St. Jude Sued over Recalled Heart Valves
The lawsuit was filed on behalf of Linda Baez, a Massachusetts woman who experienced leakage around the heart valve resulting from endocarditis, an infection of the membranes lining the cavities of the heart. This phenomenon is known as paravalvular leakage.
Baez was first implanted with the St. Jude Silzone heart valve in April 1999. Within a few months, she exhibited symptoms of paravalvular leakage and endocarditis. In November 1999, her surgeon replaced the valve with another St. Jude Silzone valve. Now, doctors say the second valve is also leaking, and the patient must undergo a third open-heart surgery to replace the valve.
The St. Jude Silzone valve is a conventional mechanical heart valve, with the sewing ring coated by elemental silver, which St. Jude contends would produce an antibacterial effect, thereby reducing valve endocarditis.
Shortly after St. Jude began distributing the 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. Early results found an increase in the incidence of paravalvular leakage with the Silzone valve. The company recalled all products with the Silzone coating in January (see related story).
The lawsuit alleges that St. Jude Medical is negligent in designing, manufacturing, and marketing a defective heart valve that was not adequately tested. The lawsuit further claims that the risks of serious bodily injury exceeded the benefits associated with the design.
The suit was filed by Robins, Kaplan, Miller & Ciresi, the firm that represented plaintiffs in such cases as the Bjork-Shiley mechanical heart valve, the Dalkon Shield, and the Copper-7 IUD.
Source: Robins, Kaplan, Miller & Ciresi L.L.P.