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 jailed diagonal branch, which are recognized risk factors for stent thrombosis. It also revealed discrepancies in the reported data and inconsistencies and misrepresentations in the study and the reporting of the study. Upon presentation of the findings of the independent evaluation, Dr. Cervinka admitted that he had made mistakes; however, changes which he made to subsequent presentations and the publication of the study in a medical Journal did not correct the reporting of the defects in the study, nor admit nor publish the errors and invalidity of the study.
Dr. Cervinka presented the results and conclusions of the study a number of times after he and the Masaryk Hospital were made aware of the defects in the study and the study reporting. As a result of the wide dissemination of the study and its erroneous conclusions that were not supported by the data, numerous clinicians stopped using the product and terminated clinical trials, and OrbusNeich suffered reputational damage. Despite many requests by OrbusNeich, neither Dr. Cervinka nor the Masaryk Hospital has made public disclosure of the defects or deficiencies in this invalid study.
Alfred J. Novak, Chairman and Chief Executive Officer of OrbusNeich, said, "OrbusNeich stents and its other products provide innovative therapies that improve the lives of patients around the world. We have taken this action only after many unsuccessful attempts to try to work with Dr. Cervinka and the Masaryk Hospital to correct the record. We informed Dr. Cervinka and the Masaryk Hospital about the inaccuracies, misrepresentations and inconsistencies that were unveiled by an independent reviewer of the study, and they acknowledged our position. Nevertheless Dr. Cervinka and Masaryk Hospital continued to widely present and publish the flawed and invalid study, resulting in damages to OrbusNeich's business and reputation. While we attempted to resolve this issue amicably, the actions by Dr. Cervinka and Masaryk Hospital have left us no other choice but to protect the reputation of OrbusNeich and our products in court."
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Stent, as well as other stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. Development stage products include the Combo™ Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com. Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich.
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