Are all these anti-patients’ rights laws necessary for autologous stem cell transplants?

Are all these anti-patients’ rights laws necessary for autologous stem cell transplants?


A long time ago as a first semester law student, I took the “Legal Method” course on how to read cases, the rules of statutory construction, and generally the analytic tools which lawyers use to analyze the law.

I still remember the professor explaining how sometimes a law is created which makes sense when created, but the reason for the law is later eliminated, but the law continues.  He gave the example of the old English common law rule barring civil wrongful death causes of action. Meaning, if one person negligently killed another, the family of the decedent could not sue the wrongdoer/tortfeasor in civil court for damages. The rule made sense when created because in England back then, the property of the wrongdoer would escheat to the state. (Lawyer or neutral phrase for the government taking your property for no good reason).  Since the state confiscated the person’s property, there was no point of a civil damage remedy for the surviving spouse or family.  Eventually, the escheat law was eliminated for wrongful death tortfeasors, but the wrongful death civil action prohibition continued for a very long time.

Eventually, some  anti-authoritarian oddball realized that the wrongful death prohibition no longer made any sense. I have to assume that the-powers-that-be back then had a knee-jerk reaction against the oddball, perhaps trying to invent new rationales for keeping the law, probably something about protecting the general public.  But eventually a wrongful death right of action was created.

I think there’s a lot of that going on nowadays in the freedom-inhibiting health care regulatory framework. Meaning and specifically, there are some laws which over-protect us based on an outdated model of the relative access to information by the parties to a health care transaction. If you’re scratching your head about what I mean, here is a more recent and closer example.

But first, a micro course on medical malpractice: There are three elements to a medical malpractice claim; a departure from the standard of care, causation and damages. Unconventional care (alternative medical treatments/integrative medicine. or however you want to call it) is by definition a departure from the standard of care. So even if the patient sought out and consented to unconventional care, the patient can still sue the unconventional care provider for malpractice if the treatment caused injury or harm (including the harm of not undergoing a conventional “effective treatment.”) Although there is a common law defense called “assumption of risk,” it didn’t apply to the doctor/patient transaction because of the perceived imbalance of knowledge between the parties.

This was the law up until the early 1980’s.  Let’s try to image what it was like back then where there was no internet, there were just three networks and we listened to disc jockeys who didn’t curse or rant about politics; they just played music.  The only medical news we got was from newspapers and the medical sections of the weekly news magazines. (For those of you too young to remember, and as hard as it is for you gen xers to believe, tens of millions of people used to purchase little booklets each week to read about the news, entertainment, science and other public interest matters, all in one glossy booklet/magazine. Quaint stuff for sure).

People who didn’t read the specialized medical literature or go to the medical conferences experienced a relative imbalance of information. And that imbalance was the rationale for not allowing assumption of risk as a defense to a medical malpractice claim.  But even in the dark pre-internet era, things changed in terms of our assessment of the imbalance of information between the doctor and patient and assumption of risk. Here’s how it happened.

A woman was diagnosed with early stage breast cancer. Let’s call her Eidth.  Her Oby-Gyn and three other doctors told her to have a mastectomy and if she did, she was told she would mostly likely live a normal life. She refused and wanted to go the “natural way.”  So she found an alternative cancer doctor in New York. Maybe he told her to get a lumpectomy, which she refused, but he still treated her with some trace mineral elements including selenium which he had been using on cancer patients for decades.

She got much worse despite the treatment and eventually was forced to have a bi-lateral mastectomy. She lived, but she sued the unconventional doctor for malpractice. It was my firm’s first case in the health care field. Because of our lack of experience, we couldn’t understand why assumption of risk wasn’t a viable defense, but all the experienced malpractice attorneys kept talking about the imbalance of information.

As luck would have it, before the trial, the New York Court of Appeals had issued a ruling that a teacher who voluntarily participated in a donkey race in a school gym might not be able to recover for his injuries from falling off the donkey, if he “expressly assumed the risk” of racing on a jack-ass in a gym.  Well, our doctor/client wasn’t a jack-ass, but why couldn’t the patient assume the same risk as the teacher. Wasn’t it just an issue of fact whether the patient had all the material information, just like the teacher, and expressly agreed to assume the risk? We thought this whole imbalance metaphor had gone on too long, given the new world of color TV, and high tech glossy magazines. Hell, people had recently begun sending each other pieces of paper and even complete documents over the phone lines with something called a facsimile machine. It was a new world of information and we thought it was time for a change.

We tried to get the federal judge to give an assumption of risk jury instruction, citing the donkey case, but she refused, citing the fact that no New York state case had ever applied the assumption of risk affirmative defense in a medical malpractice case. She was right about that, but someone has to change the law.

The trial resulted in our first million dollar verdict, but of course, since we were defense counsel, it wasn’t such a noteworthy accomplishment. We took the case up on appeal, and in what might be considered a landmark decision, the Second Circuit Court of Appeals created an assumption of risk affirmative defense to a medical malpractice case. The judges felt that if the patient was provided with enough information about the potential risks and benefits, and expressly assumed the risk of the treatment which she knew was technically a departure from the standard of care, then she couldn’t recover against the doctor. Then and now, it seemed like the right result. So my first million dollar verdict was reversed (a good thing for defense counsel).

Because it was clear that the patient really did expressly assume the risk, and maybe because of some good lawyering on our part after the case was sent back for retrial on the sole issue of assumption of risk, the plaintiff’s counsel walked away from the verdict and dismissed the case.  (More details about the case in Chapter 1 of Galileo’s Lawyer which will be released in about a week on Kindle, Nook and other eBook places)

So even in the dark ages of the pre-internet, glossy magazines and new-fangled inventions like the fax machine, patients could assume the risk of non-standard treatment. Thirty years later, there is an abundance of medical information available to every human being with a mobile device and access to the internet.  You can join web sites where members will diagnose you. Many medical journal articles are available on-line for free and there are hundreds if not thousands of web sites offering advice and medical information. You can go on-line and find every single clinical trial for every single disease. Despite all of the information at the consumer/patient’s fingertips, the government still feels the need to protect a patient from treatment which is literally taken from the patient’s body and put back the very same day. How can that be?

The point is that times have changed. We live in the era of information abundance and google doctoring. Patients have a quantum level more information than was available to previous generations. As a result, patients can and should be given more responsibility for their treatment decisions, or at least for those patients who are willing to assume the risk of less than fully “proven” treatment (which always works). That applies with ever greater force to terminal patients or patients with incurable progressive diseases like MS and ALS. And it applies with even greater force when the so called treatment is just removing some fat from the person’s body, separating the fat from the stem cells and reinjecting the stem cells during the same procedure. These overprotective laws and guidelines seem like the continued prohibition of wrongful death actions after the escheat law was changed.

Because the Kirk/Alexander/Collins/regrow/ replant/explant/exlax, bill reaffirms the FDA’s jurisdiction over some same day autologous stem cell procedures, and particularly adipose to mesychemal transplants, this bill is just as backward as any other effort to come-up with new justifications for laws which don’t make sense anymore.

It is ironic that the FDA’s original interpretation of the key phases –more than minimal manipulation, same surgical procedure and homologous – which led the FDA to decline jurisdiction over basically any same day autologous transplant, gave physicians and patients the ability to make these decisions rather than the FDA. Those were the good old days (pre-2012). Hmmm, so maybe my Legal Method recitation isn’t precisely on point since the FDA’s original interpretation was correct. Oh well, I have always found it to be a lesson worth remembering, and so might you.

Richard Jaffe, Esq.

Galileo’s Lawyer is coming out in EBook next week, Kindle, Nook and apple iBook. Chapter 9 is about the first FDA criminal investigation of a cord blood stem cell transplant clinic.

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