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