June 3, 2020

The Niche

Knoepfler lab stem cell blog

Advice to dubious stem cell clinics: shape up or shut down today

Imagine for a moment that you are out in open water swimming peacefully in the ocean off of…let’s say for the heck of it, the coast of Mexico.

You’re out there paddling around in your nifty swim trunks sipping one of those neat drinks with the little umbrellas.

Suddenly you jerk out of your inflatable swim chair and spill your drink as terror strikes because you see that unmistakable dorsal fin of a great white shark approaching you rapidly.

You’re toast.

What’s worse than a shark?

How about two sharks? You see a second one coming at you as well.

These days stem cell clinics selling non-FDA approved stem cell treatments (aka “dubious” stem cell clinics) are like our hypothetical swimmer out in open water, unprotected with two hungry sharks approaching.

One shark has always been out there trailing them in the form of the FDA.

Today it became clear with a fraud suit filed against a stem cell firm, RNL Bio, that a second, new shark has arrived upon the scene, smelling blood in the water. Perhaps an even scarier type of shark.

Trial lawyers.

So, dubious clinic owners out there reading this blog (and I know you do), if you weren’t scared enough of the FDA (or maybe not scared at all for some unknown reason), be very afraid that you will face civil litigation that could destroy your bank account and your way of life.

Think you are safe because you operate mostly outside the U.S.?

Uh, no.

Today’s stem cell fraud case is against a Korean HQ’d company, RNL, that allegedly did transplants in Mexico.

Think you are safe because to your knowledge none of your patients has had a side effect?

Don’t bet on it.

Six months ago I did a post sending you clinic operators a message that “now would be a very good time to shut down” based on actions by the FDA and FBI.

Today that message is made all the more frightening and real for you, compounded as I said by two sharks on your trail. If you choose to continue to treat patients with untested, dubious stem cell treatments, the new reality is that you must fear that they will in the future turn around and sue your pants off.

There’s an ironic paradox here.

The more patients who pay you thousands to treat them (which you’d think would be a good thing, right?) the more potential plaintiffs there will be out there in the world just waiting for the right time to sue you and of course the trial lawyers will be there to help them.

Very smart, very aggressive trial lawyers.

Kiss your money goodbye.

You don’t even have to have one of your patients have a real negative outcome directly caused by the treatment you gave.

Egged on by lawyers or by their own desire for money or their imaginations making them believe you did something wrong, the patients may sue you for all kinds of outcomes that aren’t even related to the stem cell treatment you gave them.

The bummer of course is that even if the suit is unjust you still have to defend yourself against the suit and that costs big money going to your attorneys….and you still could lose the case.

You should be very afraid at this point, but don’t freeze.

Instead take action.

Shape up and follow the rules or give it up and shut down your stem cell-related operations.

You may scoff at me and my apparent naivety with this advice, but I know that in the back of your mind there’s that fear of being sued that just won’t go away and will in fact quite to the contrary continue to torment you.