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Category: Stem cells regulation

stem cell mis-regulation

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

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…

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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

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…

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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

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…

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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

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…

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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!

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…

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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

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…

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

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

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…

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US Stem Cell Case Update; No breaking news but . . . .

US Stem Cell Case Update; No breaking news but . . . .

Per the Court’s scheduling order, the parties filed their pre-trial materials yesterday, March 29th, including what’s called the Joint Pre-trial Stipulation (“JPTS”) which lays out for the Judge what each party’s contentions are, lists disputed and agreed-to facts and legal issues. It’s about as good of a summary of the case as the judge or the public will get prior to trial. Because federal court cases like this have tight scheduling orders, it’s not an infrequent occurance that the pre-trial…

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US Stem Cell Co-Defendant Gradel Throws in the Towel; Mediation fails (big surprise)

US Stem Cell Co-Defendant Gradel Throws in the Towel; Mediation fails (big surprise)

The consent order of defendant Theodore Gradel has been filed. He is no longer involved with the company and has agreed to a permanent injunction enjoining him basically being in what the FDA considers to be the illegal private stem cell clinic business. here it is: gradelconsentdecree On top of that, the mediation between the FDA and US Stem Cells and its remaining individual defendant, Kristin Comella has failed. No surprise here. What does that mean? Well it’s obviously not…

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Breaking News in the US Stem Cell Injunction Case!

Breaking News in the US Stem Cell Injunction Case!

But first a ho hum update Last week, both parties filed motions for summary judgment. What that means is that both sides are arguing that there is no need for a trial and that the judge can decide the case on the summary judgment papers. The government argues of course that the defendants are violating FDA law by using their more than minimally manipulated products for non homologous use, and that it doesn’t fit within the same day surgical procedure…

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