OrbusNeich has filed a lawsuit in the Netherlands against Pavel Cervinka and Masaryk Hospital in Usti nad Labem, Czech Republic, alleging the hospital and Cervinka, who is the hospital’s head of cardiology, published inaccurate statements concerning the medical device company's pro-healing Genous stent.
The lawsuit stems from a study held at the hospital and for which Cervinka was the principal investigator. According to OrbusNeich's lawsuit, the clinical study randomly compared the company’s pro-healing Genous stent with a bare metal stent for treatment of a class of heart attack patients. The study reported that adverse events, including three patients experiencing stent blood clots, had occurred with use of the Genous stent. Cervinka published the study’s results in an unnamed U.S. medical journal and made presentations about the study.
OrbusNeich officials said the company and independent evaluators determined there were inaccuracies, misrepresentations and inconsistencies in the study, the study methods and the reporting of the study's conclusions and confronted Cervinka and Masaryk Hospital.
According to the lawsuit, Cervinka admitted to making mistakes and altered subsequent presentations and the published study in the U.S. medical journal. However, the company claims the changes made by Cervinka did not correct the reporting of the defects in the study, admit to the errors or publish the errors and invalidity of the study.
The company, headquartered in Hong Kong, has charged that Cervinka continued to present the results and conclusions of the study after he and the hospital were aware of errors discovered by OrbusNeich and the independent evaluators. The suit claims that this continued dissemination of erroneous information has stopped clinicians from using OrbusNeich’s stent and has ended clinical trials and damaged the company’s reputation.
“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,” said Alfred J. Novak, chairperson and chief executive officer of OrbusNeich, in a statement. “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."
The suit asks for an injunction against further publications and presentations of the study.
OrbusNeich has U.S. facilities in Fort Lauderdale, Fla., and is known for stents and balloons marketed under the names of Azule, R stent, Scoreflex, Sapphire, Sapphire II and Sapphire NC.