Law and the Multiverse Mailbag VI

In today’s mailbag we have questions about FDA regulations and superpower loss.  As always, if you have questions or post suggestions, please send them to james@lawandthemultiverse.com and ryan@lawandthemultiverse.com or leave them in the comments.

I. The FDA, Public Emergencies, and Private Cures

Scott asks “Comic book super-brains often find themselves having to create a vaccine against some horrific illness that either comes from space or is created by a supervillain. (Or, on a smaller scale, to help a friend, such as Reed Richards’ ongoing efforts to cure the Thing, or Superman’s pre-Crisis need to rescue Lois Lane and Lana Lang from an accidentally released Kryptonian superbug.) Would there be any issues in dealing with the FDA or would public necessity excuse a lot?”

We’re going to break this down into two sub-issues, public emergencies and private cures, since the issues are different.  But before we get into the details, we should mention that necessity is indeed a defense to crimes (the defense of necessity in torts is limited to property torts and isn’t really applicable here).  Consent is also a defense in both cases.  So even in cases where there aren’t specific exemptions or defenses, those can function as catch-all defenses, though there are important limitations there too.

A. Public Emergencies

In cases where a supervillain releases a terrible disease or toxin (or if they tag along on a meteor) and the public well-being is threatened, a lot of the usual regulations may be waived unofficially.  This is particularly true if a superhero delivers a cure in typical comic book fashion (e.g. freely administered, perfect cure rate, no significant side effects, etc).  What heartless bureaucrat or overzealous prosecutor would argue with a free miracle cure?  Nonetheless, are there provisions for fast-track approval of a treatment in case of a public emergency?  It turns out that yes, there are.

In the United States the Food and Drug Administration is responsible for approving new drugs, including vaccines.  FDA regulations are given in Title 21 of the Code of Federal Regulations, which is electronically accessible at GPO Access.  There are numerous procedures and requirements that can be waived in emergency cases.  We’ll discuss a couple of examples.

New drugs are submitted for FDA approval via an Investigational New Drug application or IND.  If the application is approved, the clinical trial process starts.  Under 21 CFR 312.10, IND requirements may be waived in an emergency.  The circumstances justifying a waiver are open-ended.  It’s enough that the sponsor (i.e. the applicant) give “Other information justifying a waiver” and that the FDA find that a waiver “would not pose a significant and unreasonable risk to human subjects of the investigation.”  In a serious public health emergency it’s easy to argue that the risks of fast-tracking an application are not unreasonable or significant compared to, say, everyone in the world dying of Kryptonian Ebola.

Of course, an approved IND only starts the clinical trial process.  What about actually getting the drug approved or at least administering it to patients?  If the number of patients that need treatment is small (e.g. there hasn’t been an outbreak yet), then under 21 CFR 312.310 the FDA can permit the treatment of individual patients in emergency circumstances (i.e. patients that aren’t part of a clinical trial but need the drug anyway).

For larger numbers of patients, the FDA can do things like waive the requirements for informed consent under 21 CFR 50.24.  This is often done in studies of drugs used in the emergency room where there’s no time to ask, say, a stroke victim to sign an informed consent form.  But the regulation is broad enough that it could apply to administering an experimental plague cure to people dying on the street.

B. Private Cures

Generally speaking you can’t give human subjects experimental drugs outside of a clinical trial, so a lot of the same issues discussed above apply to private cures.  But there’s another issue: unauthorized practice of medicine.  I don’t know if Reed Richards is a licensed physician, but I doubt Superman is.  Now, Ben Grimm, Lois Lane, and Lana Lang are unlikely to complain to the police or a prosecutor, so this is more of a theoretical issue, but it’s there.

Finally, physician licensure is done on a state by state basis.  A person licensed in state A can’t practice medicine in state B, not even on an emergency basis.  So even a superhero who is a licensed physician would have to bear that in mind in case of a national emergency.

II. Superpower Loss

Rae asks “How do you think the law would handle a case in which a mutant (or other powered-being) had lost his powers directly through the actions of another? (e.g. the weaponised “mutant cure” in X3, though I’m sure similar plots have been used in the comics).”

Rae wondered if the law would treat this as a crime against the person (e.g. assault) or as a property crime (e.g. theft).  Although we have theorized about treating superpowers as personal property, the courts would probably treat depowering as a crime against the person.  In tort it would likely be considered a battery if it was done intentionally.

If, however, the depowering were merely the result of negligence or recklessness, then foreseeability comes into it.  For example, if a researcher studying a ‘mutant cure’ negligently releases it into the lab, causing a fellow scientist to lose his or her mutant powers, is that damage foreseeable?  What if the researcher didn’t know the scientist was a mutant?  The answer here probably hinges on just how common mutants are.  If they’re exceedingly rare (say post-House of M) then maybe it’s not foreseeable that a lab accident could cause a mutant to lose his or her powers, since it’s literally one in twenty million or so odds at that point.  But if they’re very common (say pre-House of M), then it’s probably foreseeable.

Of course, that still leaves the issue of the measure of damages.  How much are superpowers worth, especially if the plaintiff doesn’t really derive income from their powers (e.g. Superman, Batman)?  That is a complex topic that’s beyond the scope of this mailbag.  We will, however, revisit it in a future post.

That’s all for today.  Keep your questions coming in!

18 responses to “Law and the Multiverse Mailbag VI

  1. Silver-age Superman (Superman #96 – March 1955) read an entire medical library (in another panel, he was paged as “Dr. Superman” and performed delicate optic-nerve surgery). But perhaps medical regulations were weaker on pre-Crisis Earth-One and his credentials haven’t survived the reboot.

    http://sacomics.blogspot.com/2009/02/some-nice-moments.html

    Although, post-Crisis, in (Justice League Europe # 9 – December 1989), he performed surgery on Power Girl with his heat vision. But that was in England..

    http://en.wikipedia.org/wiki/Power_Girl#cite_ref-11

    • Along similar lines, the Atom (though Ray Palmer may actually be a licensed physician, for all we know) occasionally shrinks down to smack alien virii around when conventional medicine won’t help. Would acting as a “freelance antibody” be practicing medicine at all? At his microscopic size, are the bugs now feral animals endangering the host?

      • I think that would still be practicing medicine. What Atom does could be considered a kind of highly focused surgery. What matters is what he’s trying to accomplish, not so much how he does it. For example, in Missouri the practice of medicine is basically defined as “to profess to cure and attempt to treat the sick and others afflicted with bodily or mental infirmities.” RSMo 334.010. I think that would include punching alien viruses.

        But again, I doubt anyone would actually complain, so it’s only a theoretical issue.

      • If I remove a splinter from someone, it’s not unauthorized practice of medicine. Given that removing splinters from someone is legal, wouldn’t it be similarly legal for the Atom to smack a virus? He’s just getting rid of a foreign object, same as with a splinter, except that his powers let him see and remove more foreign objects than a normal person can.

      • “He’s just getting rid of a foreign object, same as with a splinter, except that his powers let him see and remove more foreign objects than a normal person can.”

        One major difference is that Atom is performing an invasive procedure, whereas splinter removal is normally non-invasive. But in any case, the courts have developed some guidelines for what constitutes unauthorized practice of medicine. For example, here are the factors used in New York:

        “whether there was a diagnosis determining a disease, infirmity or physical condition; whether a remedy or treatment was prescribed; whether the act or acts performed by defendant were such as to endanger the public health; and whether defendant invaded the territory of the profession by specific actions solely within the province of a duly trained and knowledgeable medical practitioner.” People v. Kleiner, 664 N.Y.S.2d 704, 710 (N.Y. Sup. Ct. 1997).

        I think it’s arguable that identifying the disease-causing agent (i.e. the virus or whatever) and removing it via an invasive procedure amounts to a diagnosis of disease, prescription of a remedy, and is an action “solely within the province of a duly trained and knowledgeable medical practitioner.” You can see how removing a splinter is different in light of these factors, particularly the last one.

        Things might be different, however, if Atom were acting under the supervision of a doctor. For example, if a doctor actually diagnosed the illness, recommended the course of treatment, and instructed Atom on how to recognize the disease-causing agent, then I think Atom would no longer be practicing medicine. He’d be closer to, say, a technician operating a radiation therapy machine. How does it usually play out in the comics?

      • an action “solely within the province of a duly trained and knowledgeable medical practitioner.” You can see how removing a splinter is different in light of these factors, particularly the last one.

        I’m not convinced. There’s a difference between “within the province of a medical practitioner” and “outside the province of a normal person”. Something can be the latter without being the former and I think that’s what the example of the Atom bashing viruses is.

        A splinter is not within the province of a medical practitioner because anyone, even without medical training, can readily see it and understand what it is doing and how to remove it. I would argue that, given a person with the Atom’s superpowers, a virus is as easy to see and understand as a splinter.

        Put it another way: imagine that the patient has a magically invisible splinter–and the only guys who can remove it are medical professionals and that one guy who has the power to see invisible objects. It would not be “within the province of a medical practitioner” for the guy who can see invisible to remove it, even if it would be for everyone else. The superpower turns an activity which requires skill into an activity which does not.

      • “The superpower turns an activity which requires skill into an activity which does not.”

        Merely being small enough to see and punch individual bacteria or viruses is not sufficient. The real skill (and the part requiring medical education or at least the guidance of a doctor) is telling the disease causing agent apart from everything else floating around in the patient’s body, including their own cells as well as benign bacteria and viruses. Many viruses and bacteria look a lot alike. Even trained pathologists can make mistakes.

      • The same reasoning can be applied to splinters: the skill in removing a splinter includes being able to tell the splinter from the rest of the body.

        Of course the answer for splinters is that telling some things apart is easier than telling other things apart and splinters are one of the easy ones. I would argue that the same is true for alien viruses, as long as you have a superpower that lets you see them. Comic book alien viruses tend to be much easier to distinguish from their surroundings than real-world viruses. Besides, “alien viruses” are not really viruses–if they were, being infected with them would mean at least millions of them, and there’s no way a superhero, even punching one per second, could kill them faster than they could reproduce.

      • Right, but identifying splinters is not considered “solely within the province of a duly trained and knowledgeable medical practitioner.” Identifying specific bacteria or viruses is much closer to that.

        Even if an alien virus sticks out like a sore thumb, you still have to know what the normal stuff looks like or else it won’t actually stick out. It’s not like they come stamped “alien supervirus: please punch.”

        But like I said, this is all theoretical. The patient isn’t going to sue Atom or complain to the police or a prosecuting attorney.

      • The example that most readily comes to mind is the Doctor Who episode “The Invisible Enemy”. While the practicing medicine question doesn’t arise for several reasons, it’s still an example of shrinking down and trying to kill an alien virus. The alien virus looks like a guy in a monster suit, talks, and is certainly as easy to distinguish as a splinter is form normal skin, even to someone who is not familiar with the inside of the body.

        Suppose some villain got ahold of the Atom’s shrinking technology and went inside someone’s body to cause trouble. Trying to remove the villain using anesthesia and surgical tools would be practicing medicine, but I don’t think just chasing him into there and punching him out would be. The alien virus is exactly the same thing except that it’s already small and doesn’t need to steal any shrinking technology first.

  2. Can a superhero save us from the pending change of the very useful GPOAccess.gov into the clunky FDSys?

  3. Kathryn Scannell

    It’s easy to see how the FDA and laws regulating the practice of medicine would apply in the case where the superhero has done something like whip up a vaccine or a cure in the lab. What about religious or magical cures? Doctor Strange waves his hands and chants something incomprehensible and little Joey’s broken leg is cured. Would that also constitute practicing medicine?

    It seem to me that there must be some exceptions somewhere, because we don’t see people like televangelists doing the laying on of hands routine or praying and “healing” people through divine power getting arrested for practicing medicine without a license. Fraud, possibly, if they’re promising specific results and charging money.

    So where is the line?

    • It’s not a problem for him because he is DOCTOR Strange.

    • While I don’t want to get into a debate on the validity of a religion on a site not intended for that I will note this; in real life faith healing has not had so much observable success or appeal to the mainstream public that there would be much need for regulation. However we should remember that people who claim to be fortune tellers and psychics have charged money for giving people advice and they don’t seem to get charged with fraud. Health might be sufficiently different to create a different response.

      On another, somewhat related, note there have been more recent cases where parents who resorted to prayer instead of taking their child to a doctor were arrested after the child’s death but I don’t know the specifics.

      As for things like fraud, who knows? So far the courts in the U.S don’t like ruling on matters related to churches and religions (probably because of serious potential problems) and like to keep their rulings limited.

    • As Martin brings up, Dr. Strange can I believe practice medicine all he likes. I don’t believe he ever lost his license; his problem was that he had nerve damage that kept him from being able to work as some kind of fancy micro-surgeon. I read a Dr. Strange story the other day in which he gave up magic to become a medical consultant.

      (This didn’t last. And good thing, too. The Ancient One is in fact pretty ancient.)

    • Kathryn, I believe the line would be drawn at the point where Dr. Strange’s magic can demonstrably be shown to have actual curative effect. It wouldn’t be too hard to set up a simple trial to show his effectiveness, either.

      And yes, he is a physician, so in his particular case, the question may be moot.

      As for the Atom vs. splinter-pulling, I think the Atom’s actual ingress to the human body may be what differentiates what he does from household cures.

    • FDA doesn’t regulate the practice of medicine from what I understand, the states do. FDA regulates tools (drugs, devices, biologics) of medicine.

  4. Interesting point, Kathryn. There was a 1956 Florida case where a faith healer, Jack Coe, was charged with practicing medicine without a license, after claiming he’d healed a 3-year-old of polio and telling his parents to remove the leg braces. (The polio remained and removing the braces left him in pain.) A Florida Justice of the Peace dismissed the case, saying that Florida law exempted divine healing. That might give at least a little legal cover for Strange-type healers, though I’m no lawyer and suspect there’s a thousand things I’m overlooking.

    As a side note, Coe died later that year from polio.

    (By the way, thanks for the detailed answer to my question on the FDA! You guys rock!)

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