An important appeals case is pending not just for the defendants Cell Surgical Network, et al., but also for the FDA. It could impact the stem cell field very broadly too.
Cell Surgical Network lawsuit status
Hopefully, we’ll get a decision before the end of this year.
Cell Surgical Network is a large chain of unproven stem cell clinics. Drs. Elliot Lander and Mark Berman founded the network.
The clinics in the network market adipose cell preparations for a variety of medical conditions. None of these applications have FDA approval. The agency filed suit seeking an injunction with the case ending up in California federal district court. The FDA lost and now their appeal is pending at the Ninth Circuit.
What’s at the heart of the case? What’s new?
The FDA has defined specific adipose cell preps as drugs.
One called stromal vascular fraction or SVF is the most commonly used. The FDA says SVF is a drug. In a federal court case in Florida, the FDA prevailed over a firm called US Stem Cell Clinic, which had been selling SVF infusions. The ruling stood up on appeal. US Stem is thus enjoined from selling SVF, although a new personal injury lawsuit against US Stem raises possible questions about compliance.
However, here in California, things turned out very differently in court as I noted earlier.
The FDA lost the SVF-related case against Cell Surgical Network and others including California Stem Cell Treatment Center. California federal district court Judge Bernal ruled in favor of the chain of stem cell clinics. He ruled that SVF isn’t a drug, which is going out on a limb in my view. In addition, he took the more extreme step of saying that even lab-grown fat cells are not a drug. Years ago the FDA prevailed in a case, USA vs. Regenerative Sciences Inc., indicating that amplified bone marrow cells were a drug. So Bernal went against that precedent.
I testified in the new case before Bernal and thought he seemed hostile to the FDA.
Is SVF a drug? For now, yes and no.
As things stand now, are fat cell preps a drug or not?
We’ve now been stuck in a gray area for quite some time and part of it depends on geography. In the jurisdiction of the court that ruled in favor of the FDA in the Florida case, it would seem that SVF and similar adipose stem cell preps are now drugs. Here in the jurisdiction of the California court, I guess not?
No matter where you are in the U.S. if you are a stem cell clinic it is highly risky to be selling SVF given the legal uncertainty.
Meanwhile, everyone awaits word from the Ninth Circuit.
The Goldwater Institute on Cell Surgical Network case
The importance of this current appeals case has been further highlighted by some heavy hitters filing amicus briefs one way or another. Earlier this summer, we saw ISSCR and ISCT, two of the most important cell therapy organizations, make joint statements in support of the FDA:
- ISCT Files Amicus Brief Supporting FDA’s Authority to Regulate Unproven Stem Cell-Based Interventions.
- The ISSCR Files Amicus Brief Supporting FDA’s Authority to Regulate Unproven Stem Cell-Based Interventions
Now more groups have weighed in including The Goldwater Institute. Another less well-known group, called the Association of American Physicians and Surgeons, made similar arguments as Goldwater in its new amicus too. Both are opposed to FDA oversight here.
Free cell therapies from all regulation?
In their amicus brief The Goldwater Institute outlined their reasoning. Here are their three main points and my thoughts on each.
1. “For the FDA to treat biological materials and surgical procedures like drugs is a regulatory mismatch and needlessly harms patients.” The reality here is that biological materials can be drugs. This not only includes cells but also other biologics such as growth factors, antibodies, etc. The FDA has been conducting oversight of biological drugs for a very long time. Certainly stem cells and other cell products can be drugs, particularly if they are extensively different from the tissues from which they are extracted. That difference is clearly apparent in the case with SVF vs. endogenous adipose tissue. SVF does not exist in the human body. It’s a laboratory creation. Bernal got this very wrong and Goldwater has it wrong too.
2. “Allowing the FDA to regulate an individual’s own cells as a drug encroaches on patients’ medical autonomy.” This argument may be summed up as the old “our bodies, our cells” mentality. Even autologous biological products (e.g., a patient’s own cells) can become drugs and those that are drugs need oversight, such as for safety considerations. Sponsors also need rigorous evidence of efficacy. Often the FDA is best able to impartially make such determinations. Yes, patients should have autonomy in many cases, but that is not universal.
3. “Permitting the FDA to treat a surgical procedure as the manufacture of a drug intrudes upon state power to oversee the practice of medicine.” In my view, the type of procedure in question is not strictly a surgical one as it also includes a cell therapy manufacturing component. Using SVF is not equivalent to taking a blood vessel from one part of the body and using it as a graft into another part, which is a common example cited by those pushing against the FDA. The blood vessel in that procedure is the same as it was in the body originally.
Finally, I don’t see why only states should regulate this process. Do attorneys out there care to comment?
As most of you know, I’m not an attorney. As a scientist, I don’t see how these three arguments hold water. However, as we saw with Judge Bernal here in California, judges can and do see things differently sometimes.
I hope the Ninth Circuit is logical, does its homework on the science, and puts patient safety and well-being first. Not all FDA oversight is bad, no matter what some folks claim.
As an update, a perfect recent example of the harm of proper oversight, which would result from what Goldwater is suggesting, is the Alvaro Skupin, et al. personal injury lawsuit case where a patient was blinded in one eye from adipose-related eye injections. A HT to an anonymous friend who pointed this out.
Any thoughts on how the appeal will go?