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. Continue reading

Dozen Top Candidates To Be New CIRM President

CIRM 2.0Who might make a fantastic new CIRM President?

The California stem cell community is abuzz with this question.

This new President will not only lead CIRM today, but also in all likelihood will steer CIRM in its new incarnation after 2017, what I’ve called CIRM 2.0. At least that would be ideal.

CIRM has posted a position/candidate specification document here including a summary of the position that includes this statement:

The President of CIRM must be a nationally recognized leader with a vision, scientific credibility, and exceptional leadership skills, unassailable integrity, a keen appreciation of the financial and business aspects of scientific research, a sense of urgency and ability to deliver results, and a profound respect for the ethical issues involved in this project. He or she also must be comfortable operating in a very public capacity, adept at working with a board or other oversight body, have a good rapport with regulators, and sufficiently self-possessed to not be perturbed by criticism or controversy.

To summarize, this means the successful candidate must have great scientific stem cell chops, must be a proven leader (i.e. already held a high level leadership position elsewhere), ideally would have some business experience, being ethically unassailable (as much as possible at least), must already ideally have worked with the FDA, and not be easily spooked by public criticism or media storms. Almost everyone that I talked to thought that the person should be existing California stem cell scientist too for practical reasons.

The CIRM Presidential Search Committee tasked with finding people meeting these criteria, just met on Friday.

I’ve been talking behind the scenes with some folks in the know who are particularly interested in this question. They’ve thrown some names out onto the table, but of course not all of these people will necessarily be up for being considered and it’s not an all inclusive list. Update: To be clear, these names are NOT from me, but were suggested to me by others.

Candidates mentioned by stem cell community to me in alphabetical order by last name.

  • Jim Battey is Director of NIDCD at NIH, Former Chair of NIH Stem Cell Task Force, grew up in the Bay Area, went to Caltech.
  • Fred “Rusty” Gage is a Professor of Laboratory Genetics at the Salk, Past President of ISSCR, and a true pioneer in the stem cell field.
  • Larry Goldstein, Professor of Cellular and Molecular Medicine and Director of the UCSD Stem Cell Program, Scientific Director, Sanford Consortium for Regenerative Medicine, and another top international leader in the stem cell field.
  • Arnold Kriegstein is the Director of the UCSF Stem Cell Center and Professor of Neurology at UCSF.
  • Story Landis is Director of NINDS at NIH. She is a Neurobiologist, Former Chair of NIH Stem Cell Task Force in 2007, Graduate of Wellesley and PhD from Harvard.
  • Jeanne Loring is a pioneering stem cell researcher who is the Director of the Scripps Center for Regenerative Medicine.
  • Thomas Okarma is CEO of Asterias Biotherapeutics, and former President & CEO of Geron. Received his MD and PhD from Stanford plus on the faculty at Stanford from 1980-1985.
  • Mahendra Rao is Director at NIH of The Center For Regenerative Medicine and a long-time stem cell researcher. He received his Ph.D. from Caltech.
  • Brock Reeve, Director of the Harvard Stem Cell Institute. Strong commercial sector experience and graduate of Harvard Business School.
  • Clive Svendsen is Professor in Residence of Medicine and Director of the Cedars-Sinai Regenerative Medicine Institute. Former Director of University of Wisconsin Stem Cell and Regenerative Medicine Center.
  • Michael West, CEO of California-based stem cell biotech BioTime and long time leader in the stem cell field. Former leader of ACT and founder of Geron.
  • Keith Yamamoto is a Professor of Cellular and Molecular Pharmacology at UCSF. In addition, he is Vice Chancellor for Research, Executive Vice Dean of the School of Medicine, and Professor of Cellular and Molecular Pharmacology at the University of California, San Francisco, UCSF.

I’m sure there are more worthy candidates than just these, but this list seems like a good place to start.

Who’s your pick?