GREY:TSTIF - Post by User
Comment by
fraser2503on Mar 21, 2016 1:25pm
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Post# 24684091
RE:TSO3 south of the border
RE:TSO3 south of the borderThis has been my thinking also. As you say, once the FDA appoves the TSO3 claim for a particular scope then there will be a shift in liability when the next person is infected, or dies from the use of that scope.
The TSO3 bottleneck is (or will be) production capacity. Does this enter into the FDA decision? If they give approval for a TSO3 claim and a hospital tries to buy a VP4 and is told "We make one per day. You'll get yours in January of 2018", does this shift liability to the FDA and possibly TSO3? If someone then gets infected and dies, can the hospital then argue that they tried to follow the FDA direction and the manufacturer couldn't sell them one?
I can see the FDA holding off on approval until there is a more concrete plan for the second production facility.
Or, maybe I shouldn't look to Louis Litt for legal advice.