The “differential diagnosis” of medical treatment gone wrong is never easy to address. The physician or surgeon’s role in health care allows them great latitude in judgment. The “off-label” use of a drug or device is not uncommon and the Food and Drug Administration does not require medical device manufacturers to seek approval for every possible use to which surgeons may put a device but by doing so the practitioner takes up a significant responsibility to assure that the risk versus benefit is clearly in the patient’s favor.
This is particularly true in surgical procedures where, once the procedure has been initiated, the surgeon may encounter unanticipated difficulties or problems. The act of attempting to act in a patient’s best interest does carry with it significant medical-legal obligations to achieve a good patient result. If the physician employs significant deviations from accepted practice and the patient has a poor result they may be accused of negligence, particularly if they circumvent established drug or device warnings. The physician’s responsibility can certainly be challenging. One prominent neurosurgeon from Minnesota once observed at a FDA hearing: “If it would save a patient’s life I would be willing to spit in the wound.” Thus reflecting the fact that “anything goes” in a life-threatening situation and, once again, the risk versus benefit consideration is paramount.
Most medical situations are not, however of the life threatening variety and a number of other considerations apply. An important consideration is venue. It is sometimes the case that adequate facilities and/or equipment are not readily available and alternatives may not be possible. Weather and other natural phenomenon may be important factors when medical personnel are unable to provide the usual and customary services. The level of technical difficulty is always higher in patients who have undergone previous surgery at the same site.
In the real world in which we live medical mistakes occur not infrequently. Fortunately they typically do not result in harm to a patient.
Misadventure- A bad result despite good and reasonable effort.
Negligence- A bad result when the effort does not reflect reasonable standards of patient care.
Examples of Misadventure:
An experienced and skilled orthopedic surgeon is performing the trans-oral removal of a cervical odontoid process because of osteomyelitis. As he moves to remove another piece of the odontoid with a rongeur his hand slips and the instrument plunges against the patient’s brain stem producing instant death.
An experienced and skilled neurosurgeon is performing a standard laminectomy when the air drill he is using slips, tears the dura mater and causes injury to the nerve roots of the cauda equina producing permanent impairment of bowel and bladder function.
In these examples of surgical misadventure despite the best of efforts, terrible complications occurred. For a circumstance such as this to not have legal consequences it would have been necessary for the surgeons to have provided “informed consent” prior to surgery.
Example of Negligence:
A patient with back and leg pain suddenly develops difficulty with bowel and bladder function. Because this circumstance is considered emergent a imaging study is immediately performed and a very large disc herniation at the lumbar 4-5 level is found. The patient is immediately taken to surgery by an orthopedic surgeon. A standard limited laminotomy is performed. The surgeon notes that the ligamentum flavum is unusual in consistency and then comes upon herniated disc material. At this point the surgeon suddenly realizes that he has transected a
compressed cauda equina. The patient was immediately rendered paraplegic and remained so.
This case represents a number of important aspects regarding negligence. The surgeon acted quickly, as was appropriate, and made the right diagnosis. Even though this orthopedic surgeon performed routine discectomy in his practice he was unprepared to deal with this particular case because of inexperience and lack of adequate training. He should have called in a more experienced spine surgeon. An experienced spine surgeon would have recognized that a limited operative exposure, in this case, was an invitation to disaster. This surgeon was negligent because the unfortunate complication could have been avoided if the recognized standards of good spine practice had been met for the given circumstance. As in all spine surgery the primary responsibility is adequate exposure of the operating field.