Wednesday, May 24, 2017 4:12:45 PM
February 3rd FDA cleared ActiPatch for the foot and knee OTC USA.
If someone were to initiate a class action on behalf of published numbers of >140 Million Americans suffering from chronic and acute pain and litigate against FDA for NOT immediately issuing a general OTC clearance for ActiPatch, in February, how would it defend itself against a few billion in damages for unnecessary pain and suffering? Ooooops......
From a moral point of view, FDA has declared to the world that ActiPatch is both safe AND efficacious for reducing edema, mitigating pain and accelerating healing. So how do they live with the guilt of keeping millions in pain in say the back, shoulder, neck, week after week? I say 'easy pickings' for a Top 10 law firm.
Part of FDA management is on top of their game - RWD Real World Data; RWE Real World Experience; new classifications; re-naming PEMF as SWT -1st class. But they need to look at the common sense of a general clearance for the rest of the anatomy! They had better drain the FDA swamp part - seems to me they are naked and very, very exposed to incredible damages.
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