I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action.
But I don’t.
I just can’t get past the fact that this Florida stem cell operation allowed a nurse practitioner to inject stem cells into several patients’ eyeballs which resulted in total or partial blindness. A nurse practitioner! Legal though it may have been under Florida law, it is an inexcusable lapse of judgement. Plus, the clinic had already settled several malpractice lawsuits and is facing at least one more lawsuit involving a patient.
I am an advocate for a patient’s right to use his/her own stem cells, but that doesn’t mean that a clinic which continues to cause serious harm to patients has the right to keep injuring them.
In my opinion, US Stem Cells has done serious and irreparable harm to patients, and it needs to be stopped now, not in next few years, which seems like the FDA’s current time table. I don’t often agree with the big dog (aka Paul Knoepfler) but on this issue, I do. See his post at https://twitter.com/pknoepfler.
How the Florida clinic can be stopped sooner rather than later
One of the stem cell luminary thought leaders, Bernie Siegel mentioned to me his hope that the latest big malpractice case against US Stem Cells might shut the place down. I told him I didn’t think so. Here’s why:
Malpractice claims are typically covered by malpractice insurance, and I have to believe given the clinic’s past experience, the first bill it pays after rent is its malpractice policy premium. It’s surely tough being sued, but when you’re not paying to defend and not paying the settlement amount, it’s not quite as tough, and is not a business ending event. So I don’t think any single or even a small number of malpractice lawsuits will do the job.
More effective would be fraud or deceptive practices lawsuits. These most likely won’t be insurance covered, at least not by malpractice insurance. I think there has been at least one such case filed against the clinic by a Miami law firm. I’m rooting for the plaintiff in that case. But these cases take time, and often times, the cases are settled. And insurance or not, I assume these Florida clinic folks have made a ton of money from their stem cell patient business, and they also have a training and franchise operation of sorts, so I wouldn’t expect even a fraud lawsuit or two to put them out of business, not in the short term at least.
So where does that leave those that want to see this clinic gone now?
We have to circle back to the FDA and think about what the agency would need to do to stop this clinic now(ish). And while some parts of the proposed plan may seem harsh, shocking and almost unbelievable, all these tactics have been used against me and my physician/clinic clients in the past by the FDA and other federal agencies.
1. Get the FDA’s OCI (Office of Criminal Investigations) involved
The FDA site inspection which resulted in a form 483 inspectional observations last year establishes what the clinic is doing. The statutes as interpreted by the final guidance documents establish probable cause that the FDA criminal trifecta has been violated (introducing into interstate commerce an unapproved new drug, misbranding and adulteration). The prior warning letter and the injunction complaint establish sufficient knowledge and intent to support a probable cause finding that the crimes are felonies. That should be enough for a federal magistrate to sign-off on a search warrant.
2. Execute the search warrant and take all the clinic’s patient records. If the clinic wants to see the medical records, it will have to come down the local FDA’s office and copy them.
3. Have the warrant search for non-FDA cleared medical devices or any other devices used in connection with the alleged criminal activity. (The latter is not a slam dunk.) That might/would stop the clinic from processing the fat into the stem cell SVF (stromal vascular fraction) product.
4. Invite the Florida medical board to participate in the raid. I don’t know whether the board has taken any action against the nurse practitioner and the supervising doctor yet, but if it hasn’t, there’s probably a decent case for an interim suspension proceeding against both. These proceedings are done ex parte, meaning it’s like a star chamber, done without telling the doctor in advance of the suspension.
5. Start interviewing the clinic’s patients. Many will be supportive of the clinic, including some who have received no benefit, but some won’t be.
6. Interview all the clinic’s employees and vendors/suppliers. OCI has some interesting interviewing techniques which in effect threaten criminal prosecution to people doing business with the target without technically threatening them, but the vendors get the message.
As I said, some or all of this might seem like legal thuggery, but me and my clients have been on the receiving end of all of them (Many of these tactics are discussed in chapters 2 and 9 in my book, Galileo’s Lawyer.). Combined, these tactics will get the clinic’s attention in a way which hasn’t heretofore happened. The other purpose of my discussing this is to show the FDA’s investigative tool box in cases where it really wants someone gone.
Other Government and private actors
US Stem Cells is a public company and that opens up another line of attack. The continued publicity already has and will continue to generate some interest by the SEC (Securities and Exchange Commission) which is looking into the company’s reporting documents (10K’s and 10Q’s). It’s probably a safe bet that the company’s disclosures were inadequate. With all the federal attention, some class action firm might file a shareholder’s suit, and that kind of suit burns a lot of cash for the public company.
The private lawyers who have filed civil malpractice or fraud lawsuits or are contemplating filing will be circling in the air waiting for any government action and especially any agency or judicial decision, which will make the civil fraud or SEC claims easier and faster to resolve favorably. To that end:
The FDA and the US Attorney’s Office should do what they should have done in the beginning, file a preliminary injunction motion, and request a hearing as soon as practical.
That’s going to present some interesting conundrums for the clinic’s principals. Do they testify? If they do, they can’t lie, or they’ll be charged with perjury. Can they say they didn’t know what they were doing is illegal? They can say it, but the judge doesn’t have to believe it. I doubt they’ve been told by an FDA attorney that what they’re doing is legal, so there won’t be an “advice of counsel” defense. Ultimately, they will either be forced to testify and most likely further incriminate themselves, or they’ll fold their tent and go away. (I’d bet on the former.)
If they don’t close down, then the final step is a criminal indictment, and that will put a whole new complexion on things. There’s a saying in criminal law. “You can beat the rap, but you can’t beat the ride.”
But in this case, once the blinded patients and the other injured patients testify, a preliminary injunction case, the permanent injunction case and a criminal trial are effectively over. No reasonable judge or jury is going to let these people continue.
And that’s why this is such a horrible case for stem cell advocates like myself. The idea that these people are the poster children for patients’ unfettered access to their own stem cells is disconcerting. That this case might set precedent for all same-day surgical procedure clinics should be distressing to all such clinic operators.
Therefore, best case scenario for both sides of the debate would be for the Florida clinic to voluntarily shut its doors now. Since that’s not going to happen, next best case scenario for everyone (including and especially patients) is that the clinic be shut down by the government as soon as possible.
And after that happens, the plaintiffs attorneys circling above will swoop down pick the clinic and its operators clean. If the clinic operators have an asset protection plan involving family members or family trusts, there will be fraudulent conveyance lawsuits.
Government and private action could trigger a voluntary bankruptcy proceeding by the corporate clinic/franchise entity. If so, the bankruptcy trustee will hire an attorney whose main job will be to claw-back all the money paid to the insiders, at least in the year prior to the filing, and probably longer. Ultimately, the lawyers (on both sides) will get it all.
That’s how I see it playing out if the FDA decides to take the case more seriously.
Of course, this is just my opinion and speculation based soley on publicly available information viewed through the lens of my 35 years working my side of the street.
What effect would all of the above have on the other private stem cell clinics?
Probably make them much more careful in what they do, say, and who they do it to. And even for a guy on my side of the street, that’s a good thing.
Post Script: I’ve recently read that these people have a new marketing idea and targeted audience: They’re doing penis stem cell injections.
Here we go again!
Rick Jaffe, Esq.