New lawsuit includes big stem cell clinic chain, Cell Surgical Network

stem-cell-lawsuitDoes 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. Stem-Cell-Center-Georgia-Cell-Surgical-NetworkRobert 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.

Walraven Cell Surgical NetworkIt’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.

7 thoughts on “New lawsuit includes big stem cell clinic chain, Cell Surgical Network”

  1. I’m considering regenerative stem cell therapy for joint pains utilizing perinatal tissue technologies produce in Panama by Doctor Neil H Riordan, founder of Stem Cell Institute and applied by DR. Cheryl Johnson. Supposedly Dr. Riordan has discovered and developed two novel stem cell types that cleared FDA requirements for use in the USA.
    To quote from his literature Dr. Riordan is a scientist, clinician, and developer of regenerative medicine therapeutics, with more than 70 peer review publications and more than 40 patents and patent applications. Claims that this technology has aided thousands of patients with injuries and degenerative diseases, including a range of autoimmune conditions. A clinic by the name of RENEW LIFE REJUVENATION with offices in Missouri City and the Woodlands, Texas.
    Please advise your opinion on this type of treatment being advertise by Dr. David Martino
    Thanking you for your prompt reply.

  2. Have there been any lawsuit by stem cell donors against clinics for selling freely donated cells at spectacular mark-ups

  3. First of all, regardless of issues barring gross negligence by the physician doing the procedure, I absolutely do not believe that a lawsuit is reasonable after a thorough informed consent has been obtained. I don’t know anything about Stem Cell in eyes, but I do know about risks in all medical procedures, and if the patient assumes the risk via consent, then untoward outcomes are part of the game. Had the patient been miraculously cured, improved, or simply degradation halted, he/she would have been very happy. This ‘one way’ form of “all good/no bad” assumption is BS.

    Now, if the physician completely screwed up, over sold, etc, then that is a different story. However, barring these, signing a consent which states ‘blindness’ as a possible outcome assumes risk. And, especially given the fact that the natural course of the disease is blindness, an attempt to curtail or mitigate it, with the assumption of risks, should toss this lawsuit out immediately.

    This has nothing to do, in my opinion, with the Stem cells, but simply assumption of risk after informed consent. Its not like she went blind after a knee injection.

    However, to the previous poster, Jc.

    There is no credible research on using stem cells in such a manner. You can point to all the ‘8000’ patients out there, who have not had bad outcomes, and that might be great information. But, anecdotes… even 8,000 of them, do not count as any research. It simply is not the case. We, as a scientific community, have decided that ‘proof’ lies in verifiable and reproducible studies of adequate quality, statistical strength, and outcome. I absolutely KNOW that are some horrible studies out there which have pushed medicine one way or another. I know that there are bogus studies which were taken as ‘fact’ etc. Research doesn’t prove ‘FACT’. But it justifies procedures, medications, etc to the best of our agreed upon ability.

    I do take issue with the assumption that a ‘paid/profit’ procedure cannot be included in a study. ESPECIALLY in stem cell treatments. I don’t know exactly how this will all play out, but most studies in such a manner, have a ‘protectable’ result. ie, if you invest in the research and work, you can see financial return on the investment. Stem Cell treatments, almost by definition, precludes such an outcome because, for the most part, at this stage, the research is purely technique and efficacy. There is no ‘gain’ to putting out the research, which is why, I believe so little has been done.

    Even something as simple as PRP injections, cost, at a minimum, about $200-300 per patient/injection simply in the PRP kit. That does not include the costs of staff, facility, etc. Even if the physician provides his/her portion for ‘free’, there is a relatively big cost which must be absorbed. To have a statistically significant power for results demonstrating a real world relevant improvement, there would likely need to be at least 100 participants in the study. 1/2 of whom actually get the treatment and 1/2 procedure without treatment. The cost of procedures on 100 patients in such a manner would likely be, at a minimum, $100,000 and very likely more. For a facility to absorb those costs, it requires grant funding, which is almost purely academic in nature, or the potential to realize return on that investment in the private sector. Even if I did the above study and it showed absolute benefit to those patients, I would have no benefit, other than perhaps, to be able to continue doing the procedures with a charge from that point forward. But so would everyone else, which is the issue I believe everyone in this field is running into.

    Obviously, you cannot charge a patient who receives ‘saline’ for participating in the study. And therefore, there is no way to actually be able to ‘charge’ anyone for participation. But, this is one of the issues that we are running into and why people are skirting the research.

    1. There is evidence that in some cases proper consent is not obtained, that risks are understated, and that potential benefits exaggerated.

      As to the for-profit clinic context, the data from that kind of thing can be included in a study of course, but there needs to be care taken to avoid bias as much as possible since it is the interest of those doing the injections to see benefit. Add in other layers of potential study weaknesses from no controls, unblinded design, and insufficient power, and the quality of the data continues to drop to the point where it isn’t able to conclude almost anything due to lack of rigor.

  4. It is hard to comprehend that this is how this is reported. Cell surgical network is the largest multi center clinical trial ever to exist. There purpose is to establish safety data!!! If we look at any scientific study of any drug, or device the litany of reported adverse events is alarming. A rate of 20% complications is acceptable for FDA. . Let me ask this, are we comfortable that bone marrow transplants for cancer patients have been adequately studied?
    Bone marrow transplant is the oldest version of stem cell treatment in medical history. HOWEVER, it is done in much sicker and much more fragile patients, with someone else’s cells which ate far more dangerous. The patient who’s preparation for the bone marrow transplant can kill them, and the required immune suppression for life can kill them , and we are comfortable with this as an option BECAUSE it works well enough to save the majority of lives who receive it.
    And so we are afraid of a much safer version that has shown in studies greater impact than anything ever seen before in medicine? REALLY?
    The viewpoint is the writer it that it must be a sham. It’s a large multicenter clinical trial! That is what we want! Both clinics mentioned are involved in appropriate, needed scientific studies run by extremely willl respected clinical researchers who have committed their lives to getting ever scientific data.
    To take a study and distort it to be some profit making machine is beyond rational understanding. What scientific study of any treatment, drug, device or other new approach would ever stand up to that scrutiny? Pick any drug commercial and listen to the laundry list of complications and side effects that have been found to be reported by patients in those studies. Now take the autologous stem cell studies in the US…. we’re have 3, maybe 4 pts out of 8 thousand from cell surgical network and us stem cell combined data base likely double that number of patients. Please, find one study that has less than 3 patients with any complications out of 15,000.

    I’ll give some more analogies, what if we couldn’t use our own blood for surgery? Our own skin for skin grafts, our own bone for bone grafts? Seems absurd! To consider the use of our own tissue some radical and dangerous idea, goes against everything we know about the human body.

    Is so bizarre that we continue to see these claims based on assumption without checking facts. Presume they are Charleton’s why? Because patients pay for their treatments? And the first PhARMA stem cell drug for cancer was just announced to cost $475,000 wholesale and approximately $750 000 PER TREATMENT?
    Let’s be clear, the billions of dollars that pharma gives for research to fund studies, to make products that can be made and sold to patients for $750,000, this is not considered a problem, and studies with no funding( no pharma product to be made) , which must then be charged thi the patient to receive, are considered an agregious form of quackery? WHAT?

    in addition, as any scientist knows, you do the studies with all the precautions to understand risks we can’t otherwise know. 10’s of thousands of animal studies have already been done with obscenely minimal negative outcomes, and insanely effective healing. A dog that literally can’t walk from arthritis, jumping, playing and running up stairs?

    I keep seeing reports that this is unproven. Why aren’t you looking at the data? You would realize several things. Every major group doing proper scientific study that have large data bases with incredible safety data seem to get injunctions and law suits before they can publish. If this keeps up, there won’t be polished studies despite 25+ years of research in this country and globally all with the same incredible results.

    Check the facts, check the data, think about the ” Danger” medicine uses your own tissues, all the time. And consider this, the cases if visual loss/ blindness were reported to be because The lab. person preparing the cells for injection skipped a step which washes out collagenase. Collagenase in the eye would do a great dealer of damage. It is extremely likely that the stem cells had nothing to do with the injury, but isn’t that why we’ do the studies?

    Autologous stem cells cost anywhere from $6500 to $20,000 per treatment in the US. That cost $20,000, to $50,000 in every other country and the first strem cell treatment brought from pharma in this country is $750,000.

    Yeah, considering that in most studies of autologous stem cells have validated patient reports and study outcomes either patients are reporting cartilage, bone, muscle, brain Nerve, etc, what us this fear? . Again, in this country and in every other country doing this? How can Europe, China, Japan, south America, Mexico, Panama, France, Germany. Ireland, all report the same outcomes for the last 25 years and it’s all unproven?
    Please, attend 1 IFATS meeting where for 3 days, country after country report the same study findings, even though they have different study design, different patient populations, different genetic risks, different environmental exposures, but all the same level of effectiveness and scarce to no negative outcomes? Globally? The only way to be upset about the explosions of new healing and improved patient lives is if you are so committed to innuendo and creating fear, and if you make sure you don’t check any facts.
    But if you have a stroke, are paralyzed, need a knee replacement, or are in excruciating pain every day from athletic injuries, you may consider actually looking at the true data done under the proper scientific scrutiny. That’s what I did. I had 6 vertebral, and 2 cervical fractures, no cartilage in either knee, or my hips, but when my shoulders were frozen from scar, I looked into it. I have no pain, full cartilage, and full range of motion in my arms. 1 treatment. My co pays for the surgery to do 1 joint, let alone 4 joints and 2 spine surgeries, was more than the cost of this procedure. This field will change medicine in my opinion. And soon we’re will be combining autologous with pharma products to reach even greater s successes for patients.
    But we can’t buy into fear based innuendo as if it were factual. We’re need to look at the facts, no matter how hard they are to uncover. It’s easy to make an accusation. An unfounded, accusation using partial facts. To what end? Make sure the public isn’t helped? In think the public is smarter than that. And certainly when medicine fails, they roll go to other countries if need to get help. The whole thing is silly. Look at patient outcomes. Heck. Look at animal outcomes. There isn’t a racehorse in this country that doesn’t get their own stem cells every week.
    I hope the writer, can telescope out and realize there are advantages to using your own tissue and there will be charges to using pharma products. Why battle with fear? What does the data show? What if there is huge volume of data that can’t be published because of injunctions? Don’t harm your readership by giving a fear provoking report with half truths. Value your integrity and look at it from a broad perspective, check facts, and don’t take information from only one source no matter how reputable that one source is. It’s one source. It’s possible for there to be bias in any single source.

  5. Investagational or Experimental medicine has changed the world but only when a patient has access. Because a persons own stem cells are involved (ie no need for big pharmas manufactured cells which are in FDA trials) it begs the question who is really behind stopping these stem cell therapies. My money is on the biggest lobbying group in America…big pharma! There is more money to be made in harvesting and cloning donor cells. But anyone having experience with donor cells knows of the side effects. We are too quick to jump to the conclusion that the FDA is truly the watch guard of the people. (How can the head of the FDA also sit on the boards of 16 pharma companies).

  6. I’m greatly looking forward to Dr. Leigh Turner’s session at the International Cord Blood Symposium. Hopefully he’ll address some of this as well. Sadly it will take a combination of lawsuits and FDA action to reign in bad science/medicine. The real shame is these adult stem cells offer great hope and promise, but only as well vetted responsible medicine, and as part of a well researched and tested therapy regime.

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