Weiss: Informed consent- statutes and caselaw

Today we welcome back Larry Weiss, M.D., J.D., Clinical Professor of Emergency Medicine at the University of Maryland and overall expert in the field of medico-legal issues. Dr. Weiss has been invited all over the United States to speak on the delicate aspects of practicing medicine in the legal mine fields of modern medicine. Today he focuses on the subtleties of the medical consent process. Although the laws and statutes are focused on the state he practices medicine, Maryland, the overall concepts are secure. It’s been said before, but these ideals are something you have to master to practice medicine successfully!

Please note: This talk is for education only, please consult a lawyer for specific legal needs. 

Clinical Pearls (note: MD law is the focus)

  • General consent: signed on arrival to the hospital that allows things that are “standard, routine, and non-invasive
    • Specified consent is needed for everything else
    • Caveat: exception is emergency consent that allows life saving procedures
  • Right to refuse: Cruzan Case on medical consent ruled by the Supreme Court
    • Patient’s have a liberty interest in refusing medical care
      • exceptions: suicidal or incompetent individuals
      • Should transfer care if the patient does not agree with your care plan
  • Consent
    • Sard v. Hardy: modern consent theory
      • Pregnant patient, C-section performed, BTL performed with consent, the patient became pregnant, sued for “improper consent
      • NOW: must inform patients and disclose all material risks (significant risks) for proper consent
        • Must disclose information that a “reasonable” person would want to know
    • Dingle v. Berlin: who should consent?
      • Lap-chole, consent by attending, resident performed the surgery, pt sued after a complication as she was not told that the resident would do the majority of the work
        • The senior individual should do the consent with a note defining who will primarily do the procedure
    • McQuitty v. Spangler: how long does consent last?
      • High risk pregnancy, hospitalized for one month, physician wanted to keep pt until baby was mature, admitted and consent was signed for future c-section, abruption, emergent c-section, baby born with CP, sued for improper consent
        • Ruled that consent must be renewed as the risk/benefit changes, BUT no definition on “how often”
  • Surrogate decision making
    • Each state has a specific order of individuals who can give consent on behalf of a patient, you must cite with your state’s guidelines
      • Contact ethics committee or hospital counsel for guidance
  • End of life 
    • Cruzan case
      • Substitute decision makers should have the power to make all decisions for patients, including end of life decisions
    • All patients should have advanced directives
      • Verbal or Written
      •  A patient can change their POA verbally or revoke their existing advanced directives, but a FULL note must be written
        • Must note mental status in detail and mention decision making capacity
    • An advanced directive can only direct withholding of “life saving treatment” if the patient is in a “terminal state” or in a “permanent vegetative state”
      • for a Vegetative state it takes two physicians, one must be an expert in cognitive disorders
    • MOLST forms
      • Pre-hospital order valid in Maryland, requires informed consent
      • Deals with futility law
  • Futility
    • Ineffective medical care” as determined by two physicians (licensed)
      • in an emergency department you only need one physician
      • Family must be informed, they do not have to agree
        • Not deemed “mercy killing”

Suggested Reading

  1. ] Z. Karim, S.S. Alkhowaiter, B. Bressler, E.M. Yoshida, Informed consent and its documentation: implications for medical malpractice liability, BCMJ 55 (2013) 376–379. [BCMJ Link]
  2. Weiss. Informed Consent- MD Statutes and Caselaw. [Direct Link to Handout]
  3. Grady C. Enduring and Emerging Challenges of Informed Consent. N Engl J Med 2015; 372:855-862 [NEJM Link]
About the Author

Jim Lantry

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Just your average critical care doc: Wandering the ED and ICUs for the USAF down in the San Antonio Military Medical Center, traveling the globe to cannulate for ECLS wherever the need arises, and trying to keep up with great minds of today. E: JlantryMD@gmail.com

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