St. Jude Riata or Riata ST leads are small wires connecting a pacemaker or implantable cardiac defibrillator (ICD) to the heart. These wires have a potential to become exposed inside the body, which can cause serious injury or death.
An internal cardiac defibrillator (ICD), located in the patient’s chest outside the heart, monitors heart rhythm and delivers a high-voltage shock to the heart if serious rhythm abnormalities are detected. Connected directly to the heart tissue, the Riata and Riata ST leads serve to carry information between the heart and the defibrillator and if necessary, deliver the high-voltage shock to correct the heart’s rhythm.
St. Jude Riata and Riata ST leads are tiny wires that link to a cardiac defibrillator, and are inserted through a vein and linked to the inside of the heart to monitor and correct irregular heart rhythms. Faulty manufacturing has caused the leads to become prone to abrasion, allowing the wire to escape the insulation in a failure known as externalization.
When these exposed wires come into contact with fluids and other materials inside the body, they can short and incorrectly transmit information to the defibrillator, resulting in:
- Unnecessary shocks
- Failure to deliver a shock when needed
- Surgery to replace or remove the faulty devices
As a result of these design defects and numerous reports of patient injury or death, the FDA issued a St. Jude Riata recall in December 2011. Unfortunately, more than 277,000 of these devices had already been put into use across the world, endangering the lives of thousands of patients.
While some patients have had these wires removed and replaced, this is a risky procedure and more nearly 80,000 Americans still have active St. Jude Riata leads in their hearts.
The St. Jude Riata lawyers at our firm have significant evidence of negligence on the part of St. Jude Medical. We can base a St. Jude Riata lawsuit on a number of claims, including:
- The insulation diameters of the leads are inconsistent, which can lead to thin insulation at some points, increasing the risk of externalization.
- The lubricous interface between the inner and outer insulation was inconsistently applied. This could increase friction and facilitate abrasion.
- During manufacture, St. Jude did not cure and sterilize parts, which could compromise the strength of the insulation.
- The leads were not crimped uniformly, leading to insecure crimps.
These St. Jude manufacturing defects can lead to exposed wires and can cause serious, life-threatening injuries. St. Jude Medical displayed gross negligence in the faulty manufacturing of their ICD leads, and thus the company is obligated to remit compensation to victims injured by their defective medical devices.
Can I file a lawsuit if I have have been injured by the St. Jude Riata Lead?
Possibly. If a manufacturer produces a dangerous or defective product, it can be held responsible to those who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has been harmed by the St. Jude Riata Lead, you should contact your doctor immediately. You may also wish to contact an experienced St. Jude Riata Lead lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.