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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

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

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

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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 . . . .

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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)

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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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There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

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Recent fillings and orders which were expected: Longer papers for summary judgement. The parties jointly moved to allow each to file more pages than is allowed for summary judgment under the local rules. The parties wanted double the amount. The judge gave them less. Yesterday the parties filed a joint motion to cancel the local rule required mediation. Mediation is a waste of time in a case like this. There’s no money damages sought, and the Government already told US…

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The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

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Since my last update about these cases in early August, not much has happened, which is to be expected in federal civil litigation. Nonetheless, here is an update. Let’s start with what hasn’t happened 1. There has been no announced agreement in either case that the defendants have stopped treating patients with their SVF, stem cell therapy which the FDA claims are unapproved new drugs, adulterated and misbranded, pending the final decision by the judges in these injunction actions. 2…

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Hard choices for the stem cell defendants in the FDA’s injunction cases

Hard choices for the stem cell defendants in the FDA’s injunction cases

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As recently reported, the FDA filed permanent injunction actions against the two highest profile stem cell clinic/operators, US Stem Cells Clinic and Cell Surgical Network/California Stem Cell Treatment. See my post at http://wp.me/p7pwQD-dz As an FDA attorney who has worked on civil and criminal stem cell investigations and cases, I can tell you that these defendants are facing a major decision: whether to stop treating patients during the pendency of the permanent injunction action. Here’s what I believe to be…

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The FDA’s injunction complaints against US Stem Cell Clinic and California Stem Cell Treatment Center

The FDA’s injunction complaints against US Stem Cell Clinic and California Stem Cell Treatment Center

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Yesterday, May, 9th the FDA filed complaints seeking permanent injunctions in Florida and California federal courts against the two highest visibility U.S. stem cell operations. For the interested, here are the complaints. comella bermancomplaint What’s in the complaints? It’s pretty much as I said in yesterday’s post. The two complaints are substantially identical and no doubt prepared in Washington, primarily by the FDA with input from Main Justice (or vice versa). Both entities were inspected by the FDA, after which…

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