St. Jude Medical's Silzone Heart Valve Class Action Spreads to Sixteen European Countries: At Least 12,000 More Recipients Revea
February 12 2004 - 10:14AM
PR Newswire (US)
St. Jude Medical's Silzone Heart Valve Class Action Spreads to
Sixteen European Countries: At Least 12,000 More Recipients
Revealed `At Risk' - 36,000 Worldwide, Announces Levy Angstreich
Law Firm MINNEAPOLIS, Feb. 12 /PRNewswire/ -- A medical monitoring
and restitution class action against St. Jude Medical, Inc. in
Minnesota State Court (Ramsey County) was filed yesterday, Feb. 11,
on behalf of Silzone victims who are citizens of the European
Economic Union (EEU) comprised of sixteen countries. This class of
approximately 10,000 to 14,000 Western European patients with
defective Silzone products still implanted in them rounds out the
other major populations of Silzone victims across the world who are
suing St. Jude for the defective toxic silver coating on St. Jude's
flagship prosthetic heart valve products between 1997 and January
2000. The valve was removed from the market by St. Paul-based St.
Jude for safety reasons. According to Steven E. Angstreich, an
attorney with the Philadelphia, Pennsylvania law firm of Levy,
Angstreich, Finney, Baldante, Rubenstein & Coren, P.C., who is
serving as co-lead counsel for Shane O'Neill, a Silzone heart valve
implantee, says, "The evidence developed in the United States class
action indicates thatSt. Jude used the European Countries as its
human test site to determine if the valves were safe for use,
indeed referring to it in one internal document as `the Guinea pig
continent of Europe.' St. Jude's corner cutting in the development
of the Silzone products, its withholding of critical information
and its callous attitude towards the Silzone patients," says
Angstreich, "provide the reason why at an appropriate time in Mr.
O'Neill's suit, an application will be to the presiding state court
judgeasking for permission to assert a punitive damages claim
against St. Jude on behalf of the class." Much of this evidence has
already been presented to the Federal Court in the American class
action pending in Minneapolis, and supported the United States
District Court's recent decision to deny St. Jude's attempt to have
that case against it dismissed on January 5th, 2004. That record is
presently under seal pursuant to a case management order. Similar
class actions on behalf of American and Canadian Silzone implantees
are pending in Minnesota Federal Court and the Superior Court of
Justice in Toronto, Ontario and have already been certified to
proceed as class actions against St. Jude. Recently, on January
5th, 2004, in the class action in the U.S., the court denied St.
Jude's request for judgment in its favor based on FDA approval of
Silzone coating for prosthetic heart valve devices. The Court's
examination of the evidence against St. Jude showed there are
questions that requires a trial. This suit, filed by Shane O'Neill,
the Silzone heart valve implantee who is both a citizen of Ireland
and Canada, claims that the Silzone products were defective because
of the toxic properties of the silver coating that St. Jude put on
the valves to hopefully prevent endocarditis from occurring.
Endocarditis is a very small but serious risk following valve
replacement surgery. O'Neill had two Silzone valves implanted when
he lived in Ireland. An initial Silzone valve was implanted in him
in March of1998. That valve had to be removed and replaced
approximately nine months later, on December 23, 1998 because it
had developed a paravalvular leak. Because his surgeon was unaware
of the problems associated with St. Jude's Silzone coating, it was
replaced with another Silzone coated valve. That second Silzone
valve is still implanted in him and causes him great concern and
requires, according to medical consultants, that he (as well as
other current Silzone implantees) undergo enhanced medical
examinations. O'Neill seeks in the suit to recover the costs of
establishing court supervised trust funds to provide ongoing
medical examinations and scientific research into Silzone's
long-term toxic effects. The suit also seeks restitution from St.
Jude for the costs of the defective valves and the medical care
associated with its implant and its explantation. On an individual
basis, his suit also seeks personal injury damages for himself and
his wife related to the explantation surgery he underwentafter his
initial prosthetic valve failed. In his class action complaint,
O'Neill alleges that Silzone's silver comes off the valves' sewing
cuffs at dangerous levels; that the silver coating is toxic to
heart tissue; that the silver is responsible for causing serious
and potentially fatal complications such as paravalvular leaks
(leakage between the implanted valve and the heart tissue);
improper healing of the prosthetic valve into the heart and
thromboembolic events (strokes, TIA's heart attacks); and that St.
Jude withheld critical information relating to its safety and
efficacy from both regulatory authorities and the medical
profession. A team of international team lawyers are collaborating
to represent Mr. O'Neill and the class of EEU Silzone patients.
This legal team is comprised of product liability and class action
lawyers from England, Canada and the United States. In addition to
Angstreich's firm, lawyers from the firms of Zimmerman Reed
(Minneapolis), Kellogg & Sigelman, LLC (Washington, D.C.) and
Leigh Day & CO. (London, England) are involved in the
prosecution of the suit. For more information contact the law firm
of Levy, Angstreich, Finney, Baldante, Rubenstein & Coren, P.C.
at 800.601.1616 or on the web at http://www.levyangstreich.com/.
DATASOURCE: Levy, Angstreich, Finney, Baldante, Rubenstein &
Coren, P.C. CONTACT: Sheryl Raskin, Out There PR, +1-215-542-8887,
, for Levy, Angstreich, Finney, Baldante, Rubenstein & Coren,
P.C. Web site: http://www.levyangstreich.com/
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