Today we welcome our friend Sean M. Cleary of The Law Offices of Sean M. Cleary as a guest blogger. Sean M. Cleary completed his law studies at the University Of Miami School Of Law with the distinction of Cum Laude.
He owns and leads The Law Offices of Sean M. Cleary based in Miami, Florida. As a personal injury lawyer, he has helped several victims of negligence receive a substantial compensation. He believes in an open and flexible communication with all of his clients.
He has been listed as one of the Florida Super Lawyers and also been named a Florida Rising Star each year since 2009 till present. His legal insight combined with professionalism has made him successful at winning a majority of cases at court.
We hope you enjoy this blog.
Cyberonics Vagus Nerve Stimulator therapy Unit Recall: Injured Patients Can Take Legal Action
Vagus Nerve Stimulator (VNS) Therapy Systems developed by Cyberonics were approved by the FDA in the year 1997 for the treatment of patients with epileptic seizures and in 2005, the device became approved for the treatment of patients with depression. Cyberonics Model 106 generators that were being used in the VNS therapy called the AspireSR Model 106 generator have been recalled by virtue of software problems back in December 2015.
VNS therapy includes electronic stimulation of the vagus nerve in the neck region. The vagus nerve plays an important role in sending our body’s sensory information to the brain. This made researchers invent a system and use the concept of vagus nerve stimulation in the treatment of patients with depression and epilepsy who have shown improvement with drugs.
Since the time Cyberonics launched VNS therapy system, the Model 106 generator was recalled at least six times - October 2015, November 2015, December 2015, June 2017, November 2017, and January 2018 -as a result of various software and manufacturing defects that affected the performance of the product. In October and November 2015, Cyberonics recalled Model 106 Generators as it discovered a problem with the Verify Heartbeat Detection feature of the product. In November 2017, Cyberonics also recalled Model 3000 VNS Therapy Programmers along with the generator because of potentially serious issues. Recently, in January 2018, the generators were recalled yet again because they began displaying an unintended warning message.
More about the Software Issue
A warning from the FDA stated that the Model 106 generator experienced software issues when the device setting was incorrectly configured and called the problem as “Brute Watchdog Timeout”. The Model 106 generator would either fail to deliver or continue delivering electronic stimulation to the vagus nerve when the problem has occurred, but the patients could not make out that this was happening. According to Cyberonics, there was no option other than the patients who no longer felt stimulation from their VNS therapy system visiting their doctor for an inspection of their device in order to detect potential problems and adjust settings so as to ensure proper functioning of the device. As a result, the patients with this Model 106-equipped VNS therapy system were at the risk of developing serious complications if at all the generator stopped working. In case the generator ceased delivering electronic stimulations because of software issues, the VNS Therapy system also stopped treating the patient’s depression or epilepsy. This, in fact, leads to an increased risk of patients developing dangerous seizures or worsened depressions and other serious complications.
Patients Suffering Complications due to Cyberonics VNS Therapy System are Eligible to File a Lawsuit
More than thousands of complaints have reached the FDA, from patients who have sustained severe injuries or have lost their life after getting Cyberonics VNS therapy system placed in their body. According to the FDA’s database, about 10,000 reports of incidences including injuries, malfunction, and death were received from patients treated using the device. As Cyberonics VNS therapy systems powered by Model 106 AspireSR generators have been found linked to serious complications, patients who have been injured as a result of these complications qualify to take legal action.
Medical device manufacturing companies and firms that produce other health products ought to ensure the safety of their products as well as compliance with federal health and safety standards. If the manufacturers fail to do so, serious injuries do occur that could be life-threatening.
If you or your loved one has gone through the worsening of epilepsy or depression symptoms or any other complication as a result of the faulty functioning of Cyberonics VNS Therapy System with an Aspire SR Model 106 generator, you can file a lawsuit right away. As a first step, contact an experienced attorney that can handle medical product liability litigation and advise you further steps towards your legal rights and filing a claim to receive compensation.