Navigation Links
OrbusNeich Files Lawsuit Against Dr. Pavel Cervinka for Defamation
Date:3/21/2011

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."

About OrbusNeich

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.

Global Media Contacts:
Dan Katcher/Aaron Palash
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449

David Kujawa
OrbusNeich
+1 954-730-0711 (office)
+1 305-733-7216 (mobile)
dkujawa@orbusneich.com


'/>"/>
SOURCE OrbusNeich
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. OrbusNeich Announces Availability of Azule™ Cobalt Chromium Stent
2. Published Data From e-HEALING Registry Demonstrate Good Clinical Outcomes With Low Incidence of Repeat Revascularization and Stent Thrombosis for OrbusNeichs Genous™ Stent
3. Safety and Efficacy of OrbusNeichs Genous™ Stent Demonstrated in High-Risk Patients with Known Contraindications for Dual Antiplatelet Therapy
4. OrbusNeich Granted Expanded U.S. Patent of Genous™ Endothelial Progenitor Cell Capture Technology
5. OrbusNeichs Genous™ Stent Shows Favorable Outcomes for Treatment of Coronary Artery Bifurcation Lesions Compared to Bare Metal Stents
6. Randomized Clinical Trial of OrbusNeichs Genous™ Bio-engineered R stent™ in China Completes Patient Enrollment
7. Data from Multiple Clinical Trials of OrbusNeichs Genous™ Bio-engineered R Stent™ Demonstrate Safety and Effectiveness Across Challenging Patient Subsets as Presented at TCT 2010
8. Patient Enrollment Completed in First Randomized Clinical Study of OrbusNeichs Combo™ Bio-engineered Sirolimus Eluting Stent
9. OrbusNeichs Genous™ Bio-engineered R stent™ Shows Favorable Safety Profile and Clinical Outcomes in Combination with Paclitaxel-Coated Balloon for De Novo Coronary Artery Disease
10. 100 Percent Coverage of Struts and Complete Neointimal Coverage of OrbusNeichs Genous™ Bio-engineered R stent™ Demonstrated 26 Days Post-Implantation in STEMI Patient
11. Data Show OrbusNeichs Genous™ Bio-engineered R stent™ is Safe and Effective in Combination with Drug-Eluting Balloon
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 26, 2016 ... care operating models within the health care industry is ... financial efficiency , Deloitte offers a suite of ... business issues impacting efficient cost optimization: labor resource analysis, ... These services facilitate better outcomes and better economics ...
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... addition of the "Structural Electronics 2015-2025: Applications, ... In-Mold Electronics, Smart ... Integrated Photovoltaics Structural electronics involves ... as load-bearing, protective structures, replacing dumb structures such ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. ... accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, ... and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic ...
(Date:6/24/2016)... ... 24, 2016 , ... People across the U.S. are sharpening their pencils and ... essay contest in which patients and their families pay tribute to a genetic counselor ... National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , ...
(Date:6/24/2016)... Nevada (PRWEB) , ... June 24, 2016 , ... ... Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing operations ... in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, ... organization dedicated to helping service members that have been wounded in battle and their ...
Breaking Medicine News(10 mins):