Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process
Written by Jaimie Oh | September 06, 2012
One neurosurgeon’s battle against medical device company Vertos Medical highlights an ongoing concern over the clinical research and FDA approval of medical devices, according to a New York Times report.
Daryl F. Fourney, MD, a neurosurgeon and professor at the University of Saskatchewan, served as the lead researcher in a six-month clinical trial involving Vertos’ Mild device for lumbar spinal stenosis. At the end of the trial, patients complained of pain and in some cases underwent back surgery. The results were recently published in Neurosurgery.
Vertos reportedly accused Dr. Fourney of scientific misconduct, filed a complaint with the university and downplayed results from Dr. Fourney’s trials. For its part, the company still stands behind the Mild device and its positive effects on patients.
“The thing that gets me about this is the double standard,” Eugene Carragee, MD, orthopedic surgeon at Stanford and editor of The Spine Journal, said in the report. “The positive findings are pushed far beyond their scientific merit and the limitations of it are being ignored.”
Dr. Fourney’s falling out with Vertos sheds more light and the FDA approval process, which does not require extensive studies or clinical trials on medical devices. The issue is coming under increasing scrutiny following DePuy‘s global recall of its defective hip implants.
- A Clash Over Vertos Medical’s Promising Procedure (nytimes.com)
- Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes (earlsview.com)
- FDA Aims To Smooth Premarket Review process | Bloomberg BNA (earlsview.com)
- Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform (earlsview.com)
- Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice (pharmaceuticalintelligence.com)
- FDA to guide device makers on marketing application – chicagotribune.com (earlsview.com)
- Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device (prweb.com)
- Metal-on-Metal Hip Trials Scheduled for 2013 – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)