The Consent Form: Patient Information AND Contract for Physician Services?
by Linda Ramsey, assistant vice president, Risk Management
Informed consent is defined as a person’s agreement to allow something to happen (such as surgery) that is based on a full disclosure of facts needed to make the decision intelligently, i.e., knowledge of the proposed treatment, risks involved and alternatives a “reasonably prudent patient” would consider material. Informed consent is a legal requirement for certain procedures in Pennsylvania; it requires disclosure of risks and alternatives that a reasonable patient (as opposed to a reasonable physician) would consider material. Physicians who fail to provide the required information risk tort liability, even if the physician was not negligent in performing the procedure.
In the past, the consent form merely served as evidence to support one side or the other on whether the legally required information was shared. The case described below marks a new area of liability exposure for physicians: breach of contract for failing to perform a procedure. In this type of case, the consent form serves as the contract between the physician and the patient for the performance of a stated service. Failure to perform an identified service may result in liability for breach of contract. In the recent case below, the patient’s expectation was performance of the procedures identified on the consent form she signed: a total abdominal hysterectomy and an oophorectomy. When only the total abdominal hysterectomy was performed, she filed suit against the physician for breach of contract for failing to perform the oophorectomy.
On June 21, 2006, the Superior Court of Pennsylvania decided two issues in a case titled, Vogelsberger vs. McGee Women’s Hospital of UPMC Health System. On the first, the Court held it was appropriate to reduce an $800,000.00 verdict to $200,000.00. The second issue dealt with whether the surgical consent form constituted a contract between the physician and the patient, such that the failure to perform the identified procedures was actionable by the patient. The consent form listed the procedures to be performed as a “total abdominal hysterectomy oophorectomy;” however, the physician failed to perform the oophorectomy. The Court held the patient could sue for breach of contract.
Ms. Vogelsberger was a 32-year-old woman who presented to defendant OB/GYN, Doctor Gintilli. She had a family history of ovarian and uterine cancer, including the death of her mother from ovarian cancer when her mother was in her thirties. She reported having abdominal pain, heavy periods, and pain with intercourse. Examination and testing revealed Ms. Vogelsberger had uterine fibroids and a prior history of endometriosis. She was evaluated by Doctor Gintilli and both the records and the consent form document performance of a total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy (BSO). Doctor Gentilli performed the TAH; however, at the time of the procedure, he did not perform the BSO.
In the four years post-surgery, Ms. Vogelsberger never complained to Doctor Gentilli about the failure to perform the oophorectomy; however, she went on to develop abdominal pain and constipation. Ultimately, Ms. Vogelsberger had a lysis of adhesions and BSO. The ovaries and tubes were normal showing no signs of ovarian cancer.
Ms. Vogelsberger sued Doctor Gentilli, alleging that the failure to perform the BSO constituted a breach of contract in addition to medical negligence. The Court held that where the performance expected by the patient and promised by the physician in terms that commit the physician to the performance, regardless of the standard of care, (emphasis added), the physician may be liable for breach of contract independent of whether there was negligence or battery. The Court did specifically state that there is no cause of action based on failure to affect the “cure,” merely the agreement to perform a specified procedure or treatment and the failure to do so.
This case creates a new cause of action in Pennsylvania. Historically, physicians could not be sued for breach of contract because the Court recognized no physician could guarantee the outcome of a medical procedure. While a claim for breach of contract is currently limited to the failure by a physician to perform an expected or promised service, the Court’s imposition of required performance regardless of the standard of care, (emphasis added), is troubling.
Where procedures are dependent upon what is found during surgery or treatment, qualifying language should be used in your records and on the consent form to denote a procedure may not be performed. Such qualifying language could include: “possible” or “if indicated.” This will allow you to use your knowledge and professional judgment.
Informed consent is a process; the patient’s agreement to undergo treatment is but one step in that process. The process begins when the need for treatment is first identified and ends only when the treatment is complete. An effective informed consent process includes teaching and counseling, as well as listening and responding to the patient’s questions and concerns, and maintains the patient’s involvement until the treatment is complete. This results in better cooperation from the patient and also helps them develop realistic expectations regarding the outcome.
The Consent Form Quiz and Answers
The Consent Form Quiz (September 2006)
The Consent Form Answers (September 2006)