Stem cell clinic lawsuits proliferate with latest against Stemgenex

StemGenexThere is a growing trend of apparently unhappy patients suing stem cell clinics, which have faced more lawsuits recently and some of these cases are proposed class action suits that could have much broader impact.

The latest case is against San Diego-based Stemgenex, a clinic that has claimed amongst other things that it can treat numerous diverse afflictions and that it has had a 100% customer satisfaction rate.

KPBS reporter David Wagner also has more on this story. Wagner also noted that Stemgenex has publicly argued for less FDA oversight of stem cells even as this case was starting to unfold. Amongst the around 600 stem cell clinics in the U.S., many of these businesses also argue for less FDA oversight.

What’s the back story on the Stemgenex case?

stemgenex-lawsuitEarlier this year there were some indications of attorneys being interested in a possible class action suit in part against a stem cell clinic in San Diego, but specifics had been lacking. Now a court document has provided new detailed information.

This case is Moorer v. StemGenex Medical Group. et at. The main named plaintiff on behalf of all the potential others in the class is Selena Moorer. A second plaintiff, Stephen Ginsberg, is mentioned later in the document as part of the “financial abuse of elders” subclass.

The defendants include the following businesses and individuals: Stemgenex, Stemgenex Medical Group, Stem Cell Research Centre, Rita Alexander, Andre Lallande D.O., Scott Sessions M.D., and DOE defendants 1-100. For the first three businesses listed as defendants, I don’t know at this time how they are interrelated versus different.

There are nine separate causes of action mentioned:

  1. “Violations of Cal. Bus. & Prof. Code § 17200 et seq
  2. Violations of Cal. Bus. & Prof. Code .§ 17500 et seq.
  3. Violations of the California Consumers Legal Remedies Cal. Civ. Code § 1750 et seq
  4. Violation of Human Experimentation Law – Cal. Health &; Safety Code § 24170, et seq
  5. Violation of the Racketeer Influenced and Corrupt Organizations Act (RICO)
  6. Fraud
  7. Negligent Misrepresentation
  8. Unjust Enrichment
  9. Financial Elder Abuse”

I’m not sure why earlier in the document it lists only 8 complaints and then later the 9 complaints listed above are mentioned. There are a lot of other potentially notable things mentioned in the document as well such as that Stemgenex charges $14,900 per treatment. If I understood the document correctly, this case has now gone from being a California suit to a federal case. I’m not sure on why and what implications that might have.

Importantly, keep in mind that we do not know if any of these allegations are factual and there is no court ruling on any of them. Stemgenex reportedly did not respond to requests from KPBS for comment. If the company comments on the case I’ll do a post on that.

What about the stem cell clinic area more broadly?

More generally, as mentioned earlier, it’s been an active year for lawsuits against stem cell clinics. The community learned last week about the second of two different stem cell lawsuits against Florida-based U.S. Stem Cell, Inc. At the end of August there were indications of a possible class action lawsuit against The Lung Institute, another stem cell clinic.

I’m not a lawyer, but I wonder if class action suits, if approved, could be combined and then end up encompassing many different clinics across the U.S. as defendants.

Two top stem cell researchers, Jeanne Loring and Larry Goldstein, were quoted in the KPBS article on FDA regulation of stem cell clinics:

Jeanne Loring, a stem cell scientist at the Scripps Research Institute, spoke in favor of the proposed rules at an FDA meeting in September. Loring believes these kinds of stem cell clinics need regulation because in her opinion they are “selling something that doesn’t work, for a very high price, and taking advantage of people who are desperate.”

“They don’t want to be regulated by the FDA,” Loring said, “because they would have to demonstrate that their therapies actually work.”

“The evidence is just not there,” he (Goldstein) said. “Medical scientists are working very hard to test therapies properly. But we’re not there yet for a great many diseases that these companies claim to have therapies for.”

In an earlier post I pointed out the reasons why some stem cell clinics in the bigger picture could be particularly vulnerable to lawsuits from patients including the issue of not having FDA approval:

“A number of facts make many of the clinics very vulnerable: they have no FDA approval and arguing that they do not need it will not fly in court in many cases, the stem cell community opposes them, there is no solid science or medical data backing up what they are doing, they often make very strong marketing claims, they charge large sums of money for something insurance won’t cover, their customers who could become plaintiffs are often vulnerable patients with compelling personal stories, and the clinics often treat patients with conditions outside of their physician(s)’ areas of specialty. Each of these things could be used by trial lawyers to build a case depending on circumstances.”

I expect more lawsuits against clinics in 2017. I’d imagine stem cell clinics generally are closely following this trend (or at least they should be) and now perhaps some are equally or more worried about lawyers rather than the FDA knocking on their door.

8 thoughts on “Stem cell clinic lawsuits proliferate with latest against Stemgenex”

  1. Stem cell therapy has actually been backed by research done by NIH and pub med. I have found articles against it much less scientific and without proof…I really don’t buy into testimonials unless I know the person…So this comes as a shock to me…..

  2. Kamuyu Mwai (Dr.)

    As a medical research scientist, i do encourage & recommend that all be they medicaments, supplements, e.t.c carry an “insert” that explains what they are, side-effects, contraindications e.t.c & there be a harmonious (non-bias) study on them from all relevant bodies. There has been a trend where some individuals collude with authorities & their products are “sanctified” reason being authorities get “kick-backs” yet they (products) are duds worse, TOXIC while authorities are quick to criminalize other inventions yet helpful. To patients, i encourage them to ask questions about what they are purchasing or even being prescribed; “ALWAYS ASK QUESTIONS, ITS YOUR BODY, YOUR LIFE”!

    1. It is well known that the FDA charges companies yearly for Healthy Heart labels , ETC and to approve them accepts the very company ‘s research that wants to sell the product with no other research to check it out….Yes, ask questions, but how do we really know the truth?

    2. It seems to me that the FDA validates and approves for its own profit. Look at how many pharmaceuticals they have cleared only to later have them taken off the market because they are dangerous or cause worse side effects while other suitable helpful and less expensive alternatives without the side effects languish as simply not approved by our dear old FDA. I realize you already said a version of that….actually we agree!

  3. Richard Solomon, PhD

    My wife is a 20 year plus breast cancer survivor. I am a retired health care services provider. I have been living with age related macular degeneration for over 10 years as well as ‘early stage, low risk’ prostate cancer for almost 3 years now. For all these reasons I can understand why patients and/or their loved ones might be receptive to clinics marketing unproven treatments with stem cells. I hope the FDA, even in the context of the coming administration in DC, steps up with even more rigorous oversight of such operations. These clinics should not be allowed to take advantage of vulnerable people like this.

    1. Our FDA really does not work on our behalf, so we cannot look for them to have more rigorous oversight. They accept the “research” done by the very companies who sell the products. They do not have an independent lab check nor even a lab ran by them checking. And we all think they are protecting us…Hah!

  4. Michael Finfer, MD

    Perhaps Dorit Reiss could enlighten us.

    If you haven’t heard of her, she’s a professor of law at UC Hastings in San Francisco. She posts occasionally at Science-Based Medicine and on the Skeptical Raptor blog. I’d like to hear her take on this stuff.

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