An orthopedic surgeon in Tyler, Texas, received an FDA warning letter for violating rules that protect clinical trial participants in a device trial.
The agency cited clinical investigator Dennis Devinney for failing to obtain informed patient consent before surgically implanting an investigational medical device, which the FDA did not identify.
According to a website for the East Texas Medical Center's orthopedic institute, Devinney performs a procedure called reverse shoulder prosthesis as part of a research study at the site.
In its April 21 warning letter, the FDA claims that proper informed consent was not obtained for nine of Devinney's 19 study participants. Two patients received study-related procedures prior to consenting, and seven gave consent through a document that was not approved by an institutional review board (IRB), the agency said.
Devinney also enrolled patients who did not meet the study's inclusion criteria, the FDA said. Inspectors noted the inclusion of at least two subjects who did not qualify based on preoperative pain ratings. Additionally, baseline assessments were not documented for these subjects, the letter states.
As the study progressed, Devinney failed to report unanticipated adverse effects to the IRB, the agency claims. The letter states that, in one instance, a suture abscess was not immediately reported to the IRB. In another instance, a participant was hospitalized for pneumonia, although there was no record of the IRB being notified.