Greedy Trial Lawyer
Off-Label Use Sometimes Works, More Often Fails
Category: News Defused
A medical experiment was successful - at least partially successful. Does this singular success mean we should encourage, support or defend off-label use of medical devices or drugs? One legal blog appears to argue it does.
Why We're Proud To Support Off-Label Use
Today's papers, both in Philly and Cleveland, are reporting on a remarkable medical story. It's as close to a resurrection as today's scientific, secular world is likely to see. A man hospitalized in New Jersey, in a near-vegetative state for six years after being mugged, had his consciousness restored by deep brain stimulation.The Neurological Restoration group at the Cleveland Clinic in Hermann's home town apparently achieved this near miracle by using a "pacemaker-like" device and to deliver electric current to the man's thalamus. Supposedly there are as many as 400,000 patients in similar circumstances.
....it sounds like off-label use to us - the therapeutic use of an FDA approved drug or device for indications other than those for which it has been approved.
Off-label use - the next life it saves could be your own.
From Drug and Device Law
And, the next life lost to off-label use could be your spouse's.
For patients in vegetative or near-vegetative states, with virtually no hope of recovery, off-label use of approved medical devices would not likely be the most far-out treatment option considered. In fact, in such a circumstance who would deny the patient any treatment option presented by any practitioner of the healing arts who seems capable of rational thought.
But, the much more common off-label use of drugs is not limited to these unfortunate patients. And, the harm often far outweighs the anecdotal benefits.
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