Infections after heart surgery lead to lawsuits
During many open heart surgeries a device known as a heater-cooler is used to help patients maintain appropriate body temperatures. According to the CDC, more than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Even though the device is an essential part of these life saving surgeries, there has been controversy recently surrounding the Sorin T3 model.
Late in 2015 the FDA released their first public safety warning on the Stockert 3T Heater-Cooler System (3T), manufactured by Sorin Group Deutschland GmbH. This unit has been reported to cause infection due to the way the device was manufactured. If you or a loved one suffered from infection after open heart surgery, contact us today for a free case evaluation.
Information on infections related to heart surgery
Greg Jones Law is taking cases nationwide for those making claims that they suffered an infection or other injuries after having surgery involving the Sorin T3 heating-cooling system. Plaintiffs in these cases reported infections and infection like symptoms but were not always alert to the underlying danger of the situation. A tie to the bacteria M. chimaera was exposed to the public on June 1, 2016 by a safety communication issued by the FDA making health officials and patients alike aware of the deadly consequences of having used a defective medical device.
M. chimaera Infections potentially deadly
M. chimaera is the short abbreviation for a type of nontuberculous mycobacterium (NTM), in short a type of bacteria that can cause severe illness and even death. Most people when exposed to a dangerous bacteria begin to feel symptoms within days. Our body and our immune system are alerted to the presence of something harmful and begins to take action. Unfortunately, with this type of bacterial infection the symptoms lay latent for sometimes years after initial exposure, in some cases up to 3 years-5 years afterwards.
Without question exposure to this bacteria long term without treatment could result in death. Many who were infected also either had to undergo an additional surgery or a prolonged treatment (sometimes up to a year) of additional antibiotics.
Timeline of Events
Sorin Confirms Plant Contamination
Sorin confirms contamination of their manufacturing plant and water systems.
Sorin Recalls Defective Device
Sorin recalls 1,755 units due to a confirmatory link to the bacteria M chimaera.
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Did the device manufacturer know of risk?
It was confirmed that the manufacture of the Sorin T3 heating-cooling system did know of a link to the bacteria before the safety communication was issued by the FDA. Ultimately, the Sorin Group admitted that the bacteria M. chimaera had been detected in their productions lines and water sources.
As a result the plaintiffs in these cases are also claiming that the device manufacturer neglected to report contamination of their production facilities. By doing so they additional failed to ensure the safety of their devices.
What do I do if I suffered injuries after open heart surgery?
Patients who suffered further complications after open heart surgery using a heating-cooling device should contact an attorney as quickly as possible. The consequences of Sorin’s dangerous product have been severe enough to include death in some cases. If you or a loved one has been injured by a dangerous medical device it’s important to have an attorney who is experienced in this type of litigation on your side.
Greg Jones Law has successfully sued major medical device manufacturers for failing to warn of the dangers of their products. We have the means and the experience to represent clients throughout the United States in medical device litigation. To find out if you have a case against the makers of the medication Sorin T3 heating-cooling device contact us today for a free case evaluation. Call 855-566-3752 or contact us online.
FDA releases a report indicating they were aware of 32 cases of reported infection, with the vast potential for many more unreported cases.
M chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System: FDA Safety Communication.
Many Cases Being Filed
By 2017 many plaintiffs have filed suite against the makers of the defective device. For example, William Plourde and Freda Merrill v. Livanova PLC, Sorin Group USA, Inc. and CarboMedics, Inc., based in Massachusetts.