St. Jude Silzone Heart Valve Recall
On March 27, 2003, U.S. District Judge John R. Tunheim in Minneapolis certified a class action lawsuit against St. Jude Medical Inc. for cases involving defective Silzone(r) heart valves.
The St. Jude Silzone(r) heart valve was recalled in January 2000 after a clinical trial showed valves with a silver coating were prone to leak. About 36,000 Silzone valves have been implanted worldwide, about 10,500 in the United States. St. Jude indicated that while it will no longer distribute products with Silzone, it was not recommending explants of these products unless individual patient monitoring detected complications.
Judge Tunheim certified both a personal injury class and a class for people seeking compensation for monitoring to watch for side effects associated with the silver-coated valves.
Silzone-coated valve recipients may experience leakage around the heart valve. This condition called “paravalvular leakage,” makes the heart a less effective pump and can result in heart failure. In November 1999, the failing Silzone valve was replaced with another St. Jude Silzone valve. The second valve also leaked requiring a third surgery in May 2000.
There is also a concern that persons implanted with Silzone valves face higher risks of thrombus formation, thrombosis and stroke. A thrombus is a blood clot that can form upon the valve, affecting its operation or even rendering it inoperable. Thrombosis is a condition in which blood clots form and then move through the blood stream. These clots can ultimately cause a transient ischemic attack(TIA) or a stroke due to thromboembolism.
Capretz & Associates
Capretz & Associates filed the first federal class action lawsuit against St. Jude Medical, Inc. to seek reimbursement for Medical Monitoring costs for persons implanted with the St. Jude Heart Valves with Silzone. It is co-lead counsel in the MDL litigation before federal Judge John R. Tunheim in Minnesota.
The firm is also pursuing individual claims for injury or death resulting from the replacement of the heart valve or from complications arising from the use of the Silzone valve.
If you believe you may have a claim against St. Jude as the result of the removal or you or your doctor believe you need medical monitoring to determine if you need future medical attention, contact us today by calling our toll-free number: (800) 351-8588 or e-mail us your information by clicking here.
For a free case evaluation and consultation with an attorney, call Capretz & Associates toll free at 800-351-8588 or click here to have an attorney contact you.
All states have time limits on when a lawsuit can be filed called Statutes of Limitations. It is important you act promptly to protect your legal rights. Contact Capretz & Associates at 800-351-8588 for more information.
St. Jude Medical Information
The recall announcement and actions followed reports in a clinical trial, sponsored by St. Jude Medical and designed to compare the incidence of endocarditis (a life-threatening, postoperative infection) in valves with and without Silzone coating, of an unacceptable level of product re-operations to remove and repair silzone valves due to paravalvular leaks.
St. Jude stated that Silzone technology was first introduced in 1997 and purportedly had the potential to reduce the incidence of endocarditis in valve procedures. St. Jude Medical estimated there have been approximately 36,000 implants worldwide of St. Jude Medical heart valve replacement and repair products with Silzone coating. St. Jude has claimed that the reported complication does not involve the valve mechanism itself, but appears to be associated with the Silzone-coated sewing cuff fabric. Visit the St. Jude Medical Heart Valves website for additional information and resources.