In a ruling that could turn FDA stem cell clinic oversight on its head, Federal District Court Judge Jesus Bernal last night ruled in favor of the stem cell clinic chain Cell Surgical Network and other defendants. The FDA had been seeking permanent injunction against them. Here’s the court ruling.
Drs. Mark Berman and Elliot Lander were also named in the suit as the leaders of Cell Surgical Network.
Strikingly, Bernal sided with the defendants in almost every way. To me, the language of his ruling sounded almost like it was written by the defendants.
At the heart of this case was the FDA argument that the clinics were selling unapproved drug products in the form of adipose cell mixtures.
Bernal wasn’t having any of it.
It is nearly certain that the FDA will appeal this case. Bernal’s judgment strongly conflicts with past federal court rulings. But for now, we have to contemplate a reality for a time in which FDA oversight of some stem cell clinics could be hamstrung. The ruling even has the potential to free up other stem cell clinics that don’t use adipose cells.
Things just got much messier in this arena.
The FDA Cell Surgical Network lawsuit
The adipose cell product at the issue is called stromal vascular fraction or SVF.
The DOJ filed two similar lawsuits seeking injunction against the California defendants, where we just got the ruling, and a Florida SVF stem cell clinic firm called US Stem Cell. The latter case earlier went in favor of the FDA on summary judgment. The agency also won the appeal of the Florida case.
Now Bernal has ruled that SVF is not inherently a drug. Further, remarkably he found that even expanding the SVF adipose cells in a lab does not make them a drug. In a third main part of the ruling related to a mixture of the SVF with a vaccine, Bernal also ruled for the defense, but it was kind of a moot point since the product is no longer being made or used.
Judge embraces stem cell clinic defense
I believe Judge Bernal erred in several key ways on the science. For example, he wrongly concluded that SVF cells are not changed by the procedure to isolate them.
From Judge Bernal’s Findings of Fact and Conclusions of Law in support of his final judgment in the case:
“The SVF Cells are not altered, chemically or biologically, at any point during the SVF Surgical Procedure.”
We don’t know that’s true. In fact, as a cell biologist I believe it is wrong.
The reality is that enzymatic treatment of cells more generally, such as happens during the defendants’ preparation of SVF, can dramatically alter major cell properties. Bernal instead accepted the claim by the defense that preparing SVF does not change the cells in any way.
Further, Bernal also seemed to completely buy the defense claim that SVF cells within the lab-generated product also naturally exist in the exactly same form in the body prior to the SVF manufacture:
“Unlike manufactured drugs, the SVF Surgical Procedure does not create any cellular or tissue-based product that did not previously exist within the patient.”
Actually there is no equivalent of SVF already in the body.
The diverse cells in the product SVF don’t congregate directly together in a person. They are artificially forced together through the SVF isolation procedure, which separates them from fat and then combines together the perhaps dozen or so cell types normally spread out in fat tissue. So Bernal is wrong again here.
In my view, Bernal also made a third key error on growing the cells in the lab, which I’ll discuss in a minute.
Bernal disregards FDA
But first, why did he rule this way?
I don’t have a good explanation. It’s puzzling.
However, in a way, I’m not as shocked as it might seem by this ruling.
Earlier Bernal had ruled against the FDA/DOJ requests for summary judgment at the start of all of this. I thought his words and tone in that initial ruling showed he already was strongly leaning against the FDA.
For that reason, from the beginning the agency might have been fighting a losing battle with this judge on this case.
Since I’m not an attorney, I don’t have a clear sense of how strong the government’s case was made in Bernal’s court.
Bernal judgment conflicts with previous major rulings
At a practical level, it’s important to point out that Bernal’s ruling here goes against some very important precedent.
In that latter case, the court held that lab-expanded marrow cells were a drug. When cells are grown in culture in a lab, their inherent properties can and often do change. They can acquire mutations or epigenetic changes. Contrary to this, Bernal’s ruling wrongly states:
“Replication or propagation is a natural state for stem cells and the Expanded MSC Cells retain all of the biological characteristics of the MSC Cells.”
All of the characteristics?
I’m not aware of good evidence that growing adipose cells in a lab leaves all of their properties unchanged. To the contrary, there is compelling evidence that cell properties can change substantially when they are cultured in the lab. The cells can also be contaminated in labs.
Cell proliferation in a dish in the lab has many inherent differences from when cells expand inside the body.
This is arguably the most dangerous error in Bernal’s ruling. I hope we don’t see more clinics selling lab-grown cells that haven’t been vetted by the FDA. It’s risky. Many clinics do not follow good manufacturing practices when growing cells either.
As to the Florida case against US Stem Cell, the judgment in that court held that SVF was a drug, which was supported on appeal as well in the Eleventh Circuit. In fact, the appellate ruling made a point of disagreeing with Bernal in some ways:
“The Clinic next draws our attention to the opinion of a district court in California that, in a similar suit against a clinic offering a similar procedure, rejected the FDA’s interpretation…If significant processing steps expose the HCT/Ps to foreign substances and alter their form prior to reimplantation, then the HCT/Ps cease to be the same as they were at the time of removal. This interpretation seems, at the outset, to be the more natural of the two readings. The FDA’s view is all the more persuasive because it is consistent with its early (as well as its recent) pronouncements”
That’s a stark difference.
How will FDA oversee the stem cell clinic space for now?
A major question now, assuming the FDA appeals, is whether the specific appeals court that ultimately handles the Cell Surgical Network case appeal will see things more like Bernal or all the other judges.
The Bernal ruling will not be a good thing for careful oversight of stem cell clinic practices.
There has been a sense that the FDA may have been holding back on large-scale actions on the hundreds of SVF clinics operating in the US until this Bernal ruling came down.
This new judgment in favor of SVF clinics could make the FDA even more cautious on taking action on unproven clinics more generally.
At the same time, some clinics are likely to be emboldened by Bernal’s ruling.
It’s concerning to think about more people being put at risk. At the same time, it’s aggravating as a scientist to see a court get the science so wrong.
- I testified for the FDA/DOJ in this case and clearly have strong opinions about it.
- Defendant Dr. Mark Berman died of COVID in May of this year.