
in evaluating your case and advising you
of your rights. Without these experts,
you may never know the true value of your
case or gather the evidence to show Medtronic's
alleged misconduct.
It is important to understand that corporations
and their insurers employ the services
of expert lawyers that seek to avoid responsibility
or at least to minimize the payments that
will be made to the victims and families.
In contrast, our duty is to identify all
responsible parties, maximize the compensation
under the law and obtain justice for you.
Only established firms like Lieff Cabraser
have the staying power to investigate complex
cases thoroughly, and to send a message
to the defendants that they will not be
able to escape the power of the courts
to impose damages for their misconduct. |
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| Founded in 1972,
Lieff Cabraser Heimann & Bernstein,
LLP is an over fifty attorney
law firm with offices in San Francisco,
New York and Nashville. For the last five years,
the National Law Journal has recognized
Lieff Cabraser as one of the top 20 plaintiffs’ law
firms in America. |
| For our personal
injury cases, we bring a team of experienced
lawyers. Each client is assigned an individual
lawyer. In addition, we have on staff multiple
nurses, legal assistants, scientific analysts
and case clerks to assist the attorneys.
To learn more about our firm, click
here. |
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| Trademark
Notice: Personal Injury Lawyer America is an electronic newsletter
from Lieff Cabraser Heimann & Bernstein, LLP. Lieff Cabraser
represents clients in a wide range of cases, including personal
injury and wrongful
death lawsuits. Our personal injury attorneys
| lawyers are committed to providing the very best representation
and support possible for our clients. This website provides information
on the legal rights of the injured and the latest news on product
defects and related lawsuits. |
Lieff Cabraser
is not affiliated in any way with any trademark owner. The use of
any trademarks on this site is for product identification and information
purposes only.
About Lieff Cabraser: We have
offices in San Francisco, New York and Nashville. Our lawyers have
represented clients in personal injury, wrongful death and
rollover crashes and product defect lawsuits across America, including
residents of Alaska, Alabama, Arkansas, Arizona, California,
Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,
Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland,
Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North
Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada,
New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South
Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin,
West Virginia and Wyoming.
Among the cases our personal injury
attorneys are prosecuting are the Medtronic heart lead recall, the
AMO contact lens solution recall, the Peter Pan peanut butter recall, Guidant
pacemaker defects, SUV
rollover accidents, popcorn
workers lung injuries, and Ford
switch fires.
Disclaimer: The hiring of legal
professionals is an important decision that should not be based on
advertising alone. Please read our disclaimer. |
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| Copyright © 2008 Lieff Cabraser Heimann & Bernstein, LLP |
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