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Friday, March 22, 2013

Unbelievable Wisconsin Supreme Court ruling on informed consent

I normally wouldn't do this but you need to see excerpts from an article in the Wisconsin State Journal to understand the nature of this case. I have abridged as much as possible.

Thomas Jandre was driving to a job site when the left side of his face started drooping. He began drooling, his speech became slurred and he felt dizzy and weak in his legs.

He went to the emergency room at St. Joseph’s Hospital in West Bend. Dr. Therese Bullis did a physical exam to rule out a stroke. She ordered a CT scan to rule out a hemorrhagic stroke, or bleeding in the brain. To check for an ischemic stroke, from a clot, she used a stethoscope to listen for unusual blood flow in his carotid artery. She diagnosed Jandre with Bell’s palsy, inflammation of a nerve that controls facial movement.

Eleven days later, Jandre had a massive stroke that caused permanent damage to the left side of his body. An ultrasound showed the carotid artery along his neck was 95 percent blocked.

Bullis was negligent in not telling Jandre he could have had a carotid ultrasound when she saw him, the Wisconsin Supreme Court ruled in April. The test might have led to treatments to prevent the stroke.

The supreme court affirmed an appeals court decision that upheld a $2 million jury award in 2008 to Jandre, now 57, whose stroke occurred in 2003. The jury said Bullis wasn’t negligent in her diagnosis of Bell’s palsy but found her negligent in her duty of informed consent because she failed to discuss the carotid ultrasound.

The decision “leaves physicians in the difficult position of not knowing how much information a physician should provide to a patient about tests for diagnoses already ruled out by the physician,” said a statement by three Wisconsin MD organizations.

The groups said the decision could drive up health care costs by requiring unnecessary tests. They’re calling for state legislation to clarify informed consent.

But Dr. Sheldon Wasserman, chairman of the state Medical Examining Board, said he agrees with the ruling. “You should give patients all the information they need and more,” he said.

Jim Weis, the Wausau attorney who represented Jandre, said if Bullis had conducted a “one-minute conversation” with Jandre about the ultrasound, “the stroke would have been avoided.”

A second article noted that the doctor was reprimanded by the state medical board and fined $300. It also says that the state legislature may introduce a bill to clarify the informed consent law.


Wow! I agree that the ED physician was not negligent in arriving at the wrong diagnosis. That can happen. It's not negligence if you do everything right and come up with the wrong answer. According to the courts, her “negligence” was in not telling the patient that a carotid ultrasound could have been done.

Just how would a “one-minute conversation” with the patient have avoided the stroke? Would the patient then have had the option to demand the test? If that is so, why not skip the history and physical examination by the doctor altogether and let the patient choose from an a la carte menu of diagnostic tests when he comes through the door?

This case opens up a huge can of worms. Should all patients who are determined by an ED MD to not have appendicitis be told that they could have a CT scan and if that is negative, an ultrasound? Might as well throw in an MRI too, even though it has never been proven to be useful for that illness.

And who believes that the state legislature will solve the problem of informed consent brought up by this case? Not I.

If you think healthcare is expensive now, wait until the emergency medicine community gets wind of this case.

20 comments:

Jeremy Webb said...

It would be hard to defend a stroke case where non-con CT was performed due to new persistent neuro deficits. If you think it's bell's, no need for imaging. If something makes you think about a central etiology (CVA) enough to get CT, then neuro consult and/or MRI for confirmation are needed as CT sensitivity for new ischemic stroke is not good enough. Also, bell's shouldn't cause extremity symptoms. Without looking at the Dr's chart its hard to come to a conclusion about standard of care.

Skeptical Scalpel said...

Jeremy, thanks for commenting. Perhaps you missed something.

The details of the case as provided by the newspaper articles are insufficient to judge whether her care was appropriate.

But the doctor was not guilty of malpractice for failing to diagnose the stroke. She was found guilty of failing to inform the patient that an ultrasound could have been done.

artiger said...

Scratch Wisconsin off that list of potential states for practice relocation. Sounds like the state board there is hostile, not to mention the courts.

Skeptical Scalpel said...

What's wrong with their medical society--asking the legislators to define consent? Oh my.

Nicholas said...

I'm sort of confused by what the court is saying. But I don't see how a physician thinks listening for a carotid bruit is sufficient for ruling out stenosis? I'm all about smart application of health resources and not over testing. But I am not under the impression that bruit auscultation is at all sufficient in stroke work up.

My attendings would never let me get away w that in vascular clinic. In fact I have listened to and not heard bruits in patients w/ ultrasound & CTA confirmed stenoses so the sensitivity of the old stethoscope can't be that great or acceptable in such a high risk case.

Right? What am I missing? This ED doctor seems to have done an incomplete work up (they tend to err in the opposite direction) when proven superior diagnostic modalities were available.

Skeptical Scalpel said...

I agree that the workup might have been incomplete. However, the doc did do a head CT and at least examined the carotids. I agree also that listening for bruits is not very accurate.

I suppose the doctor would have been better off not having done the CT or examined the carotids. Then she could have said, "Stroke was not in my differential diagnosis.

Again, the court ruling and the medical board reprimand are focused on the failure to inform the patient that a carotid ultrasound was a possible diagnostic test.

That's what I don't get. What sort of precedent does that set? My imagination is on overload just thinking of the possibilities.

Anonymous said...

My accute appendicitis was found through an MRI, after a CT done one week earlier showed everything clear. I am an ovarian cancer survivor still seeing my oncologist quarterly for exams. I started having sporadic abdominal pain (6/10) and mentioned it to him at my next appointment. Because of my history, the scan and a CBC was ordered. Everything came back clear or "unremarkable". One week later another bout of really bad pain (8/10) so back to him to ask for pain medication, thinking that was my only recourse for comfort. Instead he ordered the MRI which came back with the correct diagnosis. Then emergency surgery. It's anecdotal I know, but I'm sure glad he didn't give up and just give me the pain medication with the inevitable calamity looming around the corner. I wonder what the outcome would have been if I had gone directly to the ER at the first sign of pain, instead of seeing my own doctor first.

Emily

Skeptical Scalpel said...

Interesting case and certainly unusual. Credit your doctor with an excellent diagnosis.

The problem is there isn't much in the literature to suggest that MRI is useful in such cases.

Nonetheless, you did well.

Libby said...

What if the ER doctor had mentioned the option of a carotid ultrasound and the patient declined it? Would he have a case then?
just wondering.

Skeptical Scalpel said...

Libby, yes he would have had a case. His lawyer would have sad the the doctor dd not explain the importance of the ultrasound clearly enough.

Neal Lippman said...

The problem with the idea that one should give the patient "all the information he needs and more" (aside from the obvious oxymoron, in which after having given the patient all the information he needs, the "and more" can only then be information he _doesn't_ need) is that patient's have no ability to determine the utility of various tests in their situation, as they lack the training and information base on which to make those determinations.

The result of telling patients all of the different tests that _could_ be done, without any judicious filtering on the part of the treating physician, is that the patient is left with a bewildering array of choices, with no ability to make any decision at all.

You could have an ultrasound. Why not an MRA? Or an invasive angiogram? or a CT of the neck?

There was a time when the physician, as a professional, was responsible for making a recommendation to the patient, not just to provide a listing of tests or treatments from which the patient can choose. I often explain complex treatment options to patients, only to have them ask me what I want them to do, or the surrogate question, "what would you tell your father to do if he were me?" As Wisconsin would have it, I would tell them to make their own choice, I'm just here to read the menu to you.

Libby said...

So basically the doctor is screwed any way. Give & explain in detail or concisely the "menu",the patient agrees or declines all or some items (most likely from being overwhelmed), don't mention treatments/tests because they aren't relevant, and you still get in legal hot water because the patient's body had its own agenda.

What if there wasn't a threat of a stroke at the moment the ER doctor examined him but it developed afterwards? Sometimes the body develops things slowly and sometimes they develop things rapidly.

(my Social Work classmates would claim the doctors were guilty of institutional violence or such silliness because they (doctors) have privilege and power and the patient was their victim).

Anonymous said...

My issue with your presentation of the case is that you've given it greater significance than I think it warrants, and expanded it to mean things that it plainly doesn't.

It is not an omen of rapidly expanding national liability for doctors--I don't think it opens a can of worms, and I don't think it should affect the way most ED docs do their jobs. The Court was quite careful to show that its ruling was limited to the facts before it--rather extraordinary facts, I think. Futhermore, it is a decision rooted in WI statutes and WI caselaw which defines a specific way that WI looks at "informed consent."

Back to the facts for a moment though. I think it's easy to gloss over the most damning facts for the doctor, which I submit you did. It's not a mystery whether an alternative was available. It is an undisputed fact in the case that the carotid ultrasound was "available."

Furthermore, the Court addresses (as it has done in previous cases) the notion that this requirement (from a legislative enactment, not from a court-invented rule) to inform patients about alternatives is not the same as having to give patients an "a la carte menu." The rule seems to be much more sensible--that a patient should be informed about options when certain diagnostics tests are selected.

Applied unthinkingly, that does sound onerous (considering the manifold diagnostic tests run on hospital patients, and the fractal array of other possible tests). But I again return to the facts of the case at hand. How did this doctor end up with a $2M judgment? She saw a very atypical presentation of what she thought was Bell's, she chose a "very, very poor" test (the doctor's words) to rule out stroke when a much better test was available, and she got it wrong.

This was a case with horrendous facts for the doc. Trying to expand its reach to every patient encounter in the ED--inside and outside of WI--is to read it mistakenly. And though the outcome may indeed be problematic, I don't think the outcome on the facts presented to the jury, and on the basis of WI statute, can be characterized as "stunningly stupid."

Skeptical Scalpel said...

Neil and Libby, you both make some excellent points. I agree with them.

Anon, thank you for sending me a link to the 126 page Supreme Court decision in this case. Here is the link http://is.gd/x4zIot and another link to a somewhat shorter version http://is.gd/atIPYR.

You have taken a very narrow view of both the decision and the Wisconsin informed consent law.

I am looking at the bigger picture.

There is a lot to discuss but I will try to be brief. As Supreme Court Justice Roggesack said in her dissenting opinion, "I also conclude that under the circumstances presented the jury's finding that Dr. Bullis was not negligent in her care and treatment of Thomas Jandre is inconsistent with the jury's finding that Dr. Bullis was negligent in regard to her duty to obtain informed consent." She thought the case should be retried. I agree. It makes no sense to say she was not guilty of malpractice, but guilty of negligent informed consent.

In a less than enthusiastic concurring opinion (link here: http://is.gd/DbgG7R), Appellate Justice Fine wrote:

"Of course, as we have seen, there is nothing in either Scaria or §448.30 that extends the informed-consent duty to encompass the range of possible diagnoses. This post-Scaria extension in violation of the clear language in §448.30 shifts medical-assessment judgment from the physician to the patient and leads to two no-win alternatives framed by the following question: 'Must the physician in obeisance to the patient’s medical judgment then do everything the patient wants done?'”

"If the answer to this question is 'yes,'there will be no ceiling to the already rocketing health-care costs because of the plethora of unnecessary tests and procedures such an answer will spawn. This surely would be contrary to the legislature’s recognition of the dangers to the financial integrity of our health-care system by 'the prescription of elaborate defensive medical procedures.' If the answer to this question is 'no,' then, under Bubb and its post-Scaria precursors, the issue of whether the physician will be liable under §448.30 turns on whether one of the undisclosed possible diagnoses will be seen in retrospect as the one the physician should have made, despite the fact that the physician’s actual diagnosis was not negligent. Indeed, even though Dr. Bullis was not 'negligent with respect to her care and treatment of' her patient—that is, her diagnosis of Jandre’s condition, as explained by the trial court’s instructions to the jury—the Majority, in paragraphs 26, 29, and 35, conflates the informed-consent issue with its view of what Bullis’s diagnosis should have been."

One of the previous precedent setting cases, Bubb hinged on the fact that Mr. Bubb was sent home from an ED with a TIA. He had a stroke two days later. The court ruled that he should have been told that admission to the hospital was an alternative. I'm guessing he would have opted for it.

Of course, this is all very clear in retrospect when you know the outcome, especially if you aren't the ED MD dealing with maybe 8-10 other active patients at 10 p.m.

I still say the Bullis case will be interpreted by the doctors in the trenches as 1) patients will be able to call the shots on whether they will be admitted or not and 2) a lot of unnecessary tests will be ordered.

Anonymous said...

"I still say the Bullis case will be interpreted by the doctors in the trenches as 1) patients will be able to call the shots on whether they will be admitted or not and 2) a lot of unnecessary tests will be ordered."

Totally agree with you. Here in Brazil, where health access is universal (i.e. the minority who pays taxes takes all the financial burden so that the vast majority who don't present even a dime may use the State Health System). Fingers at the ready, they demand everything and besides the lawyers, we have some encounters with police officers too. Harsh times these ones. I really feel I'm in a trench lately.

Skeptical Scalpel said...

Brazil sounds like a really great place to practice. Looks like we are headed in the same direction.

I'm almost afraid to ask what types of encounters you are having with the police.

Pascal said...

That's why here in Switzerland the US patients have to sign a "do not sue"-agreement before they even get to see a doctor in our hospital.

Skeptical Scalpel said...

Pascal, doctors have tried that sort of thing here. I believe it is not possible for people in the US to waive their right to sue. I could be wrong.

Gordon Banks said...

If it was a Bell's Palsy, then the ER doc was not negligent at all. If it was NOT a Bell's Palsy, and I suspect it was not, then she was guilty of not doing enough w/u, or not getting a neurology consult. I think the language of the decision is harmful and going to result in more unnecessary testing.

Skeptical Scalpel said...

It probably wasn't Bell's palsy. Again, the issue was not whether she missed the diagnosis. She was criticized for not telling the patient about other tests that could have been done.

I agree that the law in Wisconsin is certain to cause more tests to be done.

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