Thursday, November 11, 2010

Drs. Bots, de Groot and Kastelein To Be Deposed In Consolidated Federal ENHANCE Class Action Suits?


A six page motion (a PDF file) was filed by the lead plaintiffs in the ENHANCE consolidated federal putative class action suits this afternoon. The motion, if granted, would allow the plaintiffs' lawyers to fly to Europe and take sworn depositions, over the course of several days each, of the various European clinical researchers (including the PI, or Principal Investigator) involved in the notorious ENHANCE study. The motion will be decided by the very able federal Judge Cavanaugh, in Newark New Jersey, by December 6, 2010, according to his minute order entries.

Here is the core of the motion:

. . . .4. Lead Plaintiffs desire to take the depositions of Dr. John J.P. Kastelein, Dr. Eric de Groot and Dr. Michiel Bots, all of whom are located in the Kingdom of the Netherlands. Drs. Kastelein, de Groot and Bots are necessary and material witnesses to the Lead Plaintiffs’ proof of the claims alleged in the complaints and have crucial knowledge concerning the ENHANCE trial.

5. Dr. John J.P. Kastelein, was the Principal Investigator of the ENHANCE trial. Testimony concerning his work on the ENHANCE trial is highly germane to the core issues in these cases and will advance the interests of justice. Dr. Kastelein is expected to provide direct testimony regarding all aspects of the design, implementation and results of the ENHANCE trial from its inception through subsequent to the disclosure of the results, including his own work on the ENHANCE trial and his regular interactions with Defendants and numerous individuals in their employ. The testimony of Dr. Kastelein is necessary in the interest of justice and it is not possible to obtain his testimony in admissible form unless he is deposed under oath as to his work on the ENHANCE trial and his knowledge of facts that are relevant to the issues of these cases.

6. Dr. Eric de Groot was an expert consultant of Defendants for the ENHANCE trial, and was responsible for running the laboratory that evaluated ultrasonic images taken of patients’ carotid artery during the trial to determine changes in the artery’s intima-media thickness, known as IMT, a key measurement for the ENHANCE study. The testimony of Dr. de Groot is necessary in the interest of justice and it is not possible to obtain his testimony in admissible form unless he is deposed under oath as to his work on the ENHANCE trial, which is highly germane to the core issues in these cases.

7. Dr. Michiel Bots is an epidemiologist at the University Medical Center of Utrecht retained by Defendants as a consultant during the ENHANCE trial to review the data generated by the trial and opine as to its quality and reliability, among other things. Dr. Bots is expected to provide direct testimony regarding his work on the ENHANCE trial, the quality of the ENHANCE trial data, and his interaction with Defendants, numerous individuals in their employ, and other witnesses with knowledge of the ENHANCE trial. The testimony of Dr. Bots is necessary in the interest of justice and it is not possible to obtain his testimony in admissible form unless he is deposed under oath as to his knowledge of the facts which are relevant to the issues of these actions, including concerning documents he obtained and generated regarding the ENHANCE trial.

8. The testimony of these witnesses is material and necessary for Lead Plaintiffs to support their claims because these witnesses were directly involved in conducting or reviewing key aspects of the ENHANCE trial on behalf of Defendants and will be able to provide direct testimony on the facts and circumstances surrounding the central issues in these cases.

9. Lead Plaintiffs have no alternative to the testimony of these witnesses. . . .



10. The witnesses are not available for depositions in this country, and letters of request are necessary to secure the power to depose these witnesses in the Netherlands, which recognizes no other procedure to depose witnesses in relation to civil actions pending in other countries. . . .

I predict the motion will be granted -- and that will be decidedly bad news for New Merck, the company largely left holding the bag, for the malfeasance of legacy Schering-Plough (and its then CEO, "Fast" Fred Hassan, and then President, Carrie S. Cox). To be clear, I think Drs. Bots and Kastelein will be very friendly witnesses for the plaintiffs. The emails from 2007 and 2008 would suggest nothing less.

We'll keep you informed. If you need a background refresher on the cases, click that immediately prior link. [The stars & stripes-draped Zetia® pill image, at top, seemed apt on Veterans' Day, here in the States.]

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