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Patient 1
IN EARLY 2009, A PHYSICIAN PRESCRIBED A WALKAIDE BY INNOVATIVE NEUROTRONICS FOR MY WIFE, AN MS PATIENT. WHEN THE DEVICE WAS DELIVERED TO HER FOR A ONE MONTH TRIAL PERIOD, SHE WAS REQUIRED TO SIGN A WAIVER OF ALL LIABILITY -INCLUDING STRICT LIABILITY AND NEGLIGENCE ON THE PART OF THE MANUFACTURER-. WHEN I SPOKE WITH THEM ABOUT REMOVING THE CLAUSE, THEY REFUSED. THEY INFORMED ME THAT SINCE THE FDA APPROVED THE WALKAIDE FOR USE, THE PRODUCT WAS THEREFORE INHERENTLY SAFE. I AM MOST CONCERNED THAT ANY DME MANUFACTURER WOULD REFUSE TO ACCEPT LIABILITY FOR PRODUCT DESIGN ISSUES. APPARENTLY, INNOVATIVE NEUROTRONICS HAS DOUBTS ABOUT THE SAFETY OF THIS PRODUCT OR THEY WOULD NOT INSIST ON THEIR PATIENTS WAIVING STRICT LIABILITY. I WOULD URGE THE FDA TO DO FURTHER RESEARCH ON THIS PRODUCT TO ASCERTAIN ITS SAFETY SINCE ITS MANUFACTURER EVIDENCES DOUBT ABOUT THE SAFETY OF THE PRODUCT THEY ARE SUPPLYING TO THE PUBLIC. THE PRODUCT WAS DELIVERED IN EARLY 2009, AND WAS FITTED BY WALKAIDE REPRESENTATIVE. IT WAS NEVER USED AGAIN AND WAS RETURNED TO FACILITY, ON 06 NOVEMBER 2009.