Medical Device Lawsuit & News Blog

Rights or Wrongs: Who's on top -- the FDA or the States?

Wed, 23 Jul 2008 12:43:42 -0400

Poised on the edge of a legal precipice are patients' rights as to whether or not they can sue pharmaceutical companies and medical device manufacturers that have been approved by the federal Food and Drug Administration.

In April 2008, the Supreme Court ruled in favor of medical device manufacturer instead of the patient (Riegel v. Medtronic) because the high court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval.

This is bad news for patients as they have no legal recourse against defective medical devices or pharmaceutical drugs that are rushed to market without adequately tested pharmaceutical drugs.

The next big decision hanging in the air is Wyeth v. Levine. The Supreme Court will decide the fate of a patient who lost her arm after an injection of Wyeth's drug Phenergan. Can she sue for damages? The Court will decide whether preemption of state tort litigation is
implied by the law, even though it is not explicitly stated.

Don't you think someone has to be responsible for loss of a limb from a pharmaceutical drug?

New Heart Saving Device Technology

Mon, 9 Jun 2008 07:24:19 -0400

New Heart Saving Device Technology
The Food and Drug Administration announced approval of a heart pump that has already been in use in 40 other nations worldwide.

The Impella 2.5 Cardiac Assist Device that delivers up to 2.5 liters of blood per minute delivered by the heart pump from the left ventricle into the ascending aorta. The Danvers, Mass. Medical technology company, Abiomed Inc. manufactures the Impella 2.5 Cardiac Assist Device which according to Abiomed, the device provides quick and minimally invasive circulatory support for critical heart patients.
According to Abiomed, the Impella 2.5 medical Cardiac Assist Device will change the standard of care in catheterization labs.

How does the Impella 2.5 Cardiac Assist Device work? It is inserted through a catheter into the patient's femoral artery and then moved into the heart's left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations for partial circulatory support for periods of up to six hours.

So far the Impella 2.5 Cardiac Assist Device has been used to treat more than 1,500 patients outside the United States for up to seven days of support.

More Lifesaving Heart Device News
June 1-7 was National CPR/AED Awareness Week. CPR, a common acronym everyone is aware of is, stands for cardiopulmonary resuscitation. AED stands for Automated External Defibrillator. An AED is a small, portable device that can send an electric shock through the chest wall to the heart and restore a patient's heart rhythm to normal levels before emergency crews arrive on the scene.

The city of Boca Raton, Fla. has been a leader in the effort to promote the use of AEDs. In Boca Raton, the AED devices are carried in all the police cruisers and fire apparatus and are available in most city buildings.

Boca Raton has also made dozens of the AEDs available to community organizations at no charge, as long as someone from the group is trained to use it. Boca Raton has a proportionately large number of senior citizens and baby boomers.

Boca Raton is also purchasing the AutoPulse automatic CPR device for its rescue trucks; the city already has six of the heart devices and recently applied for a grant to purchase three more.

CPR vs. Defibrillators
Which is more effective CPR or a defibrillator? According to a recent study, both are effective but CPR costs far less. Defibrillators cost more than $1,000 and who knows if someone will be with the heart patient during his/her cardiac arrest?

Since defibrillators are costly, some think the money is better spent on CPR training.

Cardiac arrest happens when the heart beats chaotically. Automated external defibrillators or AEDs can shock it back into normal rhythm. AEDs have been successfully used by ordinary bystanders doing extraordinary things in public places.

In the study, the overall survival for both CPR and defibrillators was comparable and far better than the researchers expected. In both cases, some people panicked and failed to act with any common sense.
For diabetics, defibrillators made more sense.
If high school students were trained on CPR just like geometry and physical education, within a few years there would be an entire generation able to provide a much needed service to their elders.

Medtronic compares its stent to Abbott's

Tue, 13 May 2008 08:55:41 -0400

Medtronic Announced that is is begining a trial to compare the Endeavor stent against Abbott's Xience V stent

The Sprint Fidelis Electrode Recall

Fri, 4 Apr 2008 14:24:05 -0400

Heart disease is a serious matter and that is why one who is under the care of a physician for heart problems will be reliant on ever step of treatment to be effective. In the case of the Sprint Fidelis electrode, many heart patients were seriously let down while relying on a product to save their life. The Sprint Fidelis electrode is a defibrillator designed to keep a heart beating. Obviously, if such a product is defective then it is a very dangerous product. This is why the product was recalled and this is why there are numerous liability lawsuits against the manufacturer…and rightly so.

Medtronic Lobbying Efforts

Thu, 28 Feb 2008 12:32:40 -0400

Medtronic, which manufactures medical devices, spent $940,000 in the second half of 2007 to lobby the House of Representatives, according to a disclosure form posted online Feb. 14 by the Senate's public records office. It lobbied on provisions in farming bills that allows medical device sales representatives the ability to train with live animals.

Judicial Panel on Multi-District Litigation

Wed, 27 Feb 2008 12:15:01 -0400

The Judicial Panel on Multi-District Litigation issued a transfer order, transferring all Medtronic Sprint Fidelis case (MDL No. 1905) filed in various federal courts to the District of Minnesota. The Panel's transfer order can be view at http://www.jpml.uscourts.gov/Hearing_Info/Newly_Transferred/MDL_1905-TransferOrder-Corrected.pdf.

Drug-coated stents aren't perfect.

Mon, 25 Feb 2008 08:26:38 -0400

After drug coated stents gained widespread use, experts noticed that the rate of fatal or nonfatal blood clots increased beyond those for patients who did not receive a drug-coated stent . The clotting risk was confirmed in medical trials. Thus, the FDA now recommends that patients who receive drug-eluting stents also be given dual anti-platelet therapy -- for example, Plavix (clopidogrel) and aspirin -- for a year after they receive the device.

Medtronic Sprint Fidelis Cases

Sun, 24 Feb 2008 12:55:36 -0400

Judicial Panel on Multi-District Litigation Transfers all Medtronic Sprint Fidelis Cases filed in Federal Courts to District of Minnesota.

MEDTRONIC SPRINT FIDELIS ELECTRODE RECALL

Tue, 5 Feb 2008 08:30:06 -0400

Sprint Fidelis leads are manufactured by Medtronic Inc, and are specific models of thin wires, or cardiac electrodes that connects to a cardioverter-defibrillator that is implanted for cardiac resynchronization therapy defibrillation directly linked to the heart. These medical devices protect patients from what may be life threatening heart rhythms occurring.

A defibrillator works by monitoring heart rhythms, and then delivering an electronical shock to aid in the restoration of a normal heart rhythm whenever irregular heartbeats are detected. If the heart goes to fast, then the medical device will work to slow the heart rate back down. Defibrillators are implanted surgically in patients that have been diagnosed to be at risk for sudden cardiac arrest.

With Medtronic Inc being the nation's leading manufacture in heart implant devices, the company announced on October 14, 2007 that there is a defect with the critical electronic lead component in the heart defibrillator. As a part of the warning, Medtronic has estimated that anywhere from 4,000 to approximately 5,000 patients with the defective Sprint Fidelis lead may experience a lead fracture within the first 30 months of implantation. The announcement came after Medtronic reviewed 30 months of data from two current studies that revealed the implanted heart device to show several fracture problems.

It was on October 15, 2007 that the New York Times reported the a result of the Sprint Fidelis defected electrical wire, there may have been hundreds of malfunctions, and that this may have also played a role in the death of five patients that used Medtronic defibrillators.

With approximately 268,000 patients worldwide in October of 2007 having been implanted with the Sprint Fidelis leads, 172,000 of these patients are in the United States, Medtronic Inc has announced a voluntary worldwide suspension of the distribution of all Sprint Fidelis defibrillation leads. Some of the models that are included in the recall are: 6930, 6931, 6948, and 6959. Should a patient have received the Medtronic defibrillator after it was introduced in 2004 should contact a physician to inquire about options. Medtronic is all advising all physicians and surgeons to no longer implant the leads, and even to return any unused products. The FDA is considering what Medtronic is doing as a recall of the medical devices.

A medical device recall is when a medical device is discovered to be defective, could be a health risk, or even both. If a medical device that is implanted should be recalled, this does not necessarily mean that the device has to be removed. Sprint Fidelis leads are being recalled due to fractures in the leads themselves. The defective electronic wires could cause the defibrillator to possibly deliver shocks that are unnecessary, or may not even operate at all. There have even been cases where death has resulted from the Sprint Fidelis lead fractures possibly being the related cause.

Patients who may have experienced multiple shocks, lightheadedness, fainting, or palpitations, and have the Sprint Fidelis defibrillator implanted, should immediately contact and follow up with a physician. As it may not be necessary to remove the actual medical device, it may be determined that there is a need for just monitoring closely for signs of a fractured lead, or just to surgically add a replacement lead.

Medtronic Inc has also made available to physicians a patient management recommendation to provide guidance in how to reduce any risk in affected patients and also to ensure that medical devices are more effectively set to monitor properly for potential fractures.

If there has been any experience with the Medtronic Sprint Fidelis defibrillator leads, click here to set up a no obligation consultation.

Unsafe Wire Leads and Heart Device Implants

Thu, 1 Nov 2007 08:31:51 -0400

Medtronic and the FDA told doctors to stop using the Sprint Fidelis lead last week.

What is a lead? A defibrillator contains two parts. The first is a computerized device that monitors heart rate and determines when to send jolts of electricity. The second is a lead, which is a wire covered in insulation that doctors thread through the veins. The lead stretches from the computerized device implanted near the collarbone to the heart, where it is secured into the heart muscle with screws.

Electrical signals from the heart travel through the lead to the device, and the device sends its shocks, when needed, back through the same lead.

Previously, leads had a diameter of 4 millimeters, but they are getting smaller. The smaller the lead, the easier the lead is to implant and push through the blood vessels. Medtronic's is about 2.2 millimeters. Its size might be one reason the Medtronic lead is more likely to break than older leads.

Batteries power the devices but run down after five to seven years, at which point the device is replaced surgically. During replacement, the wire lead remains and is used for the next device because the lead is difficult to remove. After years sitting in a vein, blood vessel tissue grows around the lead.

If the first wire is bad, another wire can be threaded through. Although the old wire can be removed if there's not enough room for both, about 1 percents of patients who undergo surgery die in the process.

What goes wrong with a heart device? The leads can go bad because the wire breaks (which is happening in the Medtronic cases or the insulation cracks.

When a lead breaks or cracks, the device starts to receive electrical noise and thinks the heart is not beating right. A pacemaker might send a tiny shock to the heart, but with defibrillators, patients can really feel the power. Some people describe it as being struck by lightning.

Routine checkups can sometimes give clues that a device is malfunctioning. Doctors measure the size of the electrical signal coming from the heart; how much energy it takes to pace the heart; and the impedance of the wire. Most likely, lead fractures are difficult to predict.

Heart patients who have Medtronic defibrillators need be concerned only if their lead is a Sprint Fidelis lead numbered 6930, 6931, 6948 or 6949.

A small number of other defibrillators also use the Sprint Fidelis leads. If curious, a patient can examine information that came with the defibrillator. People who find they have a potentially problematic lead should ask their doctor how often they should come in for a checkup.

Medtronic has recommendations for physicians on how to program the device to detect potential lead failures and protect a patient from surprise shocks. They can make the device less sensitive so that if it does go bad it will be less likely to deliver a jolt.

Read More In: http://www.latimes.com/features/health/la-he-closer22oct22,1,2619327.story?coll=la-headlines-health