First Lawsuit Filed Against St. Jude Medical Alleging Defective Heart Valves (News Release)
May 8, 2000
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The first personal injury lawsuit in Minnesota involving a Silzone® heart valve was filed by Robins, Kaplan, Miller & Ciresi in Ramsey County District Court, State of MN, against St. Jude Medical, Inc. of St. Paul, MN on May 8, 2000. The lawsuit was filed on behalf of a Massachusetts woman who experienced leakage around the heart valve. This phenomenon, known as paravalvular leakage, makes the heart an inefficient pump that can result in serious heart-related health risks including heart failure.
The St. Jude Silzone® valve is a St. Jude conventional mechanical heart valve, with the sewing ring coated by elemental silver, which St. Jude intended to produce an antibacterial effect, thereby reducing valve endocarditis. Shortly after St. Jude began distributing the Silzone ® valve in the United States in March 1998, it began a long-term, clinical follow-up trial designed to determine the effect of the Silzone® coating on the incidence of valve endocarditis. The study was divided into two groups, the first group consisting of patients implanted with the standard St. Jude heart valve, and the second group implanted with the new Silzone® valve.
Early results found an increase in the incidence of explants due to paravalvular leak with the Silzone® valve. In the first 800 patients, the 400 implanted with the standard St. Jude valve had one case of explant due to paravalvular leak, compared to eight cases of explant due to paravalvular leak with the Silzone® valve. On January 21, 2000, St. Jude recalled all products with the Silzone® coating.
Persons with medical questions concerning this information should talk to their cardiologist or other doctor.
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