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Thread: Chaos, unfairness and illegality in the us stem cell case

  1. #1

    Default Chaos, unfairness and illegality in the us stem cell case

    "I think the stem cell institutional mafia should read some of these letters, and maybe it will restore some needed humility and compassion which is often lost when institutionalists concern themselves with the Public rather than actual people." Wishful thinking Mr. Jaffe.

    July 17, 2019 Richard Jaffe

    I have been following and writing about the US Stem case (and the FDAís parallel California case) since the company received it warning letter and throughout the litigation. Last month, the judge issued the final injunction order. Here it is.

    The order among other things calls for the destruction of all SVF product in the defendantsí possession, which destruction is to be supervised by the FDA. (page 9, paragraph 10)

    That caught me by surprise. I might have missed something in the pleadings and motions in the case, but I did not know or appreciate that the company was storing or banking SVF for patients, or possibly even non patients who just wanted to bank their stem cells. I wonder whether the Judge knew that.

    Caveat: I havenít seen the US Stem Cells SVF banking agreement, but I have worked on some cord banking agreements. There is one thing I am fairly confident about, and that it that the product is owned by the patient/consumer and not by the banking facility, in this case, US Stem Cell or some affiliate.

    Legally, the relationship between the US Stem Cell and the SVF donor is a bailment, not unlike, (but much more complicated obviously) than when you check your coat with the coat check or when you park your car in a commercial garage. The difference of course is that the entity holding the property helped create it. But that does not change the ownership issue.

    Federal civil procedure defines parties as either necessary or indispensable. My impression, (rather than my considered legal analysis) is that the owner of the property would be an indispensable party, unless the bailment agreement specifically conferred on the bailee (the party holding the property in trust for the owner/bailor) granted it the exclusive right to dispose of or defend the property or something like that, and I would doubt there is such a provision in the banking agreement.

    Normally, failure to join an indispensable party would be brought up by the defendant in a federal case, but I donít think it was. I would argue that the government lawyers had an obligation to bring it up, since it the government is not just an ordinary litigant. I think the issue could also be raised by the court itself, if the court becomes aware of the issue. (Just my impression based on past work on related issues, not a considered legal opinion). I seem to recall that failure to join an indispensable party is a fatal defect to a case, whenever it is raised, even on appeal.

    After the injunction order was issued, US Stem Cells notified all of its banking customers of the injunction order requiring the destruction of their property and advised them to either write to the court or hire an attorney. (alittle late in my book). Iíve heard that there is a Florida attorney who is trying to find enough customers/clients to collect an adequate retainer.

    The case docket lists 200 or so letters from customers who have banked their stem cells/SVF.

    Here they are




    I think the stem cell institutional mafia should read some of these letters, and maybe it will restore some needed humility and compassion which is often lost when institutionalists concern themselves with the Public rather than actual people.

    These letters from the SVF owners show the outrageous result of the Courtís order. I have to wonder whether the judge knew that the order would cause the destruction of property of people who were not parties to the lawsuit. These peopleís property is being taken away from them without due process or just compensation. Last time I checked, that is illegal under the Fifth Amendment rights, and actionable under 42 U.S.C 1983, and could result in money damages as well as injunctive relief against the government. Who would you sue? The government and its lawyers for sure. Maybe the defendants also. But the Government is the party whose attention you need to get.

    What would be the goal of the lawsuit? Thatís pretty simple: Ask the judge to modify the order to allow the SVF owners to remove their property from US Stem Cell, and if necessary, have it shipped someplace else. There might be a procedural wrinkle or two to deal with first, but thatís where the case should end up.

    Hereís hoping . . . .

    Rick Jaffe,
    First treatment in 2007. Pioneering ever since.


  2. #2

    Default The Court has temporarily stayed the destruction of our Stem Cells

    Received this from my Attorney who is representing over 60 US Stem Cell customers

    Dear Group,

    ďI am happy to report that the Court has stayed the immediate destruction of the stem cells. In ruling on a motion for clarification filed by US Stem, the Court has stayed the destruction of the stem cells until 30 days after (i) the expiration of the dealine to timely file a Notice of Appeal by US Stem or (ii) if US Stem files a notice of appeal, the issuance of a mandate by the appellate court. That is the good news Ė for now your stem cells are not to be destroyed.

    However, the Court also shows tremendous skepticism that anyone can legally own the stem cells because the stem cells constitute SVF Product and SVF Product is an adulterated and misbranded drug.Ē

    Received this from US Stem Cell

    Dear Stem Cell Bank Customer,

    ďThe court has granted our motion to postpone the destruction of your stem cells.
    On July 19th, 2019, U.S. District Judge Ursula Ungaro of the Southern District of Florida agreed to stay (or postpone) the destruction requirement within the order that stated: that "[w]ithin thirty (30) calendar days after the entry of this Order, Defendants, under FDA's supervision, shall destroy any and all SVF Product that is in Defendants' possession, custody, or control." More information is forthcoming.

    Please note that we are working diligently to consider all options for our patients. As always, the health of our patient community is our priority.

    Thank you,

    U.S. Stem Cell, Inc
    13794 NW 4th Street, Suite 212
    Sunrise, FL 33325
    Tel: (954) 835-1500
    Fax: (954) 845-9976Ē

  3. #3


    Thanks for sharing this! One thing that really irks me is why someone on the court, who likely has little if any scientific knowledge or medical experience, is once again going to determine the fate of patients, who with informed consent, agreed to treatment and in the case of US Stemcell storage of their own stemcells. Our cells are not drugs and the FDA's abuse of power in this matter has cost lives. The court should not allow this to happen. Patients deserve the right to determine the type of medical care they want without government or academia interfering. Sadly, there is so much money at stake, that is probably not going to happen anytime soon.
    First treatment in 2007. Pioneering ever since.


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