Search Results for: Judge Jesus Bernal

Judge drops a bomb on FDA in Cell Surgical Network stem cell clinic case

Cell Surgical Network stem cell clinic chain

In a ruling that could turn FDA stem cell clinic oversight on its head, Federal District Court Judge Jesus Bernal last night ruled in favor of the stem cell clinic chain Cell Surgical Network and other defendants. The FDA had been seeking permanent injunction against them. Here’s the court ruling. Drs. Mark Berman and Elliot …

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In landmark step, judge does not defer to FDA in stem cell clinic chain case, orders full trial

Judge-Jesus-Bernal

In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a …

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9th Circuit hearing on FDA appeal of Cell Surgical Network case: maybe encouraging?

Cell Surgical Nework

I was able to watch some of the 9th Circuit Court hearing today on the FDA appeal of its loss in the Cell Surgical Network lawsuit. This post is my brief impressions as a scientist. What went down? Do the three judges seem to be leaning one way or another? The ruling in this case …

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20 stem cell & regenerative medicine predictions for 2024

Stem cell, crystal ball, predictions

Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024. You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please …

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Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

Burst Biologics, Christopher Jones

The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The …

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FDA appeals Cell Surgical Network lawsuit verdict

Cell Surgical Network stem cell clinic chain

The FDA has finally filed an appeal of the Cell Surgical Network lawsuit verdict.  It took them a very long time for some reason. The stem cell clinic chain Cell Surgical Network and other defendants had prevailed in a federal district court here in California in front of Judge Jesus Bernal. Their adipose cell product, stromal …

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Weekly reads: CRISPR, FDA stem cell loss, pioneering AMD study, MS, Verve Therapeutics

FDA stem cell policy flow chart.

The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics. I believe the ruling was founded in part on …

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Top stem cell stories of 2021: COVID, diabetes, human embryos, clinics in court

regenerative medicine, stem cells 2021

The past year was all over the place for the stem cell and regenerative medicine field. As you can see in my scoring of my 21 predictions for 2021, quite a few things were surprises in terms of what did and didn’t happen. Here’s an overview of the top stories of the year in our …

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New suit for vision loss against Cell Surgical Network clinic

Dr. Alvaro Skupin listing on the Cell Surgical Network website. Screenshot.

A stem cell clinic in the Cell Surgical Network chain has just been sued allegedly for causing vision loss in a patient. By my count, across the U.S. this makes at least 5 patients who have said they were either totally blinded or had some major vision loss after getting stem cells injected into their …

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US Stem Cell clinic loses appeal, could impact pending Cali case?

us-stem-cell-clinic

The FDA filed two suits against unproven stem cell clinic firms in 2018 seeking permanent injunctions against them including US Stem Cell in Florida and Cell Surgical Network, et al. here in California. There’s been a major new development in this story that I see as good news. Court rejects US Stem Cell clinic appeal …

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