Is There an Issue With Patient Notification?

Allegations involving a regenerative therapy study at a New York-based hospital and a U.S. Food and Drug Administration (FDA) warning are shedding light on what one physician claims is an issue with patient notification.

The allegations came to light after Pravesh Gadjradj, M.D., MSc filed a complaint with NewYork-Presbyterian/Weill Cornell Medical Center. Dr. Gadjradj was a visiting researcher at the medical center and came across a warning from the FDA regarding a regenerative therapy product that had reportedly been used during surgery in 40 patients.

The surgeries were allegedly documented by Hansen-MacDonald Professor of Neurological Surgery and Director of Spinal Surgery at the Weill Cornell Medicine Brain and Spine Center Roger Härtl, M.D. The regenerative therapy product was allegedly used prior to the FDA warning.

The New York Times was able to review the complaint filed by Dr. Gadjradj. In a recent article it says that in the complaint “Dr. Gadjradj said Dr. Härtl requested that he ‘delete’ the research file on the project and ‘never bring up the topic again.’” Additionally, Dr. Gadjradj said that “he was concerned that Dr. Härtl had not gone on to inform the patients, according to the complaint, and instead ‘covered it up.’”

The regenerative therapy product was manufactured by Boise, Idaho-based Smart Surgical, Inc., doing business as Burst Biologics. According to an FDA warning letter issued February 2022, Burst Biologics manufactured “products derived from human umbilical cord blood, namely, BioBurst Fluid and BioBurst Rejuv, for allogeneic use.”

The warning letter indicated that the products violated several laws due to unapproved uses. Additionally, according to the warning letter, Burst Biologics deviations in manufacturing indicated that use of the products “raises potential significant safety concerns.” These deviations included “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing processes, and deficient environmental monitoring.”

Dr. Härtl provided the following comment to OTW. “Patient safety has consistently been my primary concern and remains so. I have not observed any unexpected adverse events in my patients that can be directly attributed to the use of Bioburst Fluid. I discontinued the use of Bioburst Fluid before the FDA warning letter was issued and dispute any implication that we used or studied it in an inappropriate manner.”

He continued, “Further, I want to make it clear all relevant data related to the use of BioBurst Fluid remain on file, and any suggestion otherwise is not true.”

While the warning letter indicated potential significant risks, there is no actual requirement in the letter that patients be notified. What are your thoughts on informing patients in similar situations? Let us know in the comments below.