Documentation that the patient gave informed consent can be very important in medical malpractice litigation. Most medical providers feel that if they have a detailed informed consent form that contains the potential risks of a procedure that they should be protected in malpractice litigation.
Hospital administrators and their counsel often draft these multi-page forms. Thinking that compliance to the informed consent process is an affirmative defense in a suit can be a costly mistake. A signed informed consent form may be deemed as not relevant in some cases and thus inadmissible.
Informed Consent in Pennsylvania
The state's MCARE provisions explain that informed consent is necessary prior to having a medical procedure. Physicians owe a duty to obtain a patient's informed consent, or that of their personal representative prior to conducting the following:
- Surgery & anesthesia
- Radiation or chemotherapy
- Blood transfusions
- Implanting a device
- Usage of medications or devices which are experimental
Purpose of Evidence
Evidence that is admitted by a court because it is relevant and has some practical purpose to assist a jury is said to have probative value. Essentially, it is evidence that can assist with proving or defending a disputed issue. Evidence that the court finds may confuse a jury or create prejudice is generally excluded. Those defending hospitals in medical malpractice litigation are often quick to reference a signed informed consent form, although the process of consent is not an issue in the matter.
Relating to Negligence
Defendants are often quick to produce a signed informed consent agreement in litigation; this is often done to show jurors that the plaintiff was aware of the risks. In this scenario, the informed consent agreement may be mistakenly confused with a waiver of patient rights. The reason a plaintiff signs an informed consent form is actually to confirm they are aware of the possible risks associated with a procedure when the standards of care are met. These agreements do not serve as a patient's acknowledgment that they accept the risk of being treated in a negligent manner.
Supreme Court Decision
In 2015, the PA Supreme Court issued a ruling in Brady v. Urbas regarding whether to allow informed consent. A plaintiff with hammertoes had surgery which created a cosmetic deformity where the toes were very short and left her with chronic pain. A second surgeon restored the length of the toes in a bone graft procedure and the pain was also relieved. A medical malpractice claim was brought against the first surgeon and the patient sought to exclude the informed consent forms from evidence, citing they were irrelevant in determining if the standards of care were met.
The Supreme Court ultimately ruled that consent is not related to the risks of surgery that are caused by negligence. By signing an informed consent agreement, a patient is not automatically assuming the potential risks of a surgeon operating negligently. Many surgeons question this ruling by saying that they should be able to introduce evidence that a complication is possible without demonstrating negligence.