LMA Package Insert Key Evidence In Anesthesia Malpractice Case

[wtbcrna, MSN, DNP, CRNA]

"In a Connecticut courtroom a manufacturer's package insert for a laryngeal mask airway became a key piece of evidence in a medical malpractice lawsuit. When a medical malpractice lawsuit is brought the plaintiff must prove that a deviation from the standard of care, by the defendants, led to the injuries for which they are seeking a remedy. The standard of care is determined by the testimony of expert witnesses brought by both sides. It is then up to the jury to consider the testimony of the battling experts and decide what was THE standard of care and whether there was a deviation from it. The court itself does not determine the standard of care for the jury. In the case that follows, a manufacturers device manual/ insert was allowed into evidence in such way that the warnings in the insert itself were seemingly presented as a publication of the standard of care. While written materials like anesthesia textbook, research papers, professional association recommendations. guidelines and standards and even package manuals/inserts can be relied upon by expert witnesses when testifying as to standard of care, in and of themselves they do not establish the standard of care absent expert witness testimony."

http://lawmedconsultant.com/6095/lma-package-insert-key-evidence-anestheisa-malpractice-case/

[detroitdano]

Doesn't mean that you ain't gettin' sued!

"With regard to the verdict, the irony is Miett (the MDA) was not found liable for the injuries to the plaintiffs, presumably since he was not in the room when the decision was made to use the LMA. He had been named in the lawsuit solely based on his preoperative examination failing to note that an LMA should not be used if a general anesthetic was required. However it also never said an LMA SHOULD be used. His testimony however was devastating for his fellow defendants. The jury found that AANL's agents, Richeimer (CRNA) and Calobrisi (another MDA), were negligent in their treatment of the plaintiff and that their negligence was a substantial factor in causing her injuries and damages. The jury awarded damages for Karla Rosa in the amount of $8,541,808. The jury awarded damages for Delmar Rosa in the amount of $2 million."

[jwk]

I'm waiting for this same concept to be used against "sedation nurses" and other non-anesthesia providers in a case involving propofol.

[traumaRUs, MSN, APRN]

Ugh.....agree with dr miett in that much of the documentation found on medical devices is there due to litigation reasons. A total shame the verdict was in favor of the plaintiffs. Maybe we need consent forms where the pt has to accept some responsibility for their own care. Perhaps if the pt wasn't morbidly obese they would have developed a hernia to start with...

[wtbcrna, MSN, DNP, CRNA]

I'm waiting for this same concept to be used against "sedation nurses" and other non-anesthesia providers in a case involving propofol.

It would be an interesting court case. The main differences IMO would be that propofol has a well established (well over 200k) safety record for use by non-anesthesia persons, and propofol use by non-anesthesia providers is backed by the American Society of Gastroeneterologists.

This was not the case for LMAs though.

[wtbcrna, MSN, DNP, CRNA]

Ugh.....agree with dr miett in that much of the documentation found on medical devices is there due to litigation reasons. A total shame the verdict was in favor of the plaintiffs. Maybe we need consent forms where the pt has to accept some responsibility for their own care. Perhaps if the pt wasn't morbidly obese they would have developed a hernia to start with...

It is ironic when morbidly obese patients come to surgery and expect the exact same outcomes and anesthetics as a healthy person with a normal BMI.

[detroitdano]

Could be simple enough. Just add an extra box to the pre-ops with an actual consent line for patients, saying any complications due to body habitus is on the patient...obviously it needs to be worded a little nicer lol.

We had a lady who coded and died due to trach complications in my ICU a few years back. She was the worst candidate for the intervention they gave her as she had a BMI of about 70, but she consented and took the risk. I bet I'll be getting something about deposition any day now on that matter.

[manusko]

Would you guys pop a LMA in on this same type of pt? I would not and I think our training and common sense tells us that it would be inappropriate.

[wtbcrna, MSN, DNP, CRNA]

Could be simple enough. Just add an extra box to the pre-ops with an actual consent line for patients, saying any complications due to body habitus is on the patient...obviously it needs to be worded a little nicer lol.

We had a lady who coded and died due to trach complications in my ICU a few years back. She was the worst candidate for the intervention they gave her as she had a BMI of about 70, but she consented and took the risk. I bet I'll be getting something about deposition any day now on that matter.

You can never make a consent that covers every eventuality.

[wtbcrna, MSN, DNP, CRNA]

Would you guys pop a LMA in on this same type of pt? I would not and I think our training and common sense tells us that it would be inappropriate.

It is hard to say what you would do or not do unless you're in the exact same situation. The CRNA could have anticipated a difficult intubation, and decided they didn't want to paralyze and intubate the patient with potentially difficult airway.

IMHO a major consideration before awarding compensation should have been the patient's BMI. The patient put themselves at major risk just by being morbidly obese.

[traumaRUs, MSN, APRN]

Agree and then when pts lie to us and it impacts their care, well, they should bear some responsibility IMHO.

[ssrhythm]

I had become, over the last year, a little more open to putting an LMA in slightly obese patients and pts with well controlled DM, but one of our general surgeons told me about a CRNA here years back that had an obese diabetic aspirate and later die from complications related to the pneumonia that followed. He said he witnessed the lawyer ask a series of questions about the patient that were taken word for word from the LMA package insert. The CRNA got burned. Now, I don't care if it is a three minute cysto case, if the patient is obese or diabetic, they are getting intubated. If it looks to be a difficult airway, I'd rather deal with that up front and in control rather than when the procedure is going on. There are far too many "safe" options available to be going up against what you will face if an LMA anesthetic goes bad on a patient who fits the criteria warned against on that package insert.