WOULD A DOCTOR ACTUALLY USE A DEVICE THAT WAS NOT FDA-APPROVED WITHOUT A PATIENT'S APPROVAL?
Sadly, the answer is yes; and, it happened right here in Chicago. Myxo ETlogix annuloplasty rings - that were different in design from previously approved devices - were implanted in patients at Northwestern Memorial Hospital (NMH) based on the approval of the doctor and the pharmaceutical company who both stood to profit from the product. Importantly, two critical links in the chain were missing before the device should have been implanted: (1) approval from the FDA and (2) consent from the patient to use an investigational device. As an investigational device that posed a significant risk, the doctor and NMH should have received approval from the FDA and an Internal Review Board (IRB) prior to the implantation of the myxo device for clinical testing. FDA approval is obtained by submitting an Investigational Device Exemption (IDE) application to the FDA.
Pursuant to FDA regulations, in order to conduct a significant risk device study, a sponsor must: (1) submit a complete IDE application to FDA for review and obtain FDA approval of the IDE; (2) submit the investigational plan and report of prior investigations to the IRB at each institution where the investigation is to be conducted for review and approval; and (3) select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed investigator agreements from them.
The FDA found that Edwards Lifesciences, who manufactured the ring, erred when it failed to seek clearance for the devices because the shapes and materials were different than other rings on the market. The Law Offices of Jeffrey J. Kroll and The Law Offices of Newman, Boyer & Statham currently represent a woman who had the ring implanted without knowing it was non-FDA-approved.
Contact the Law Offices of Jeffrey J. Kroll today at (312) 676-7222, if you have been injured by a doctor's negligence.
