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Comments

Daniel Newby

1: http://washingtontimes.com/upi-breaking/20041207-112909-2510r.htm

2: http://www.kpho.com/Global/story.asp?S=2673568

The first link says "Bach McComb last year co-hosted a seminar sponsored by Powderz Inc. ..." And the second link says "...Powderz Incorporated, is one of four Tucson businesses owned by Chad Livdahl and Zahra Karim" and "TRI's president and chief executive officer is listed as Chad Livdahl." Finally, I can't find it now, but I read somewhere else that TRI was outright advertising their botulinum toxin to cosmetic surgeons. Maybe there is something to the lawsuit after all.

It gets even dumber. The Palm Beach Post story you linked to says "Telling the Kaplans they were simply dehydrated, the Toias gave them a 'Myer's cocktail,' a solution containing ascorbic acid, magnesium and vitamins, according to the lawsuit." But isn't ascorbic acid a diuretic and magnesium an osmotic laxative? Hardly an ideal treatement for dehydration.

I am reminded of the Harlan Ellison's saying that "The two most common things in the universe are hydrogen and stupidity."

MaDhOuSe MaDmAn

"a back cracker"
I love it. ;-}

Orac

You don't honestly expect people to be responsible for their own choices, do you? Certainly our legal system doesn't.

This is also a good example of why alternative medical practitioners should not be dispensing "conventional medicine." When a complication occurred, the chiropractor had no clue what to do and could only offer a bogus remedy.

Bill

Apparently no licensed physician was involved in administering the botulinum toxin in this case; therefore a crime was committed. I suspect a civil suit is the least of the worries for the perpetrators here. Expect felony assault charges at a minimum with potential murder charges looming pending the disposition of the victims medically.

Matt

This is a better product liability case than a medical negligence case. The Kaplans are suing the manufacturer and the distributors. Drugs not technique are, in part, being faulted here. You craftily argue, in so many words, the two most favored defenses in product liability cases: Comparative negligence and the “open and obvious” doctrine.

Comparative Negligence: Unless the Kaplans knew or should have known they were being injected with a poisonous knockoff drug, it is hard to argue they were 100% comparatively negligent in poisoning themselves. If they did know, the Kaplans may be found to be up to 100% comparatively negligent and recover nothing. Comparative negligence is not an all or nothing defense.

Open and Obvious: If a reasonable person would not and should not have known that the knockoff was poisonous, then the danger of being poisoned was not "open and obvious under the law. The open and obvious doctrine is a favorite and very successful defense of product liability defense attorneys. It is a complete defense. The courts have raised the bar, not lowered it, for plaintiff's to prove that a danger was not open and obvious.

There is an objective test to decide whether a product-related danger is open and obvious. The focus is on the typical user's perception and knowledge and on whether the relevant condition or feature is fully apparent, widely known, commonly recognized, and anticipated by the ordinary user.

Here, the facts will likely show that the Kaplans were not aware that the knockoff was poison. More important, objectively does the average joe think he will suffer from botulism from a botox knockoff? He may think he has some risk, but not being poisoned. That will be enough to put it in front of a jury to decide. Kaplan may have known McComb was a quack and a fraud, but that is not the open and obvious risk at issue: “Poison can hurt you” is, and the average joe would not think he was being injected with poison so that it would be open and obvious that poison can hurt you. On the other hand, it is pretty open and obvious to everyone who has had any medical procedure performed on them that there are always risks. Doctors and hospitals make you sign acknowledgements of those risks. But usually they are specifically identified so that the patient is well-informed enough so that the open and obvious type argument has merit. Here the risks, as so far detailed, are less specific: crappy doctor, cheap clinic, knockoff drug.

Kaplan’s case could be a classic res ipsa loquitor case; the thing speaks for itself. In this type of case, the defendants have to prove that they were not negligent, instead of the plaintiff proving they were. The rationale is that product was in the defendants’ possession until it went into the Kaplans’ heads. Defendant explain to us why you were not negligent in allowing your stuff to be injected into the Kaplans’ heads.

Alban Berg

Thanks, Matt for a little legal sanity midst all the frothing doctors. IF the knock off botulism drug was marketed as safe, then the Kaplans may have a products liability case. (I find the "If" hard to believe, but that's why we have summary judgment)

The blogger thinks smart people would have gone to a doctor for this procedure---he may be right. On the other hand, the blogger could simply be acting as a dirty, rotten monopolist denouncing all/any efforts tp undermine the medical monopoly.

Finally, doctors (when they make mistakes) are so fond of saying that medicine it an art, not a science, i.e., often they have no idea what they're doing. IF that's so, shouldn't they be a little more humble when denouncing chiropracters as quacks? They probably are, but they do make a lot of people happy.

ck

Palm Beach Post (http://www.palmbeachpost.com/localnews/content/local_news/epaper/2004/12/04/s3f_botox_1204.html):
"The toxin made by the Toxin Research International lab is not approved for use in humans in the United States. But cosmetic surgeons say it is used as a black-market, low-cost alternative to Botox."

Man I'm glad we have the FDA to keep an eye on what should be used on patients and what is unsafe. While you can argue whether alternative medical practitioners are quacks or not, I think we can all agree that MDs are far more rigorously trained, and would be less likely to put a patient at such a dangerous risk in using a non-FDA-approved knockoff drug. In light of the fact that the drug was a knockoff and not approved for medical use, Matt, I think this would actually qualify more for a medical negligence case. Unless the vial was sent out not meeting TRI's manufacturing specs, I think the only person to blame is the practitioner.

ck

On the bright side for McComb, he'll have lots of time to develop his story before investigators can start prodding him for questions.

...Sorry, couldn't resist...

CodeBlueBlogMD

Matt--

The Kaplan's behavior -- especially given his professional training and his personal friendship with McComb -- indicates that they knew this was not the standard protocol, not the standard clinic for this procedure, and not the standard clinician to perform the procedure. So comparative negligence is high.

As for the "open and obvious" defense; first, I have a hard time using the word "objective" when applying it to how someone might portray the "average Joe" in court. That's a subjective test if ever there was one. Nonetheless, the Kaplans have become wealthy on the basis of his medical knowledge. So, the "average Joe" in this case is a smart, successful licensed medical practitioner, not the Bell South lineman.

Second, no one can know all the possible bad outcomes from a decision. We try to teach children that the spectrum of outcomes from any decision is broad and can range from life to death even when the choice seems deceptively simple. It has to be neither open nor obvious. In this case, however, the spectrum of outcomes when dealing with an injectible medication derived from a poison -- in the eyes of a trained medical professional -- is at least strongly skewed to the side where severe adverse outcomes lie. All medical practitioners know that the catastrophic unanticipated outcomes can and do occur and are more frequent as the complexity of the drug and the procedure increase.

Back to the children, though, if we are to teach them how to assess possible outcomes in order to make good decisions, how can we simultaneously illustrate for them the (no threshold) liability option? In other words: no matter how bad a decision you make or how many people suffer because of your bad decision -- including yourself -- there is always the option of blaming someone else (because you can always make that case some way) and getting monetary compensation. This relieves the child from having to learn enough, think enough, and have enough guts to make the best possible decision that leads to the least likelihood of an adverse outcome. This is what I meant by "lowering the bar." I wasn't talking about anything that might happen in the courtroom.

I thoroughly enjoyed your input. I think a useful blog feature would be a crossfire or a face-to-face / side-by-side analysis of hot topics/cases in the news that are illustrative (like this amazing Carl-Hiasen-like incident). I think that, as soon as the new year is firmly in place I'm going to ask for contributors for that feature.

CodeBlueBlogMD

Alan--

I checked my keyboard and there was no froth on it. The "drug" in question was a supoerconcentrated formulation that was not supposed to be sold for use in humans. That's my point. Everyone in this case probably knew that McComb was buying laboratory-grade Botulinim toxin and diluting it illegally. In this way they were getting 100x their money's worth, paying, say $5.00 for what would cost them $500 from a plastic surgeon.

There is, right nopw, some question as to whether this lab supply company was implying one could use the Botulinum toxin in this illegal way -- but that is a different issue and remains to be seen.

You have me all wrong insofar as regards the medical monopoly. I could not agree with you more. Not a day goes by that I don't wish I could market myself for my skills, training, and outcomes. I also have no problem with consumers choosing any practitioner they like, including osteopaths who are suspended and under investigation for five deaths. However, what I DO object to is the civil litigation system covering the asses of those same consumers when they don't do their homework or act with blalant disregard of the dangers they are invoking.

I did not imply that smart people would go to licensed practitioners; however, I did imply that since Kaplan is a smart guy, and a successful medical practitioner and entrepeneur, he certainly knew better (and had the wherewithal to back up that knowledge)and better understood the risks of the unconventional scenario in which he was participating.

I do not, at all, believe that medicine is art -- at all. I agree with you that when you hear medicine is an "art" you should probably run because the practitioner is telling you that there are objective things he doesn't know or is not aware of and he doesn't want to be held responsible. Medicine is a science, and it becomes a stricter science every day. And every day that this happens, medicine becomes less an "art" thank God.

I have no problem with "quacks," and would consider them a necessary evil if we had an open marketplace (as you correctly, I believe, implied above)in which the government was not involved and I was allowed to lay out the data for the public to examine and make their choices by. Then, if you want to have your feet stretched or your vetebrae cracked -- please do.

My problem with alterative practitioners is that they actually take advantage of the system and do harm. Lawsuits filed on the behalf of the largest groups of alternative practitioners have wedged them into the licensing system, and further lawsuits have enabled these same groups to be reimbursed by the government (Medicare/Medicaid) for their services.

So we have the worst of all worlds. The government stamps its approval and provides incentive for practitioners to utilize services. In the meantime, because data about efficacy are scant to nonexistent, the practitioners are forced to advertise by taking advantage of the consumers lack of medical sophistication and poor grasp of data and statistics. So the answer is to open up the system, get the government out, create a system where the consumers have to make health care purchasing decisions and allow consumers to make mistakes while simulataneously raising the bar as to what constitutes malpractice and what is expected from reasonable consumers while making choices.

Now you can see my approach in this particular case. Cosmetic surgery is one of the few medical areas where there is -- more or less -- a free market system. Consumers pay cash, up front. They need to do the research, ask questions, shop around and be careful -- because there are a lot of practitioners and a lot of choices.

Kaplan knew all this. More than the "average Joe." He is responsible for the bad choice he made.

Alban Berg

Dear Dr. CodeBlue,

Thank you for your thorough response--probably much more than my snarky posting deserved. I would just make two points.

First, the suit, as you describe it, is "against the makers and distributors of a botulism toxin"--not the medical (or "medical") service providers. If it is a product liability suit, then the Kaplans can claim that they were misled by the product manufacturers-- regardless of whether they were stupid in their choice of practitioner.

In this instance, it seems to you unfair, unjust, whatever that the Kaplans can recover damages due to their own stupidity and greed from a botulism toxin maker. You may be right. BUT, it doesn't matter legally. Everyone--the rich and poor, stupid and bright, greedy and generous--can rely upon statements and representations of manufacturers and sue if such statements are erroneous/misleading.

Now, you say that's wrong and therefore the whole legal system is screwed up. Again, you may be right. However, one anecdote proves nothing--an entire complex system of rules cannot be declared screwed up simply because it produces some anomolous results. That's like critiquing an entire medical protocol on the basis of one patient's bad reaction. The question is whether as a whole the product liability creates the correct incentives/furthers overall social welfare. The handful of sensationalized press accounts of medical mal hardly paints a realistic picture.

Second. I couldn't agreemore that "the answer is to open up the system, get the government out, create a system where the consumers have to make health care purchasing decisions and allow consumers to make mistakes."

The problem is that consumers have difficulty making good health care choices due to information asymmetry. As that recent New Yorker piece showed, no one (excpet perhaps the insurance companies) knows the basics about physician/hospital performance. When I walk into a doctor's office--or worse are wheeled into his operating room, I really have almost NO way, save rumour to evaluate his skills or monitor his performance. One cannot possibly contract efficiently under such conditions--thus the medical malpractice regime which is really a form of government mandated insurance.

There is an exception to this information deficit--fertility clinics, which do not of course primarily receive insurance reimbursements, and I'm told commonly post success rates.

Would most doctors be happy in a world in which their success rates/performance metrics were required to be posted on their waiting room walls? If they would, then I'd be happy to scrap med mal.

coturnix

What do you make of this:


http://www.jregrassroots.org/jre/viewtopic.php?t=11256&start=0&postdays=0&postorder=asc&highlight=

Joe P.

"Here, the facts will likely show that the Kaplans were not aware that the knockoff was poison." Matt

This is what I love about lawyers. *No one* knew that the knock off was a "poison",i.e., that it would paralyze the happy couple. Otherwise why would it be given and taken? Can I get me a "Duh"?

Except that botulinus toxin is a poison, and will remain so, "poison" now being used in a more cautionary way, since the toxin was first found as a dangerous agent.

Berg:"Thanks, Matt for a little legal sanity midst all the frothing doctors. IF the knock off botulism drug was marketed as safe,...."

Here it is again. Botulinus toxin is *not safe*. If the product was home-diluted, it was not even marketed "as safe" to begin with.

Further, the fact that M.D.'s say that medicine is an art does not mean they will create practice as art when there is a fairly well proven alternative.

Alban, you are applying what is a platitude [at its worst use] in order to create a whole profession, Chiropractic. It would also be like saying that walking down the street is an art, therefore I will try anything I can imagine to get down the street.

Nor is there an "art" defense for malpractice that stands over the "accepted standards of practice" is there? Or as an excuse for bad outcomes, though the Lawyers, ever vigilant, are working on it, I'm sure, and am much reassured.

Chiropractic is fine with me, but I await with glee the time when "treatment outcomes" or "outcome related therapies or practice" are used by the Government to make payments. Naturally, Chiropractic will be initially verified as effective, until people start doing actual controlled studies. This will also be difficult, I think. But it will also be humorous. I am thinking of developing some snake oil in order to get into the fray and hopefully make myself rich.

Do Chiropractors ever do anything resembling a study? I remember when they started delivering babies, then discovered, Lo and Behold, that they could get sued because, Yes Virginia, there are standards.

I have seen some good Chiropractors, who know when they have turn the God-playing role over to the M.D.s..

But is there any penalty for,or defense against, the fact that the Kaplans are bald-faced Fools?

Oh,no - snif, snif - we are all victims - boo hoo.

At least Mr. Kaplan should be sued by his wife, since, as usual, anything goes.

George

The Kaplans are "paralyzed, mute, and immobile." I say that's penalty enough. Even if they do get money from their suit, they are still paying for their choice of treatment, every single day. But are we to say the practitioner shouldn't be held responsible for his actions as well?

CodeBlueBlogMD

Coturnix--

I am an admirer of many things you ahve written, although there are many issues over which we would likely debate for hours.

I thought your essays on Darwin's methodology were nothing short of brilliant.

I think the hypothesis of Bush having A fib is floatable. The pictures with the rumpled jackets are laughable to any scientist, and the speculations that Bush has megalomania and -- of all things -- Wernicke Korsakoff syndrome, are absurd.

coturnix

Thanks, that's what I thought. The psycho stuff is for the tin-foil hats - I did not pay much attention to that. A-fib is really what I was asking about - any more insights?

Alban Berg

Dr. Joe P. (and all the other doctors on the thread) miss the point re: product liability. Of course, botulism is a poison, but presumably if properly prepared, it simply paralyzes wrinkle-forming muscles. If, however, the Kaplan's suppliers sell botulism toxin with incorrect instructions for its use, they may be committing product liability. The linked news story did not state how the toxin was sold; we don't know. The doctors are just making up facts to fuel their favorite pastime of lawyer-bashing.

Now, as the medicine qua art. As a statistician who once dealt with these issues frequently, I am amazed at how much of medicine is not based upon sound empirical evidence Commonly accepted protocols--from yearly check-ups to routine episiotemies--just sort of get adopted without controlled studies demonstrating effectiveness. Thus, the line between medicine and chiropractice may not be as black and white as doctors like to think.

a bit to think on . . . chiropracters have to make people happy as most insurance doesn't cover them; how hard do doctors work in providing service-with-a-smile, consumer-satisfaction? If doctors hate quackery, the route to stamping it out is better customer service, not high handed, inquisitorial denunciations.

Joe P.

Berg, I did not miss any of your points. Playing with words does not impress me, as in proving that the fact that many medical treatments are not "proven effective" means they are not more effective than doing nothing, and thus are all "art". Certainly any that are no more effective than doing nothing are to be condemned, not praised as "art".

By the way, Chiropractic is in fact covered by insurers, including the State Accident Insurance Fund in Oregon, Worker's Compensation, at least for post injury rehab. That is perhaps the true province of the Chiropractic, which has only fairly recently becomes aware of bacteria.

One becomes suspicious when every x-ray read by some Chiropractors is "abnormal", and everyone turns out to have "one leg shorter than the other", etc..

Certainly McColmb should be sued, if anyone, but I would not rule out Mr. Kaplan, either. Why are they not being sued?

It's a riot!

Alban Berg

I stand to corrected re: insurance and chiropracters. Well, you have a real point. The line between doctors and chiropracters may not be crystal clear--but certainly we shouldn't be subsidizing them via our insurance premia.

kt

Bach McComb needs to be stopped. He has ruined many lives. I used to see young people fill his office on the days he was there...working in a office again with a chiropractor. For the right price, money up front, you could walk away with a scrip for oxycontin,xanax, just about anything that would put you out of your misery. He gets rich and the young people suffer or die. You think he did this so he won't have to face the jury?

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