TS03 Inc Trust Units TSTIF

RE:RE:RE:FDA stance after approval

[binjo222]

echo2, your two recent posts give a succient and well-reasoned view of the overall environment that TSO3 is now.  I agree with all you have said, but having worked in the healthcare field on the admin side, I would put a slightly different spin on one point you made.  

You said the process would proceed "with lawyers biting at everyone's heels."  Once the FDA estblishes that a given flexible scope could have been sterilized by a process the FDA recognizes, but it was not, resulting in a super bug being transmitted, then the legal sharks won't be "biting at heels," they'll be chewing off legs.

I'm not a lawyer, but from what I've seen, as long as the medical center did what the FDA requires, and there were no mistakes made in the process, the courts usually hold them harmless.  Surgery, after all, does involve a level of risk.  Even minimally invasive surgery.  Once high level disinfection is not 'the approved game in town,' that legal protection will evaporate.  The lawyers for medical centers will be pushing for an upgrade to cover their own butts.  Sad to say, but that's the dynamic I saw in in the medical field.