Does a new lawsuit including Cell Surgical Network and its leadership as defendants pose a broad test to this entire chain of stem cell clinics, which may be the largest such affiliated clinic group in the U.S. and potentially even in the world?
Will lawsuits substantially impact stem cell clinics?
Lawsuits against unproven, for-profit stem cell clinics seem to be growing in numbers the last few years. Some of us have been speculating on the potential impact of such lawsuits as I’ve written here and also see this guest post, which in part reflects work in a published paper on this topic by other researchers.
How much impact will such lawsuits have on the practices of U.S. clinics?
It’s an important question because although a number of such lawsuits are still active and others have been settled (potentially impacting malpractice insurance rates and insurance availability for clinics moving forward), I haven’t seen definite evidence that the clinics are altering what they are doing in major ways specifically because of lawsuits yet. However, that could change. As the number of lawsuits potentially keeps on growing, they may have clearer impact on clinics. Some specific types of lawsuits could have relatively more impact as well.
For instance, it will be interesting to see if either of the two existing proposed class action lawsuits against some other unproven, for-profit stem cell clinics (here and here) are given class status by courts as class action suits could have more major impact than individual cases. If class status is denied in one or both cases, then impact would likely be more muted.
The new lawsuit mentioned at the start of this post (see filing here) in Georgia involving Cell Surgical Network and discussed in a recent article in The Atlanta Journal-Constitution by journalist Johnny Edwards has at least hypothetical potential for outsized impact too.
A new allegation of a severe adverse eye event
Like other recent lawsuits, this one alleges that a stem cell clinic caused a patient to lose vision. Patient Doris Tyler, according to Edwards’ newspaper piece and the court filing, reportedly went to Stem Cell Center of Georgia and received stem cells from Drs. Robert Halpern and Jamie Walraven as well as a nurse for age-related macular degeneration.
The unproven treatment reportedly consisted of autologous fat stems injected bilaterally, allegedly resulting in total loss of vision in both eyes. While Tyler’s vision was already being impacted by her disease, apparently she still could see well enough to do many things independently prior to getting the injections of fat stem cells into her eyes. (Note that bilateral eye injections with unproven therapies are considered particularly risky to patients, and it is unclear why it was done in this and other similar cases from recent years. Also, why would an IRB approve such a risky approach?)
This train of events may sound very familiar to those who have been following the stem cell clinic arena overall, as in Florida there have been lawsuits and documentation of some patients also getting fat stem cell injections into their eyes resulting in lost vision and retinal detachment (e.g. see other recent case here).
Cell Surgical Network as a defendant
Part of what makes this new Georgia lawsuit so distinct though is that it is not only against the local Georgia clinic itself and its medical staff, but also includes Drs. Elliot Lander and Mark Berman as well as their organization, Cell Surgical Network, as defendants.
The lawsuit argues that Lander, Berman and Cell Surgical Network, although HQ’d in California, should also be defendants because Stem Cell Center of Georgia is part of Cell Surgical Network. It’ll be interesting to see if this argument flies in court or if instead the case gets condensed down to focus just on the Georgia defendants.
It’ll be up to a judge to decide of course, but just on a quick glance there do seem to be some concrete interconnections between Cell Surgical Network and its network members. For example, see screenshot above from the Stem Cell Center of Georgia website with links to Cell Surgical Network and a network logo. I also saw other connections on the Georgia clinic website such as a link to the Cell Surgical Network website at the bottom of the homepage, which seems to encourage other physicians to connect to the overall network.
Conversely, Dr. Walraven and the Georgia clinic are also listed on the Cell Surgical Network website (picture at left).
My understanding is that Cell Surgical Network also can provide specific training and other resources to individual network members. It is unclear to me what the financial relationship if any is between the whole network and the members.
Note that the allegations in the Georgia lawsuit are unproven and it’s impossible know how the case will turn out.
Risks of eye injections by another clinic were apparent earlier, in January 2016
Importantly, an FDA inspection report of California Stem Cell Treatment Center last year (note that “(b) (4)” is a portion redacted by the FDA in the 483 inspection report) also mentioned an eye problem:
“Serious Adverse Event Report submitted on 11/08/2016 to your firm reporting that SVF manufactured using the (b) (4), (b) (4), and (b) (4) manufacturing procedure was administered to a patient’s eyes and this patient subsequently experienced retinal detachment in the left eye. This event was not investigated and not reported to FDA.”
This might be referring to the same patient, Doris Tyler of the Georgia lawsuit, but I’m not completely sure. It appears that at the Georgia stem cell clinic that patient Doris Tyler got stem cell injections into her eyes starting September 7, 2016 according to the court filing so the report of the negative outcome she allegedly had could have been the one mentioned a few months later on 11/08/2016 and overall this might be one and the same situation.
Earlier than these dates back in January 2016, I reported here on this blog about a lawsuit involving a Florida stem cell clinic that had injected fat stem cells into patient eyes and allegedly caused vision loss. If Cell Surgical Network, the Georgia stem cell clinic, or their IRB had been aware of the possibly seriously problematic situation in Florida substantially earlier that same year with what seemed to be a very similar protocol, I wonder if perhaps they wouldn’t have proceeded?
Comment from Cell Surgical Network
More broadly, I reached out to Drs. Berman and Lander for comment on this lawsuit as I wanted to include their perspectives for balance. Here’s what they had to say in reply:
“CSN currently remains an Investigational network and we have never made claims about point of care SVF. We have now documented 8,000 patients online with self-reported patient follow-up demonstrating exceptionally few adverse events. We have even published the largest peer reviewed safety data paper on SVF to date, reporting on over 1500 deployments. We have many areas where we can quote reasonable data so we can better inform our patients but we never try to sell them on an investigational procedure. While an IRB committee approved the macular degeneration procedure, upon hearing of the adverse event of retinal detachment in the Georgia case, this protocol was promptly halted. The utility of the network is that such an adverse event can be identified and all network members can be notified and kept from repeating a potentially adverse event until better understood as to exact etiology. So far, this is the only IRB approved procedure we have had to stop – clearly demonstrating the safety and utility of CSN as a network.
To be clear, the easy to read IRB approved Informed Consent included all potential complications. We have posted no literature that was used to “convince” the patient that our affiliates could consistently or ever actually treat Macular Degeneration – only that it was currently under investigation. A few of the early patients actually had positive responses. While a board certified ophthalmologist (retinal specialist) was involved with her care, we otherwise had nothing to do to effect the patient’s problematic outcome. We still stand by personalized cell therapy as being one of the safest and most effective ways of repairing multiple maladies through a rather simple surgical procedure.”
So, CSN indicates that they’ve had very view adverse events and in that scenario there may be relatively less of a threat to the network from potential additional patient lawsuits.
We’ll have to wait and see what happens with this case.