By: Anthony H. Gair, Esq.
This New York malpractice case involved a fifty-three year old man who was diagnosed with squamous cell carcinoma of the mouth encompassing the soft palate, the uvula, the tonsil and the base of the tongue. He underwent extensive radiation therapy and fortunately the cancer was irradicated. The patient developed osteoradionecrosis of the mandible following a wisdom tooth extraction by his dentist who was well aware that he had undergone radiation therapy.
As a result, he had to have three major surgeries involving removal of part of the mandible and extensive bone grafting and reconstructive surgery.
The definition of osteoradionecrosis is bone death due to radiation. Teeth removed in irradiated jaws often initiate Osteoradionecrosis.¹
In patients who have undergone radiation therapy for cancer of the mouth, the tissues in the mouth become hypoxic. Further, the vascular supply to the tissues is impaired and blood vessels are destroyed as a result of the radiation. The tissues also become hypocellular. These effects on the tissues of the mouth are permanent.
The important issues in the development of Osteoradionecrosis are endothelium, bone, periosteum and fibrous connective tissue of the mucosa and skin. The effects of radiation on the tissue level are endothelial necrosis, hyalinization, and thrombosis of vessels. The periosteum becomes fibrotic and bone osteoblasts and osteocytes undergo death with fibrosis of the marrow spaces. Mucosa and skin also undergo fibrosis, with decline in the cellularity and vascularity of the connective tissue. The result is a composite tissue which is hypovascular and hypocellular and has proved to be hypoxic compared with non-irradiated tissue. Once any wound is created, it would be unrealistic to expect effective healing, given the hypovascular, hypocellular and hypoxic nature of the affected tissue.²
It was the plaintiff’s contention that when a tooth is extracted a wound is always created at the site of extraction and that as a result of the radiation induced hypoxia, hypovascularity and hypocellularity of the tissues there will be problems with the healing process which may often lead to infection spreading to the bone and leading to osteoradionecrosis. This is even more so in patients with periodontal disease, which is often the case in those facing tooth extraction.
It was plaintiff’s contention that the defendant had no experience in treating patients who had radiation therapy of the mouth and should have obtained a consult from an experienced oral surgeon prior to extracting the tooth. The plaintiff also claimed that the plaintiff was not seen often enough in order to prevent the progression of periodontal disease which ultimately necessitated the extraction. Once the decision to extract the tooth was made, it was plaintiff’s claim that proper practice required that the plaintiff undergo a regimen of hyperbaric oxygen therapy to increase oxygen and vascularity of the tissues in order to improve the ability of the wound at the site of the extraction to heal and thus prevent infection.
Ongoing periodontal disease is suspected as an equal initiating fact to tooth removal and is the primary contributing factor in many cases of osteoradionecrosis attributed to tooth removal alone. Irradiated patients are recommended to undergo from 20 to 30 sessions of hyperbaric oxygen treatment before the onset of dental/oral surgical treatment plans in which tissues are wounded. They should also undergo 10 sessions of such treatment after their most extensive surgical procedure in the treatment plan.³
Finally, there was an informed consent claim, it being plaintiff’s assertion that at the time of the extraction it was well documented that osteoradionecrosis could result following tooth extraction in an irradiated patient. Plaintiff claimed it was a predictable, well known and foreseeable risk which the defendant failed to disclose to the plaintiff.
There was a concern that a jury would feel that the case was not serious and merely a patient unsatisfied with his dentist. Further, it was felt they might not accept the claim that it was a departure from proper practice not to have sent the patient for hyperbaric oxygen therapy prior to extraction.
Hence, at trial in New York Supreme Court, New York County, the examination of the defendant was directed to leaving no doubt about the seriousness of osteoradionecrosis, the potential for its developing, the defendant’s lack of experience and his failure to divulge any information to the plaintiff.
“Q. During the course of your treatment did you become aware that the plaintiff had been diagnosed as having squamous cell carcinoma, cancer of the mouth and oral cavity?
A. Yes, I did.
Q. And that carcinoma involved the soft palate, is that right”
A. That is correct.
Q. The roof of the mouth, is that right?
A. Correct.
Q. And it also extended into the tonsils, is that right?
A. I believe it did, on the left side.
Q. And the base of the tongue?
A. Yes.
Q. And extended to the uvular, the lesion extended to the uvular down into the throat and tonsils?
A. Down into the left and back, yes.
Q. Across the midline of the mouth, is that right?
A. Correct.”
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“Q. You were sent a consultation report by the oncologist, is that right, prior to radio therapy being instituted?
A. Yes, I believe so.
Q. And subsequent to the completion of the radio therapy, you were sent a treatment summary record, is that right?
A. Yes.”
Once it was established that the defendant was aware that the plaintiff had undergone radiation of the mouth, his lack of experience in treating such patients was established.
“Q. Incidentally, prior to treating the plaintiff, had you ever treated any patients who had received radiation therapy of the oral cavity in the mouth?
A. Not to my knowledge.
Q. Had you?
A. Not that I’m aware of.”
The following line of questioning was directed towards obtaining defendant’s admissions as to the effect of radiation on the tissues of the mouth.
“Q. Doctor, would you agree that one of the effects of radiation of the area of the jaw and mouth is reduction of oxygen in the tissues?
A. Yes.
Q. That’s known as hypoxia, is that right?
A. That is true.
Q. Hypo meaning less?
A. Correct.
Q. Would you also agree that radiation reduces the vascularity, the blood supply of tissues in the mouth?
A. I would agree with that, yes.
Q. In other words, it impairs the blood supply, fair enough?
A. Fair enough.
Q. And would you also agree that it causes a decline in the cellularity of the tissues, it kills cells?
A. Yes, I would agree with that.
Q. Now, would you also agree that the hypovascular, hypocellular and hypoxic nature of the irradiated tissues lessens the tissues healing ability?
A. I would agree with that.
Q. And is it correct, Doctor that when a tooth is extracted in the mouth, when a tooth is extracted a wound is created?
A. A surgical wound is created, yes.”
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“Q. In a patient who has undergone or underwent, I believe, 6,600 rads of radiation, were you aware that the extraction of the tooth in such a patient could lead to osteoradionecrosis?
A. It could, yes, it could.”
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“Q. And would you agree that the reason it can lead to osteoradionecrosis is because of the lessened healing ability of hypoxic and hypovascular tissue?
A. Yes.
Q. So, Doctor, is it fair to say that the pathogenesis, the originating cause of osteoradionecrosis is a nonhealing and hypoxic wound.?
A. Yes.”
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Once the defendant admitted to the truth of plaintiff’s contentions, the fact that no information was imparted to the plaintiff was established.
“Q. I don’t want to belabor this. It was your opinion the extraction was an easy one?
A. That’s correct, sir.
Q. That’s what you told the plaintiff?
A. Correct.
Q. We are in agreement you never told him anything about possibility of developing osteoradionecrosis, is that right?
A. That is correct.
Q. Now, Doctor, you are also – we are also in agreement, are we not, that you knew that the extraction of a tooth in a patient who had received radiation therapy, over 6,600 rads of radiation therapy in the jaw and mouth could lead to osteoradionecrosis, correct?
A. As a general statement, yes.”
“Q. In any event, despite your knowledge that it could be caused by the extraction of a tooth in an irradiated patient, who had irradiated tissues in the mouth, you didn’t tell anything to the plaintiff about it?
A. No, I didn’t mention anything about osteoradionecrosis to the plaintiff.”
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The fact that despite defendant’s lack of experience in this area, he never obtained a consult was then brought out.
“Q. You knew the pathogenesis, the originating cause of osteoradionecrosis was a nonhealing hypoxic wound, correct?
A. Okay.
Q. Correct?
A. Correct.
Q. And by hypoxic we mean a wound that didn’t have enough oxygen in it, correct?
A. Correct.
Q. And we know that radiation creates hypoxia in the tissues, it decreases the oxygen, we agree on that?
A. Correct.
Q. And when you extracted this tooth, you didn’t know, you didn’t know the extent to which the oxygen in the tissues had been affected, fair enough?
A. Correct.
Q. And you didn’t seek a consult to determine how they were affected?
A. Correct.”
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“Q. Did you call an oral surgeon experienced in treating patients who had received radiation in the jaw and mouth?
A. No, sir.”
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“Q. You didn’t call anybody up who had any experience dealing with this, did you?
A. That’s correct.
Q. And you had absolutely no experience, did you?
A. That’s correct.”
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Finally, the fact that defendant never considered pre-extraction hyperbaric oxygen therapy nor give the plaintiff the option of same was established.
“Q. It should be considered the use of hyperbaric oxygen therapy in treating a patient where there is some trauma, some surgical intervention, fair enough?
A. Okay.
Q. You didn’t consider that when you took this tooth out, did you?
A. No, I did not.
Q. You didn’t consider anything about hyperbaric oxygen therapy, did you?
A. No, sir, I did not.
Q. In fact, you weren’t really even that cognizant of it, were you?
A. No sir, not in the essence here.
Q. So therefore you obviously didn’t discuss it with the plaintiff?
A. That is correct, sir.
Q. So the plaintiff, while he was under your treatment, never had the option of even deciding whether that was something he should undertake, did he?
A. I did not make that recommendation to him, no.
Q. Not only didn’t you make that recommendation to him, Doctor, you didn’t even make it known to him, did you?
A. No, sir, I did not.”
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“Q. Did he have a right to know about its availability?
A. I would say he had a right to know, yes.
Q. And you deprived him of that right, did you not, sir?
A. I did not make him aware of that.
Q. You should have done that, correct? At least told him about it so he had an option?
A. Yes.”
By tailoring the questioning of the defendant to the plaintiff’s contentions and thereby obtaining admissions to the main elements of plaintiff’s theory, the defendant was effectively boxed in. He, in fact, admitted the claims of lack of informed consent. The case was successfully settled following the close of plaintiff’s case.
1. Marx RE, Johnson RP: Studies in the Radiobiology of Osteoradionecrosis and Their Clinical Significance. Oral Surgery, Vol. 64, No. 4, Oct. 1987.
2. Wilcher DK, Miller RI: New Concepts in the Pathnophysiology and Treatment of Osteoradionecrosis. Military Medicine 151, 6:331. 1986
3. Marx and Johnson, supra.
The New York Medical Malpractice Attorneys at Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf have years of experience representing patients who have been injured or have died as the result of medical malpractice.