A recent Sorin 3T lawsuit filed in Southern California claims that the manufacturer, Sorin Group, had reason to know that its heater-cooler system posed a danger to patients, causing serious infections.

Plaintiff Edward E. alleges that he developed life-threatening medical conditions as a result of undergoing heart surgery, using the Sorin 3T.

About the Sorin 3T

The Sorin 3T is designed to maintain or regulate a patient’s body temperature during a surgical procedure that can be done within a 6 hour time period. It does not come into contact with the patient; instead, the Sorin 3T uses temperature-controlled water, which is sent through a heat exchanger and circulated through a thermal blanket.

The device at issue in the present Sorin 3T lawsuit is categorized as a Class II medical device under FDA regulations. Approximately 43 percent of all medical devices are placed into the Class II category, and include powered wheelchairs, prophylactics and pregnancy test kits. Although they are deemed to be of minimally higher risk to patients than Class I devices, they are generally simple in design and are not placed inside a patient.

FDA approval for the Sorin 3T in 2006 was the result of the controversial 510(k) Premarket Notification process. Medical device manufacturers who are able to demonstrate that a new product is “substantially equivalent” to an older version are allowed to introduce their device to the market without having to go through the time and expense of clinical trials and safety testing.

Unfortunately, as the growing number of Sorin 3T lawsuit filings demonstrate, medical devices cleared through the 510(k) regulatory pathway have resulted in thousands of needless patient injuries and deaths.

What Inspections Revealed

Edward’s Sorin 3T lawsuit goes into some detail about the issues surrounding the product. Specifically, the complaint says that Sorin’s “cleaning/disinfection procedures” and instructions were “insufficient to properly disinfect the Sorin 3T.”

It goes on to describe the results of an inspection conducted of the Sorin factory, where FDA inspectors allegedly found deficiencies in how the devices were cleaned and sterilized. Five years later, European health authorities reported several cases of bacterial infections among open heart surgery patients in several countries – noting that the outbreak had started in 2011.

Edward’s Case

Edward’s Sorin 3T lawsuit indicates that he underwent open heart surgery in April of 2015, during which the device was employed. During the operation, he says the surgical site came into contact with a strain of bacteria known as M. chimaera.

This infection, he says, resulted in the development of acute/chronic bronchitis and a pulmonary embolism, starting approximately one year later. Citing the findings of FDA and European inspections, Edward claims the Sorin 3T was defective in its design, which prevented it from being thoroughly cleansed and sterilized.

Edward accuses defendant of negligence, manufacturing defect and failure to warn. He is seeking damages for medical expenses, pain and suffering, emotional distress and punitive damages.

Edward’s Sorin 3T lawsuit is Case No. 2:19-cv-06407-MWF-JPR , California Superior Court, Orange County.