The U.S. Stem Cell summary judgment decision has just come down. It’s 30 plus pages.
here it is.
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 the court of appeals, starting with the filing of a notice of appeal.
The big question
Will the company comply with the injunction order? My guess is that the lawyers will tell the company that it’s over, (unless some court issues a stay of the judgment, and I think that’s unlikely).
It’s one thing to defy the FDA’s asserted position in a warning letter and guidance documents. It is an entirely different thing to violate a federal court injunction order. That carriers civil and criminal contempt penalties and a ticket to a federal trial (bench for civil contempt, and a jury for criminal contempt). Done that, it’s not fun for the client.
The US Stem Cell affiliates throughout the country are going to have to do some hard thinking about this, at least those who haven’t moved on yet from SVF products derived from fat.
I’ll write about this again, once I have reviewed the judge’s decision closely. While I think this decision is legally significant, practically, it will have less effect than the regulators might expect, because, as I’ve said many times before, this was expected and many in the field have moved on to new HCT/P’s and here we go again, from the beginning.
Rick Jaffe, Esq.