The FDA sent a warning letter to Providence Sacred Heart Medical Center in Spokane, Washington regarding serious irregularities in its study of the Medtronic CoreValve device. The device is intended for patients with severe aortic stenosis, a condition that may lead to heart failure and sudden cardiac death. Medtronic promoted the clinical trial of its device and has multiple centers utilizing it at this time in conjunction with the trial. The trial makes use of a non-FDA approved, investigational device for transcatheter aortic valve implantation (TAVI).  Flagrant violations of trial protocols were recently identified by the FDA which led to the FDA sending a warning letter to the site and manufacturer and its principal investigators.

The reported violations include:

1. A researcher failed to obtain informed consent from subjects who underwent screening tests that were research-specific, such as CT angiograms.  These tests have various risks to patients, and the failure to obtain the necessary consent is a substantial concern.

2. Some patients were already in the clinical trial before signing consents, and one consent was signed more than two months after beginning the clinical trial.

3. Timely notification to the manufacturer and the Institutional Review Board was withheld when some significant clinical events occurred that deviated from the original investigational plan.  A patient underwent several surgeries, two of them emergently, and the events were not reported for over a month, far beyond the five day period the rules require.  A coronary bypass was performed on another patient, and it was not reported at all.  Of greatest concern, two patients died and their deaths were reported late.  Timely reporting is a cornerstone to safe clinical trials and allows for adjustments and discontinuance of studies when appropriate.

4. The FDA also found flaws in the maintenance of general medical records pertaining to the subjects, including failing to record baseline vital signs, lab values and postop ECGs.

The FDA is requiring correction and compliance with the applicable rules, and Medtronic has indicated that the violations are limited to this one site.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.