Pennsylvania law requires that physicians acting in nonemergency situations first must obtain their patients' "informed consent" prior to performing surgical or operative procedures. The doctrine of informed consent requires that a physician disclose to each patient the material facts, risks, complications, and alternatives to surgery that a reasonable, prudent person would consider significant in deciding whether to undergo the surgery. Where incisions, excisions, or sutures are made and surgical instruments are used, the procedure qualifies as one for which the physician must obtain the patient's informed consent.
The doctrine of informed consent arises from the notion that a patient and a physician are entering into a contract. For the contract to be valid, both parties must understand and agree upon the nature of the procedure and both the expected and the possibly unexpected results. The physician need not disclose all information that he or she knows, but must generally advise the patient of the facts, risks, complications, and alternatives to surgery.
Pennsylvania appellate courts have recently decided several cases that explore the limits of informed consent. In one case, a woman who underwent surgery for esophageal cancer claimed that in response to her questions prior to surgery her surgeon told her that he performed the procedure about once each month. She further claimed that after undergoing the surgery with unsuccessful results she discovered that the surgeon in fact only performed the procedure five times each year.
The Pennsylvania court ruled that patients who question their surgeons prior to surgery about their surgeons' competence, experience, and expertise are seeking information that is highly relevant to them in making an informed decision about surgery. "A particular surgeon's skill, which many times is borne by virtue of experience, is important to those making a choice of their personal surgeon," the court noted.
In another case, a young man sued a group of surgeons over complications that arose following his surgery for spinal fusion, in which the surgeons used bone screws to fuse the young man's vertebrae. The screws were approved by the FDA for use in long bones but not for use in the bones of the spine. The manufacturer's literature enclosed with the screws advised that in most instances the screws eventually must be removed due to various complications that arise following surgery.
Several years after the initial surgery, the young man had to undergo surgery for the removal of the screws. In connection with the second surgery, he discovered that the screws were not FDA approved for use in the spine and that eventual removal of the screws had been recommended by the manufacturer. He had been advised of neither issue prior to his first surgery.
In the lawsuit brought by the young man, his surgeons maintained that informed consent disclosure need not include details about implanted devices. They also raised concerns that FDA approval should not be an element of informed consent. At the time, no bone screws were approved by the FDA specifically for use in the spine and orthopedic surgeons across the country were regularly using the nonapproved screws for spinal surgery. The surgeons claimed that their use was an appropriate "off label" use of the bone screws and was not a "risk" of surgery.
The court decided that the doctrine of informed consent mandates that a physician share information with his or her patient regarding the limits of FDA approval when the physician is making an innovative or "off label" use of a medical device. Patients, the court observed, might well assume that any device used in surgery was approved by the FDA, "a well known federal agency charged with regulating the commercial distribution of medical devices." The court found that the use of the bone screws constituted a "risk" and a "fact" that a reasonable, prudent patient would consider relevant to the decision to undergo spinal surgery.
Where an operative procedure is conducted without the patient's informed consent, the patient may have a legal claim for both medical negligence and "battery," which can generally be defined as an unwanted touching. Unlike most medical malpractice cases, in battery claims the patient need not prove that the doctor was negligent. The patient must only prove that the doctor conducted a procedure without the patient's informed consent. The amount of damages suffered by the patient is determined by the jury and must be supported by some evidence produced by the patient.
Doctors need not enlighten all of their surgical patients with the details of their education and experience. However, they must provide accurate and truthful answers to those patients who inquire. They need not guarantee the reliability of devices that they implant, but they must share information about the limits of FDA approval and any known risks. The entitlement to this information is something that patients should value and take seriously. When signing an informed consent form, patients should take time to read the form and, if necessary, ask for more information.