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

2nd lawsuit alleging a U.S. stem cell clinic caused blindness

Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients.U.S. Stem Cell, Inc.

What are the concerns?

Earlier this year a publicly-traded stem cell business in Florida called U.S. Stem Cell, Inc. was sued along with other defendants by a former customer Elizabeth Noble, alleging harm done via an experimental stem cell “treatment” for vision. That case appears settled.

SEC filings by U.S. Stem Cell also disclosed another suit against them involving a different plaintiff, Patsy Bade. Note that U.S. Stem Cell Inc. used to be called Bioheart, Inc., has a subsidiary called U.S. Stem Cell Clinic LLC, and that Kristin Comella is a leader of U.S. Stem Cell.

From the SEC Filing by U.S. Stem Cell:

“On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D. During the six months ended June 30, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company.”

I’ve been wondering about the circumstances of Bade’s suit, which like the Noble case was mentioned as being in Broward County, but the Bade case didn’t appear on their county court website. As a result, I did other research as time permitted.hollywood-eye-institute

court search in the adjacent Miami-Dade County using the search term “Bioheart”, again the old name of U.S. Stem Cell, Inc., revealed that Bade had filed a lawsuit in that county against some of the same parties involved in the Noble case.

Bade has apparently settled with US Stem Cell, Inc., but as best as I could tell as a non-attorney she has not so far settled with Dr. Shareen Greenbaum and her place of business the Hollywood Eye Institute.

What did Bade claim had happened?

She alleged that a stem cell treatment she received caused her to go blind, an allegation that remains unconfirmed to my knowledge. This case raises pressing questions though. I recommend reading the amended complaint document if you want to at least try to learn more. It is publicly available on the court site and I have posted it here. U.S. Stem Cell, Inc. and its leader Kristin Comella are mentioned extensively in the amended complaint.

Continue reading

FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces

FDAThe FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs.

That would be a good thing for patients who are often being put at risk by many of the clinics. This is the reality no matter what some of the patient advocates who promote the clinics might say. Such finalized FDA regs that unambiguously state that, for example, fat stem cells are drugs, would be bad news for the clinics that are after patients’ money. Update: It is important to note that not all patients or patient advocacy groups are pro-clinic and anti-FDA. Every patient has a different story and I’ve met many that know the clinics aren’t some kind of Robin Hoods of stem cells.

It is perhaps not surprising then that at the planned upcoming public FDA meeting on stem cell regs in April, there’s going to be a crowd of anti-FDA, anti-regulation forces converging to speak. The agenda of this meeting, with a few notable exceptions, reads like a who’s who of the for-profit stem cell clinic world. I’ve pasted the agenda at the bottom of this post.

An interesting additional factor going on here is that there are some highly respected organizations also coming to the meeting that, reading the tea leaves, are also almost certainly going to advocate that the FDA be less comprehensive in its regulation of stem cells to accelerate translation. For instance, CIRM recently has made some statements about the FDA needing to speed up and maybe not be as strict.

CIRM probably realizes that there will be many folks at this FDA meeting who have no particular interest in participating in the standard FDA approval process at all. These stem cell clinic folks may cheer on statements from CIRM, if such are made, that come off as wanting a weaker FDA regulatory sphere for stem cells. I cannot imagine that CIRM would want that and I know that CIRM does not support these clinics.

As a result, there’s a vital need for CIRM to choose its approach to this meeting very carefully and cautiously. It may be a fine tightrope to walk. Accelerating evidence-based treatments based on stem cells is one thing, but weakening much-needed regulatory oversight that leads in the near future to clinics taking more money from more patients that they put at risk is quite another.

In short, CIRM’s agenda is very different than that of the clinics. Yet the stem cell clinic crowd could even be hoping to use CIRM’s words at this meeting for their own future publicity. They might even try to get their picture taken with CIRM staff to use on their websites. Historically the stem cell clinics have been very anti-CIRM, but that doesn’t mean that they won’t pounce on a PR opportunity if it arises.

The Alliance for Regenerative Medicine (ARM), which has done and continues to do amazing things, is also likely to push for a relatively more permissive stem cell regulatory construct at this meeting too. I hope that they are cautious not to align themselves with the dubious clinics. The membership of ARM consists of good citizens of the stem cell and regenerative medicine biotech community who work with the FDA and follow regs. This is a night and day difference from the stem cell clinics.

Regardless of how this meeting plays out, it will be fascinating to see and hear the views at this unprecedented gathering.

The agenda as of Feb. 10.

Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15 Public Hearing Draft Agenda April 13, 2016 FDA White Oak Campus 10903 New Hampshire Ave, Building 31, Room 1503, Great Room Silver Spring, Maryland 20903

8:00-8:15 AM: Presiding Officer Opening Remarks and Introduction of Panel Members 8:15-9:46: Session 1 • 8:15-8:18: Allosource • 8:19-8:22: Atlanta Medical Center • 8:23-8:26: AZ Pain Centers • 8:27-8:30: Birth Tissue Recovery, LLC • 8:31-8:34: California Stem Cell Treatment Center and Cell Surgical Network • 8:35-8:38: CAREStream America • 8:39-8:42: Celebration Stem Cell Center • 8:43-8:46: Centeno-Schultz Clinic • 8:47-8:50: Harvard Apparatus Regenerative Technology • 8:51-8:54: INCELL Corporation LLC • 8:55-8:58: Intellicell BioSciences • 8:59-9:02: Johnson & Johnson • 9:03-9:06: LifeLink Tissue Bank • 9:07-9:10: LifeNet Health • 9:11-9:14: Long Island Plastic Surgical Group • 9:15-9:18: MedCentris • 9:19-9:22: Info Health Global • 9:23-9:26: Millennium Medical Technologies • 9:27-9:30: MiMedx Group, Inc. • 9:31-9:34: Minnesota Medical & Rehabilitative Services • 9:35-9:38: Musculoskeletal Transplant Foundation • 9:39-9:42: National Spine & Pain Centers • 9:43-9:46: Oregon Regenerative Medicine 9:47-9:55: Questions from panel 9:55-10:25 Break 10:25-11:56: Session 2 • 10:25-10:28: Organogenesis Inc. • 10:29-10:32: RTI Surgical • 10:33-10:36: StemGenex, Inc. • 10:37-10:40: U.S. Stem Cell Inc. (FKA BIOHEART Inc.) • 10:41-10:44: Robert W. Alexander, M.D. • 10:45-10:48: Scott R. Graham, M.D • 10:49-10:52: Shay Bess, M.D. • 10:53-10:56: Julie Cerrone • 10:57-11:00: Ann A. Connolly • 11:01-11:04: Shawn Connolly • 11:05-11:08: Elio Coradin • 11:09-11:12: Terri Coutee • 11:13-11:16: Charles S. Cox, Jr., M.D. • 11:17-11:20: Pamela Fricke • 11:21-11:24: Brian Gates • 11:25-11:28: Jarvis P. Green • 11:29-11:32: Candace Hart • 11:33-11:36: David Jacobs, M.D. • 11:37-11:40: Carolyn M. Salafia, M.D. • 11:41-11:44: George U. Sauter • 11:45-11:48: John Klimkiewicz, M.D. • 11:49-11:52: Samantha Wilkinson • 11:53-11:56: Rebecca Baergen, M.D. 11:56-12:00 Questions from panel 12:00-1:00: Lunch: Ala Carte items will be available for purchase on site 1:00-1:35: Session 3 • 1:00-1:03: MaryAnn Chirba, J.D. • 1:04-1:07: Case Western Reserve University • 1:08-1:11: Indiana University School of Medicine • 1:12-1:15: Wake Forest University School of Medicine • 1:16-1:19: Navigant Consulting • 1:20-1:23: OrthoKinetic Technologies, LLC • 1:24-1:27: Parenteau BioConsultants • 1:28-1:31: Alston & Bird LLP • 1:32-1:35: Topher Stephenson, M.D. 1:36-2:52: Session 4 • 1:36-1:42: Alliance for Regenerative Medicine • 1:43-1:49: Alliance of Wound Care Stakeholders • 1:50-1:56: American Association of Tissue Banks • 1:57-2:03: Bipartisan Policy Center • 2:04-2:10: California Institute for Regenerative Medicine • 2:11-2:17: Coalition of Wound Care Manufacturers • 2:18-2:24: Curemonos • 2:25-2:31: Foundation for the Accreditation of Cellular Therapy • 2:32-2:38: International Society for Cellular Therapy • 2:39-2:45: National Center for Health Research • 2:46-2:52: Patients for Stem Cells 2:52-3:00: Questions from panel 3:00-3:30: Break 3:30-4:53: Session 5 • 3:30-3:36: The Amputee Coalition • 3:37-3:43: The Cord Blood Association • 3:44-3:50: The Cure Alliance • 3:51-3:57: Academy of Regenerative Practices • 3:58-4:04: Alliance for the Advancement of Cellular Therapies • 4:05-4:11: American Association of Neurological Surgeons and Congress of Neurological Surgeons • 4:12-4:18: American College of Surgeons • 4:19-4:25: American Society of Plastic Surgeons • 4:26-4:32: Biologic Orthopedic Society • 4:33-4:39: International Cellular Medicine Society • 4:40-4:46: International Federation for Adipose Therapeutics and Science • 4:47-4:53: The Plastic Surgery Foundation 4:53-5:00: Questions from panel 5:00-Close: Closing statement from Presiding Officer