Narrowed Stemgenex suit proceeds as court implies stem cell clinic loopholes

stemgenex

Screenshot from Stemgenex website on reported patient satisfaction rates

Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false?

Do such clinics not bear any legal requirement to provide informed consent to patients?

A new court ruling raises such striking questions.

San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem cell offerings to patients suffering from a variety of conditions and last year a lawsuit was filed against the clinic on behalf of some of their customers. The proposed class suit included a number of allegations and much of it is centered on how the clinic marketed its offerings online on its website. The screenshot above from some months back, for instance, seems to claim 100% patient satisfaction.

A judge has now issued a mixed ruling that part of the lawsuit against Stemgenex can continue, while most other parts cannot. For three different takes on the court ruling see what appears to be a Stemgenex PR here mostly claiming victory, a blog piece by Harvard Law Professor Rebecca Tushnet here, and an LA Times piece here by Michael Hiltzik.

The key take home messages from Hiltzik on the overall ruling:

“Judge Antony J. Battaglia dismissed several claims brought by three former patients at the clinic, including an allegation that Stemgenex has misled patients because it has produced no evidence that its treatments have any scientific basis. He said it’s unclear that the plaintiffs would be able to show that Stemgenex’s representations about the effectiveness of its treatments are “actually false or misleading” because they haven’t shown that the clinic’s claims have “actually been disproved.”

But he allowed the case to proceed on grounds that Stemgenex misrepresented customer satisfaction statistics on its website. The clinic claimed 100% patient satisfaction, even after the plaintiffs themselves complained that they hadn’t seen any improvement in their medical conditions.”

Therefore, as to claims of 100% patient satisfaction, the case can proceed, but most of the rest of the case at least at this point is out.

Aspects of the judge’s ruling are concerning such as this statement:

“False-advertising claims based on a lack of substantiation, rather than provable falsehood, are not recognizable under the California consumer-protection laws.”

Is it then the case based on California law that consumers here at present can be recruited by dubious advertising by stem cell clinics and the state won’t protect them unless the advertising claims can conclusively be proven false?

It may be in this particular case that the plaintiffs did not present enough evidence to make such a claim here, but more generally the court language suggests a very high hurdle for challenges to stem cell clinic marketing and even medical marketing more generally. As to stem cells, context is important. In general, how does one prove a stem cell clinic’s advertising is definitively false when concrete information is hard or impossible to come by? Most clinics never publish their data, they generally won’t share their cells with independent researchers to test, and much of what they are doing is considered confidential.

Stemgenex

Stemgenex

Was Battaglia’s court aware of FDA broad warnings about stem cell clinics and offerings across the U.S.? The FDA rightly recognizes the potential of stem cells as the basis for new treatments but is very cautionary in general about what is being marketed directly to consumers already:

“the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.

FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.”

That’s strong language in past years from the FDA, but since the FDA has not really subsequently backed this talk up with actual actions related to stem cell clinics marketing non-FDA approved offerings (such as the 100+ clinics here in California), how seriously do people take the language alone? I would hope a court would take it seriously, but it’s hard to say and the lack of FDA action puts more pressure on states and the civil courts in a sense to potentially oversee stem cell clinics. Are states and courts adequately prepared to do so? I also wonder if Battaglia’s court read new 2016 ISSCR guidelines that raise issues regarding stem cell clinics.

Another section of the court statement remarkably suggests that in its view of California law that patient informed consent may not be required by stem cell clinics:

“…the stem cell treatments are at least ‘reasonably related’ to maintaining or improving the health of a prospective customer and do not constitute ‘pure research’…to the extent that stem cell treatments represent a fairly newer body of research and development, the court does not find the innovative nature of the treatment to rise to the level of requiring informed consent under the Code.”

This blows my mind as a scientist, but maybe as a matter of law it is accurate? Maybe not?

What the clinics are doing is highly experimental in most cases and it seems to me that proper consent must be obtained or patients will be at much greater risk. The clinics themselves sometimes outright state that they are doing experimental research and they get their offerings listed on clinicaltrials.gov. They seem to like to think of and portray what they are doing as clinical trials. How can consent not be required in such a context? Is it because of some idiosyncrasy of California law on consent?

The court’s language suggests that California stem cell clinic patients in general may get the worst of both worlds right now as paying research subjects subject to questionable advertising for unproven experimental offerings who nonetheless mostly are without some key state protections. This ruling seems to temporarily create or at least highlight some big potential loopholes that could transcend this one fascinating case.

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.

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