Stemgenex motion to dismiss aims to rebut stem cell suit claims

motion-to-dismiss-stemgenexSan Diego-based stem cell business Stemgenex is the subject of a suit over allegations about stem cell treatments. The company has now filed a motion to dismiss the case.

To me as a non-attorney, the Stemgenex motion to dismiss seems to emphasize overall vagueness of the plaintiff’s case and argues in part that there is insufficient detailed support of each claim.

From my reading of the plaintiff’s suit document, the case seems focused on alleged issues with Internet marketing claims and it provides details mainly on that level. Are all nine claims related to that? I’m not sure.

The motion to dismiss also asserts that there is a lack of detail on the specific alleged roles of each defendant as pertains to the nine claims. I’m more accustomed to reading, writing, and critiquing scientific materials (e.g. papers and grants), so court documents seem somewhat foreign to me and I don’t know what the expectations are for claims. I do feel like there are some lacunae in terms of specific details of the nine claims in the case, but is that par for the course at this stage?

Stay tuned as we all learn more about this situation and hopefully one or more experts in legal matters will weigh in on it.

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

Vote now for your pick for Stem Cell Person of the Year 2016

Vote on your pick for the top stem cell outside the box thinker and positive impactor in 2016 from the 20 choices below. The top 10 vote getters will be finalists from which I will have the tough task of picking the one winner as Stem Cell Person of the Year along with the $2,000 prize and recognition.

You can vote once per day. The voting closes in 10 days on December 15th at 11:59pm Pacific Time. Read more about the 20 nominees here.

20 Nominees for Stem Cell Person of the Year 2016 Award

stem-cell-person-of-the-year-awardI received a score of great nominations for the Stem Cell Person of the Year 2016 Award and have briefly described the twenty nominees below. The point of the award is to honor the top positive stem cell leader who specifically thinks outside the box and takes risks.

I’ve started an on-line vote where you can vote once per day for your favorite nominee(s) for Stem Cell Person of the Year. The top half or so of nominees getting the most votes will be the finalists from which I will choose the final winner, who receives the $2,000 prize and international recognition as a global leader in the stem cell and regenerative medicine field.

Past winners of the Stem Cell Person of the Year Award include the following:

  • Top stem cell scientist Jeanne Loring in 2015.
  • Pioneering vision and pluripotent stem cell clinical researcher, Masayo Takahashi in 2014.
  • Neural stem cell scientist and very effective Italian politician Elena Cattaneo in 2013.
  • Stem cell patient advocate Roman Reed in 2012.

Here are the 2016 nominees in alphabetical order by first name with some description of who they are and a bit of the words from the person(s) who nominated them in some cases. Where I could find a link to websites describing their accomplishments, I have provided those.

Amy Wagers, Professor at Harvard. She has a long track record of cutting edge research on stem cells including recently very provocative work on the role of stem cells in human aging and approaches to reversing aging.

Arnold Caplan, Professor at Case Western Reserve. He is often considered the “father” of the mesenchymal stem/stromal cell (medicinal signaling cell) field and has done important research on MSCs over many years.

Connie Eaves, Distinguished Investigator at Terry Fox Laboratory at UBC. She has a remarkable track record of innovative research on stem cells including both normal and cancer stem cells and a reputation as a fantastic mentor and leader in the field more generally. “Brilliant scientist with unmatched piercing view of science”.

Hiroshi Nagashima, Professor at Meiji University, Tokyo. “A true translational scientist (with a wicked sense of humor!)” He works in part on cloning technology and could revolutionize organ transplantation approaches leading to huge impact.

Jim Gass. Jim is a patient who suffered a stroke and then sought stem cell treatments to try to reverse some of the damage. Somewhere along the lines, one or more of the unproven stem cell therapies he received caused him to develop a spinal tumor. He had the courage to go public with his story and describe his experiences, potentially risking litigation. “A gutsy man who has prevented others from getting injured.”

John Pimanda, Associate Professor of Medicine and Stem Cell Biology, UNSW Australia. He researches transcriptional regulation of adult stem cells and now the use of fat stem cells for spine injury.

Judy Roberson. She is a tireless Huntington’s Disease (HD) advocate, always working to make a positive difference. “She is a straight shooter who will tell you what she thinks and work to make it a reality.”

Jun Takahashi. He is a Professor at CiRA and pluripotent stem cell biology researcher. Jun has done pioneering IPSC research and is working to start a very exciting Parkinson’s Disease clinical trial using IPSC in Japan.

Margaret Goodell, Professor at Baylor College of Medicine. She is an internationally respected scholar in the stem cell field. She conducts cool, innovative research on transcriptional and epigenetic regulation of hematopoietic stem cells and how this goes awry in leukemias.

Mike West. Often mentioned as one of the founders of the regenerative medicine field, he is the leader of BioTime and is a thought leader in the field. “Mike knows all about taking risks in regenerative medicine leading to big, positive leaps forward.”

Nissim Benvenisty, Professor of Genetics at the Hebrew University of Jerusalem. He is a super-prolific, long-time stem cell researcher. His latest work this year was on revolutionary production of haploid ES cells.

Oliver Brustle, Professor and Director of the Institute of Reconstructive Neurobiology and Professor of Reconstructive Neurobiology at the University of Bonn Medical Center. He conducts innovative neural stem cell research and is a globally respected stem cell leader.

Randy Mills, President and CEO of CIRM. He has been a leader in stem cell biotech for years and has shaken things up at the helm of CIRM with a much more translational emphasis. “Randy has CIRM on track to meaningful clinical outcomes in a way that I cannot imagine another leader could have achieved. The outcome will change the world.”

Richard Ambinder, Johns Hopkins Hospital. Professor Ambinder has done pioneering work in the area of stem cells and viruses, including HIV, as well as stem cells for patients with hematopoietic malignancies. A scientist with a prodigious publication record of high-impact papers.

Robert Lanza. He has been a regenerative medicine leader for, what, decades? Long time scientific leader behind ACT and then its new incarnation as Ocata, which was purchased by Astellas and he leads global regenerative medicine at Astellas.”We expect something new and big from Bob at every turn”.

Sally Temple, Scientific Director, Co-Founder, and Principle Investigator at the Neural Stem Cell Institute. She is also the President of ISSCR. Scholar and innovative researcher in the stem cell field with a focus on stem cells in the brain. Past MacArthur Fellow. “One of the brightest developmental biologists in the world and a natural leader.”

Sheng Ding, Senior Investigator, Gladstone Institute of Cardiovascular Disease. Dr. Ding has done some of the most creative and impactful research in the stem cell field to date, and continues to crank out new discoveries in particular related to chemical reprogramming. He also has co-founded a number of exciting biotechs including Fate Therapeutics. “He has been a positive leader in the stem cell field, and his outside-of-the-box thinking has greatly enhanced our collective efforts to advance the field.”

Shoukhrat Mitalipov, Professor at ONPRC and OHSU. Shoukhrat is a top researcher in the stem and germ cell arenas of research including cloning and mitochondrial transfer, with cutting edge high impact papers published every year. “Fearless and one of the premier innovators in the field”.

Ted Harada (posthumous). Ted was one of the most prominent patients participating in a stem cell clinical trial ever. He fought for patients and efforts such as right to try every step along the way, and brought people together in the field. You can see his obituary and tributes here.

Theresa Liao. Powerful advocate for the use of stem cells to treat recessive dystrophic epidermolysis bullosa (RDEB). Through relentless advocacy she has made a profound difference in this area of clinical research.  “A parent and visionary patient advocate.”

Top 10 list of ways for scientists to deal with Trump election

president-trump-thumbs-up-for-scienceSince Donald Trump was elected our new president the scientific community has tried to adjust to this new reality or at least absorb the shock that many felt. Responses from scientists range from “not my president” to “maybe it won’t be so bad”. Mostly it seems people are stressed about an uncertain future for science and our country overall. If you just look at a science-related Twitter feed you can feel the palpable tension in the air.

How should we scientists deal with this new reality from a utilitarian point of view? Below I’ve listed top bullet point ideas. Many would mean scientists have to go outside their comfort zones. I believe it is worth it to do so even if this is uncomfortable for many.

  • Become more politically active overall. It may not always come naturally for many scientists, but more than ever it is time to dive in.
  • If you see specific instances of injustice (sexism, racism, homophobia, xenophobia, etc.) including in your science community, seriously consider taking action such as saying something. Already several people I know have had bad experiences post-election including with racism. There are risks to speaking out, but silence can do great harm too.
  • Advocate for science funding and support the NIH, NSF, NASA, etc.
  • Promote the reality that science is a key part of a democracy.
  • Invest more time than ever in your trainees and work to instill in them the core values of science. The next generation of scientists are an amazing resource for positive change in the future.
  • Reach out to Republicans, whichever party you belong to if any. Make the point that science funding is a non-partisan issue that also bears on our economy and national security. If you are a Republican scientist, reach out to your fellow party members about science.
  • Recommit yourself even more actively to the importance of diversity in science that transcends borders. Our global scientific community should not let borders block collaborative science and continue to embrace our diversity.
  • Support the free press. Get or renew a subscription to important magazines and newspaper(s) that are unafraid in their coverage. Of course scientists can’t do everything and a free press that rigorously does its job is essential.
  • Keep your expectations high for a fact- and data-based reality. A democracy runs on data/facts or it runs into serious trouble.
  • Finally, keep doing your science and rightly believe in making a difference through that work.

Please add your own ideas in the comments.