| St. Jude Silzone Heart Valve
The St. Jude Silzone® heart valve was recalled in January 2000
after a clinical trial showed valves with a silver coating were
prone to leak. 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.
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
removal of these products unless individual patient monitoring detected
complications.
St. Jude recently urged a Minnesota court to dismiss the cases
on the basis that plaintiffs' state law claims were not permitted
because the Silzone® device underwent the pre-market approval
processes of the Food and Drug Administration. In rejecting St.
Jude's argument, the Court noted that both the Minnesota and United
States Supreme Courts generally disfavor what is called "preemption"
of state laws. The Court also noted that plaintiffs' allegations
include "claims that the defendant repeatedly violated the
requirements [of federal law that govern medical devices] by among
other things withholding negative clinical results, ignoring labeling
requirements, and using misleading marketing information."
The Court went on to say that "[t]he contested issues of fact
in this case, if found in plaintiff's favor, would result in a verdict
for the plaintiffs."
Time Limits on Filing Suit
Every case has a statute of limitations that will apply.
It varies by the type of case and the state where the case is filed.
Don't wait until there is trouble or until the end of your case
to get a lawyer. Your attorney would prefer to be involved every
step of the way, to monitor your case, to guide you, to prevent
trouble, and to assist you.
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Irwin & Boesen represents persons who have
been injured by dangerous medical products. Please contact
us for an honest evaluation of your case. |
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