Medical error: IV push vs. intra-arterial of Phenergan

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See: http://www.nytimes.com/2008/09/19/us/19scotus.html

Medical summary: PA attempts to give Phenergan as an IV push, but injects into an artery. Pt loses her arm, sues, and wins.

Legal question: Since the drug manufacture warns of the intra-arterial risk and their warnings and drugs are FDA approved, should the pt be able to sue? Should FDA approval be an approval of risk-benefit, or a minimum standard?

What do you guys think?

I think, given what the FDA process is today, it should be considered a minimum and people should be able to sue.

 

[edmadison]

See: http://www.nytimes.com/2008/09/19/us/19scotus.html

Medical summary: PA attempts to give Phenergan as an IV push, but injects into an artery. Pt loses her arm, sues, and wins.

Legal question: Since the drug manufacture warns of the intra-arterial risk and their warnings and drugs are FDA approved, should the pt be able to sue? Should FDA approval be an approval of risk-benefit, or a minimum standard?

What do you guys think?

I think, given what the FDA process is today, it should be considered a minimum and people should be able to sue.

Well, there are a couple of problems with your questions/statements. First, promethazine is not approved for IV use at all, let alone IVP. Do we use it IV off label, sure, but we do so at our own risk. Side effects with rapid administration are well known. Second, virtually everything a provider does could be grounds for a lawsuit. Finally, the FDA doesn't set any standards of care. It is looking at a medication's overall safety and its efficacy to treat certain conditions. Certainly FDA approvals and manufacturer warnings contribute to the standard of care, but actual local practice determines what the standard of care is. Without this distinction, there would be almost no drugs available to treat children.

You must look at the particular situation to determine liability. Can using a medication for an off label purpose fall within the standard of care? Certainly. Does giving promethazine directly into an artery "IV" (not really an IV, right?) Push meet with the standard of care? No. Would giving promehazine IVP in a vein meet with the standard of care, I would argue no, but I'm not an expert.

Ed