US Stem Cell Inc (USRM)

[Dragon Lady]

What if there was an agreement that this could be FDA approved in a quick and inexpensive process. Perhaps that is what the court might be working on. Just a thought that came to mind when listening to the court audio. It seemed like the FDA was concerned with safety, while USRM was concerned about the delays and revenue. While obvious the 3 judges want to do the right thing. Wouldn't that be a big win for all, just saying.

Uh - NO to all thee above.

Zues has already weighed in 100% correctly on this.

An appellate court does not "re-trial" or "re-hear" cases or "alter arguments or complaints made" in cases before them, etc. NOT what an "appeal" is about, or even for ??

The scope and reach of what an appellate court can or can not do is VERY NARROW and set by the SCOTUS aka Supreme Court of thee United States.

https://www.justice.gov/usao/justice-101/federal-courts

https://www.uscourts.gov/about-federal-courts/court-role-and-structure/about-us-courts-appeals

An Appellate ruling can ONLY focus on and thus rule on basically 2 narrow issues -

1) Was there a gross error by the judge in some form of "carrying out justice" as defined by what the "role" of a judge is. This rarely ever happens in appeals. Federal district judges are extremely experienced and highly vetted for their legal expertise, etc. Moreover, "minor errors" such as little mistakes are allowed by the appeals court - as long as it didn't cause some earth shattering "miscarriage of justice" to occur.

2) That leave the only other issue a appeals court can rule on or decide - and that is, "WAS THERE A TRIALABLE ISSUE OR ISSUE OF FACTUAL DISPUTE" in existence that the lower court failed to "see" or just overlooked or made an error regarding their decision, etc.

THAT = where USRM and their case is at. It's especially applicable and prudent when a SUMMARY JUDGEMENT was granted in the lower court - as that is essentially a "One fell swoop, stroke of a pen" by a judge that denied one side their full and much lengthier "RIGHT TO BE HEARD" such as their expert witnesses, their counter arguments to the FDA in the case of the USRM case specifically etc.

And THAT is where the line of questioning of judge Marcus primarily, and then semi-backed by Sr judge Ginsburg was leading. Marcus specifically used/uses thee words or closely paraphrased wording of, "WAS THERE NOT AN ISSUE OF FACT OR A TRIALABLE DISPUTE HERE. I'm holding a statement right here in my hand by a expert witness that was not able to be heard, one the defendant had ready and that expert appears to be able to potentially dispute the FDA's position" blah blah blah.

THAT = where all this hinges. And the ONLY RESULT can be to then "remand the case" back down the original court with a ruling that will read something like, "The appeals panel finds that the move to summary judgement was in error, as a clear issue of disputed fact was at hand, a trialable issue of fact with supporting science that was to be presented by the defendants. Therefore, we remand this back to the district court and strike the motion for summary judgement until the issues in dispute can be heard before the district court" and then a whole wash-list of case law will be cited blah blah - a long written brief explaining why the appellate is overturning the lower court's initial ruling.

THEN - it goes back to the district court and A LONG TIME WILL ENSUE - as in likely a move to a bench trial complete with expert witnesses to be heard from both sides, all the things that go with same which is a crap ton of pre-trial hearings, motions filed to "try" and exclude things one side or the other does not like, etc.

It will be a lengthy and long process still - but still a shot over the bow of the FDA if, if, IF USRM at least gets a "remand back down" to the district court and effectively thus "THEIR DAY IN COURT" at a "bench trial" at a minimum.

That is how it "works" - there is no chance of some "new middle ground to be found with the FDA" blah blah as the LAWSUIT IS FILED and the COMPLAINT and ISSUES OF FACT are already "on the table".

IF the FDA wanted some "middle ground" they'd of never sued USRM and the CA clinic in the first place- and used the DOJ for same, etc ???

The ONLY other way this ends, and it's probably in the WHEN HELL FREEZES OVER CATEGORY would be for the FDA to just drop both cases and walk away - and that IMO ain't gonna happen.

ONLY OTHER WAY BEYOND THAT = the legislator, aka Congress would have to enact specific new "STEM CELL LAWS" and they, the Congress would have to write some "middle ground" method as you're describing or whatever they want and pass it through the House and then to the Senate and eventually have the POTUS sign it into law and all that jazz.

Good luck on the US Congress - about as "functional" right now as a three ring circus = I'd put "stem cell legislation" about 968th on their priority list = about 2032 to finish a new bill and get it passed the way that mess is operating as of right now.

That's the Reader's Digest version - of what is happening.