News | March 21, 2011

OrbusNeich Files Lawsuit Over Stent Clinical Trial Results

March 21, 2011 - OrbusNeich today announced it filed a lawsuit in the Netherlands against a doctor and principal investigator of a trial examining OrbusNeich's Genous coronary stent. The results of the study reported adverse events with the stent, but a review of the study by OrbusNeich and independent evaluators showed the study contained many inaccuracies, misrepresentations and inconsistencies.

The suit names Dr. Pavel Cervinka and Masaryk Hospital in Usti nad Labem, Czech Republic, where Cervinka is head of the hospital's cardiology department. The suit relates to a clinical study conducted at the Masaryk Hospital, which randomly compared the Genous stent with a bare metal stent for treatment of heart attack patients.

The lawsuit alleges Cervinka and the Masaryk Hospital have committed unlawful acts and asks for an injunction against further presentations or publications of the study. OrbusNeich also requests that the court's decision be submitted for publication in the U.S. journal in which the study was published by Cervinka and an acknowledgement of the decision also be placed by Cervinka in the journal.

After the first presentation of the study at the American College of Cardiology (ACC) in March 2009, OrbusNeich contacted Cervinka to discuss the study and investigate the circumstances surrounding the reported adverse events. In response, Cervinka provided limited information on three patients who experienced a stent thrombosis (blood clot). The company said an independent evaluation of the data relating to those patients revealed procedural complications for all three patients, namely under-expansion of the stent, geographic miss and malapposed struts in a jailed diagonal branch. The company said all these factors 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, Cervinka admitted that he had made mistakes. However, changes that 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, the company claims.

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, numerous clinicians stopped using the product and terminated clinical trials, and OrbusNeich suffered reputational damage, the company claims.

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