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Defective Pacemaker Lawsuits in Tennessee

Why patients are having their pacemakers removed

Many Americans suffer from heart problems. Heart disease is actually the most common of all health problems, and cardiologists often have limited options in how they can treat a patient. Medication regimens and stents for patients with blood flow blockages have been among the most effective treatment methods for many, short of performing open heart surgery.

Pacemakers have also been a highly effective treatment option for those suffering from heart rhythm problems that are consistent with varying levels of congestive heart condition. Pacemakers have extended the lifespan of many of these patients with major success.

However, in the past couple decades, patients have reported problems with some devices as well as instances of improper device installation. When this happens, it’s essential to consult with a defective medical device attorney to discuss options for financial recovery.

Here’s what you should know about the pacemaker recalls:

What does a pacemaker do?

Pacemakers work well in helping the heart maintain a steady and even rhythm pattern. The parameters of the device can be set for those whose experience difficulties such as bradycardia, tacky-bradycardia, and blockages of the electrical impulses for a variety of reasons.

Bradycardia is a heart that beats too slowly, tacky-bradycardia is a heart rate that alternates between too slow or too fast, and the blockages are interruptions in the normal electrical signal that controls the heart rate.

Defective pacemaker recalls

The FDA has received many complaints regarding pacemakers over the past 2 decades. The primary manufacturers that were implicated in the complaints were the Guidant Corporation and Medtronic beginning in 2005.

In Tennessee, St. Jude was also included on the recall list due to a hacking potential of their device software. Considerable improvement was made on the medical devices, including a patch for the software problem, resulting in a more effective operation.

However, there have still been complications for patients being equipped with pacemakers. The U.S. Food & Drug Administration (FDA) has published a recall list that is available for public viewing. If you’ve been affected by one of these recalled devices, it’s best to consult with an attorney who is experienced in representing these often complicated product liability and medical malpractice cases as soon as possible.

Filing a defective medical device injury claim

The reported list of recalled devices is extensive, and as many as 500,000 patients have been affected by specific recalls. The process of financial recovery is difficult. Some cases are merely claims against the manufacturer when the electrical products are installed correctly by the cardiologist or surgeon treating the patient.

There are also cases where both the defective device and the installation professional themselves produced problems for the patient, which would establish grounds for both a product liability claim and a medical malpractice claim.

These cases can be complicated because both parties still defend the claims based on level of responsibility, and many times the legal counselors of each party will attempt deflecting as much negligence to the other as possible.

Product liability claims involving defective pacemakers

Manufacturers of all products in the United States are held to the strict liability standard, which means that negligence in these cases doesn’t need to be proven by the plaintiff or their attorney. They must only prove the association of the use of the product with the injury incurred by the client.

The recall list helps make that association for most representatives, with the next concern being the level of damage suffered by the client. In cases involving heart pacemakers, death has even occurred. Other cases have also included damage to the heart muscle or other area of the body if the defibrillator component of the device engages needlessly. More problems that can arise include over-amplification or failure to sense certain nuances in lower heart rate situations.

Medical malpractice claims

Medical malpractice cases can be more difficult than a product liability claim. They are always isolated instances that must include evidence of negligence on the part of the physician, surgeon, or the facility where the installation is performed.

Installation is a surgical procedure, and there are certain inherent risks with any particular heart surgery procedure. Among those risks, the potential for an infection to develop following the surgery is the most prominent. Not only can infections be superficial at the external incision wound, but pacemaker infections can also develop inside the body and impact the heart directly.

This responsibility falls on the surgeon and facility in most cases, but it can still pose difficult legal challenges. Doctors are considered expert witnesses in legal cases, and their personal testimony can carry more weight than a typical defendant in a lawsuit.

If they follow the standard of care, they are usually not guilty of malpractice. These cases are significantly more about the medical technicians, and less about the performance of the device. They are always strongly defended, making experienced and aggressive legal representation imperative for a successful claim processing.

Can you file a defective pacemaker lawsuit?

Always remember that the attorney you select to represent your case can make a major difference in the final outcome. All Tennessee residents with pacemaker problems should contact Gilreath & Associates for a comprehensive evaluation of your case due to their track record of success.

Contact us today for your free consultation.

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