The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally going to be a drug product requiring premarket approval.
You can see my first quick take on these federal suits here as well as initial responses to the suits from the firms here and my Q&A with Patti Zettler on the cases here. It seems that the California case will unfold in the US District Court Eastern District of California in Irvine.
There’s still a great deal of uncertainty about what happens next. Here are what I see as the top 10 questions about these cases below.
- Who wins? The biggest question is whether the FDA or the stem cell clinic firms will prevail in court. Of course, you never know, but I’d say USRM and CSN face really long odds for a variety of reasons.
- Will the main defense be ‘patient rights to own stem cells’? I don’t see a clear legal basis to counter the FDA’s actions, but my impression is that the two firms both seem in their initial responses to have invoked what they see as patients’ rights to use their own cells. While there might be some scattered legal precedents for patients having rights to their own biological materials, I don’t see this defense flying. I’ve written before how we all may have fewer rights than we think to our biological materials like cells once they are removed from our bodies. See “Our bodies, not our cells?”
- Will these clinic firms also cite the new Right-To-Try law in their defense?
- Who will side with clinic firms if anyone? It’ll be interesting to see whether other entities take sides with the clinics. For instance, will the Goldwater Institute, which has taken a libertarian, I’d say somewhat anti-FDA stance on stem cells, support the defendants against these injunction suits? Or will conservative think-tank-like organization have to think twice given that both firms have been linked to patients allegedly losing vision? I’d lean toward predicting that Goldwater will not get involved, but we’ll see. Will other groups like Right-To-Try organizations might chime in? Nobody?
- Will FDA ask for and if so get temporary injunctions? So far, no, but much may depend on the next question.
- And related, will one or both clinics voluntarily shut down their offerings to patients in the interim as the suit progresses?
- Will CSN lose a substantial number of its affiliates in the sense of some of those ~100 affiliates at least temporarily stopping stem cell injections or going their own way outside of CSN?
- Will FDA expand on stem cell clinic oversight with substantive action against other clinics while the current cases are pending? Or is this going to be the peak of activity from Gottlieb’s FDA?
- More patient suits on clinics? Will other clinic customers potentially see the federal suits as a foundation for civil suits against more stem cell clinics? There are already quite a few suits recently settled and ongoing.
- Move some offerings offshore? Will either of the two firms shift some of their clinic efforts outside the U.S.? We’ve seen that before quite a few times with stem cell clinics including Celltex. If USRM or CSN, which notably both already have some international presence, shift substantial adipose stem cell offerings to other countries, will they retain an active U.S. presence doing something?