OrbusNeich sues its principal investigator
OrbusNeich has filed a lawsuit against Pavel Cervinka, MD, and the Masaryk Hospital in Usti nad Labem, Czech Republic, alleging that Cervinka, principal investigator of a trial evaluating the company’s Genous stent, committed "unlawful acts." The company has asked for an injunction against the presentation or publication of the study.

Hong Kong-based OrbusNeich claims that the study, comparing the company’s Genous stent to a bare-metal stent in MI patients, held many "inaccuracies, misrepresentations and inconsistencies."

The company has asked that the court’s decisions and an acknowledgement of the decision by Cervinka be submitted for publication in the U.S. journal where the study was published.

The trial, presented at the 2009 American College of Cardiology (ACC) meeting reported adverse events within the trial that were related to the OrbusNeich stent. After the symposium, leaders at OrbusNeich contacted Cervinka to discuss study findings and charge that the doctor provided limited information about three patients who experienced stent thrombosis during the trial.

According to the company, an independent evaluation of the trial patients who experienced an event of stent thrombosis revealed that there were procedural complications in all three patients and discrepancies within the reported data.

OrbusNeich said that during the evaluation Cervinka admitted to mistakes; however, changes about the errors were not made to the presentations and publications that housed the study results.

Because the company said that Cervinka presented the results of the trial even after the defects of the study were known, OrbusNeich suffered reputational damage because of the number of clinicians who ceased using the Genous stent due to the trial results. The company said that neither Cervinka nor Masaryk Hospital made the study deficiencies public.

“We have taken this action only after many unsuccessful attempts to try to work with Cervinka and the Masaryk Hospital to correct the record. We informed 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,” Alfred J. Novak, chairman and CEO of OrbusNeich, concluded. “Nevertheless 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 Cervinka and Masaryk Hospital have left us no other choice but to protect the reputation of OrbusNeich and our products in court.”