Helpful Zettler insights from Q&A on FDA suits against stem cell clinics

At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network).

What does this big development mean in practical terms and how might it play out?

For some discussion and potential answers, I turned again to Professor Patricia Zettler of George State University School of Law, an expert on stem cell oversight, the FDA, and regulatory legal matters.

I think you’ll find our quick Q&A below to be very helpful in getting a clearer sense of the possible meaning and implications of these suits as well as what might happen next. Overall, Zettler had this take: “FDA’s action is a fascinating, and I think ultimately, positive development.”

PK: What if anything is the immediate effect of these 2 suits by DOJ? In theory can the firms just continue business as usual for the time being? 

PZ: A permanent injunction does not go into effect immediately after the government files its complaint. FDA explains in its Regulatory Procedures Manual that after the complaint is filed a decree of permanent injunction must be entered, which defendants can agree to as part of a settlement, or if defendants do not agree to settle, the judge can grant the government’s request for the injunction after a trial.  In other words, unless the firms have agreed to stop producing and marketing their products, I think this does mean that the firms can technically continue their business for now.

PK:  What about a temporary injunction? If such quicker action were going to be pursued by FDA, would we probably already know?

PZ:  I think we would already know if the government were seeking a temporary injunction—I think that would have been included in these complaints.

But the government can ask the firms to agree to cease producing and marketing their products while the litigation is ongoing.  And we would or will know if such an agreement is made, because a document will be filed with the court indicating that the defendants have agreed to hold off during litigation. In the USA vs. Regenerative Sciences case, for example, the firm agreed to cease producing its product while the litigation was ongoing basically when the government filed its complaint.  If the same thing happened in one or both of these new cases, that might explain why the government did not seek a temporary injunction. Because the government’s complaint was filed so recently, an agreement may have been reached like the one in the Regenerative Sciences case but it isn’t yet public. Or, given that each set of defendants either had been warned by FDA or been the subject of regulatory action previously and had not stopped their activities before FDA filed the complaint seeking the injunctions, it may be that they are not willing to enter into such an agreement.

PK: How long might these court cases take?

PZ: It’s tough to predict, but it will certainly take a while if the cases are litigated rather than settled. For example, in the Regenerative Sciences case, FDA filed its complaint asking for a permanent injunction in August 2010, and the trial judge granted that request in July 2012.  Regenerative Sciences then appealed, and the D.C. Circuit affirmed the district court’s judgment in February 2014.

Having spoken to some of the defendants, you probably have a better sense than I do as to whether they intend to litigate this—but I would guess perhaps yes, given some of their statements arguing that they are not subject to FDA regulation and the fact that the activities that FDA has asserted are illegal appear necessary for their current business models.

PK: Is that past USA vs. Regenerative Sciences case, in which FDA prevailed on the question of proliferated stem cells as drug products requiring premarket approval, relevant here in other ways? At least in the new USA vs. California Stem Cell Treatment Center, et al. suit, proliferation of stem cells was mentioned. Other relevant case law?

PZ: Yes, I think the Regenerative Sciences case is relevant. The legal theory on which FDA is proceeding is very, very similar (e.g., the defendants have violated the law by causing drugs to become adulterated and misbranded while holding them for sale after shipment in interstate commerce), as are many of the high level facts (e.g., we’re talking about cells taken from the patient’s own body that are then processed and mixed with other products). I think if the courts in these cases follow Regenerative Sciences, FDA should prevail. One wrinkle is that the Regenerative Sciences case was decided in the D.C. Circuit. This means that the Regenerative Sciences opinion may be persuasive to federal judges in the Southern District of Florida and Eastern District of California, where these cases have been brought, but it is not controlling precedent. That is, federal courts in different circuits could come out differently.

Regenerative Sciences is the most relevant and analogous case that I can think of. There are some other potentially relevant cases, such as on the issue of whether FDA’s drug-related actions impermissibly regulate the practice of medicine—which seems like an argument the defendants may be likely to make.  But in my view, I think FDA is on strong legal footing here, especially in light of the Regenerative Sciences case.

PK: Both defendants have mentioned “patient’s rights to their own cells” and this could become part of their defense. Is there any legal basis or precedent for that being relevant here?

PZ: The notion that patients have a so-called right to their own cells is not legally relevant in my view. As FDA explained in the complaint, these interventions are not simply the patients’ own cells, but rather drugs and biologics that undergo a multi-step manufacturing process during which the cells that originated from the patients are processed through “numerous steps” and mixed with other products, and so on. Moreover, as FDA explained, these cells are more than minimally manipulated and not for homologous use, among other things. But the “rights” language might be relevant in terms of public opinion. The language is reminiscent of the “right to try” language, and might similarly resonate with certain patients and politicians.

Something that is arguably more legally relevant is the idea that the defendants are engaged in the practice of medicine, not the manufacture and marketing of drugs and biologics. But assuming the courts follow Regenerative Sciences, that argument should not be persuasive. And, in my opinion, the practice of medicine argument is a bit of a red herring anyway, because whether a particular technology or intervention is within FDA’s jurisdiction simply depends on the relevant language in FDA’s statutes. If FDA’s statutes say it can regulate a technology, it can regulate that technology, regardless of whether FDA regulation will affect medical practice.  In case it’s helpful, I have a long law review article that discusses this idea in much more detail, including some discussion of the Regenerative Sciences case.

PK: Since Cell Surgical Network (with ~100 member affiliates) is mentioned as a defendant, in theory might any ruling here apply to the whole network including all those affiliates across the country?

PZ: I suspect not, depending on what it means to be an “affiliate” of Cell Surgical Network. I say this because the defendant is “Cell Surgical Network Corporation” and I assume the affiliates are not formally part of the corporation. That said, there may be some practical reasons why an injunction against Cell Surgical Network would limit the affiliates’ ability to continue to sell these interventions—if, for example, Cell Surgical Network can no longer sell products that enable the affiliates to provide these interventions, or the action simply encourages affiliates to come into compliance with FDA requirements (or deters affiliates from continuing to sell these interventions).

PK: To your knowledge are these cases involving DOJ in the stem cell sphere unprecedented?

PZ: I wouldn’t say these cases are unprecedented because of Regenerative Sciences. The legal rationale for these cases is very similar to that in Regenerative Sciences.

Also, I’m not sure if this is what you’re asking, but the involvement of DOJ is not significant.  FDA, like many agencies, does not have independent litigation authority and so all FDA cases are litigated through DOJ. That is, whenever FDA litigates something, DOJ is involved too.

PK: Any overall sense or predictions on the most likely outcome of the suits?

PZ: I think FDA has strong legal arguments in favor of its request for an injunction.  Additionally, FDA has a strong public health argument as well.  Unlike in its Regenerative Sciences complaint, FDA is pointing to serious adverse events that have already occurred as a result of the defendants’ actions, including blindness, hospitalizations, and so on.  For the California Stem Cell Treatment Center et al action, there is also the use of the Vaccinia Vaccine, which frankly sounds quite scary.  The strong public health arguments may make a judge more inclined to agree with FDA here.

PK: Other relevant considerations here?

PZ: I think this is a positive development. It shows that FDA is becoming more serious about its regulation of stem cell clinics, and is willing to do more than send warning letters when patients are at risk of serious harm. And this action may help stop not just the defendants, but also deter other clinics that may be providing similarly dangerous interventions to patients.