As the “baby boomer” population continues to age, increasing numbers of medically complex patients require and pursue comprehensive surgical and restorative dentistry. Although these treatment scenarios are often highly successful, and may result in positive, even life-changing, functional and cosmetic improvements, severe dental professional liability claims and lawsuits continue to occur.
 
This case study involves elements and allegations common to an increasing number of severe claims. The fact patterns often include multiple co-morbidities, extensive oral surgery and restorative care, and a failure to seek/obtain medical consultation to address key patient safety issues. Moreover, in-office procedural sedation is often a significant contributing factor to, or the primary cause of, the adverse outcome that leads to the claim/lawsuit.         
   
Claim Case Study
Practitioner: General dentist   
Claimant: Spouse of a male patient, aged 75 years, with a history of type 2 diabetes (T2D), congestive heart failure (CHF), hypertension (HTN), chronic kidney disease (CKD), stroke and obstructive sleep apnea (OSA)
 
Risk management topics: patient assessment and selection, medical consultation, medication risks, evidence-based clinical guidelines, regulatory compliance, and documentation
 
Facts:
The patient sought consultation and treatment from a general dentist to address his failing dentition, resulting from years of neglect and poor home care. Due to the presence of significant dental and periodontal disease, the dentist recommended extraction of the remaining 22 teeth. After discussing several possible treatment options, the patient decided on implant supported dentures to replace his natural teeth.
 
During the initial treatment consultation, the patient mentioned that he suffered anxiety during dental treatment, and he was worried about the dental extractions. The dentist recommended administration of an “anxiolytic” agent on the day of surgery to make the patient more comfortable. The patient agreed. The dentist also recommended that an antibiotic and pain medication be taken before the procedure.    
 
The patient’s current medications included aspirin and Xarelto (rivaroxaban) due to his history of stroke. The dentist expressed concern about the risk of excessive post-surgical bleeding. Therefore, he sought “medical clearance” specifically to stop these medications prior to surgery. The patient’s primary care physician agreed and provided a schedule to stop and re-start the drugs.
 
About an hour before surgery, the patient took three prescribed medications: one (1) antibiotic capsule (amoxicillin 500 mg), one (1) analgesic tablet (oxycodone/acetaminophen 7.5 mg/325 mg) and two (2) anxiolytic tablets (triazolam 0.25 mg). Before beginning the procedure, the patient’s blood pressure measured 160/85 and his blood oxygen level was 85%. He stated this oxygen level was “normal” for him, because of poor blood circulation in his hands.
 
After administering eight (8) cartridges of anesthetic (lidocaine 2% with 1:100,000 epinephrine) to obtain local anesthesia, the doctor proceeded with the extractions.
 
During the procedure, a staff member advised the dentist that the patient was no longer taking deep breaths when urged to do so. The dentist decided to administer oxygen via nasal cannula. During the ten to fifteen minutes it took to locate the necessary materials and accessories to set up supplemental oxygen, the surgery continued.
 
When the extractions were nearly complete and supplemental oxygen was started, the patient appeared to be non-responsive. At that time, the doctor and staff began to monitor the patient’s vital signs. The automated blood pressure cuff device displayed an error message. The pressure was too low to properly register. The pulse oximeter read 80 percent. As they were unable to arouse the patient, the doctor began to administer CPR and directed staff to contact emergency medical services (EMS).
 
Upon arrival, EMS assumed care. Epinephrine and other emergency medications were administered during the 45 minutes that CPR continued, after which the patient was pronounced dead, and treatment was discontinued.
 
Key Allegations:

• Wrongful death due to negligent care, including failure to refer to a sedation-qualified dentist (the doctor did not have a sedation permit);
• Failure to recognize the risks of medications administered;
• Failure to properly monitor the patient and document the results during sedation;
• Failure to recognize and appropriately respond to a medical emergency.

 
Alleged Injury/Damages:
Death, resulting in medical expenses, funeral and burial costs, lost income, and loss of consortium. The plaintiff’s demand exceeded $1.5 million.   
 
Analysis:
Many dental patients do not understand why a dentist needs a detailed medical history. They may feel that “it’s just a dental visit” and may not provide complete information about medications and/or conditions. However, in this case, the patient disclosed a complete medical history and detailed medication list. The dentist did document his concerns and actions regarding aspirin and Xarelto. Nevertheless, no documentation exists to confirm that the dentist discussed the status or potential impact of other medications and conditions with the patient or with the patient’s physicians. For example:

• The status and control of T2D. The antibiotic prescription may have been initiated in part due to T2D (possibility of infection/impaired healing). However, no rationale was documented.
• HTN—controlled? The patient’s blood pressure of 160/85 was likely to be lower than normal, as it was taken after the administration of an opioid and benzodiazepine. It is difficult to determine if HTN was controlled, since he was a new patient with no baseline pressure in the dental healthcare information record, and no blood pressure control history from the physician.
• CKD. How severe was the patient’s kidney disease? Should it be considered in medication dosing (by lowering standard adult dosages) for local anesthetic, triazolam, oxycodone and amoxicillin?
  • Yes, for each of these medications, depending upon the patient’s glomerular filtration rate (GFR), creatinine clearance, and/or other factors. This was not investigated in the medical consultation and there is no documentation that it was considered by the dentist. For a general overview, see this resource.
• CHF. Could this have a negative effect on respiration during the long and stressful procedure with the patient in a near-supine position?
  • How severe was the patient’s CHF? Was he symptomatic? Unknown. This could place the patient in ASA class IV. Depending upon the recommendation source, procedural sedation in the dental office setting for ASA III and IV patients may be contraindicated, or medical consultation regarding the planned sedation should occur before proceeding.
• OSA. Are OSA patients at higher risk during procedural sedation than other patients?
  • Yes. Consider this resource as one example. OSA also is mentioned as a risk, associated with obesity, in the American Dental Association (ADA) Guidelines for the Use of Sedation and General Anesthesia by Dentists (2016)—current at the time of the incident. Note that the patient’s BMI was 35 (obese = a BMI of 30 or greater).
• Although not discovered until the day of the surgery, would a “prudent dentist” postpone the procedure with a blood oxygen level of 85 percent? Is the patient’s statement that this was “normal” sufficient justification to proceed? The answer in hindsight is, of course, no. Even if true, the other factors described raise significant safety concerns.  

 
It is important to note that the dentist did not intend to provide procedural sedation, but instead desired only to minimize the patient’s dental anxiety. Even so, the medications and dosages administered did constitute “sedation” according the ADA guidelines mentioned previously.
 
The following comments regarding the ADA guidelines and the state’s sedation permit requirements provide further context.

• In the ADA guidelines, “minimal sedation” is defined. The parenthetical phrase “previously known as anxiolysis” equates this level of sedation with anxiolysis.
• Although the state in which the incident occurred did allow a dentist to provide anxiolysis without a sedation permit, the medications and dosages prescribed did not meet the state’s definition of anxiolysis. The dose of triazolam was two or more times that recommended for this patient’s age, and it was combined with an opioid. A permit was required for this situation.
• Dentists must understand and comply with state requirements. Be aware that wide variations exist among state sedation permit rules and education requirements. And, as in this case, state rules and regulations may not be consistent with current clinical guidelines.  
• Administration of triazolam 0.5 mg would indicate “moderate sedation” according to the ADA guidelines, which state, “The administration of enteral drugs exceeding the maximum recommended dose during a single appointment is considered to be moderate sedation and the moderate sedation guidelines apply” [for patient assessment and monitoring]. Similarly, combining enteral sedation medications also indicates that moderate sedation guidelines apply. Although oxycodone/acetaminophen was administered for pain management, its sedation effect is important to the outcome in this case. Consider the “black box warning” regarding “profound sedation, respiratory depression, coma and death”  that applies when mixing triazolam (and other benzodiazepines) with opioids. The medications, as administered, may not have been solely responsible for the adverse outcome. Nevertheless, in combination with the multiple factors described, a valid defense of the case would not be possible.

 
Although adverse outcomes leading to severe injury or death may occur without a breach of the standard of care, defense experts could not support the insured’s care with respect to the medications administered and related matters. Issues included:

• Although a comprehensive history was obtained from the patient, the dentist’s limited review of the history and subsequent actions/inactions could not be supported.
• The dentist was unaware of state permit requirements. As a result, the pre-treatment patient assessment did not comply with state requirements and failed to meet the standard of care.
• The patient’s vital signs were not monitored to the level necessary to meet the standard of care for any sedation level.
• Procedures, protocols and staff training for medical emergency care were inadequate and/or undocumented.  

 
Outcome:
Given the facts of the case and the lack of defense expert support, the defense team recommended to seek early settlement. Although direct negotiations did not result in settlement, mediation was successful. The case closed with payment and expenses totaling just over $1,000,000—well below the original plaintiff demand.
 
Severe claims often result in concomitant state licensing investigations, whether due to mandatory reporting (as in this case) or investigations that occur subsequent to required National Practitioner Databank reports. The case resulted in an immediate suspension of the dentist’s license, with definitive action delayed due to a backlog of investigations, in part due to the COVID-19 pandemic. The dentist later surrendered his license, and the board closed the investigation without further action.   
 
This case represents an example of the multiple risks and safety issues that may be associated with medically complex patients. Although medical consultation was sought, the scope of the requested consultation was very narrow. Depending upon the individual patient’s history and conditions, it may be prudent or necessary to include specific information about the dental treatment to be undertaken and the planned medications, with specific medical assessment questions involving the patient’s co-morbidities. Even so, a physician’s positive response to proceed with dental treatment should be cautiously considered. It is one part (albeit an important one) of the decision to treat. The final decision rests with the dentist and a fully informed patient. Even though the physician may be named in a subsequent lawsuit, in nearly all cases primary liability rests with the dentist, who must meet or exceed the standard of care.  
 
Article by: Ronald Zentz, RPh, DDS, FAGD, CPHRM
CNA Dental Risk Control


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