STEM CELL SHOCKER: CALI. FEDERAL JUDGE DENIES THE FDA SUMMARY JUDGEMENT AND ORDERS A TRIAL

barbara

Pioneer Founding member
STEM CELL SHOCKER: CALI. FEDERAL JUDGE DENIES THE FDA SUMMARY JUDGEMENT AND ORDERS A TRIAL IN THE CELL SURGICAL NETWORK CASE
January 28, 2020 Richard Jaffe

Ok, let me get this out of the way up front. I predicted publicly and privately that the California federal court judge would follow the reasoning and result of the Florida federal judge who granted summary judgement to the FDA and issued a permanent injunction barring the Florida stem cell operation from using its SVF (stromal vascular fraction) product in humans.
I am very happy to report that I was wrong, (at least for now and until there is a trial).
Here is the judge’s opinion
stemcelldecision
The bottom line is that the California federal judge found a disputed issue of fact which requires a full trial. The issue of fact and how the judge got there is important and could foreshadow a result which the FDA and the stem cell institutional mafioso won’t like.
So, what is the issue of fact?
Here is the judge’s words and they are short and simple:
“The parties dispute whether the SVF Procedure alters the SVF cells (citation to brief omitted). Because both parties have submitted competing evidence on this point, there is a triable issue of fact and summary judgement is not appropriate.”
(Order at last page).
Why is it important/critical/dispositive whether or not the SVF Procedure alters the SVF cells?
The FDA argued that the procedure creates an unapproved, adulterated and mislabeled new drug.
The Defendants argued that they are doing a surgical procedure which falls under the single surgical procedure (“SSP) exception to full drug regulation of HCT/P’s under 21 CFR 1271
If the SSP exception applies then the FDA loses. If it does not, the FDA wins.
Here is how the judge phrases it:
“While the SSP exception could apply to a procedure that removes SVF cells by removing adipose tissue from a patient and implants only extracted SVF cells back into the same patient, it only applies if those cells remains unaltered.”
The count then concludes with the language first quoted.
There are prior steps to the judge’s reasoning/conclusion, relating to whether you compare the total product removed (adipose tissue which includes fat and other stuff) versus what is reimplanted (SVF), or do you look at the target of what is sought to be removed (the SVF) and compare that to what is reimplanted (the same SVF, according to the defendants).
The judge choose the latter, which required him to dig deeper into whether the cells were altered, i.e. whether they were the same as what was taken out.
He determined that the parties had different views about that. In other words, there was a factual dispute about a critical element of the case, and factual disputes are resolved by trials, not by summary judgment. Hence the denial of the government’s summary judgment motion. This is a big loss, (albeit interim) for the FDA.
Something else that the feds won’t like is that the judge did not show the almost universal deference given to an administrative agency’s interpretation of its own statutes and regulations. The judge thought that the agency’s view of “what is taken out of the body” was overly broad and didn’t make any sense. Basically, the judge accepted the defense view on this, and then held that there is no deference to an agency’s opinion which is not realistic and doesn’t make sense. Ouch!
Something else the judge didn’t like, and something which I found really offensive about the government’s efforts, was its attempt to bar defendants Berman and Lander from testifying either as an expert or any way else. I think the judge was offended by that whole argument and called out the government on it, at one point castigating the government for wasting the his time. Really Big Ouch on that one.
So, what’s next?
Per a court approved December 2019 joint stipulation, the parties have 14 days to submit a proposed schedule for the trial and whatever else has to be scheduled, but perhaps the government might try something else. We’ll see.
What is the effect of this order?
As a lawyer on the side of the private stem cell clinics, this is very good news for these clinics. I happen to think that the SVF taken out is the same SVF put back in, because ultimately all the process does is strip out the fat and the structure from the remaining SVF. If the judge thinks so too, then the government is going to lose the injunction case, at least based on the judge’s analysis in his order today.
This could set up an appeal by the government, and could result in conflicting decisions between the Ninth and Eleventh Circuits (home of appeals from Florida).
This is also good news for the Florida clinic because a federal judge has accepted the argument it had made, but unfortunately, it was not the federal judge on its case. Still that’s why they have appellate courts.
This is also welcome news to the customers who have banked their SVF with the Florida operation, to the extent the material had not been destroyed (and last I checked a few months ago, it hadn’t been).
Finally, it is very, very good news for the physician affiliates of the Cell Surgical Network, as well as other physicians using SVF, (at least outside the Southern District of Florida.) The judge’s opinion is a clear indication that the only legal hurdle left is whether the SVF coming out is the same SVF going back in. If it is, and the judge so finds, then there’s going to be a substantial uptick of SVF procedures being offered in this country (outside of the Southern District of Florida). But then again, I’ve been wrong before, so we will just have to see what happens.
A shout out to federal Judge Jesus G. Bernal for this important decision standing up to the government, and to the very excellent work of defense counsel, the very venerable Venerable law firm.
Rick Jaffe, Esq
 

gh253

Member
Dr. Centeno blogged that the "Kisor" case may open the door for CSN to argue that the FDA changed 21 CFR 1271.15(b) illegally. I don't know anything about the legal side of this, but would this present an opportunity for a patient or patient group to sue the FDA? Do you know where to find a lawyer other than Jaffe (who already stated in the comments of that blog post that he doesn't agree with Centeno, although he seemed to miss the point) whom one could discuss this with?
 
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barbara

Pioneer Founding member
Dr. Centeno blogged that the "Kisor" case may open the door for CSN to argue that the FDA changed 21 CFR 1271.15(b) illegally. I don't know anything about the legal side of this, but would this present an opportunity for a patient or patient group to sue the FDA? Do you know where to find a lawyer other than Jaffe (who already stated in the comments of that blog post that he doesn't agree with Centeno, although he seemed to miss the point) whom one could discuss this with?
I know several years ago patients had a serious discussion about a class action lawsuit. Money and the chances of winning a case against the FDA at the time were issues that seemed insurmountable. There are some attorneys out there, but I personally don't know their names. Dr. Centeno would probably be a good source however. You can reach out to him via his blog. Let me know if you get a response.
 

gh253

Member
I emailed him yesterday and haven't heard anything back yet. Do you know if the court granted the FDA deference in the Regenerative Sciences case?
 

barbara

Pioneer Founding member
I emailed him yesterday and haven't heard anything back yet. Do you know if the court granted the FDA deference in the Regenerative Sciences case?
This is from Wikipedia. "
Decision
On February 4, 2014, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s injunction against Regenerative Sciences’ use of the Regenexx-C Procedure and also dismissed the counterclaims. The court found that the stem cell mixture used in the procedure fell well within the Federal Food, Drug, and Cosmetic Act’s definition of a drug and, by extension, a biological product, thereby triggering federal regulations. The counterclaim holding that the procedure was not a drug but part of the practice of medicine was rejected by the court, who emphasized that the mixture itself was the subject of the case, and that it is still considered a drug and biological product even when used in the practice of medicine.[19] The court also found that the mixture used in Regenexx-C could not be exempted from manufacturing and labeling requirements of the Federal Food, Drug, and Cosmetic Act as a compound drug because mesenchymal stem cells have not been FDA-approved as components for use in compound drugs.[20] Having rejected the counterclaims and establishing that the Regenexx-C mixture is both a drug and subject to FDA regulation, the court then found that these regulations had been violated, and upheld the injunction."

If you haven't heard anything in a few more days, let me know and I will contact Dr. Centeno and ask about good attorneys.
 
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