Of patients who are hospitalized in this country, between 1 and 2% of them will suffer some sort of negligent injury, according to a Harvard study. Only about 2% of those, in turn, will result in a malpractice claim. Even though those percentages are small, based on the sheer volume of patients, they add up to large numbers of malpractice suits brought against physicians every year. But are these always cases of negligence, or are they sometimes just avoidable bad outcomes?
A panel of experts convened at the 2006 Combined Otolaryngology Spring Meeting (COSM) in Chicago to look at some specific cases and try to inject a little bit of black and white into the sometimes gray area of negligence, malpractice, and bad outcome.
The panel included David W. Kennedy, MD, who served as moderator of the discussion; James A. Stankiewicz, MD; Donald C. Lanza, MD; Rodney P. Lusk, MD; Douglas E. Mattox, MD; Andrew N. Goldberg, MD; and special guest Patricia J. Foltz, JD, a malpractice defense lawyer from Chicago.
Healthy middle-aged female. Over several years, she has had multiple right-side polypectomies performed in-office. One year ago, she had in-hospital right-side polypectomy and right-sided functional endoscopic sinus surgery (FESS). Postoperative pathology showed previously unsuspected inverted papilloma. Patient subsequently had a right lateral rhinotomy and then was referred to a specialist for persistent disease four months after the lateral rhinotomy. The patient now has a tumor on the skull base.
Should this have been detected sooner, and what is the standard of care for submitting pathology in office polypectomy?
Dr. Mattox: Even if it’s in-office, I think tissue removed should be submitted for pathology.
Dr. Lanza: I agree. I had an occasion once where I was convinced that a patient who had no history of vocal polypectomies elsewhere and polyps were normal. I almost thought not to send the tissue. The day after Christmas that pathology came back malignant melanoma.
Dr. Stankiewicz: If you know a patient-you have operated on that patient and you know the diseases they’ve had. If they come in with an obstructive polyp and it looks typically like what you’ve seen in the past, I think it’s okay to remove that and not send it to pathology. But if you don’t know the patient or are operating on them for the first time, then you should absolutely send it to path.
Ms. Foltz: As your lawyer, I’m going to always advise you to send it, because what’s the downside? One important caveat to that, though: Never let a lawyer tell you what the standard of care is.
Dr. Kennedy: This is one of the reasons why I think it’s very important to use suction traps with the microdebrider-so that all of the material gets submitted in case there’s a tumor hiding somewhere in there.
Ms. Foltz: In Illinois, the law requires that all tissue removed in a hospital setting be sent to pathology. It may not be in your hospital bylaws, but don’t assume that means it’s not a state law.
Was it appropriate to do the lateral rhinotomy or was that outside the standard of care?
Dr. Goldberg: I’m one who typically approaches these with an endoscopic approach; I think my visualization is better. I definitely believe you should inform the patient that there are two ways to do this operation.
What should be disclosed to the patient?
Ms. Foltz: I have always believed that the standard of care requires us to disclose unanticipated outcomes, because if something goes wrong during surgery or during treatment, you can’t get appropriate informed consent without disclosing what really happened. Now, when you’re talking about seeing someone else’s mistake, you are not legally obligated, at least not in Illinois and not by federal law, to disclose that you think the other person may have made a mistake.
A 42-year-old male is scheduled for bilateral total ethmoidectomy. Preoperative CT shows mild to moderate ethmoid disease bilaterally. No polyps, but CT revealed a low-lying skull base. Endoscopic sinus surgery was performed. The procedure took 2-1/2 hours and the blood loss was significant (900 cc). Postoperatively, the patient had a CVA and altered sensorium. At pathology, he had both gray and white brain matter bilaterally. There was a brain hemorrhage; he also had an aneurysm that had to be fixed by neurosurgery. The patient survived but had permanent brain damage as a result of the injury.
Is this a case of negligence or just a bad outcome?
Dr. Stankiewicz: This was a very interesting case I participated in about 15 years ago. It changed my mind about what is defensible and what isn’t. Basically, the decision at trial was this was a low-lying skull base-it could have happened to anybody-and this was a bad outcome but not enough to prove negligence.
Ms. Foltz: It is absolutely true that a bad outcome is not enough to prove malpractice. But remember, there will always be someone out there, I guarantee you, who will testify against you and there is nothing you can do to guard against them. My suggestion is if you have an outcome that is not what you expected or desired, the best thing you can do to try and avoid a lawsuit down the road is to talk to the patient honestly and empathetically about what happened.
Dr. Kennedy: A recent case that I know of was a very similar injury, where the patient had somewhat more brain damage and they ended up having to turn off the respirator. That case settled for $7.5 million, so it shows that this is not necessarily the way it will go.
Dr. Stankiewicz: In big metropolitan areas you, as the treating doctor, can be in big trouble in a case like this. This particular case was in a very affluent physician-friendly area. In a major metro area, and an outcome like that, you’re going to have some real defense problems.
Dr. Lanza: I would submit that, defensible or not, bilateral removal with the skull base and/or multiple brain tissue removal during elective sinus surgery is well outside the standard of care.
Your patient is undergoing an endoscopic orbital decompression for Graves’ disease. Your assistant is a well-trained senior resident and he is operating while you are observing on the video screen. The resident is removing the bone posterior near the optic canal and he slips and clearly impacts the optic nerve. The videotape is running.
When do you talk to the family?
Dr. Kennedy: I would probably tell the family, while the patient was still asleep, that we are concerned that there was some trauma to the optic nerve. We will have to see how his vision is after he wakes up, but that we do have some concern.
Dr. Lanza: I would devote all my attention to the patient and not think anything about discussing it with the family. I would spend my time taking care of the specific event-awaken the patient, evaluate the vision, and then discuss it fully with the family.
Dr. Mattox: Our approach in situations like this is to get the family informed and on board early on, though obviously not at the expense of taking care of the patient.
Ms. Foltz: Obviously, the patient’s safety comes first. Once you’ve got that patient into recovery and gotten things stabilized, then you go out and you talk to the family. But I don’t think there is immediately any need to say who did what within the surgery.
What do you tell the family?
Dr. Lusk: As a pediatric otolaryngologist, I have actually been in similar situations several times. I would not immediately say that a resident was involved unless I was asked specifically.
Dr. Goldberg: It seems to me that disclosing that it was the resident who made the breach of the optic shifts the focus from what’s going on with the patient, and taking care of them, to whole separate set of issues that clouds things. Not that you would try to hide it, but it seems like not the right time to go into that kind of detail.
Dr. Mattox: Our counsel was more aggressive and advised immediate disclosure early on and tell them that, at the time of the incident, the instrument was in the hand of a resident. Emphasize that the resident was competent to perform this portion of the procedure, and that this is a known complication and could just as easily have happened had it been my hand.
Dr. Stankiewicz: The problem with that is, unless you have informed the family ahead of time that a resident will be involved in the surgery, you’re opening up a whole can of worms. That brings up another issue: When we’re teaching residents, do we have to disclose that a resident will be involved in the case?
Ms. Foltz: I hate to have to tell you this, but CMS [Centers for Medicaid and Medicare Services], your favorite federal agency, in February 2005, changed the guidelines for the informed consent requirement. It is now required that, in writing, every individual who is going to participate in the surgery be disclosed. It still hasn’t been put into effect in every institution, and CMS has told us that they don’t know when they are going to start enforcing it. On a bit of a side note, there was a case in Illinois where a resident was actually sued for battery, not negligence, and was subjected to punitive damages because that resident was not part of the consent process and the attending had not advised the patient. If you’re in a teaching institution, you should be telling every patient you have that physicians who are residents will be participating in your surgery.
©2006 The Triological Society