Medtronics Lawsuit News Attorneys | Medtronic Lead Failure Lawyers

Patients subject to the Sprint Fidelis recall continue to suffer from a Medtronic lead failure leading to a surgery to replace the defective lead. The Multidistrict Medtronics lawsuit is currently under appeal and lawyers representing victims are continuing to fight for the right to bring a claim for compensation.

If you have been diagnosed with an abnormal heartbeat, either too fast or irregular, doctors may suggest you consider an implanted cardioverter defibrillator (ICD) to help regulate the heartbeat.

A defibrillator is a small device, about the size of a pager, which is placed inside the chest. Small wires, called leads, from the defibrillator connect with blood vessels in the heart. These wires allow the device to monitor the beating of the heart. If the heartbeat is too rapid or irregular, the device provides an electrical shock that helps the heart to resume a normal pattern.

Certain heart conditions, such as ventricular tachycardia and ventricular fibrillation can cause the heart muscle to flutter instead of pump. When this happens, the heart is unable to move blood, which contains essential oxygen, through the body. Ventricular tachycardia can result in faintness, chest pain, weak pulse or dizziness. Ventricular fibrillation is even more serious, and can result in cardiac arrest and sudden death.

When a person has had an episode of irregular heart rhythm, doctors often use a defibrillator to ensure the heart can be monitored at all times and that any disorganized heart activity can be immediately remedied.

However, you should also talk with your doctor about concerns with defibrillators.

Be sure to ask:

• How effective a defibrillator is for your specific heart condition? A recent study in the Canadian Medical Association Journal suggested that defibrillators might not be effective for people with heart failure. It also questioned the effectiveness of defibrillators in elderly patients with additional illnesses such as diabetes, cancer of kidney disease.

• What physical and psychological changes can you expect after the defibrillator is implanted?

• How much discomfort should you expect to feel if the defibrillator delivers a shock?

• What limitations, if any, can you expect after the procedure?

• How can you best prepare for this change in lifestyle?

• How reliable is the proposed defibrillator and its parts? Obviously, you are relying on this device to maintain your health. Knowing if it has had any problems is important. In fact, one defibrillator has recently recalled the wires, or leads, because they could fracture. The Sprint Fidelis wires, manufactured by Medtronic, had a higher tendency to break, which meant they did not always deliver the necessary electrical jolt, or, conversely, delivered an inappropriate level of electricity.

We represent all Medtronic lead failure clients who suffered a lead fracture or failure on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation case review please call toll free or fill out our short online contact form and a Medtronics lawsuit lawyer will contact you to answer any of your questions.

Medtronic Lead Lawsuit News | Sprint Fidelis Recall

The Medtronic lead lawsuit Multidistrict litigation continue even though there have been setbacks and we continue to push for the Medical Device Safety Act legislation which will help protect patients with medical devices. The Sprint Fidelis recall failure rate of defibrillator leads continues to leave heart patients in the difficult position of not knowing if or when they could suffer a lead fracture.

Understanding Ventricular Fibrillation

For a person with a heart condition, ventricular fibrillation is one of the most frightening diagnoses. However, by understanding what it is and how to prevent it from re-occurring, you can help improve your prognosis.

Ventricular Fibrillation and the Heart

With ventricular fibrillation, the electrical system in the heart becomes disorganized. Normally, electrical impulses provided cues to the four chambers of the heart, allowing them time to fill with blood and then open, pumping blood within the heart and allowing it to flow throughout the body. The opening of the valves in the chambers of the heart is the heartbeat.

When a person has ventricular fibrillation, the ventricle quivers instead of pumps, which doesn’t allow it to fill with blood. The heartbeat is irregular and extremely rapid, up to 350 beats per minute. The heart is not able to sustain this pace for more than a few minutes. Without immediate medical treatment, the heart will stop, sending the patient into cardiac arrest, which is often fatal.

Causes of Ventricular Fibrillation

The biggest cause of ventricular fibrillation is a recent heart attack. A variety of pre-existing heart conditions can also make a patient more susceptible. Heart damage from a previous heart attack, a congenital heart defect, or heart conditions such as myocarditis or cardiomyopathy as well as heart surgery and medications can lead to ventricular fibrillation.

Another condition, ventricular tachycardia, if left untreated, can lead to ventricular fibrillation. With ventricular tachycardia, the heartbeat is rapid (100 beats per minute) but regular. Blood is unable to move efficiently through the body and a person with tachycardia may feel chest pain, have a weak pulse, feel short of breath or feel dizzy or faint.

Anyone experiencing any of these symptoms should see a doctor immediately.

Treatment for Ventricular Fibrillation

Doctors treat abnormal heart rhythms by providing an electrical shock. Once the patient’s heart is under control, doctors may insert a device called a defibrillator into the person’s chest. The wires in the defibrillator connect with the heart so the defibrillator can monitor the heart activity and administer electrical shocks as needed to make sure the heart is pumping efficiently.

Although most patients who have defibrillators find that it is a reassuring medical device, some who have a defibrillator manufactured by Medtronic using a wire called Sprint Fidelis, have not been as reassured.

The Sprint Fidelis wire, or lead, which connects to the heart, can fracture or break, thereby providing too great electrical shocks, or conversely, not providing enough electrical shock as needed. If you are a patient with a Sprint Fidelis lead, we encourage you to contact your doctor to discuss your medical options.

We also encourage you to call us. We represent all Sprint Fidelis lead fracture clients on a contingency basis, which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free or fill out our short online contact form and a Medtronic lawsuit attorney will contact you to answer any of your questions regarding the ongoing litigation.

Medtronic Lawsuits | Medtronics Defibrillator Lawsuit News

It is estimated there are 150,000 heart patients throughout the United States affected by the Medtronic lead recall who have a recalled defibrillator lead wire and are at risk of a lead fracture. Medtronic lawsuits continue to be filed on behalf of patients who have suffered a lead fracture. The Medtronic Sprint Fidelis leads were removed from the market by Medtronic on October 15, 2007 due to the reporting of fractures in some wires and patients deaths associated with the defibrillator leads. Approximately 268,000 Medtronic leads were implanted in patients around the world. Medtronics Sprint Fidelis defibrillation leads were recalled because the leads (electronic wires) are prone to fracture or break.

If you or a loved one has suffered from a lead fracture and had to undergo an additional surgery please contact us for the latest Medtronics defibrillator lawsuit news. We are continuing to fight for patients who have been affected by these defective Medtronic heart leads.

What is Ventricular Tachycardia?

Ventricular tachycardia is a fast heartbeat in that originates in the ventricles of the heart. With tachycardia, the heart can beat 100 times per minute. This episode is diagnosed as tachycardia if it lasts more than 30 seconds and if the heartbeats are fast, but regular. Because of the rapid heartbeat, the ventricle is not able to fill with blood properly, and enough blood is not pumped through the heart and throughout the body.

What Causes Ventricular Tachycardia?

Ventricular tachycardia is usually caused by previous heart damage from scar tissue after a heart attack, a congenital heart defect, an infection such as myocarditis, or an inflammation such as cardiomyopathy. It can also occur after heart surgery or after using medicines to adjust the heart rhythm.

Occasionally, ventricular tachycardia is unrelated to a pre-existing heart condition and occurs because of an imbalance of electrolytes or potassium, or due to a lack of oxygen.

What are the Symptoms?

A person with ventricular tachycardia may notice an abnormally fast heart rate. With an insufficient amount of blood delivering oxygen through the body, a person may feel dizzy, lightheaded or faint. He may experience pain (angina) in his chest, shortness of breath or a weak pulse.

Someone with symptoms of ventricular tachycardia should get help immediately, since this condition could develop into a very serious condition called ventricular fibrillation, which can cause sudden death.

Diagnosing Ventricular Tachycardia

In order to effectively treat a rapid heartbeat, the cause of it must be determined. Doctors will perform a number of tests to pinpoint the source of the problem. An electrocardiogram (also called EKG or ECG) tracks the electrical activity in the heart over a period of time, often 24 hours. An echocardiogram uses ultrasound technology to create a clear picture of the heart in order to show how well it is functioning.

Treatment Options for Ventricular Tachycardia

If the cause of ventricular tachycardia is a heart problem (as opposed to a temporary imbalance of fluids or electrolytes), it is vital to keep the heartbeat from becoming too rapid or irregular.

Doctors may prescribe antiarrhythmic medicines, beta-blockers or calcium channel blockers to help regulate the heart.

Alternatively, doctors may insert an implantable cardioverter defibrillator (ICD) in the patient’s chest, on or near the heart. This small device monitors the heart rate and provides electrical shocks if it detects a need to adjust the heart rate.

While ICDs are often used safely, a recall of the Sprint Fidelis leads used in Medtronic’s defibrillator is causing great concern among patients. These leads, or wires, which have been used in nearly a quarter million ICDs, have shown a higher rate of breakage, which means that the ICD may not shock a heart when needed, or conversely, may provide too great a shock unnecessarily.

If you have a Medtronic defibrillator using Sprint Fidelis leads, you should be aware of your medical and legal options including the option of filing a Medtronic lawsuit. Please contact us for a free no-obligation consultation from a Medtronic recall attorney.

Medtronic Recall News | Sprint Fidelis Lead Fracture Lawsuit

Patients continue to suffer from a Medtronic Sprint Fidelis lead fracture following the 2007 Medtronic recall of defibrillator leads. If you or a loved one has suffered from fractured leads please contact us today for a free consultation and information how we can help.

What is a Defibrillator?

We’ve seen them used on the TV hospital programs, when the young intern nervously applies paddles to a patient’s chest and shocks the heart back into a regular rhythm.

If you have abnormal heart rhythms, the daily reality is probably not as dramatic as is seen on the TV screen. Many people today have an internal device implanted in their chest that monitors the heartbeat and applies an electric shock to sustain a safe and regular rhythm.

An internal cardioverter defibrillator (ICD) is smaller than a pager and is placed on or near the heart, with wires connecting to the blood vessels that send electric impulses into the heart.

How Your Heart Works

The heart is a muscle, pumping blood throughout the body. Blood goes from the heart to the lungs, where it receives oxygen and then goes through the arteries to every system of the body carrying essential oxygen and nutrients. On the return trip, veins carry blood that is oxygen poor back to the heart and to the lungs for more oxygen. This cycle repeats itself constantly.

The heart has four chambers that are essential in this process: the right atrium, the right ventricle, the left atrium and the left ventricle. A valve on each side of the heart regulates the blood traveling from the atrium to the ventricle. Within the right atrium, is the sinus node. This group of cells is the heart’s natural pacemaker. It provides electrical impulses that trigger the valves opening, which in essence, is the heartbeat.

A strong heartbeat pumps blood efficiently through the body, however, if the heart is damaged through illness or injury, it cannot pump enough blood throughout the body. Organs cannot get enough life sustaining oxygen, and the oxygen-poor blood cannot be removed sufficiently.

Using a Defibrillator

If the heart beats too quickly, for example, the heart valves open too quickly to allow the atrium and ventricle to fill with enough blood to pump well.

The defibrillator can monitor this problem and provide an electric shock that helps the heart return to a normal rhythm.

If you have a heart condition such as ventricular tachycardia or ventricular fibrillation, a defibrillator can be a lifesaving device. It is often the preferred method of treatment, instead of or in addition to medicine to regulate the heartbeat.

One serious concern has arisen for the use of defibrillators manufactured by the medical technology company, Medtronic. Defibrillators manufactured by them between 2004 and 2007 used a wire (also called lead) with the brand name Sprint Fidelis.

The wire can fracture or break, which may cause the defibrillator to fail to give a necessary shock, or conversely, provide too great a shock. The Medtronic recall was announced after 5 patients died.

If you have the Sprint Fidelis wire in your defibrillator, contact your doctor to discuss medical options. But you may also have legal questions.

We represent all Sprint Fidelis lead fracture clients on a contingency basis, which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free or fill out our short online contact form and a Medtronic recall attorney will contact you to answer any of your questions regarding the ongoing litigation.

Medtronic Lawsuit | Sprint Fidelis Lead Recall Attorney Lawyer

Patients and families have continued to look at their options of filing a Medtronic lawsuit following the 2007 Sprint Fidelis lead recall. Defibrillator lead fractures have caused heart patients to suffer unnecessary shocks and subsequent surgeries to replace defective leads.

How The Heart Works

For anyone with heart disease, it is important to have as much information as you can in order to understand your condition, the disease and treatment options.

The first step is to understand the function of the heart. The heart is a muscle that ensures blood, which carries life-giving oxygen, is pumped throughout the body.

The heart is about the size of a fist, and rests in the chest, just to the left of the sternum. It consists of four chambers, a right atrium and right ventricle and a left atrium and left ventricle. If you put your hand to your chest, you can usually feel your heartbeat, which is the continuous pumping action of the heart. When your heart beats, two actions are taking place.

On the right side of the heart, blood that has traveled throughout the body is pumped into the right atrium. Within the right atrium, the sinus node provides an electrical impulse that initiates each heartbeat. The right atrium contracts, opening a valve that sends this oxygen poor blood into the right ventricle, where another contraction takes place, and the blood travels to the pulmonary artery, and then through blood vessels in the lungs where it picks up more oxygen as we breathe.

At the same time, on the left side of the heart, oxygen rich blood returns from the lungs through the pulmonary veins. This blood enters the left atrium and as the atrium fills, it contracts, sending blood to the left ventricle. Once the left ventricle fills, it also contracts and blood is sent to the aorta, which is the main artery carrying blood from the heart to the body.

The left and right atria contract at the same time and the sound of the valve closing as the blood is sent to the ventricles creates the “lub” or first part of the heartbeat. Then the left and right ventricles contract, sending blood to the pulmonary artery and aorta. The sound of the valves closing after that action causes the “dub” or second part of a heartbeat.

If any of the four parts of the heart is not able to pump efficiently, it affects the heart’s ability to provide oxygen throughout the body. Some people have medical conditions that affect their heart’s ability to pump regularly and efficiently. Doctors may recommend that they use a device called a defibrillator to regulate pumping.

Patients who received defibrillators between 2004 and 2007 should determine if they have the Medtronic defibrillator that used wires or leads called Sprint Fidelis. These leads have since been recalled because of potential fractures or breakage that have led to injury and death.

If you have a defibrillator containing Sprint Fidelis lead, contact your doctor to discuss your medical options. If you or a loved one has suffered a Medtronic lead fracture please call or fill out our online contact form and a Medtronic lawsuit attorney will discuss your case at no charge and explain your legal options.

Medtronics Recall News | Sprint Fidelis Lead Information

A defibrillator is an electronic device used to correct an abnormal heartbeat by delivering short measured electrical shocks to the heart muscle or chest wall. The device can be external, transvenous or implanted. Implantable devices, also known as automatic internal cardiac defibrillator or AICD are similar to pacemakers in that they monitor the patient’s heartbeat and automatically deliver electrical shocks for abnormally dangerous arrhythmias based on the device’s programming.

The AICD is a small, battery operated impulse generator which is implanted under a patient’s skin in the upper chest region near the shoulder. A small electrode wire or lead passes from the generator through the vein to the right ventricle of the heart. Implantation of AICD is similar to that of a pacemaker, with the AICD providing more permanent protection against sudden cardiac arrhythmia and possible sudden cardiac death. Patients with AICD may experience improved life conditions and can typically live a normal, healthy life.

Medtronic, Inc., headquartered in Minneapolis, Minnesota and known as the world’s leading medical technology company, pioneered the development of implantable cardiac devices. Medtronic, Inc. introduced the Sprint Fidelis lead which has the advantage over other defibrillator lead models because it is thinner and thus much easier for doctors to thread through to the heart. In 2004, the lead received FDA approval and was widely used throughout the world with over 268,000 of the devices being implanted by 2007.

However, the Medtronic leads, prior to being approved by the FDA, had little human research or trials on its safety. Soon after the Sprint Fidelis lead was introduced, it was discovered that the leads were fracturing, sometimes within two to three years after implantation, resulting in inappropriate and unnecessary shock, or worse, outright failure of the device to deliver the appropriate and potentially life-saving electrical shock. Deaths and injuries have been reported and investigated where the Sprint Fidelis lead was a likely contributing factor. As recently as March 2009, Medtronic has identified at least 13 deaths in which a Medtronic lead fracture may have been “a possible or likely contributing factor.”

On October 15, 2007, Medtronic, Inc. issued a recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Medtronic referred to this “recall” as a voluntary suspension, while the FDA considered the removal of the Sprint Fidelis leads to be a recall. To determine if your lead has been recalled, check your patient ID card or wallet card. Under Model #, look for any of the following numbers: 6930, 6931, 6948 or 6949. Any of these numbers indicates you have a recalled lead.

We represent all Medtronics recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic lawsuit attorney will contact you to answer any of your questions.

Medtronic Lawsuits News | Medtronics Recall Attorney Lawyer

Medtronic lawsuits continue to be filed on behalf of patients affected by the Sprint Fidelis Medtronics recall. Implantable Cardioverter-Defibrillators (ICDs) are implanted heart devices that shock dangerous abnormal heart rhythms back to a normal rhythm. The lead is a wire that connects the ICD to the heart. Medtronic, Inc., a Fortune 500 company based in Minnesota, manufactured Sprint Fidelis Leads, which are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart.

On October 15, 2007, Medtronic, Inc. announced that it was voluntarily suspending worldwide distribution of the Sprint Fidelis family of defibrillation leads after receiving reports of five (5) fatalities linked to lead fractures. This included four Sprint Fidelis Models: 6930, 6931, 6948, and 6949. The Food and Drug Administration (FDA) considered this removal action to be a medical device recall. The recall pertains to the Sprint Fidelis lead only, not the implanted defibrillation or pacemaker device. These leads were recalled because of the potential for lead failure. These electronic wires are prone to fracture in a small number of patients. When the lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.

Approximately 268,000 Fidelis leads have been implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States. At the time of the recall, Medtronic had confirmed 665 chronic fractures in returned leads and estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. As of March 13, 2009, the FDA’s MAUDE database, which contains reports of adverse events involving medical devices, had 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient’s death.

Unfortunately, there is no reliable way to test whether a lead may fracture. The FDA recommends that patients who have had the Sprint Fidelis lead implanted immediately contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Routine removal is not recommended by the FDA or Medtronic as the risks of removal in most patients exceed the small risk of lead fractures. Therefore, it is generally recommended to leave functioning leads in place.

However, there are two alternatives to removing the lead, neither of which is particularly comforting to a patient with the device. One is to continue using the lead while monitoring closely for signs of fracture. The other is to surgically add a replacement lead, which does not require removing the Sprint Fidelis lead but does require that it be capped or covered with a small plastic insulation.

We represent all Medtronics recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic lawsuits attorney will contact you to answer any of your questions.

We are continuing to fight for patients rights who have been affected by the Medtronic recall of Sprint Fidelis leads.

Medtronic Lead Recall News | Medtronics Lawsuit Lawyer

It is estimated there are 150,000 patients in the United States affected by the Medtronic lead recall who have a recalled defibrillator lead wire and are at risk of sudden death. The Medtronic Sprint Fidelis leads were removed from the market by Medtronic on October 15, 2007 due to the reporting of fractures in some wires and patients deaths associated with the defibrillator leads. Approximately 268,000 Medtronic leads were implanted in patients around the world. Medtronic’s Sprint Fidelis defibrillator leads were recalled because the leads (electronic wires) are prone to fracture or break causing major complications and the potential for patient fatalities.

Medtronic Sprint Fidelis Lead Fracture May Be Increasing

A recent study by Dr. Robert Hauser and Dr. David Hayes titled “The Increasing Hazard of Sprint Fidelis Implantable Cardioverter-Defibrillator Lead Failure” analyzed Medtronic lead failure rates compared to other ICD leads currently implanted in patients. They reported that the risk of failure of Sprint Fidelis leads was much higher compared to other defibrillator leads after the first year. The researchers reported that the most recent evidence shows the trend of Medtronic lead fractures increasing over time.

Medtronic’s current recommendation for patients is that they monitor them for lead fractures as opposed to having the leads replaced. This is due to the serious risks and complications associated with lead extraction surgery. A disturbing finding of the research was that 50% of patients received inappropriate shocks when their Sprint Fidelis leads failed. These shocks are extremely painful and many patients suffer from psychological effects due to the trauma of being shocked multiple times following a lead fracture.

We represent all Medtronic lead recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.

Medtronic Lawsuit News 2009

There was good news this week for any patients or families who have suffered from a Sprint Fidelis lead fracture and filed a Medtronic lawsuit.

Health Leaders Introduce Legislation Reversing Supreme Court’s Medical Device Decision

U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, today introduced legislation in the House that will reverse a U.S. Supreme Court decision that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.In February 2008, the U.S. Supreme Court, for the first time, immunized medical device companies from lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc., the Court found that those claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision ignores both congressional intent and 30 years of experience in which federal regulation, through the U.S. Food and Drug Administration (FDA), and tort liability played complementary roles in protecting consumers from device risks.

The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings. It also removed one of the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians.

The Medical Device Safety Act of 2009 protects patients from dangerous and defective devices by correcting the Court’s flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.

“Yesterday the Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product,” Pallone said. “Today, we introduce legislation that gives patients that same right when injured by a medical device. This legislation puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year. We introduce this legislation today with strong bipartisan support, and I look forward to moving it through my subcommittee quickly.”

“As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety,” said Chairman Waxman. “The Court noted that these lawsuits ‘uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.’ The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products.”

The Court premised its decision on the theory that approval by the FDA adequately protects patients from unsafe medical devices, but the two lawmakers said that theory has proven false time and again. They point to numerous recent stories of patients who have suffered serious injuries from defective FDA-approved devices or devices without adequate safety warnings, like implantable cardiac defibrillators and pacemakers.

The Medical Device Safety Act of 2009 is endorsed by the National Conference of State Legislatures, the New England Journal of Medicine, the American Bar Association, AARP, the Center for Justice & Democracy, Consumer Federation of America, Consumers Union, Homeowners Against Deficient Dwellings, National Association of Consumer Advocates, National Consumers League. OWL – The Voice of Midlife and Older Women, Progressive States Network, Public Citizen, and the National Research Center for Women & Families

A companion bill has been introduced in the U.S. Senate by Sens. Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor & Pensions Committee, and Patrick Leahy, Chairman of the Senate Judiciary Committee.

We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic lawsuit attorney will contact you to answer any of your questions.

FDA Medtronic Recall Updates | Medtronics Lawsuit News

Following the latest court decision involving preemption in the Medtronics lawsuit for the recalled Sprint Fidelis leads it is interesting to see the increasing number of reports regarding the inner-workings at the Food and Drug Administration. According to a recent New York Times article, nine government scientists complained to the FDA commissioner regarding FDA managers and their lenient relationship with corporations seeking approval for medical devices.

Internal documents and medical reviews reveal that the agency scientists were critical of the medical device approval process that they felt lacked adequate testing of medical devices. In one specific example, the scientists alleged that an agency supervisor pressured them to change reviews of a breast imaging device among others. The increasing information regarding the inability of the FDA to adequately evaluate medical devices such as the recalled Medtronic Sprint Fidelis leads and drugs is especially disturbing considering that the medical device and pharmaceutical industry has been using the FDA approval process as a shield from any liability for products that turn out to be dangerous.

Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. Medtronics leads consist of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.

The Sprint Fidelis leads recall was due to the potential for lead fractures. After reports of fractured leads and at least 5 patient deaths, Medtronic recalled their Sprint Fidelis leads. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.

We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.