An update on MRONJ – and the successful defence of a difficult claim

Helen Kaney, Dental Protection’s lead dentolegal consultant for Scotland, reports on the robust defence of a member in a complicated case several years in the making

A Dental Protection member was treating a patient in 2014. The patient had attended the member’s practice for several years before the treatment in question and had a number of extractions done over the years by several dentists. The patient was an elderly man and had a complicated medical history. He was taking oral bisphosphonates (alendronic acid), corticosteroids (prednisolone 1mg) and calcium supplements (adcal).

At one point in 2009, prior to an extraction of LR6 by a previous dentist in the practice, advice had been sought from a local oral surgery department about whether the extraction of LR6 should be carried out in a general dental practice setting or, given the patient’s medical history, the patient should be referred. Advice at the time was that it was reasonable for the extraction to be carried out in a general dental practice setting.

What national guidance says

In 2011, the Scottish Dental Clinical Effectiveness Programme (SDCEP) issued national guidance for dental practitioners in primary care on the oral health management of patients prescribed bisphosphonates.[i] This guidance classified patients as either low or high risk of developing bisphosphonate-related osteonecrosis of the jaw (BRONJ). Low risk patients were those taking bisphosphonates for the prevention or management of osteoporosis. A patient was classified as high risk in certain circumstances, including when there was the concurrent use of systemic corticosteroids or other immunosuppressants. For low risk patients, straightforward extractions could and should be carried out in primary care as ‘atraumatically’ as possible with review indicated at four weeks and referral to an oral surgery/oral and maxillofacial specialist if the surgical site failed to heal within four to six weeks. When managing a higher risk patient, the guidance recommended contact with an oral surgery/oral and maxillofacial specialist to determine whether the patient should continue to be treated in primary care for any extraction or whether referral was appropriate. The guidance stated that advice should preferably be sought by letter.  

This 2011 guidance was replaced in March 2017[ii] with updated guidance that also classified a patient taking concurrent bisphosphonate and corticosteroids as higher risk of developing medication related osteonecrosis of the jaw (MRONJ). For higher risk patients, dentists in primary care were advised to explore all possible alternatives to extraction; but if extraction was the most appropriate treatment then the patient should be treated in the same way as a low risk patient, with straightforward extractions performed in primary care. Healing should be reviewed and if the extraction socket had not healed at eight weeks, and it was suspected that the patient had developed MRONJ, the patient should be referred. As clinicians are aware, MRONJ can also happen spontaneously without prior clinical care.

What happened next

The patient had ongoing needs in relation to his periodontal condition and he struggled with plaque control. The Dental Protection member took over the care of the patient in 2013 and provided routine care including the extraction of UL6 and ongoing periodontal treatment. A periodontal abscess in relation at LL6 was diagnosed in 2014 and appropriate treatment provided. The patient was seen one week later for sub-gingival debridement of LL6 under local anaesthetic and further treatment was provided for approximately four weeks. The patient then attended requesting that the tooth was extracted. Given the patient’s medical history the patient was informed of the risk of infection and poor healing, which might require referral. As the practice had previously been advised – albeit before the 2011 guidance was issued – that extractions should be done in primary care, the practitioner proceeded to extract LL6 and the extraction was straightforward and unremarkable.

Of note, the 2017 guidance recommends advising the patient of the risk of developing MRONJ, but also states that the practitioner should “ensure that they understand that the risk is small so that they are not discouraged from taking their medication or undergoing dental treatment”.

The patient in this case returned to the practice six days later with swelling and wound exudate, and appropriate treatment was provided by the member’s colleague. The patient was then reviewed four days afterwards and referred, following which the patient was diagnosed with BRONJ/MRONJ and had significant surgery on two occasions, lost two teeth and sustained significant facial scarring.

The patient raised a clinical negligence claim against the dentist alleging that there was a failure to inform of other treatment options and warn of the risk of extraction – essentially an allegation of failure to obtain consent, with the patient alleging that he should have been referred to a periodontal specialist to avoid losing the tooth, failing which to hospital for the extraction. There was also an allegation of failing to take a radiograph prior to the extraction.

Defending the claim – how Dental Protection helped

It was considered that the claim was defensible for a number of reasons and several expert reports were obtained: from a general dental practitioner, an oral surgeon and a maxillofacial consultant. There was some concern as the records were brief and the 2011 SDCEP guidelines, which were applicable at the time, had not been followed to the letter prior to the extraction of LL6, in that advice had not been taken before the extraction in question.

The GDP expert took the view that the guidelines were based on the sources of information and expert consensus at the time of issue but did not override a clinician’s right and duty to make decisions appropriate to each patient, with their consent. The expert did state that departures from guidance and the reasons for this should be fully documented in the clinical records. The expert was of the view that the dentist had treated the periodontal abscess at LL6 on three occasions in order to attempt to manage the problem without extracting the tooth but extraction was in the end unavoidable.

Although specific advice had not been taken on this occasion, advice had been taken previously – with a previous dentist advised to undertake extraction in general dental practice and refer if problems arose. At the time of the extraction of LL6 in 2014, the patient’s drug regime had not changed, nor had the risk; albeit the 2011 guidelines were in place at that time. The expert opinion was therefore that it was reasonable to carry out the treatment in general practice. There is only one way to carry out a simple extraction and the treatment provided would have been the same whether done in primary care or in hospital. The expert was also of the view that a radiograph was not necessary prior to this extraction and that it is not normal practice for a dentist to take a radiograph prior to extracting a tooth.

The opinion of the oral surgeon expert was supportive and the maxillofacial consultant expert’s view was that the patient was likely to have developed MRONJ even if the extraction had not taken place on the date in question and that, as practitioners will be aware, MRONJ does not necessarily follow a surgical procedure and can occur spontaneously. Delaying the extraction would not, on the balance of probabilities, have prevented the situation that occurred and the development of MRONJ may well have been already inevitable when the extraction took place. Delaying the extraction would probably have increased the risk.

With such robust expert opinion, the solicitors instructed by Dental Protection exchanged expert reports at the appropriate time, as part of the usual court procedure. The patient’s legal team then sought agreement that the case should be dropped by them on a no expenses basis, but due to the strength of our expert reports, Dental Protection stated that we would defend the case to trial unless expenses were conceded. The patient, via his solicitors, in the end conceded full expenses, which will be met partly by an insurance policy and partly by the patient’s solicitors themselves.

This was an excellent outcome for Dental Protection’s member in a case that had been running for several years and we were delighted to achieve the right result in the end.

Learning points

Can any lessons be learned from the case? There are probably several. The dentist in this case had acted properly throughout but the challenge came in proving that when the patient raised a clinical negligence claim, and more detailed records would perhaps have made the situation easier to defend. In particular, it would have been helpful for there to have been a more detailed note of the consent discussion with the patient, in which the patient was told about the risks of extraction in light of his medical history.

The available medical history information was also not particularly easy to understand within the records, and whilst it was the case that the practitioner was fully aware of the patient’s medical history, the record keeping in relation to this could have been better. Good communication and good follow-up with patients after procedures are also known to reduce risk in general terms. Ultimately though, Dental Protection was pleased to be able to defend our member in this interesting but undoubtedly stressful case.