HONG KONG, March 21, 2011 /PRNewswire/ — OrbusNeich today
announced that it has filed a lawsuit in the Netherlands against
Dr. Pavel Cervinka and Masaryk Hospital in Usti nad Labem, Czech
Republic, where Dr. Cervinka is head of the hospital’s Cardiology
Department. The suit relates to a clinical study conducted at the
Masaryk Hospital, in which Dr. Cervinka was the Principal
Investigator, which purported to randomly compare OrbusNeich’s
Genous stent with a bare metal stent for treatment of a class of
heart attack patients. The results of the study reported
certain adverse events with the OrbusNeich stent. However,
upon a review of the study by OrbusNeich and independent
evaluators, it was revealed that there were many inaccuracies,
misrepresentations and inconsistencies in the study, the study
methods, and the reporting of the study conclusion.
The lawsuit alleges that Dr. Cervinka and the Masaryk Hospital
have committed unlawful acts and asks for an injunction against
further presentations or publications of the study.
Additionally, OrbusNeich requests that the court’s decision be
submitted for publication in the U.S. Journal in which the study
was published by Dr. Cervinka and an acknowledgement of the
decision also be placed by Dr. Cervinka in the Journal, as well as
other remedies.
After the first presentation of the study at the American
College of Cardiology in March 2009, in accordance with the
practice of proper corporate responsibility and a serious concern
for patient welfare, OrbusNeich personnel contacted Dr. Cervinka to
discuss the study and investigate the circumstances surrounding the
reported adverse events. In response, Dr. Cervinka provided limited
information on three patients who experienced a stent thrombosis
(blood clot). An independent evaluation of the data relating to
those patients revealed procedural complications for all three
patients, namely under-expansion, geographic miss and malapposed
struts in a
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