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 Stem Cell Clinic what it wanted (stop selling stem cells). The offer was declined. Nothing has changed. The judge should grant the motion.
Summary Judgment motions are due on or before March 11, 2019, which is this Monday. Look to both sides moving for summary judgement.
Here are the arguments each side will make:
The Government’s motion:
- There are no disputed facts requiring a trial. US Stem Cell Clinic (USSCC) is extracting MSC’s from adipose tissue and processing the material into some kind of (SVF) Stromal Vascular Fraction, which it is using autologously on patients for a wide variety of non homologous uses.
- The extraction process and subsequent processing of the HCT/P’s constitute “more than minimal manipulation.” as defined by FDA regulations and guidence documents.
- As a result, the products are regulated as 351 (new drugs) not just 361 matieral (same day surgical procedure, homologous use and not more than minimal manipulation).
- There is no NDA or IND on file for the new drugs.
- The lab producing the product is not cGMP or cGTP compliant per FDA inspection memorialized in a 483 inspection report and a subsequent warning letter.
- As a result, USSCC’s prior and continued use of these products is illegal under Federal law, and specifically, introducing into interstate commerce an unapproved new drug. In addition, the drug is misbranded (since there is no approved labeling and instructions for use) and adulterated (because the drug manufacturing facility is not cGMP and cGTP compliant, and other reasons).
- The court should give deference to the FDA’s opinion under the Chevron doctrine, and there is direct precedent supporting the FDA’s and rejecting the Defendant’s anticipated argument (practice of medicine) in the Regenerative Sciences case decided by the DC Circuit.
US Stem Cell Clinic’s motion
- There are no disputed facts requiring a trial. USSCC is extracting MSC’s from adipose tissue and processing the material into some kind of (SVF) Stromal Vascular Fraction, which it is using autologously on patients, for homologous use.
- The SVF is not more than minimally manipulated as the character of the cells are not being altered.
- The material is removed and reimplanted during the same surgical procedure making the procedure exempt under 21 CFR 1271.15, under which the FDA has declined jurisdiction to regulate this and other similiar surgical procedures.
- USSCC is involved in the practice of medicine which is a matter of state law and not within the FDA’s jurisdiction, like any other surgical procedure that uses the patient’s own blood product for same day reimplantation.
- (If they’re clever, they might come-up with something else which hasn’t been talked about much, but we’ll just have to wait and see).
Government 1 — US Stem Cells 0,
is my prediction
Will it matter?
Not as much as the Government (and the stem cell institutional players) think and hope.
Why is that?
Once you’re bitten by the stem cell bug, you don’t get out just because of a little set-back like a permanent injunction (even affirmed by the Court of Appeals). You adapt (or metastasize depending on one’s perspective). The public company involved or related to the lawsuit is non essential and expendable. There are other public company shells to be had in the next iteration of the business.
Stem cell therapy is the center of the medical universe right now. It’s intoxicating especially for participants who are not licensed physicians. Just look at all the chiros and naturopaths getting into it. And let’s face it, it’s a growth industry with great financial rewards, like the gold rush or the wild west. Once you’re bitten….
My guess is that Comella and her crew already have their Plan B figured out and ready to go, and it wouldn’t surprise me if Plan B is already up and running in a small way. And since she’s not a licensed health care practitioner, she doesn’t have to worry about a state medical board stopping her.
So I’m betting that regardless of inevitable permanent injunction granted on summary judgement or its affirmance by the Court of Appeals, she’s not leaving the field so fast.
Rick Jaffe, Esq.