I was able to watch some of the 9th Circuit Court hearing today on the FDA appeal of its loss in the Cell Surgical Network lawsuit.
This post is my brief impressions as a scientist. What went down? Do the three judges seem to be leaning one way or another?
The ruling in this case could shape key aspects of FDA oversight of various cell therapies for years to come.
The original Cell Surgical Network lawsuit
In the original ruling, Judge Jesus Bernal went in favor of Cell Surgical Network (and California Stem Cell Treatment Center, etc.) arguing that the fat cellular therapy product SVF is not a drug. This was a big victory for stem cell clinics.
The FDA says SVF is a drug and should be subject to drug-level regulation. Bernal disagreed and the FDA appealed to the 9th Circuit.
There are many complexities here, but it still boils down to whether the FDA can regulate SVF as a drug.
In a similar case in Florida, the FDA prevailed including on appeal in the 11th Circuit Court so Bernal’s later ruling conflicted with that.
Impressions on the appeal hearing
The 11th Circuit Court decision was a big factor in today’s 9th Circuit Court hearing.
If you are hoping the FDA prevails in this current appeals case, as I am, one potential positive is that the three judges here pushed the Cell Surgical Network attorney, Nathaniel Garrett of Jones Day, on why they should go against the 11th Circuit. It wasn’t clear to me that the judges were fully convinced they should.
There was also much discussion of the “such HCTP” definition of biologics. Frankly I have no clue about whether the judges were leaning one way or another on this. It’s weird that this entire case could come down to the single word “such.”
The judges pressed the government lawyer Adam Jed (he’s the one arguing the FDA’s case in a sense) on several issues too. I’m not an attorney but Jed seemed extremely well prepared and eloquent to me.
For example, Jed’s analogy to a skin graft was very effective. Jed said a skin graft wouldn’t be the same if the skin was dissolved first before being given back to the patient. For me at least that effectively highlighted how different SVF is from fat tissue in the body.
One of the judges, I think Judge Wardlaw, also kind of helped Jed out a bit by bringing up the issue of the use of enzyme. This allowed him to introduce the question of whether traces of enzyme could remain in the SVF. Maybe not but can we be 100% sure?
Reading the tea leaves?
On the other hand, I was surprised that the DOJ had not disputed that SVF cells (specifically the cells, not the tissue) were unchanged during the SVF process. For me as a scientist, the SVF cells seem clearly different than the original fat tissue that is removed. The judges brought up that the government didn’t dispute that the cells are essentially the same. I’m not sure why the feds conceded this point. That could be an overall problem for their case.
Jed and Garrett both did a great job. It felt like the three judges here pushed Garrett more than Jed though.
Just going on my impressions of the judges’ language and tone overall they also seemed more inclined to defer to the FDA and be consistent with the previous 11th Circuit ruling that favored the FDA. Judge Sung in particular seemed to me to be skeptical of some of Garrett’s arguments. She said relatively much less to Jed during his presentation.
Judge Friedland casually also mentioned the question (if they ruled in favor of the DOJ) of what would happen next. Did that say something about her leaning one way or another? I felt like it did.
By contrast, when Judge Bernal was hearing the original case, he seemed to me to be somewhat hostile to the government case. I predicted he would rule against the FDA and he did. Note that I briefly testified in the original case before Bernal.
Looking ahead on Cell Surgical Network case
If I had to guess, I’d say the judges will rule in favor of the FDA on this appeal.
However, I wouldn’t be that surprised if I was wrong.
The answer to Judge Friedland’s question of what happens next if the DOJ prevails still isn’t clear to me. Will it ultimately lead to an injunction?
Flipping it around, should Cell Surgical Network prevail, it seems likely that SVF will become more widely available for various conditions. I also wonder if such an outcome could influence FDA oversight of many other clinic firms using other kinds of cells.
Note that this particular appeal hearing did not seem to pertain to lab-grown SVF cells, on which Judge Bernal also puzzlingly ruled in favor of the clinics. I’m not sure how the question of oversight of lab-grown SVF will be resolved. Growing cells in a lab can make much more product available, but it also increases potential risks associated with their subsequent use so it’s a very important point. The FDA had previously prevailed in another court case that lab-grown cells, bone marrow cells in that case, are drugs.
In my 2024 predictions for the stem cell and regenerative medicine field I said I thought the FDA would prevail. I’m hoping to be right on that one.
It could take anywhere from weeks to months to get the final ruling on this appeal.
The law does indeed incorporate ethics. As does science. I’ve had many ethics courses over the years, and many ethical debates with colleagues and laypeople.
Also, it’s unclear what the statement “People with medical conditions that mainstream pharma can’t/won’t address need more options” is supposed to mean. Phama (both small molecule drugs and biologicals ‘Biopharam to some’) is looking at pretty much any condition that these ‘SVF treatments’ do. Most of medical science is striving for cures. In fact, many of the paths of research are using SVF or other forms of similar biologics. And one thing is clear from the research: that is just sucking up some tissue, taking some cells, and injecting those cells into the bloodstream or elsewhere doesn’t really cure most any condition.
Anecdotal evidence like “Dr So-and-So said they saw improvements” isn’t medical science. And it doesn’t prove any curative effect. Worse, if there is profit to be made, there is every reason to be skeptical if someone claiming positive effects.
The laws in question are there to protect people, from bad medicine, and from unethical medicine. The literal application of these laws he FDA cites are the ethical guardrails we MUST have in place to protect those desperate who might be prayed upon by the unethical.
Thanks for your analysis.
I do appreciate your opinion as a scientist, but I think it’s also important to have a broader, more panoramic view of this pending decision. This view should incorporate not only the “science” of SVF as such, but also the human aspect of the issue.
Although the judges won’t admit it openly, I believe they do consider the real-world implications of their decisions. People with medical conditions that mainstream pharma can’t/won’t address need more options. When I interviewed Dr. Berman, he discussed the remarkable improvements he saw in so many of his SVF patients. The 9th Circuit now has the opportunity to expand this healing vision.
To divorce the legal/scientific from the ethical/humane is to do a grievous disservice to American jurisprudence itself. Reflexive deference to the government position is an antiquated, anachronistic, tired doctrine of yester-year. Justice requires that jurists strive to move the law forward and upward in their statutory/regulatory interpretations. This means listening to the cries of the sick and disabled who, although not in the courtroom, must be granted some form of tacit legal standing.
I believe the court will make the right decision, taking into account the law, the science, the voice of the people, and the over-arching, ever-pervasive principle of fundamental fairness.
Thanks again.
Am I getting this right? Even if a treatment doesn’t work and costs a lot, the ethical choice is to rule for the clinic that is doing this?
Honestly, I believe that the ethical decision would be to protect the sick and disabled from those who would take advantage of them.