While working yesterday, I had the zoom California stem cell trial playing sort of as background music. Here are some of my quick takeaways.
1. My strongest impression was of the Judge. As a lawyer who does trial work, he was wonderful to watch. He is very, very sharp, but he’s also very laconic. Lawyers object. He thinks about it for a second, then gives a short response, usually 1 word. I think he was on the money every time. No detectable bias. He moved things along well but politely and had a nice touch of humor, but low keyed. No ego. No bombast. (No Judge Ito) He was barely there, but ever-present. Masterful and an absolute pleasure to see him work.
2. The government presented the compliance officers who did the inspections. Very cut and dried. They were as you would expect them to be on direct. Factual with a narrow focus.
3. The cross-examination was very competent. The main points as you would expect were 1. none of the inspectors have any competence or experience investigating or inspecting a surgical facility. 2. That the defendants and their operations were fully compliant with the applicable surgical requirements in terms of good surgical practices, safety, and sterility, or at least these government agents don’t know anything about the requirements and have no information that that is not the case. 3. None of them even have ever inspected such a place, though they did see some video of some cornea operation. (and they all had recently stayed in a Holiday Inn). The cross was effective on that point. 4. Defense Counsel kept correcting the witnesses for using the word product instead of treatment, which the judge endorsed, saying that was the issue in the case, whether SVF was, in fact, a product. I am sure the defendants were happy to hear that and smiled every time defense counsel made that objection and smiled again, every time the judge agreed and once again, every time the government witness had to apologize, and that happened often.
4. The case involves more than SVF same-day surgical procedures. Some patients received this vaccina stuff (smallpox vaccine or something like that) which complicates things for the defense. Also, some patients had their cells expanded by American Cryogenics, who also received a warning letter. That’s a tough fact for the defense since there is case law on the expansion of stem cells via the Regenerative Sciences case which is a federal circuit court authority. My guess is that the defense will (or should at least) try to use the change in the judicial deference standard to argue that the case would be decided differently today (to the extent that the opinion deferred to the FDA). But you try the case you have, not the one you wish you had.
5. Paul Knoepfler was a government witness. I missed the direct, but from what I know, I think his only connection to the case was an exchange of communications with Mark Berman about his treatment and clinic. The cross tried to show bias. Something I didn’t know was that his lab received 2 million bucks from the California Stem Cell program. Having read his posts about Berman et al, and knowing their interaction, and understanding the issues in the case as I do, I’m going with his testimony won’t move the needle either way. It is pretty clear that he has a very specific point of view, but it’s the judge, not Professor Knoepfler who gets to decide if SVF is a new drug or part of a surgical procedure beyond the jurisdiction of FDA regulation, and that brings up two important points.
6. A big (and of course expected) part of the cross was trying to establish the limits of the FDA jurisdiction. The witnesses conceded that the FDA didn’t have jurisdiction over “the practice of medicine” in the abstract. There was a lot of back and forth on cross with the government witnesses on this point. But of course, the issue was the SVF and the key buzz concepts of more than minimal manipulation and homologous use, with ample defense references to 1271.15 (the same-day surgical procedure exemption.)
7. Another point briefly inquired on in cross was the cGMP requirements and jurisdiction to enforce them under the chapter (21 CFR 1271). The FDA’s current position is that regardless of 1271.15 (same day surgical exception) and even if SVF is held not to be a new drug, the place still has to comply with cGMP and good tissue practices which it didn’t. The defense is going to dispute that and the judge is going to have to decide the issue. As the guy who wrote probably wrote the first opinion clearing autologous MSC’s, I can tell you that wasn’t the FDA’s opinion back when the issue first came up in the early to mid-2000s. The FDA’s position was that no jurisdiction meant no jurisdiction because it was the practice of medicine and it was a state law matter. But things change I suppose. It will be interesting to see how the judge handles that matter.
8. Finally, all the lawyers were perfectly competent and quite good. The direct case on a technical case like this is not much of a test for a lawyer. The cross is where a lawyer can show her stuff. And she was quite good, very methodical, though perhaps a touch too scripted. It was obvious that she had a template for questioning all of the same kind of witnesses and I think by the third one, people following the examination could say her lines before she said them (you’re not a medical doctor, you didn’t go to medical school, you don’t have any training in medicine). The judge is a smart guy, and I’m guessing he would appreciate it if she shortens the script, because he gets the point.
The judge knows the issues cold. He has already written an extensive summary judgment opinion on the case, and if the defense was really clever, they’d make sure that every question they asked was geared to essentially reinforcing what the judge already said previously. Apart from the new (and somewhat thorny) issues, it’s their case to lose because they’ve already done a hell of a job so far.
Rick Jaffe, Esq.