The Director of Proceedings charged that Dr N (the Doctor) was guilty of professional misconduct.
The charge alleged that the Doctor:
- administered the unapproved medicine Novielle Gel Plus to the patient as dermal filler without first obtaining her informed consent in that he failed to advise her:
a.that it was an unapproved medicine; and/or
b.there was a risk of a granuloma forming.
- administered the unapproved medicine Novielle Gel Plus to the patient as dermal filler without first taking adequate steps to ensure it would be safe and efficacious when used as a dermal filler. In addition, he administered it to the patient when she was not known or identifiable to him at the time that was done which was a breach of the Medicines Act.
- failed to refer the patient for specialist care in a timely manner when symptoms of inflammation or infection arose and prescribed further medication and provided further treatment without adequate clinical justification.
- failed to adequately document the care that he gave to the patient.
The Doctor admitted the charge and the Tribunal found that the charge was made out in all respects. The Tribunal found that the Doctor’s conduct in relation to each of the four particulars both separately and cumulatively amounted to professional misconduct.
The hearing proceeded on the basis of an Agreed Summary of Facts.
Novielle Gel Plus is an injectectable polymer which is approved for use in the USA for use in vocal cord augmentation. It was also marketed in the USA as a dermal filler. However, at no time was it approved for use as a dermal filler in the USA.
At the time of the events which are the subject of the charge Novielle Gel Plus was an “unapproved medicine” in New Zealand. This meant that the product could only be supplied and administered in accordance with the Medicines Act 1981, which requires that unapproved medicines may only be administered to a patient who was known or identifiable to the prescriber.
While visiting with family in New Zealand the patient consulted with the Doctor, on 24 July 2009, about the hollows on her face beneath her cheeks. The Doctor recommended the patient undergo a malor / cheek lift. The Doctor told the patient it would involve him injecting dermal filler into the hollows. He explained that the product was safe and he had used it for the last 5 years without complication.
The Doctor explained the common side effects such as bruising, slight swelling and tenderness. The Doctor did not advise the patient that a significant risk associated with the administration of dermal filler is the formation of granuloma. At no time did the Doctor tell the patient that the product he was intending to use was an unapproved medicine in New Zealand. He told the patient that he was intending to use a product that he had used since 2005, when in fact the product he would be actually using that day was a different brand to that which he had used in the preceding years.
At the time the Doctor was supplied the Novielle Gel Plus the patient was not a patient known or identifiable to him under the requirements pertaining to unapproved medicines by the Medicines Act 1981.
After a couple of weeks the patient developed swelling and inflammation in her cheeks and she received treatment from her GP on the recommendation of the Doctor. In the following months, the patient continued to develop swelling and inflammation in her cheeks and a number of granuloma formed on her face.
The patient decided to return to New Zealand to see the Doctor. By this time a large granuloma had developed which was drained by her daughter’s GP prior to seeing the Doctor. The Doctor saw the patient on 25 October 2009 and without any clinical justification injected KenacortA into each granuloma, provided laser therapy and prescribed further medications. Two weeks later the Doctor reviewed the patient and followed the same course of action as he had on 25 October 2009. The Doctor arranged for follow up treatment to be provided by her GP. The Doctor accepted his advice was without clinical justification and that he should have referred her to a plastic surgeon.
The patient returned to Australia and the ongoing difficulties continued. In March 2010 the patient consulted a plastic surgeon. Her most recent surgery was in November 2012, having undergone nine other surgical procedures in an attempt to remove the granuloma from her cheeks.
Other than his notes taken at the initial consultation, the Doctor failed to make any record of the care that he provided to the patient.
The Tribunal ordered that the Doctor be:
- subject to three conditions of practice for 2 years;
- fined $8,000; and
- pay costs of $9,400.
The Tribunal directed that a copy of its decision and a summary be published on the Tribunal’s website and the New Zealand Medical Journal.