Thanks for the link!
Some comments:
"FDA made no attempt
to prove that the SVF cells were altered before being implanted back into the same
patient. [Doc. 42-1, pp. 3-4]. "
What the 'ell?
"The collagenase enzyme and
centrifugation isolate the SVF cells from unneeded and unused components of the
adipose tissue, but do not alter the SVF cells. [Doc. 45, p. 2; Doc. 45-5, pp. 4-5;
Doc. 45-6, p. 8; Doc. 51-1, pp. 4-6]. "
If true, it means the FDA don't want to accept the truth.
"FDA conceded that the issue of the
regenerative characteristics of the SVF cells and whether the cells were affected by
the processing of the tissue were issues of fact. [Doc. 59, p. 6, n.5, p. 7-8, n.8]. "
OK then, what's the problem for the FDA?
"FDA asserted that there had been three “adverse medical events” allegedly
involving the SVF Surgical Procedure, but offered no proof that the risks associated
with that procedure are greater than or different from those typically associated with
surgery. [Doc. 42, p. 15; Doc. 42-1, pp. 8-10; Doc. 51-1, pp. 8-9]. "
Just goes to show how ignorant the judge was on this particular case.
"2017 Guidance, pt. III, Example
7-2. The 2017 Guidance is a wholly new prohibition on a particular procedure, under
the guise of interpreting an existing exception that permitted that procedure. The
statement in the 2017 Guidance that “cell isolation would typically cause the adipose
tissue to no longer be ‘such HCT/P’” is disingenuous, because the phrase used in the
actual regulation is “implants such HCT/Ps,” thus making it clear that the relevant
HCT/P is what is to be “implanted,” i.e., the cells, not the tissue. "
Not only are FDA trying to change the rules, they are are making things up as they go along.
"FDA asserted, but did not purport to prove, that the SVF cells removed from
the patient and implanted in the same patient in the SVF Surgical Procedure were
not “in their original form.” USSCC provided unrebutted evidence that isolating the
SVF cells from the adipose tissue did not alter the cells. "
FDA can't even back their own claims!
The judge obviously wasn't smart enough to understand the complexity of what was going on and the FDA, well, in this case are NOT looking out after the best interest of the public.
I found other contradictory comments from the FDA as well. This case should be COMPLETELY overturned.
