Suing Your Clinical Investigator


Correction to original post issued 10:35am ET 03/29/11

This may be a first.  A cardiovascular medical device company has sued one of their clinical investigators for defamation.The accusations appear to be centered around procedural errors/complications that are causative of the clinical complications found in the study. In short, it means that something the investigators did during the procedure may be responsible for certain subsequent patient complications.

The suit alleges that the investigator failed to fully disclose the underlying causes.  Failure to disclose was likely for two reasons:

  1. It is easy to blame the study device rather than one’s clinical abilities, after all it is under clinical investigation.
  2. It is more difficult to accept responsibility and more important the potential liability for one’s own actions.   The sponsor usually has deeper pockets and clinical trial insurance in case of any patient suits.

In short, OrbusNeich alleges that the study is flawed:

“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 company seems to have acted correctly by first contacting the investigator to seek remedy. While admitting his mistakes, the investigator refused to publicly correct any of his findings even after an independent evaluation:

“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.”

Worse still, this investigator, Dr. Cervinka from Masaryk Hospital (Usti nad Labem, Czech Republic) continued to present this allegedly flawed study.

Alfred J. Novak, Chairman and Chief Executive Officer of OrbusNeich, is quoted in the press release:

“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. “

Do you think the company act correctly in this case?  Do you think this will hurt OrbusNeich with investigator recruiting when trying to conduct future trials or studies?  Are you aware of any other incidents of companies suing a clinical investigator?  I would love to hear your input.

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