The MedMal Room: The $12 Million Misoprostol Case
When routine replaces reflection, consent becomes a courtroom exhibit. A $12 million verdict shows why forensic ethics belongs in every labor unit.
Preamble:
According to the American College of Obstetricians & Gynecologists (ACOG), informed consent should be obtained before any diagnostic or therapeutic procedure, ideally early enough in the clinical course to allow time for reflection and questions. It should also be revisited whenever new information arises or the treatment plan changes, ensuring that consent remains informed, voluntary, and current throughout care.
Should there always be an informed consent for induction of labor? When a physician prescribes a medication that has been deemed safe by a professional organization does that mean no informed consent is needed? Do patients have a reasonable expectation to be informed when a doctor recommends a medication whose manufacturer explicitly cautions against such use due to identified risks, and it has not been approved by the regulatory authorities?
The Case
A 38-year-old woman, pregnant for the first time, is admitted for induction of labor at 39 weeks. The reason: she’s 39 weeks pregnant. Not hypertensive. Not diabetic. Just term.
No informed consent for induction is obtained. No documented discussion of risks, alternatives, or the off-label nature of the medication.
