On March 3, 2017, the Texas Medical Board (TMB) will decide on a sanction for Stanislaw Burzynski, M.D. Ph.D. in the current case against him. Because I am his long-time former attorney who handled both of his prior medical board cases and was the attorney on this case until a few months before the hearing, I have a unique perspective. But there’s a caveat: I am still bound by the attorney/client privilege. However, it’s a free country, and I can give my opinion based on public documents, what was told to me by people on the other side, and my perspective.
Some Background about Medical Board Cases
Over the last three plus decades I have defended medical mavericks in board cases in maybe thirty states. In most states, medical board investigators investigate the complaints and a panel of the medical board members decides whether a complaint will be prosecuted. Medical board cases are prosecuted by the medical board’s litigation department (like in Texas) or the state attorney general’s office (e.g., California). Ultimately, the members of the medical board decide the case, usually advised by the medical board’s general counsel (like in Texas) who is the boss of the litigation department, which prosecutes the case. Very cozy and efficient isn’t it?
The above cartoon is how it looks from the defense table in these cases.
In fairness, most states now have an administrative law judge (ALJ) who is independent of the board, and who either hears the case, or advises the board members about the legal issues (Washington is an example of the later). But even in states where the ALJ hears the case and issues a decision, the ALJ is just issuing a “proposal for decision” (PFD) which is sent to the board for review. In most states, the boards have almost complete discretion to accept or reject all or any part of the ALJ’s PFD, and can simply write its own decision based on the record in the case (like in California).
The frustration for defense counsel in these administrative cases is that you could get a perfectly reasonable decision from a neutral, professional judge, only to have it completely rejected by the medical board, just because….
The First Burzynski Medical Board Case
That happens all the time with medical mavericks and that’s exactly what happened to me in Burzynski’s first medical board case in the 1990’s. After six years of litigation, the ALJ cleared him of the most serious charges, only to have the charges reinstated by the medical board. (If you want the details, see chapter 2 in Galileo’s Lawyer. https://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301/.
However, the board’s reinstatement lasted less than two hours. We got an immediate TRO freezing the board’s decision, then a preliminary injunction pending the protracted appeals process. By the time the Court of Appeals affirmed the board’s order two years later, it was moot and no longer had any practical effect. (Described in detail in my book). I don’t think the board was happy with Burzynski or his lawyer.
Many years later, in its 2011 legislative session, the Texas Legislature recognized the general problem of the medical board making arbitrary changes to ALJ’s decisions and passed a compromise, partial fix. Before I tell you the fix, here’s what you need to know about administrative law decisions, regardless of whether they are made by a judge or a board. Each decision has three parts: findings of fact, conclusions of law, and a sanction (if a violation is found).
Prior to the 2011 change in the law, the TMB like most administrative agencies, could accept, reject or change any of the three components of an ALJ’s PFD. However, after the 2011 change, the TMB lost its ability to alter or reject a finding of fact or a conclusion of law. The compromise was that Texas ALJs could no longer issue proposed sanctions. The upshot was that if the ALJ found no violations, the TMB’s only remedy was to appeal the ALJ’s decision to the Texas district court, and good luck with that.
On the other hand, if an ALJ sustains some allegations of misconduct, meaning the judge issues findings of fact and conclusions of law against the doc, the Board decides the sanction.
Burzynski/Medical Board: Round 2
The TMB went after Dr. Burzynski again between 2010 and 2012, and that case was governed by the new law. Right before the hearing in April 2012, I received a favorable legal ruling which effectively cut the heart out of the board’s case. Because the ruling was unchangeable by the board based on the 2011 law, the board was forced to withdraw its case against Burzynski. That was very good for us, because it’s always better not try a board case. It was even better because the medical board was forced to dismiss its own case.
It was probably sort of humiliating for the TMB since many in the medical establishment and the quack busters/sceptics were adamant that that Dr. Burzynski’s license be revoked and that his clinic be shut down. The board didn’t get it done.
After losing that case, the TMB almost immediately went after Burzynski again. This was a continuation of what the various branches of government had done to him in the 80’s and 90’s. I called it “whack-a-mole” in my aforementioned book.
So starting in 2013-2014 the board began anew. It started with a simple complaint piggybacking on some warning letter the FDA wrote about Burzynski’s web site promoting the clinical trials. The board claimed that the FDA letter was proof of false advertising under state law or the letters themselves were actionable.
Then the case metastasized into a 204 page complaint, alleging hundreds of violations for dozens of patients both in and out of clinical trials, ethical clinical trials violations, advertising violations, and billing insurance violations. It was a cacophonous symphony of crazy medical propositions (like that after a patient had brain surgery which successfully, but temporarily removed a malignant brain tumor, it was wrong for Burzynski to treat him without another brain biopsy, even though those brain tumors inevitably grow back and he already had radiological evidence of recurrence), and inane medical theories, (like all of his cancer patients in his private medical practice had to be on clinical trials). It was probably the longest and most over-the-top complaint ever filed by the board, but our answer was also probably the longest and most detailed.
It was evident from the tone of the complaint and confirmed by conversations with staff that the TMB was out to ruin Burzynski and show the entire country that his treatment didn’t work, that he knew it, and that he was a fraud and charlatan, preying on the most vulnerable, the terminally ill. The stated goal was to thoroughly discredit him, his treatment and his clinic in such a forceful manner that the revocation of his license, which was the goal, could not be questioned by any reasonable person. It seemed to me these guys were also looking for payback for their previous legal failures and the prior failures of the Department of Health and various other state and federal agencies to put him out of business. (And I take part of the blame/credit for helping that not happening).
When you’ve got lemons, make lemonade, so this case was an opportunity to show that Dr. Burzynski was a medical pioneer, that he was helping some, and in fact saving the lives of patients who would have died without him.
I worked on and prepared the case for the better part of two years. I left the case a few months before the hearing and was replaced by a team of lawyers from two highly regarded boutique law firms. The head of the team was Dan Cogdell, a luminary in the Texas criminal defense bar. We had worked together on Burzynski’s two federal criminal trials in the mid 1990’s. Over the decades, I have met a few lawyers as good as Cogdell, but never anyone better.
I lost touch with the case, but was pleased to learn that in October 2016, ALJs threw out all of the serious accusations and especially the alleged standard of violations which allegations I thought were idiotic, and most of the dozens if not hundreds of specific misconduct alleged against Burzynski. But the judges did sustain eight or so relatively minor offenses, like failure to supervise unlicensed physicians, aiding and abetting the unlicensed practice of medicine, some specific informed consent charges, and some inadequate documentation. Here is the decision. https://cis.soah.texas.gov/dmwebbasic/tokweb27.ASP?WCI=opendocument&SKEY=407545_0_9_63&localtimezone=480
The press considered the decision a victory for Burzynski and major defeat and embarrassment for the board. Despite all the bluster in the board’s complaint about what a quack and charlatan Burzynski was and how he was hurting patients and conducting illegal and unethical human experimentation, the ALJs rejected all of those charges. The ever colorful and entertaining Cogdell was quoted as saying that the decision was a pimple not cancer.
Perhaps most rewarding as the former attorney were the ALJs findings that Burzynski was a medical pioneer and had helped some of his patients, which is exactly what we told the judges we’d prove from the get-go. Based on the ALJs’ decision, Cogdell and his diligent, highly skilled trial team did excellent work, and Burzynski and his patients have much to be thankful for.
So this is now the third time in twenty plus years that the TMB has tried and failed to prove that Burzynski is providing a worthless treatment and/or is hurting people, and the second time a judge found that he was helping people (the first being the original board case).
But per the Texas administrative rules discussed above, because the ALJs did sustain some charges, the Board gets to decide on the sanction.
Like many medical boards around the country, the TMB publishes disciplinary guidelines.
The guidelines have a have a low and a high range of sanctions. Many sanction even on the low range seem onerous to me. Some of the sanctions on the high range seem crazy oppressive for some relatively minor violations.
Not surprisingly, board staff prosecutors are asking for severe sanctions; stayed license revocation, pending completion of a lengthy probation period, $360,000 in fines, restitution of almost 20k, oppressive monitoring, informed consent approval, plus the standard CME course work and passing the jurisprudence exam. (The board staff’s proposed sanction awaiting the board’s signature on March 3rd is attached as a pdf at the end). My view is that the way the proposed order is written, he’ll never get out from under it, which is exactly what the board intends.
My problem with board staff’s proposal is threefold. First, structurally, the board is wearing too many hats. The board decided to prosecute to case, prosecuted the case and now gets to decide the sanction. Legal though it is technically, I have a general problem with that. I think most reasonable people would think that the same entity which investigates, decides to prosecutes, and prosecutes shouldn’t decide on the sanction. The fact that there are nominally separate departments doesn’t change the inherent lack of fairness in the process. It’s only in administrative law, which has fewer constitutional protections than regular legal proceedings, that the government can get away with this kind of thing.
My specific problem is that people are only human. I don’t see how the board can be fair, given its prior – let’s say, unsatisfying previous experience with Dr. Burzynski. The proposed sanction order was drafted by or under the supervision of the Board’s head of litigation, who works under the board’s general counsel, who by the way, was the head of litigation who worked out the dismissal of its 2012 case against Burzynski.
I know and like these guys, and most of the board’s attorneys are competent and diligent (though they are overworked and underpaid, if anyone in the Legislature is listening). I also respect the many members of the TMB whom I’ve appeared before, but still…. I don’t see how they can be objective in this case. Despite their politeness and overt professionalism, I’ve sensed a great deal of ill will towards Dr. Burzynski, probably in part because, heretofore, things haven’t gone as they and Burzynski haters have hoped. Based on media reports, many in the mainstream fault the board for the fact that Burzynski is still out there. I think that will color the board’s judgment in deciding on the sanction.
My other problem is that I think, generally speaking, conventional medical professionals do a poor job properly evaluating and valuing medical mavericks. Board members in all or most states are picked by the governor. They aren’t necessarily the best or smartest physicians. Generally, the governors pick politically connected docs and/or those who package the most money for the Governor’s election campaign. They are typically medical insiders who know how to get along, and who are in the high priesthood of what I call the church of medical orthodoxy. Their orientation is not forward thinking, and in the case of Texas, I think the medical board unnecessarily stifles medical innovation.
But it’s not just me saying so. In both the current Burzynski case and the case in the 90’s, the ALJs questioned how medical progress would occur if the board could sanction a doctor like Burzynski for being an innovator. It’s a point which the Texas Legislature should take to heart.
So what’s the solution?
The Texas legislature should finish the job it started back in 2011. Change the law and let the ALJs decide the whole medical disciplinary case. If the board doesn’t like the result, let it appeal to the courts (with the aforementioned “good luck”). Texas ALJs are very, very good, (even if they occasionally don’t see the brilliance of my arguments or the righteousness of my clients). Plus, as discussed, there are written guidelines with high and low sanction levels and exacerbating and mitigating factors. Public health will be well-protected by allowing Texas ALJs to decide the entirety of medical disciplinary cases.
Ironically, this legislative session the TMB is currently in Sunset Review, which means that technically the Legislature is deciding whether to continue the board for another 10 years, and if so, under what conditions. The legislative review committee has issued its report and big surprise, it decided that the state needs the medical board to protect the public. Here is the sunset commission’s report.
Sunset review won’t help Burzynski next week, but I think if some of the TMB savvy legislators like Bill Zedler or Lois Kolkhorst, or even a formidable guy like Lt. Governor Dan Patrick (whose show I recall doing a long time ago) take an interest in this case and let the board know they’re watching, and that this could be the last case the board ever decides, maybe just maybe……
Rick Jaffe, Esq.
Board Staff’s proposed sanction order: