The FDA has finally filed an appeal of the Cell Surgical Network lawsuit verdict. It took them a very long time for some reason.
The stem cell clinic chain Cell Surgical Network and other defendants had prevailed in a federal district court here in California in front of Judge Jesus Bernal.
Their adipose cell product, stromal vascular fraction or SVF, might for the moment to be legal to sell in some of California at least. Bernal ruled it is not a drug.
Appeal of Judge Bernal’s ruling on Cell Surgical Network lawsuit
I’ve written before how I believe that Judge Bernal made some big scientific mistakes in his final judgment and findings of fact. I won’t rehash all of those, but Bernal bought every major argument from the defense.
I disagree with the defendants’ characterizations of the processes and products at issue here. In my view SVF is a drug and especially when you expand SVF in a lab, it should be a drug. Risks are increased by growing cells in a lab.
It’s not clear why Bernal was so one-sided.
Good odds on the appeal
The extreme nature of his ruling could be a weakness. I believe that the FDA has an excellent chance of getting the ruling overturned.
One main reason is that the Eleventh Circuit Court of Appeals earlier ruled in favor of the FDA in a very similar Florida case. There the FDA had initially prevailed to get a permanent injunction of sale of SVF and the defendants (US Stem Cell) had appealed. Then in the appellate ruling, the court went out of its way to be critical of Judge Bernal’s initial ruling against summary judgment requested by the FDA in the California case.
Of course, the Ninth Circuit will decide whatever it wants, but the Eleventh Circuit judgment could be a powerful precedent. The Eleventh Circuit is kind of viewed as a top appellate court as well. Note that I testified for the FDA in the case before Bernal.
Part of Bernal’s judgment also conflicts with the earlier ruling that lab-grown stem cells are a drug in the key Regenerative Sciences case.
He seems to be way out on a limb overall.
Looking ahead on the Cell Surgical Network lawsuit
So far the FDA/DOJ hasn’t said exactly why it is appealing the ruling.
What are the key flaws in Bernal’s verdict in their view? It could be months before court documents answer such questions.
As far as I can tell, the FDA hasn’t issued a press release either, which seems odd.
One big practical question is whether the feds will request a stay of Bernal’s ruling pending appeal.
The appeal case will get moving early in 2023 and maybe we’ll see a ruling by the end of 2023. What happens in the interim with SVF clinics, especially here in California?
Meanwhile, as much as the Bernal ruling muddied things in the SVF space, it shouldn’t impact FDA oversight of many hundreds of unproven stem cell clinics selling distinct products that are often clearly noncompliant.
Why are we still seeing no major new action by the agency on stem cell clinics? There continues to be just one letter here, another there. Drops in the bucket.