I received some feedback and would like to respond:
After all, this was a jury court case that is being described, and we cannot perform medicine in isolation.
I appreciate this thoughtful discussion. While I completely agree that the primary clinical failure was the delayed response to two hours of tachysystole with Category II/III tracings, these issues that are described are not mutually exclusive. The standard of care for management doesn't negate our ethical obligation to discuss off-label medication use during the consent process—this is particularly salient when adverse outcomes occur and documentation becomes scrutinized. ACOG's evidence-based recommendation for misoprostol's efficacy doesn't eliminate the medicolegal reality that off-label use requires disclosure, especially given that many patients are unaware their induction agent lacks FDA approval for this indication. My intent was not to "fear monger" about a medication that is being used regularly, but to highlight how gaps in informed consent documentation can compound liability when clinical management falters, which serves our patients and our specialty better than dismissing the consent conversation entirely.
How would you feel if you were not informed about complications warned about by a manufactures who says not to use it, and a complication described in the manufacturer’s warning happens to you?
sigh, the off label use and description on the label reads like they are trying to avoid lawsuits against the manufacturer of the drug for poor outcomes and do not represent the tide of literature that supports its use in this way. Further in this anti science version of the FDA and CDC I'm not sure how we are supposed to practice at all. Lastly cytotec is a dirt cheap drug and they would have no financial incentive to ask the fda for this indication (problematic in itself) at great cost and liability (as above) and is a separate question then mechanistically does it work this way
I received some feedback and would like to respond:
After all, this was a jury court case that is being described, and we cannot perform medicine in isolation.
I appreciate this thoughtful discussion. While I completely agree that the primary clinical failure was the delayed response to two hours of tachysystole with Category II/III tracings, these issues that are described are not mutually exclusive. The standard of care for management doesn't negate our ethical obligation to discuss off-label medication use during the consent process—this is particularly salient when adverse outcomes occur and documentation becomes scrutinized. ACOG's evidence-based recommendation for misoprostol's efficacy doesn't eliminate the medicolegal reality that off-label use requires disclosure, especially given that many patients are unaware their induction agent lacks FDA approval for this indication. My intent was not to "fear monger" about a medication that is being used regularly, but to highlight how gaps in informed consent documentation can compound liability when clinical management falters, which serves our patients and our specialty better than dismissing the consent conversation entirely.
Great article. Really eye opening for me how we can become a bit complacent about these issues when they become routine
The big question is whether we always need court cases to know when informed consent is needed.
Most cases are confidential either settlements or jury verdicts. But they exist. Here is one close: https://www.robinskaplan.com/experience/96-million-for-improper-use-of-cytotec-to-induce-labor-leads-to-brain-injury?utm_source=chatgpt.com
Thank you.
How would you feel if you were not informed about complications warned about by a manufactures who says not to use it, and a complication described in the manufacturer’s warning happens to you?
sigh, the off label use and description on the label reads like they are trying to avoid lawsuits against the manufacturer of the drug for poor outcomes and do not represent the tide of literature that supports its use in this way. Further in this anti science version of the FDA and CDC I'm not sure how we are supposed to practice at all. Lastly cytotec is a dirt cheap drug and they would have no financial incentive to ask the fda for this indication (problematic in itself) at great cost and liability (as above) and is a separate question then mechanistically does it work this way
I am a nurse paralegal that works for a medical malpractice defense firm. Can you site the court case?