April 28, 2009

Written Authority For Standard Of Care

A doctor gets sued for an adverse Zyprexa outcome.

The case involves an outpatient with depression who received Zyprexa.  One week later he had neuroleptic malignant syndrome.

Important elements:

It was July (e.g. hot.)

The patient had originally been given various antidepressants for recurrent Major Depressive Disorder.  Final regimen was Effexor XR 150mg/d, Zyprexa 10mg/hs, and Klonopin 1mg twice a day. The psychiatrist documented extensively the risk of diabetes, and sent him for initial blood work, but did not document any discussion about the risk of NMS.

The first symptom was a high fever and malaise.  The man went to a medical ER but in reporting his symptoms (fever, weakness), he did not disclose he was on any psychiatric medications (he thought it not pertinent.)  Triage nurse took his temperature (103) and gave him Tylenol.  By the time the doctor saw him, he felt a little better and the temp was 99.7  The ER discharged him with "fever of unknown origin" but reportedly told him it was "probably the flu."

Continued to feel worse with consistent fever.  He called the psychiatrist and told him he had been evaluated by the ER.  Importantly, he did not tell the psychiatrist that he had not told the ER that he was on Zyprexa.  Psychiatrist told him to continue with Tylenol, etc, and if he got worse to go to the ER, etc, etc.

The next day he collapsed, and brought by ambulance to another ER, where he was ultimately diagnosed and treated for NMS.

The plaintiff alleges, among other things:

  1. NMS is a well known, extremely dangerous, albeit rare, side effect of Zyprexa.
  2. Psychiatrist failed to inform him of the risk of NMS with Zyprexa.
  3. Psychiatrist failed to properly evaluate the patient during the phone contact.
No suit was brought against the first ER, as the plaintiff('s attorney probably) felt the case against them was not as strong because the patient didn't mention any psychaitric medications.

Let's go through some of the points:

Informed Consent:

The patient was not informed of the risks and alternatives.

I'd argue that it's not unusual that a psychiatrist not mention the risk of NMS.  There are simply too many side effects (for any drug) for complete "informed consent."  Neither is there much room or time for a complete discussion of alternatives.  Not disclosing the risk of NMS does not violate the standard of care because reasonably prudent psychiatrists, indeed, the vast majority, do not either.  However, it is up to the doctor to be aware of the risks.

Clinical point: the fact that the doctor had extensive documentation about diabetes is a bad thing, not a good thing. Just on number of words alone, it appears that diabetes carried more importance than anything else that happened in that session, let alone NMS.  Consider that all notes are real estate: if you devote ten times as much space to diabetes than to "-SI" (no sucidal ideations) then it appears that diabetes was ten times more important to you.

Zyprexa is not indicated for depression.

Irrelevant, of course, but in a trial it is brought up to show the doctor is a cowboy.  Remember, a jury of laymen think FDA approval means much more than it does; they are already heavily biased towards this thinking. Try answering this question on the stand: "So the FDA spends millions of dollars deciding indications just so you can ignore it?" This is why (in my opinion) the doctor's defense should not be that he tried approved treatments first, and then tried unapproved treatments, because it confirms that FDA approval means more than it does. 

The doctor's argument should simply be that there is considerable evidence supporting it's use, most of psychiatry already does this quite commonly, and is thus well within the standard of care.  Period. 
Otherwise you're expanding the issue to include not just "did you miss NMS?" but "do you even know what you're doing?"

Failure to diagnose NMS:

Doctor says that NMS was "on his mind" as part of the differential diagnosis, but was dismissed because the ER had evaluated him; had he known the ER did not know about the Zyprexa, he would have stopped the Zyprexa and sent him back to the ER.

Is reliance on another doctor a legitimate defense?  Only if you are confident the other doctor's care.  Would you let your kid stay over some father's house just because that father had kids of his own?  Additionally, even if the patient did actually have the flu, it would not preclude having NMS.  So the ER's evaluation was an example of information bias: a block of information that seems useful because of its size, but is actually uninformative-- and misleading. 

The doctor also stated in his deposition that NMS was unlikely because the patient was already on Klonopin, which, as the treatment for NMS, should have prevented it.

This was bad.  Not only is it factually untrue-- Klonopin wouldn't protect against NMS-- it portrays the doctor as uninformed and dangerous.  It's an easy attack for the plaintiff's expert.  Teaching point: don't say anything at a deposition that can be fact checked unless you're sure of your facts.  Leave all that to your expert.  Most doctors think they can create such a good defense for themselves at the deposition that the case will be dropped, but that is very unlikely to happen.

Doctor also stated that the patient did not have any other symptoms of NMS: he was clear and logical in the phone interview; the ER also did not note any confusion, nor did the ER note any rigidity  The patient complained of nothing else to the doctor.

This is the defense.   Is the standard of care to work up every case of fever (but without confusion or rigidity) for NMS?  Would a reasonable psychiatrist send a person to the ER for possible NMS if the only symptom present was a fever?  It's also helpful to work backwards: it's unlikely most psychiatrists would have worked up NMS based on fever alone even if the drug was Haldol, which has higher rates of NMS.  Ask it another way: how many times do psychiatrists confront fevers in their practice for which they do nothing?


In the course of deciding what is standard of care, plaintiff's will (and should) ask what determines standard of care?  What books and journals do they rely upon?

Think about your response.  Think about what the plaintiffs are really asking.  They want to make sure you are a real expert, using real science, etc.  Saying "November 2008 issue of Wired" is not going to work.  So how do you respond?  How do you convey to them that what you are saying is grounded in established psychiatric knowledge?

You don't.  The question is a trap.  If you say, "The Textbook of Psychiatry" then you are holding that book up as the standard bearer for everything.  "So you're saying he did everything right according to the NMS chapter, but doesn't the other chapter say Zyprexa is not indicated for depression, and has the potential to worsen depression?  So why would anyone use it?"  Etc.

Here is what I would respond:

No text or person decides "the standard of care."  Standard of care is the care ordinarily given by at least a respectable minority of competent practitioners.  Psychiatry has guidelines, but they must be interpreted in the context of individual patients.  Insurers may have certain requirements for reimbursement, but these are not de facto standards of care; nor should the denial of reimbursement be taken to imply substandard care.

Some regulatory bodies, such as JCAHO, also have guidelines, but these are definitionally "best practices," not "ordinarily used practices."  They are at a higher standard; and consequently care that meets JCAHO standards is therefore well within the standard of care.

Importantly, JCAHO standards are about procedures, not judgments.  For example, JCAHO has a policy on how to implement restraints and seclusions, but not when to implement them.  If an adverse event occurs during a restraint episode, and JCAHO standards were met, then standard of care on how to use them was definitely met (though, again, not meeting JCAHO standards does not necessarily mean standard of care was not met.)  However,
the decision to use restraints might not be standard of care.

There are many texts psychiatrists use to inform their practice (Gutheil's Clinical Handbook of Psychiatry and the Law, APA's Textbook of Psychiatry, etc) but none of those determine standard of care, ever.  This is why we use experts in malpractice cases.   Courts use expert testimony for the purpose of determining what is standard of care, and whether care delivered met that standard.  An expert will also assist in the determination of whether, to a reasonable degree of medical certainty, the care delivered was the cause of the patient's injury. 

Opposing experts will often disagree as to what is standard of care.


You make a good point, that... (Below threshold)

April 28, 2009 12:20 PM | Posted by Craig: | Reply

You make a good point, that the standard of care isn't a black/white issue, there is no cookbook approach to most fields of medicine (as I always tell my clients, that's a good thing for doctors and nurses, because if there was, we'd program robots with those instructions, and off they'd go).

However, having sent a similar request in every single case I've handled in a decade, it's not so much that he thinks you have anything responsive -- it's just that if you *do*, the other attorney wants to see it, so that he's not surprised when you are sitting on the witness stand, and open Harrison's to page 459 and read chapter and verse.

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Reminds me of the problem o... (Below threshold)

April 28, 2009 1:06 PM | Posted by Dr Benway: | Reply

Reminds me of the problem of creating a computer capable of understanding a spoken language, such as English. Before a machine might understand something like the old bumper sticker, "One nuclear bomb can ruin your whole day," you'd first need to teach it about nuclear bombs, then about anti-proliferation movements and political parties in the US, then about what a "day" is and how it can be "ruined," and finally, about the humerous use of understatement. Essentially, you have to put the history and context of everything in the world into the machine before it gets the joke.

So I agree that a "written authority" for standard of care doesn't exist in any manner that might have meaning for a particular patient and physician at a particular moment in time. However, I wouldn't want to convey the impression that general clinical guidelines don't exist.

If we're all trying to be science-based, we ought to have some ability to resolve our disagreements using appeals to evidence.

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Craig's right. The opposing... (Below threshold)

April 28, 2009 2:23 PM | Posted by Anonymous: | Reply

Craig's right. The opposing lawyer wants to know if you rely on any texts. If you do, he or she will go through them and compare your testimony to the texts you rely on. Any discrepancies will be fodder for impeaching your testimony (which is to say your opinion).

The other lawyers may or may not have reached the point where they will attempt to have the court say you are not qualified to testify an expert. You don't say what the questions are that the lawyer sending the email is having you answer as an expert. Standard of care seems to be what you see the issue as, but I can't tell that for myself from this brief post.

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Reading between the lines, ... (Below threshold)

April 28, 2009 2:37 PM | Posted by Craig: | Reply

Reading between the lines, sounds like whether the use of restraints was within the standard of care on a particular patient (probably in relation to a fall or some self-inflicted injury that the restraints would've prevented). Which, actually, is the perfect example to show that the SOC is fluid and dynamic -- it takes a judgment call to know when they're called for and when they're not.

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Maybe before you mix all th... (Below threshold)

April 29, 2009 7:54 PM | Posted by Anonymous: | Reply

Maybe before you mix all this shit together you should actually have an idea of what can happen.

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ouch. this doc is not in go... (Below threshold)

April 30, 2009 1:11 PM | Posted by MedsVsTherapy: | Reply

ouch. this doc is not in good shape.
note to docs: figure out how to get hold of "pmi" sheets, and how to get a pt to sign noting that he or she has received pmi, and this has been reviewed in person. if you don't know what a pmi sheet is, you are headed toward eventual trouble, just like this doc in the court case. LASTP: thanks for the forensic file.

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"Remember, a jury of laymen... (Below threshold)

April 30, 2009 8:06 PM | Posted by vinnie: | Reply

"Remember, a jury of laymen think FDA approval means much more than it does..."

Let's not imply that laymen know less than "experts". I have gone to doctors that didn't understand what FDA approval means.

Then again maybe doctors are just laymen with degrees....

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Doctors are laymen with deg... (Below threshold)

May 4, 2009 6:42 AM | Posted, in reply to vinnie's comment, by acute_mania: | Reply

Doctors are laymen with degrees. Scientifically minded people don't take vague and useless terms like mood stabilizer, atypical antipsychotic, dirty drug, stabilize from above/below, etc.. seriously.

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"So the FDA spends millions... (Below threshold)

May 13, 2009 1:57 PM | Posted by psychohistorian: | Reply

"So the FDA spends millions of dollars deciding indications just so you can ignore it?"

"It would be more accurate to say that the FDA does not spend millions of dollars finding extra indications for drugs that have been proven safe. That is left to additional studies, which in the case of..."

Then again I'm definitely not a psychiatrist, so I may be way off.

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