May 31, 2020

The Niche

Knoepfler lab stem cell blog

Stem Cell Lawsuits

5 min read

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 judgment 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 permanent injunction. You can read the new ruling here. The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of …Read More

6 min read

Last year around this time I took my annual plunge to make 20 predictions for the coming year for the stem cell and regenerative medicine field. I even made a crystal ball graphic to highlight the complexity of the stem cell ecosystem into which these predictions were embedded (see image) for 2019. How’d I do? Below I grade my 20 predictions for this year. You can in addition see my grading of my 2018 predictions here. In the next week or so I’ll also …Read More

3 min read

As I broke the news yesterday, the high-profile fat stem cell clinic firm U.S. Stem Cell (USRM) just lost a groundbreaking court case. Here is the FDA’s official reaction today to the court ruling. Also, since the ruling major media have been covering the court ruling. Here are some examples: From the Washington Post from William Wan and Laurie McGinley we have FDA wins groundbreaking case against for-profit stem cell company. Michael Hiltzik of the LA Times has a blunter headline. Backing the FDA, a …Read More

3 min read

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S. It’s a big victory for science, regenerative medicine, and patients. …Read More

5 min read

Unproven stem cell clinics are facing a variety of lawsuits these days including two prominent cases filed by the FDA. There are widespread patient suits against clinics as well. In April we saw a new kind of suit in the form of the NY State Attorney General (AG) Letitia James filing against a Manhattan clinic. I’m not going to rehash the allegations (see the above link to my piece with more info), but this one quote from the AG office has some key details: …Read More

3 min read

The New York State Attorney General (AG) filed suit this week against a Manhattan stem cell clinic. It’s a landmark case. The defendants are Image Plastic Surgery, LLC, Park Avenue Stem Cell, and Joel B. Singer, M.D. The clinic markets adipose stem cell injections for a variety of health conditions. Park Avenue Stem had belonged to the clinic chain Cell Surgical Network, which itself is facing both a federal lawsuit seeking a permanent injunction and a patient lawsuit naming them as a co-defendant.  An …Read More