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Tag: SVF

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

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Yesterday, October 27th, the Feds filed a notice of appeal of Judge Jesus Bernal’s decision awarding Cell Surgical Network and their founders, the late Mark Berman and Eliot Lander, judgment in the FDA’s attempt to shut them down for their SVF (stromal vascular fraction) stem cell treatment. Of course, the feds were going to appeal. Contrary to the Florida district court and the Eleventh Circuit in the US Stem Cell case, Judge Bernal found that SVF was not more than…

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The United States vs Your Own Stem Cells: Trial days Three and Four

The United States vs Your Own Stem Cells: Trial days Three and Four

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The FDA’s case against the California Stem Cell network went forward last Thursday and Friday for the third and fourth days. Yesterday, Monday was an off day. The trial resumes today at 8:30 PDT. Very briefly, (I hope because I have a lot on my plate today) here are my main observations: 1. The judge has already made up his mind about the case. In a sense that is an obvious implication of his decision denying the government summary judgment….

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For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

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If you are in the business of providing autologous stem cell transplants during the same surgical procedure for therapeutic purposes, the next couple of months are going to be very consequential for you because of the decisions in the two big cases in the field. The appeal of the US Stem cell case is now under consideration by the appellate court. Oral argument was held on January 13th. By some accounts, the judges gave the government a hard time. But…

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Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

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Yesterday, California federal district court judge Jesus G. Bernal on his own adjourned the the FDA’s trial against Cell Surgical Network (“CSN”) and their owners Mark Berman and Elliot Lander. The parties were ordered to meet and confer about a new trial date to take place after November, 2020. The trial had been scheduled to commence on July 28th. Because of my deep interest in the case, I have been checking the Riverside Ca. Covid-19 numbers and once the numbers…

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Stem Cell Shocker: Cali. Federal Judge Denies the FDA Summary Judgement and Orders a Trial in the Cell Surgical Network Case

Stem Cell Shocker: Cali. Federal Judge Denies the FDA Summary Judgement and Orders a Trial in the Cell Surgical Network Case

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Ok, let me get this out of the way up front. I predicted publicly and privately that the California federal court judge would follow the reasoning and result of the Florida federal judge who granted summary judgement to the FDA and issued a permanent injunction barring the Florida stem cell operation from using its SVF (stromal vascular fraction) product in humans. I am very happy to report that I was wrong, (at least for now and until there is a…

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There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

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Recent fillings and orders which were expected: Longer papers for summary judgement. The parties jointly moved to allow each to file more pages than is allowed for summary judgment under the local rules. The parties wanted double the amount. The judge gave them less. Yesterday the parties filed a joint motion to cancel the local rule required mediation. Mediation is a waste of time in a case like this. There’s no money damages sought, and the Government already told US…

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