St. Jude Class Action Lawsuit Filed Over Defibrillator Lead Problems
St. Jude Medical faces a class action lawsuit over allegedly defective defibrillator leads, with investors claiming that the company’s actions violated federal securities laws.
The St. Jude class action lawsuit (PDF) was filed by the Norfolk County Retirement System in the U.S. District Court for the District of Minnesota on December 10, alleging that the medical device manfacturer made false and misleading statements to investors and federal securities officials by concealing problems with St. Jude defibrillator lead wires, specifically regarding information about the safety, durability and manufacturing processes of the Durata lead.
Defibrillator leads are small wires used to connect implantable cardioverter defibrillators (ICD) to the heart. The lawsuit comes just weeks after the FDA announced that inspections of the manufacturing facility where St. Jude defibrillator leads are made uncovered numerous and serious manufacturing deficiencies.
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Learn MoreThe St. Jude Durata lead was introduced as a second generation of the recalled Riata leads, which were removed from the market amid reports of problems with the insulation that allowed the small wire to become exposed inside the body. The newer leads featured a redesigned insulating material.
Originally introduced in 2006 as the St. Jude Riata ST Optim, the new generation of leads were subsequently renamed the St. Jude Durata in 2008, as concerns arose with the older Riata models.
Although St. Jude has tried to shield its Durata leads from the fallout surrounding its recall of Riata and Riata ST defibrillator leads, concerns have been raised about the manufacturing processes with the Durata leads and some reports have suggested that the new leads may also be prone to problems where the wire may poke through the insulation, leaving bare electrodes in nearly direct contact with patients’ hearts.
According to the investor lawsuit filed against St. Jude, the company perpetrated fraud and misled investors on the safety of the Durata leads, resulting in inflated stock value.
In October, the company announced it would likely receive a warning letter from the FDA due to problems with the Durata lead, resulting in a series of stock value drops, including the largest, a 12% drop after the FDA issued the expected warning letter.
“Defendants knew that the Company’s previous generation of leads, marketed under the names ‘Riata’ and ‘Quick,’ had suffered from significant design flaws in the composition and construction of their insulation,” the lawsuit states. “Because these flaws created a risk of possibly lethal electric shocks or tissue penetration, St. Jude had stopped marketing those products. The company claimed that these potentially lethal manufacturing defects had been resolved in its new line of Durata Leads by using an improved insulator called ‘Optim,’ a co-polymer of silicone and polyurethane approved by the [FDA] in 2006.”
A growing number of individuals throughout the United States are also pursuing a product liability lawsuit over the St. Jude Riata leads, alleging that manufacturing defects made the insulation weaker at certain points, allowing the wire to penetrate and become exposed inside the body. This could result in unnecessary shocks or cause the defibrillator to fail to provide a life-saving jolt when needed.
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10 Comments
JoyceJuly 9, 2021 at 1:16 pm
St Jude refused to accept blame for defects
willieSeptember 10, 2019 at 6:33 pm
A year ago I was hospitalized with a bad infection the doctors claimed they did not know where it came from I believed them. This year un Feb. I was I came down with same problem t. They told me the leads on my defibrillator became infected and infected my entire body. The results were the removal of my defibrillator and the shut down of my kidneys. There were other complications as a resu[Show More]A year ago I was hospitalized with a bad infection the doctors claimed they did not know where it came from I believed them. This year un Feb. I was I came down with same problem t. They told me the leads on my defibrillator became infected and infected my entire body. The results were the removal of my defibrillator and the shut down of my kidneys. There were other complications as a result of my salutation that I would like to discuss wish your firm. a year ago I was ho
JanetteMay 30, 2019 at 9:46 pm
My husband got a st. Jude pacemaker implanted and had to be put on life support after the surgery. He never regained full consciousness and passed away after five months.
GeorgettaDecember 16, 2018 at 3:25 am
My husband received his second device the end of January 2013. His first device lasted about 10 years. The second lasted only 2 years and two weeks. He passed away on February 15, 2015. His device never shocked him, his last words were "I can't stand." as he fell in the snow. I believe St. Jude is responsible for his death since they knew the devices were faulty. His device is on the recall[Show More]My husband received his second device the end of January 2013. His first device lasted about 10 years. The second lasted only 2 years and two weeks. He passed away on February 15, 2015. His device never shocked him, his last words were "I can't stand." as he fell in the snow. I believe St. Jude is responsible for his death since they knew the devices were faulty. His device is on the recall list.
DeborahMay 10, 2017 at 7:03 pm
I had my defibrillator implanted in 2009 within the first year my doctor told me that something had made my heart much worse and I was referred to the Mayo Clinic. My heart is damaged beyond repair and no longer beats on its own. I am totally dependent on the difibrillator. Last year I had to have it replaced. The doctor had to tug and tug to remove the old one. After reading the post above I am s[Show More]I had my defibrillator implanted in 2009 within the first year my doctor told me that something had made my heart much worse and I was referred to the Mayo Clinic. My heart is damaged beyond repair and no longer beats on its own. I am totally dependent on the difibrillator. Last year I had to have it replaced. The doctor had to tug and tug to remove the old one. After reading the post above I am scared to death. Seven years passes quickly. After the surgery the doctor indicated next time we should try a different brand. Why? I think I know now.
LyleApril 26, 2017 at 2:49 am
I was implanted with a pace maker/defib in May 2014.Since getting it I have discovered it floats around in my chest and I also have pain at the unit.Lumps also started showing up around my unit that are sore.
mikeOctober 24, 2014 at 1:24 am
I'm getting shocked by my st jude pace maker , like holding a 9 volt battery to your tongue
JeromeFebruary 28, 2014 at 5:53 am
I was also Implanted with the Riata 7000 in 2008 and haqd a incident one day while in the shower when I got 2 shocks and I never moved that fast ever in my life to get out of the shower get dressed and called the hospital. Then whenever I got my new Pace make/ Difib. in May 2012 one morning my heart rate went up to 266 beats per minute and I did'nt even get a shock that time. I feel that St Jude n[Show More]I was also Implanted with the Riata 7000 in 2008 and haqd a incident one day while in the shower when I got 2 shocks and I never moved that fast ever in my life to get out of the shower get dressed and called the hospital. Then whenever I got my new Pace make/ Difib. in May 2012 one morning my heart rate went up to 266 beats per minute and I did'nt even get a shock that time. I feel that St Jude needs to go ahead and just settle this lawsuit because they're putting peoples lives in danger. When I contacted them they quickly offered me a $1,000.00 which I turned down because they were just trying to pay me off to keep quite. Now if they would only settle this claim maybe then others needing there products may decide to start to believe in them again
AlbertSeptember 7, 2013 at 5:35 pm
My Mother past away 2 months ago because of a defective lead that corroded and grew in to her artery. When the Dr. went to replace it he pulled on it and it ripped and she bleed to death right there on the operating room table. I feel something that was suppose to save her life killed her. What can me and my family do about a lawsuit since I believe this is a wrongful death due to negligence of th[Show More]My Mother past away 2 months ago because of a defective lead that corroded and grew in to her artery. When the Dr. went to replace it he pulled on it and it ripped and she bleed to death right there on the operating room table. I feel something that was suppose to save her life killed her. What can me and my family do about a lawsuit since I believe this is a wrongful death due to negligence of the company it was made by.
JohnFebruary 26, 2013 at 10:19 am
On May 8th 2008 I had a heart attack I was in a coma on life support 3 days later I work up. Kaiser Permanente placed a St Jude defibrillator in me that the lead wire failed 3 times from May 2008 to November 2012