It’s been a long saga for the FDA and the unproven stem cell clinic group called Cell Surgical Network, headquartered in Beverly Hills. A court case involving the two has been unfolding for many years. It has big implications for agency authority and the hundreds of stem cell clinics across the U.S. The case took […]
I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them
FDA wins big in key federal stem cell clinic court case Read More »
Remember the Lung Institute? Many patients raised red flags about their experiences there. It was also once known as the Lung Health Institute. More generally, patients who have been harmed by stem cell clinics have had to rely on other ways beyond the FDA to try to do something about it. The FDA has been
Lung Institute stem cell clinic loses class action suit, patients awarded $9M Read More »
An unproven Georgia stem cell clinic called Superior Healthcare and other co-defendants recently lost a key court case. Some of you may remember that the Attorney General (AG) of Georgia Chris Carr and the FTC have been collaborating on this case. Now we have the good news that they have won the case via a
Georgia AG & FTC win Superior Healthcare stem cell clinic case, seek $17 million Read More »
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
9th Circuit hearing on FDA appeal of Cell Surgical Network case: maybe encouraging? Read More »
A patient who got scientifically unproven and non-FDA-approved stem cells from Dr. Alvaro Skupin, filed suited against him, his wife who is often known as Doctora Nancy or Dra Nancy Alvarez, and associated businesses. These firms include the stem cell clinic known as Mother Stem Cell Institute in Florida, where the injections apparently took place.
Suit against Dr. Alvaro Skupin & Dra Nancy Alvarez over blinding at clinic is settled Read More »
It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several
Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions Read More »
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
FDA appeals Cell Surgical Network lawsuit verdict Read More »
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
Judge drops a bomb on FDA in Cell Surgical Network stem cell clinic case Read More »
Dr. Paolo Macchiarini exemplifies how things can change quickly in the stem cell world and go from sky highs to deep lows. Stem cell rollercoasters Over the years, a few academic stem cell researchers as well as some operators in the unproven clinic sphere have had dizzying ups and downs. There’s John Kosolcharoen. His company
Paolo Macchiarini guilty in criminal stem cell case but does a Houdini again Read More »