Browsed by
Category: Stem cells regulation

stem cell mis-regulation

Should you be worried if you banked your SVF/Stem Cells?

Should you be worried if you banked your SVF/Stem Cells?

Comments 1 comment

The injunction entered by the Florida federal district court judge in the US Stem Cell case ordered the company to destroy all of the SVF product which it was storing for their patients and SVF banking customers. I did not think that was right, in large part because the owners of the stored product were not parties to that lawsuit. See my previous post: http://rickjaffeesq.com/2019/07/22/breaking-new-on-the-us-stem-cell-case-svf-destruction-order-stayed-and-svf-owners-intervene-in-the-suit/ here is the final injunction order: permanentinjunctionorder The basis of the judge’s destruction order was…

Read More Read More

Breaking New on the US Stem Cell Case: SVF Destruction Order Stayed and SVF Owners Intervene in the Suit

Breaking New on the US Stem Cell Case: SVF Destruction Order Stayed and SVF Owners Intervene in the Suit

Comments 1 comment

Last week was busy in the US Stem Cell case and some much needed help arrived. First, to their credit, the defendants in the case moved to stay the SVF destruction order for the product it was banking for patients/customers. Although the judge was skeptical that these people had a prioprietary interest in their banked SVF product, she did grant the stay, on technical grounds, basically saying that she’ll continue the stay until the later of the expiration of the…

Read More Read More

Chaos, Unfairness and Illegality in the US Stem Cell Case

Chaos, Unfairness and Illegality in the US Stem Cell Case

Comments 1 comment

I have been following and writing about the US Stem case (and the FDA’s parallel California case) since the company received its warning letter and throughout the litigation. Last month, the judge issued the final injunction order. Here it is: permanentinjunctionorder The order, among other things, mandates the destruction of all SVF product in the defendants’ possession, which destruction is to be supervised by the FDA. (page 9, paragraph 10) That caught me by surprise. I might have missed something…

Read More Read More

The Private Stem Cell Field Moves On; Maybe This Time They’re Be Smarter or More Cautious

The Private Stem Cell Field Moves On; Maybe This Time They’re Be Smarter or More Cautious

Comments 0 Comment

With the recent Summary Judgment decision in the US Stem Cell case, my prediction is that the fat-based stem cell business will slow down and eventually cease to be a thing. Here is the judge’s decision http://rickjaffeesq.com/wp-content/uploads/2019/06/USRM-lawsuit.pdf Lawyers will tell potential entrants into the field that a federal judge has held the use of autologous fat-based products to be illegal, at least pending and barring a different result in the FDA’s companion case in California. However, I do not think…

Read More Read More

Florida Federal Judge Grants Summary Judgment to the FDA against US Stem Cell; Game Over except for the obligatory appeal

Florida Federal Judge Grants Summary Judgment to the FDA against US Stem Cell; Game Over except for the obligatory appeal

Comments 0 Comment

The U.S. Stem Cell summary judgment decision has just come down. It’s 30 plus pages. here it is. USRM lawsuit Result: FDA 1, US Stem Cell 0. Game over except for the appeal, which will take at least a year. I haven’t had a chance to closely read the decision yet, but I am expecting that the judge accepted the FDA’s position in toto. The judge has or will issue a final judgment, and then the case goes up to…

Read More Read More

US Stem Cell Pre-Trial Conference Now Set for June 7th, so look for a decision before then, or another court ordered adjournment

US Stem Cell Pre-Trial Conference Now Set for June 7th, so look for a decision before then, or another court ordered adjournment

Comments 1 comment

On May 9th, the judge in the U.S. Stem Cell case put off the pre-trial conference from May 29th until June 7th, meaning she’s not quite done with the summary judgment decision and needs alittle more time. It’s a big complicated case with alot of papers flying back and forth. Normally judges try to decide summary judgment motions in 60 days or so. If she issues her decision in early June, that would be basiclly two months since the cross…

Read More Read More

US Stem Cell Case Update: Judge Puts off Pre-Trial Conference for Three Weeks

US Stem Cell Case Update: Judge Puts off Pre-Trial Conference for Three Weeks

Comments 0 Comment

Yesterday, May 9th, the Judge in the FDA’s case against US Stem Cell and Kristin Comella entered an order changing the pre-trial conference date from May 17th until June 10th. The trial has been pushed back from June 10th until June 24th. Why: The obvious reason is that she hasn’t finished her decision on the parties’ cross motions for summary judgment, and there’s no point having a pre-trial conference with summary judgment motions pending. So, she’s giving herself another couple…

Read More Read More

The Niche Weighs in on the Manhattan Stem Cell Clinic’s Answer to the AG’s Lawsuit, and Some Breaking News!

The Niche Weighs in on the Manhattan Stem Cell Clinic’s Answer to the AG’s Lawsuit, and Some Breaking News!

Comments 0 Comment

I represent the Manhattan stem cell doctor whom the NY AG has recently sued for false advertising and fraud. Her is the NY Times story about the lawsuit: https://www.nytimes.com/2019/04/04/health/stem-cells-lawsuit-new-york.html I decided not to comment as part of the mass media’s coverage of the AG’s filing the lawsuit, because I needed to take a hard look at the complaint and think carefully about any response. I did, and put together an Answer and Counterclaims. Here is my prior post which has…

Read More Read More

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Comments 0 Comment

Earlier this month, the New York Attorney General’s Office filed a false advertising case against a Manhattan Stem Cell clinic owned by Joel Singer, M.D. The clinic offers autologous stem cell transplant procedures for a wide variety of medical conditions. The clinic used to be affilated with the California Cell Surgical Network run by Mark Berman and Elliot Lander, who as you know, are defendants in one of the two FDA’s civil injunction lawsuits. Here is the Washington Post article…

Read More Read More

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

Comments 0 Comment

Per Pacer, on April fools day (with whatever significance that has to you), both sides submitted their replies on their respective summary judgement motions. The case is now as lawyers say, sub judice, (submitted for and pending decision). No big surprises in these last papers. The government says the defendants are violating FDA laws and regulations, based on the FDA’s interpretation of the FDA statutes, and that the defendants admit the violations. The defendants argue that they are not subject…

Read More Read More