California FDA Stem Cell Case Adjourned Again

California FDA Stem Cell Case Adjourned Again

Although the Pacer docket does not reflect it yet, I have heard from a client who is in communications with one of the parties that the FDA’s case against the Cell Surgical Network and Drs. Berman and Lander has been adjourned again, this time until early May.

I have lost count of how many times it has been adjourned, but it’s been at least three and maybe four or even 5 times.  It is certainly starting to look like the trial will not go forward until the pandemic is fully in control, and no one thinks that is going to happen by May.

However, according to media reports, that won’t happen until the country hits herd immunity through vaccination, and that’s not expected to happen until the late summer or fall (and that assumes the as yet untested notion that the current vaccines will be at least 50% effective against the new COVID strains). So, in short, expect another delay in May, with a rescheduled September ish date, and then it’s probably 50-50, one more delay (at least). Another data point to follow is when the federal courts allow jury trials. You would think when they allow potential jurors into courts, they’ll allow attorneys, paralegals, and witnesses to do live bench trials.

What that means is that the Eleventh Circuit’s decision in the Florida US Stem Cell case will come down before California District Judge Bernal issues his decision (if he ever does). Technically, federal appellate decisions are only binding on the district courts in that circuit, but they are considered persuasive authority for other district courts in other circuits, meaning district courts in other circuits have some leeway to distinguish or not follow it for other considerations.

So the wait continues for the first post-limitation on federal judicial deference to the FDA’s interpretation of its own regulations case.

Rick Jaffe, Esq.

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