As anyone following the private stem cell clinic saga knows, on August 30, 2022, California District Court Judge Jesus Bernal issued his decision and final judgment on the FDA attempt to enjoin Drs. Mark Berman and Eliot Lander from continuing to use their adipose stem cell treatments on patients. Their affiliate based company Cell Surgical Network (“CSN”) had many physicians throughout the country who were operating with their protocol and reporting data, which data was collected and collated by a pretty sophisticated (and expensive) data collection program. Based on the collected data, the two produced some very interesting journal articles (which were of course ridiculed and or ignored by the stem cell mafiosi because the data was not from a randomized or controlled clinical trial approved by the FDA).
By way of legal history, Judge Bernal’s final decision was not all that surprising since a couple years back, he denied the FDA’s motion for summary judgment and signaled that he was going to rule in the Defendants’ favor. Here is my posts about that: https://wp.me/p7pwQD-C1. I followed some of the trial, and in particular the government’s case. Let me just say that Judge Bernal was hard and very skeptical about the government’s case.
While it seemed clear that the Judge had made up his mind, after summary judgement (and I believe after the trial) the Eleventh Circuit affirmed the Florida District Court’s granting of summary judgment against the very similar product and procedure used by the U.S. Stem Cell operation (yea, the place which infamously had an NP inject their product into some patients’ eyes, with a poor outcome). Of course, a circuit court is higher than a district court and circuit court decisions are binding on the district courts in that circuit. However, circuit court opinions are only persuasive authority for district courts in other circuits; meaning, Judge Bernal did not have to follow the Eleventh Circuit’s decision or analysis or result. And he didn’t.
And to go sideways and a step and half forward
Not only did he not follow the Eleventh Circuit’s view that the core product, SVF (Stromal Vascular Fraction) was not an unapproved new drug, Judge Bernal also did not follow (or even mention) the DC Circuit’s persuasive precedent that expanding cells was “more than minimal manipulation” which under the DC Circuit’s logic would make CSN’s expanded SVF doubly illegal. So, Judge Bernal also denied the government attempt for judgment on the the doctors’ use of expanded SVF HCT/P’s That Jesus Bernal is one tough and independent judge.
But there is more
The place where I thought the judge was going to draw the line in the sand was their use of some highly restricted vaccine product which was added to SVF to treat terminal cancer patients. (FYI, for the past three or four decades I have been a persistent advocate that terminal cancer patients should be able to take anything they can get their hands on, as long as they were given proper informed consent. But even for a guy like me, I didn’t think the judge would go that far, and I thought he would slap them on the writ for that.
And yet, not. The judge found as a matter of fact that the two had stopped treating advanced cancer patients with this combination because the government stopped allowing them to get it a year before the government filed its lawsuit. Judge Bernal held that the facts meant that the government did not have “standing” which is a threshold requirement for a court to exercise jurisdiction over a claim. Technically, it might actually be the flip side of standing which is mootness, since the product was not available to the two since before the lawsuit. Whatever, he tossed the claim on a lack federal subject matter jurisdiction finding, against the FDA for physicians using an unapproved new drug that had a restricted access component. Like I said. That’s one independent-minded Hombre!
The judge’s decision has much good stuff in terms of simple and clear findings and conclusions of law. Laymen can actually understand his decision. Those in favor of people making their own decisions about the use of their own body parts without the federal government’s oversight/interference will really enjoy reading the findings of fact and conclusions of law. Here it is. CSNfindingsoffact
So where are we and what’s next?
What I can say with confidence is that in the Eleventh Circuit, autologous SVF is still illegal. Ok, no great reveal here.
One California federal district judge has decided not to follow the Eleventh’s SVF finding, and has held that autologous SVF is the practice of medicine (surgery) over which the FDA has no direct authority. He has also held, contrary to the DC district and circuit court, (though without acknowledging either opinion) that expanding cells does not turn them into an unapproved new drug.
So what does that mean?
Maybe not as much as you think. Not even other district courts in the 9th Circuit are bound by Jude Bernal’s decision. It is some authority, in this circuit, as it is in district courts in all circuits, other than the Eleventh and DC Circuits which have on-point circuit authority to the contrary, which is binding on all district courts in those circuits.
Theoretically, stem cell docs could start administering SVF anywhere in the Ninth Circuit and could point to Judge Bernal’s decision, if the FDA would come knocking on their doors. Of course, different federal judges might have a different view than Judge Bernal. So, the place to do it would be as close as possible to Judge Bernal’s courtroom! To the good, the FDA has a fairly lengthy process before it even files suit, like a few years. And that leads us to…
Although Judge Bernal certainly has the authority to disregard circuit authority from other circuits, the DC circuit is just not any other circuit. It is the second most powerful and influential court in the country and it is much more government friendly than other circuits. Which is why, for example, the FDA had Regenerative Science’s lawsuit seeking a declaration that expending stem cells was legal dismissed in the Colorado district court, and then immediately refiled its injunction action against the company in the DC district court. Both the district and circuit courts agreed with the FDA that expanding stem cells is more than minimal manipulation and turns the product into an unapproved new drug.
The bottom line is that Judge, Bernal’s decision throws a giant monkey wrench in the FDA’s enforcement policy against private stem cell clinics that use autologous HCT/P’s non homologously. The feds cannot accept this decision, and they most certainly will appeal. The appeal should take a year or so.
In the uber liberal pre-Trump days, I’d give a hundred to one odds that the decision would be overturned by the Ninth Circuit. Now with the all the Trump circuit court appointees, it’s harder to say. If two of the three-judge panels are Trump appointees or libertarian leaning like the right great Judge Bernal, then I’d say there’s a good chance there could be an affirmance. With two Democrats, the decision will be overturned and probably the appellate court will order him to enter judgment for the Government.
I haven’t said much about what I actually think about the decision, but anyone familiar with my stem cell posts can figure it out.
Let me just say that I found his decision refreshing in the sense that it was simple, clear and actually comports with common sense and real world practicalities.
The treatment is a surgical procedure involving a person’s own tissue. Nothing new about that. More to the point, historically, surgery is an area of medicine in which the the FDA has much less of a role than in other medical specialties, (other than their use of medical devices).
If you ask people on the street whether the FDA should be able to regulate a person’s own body parts even if the parts have to be moved around by a surgeon, I think most people would think that’s crazy. So, thank you Judge Jesus Bernal for finally bringing some common sense to an area of law which hasn’t seen much from the federal government in the past couple of decades.
Rick Jaffe, Esq.
And Mark, you called it!