Lawsuits Over tPA for Stroke

[docB]

Interesting new article in Annals this month. As we've all suspected tPA for stroke will get you if you give it or not.

Liang and Zivin article

There are now more lawsuits for not giving it than for giving it. Every stroke patient can now expect either a full recovery or a generous jackpot. Everybody wins.

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[leviathan]

Interesting new article in Annals this month. As we've all suspected tPA for stroke will get you if you give it or not.

Liang and Zivin article

There are now more lawsuits for not giving it than for giving it. Every stroke patient can now expect either a full recovery or a generous jackpot. Everybody wins.

Hey docB

You will have to enlighten me on the medicolegal aspects of care in the US. Are you saying that you can *still* be sued if you push tPA and they bleed out, regardless of whether or not they sign a waiver accepting the risks?

 

[docB]

Hey docB

You will have to enlighten me on the medicolegal aspects of care in the US. Are you saying that you can *still* be sued if you push tPA and they bleed out, regardless of whether or not they sign a waiver accepting the risks?

Yes.

First, just to preclude someone else from saying it, we can get sued for anything but they may not win the case.

The article clearly states that there is higher liability now from not giving tPA than for giving it. However they do note 2 cases where tPA was given and the patient (or likely the family) sued for the bleed. Waivers are standard practice but of little use in the lawsuit. Generally the plaintiffs argue that they were not told of the specific complication they got or that they did not have capacity to consent, which is a powerful argument when it comes to a very risky drug that is only given to people acutely suffering from a significantly morbid stroke.

In America warnings and statistics mean different things than they do in the rest of the world. The warning "This might happen." actually means to patients "This might happen to other people but not to you." The figure "5%" again means "5% of people other than you."

 

[leviathan]

Yes.

First, just to preclude someone else from saying it, we can get sued for anything but they may not win the case.

The article clearly states that there is higher liability now from not giving tPA than for giving it. However they do note 2 cases where tPA was given and the patient (or likely the family) sued for the bleed. Waivers are standard practice but of little use in the lawsuit. Generally the plaintiffs argue that they were not told of the specific complication they got or that they did not have capacity to consent, which is a powerful argument when it comes to a very risky drug that is only given to people acutely suffering from a significantly morbid stroke.

In America warnings and statistics mean different things than they do in the rest of the world. The warning "This might happen." actually means to patients "This might happen to other people but not to you." The figure "5%" again means "5% of people other than you."

So another 'damned if you do, damned if you don't" scenario. Why do I want to be a physician again?

 

[DrMom]

Yes.

First, just to preclude someone else from saying it, we can get sued for anything but they may not win the case.

The article clearly states that there is higher liability now from not giving tPA than for giving it. However they do note 2 cases where tPA was given and the patient (or likely the family) sued for the bleed. Waivers are standard practice but of little use in the lawsuit. Generally the plaintiffs argue that they were not told of the specific complication they got or that they did not have capacity to consent, which is a powerful argument when it comes to a very risky drug that is only given to people acutely suffering from a significantly morbid stroke.

In America warnings and statistics mean different things than they do in the rest of the world. The warning "This might happen." actually means to patients "This might happen to other people but not to you." The figure "5%" again means "5% of people other than you."

So what does one do in this situation? I'm assuming that it helps if you clearly document in the chart exactly what you told the patient/family (and put the specifics on the consent form before they sign). Obviously won't prevent someone from filing a lawsuit, but would be good to show that they were informed.

Any other thoughts/recommendations?

 

[docB]

So what does one do in this situation? I'm assuming that it helps if you clearly document in the chart exactly what you told the patient/family (and put the specifics on the consent form before they sign). Obviously won't prevent someone from filing a lawsuit, but would be good to show that they were informed.

Any other thoughts/recommendations?

This is where it's helpful to work at a "Stroke Center" or at least be familiar with the protocols used by stroke centers. Point of info: when our stroke center was going to open we all thought it meant that there'd be a neurologist there to make the tPA vs. no tPA decisions removing us from the legal cross hairs. Doesn't really work that way. In my stroke center we can get neuro on the phone 24/7 and we collaboratively decide on tPA. It's better, not perfect.

Having an iron clad protocol to stand behind is a big help. At my place we have a pathway that gets initiated with an overhead page as soon as internal or external triage IDs a patient with a neuro deficit of less than 3 hours. CT then takes the patient IMMEDIATELY, that means from triage or off the ambulance gurney and scans them. The rads then calls the EP with the read. If the patient has no bleed, has a reliable history of onset less than 3 hours, has an NIH score of >4 and <26, has no contraindications to, consents to tPA and neuro agrees we lyse.

I think that if you follow a pathway like that you're about as safe as you can be. The biggest liability most of us face is that without a protocol we often have delays getting the CT scan done. If your patient loses their window waiting for a CT you are on the hook even though it's not really your fault. Someone's gotta pay.

 

[danielmd06]

A good article. Maybe. I think.

Thanks for the posts.