Bisphosphonate Therapy is an Important Pre-Surgical Consideration

Background Facts

A 54-year-old, post-menopausal accountant (Ms. P) presented to an oral and maxillofacial surgeon (Dr. T) on referral from her general dentist, for the removal of a vertically fractured and non-restorable lower left second molar. But for her longstanding fears about dental treatment, and her resultant desire to be “asleep” for the extraction, the general dentist would have performed the extraction himself, as it did not appear, radiographically or clinically, to be an overly difficult procedure, partly due to mild tooth mobility.

Based upon the responses the patient provided on the oral surgeon’s history intake form, her only medical issues were related to laboratory outcomes, which demonstrated a moderately elevated serum calcium level, and a bone density study some 5 years prior to the current visit which revealed widespread osteopenia with focal areas of osteoporosis. As a result, she had been on a regular oral regimen of a bisphosphonate, prescribed by her primary care physician, since shortly after the diagnoses of osteopenia and osteoporosis were made.

After briefly discussing the patient’s medical history with her, the oral surgeon stated that he was not concerned with her bone condition or the medical treatment for it, especially because the monthly oral dose had been taken 20 days earlier, and because she had suffered no associated problems during her 4 ½ years taking the medication. A surgical appointment was scheduled for 3 days later, when the patient would be able to bring a friend to drive her home after the extraction under IV sedation.

On the day of surgery, Ms. P was handed a consent form by a dental assistant, and asked to read it, after which she was to sign it. The patient had some questions regarding risks, and the assistant assured her that this form was “just for the lawyers”, so she shouldn’t be concerned. The assistant added that Dr. T is an excellent surgeon, so all of his patients do well and there was nothing to worry about. The patient signed the form before the doctor came into the room, and nothing was said about it or its contents after he arrived. A nitrous oxide/oxygen mixture was given through a nasal mask, sedatives were injected intravenously followed by local anesthesia, and the tooth was routinely delivered by forceps, after which the site was irrigated and sutured. Ms. P was discharged home in the care of her friend and told to return in a week for suture removal.

At that post-op visit, the patient complained of continuous, low-grade discomfort and tenderness. Dr. T examined the area when he removed the suture, and noticed a sharp ledge of alveolar bone, which he reduced with a Rongeur and a bone file. Ms. P was discharged and advised to return if she developed any problems or had any concerns. Two weeks later, she returned with continuing symptoms, so the site was irrigated and packed with dry-socket dressing, with a prescription given for Amoxicillin. This was followed by weekly visits, each time with increasing pain, which was repeatedly treated with the same process of irrigating and placing the sedative dressing. Approximately 3 months after the extraction, Dr. T took a radiograph for the first time post-operatively, a panoramic film, and noted areas of what looked to be bony sequestra and poorly defined radiolucencies. A specimen of bone was taken and sent for pathology, with a diagnosis of “osteomyelitis vs. osteonecrosis” returned.

Legal Action

After Ms. P’s retained attorney obtained the dental and hospital records, and had an expert review them, a lawsuit was instituted against Dr. T, alleging negligence and lack of informed consent. The major claims of negligence were the failure to consider and protect against the well-known effects of bisphosphonates, the failure to coordinate care with the patient’s primary care physician, and the failure to timely diagnose and act on the bony destructive process post-operatively, thereby leading to spread to the inferior alveolar nerve and paresthesia.

Of particular concern was Ms. P’s articulate deposition testimony regarding the issue of informed consent. The night before the extraction, she read on the internet about some potentially severe side effects after dental surgery in patients taking bisphosphonate drugs, and she had planned to discuss that concern with Dr. T, but the dental assistant made the whole process seem so routine that she felt lulled into signing the form and proceeding without further discussion.

When that assistant was deposed, she acknowledged that she had no true understanding of any of the risks set forth on the form and no ability to substantively respond to any of the patient’s questions about the form contents, but she trusted Dr. T and his abilities so deeply, and had heard his discussions with patients so many times, that she believed that she had acted appropriately. The assistant added two important points: that Dr. T had given her permission to handle the informed consent process with patients, and, as was evident on the form itself, there was no written risk which spoke to what happened to Ms. P.

Case Defense Steps

Defense counsel obtained an expert who was a board-certified oral surgeon. The expert was in full agreement with the surgical approach taken by Dr. T, including that his assessment of the longstanding use of the bisphosphonate without problems was sound; that Dr. T was knowledgeable enough about bisphosphonates that no consultation with the physician was initially needed, and even if obtained, nothing differently would have been done; and that repeated post-operative follow-up visits, adding the antibiotic Amoxicillin, taking a radiograph and biopsy specimen when the situation did not resolve, and referring as he did were all proper in every regard. However, the expert did not agree with the propriety of the informed consent process.

Dr. T’s attorneys submitted an expert affidavit to the Court with the aforementioned opinions, in an attempt to have the negligence claim dismissed. The plaintiff’s attorney’s expert did not adequately refute the defense approach, so the negligence claim was dismissed, but the claim for lack of informed consent was allowed to stand and proceed to a jury. In the lead-up to trial, plaintiff’s counsel expressed that he did not wish to base his entire trial on the consent claim, thinking that the jury would not take it seriously enough, so he sought only to have his client reimbursed for her out-of-pocket medical costs in exchange for discontinuing the lawsuit. Only upon Dr. T’s agreement to do so were those settlement terms accepted, thereby ending the case.

Takeaways

When obtaining a patient’s informed consent, oral surgeons and all dentists should understand that informed consent is not simply a signed piece of paper, regardless of how much detail that form contains. Consent is a give-and-take process between doctor and patient, in language and terms understood by the patient, in which the patient is advised of the benefits of, alternatives to, and the foreseeable risks associated with the planned procedure. The process must be specific to the procedure and to the individual patient, taking into account that patient’s medical, surgical, and social history; when doctors discuss risks not included on pre-printed forms, those should be documented in the chart. Obtaining informed consent is generally not delegable to a person other than the practitioner about to perform the procedure, although in some limited situations, a similarly trained practitioner who knows the case-specific facts may stand in for that purpose, but a dental assistant or other non-professional staff member is incapable of playing that role, as this case clearly demonstrates.

In a similar vein, it is all too common for non-professional office staff to render opinions, give advice, or otherwise comment upon treatment-related issues. Practitioners must realize that they are liable for any and all consequences which may arise from the actions of their staff members, so staff training is necessary to make the members aware that they must not provide any such information or recommendations to patients, other than for entirely administrative purposes. This concepts holds, as well, for telephone interactions between the patient and office members, when the practitioner is rarely present and when patients frequently ask questions about their care or condition; such inquiries must be directed to the practitioner.

The concept of obtaining medical clearance from a patient’s physician is a judgment determination, but it ought to at least be considered when a patient presents with medical conditions, medication regimens, and social habits which the practitioner is either concerned about or unfamiliar with. If a dentist/oral surgeon does consult with a physician, best practices dictate that the substance of the interaction be documented, preferably with a writing directly from the physician consultant, but minimally with a detailed, contemporaneous chart entry; in the event of subsequent litigation based upon a medical issue, such documentation will provide defense counsel with strong evidence of the dentist/oral surgeon having taken appropriate steps.

It is not the purpose of this case study to advise as to what treatments are appropriate, as that is left to the practitioner’s judgment, but certain concepts – such as developing differential diagnoses when problems arise, ongoing determinations as to when to use radiographs, and when to make referrals – are best considered with all patient interactions.

Finally, it is impossible to know what will ultimately lead to case resolutions, but when insurance carriers retain defense counsel who are experienced and aware of all available approaches, oral surgeons and other professionals are best protected. And when practitioners’ liability policies allow them to decide whether or not to settle, they control their own destinies.

To help you practice more safely, MedPro Group has put together a variety of consent forms—you can click here to review and download them.

Note that this case presentation includes circumstances from several different closed cases, in order to demonstrate certain legal and risk management principles, and that identifying facts and personal characteristics were modified to protect identities. The content within is not the original work of MedPro Group but has been published with consent of the author. Nothing contained in this article should be construed as legal, medical, or dental advice. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your personal or business attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.