The FDA’s California stem cell case has a new trial date, sort of

The FDA’s California stem cell case has a new trial date, sort of

When last I reported on the FDA’s injunction action against the California stem cell treatment operation, the judge had adjourned the July trial date because of the recent alarming uptick in COVID-19 cases in the area. The court ordered the parties to confer and come up with a new proposed date in November or thereafter.

The defense’s response to the order was unusual. It attempted to seek an earlier remote video trial. The judge was not prepared to do that just yet, but after further discussions, a few days ago, he issued an order setting a new trial date for November 10, 2020. HOWEVER, the judge ordered a telephone conference on October 19, 2020, to determine whether “1) [the] trial . . . can safely be conducted in-person, consistent with public health guidance; and/or 2) trial can fairly and reliably be conducted through remote appearances by witnesses and counsel.” Meaning, it is not at all clear that the trial will go forward on November 10th.

We already know that the Defendants want to go forward with a remote video trial. My guess is that the FDA might be reluctant. Based on the judge’s decision denying the FDA summary judgement, (the details of which I explained in a previous post, and here is that post: )
the judge agrees with the defense’s position that the procedure removes and reimplants the same thing, namely SVF. Hence the procedure is covered by the same day surgery exception. Therefore, it is not subject to the FDA’s regulatory authority. In short, the FDA is going to have to change the judge’s mind. I would speculate that the feds think they have a better chance of doing that in a live trial. If so, that would suggest that the feds will hold out for a live trial.

There might be another reason for the feds trying to delay the trial. Right now, there is a giant storm cloud over SVF and the California Stem Cell operation. I do not have any direct knowledge, but my experience tells me that kind of cloud is very bad for business. Since the FDA can read the tea leaves, it knows it has an uphill battle with this judge, and it will take the agency at least a year to get an appellate review of the district court’s decision. In the meantime, the FDA is continuing with its PR campaign on the illegality of this and other stem cell products and procedures. So, delaying this case might appear to the agency to have some benefit. But that is all speculation on my part. All we know for sure is that there is a new trial date, but in these uncertain times, it cannot be said that the case will actually be tried on that date.

Rick Jaffe, Esq.

7 thoughts on “The FDA’s California stem cell case has a new trial date, sort of

  1. What is your view of the argument that the expanded product does not fall under the FDCA? While I’d like the judge to agree, it seems silly.

  2. I wouldn’t say it was a silly argument. However, tge sane argument was made by the stem cell clinic in the Regenerative Science case, and ir was rejected by both the District Court and the district of columbia appeals court, and thus the district court In this case must reject it

    1. Why would Venerable reintroduce an argument the court must reject? Does Kisor permit the court to revisit the SSP exception or other issues?

        1. I think what they are doing is preserving the issue for appeal in the new reduced post Chevron deference to administrative agency world. I don’t recall off the top of my head whether Chevron deference was specificly cited by the DC circuit in Regenerative Science, but if it was, then arguably even a district court could come to another conclusion, despite a appellate court’s holding that expansion is more than minimal manipulation. So, I don’t fault them for raising the issue. It’s the right move for both reasons.

          1. The DC court opined, “Moreover, the FDA’s conclusion that the Regenexx™ Procedure does not meet the regulatory definition of “minimal manipulation” is entitled to “substantial deference.”” (— so, since the DC court granted the FDA deference on this issue of whether expansion qualifies for the SSO expecting in the RS case, the court can now consider the scientific details of this question? Must it still dismiss the notion that a cell-based preparation escapes the FDCA’s purview altogether?

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