Informed consent in Maryland medical malpractice cases involves the question of whether the patient had a meaningful opportunity to be an informed participant in the patient's own health care decisions. Under the doctrine of informed consent, a physician treating a mentally competent adult under non-emergency circumstances may not provide treatment without the patient's informed consent.
There is no question that medical malpractice is interwoven with informed consent. Isn't it medical malpractice for a health care provider not to fully apprise the patient of all of the risks? But since the Maryland Court of Appeals first recognized informed consent in 1977, Maryland case law has consistently emphasized the critical differences between malpractice and informed consent. The Court of Appeals tells us that informed consent and medical malpractice claims may "both sound in negligence, but are separate, disparate theories of liability.”
Under Maryland law, a doctor has a duty to explain the proposed treatment or procedure and risks of the procedure to the patient and to properly warn him of any material risks or dangers inherent in, or collateral to, the therapy, such that the patient can make an intelligent and informed choice about whether or not to undergo such treatment. This duty to disclose under Maryland law requires a physician to reveal to his patient (1) the nature of the ailment, (2) the nature of the proposed treatment, (3) the probability of success of the contemplated therapy and its alternatives, and (4) the risk of unfortunate consequences associated with such treatment.
So the doctrine creates a duty to "explain the procedure to the patient and to warn him of any material risks or dangers inherent in or collateral to the therapy" to enable the "patient to make an intelligent and informed choice about whether” to undergo treatment. Our malpractice laws do not always make sense but, with informed consent, they do.Maryland Law Is Informed Consent from the Patient's Perspective
Unlike some other jurisdictions such as Massachusetts, Maryland views the question of informed consent from a reasonable patient perspective. In other words, the Maryland standard focuses on considering what a patient would need to know in order to make an informed decision. So for informed consent in Maryland, the jury looks to the choice of treatment, and any associated risks, from the perspective of the reasonable patient. Martinez v. Johns Hopkins Hospital, 212 Md.App. 634, 70 A.3d 397 (2013)
Other jurisdictions focus on what a typical physician would say to a patient receiving a similar therapy or procedure. In this case, medical testimony would be required to establish the scope of the breach of the doctor's duty in a medical malpractice action.Elements of Informed Consent
In Maryland, we are not required to procure expert medical testimony to establish the scope or the "breach of the doctor's duty," but medical testimony is required to establish (1) nature of the risks inherent in a particular treatment, (2) probabilities of therapeutic success, (3) frequency of the occurrence of particular risks, (4) nature of available alternatives to treatment and (5)whether or not disclosure would be detrimental to a patient. In fact, under Maryland law, this testimony can also be provided by the testimony of the defendant medical doctor.Material Risks Only
In Maryland, only "material" risks must be disclosed by the doctor to the patient. What constitutes material? There is no bright line rule for what risks are material. Again, it falls back to what the reasonable patient would believe to be material. The battles over materiality may also look to the policies of the doctors or the hospital that gave the procedure.
Most health care providers in Maryland have specific policies that state which health interventions require a signed consent form. For example, surgery, medication, anesthesia, or any invasive procedure usually requires a signed informed consent. But a written informed consent is just the beginning of the informed consent process and should be the culmination of a dialogue between doctor and patient, not the entire dialogue.
Duty to disclose material information to the patient is not restricted because the proposed treatment or therapy is not surgical or invasive. All possible material risks must be disclosed.Causation
The last step in the informed consent analysis is causation. Most jurisdictions use an objective test for causation. A minority of jurisdictions, such as Washington, DC, Arizona, and New Hampshire, use a subjective test. The objective test is whether a reasonable prudent person in the patient's position would have had the surgery or therapy had the risk been disclosed by the medical professional. The subjective test is whether the particular patient (i.e., the plaintiff) would have consented to the surgery if he had been fully apprised of the risk. procedure after being informed of the risk by the health care professional. Like most jurisdictions, Maryland applies the objective test of causation.
Informed consent cases under Maryland law, like most jurisdictions, are couched as tort actions for negligence as opposed to battery or assault. For a medical malpractice case in Maryland, the rendering of medical services absent informed consent must be presented separately in the complaint as a separate and new count of negligence.Broad Language Forms May Not Provide Informed Consent
Some of these surgical or hospital consent forms are so broad and generic that they do little to articulate specific risk to patients beyond "bad things could certainly happen". Many patients remember signing one of these "every risk in the world" forms and assume it is the death knell for their informed consent claim. Often, it is not.
Also, the mere fact that the risk is listed does not mean the patient assumed the risk of the injury. If you are trying an informed consent case, this is the one that hat has to be crystal clear to the jury.
Whenever a doctor performs a medical procedure or renders treatment, they are required to (a) “inform” the patient by explaining the risks and benefits of the procedure; and (b) obtain the patient’s express “consent” to go ahead with the procedure. This is what is known as obtaining “informed consent.” If a doctor fails to get informed consent and the patient is harmed during the procedure, they can sue the doctor for malpractice even if the injury was a normal risk.
The common practice in the medical profession is to have patient’s sign a consent form as evidence of informed consent. However, simply signing a form consenting to a procedure is NOT enough. The doctor needs to actually have some discussion with the patient and make sure he or she understands the risks.
There are some exceptions to the requirement that a doctor obtain “informed consent” before a medical procedure: (1) if there is a life threatening emergency and there is no time to obtain informed consent; (2) if the patient is unconscious or incapacitated and not able to give consent; and (3) if the patient voluntarily waives consent.
To obtain informed consent, the doctor must disclose and explain the risks of a procedure to the patient. However, this does not mean that the doctor must disclose every potential risk not matter how minor or unlikely. Under Maryland law, only “material” risks must be disclosed to the patient. There is not clear definition of what make a risk “material.” This is something that the courts apply on a case-by-case basis.
No. A minor (anyone under the age of 18) lacks the legal capacity to give effective informed consent because they are not considered competent. When the patient is a minor, informed consent must come from the parents or legal guardians.
If you believe you have a medical malpractice case in Maryland, call Miller & Zois at 800-553-8082. We will give you legal advice at no cost or obligation. You can also get a free on-line consultation here.More Information on Informed Consent
- Informed Consent Maryland Pattern Jury Instruction
- Motion in Limine Regarding Consent Form in a Malpractice Trial
- Maryland's Statute of Limitations
If you are doing legal research on informed consent law in Maryland, here are some key cases you will want to focus on in your research:
- Dorchy v. Hsieh (2019 unreported) (underscoring that a certificate of a qualified expert and report attesting to the doctor's departure from the relevant standard of care that proximately caused the injury may not be needed in a straight informed consent case).
- Hill-Higgins v. Boucree (2019 unreported) (in a dental malpractice case that underscores why you will almost certainly eventually need an expert, the court ruled that the Montgomery County trial court correctly found that the absence of expert testimony regarding alternative treatment to address the tooth pain was fatal to the plaintiff's informed consent case).
- Armacost v. Davis, 462 Md. 504 (2019) (if there was an error in giving general foreseeability instruction to the jury in a trial against neurosurgeon, the issue was moot because the neurosurgeon prevailed on informed consent claim although he lost on negligence).
- Shannon v. Fusco, 438 Md. 24 (2014) (the court underscored the elements of an informed consent case, which include: (1) the duty to disclose to the patient material information that "a physician knows or ought to know would be significant to a reasonable person in the patient's position in deciding whether or not to submit to a particular medical treatment;" (2) breach of that duty by failing to make an adequate disclosure; and (3) proximate causation," citing Sard v. Hardy.
- Burks v. Allen, 192 A.3d 847(2018) (this is a Miller & Zois case where the court affirmed the jury's $10 million wrongful death verdict for our clients in an informed consent case involving a critical care physician's use of Kayexalate).
- Martinez v. Johns Hopkins Hospital, 212 Md. App. 634, 70 A.3d 397 (2013) (holding that informed consent evidence was prejudicial because it as "improperly used to conflate the negligence issue' because an informed consent allegation had not been properly pled in the Complaint)
- Fusco v. Shannon, 210 Md. App. 399, 63 A.3d 145, (2013) (informed consent and medical negligence are separate and distinct claims that require proof of different elements)
- Schwartz v. Johnson, 206 Md. App. 458, 49 A.3d 359 (2012) (trial court properly granted motion in limine and precluding evidence of informed consent)
- McQuitty v. Spangler,410 Md. 1, 18,976 A.2d 1020 (2009) (court overrules Reed v. Campagnolo - see below -- finding that in an informed consent lawsuit in Maryland is viable when doctor withholds important information about a proposed course of medical treatment causing the patient to decide on medical treatment that he/she would not have made with the correct information.)
- Dingle v. Belin, 358 Md. 354, 749 A.2d 157 (2000) (finding that "evidence of informed consent...is both irrelevant and unduly prejudicial in medical malpractice claims without claims of lack of informed consent")
- Landon v. Zorn, 389 Md. 206, 230, 884 A.2d 142, 156 (2005) (upholding Worcester County trial judge's ruling to instruct the jury on a malpractice but not on an informed consent in a failure to diagnose necrotizing facitis [flesh eating bacteria] case)
- Reed v. Campagnolo, 332 Md. 226, 242, 630 A.2d 1145, 1153 (1993) (in later overruled opinion, court says in answer to certified question from U.S. District Court that the duty to obtain informed consent arises only when a medical treatment or procedure has been proposed by a physician involving an "affirmative violation of the patient's physical integrity.")
- Zeller v. GBMC, 67 Md. App. 75, 506 A.2d 646 (1986) (holding in a Baltimore malpractice case that a doctor's rendering of medical services without patient's informed consent constitutes separate and new count of negligence that needs to be pled as a separate count).
- Sard v. Hardy, 281 Md. 432, 379 A.2d 1014 (1977) (Maryland high court first recognized as a separate negligence-based (as opposed to battery) cause of action of informed consent against a surgeon in a tubal ligation sterilization case in Talbot County -- the court also looked at other jurisdictions in determining the subjective test should be the law in Maryland).