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[1999] VSC 113
Supreme Court of Victoria
1999-04-23
Mandie J
Original judgment source is linked above.
DENTIST - appeal against decision of Dental Board - professional misconduct - gross negligence or incompetence in dental treatment - prescription of drug without obtaining informed consent or establishing adequate protocol for treatment.
"Every such appeal shall be in the nature of a re-hearing and the Supreme Court shall entertain inquire into and decide upon the appeal and for that purpose may do all such matters and things relating thereto and in the same manner and to the same extent as it is empowered to do in the exercise of its ordinary jurisdiction, and its decision shall be final and without appeal."
"(a) That you... have been guilty of professional misconduct in that you provided grossly negligent dental treatment to your patient. Ms Antonella Ciccone, on frequent occasions over the period from 18 June 1996 to 14 January 1998. (b) That you ... have been guilty of professional misconduct in that you: (i) used a drug, namely 2,3-Dimercapto Succinic Acid (DMSA), in the treatment of your patient, Ms Antonella Ciccone, when you knew, or should have known, that DMSA had not been approved for use in Australia by the Therapeutic Goods Administration, under either the Therapeutic Goods Act 1989 (Cth) or the Therapeutic Goods (Victoria) Act 1994 (`the Therapeutic Goods legislation'); (ii) used the drug, DMSA, in the treatment of your patient, Ms Antonella Ciccone, when you knew, or should have known, that: * no application had been made by any drug company to register DMSA in this country; * The Therapeutic Goods Administration had evaluated no data pertaining to DMSA as a chelating agent, and had no knowledge of any properly conducted trials to show evidence of its safety or efficacy; * the DMSA has known risks and potential for adverse effects on patients; and * there were significant doubts as to its efficacy in the treatment of chronic mercury exposition from dental amalgam fillings. (iii) imported the drug, DMSA into Australia, or acquired the drug, without complying with the Therapeutic Goods legislation; (iv) used the drug, DMSA, in the treatment of your patients, including Ms Antonella Ciccone, without: * informing them of the matters listed in paragraphs (i), (ii) and (iii) above; or * providing them with full information about the advantages, disadvantages, risks, contra-indications, adverse or beneficial consequences, and side effects of the use of DMSA; or * informing them whether there were other alternative drugs and procedures which could have been used in her treatment in its stead; (v) failed to obtain the fully informed consent of your patients, including Ms Antonella Ciccone (ie their consent after they had been fully and properly informed of all relevant matters), to the use by you of the drug, DMSA, in their treatment; and (vi) failed to establish an adequate and appropriate protocol to monitor any side effects or adverse consequences suffered by your patients, including Ms Antonella Ciccone, as a result of the use of the drug, DMSA, and failed to establish an adequate and appropriate protocol to manage any such adverse consequences or side effects. (c) That you... have been guilty of professional misconduct in that you: (i) failed to maintain proper and adequate dental and clinical records of the treatment of your patient, Ms Antonella Ciccone, or of the drugs (and particularly DMSA) which you prescribed to her and used in the course of her treatment; and (ii) failed to properly record the administration of Schedule 4 Poisons (as specified in Schedule 4 to the Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 1995) in relation to your treatment of Ms Antonella Ciccone."
The Board found the charges in (a), (b)(iv)(v) and (vi) and (c) proved ((b)(i) and (ii) were not pursued). Another charge relating to a breach of the Dental Regulations which incurred a reprimand need not be mentioned further.
(a) The Chairman of the Board, Dr Anthony D. Robertson, Dentist, L.D.S. Vic 1972, B.D.Sc. Melb 1973 (Board Member since February 1993);
(b) Professor John K. Harcourt OAM, Prosthodontist, L.D.S. Vic 1953, B.D.Sc. Melb 1954, M.D.Sc. Melb 1956, F.R.A.C.D.S. 1965, D.D.Sc. Melb 1968, F.I.C.D., F.A.D.M. 1983 (Board Member since February 1987);
(c) Dr Ross King, Dentist, L.D.S. Vic 1960, B.D.Sc. Melb 1961, F.I.C.D. 1995 (Board Member since March 1993); and
(d) Dr Deborah J. Cole, Dentist, B.D.S. Adel 1980, Grad. Dip. Health Admin (S.A.I.T.) 1987, M.B.A. (S.A.I.T.) 1990 (Board Member since February 1996).
"(a) you Dr Campbell... have been guilty of professional misconduct in that you provided grossly negligent dental treatment to your patient Ms Antonella Ciccone, on frequent occasions over the period from 18 June 1996 to 14 January 1998; (b) ... you have been guilty of professional misconduct in that you: (i) used the drug, DMSA, in the treatment of your patients, including Ms Antonella Ciccone without * providing them with full information about the advantages, disadvantages, risks, contra-indications, adverse or beneficial consequences, and side effects of the use of DMSA; or * informing them whether there were other alternative drugs and procedures which could have been used in her treatment in its stead. (ii) failed to obtain the fully informed consent of your patients, including Ms Antonella Ciccone (ie their consent after they had been fully and properly informed of all relevant matters) to the use by you of the drug, DMSA, in their treatment; and (iii) failed to establish an adequate and appropriate protocol to monitor any side effects or adverse consequences suffered by your patients, including Ms Antonella Ciccone, as a result of the use of the drug, DMSA, and failed to establish an adequate and appropriate protocol to manage any such adverse consequences or side effects. (c) That you... have been guilty of professional misconduct in that you: (i) failed to maintain proper and adequate dental and clinical records of the treatment of your patient, Ms Antonella Ciccone, or of the drugs (and particularly DMSA) which you prescribed to her and used in the course of her treatment; and (ii) failed to properly record the administration of Schedule 4 Poisons (as specified in Schedule 4 to the Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 1995) in relation to your treatment of Ms Antonella Ciccone."
"Having considered the evidence led in this inquiry and the submissions... the Dental Board of Victoria: 1. reprimands Dr Campbell 2. Imposes a suspension with a conditional termination as follows: The registration of Dr Campbell as a dentist under the Dentist's Act 1972 and consequently his entitlement to practise as a dentist in Victoria is suspended for a minimum period of 3 months commencing on Monday September 7, 1998. Provided that the following conditions are met within the period of three months the suspension of the registration of Dr Campbell as a dentist will terminate on December 7, 1998 and he will be entitled to resume practice as a dentist in Victoria. The conditions are as follows: a. That Dr Campbell attends and successfully completes a course or courses approved by the Board in the fields of dental radiography and radiology, endodontics, and resin composites and glass ionomers. The Dental Board of Victoria also requires Dr Campbell to certify to the Board that he attended the above courses and satisfactorily completed their requirements within 14 days of attending each course. b. That he receives counselling from an authorised officer or officers of the Dental Board of Victoria regarding dental record keeping, and the issue of informed consent with regard to the treatment of his patients. c. That he submits written protocols for approval by the Dental Board of Victoria for the use of the drug DMSA as follows: * Information for patients to enable them to make a fully informed decision * Consent forms that satisfy the requirements of TGA * Workplace protocols including the monitoring and managing of any adverse side effects of the administration of the drug DMSA 3. The Dental Board of Victoria imposes the following conditions on the practice of dentistry by Dr Campbell: Subsequent to his resumption of practice the Dental Board of Victoria: Imposes as a condition on his practice the requirement that Dr Campbell allows his dental practice records and adherence to the protocols referred to above to be subjected to inspection by the authorised Officers of the Dental Board of Victoria within two months of resumption of practice and thereafter at four monthly intervals to satisfy the Dental Board of Victoria that he has complied with the stated policies of the Dental Board of Victoria."
"4. With regard to the finding of professional misconduct related to grossly negligent dental treatment for patient Antonella Ciccone, the Board relied on the evidence of Ms Ciccone herself, and upon the evidence of the expert witnesses, Dr Nervo, Dr Wilson and to a lesser extent Dr Clausen, who was most unfortunately not available for questioning or cross examination on his reports. 5. Dr Wilson had carried out his examination in a most thorough manner. He assessed the quality of the care provided to Ms Ciccone. He conducted a most detailed clinical examination of her mouth, having access to radiographs previously taken by Dr Campbell and Dr Mighalls (whom Ms Ciccone later consulted). Dr Wilson, by virtue of his detailed preparation, and precise presentation of facts made a favourable impression on the Board. His expert evidence, and in particular all of the conclusions he reached about the standard of treatment provided by Dr Campbell to Ms Ciccone, was accepted by the Board in all respects. The Board came clearly to the view that Dr Campbell's dental treatment of this patient was grossly deficient in a number of different respects and over a long period of time, and fell considerably short of acceptable standards of dentistry. 6. Dr Gary Nervo (a specialist endodontist) was called to give evidence as to the quality of the endodontic treatment provided to Ms Ciccone, and also to comment on Dr Campbell's radiographic technique and clinical record keeping, as it relates to endodontic treatment. He highlighted Dr Campbell's `failure to follow standard procedures taught in all dental schools...' with regard to radiographic technique. He also commented on the poor quality of endodontic treatment performed, and on the inadequate nature of his record keeping. 7. The Board notes both the above expert witnesses have been, or still are, clinical examiners in the undergraduate dental course. Both witnesses, independently in their written reports, note that the standard of dental work, performed by Dr Campbell in Ms Ciccone's mouth, would fail to meet the standards expected of an undergraduate student presenting at the final examination. 8. Dr Clausen, a dental expert witness, submitted two, albeit brief reports on behalf of Dr Campbell. Dr Clausen did not appear before the Board due to his imminent departure for overseas. The Board noted that this report itself contained adverse comments regarding various significant deficiencies observed in Ms Ciccone's dental restorations, but tended to minimise the significance of these deficiencies. The Board did not have the opportunity to have Dr Clausen's views tested by cross-examination. On balance, the Board accepted the more carefully considered and presented opinions of Drs Wilson and Nervo in preference to Dr Clausen's statements where they did not agree." (Emphases Added.)
"9. During cross-examination by Mr Monahan, counsel assisting the Board, Dr Campbell was reluctant to concede a number of very obvious deficiencies in his performance of dental procedures including resin composites, endodontics, dental radiology and radiography, despite the evidence of the three expert witnesses, including his own expert, Dr Clausen. He made statements which differed significantly, even from the opinion expressed by his own expert, which was a matter of significant concern to the Board. 10. With regard to the issue of informed consent for patients using the drug DMSA, the Board accepted the evidence of patients Ciccone, Nechwatel and Sedgwick. Each was able to categorically state that they had not signed any consent form relating specifically relating to the use of DMSA, nor had they been advised as to the status and possible adverse effects and implications of the use of DMSA. The Board notes that Dr Campbell was unable to produce any consent forms (as at F7), or duplicate copies of the consent forms in question, and Rainbow Pharmaceuticals also had no consent forms from Dr Campbell since late 1997, and none at all for 1998. The Board accepts the truth of the accounts given by the patient witnesses, and found it difficult to accept the evidence of Dr Campbell and Ms Krishna, that the consent forms may have been signed by certain of those patients but have since been lost. 11. Ms Ciccone stated that, had she been aware of the status of the drug DMSA, she would in fact not have agreed to use it. 12. Dr Laurie Mashford, Clinical Pharmacologist, gave evidence that, given the status of the drug DMSA which is unregistered for use in Australia, and approved for importation by the Therapeutic Goods Administration (TGA) only under certain very specific conditions, clinicians need to be meticulous with the monitoring of their patients, and that DMSA should only be used once the patient is fully informed as to all the possible implications of using the drug. The Board found Dr Mashford's evidence to be authoritative and convincing. In giving his evidence, Dr Campbell stated that he relied on verbal communication, and on very limited written instructions and information, in the form of his consent form (F7), a document entitled `DMSA Protocol' (G13), and a reprint of a research article by Drs Campbell and Godfrey (H3) in providing patients all the information they required to make a fully informed decision, regarding the use of the drug DMSA. It was the Board's view, after examining the documents, that a reasonable patient could not be expected to make a fully informed decision on the basis of such information alone, and that the documents were one-sided, unbalanced and deficient in detail with regard to the possible adverse side effects of the drug. 13. By his own admission, Dr Campbell had no protocol in place to monitor any side effects of the drug DMSA, other than a written instruction for his patients to contact him should any problems arise. The Board formed the strong view that Dr Campbell's protocols for the informed consent, administration, monitoring and recording of this drug therapy (i.e. for DMSA) were totally inadequate, and could expose his patients to harm. 14. The records maintained by Dr Campbell were so deficient in detail that it was not possible to establish their accuracy. Recording full details of the administration of schedule 4 poisons is mandated under the Drugs, Poisons and Controlled Substances Act 1981. Reliable records are vital, both for the treatment of the long term patient, and for situations where a patient may transfer to another dentist, requiring the transfer of comprehensible and detailed clinical and personal information. Access to such information is important for the well-being and protection of the public. 15. In assessing the evidence, the Board took account of the serious nature and effect of the allegations made against Dr Campbell and applied the test set out in Briginshaw v. Briginshaw. The Board found the facts as summarised in these Reasons to be convincingly proved to its reasonable satisfaction. 16. In this Inquiry, the Board had been asked to consider whether Dr Campbell had been guilty of professional misconduct under Section 25(1)(b) of the Dentists Act 1972. In deciding that the conduct of Dr Campbell amounted to professional misconduct, the Board considered and applied the test laid down in the matter of Adamson v. The Statutory Committee of Queensland Law Society, which held that the test of professional misconduct is whether the conduct violates or falls short to a substantial degree of the standard of professional conduct observed or approved by members of the profession of good repute and competency. The Board concluded that Dr Campbell's conduct fell way short of that standard in many respects. 17. The Board additionally relied upon the case Pillai v. Messiter which states that `departures from elementary and generally accepted standards, of which a medical practitioner could be scarcely heard to say that he or she was ignorant could amount to such professional misconduct...' It is the Board's strong view that Dr Campbell's behaviour constituted such professional misconduct." (Emphases Added.)
"... there may be cases of infamous conduct in which it is arguable that there is nothing unethical involved and no appeal to a moral standard. Such a case I should regard as existing where, there being no circumstances of emergency and proper equipment being available, a surgeon operated by a long abandoned technique or in an unclean manner, e.g. amputating a limb without an anaesthetic or without taking proper precautions for asepsis. I think I should emphasise too that it must be a rare case indeed, if such a case can exist at all, in which mere negligence which might found a claim against a medical practitioner for damages for negligence would amount to infamous conduct in a professional respect. This, of course, is far from saying that gross negligence might not amount to infamous conduct especially if such negligence was aggravated by lack of concern for the welfare of the patient."
"... but the ultimate question whether the conduct of the appellant which is challenged is infamous conduct in a professional respect must be decided by the Court on the evidence before it on the appeal. Where the matters involved in the judgment are medical matters, the Court will of course pay great attention to the opinion of the Board which is composed of medical experts of great eminence." (Emphasis added.)
"The expression `unprofessional conduct' was considered in Re R, A Practitioner of the Supreme Court [1927] S.A.S.R. 58 and the following was said in the joint judgment of Murray C.J., Angas Parsons and Richards JJ.: `In our view `unprofessional conduct' is not necessarily limited to conduct which is "disgraceful or dishonourable", in the ordinary sense of those terms. It includes, we think, conduct which may reasonably be held to violate or to fall short of, to a substantial degree, the standard of professional conduct observed or approved of by members of the profession of good repute and competency.' This statement was affirmed in Re - A Practitioner of the Supreme Court [1937] SASR 316, 320-1 and the Full Court in that case added the observation: `... but the real standard is not any pedantic standard at all, but such a standard of conduct as commends itself to practitioners of good repute and good standing.' ... It is recognized that negligence and want of professional skill are not necessarily in themselves misconduct. In Re W.C. Moseley (1925) 25 S.R. (N.S.W.) 174 Street C.J., with whom Gordon and James JJ. concurred, said: `I agree that mere neglect or delay in the transaction of a client's business does not necessarily amount to misconduct of such a character as to be punishable by the court in the exercise of its disciplinary jurisdiction, but it may do so, and each case must depend upon its own circumstances. It may be difficult sometimes to know where to draw the line, but, wherever it should properly be drawn, I think that, in the present instance, the neglect was of such character, and took place in such circumstances, as to carry the case well over it and into the region of professional misconduct.' In Re a Solicitor [1972] 1 W.L.R. 869, at p.873, Lord Denning M.R., with whom Karminski and Orr L.JJ. concurred, said: `In my opinion negligence in a solicitor may amount to a professional misconduct if it is inexcusable and is such as to be regarded as deplorable by his fellows in the profession."
"With the latest, and further, amendment it is arguable that the substitution of the new statutory test of `professional misconduct' may introduce for consideration a wider class of conduct than has hitherto been regarded as relevant. But that is a question which can remain for a future case. It may not be examined in this appeal, because of the way in which the case was conducted before the Tribunal. `Misconduct' means more than mere negligence: The words used in the statutory test (`misconduct in a professional respect') plainly go beyond that negligence which would found a claim against a medical practitioner for damages: Re Anderson, (at 575). On the other hand gross negligence might amount to relevant misconduct, particularly if accompanied by indifference to, or lack of concern for, the welfare of the patient: cf Re Anderson at (575). Departures from elementary and generally accepted standards, of which a medical practitioner could scarcely be heard to say that he or she was ignorant could amount to such professional misconduct: ibid. But the statutory test is not met by mere professional incompetence or by deficiencies in the practice of the profession. Something more is required. It includes a deliberate departure from accepted standards or such serious negligence as, although not deliberate, to portray indifference and an abuse of the privileges which accompany registration as a medical practitioner: cf Allinson (at 760-761). These are the approaches which have been taken in our courts. They have been taken in the courts of England where such misconduct is alleged. And they have similarly been taken in the courts of the United States. The entry in Corpus Juris Secundum, vol 58, (1948) at 818, reads: `Both in law and in ordinary speech the term "misconduct" usually implies an act done willfully with a wrong intention, and conveys the idea of the intentional wrongdoing. The term implies fault beyond the error of judgment; a wrongful intention, and not a mere error of judgment; but it does not necessarily imply corruption or criminal intention, and, in the legal idea of misconduct, an evil intention is not a necessary ingredient. The word is sufficiently comprehensive to include misfeasance as well as malfeasance, and as applied to professional people it includes unprofessional acts even though such acts are not inherently wrongful. Whether a particular course of conduct will be regarded as misconduct is to be determined from the nature of the conduct and not from its consequences.'"
"It was not disputed that acts or omissions in the course of professional practice if so grossly negligent as to attract the strong reprobation of the professional brethren of good repute and competence might amount to misconduct in a professional respect, although wholly lacking in moral obliquity: Ex parte Meehan; Re Medical Practitioners Act [1965] NSWR 30; Re Anderson & the Medical Practitioners Act 1938-1964 [1967] 85 WN (Pt 1) (NSW) 558 and Qidwai v Brown [1984] 1 NSWLR 100. It is necessary, however, for professional reprobation to be established by the evidence of an appropriately qualified person or persons. Here the respondent relies upon, and only upon, the evidence of Professor Buchanan; and although the source was well qualified the testimony was insufficient."
"I will present discussion on different areas of the treatment provided, and I will end each part with an opinion on the treatment provided. Self-threading dentine pins are effective means to retaining restorations, and require significant forces to remove by direct traction (200 to 300 N). They are a means of restoring badly broken down teeth, and have traditionally been used to retain large amalgam restorations. A general rule of thumb is to use 1 pin for each cusp missing. There has been a trend away from pins for amalgam restorations, and the use of retentive features cut into the tooth such as pinholes and slots. The principle behind these measures is to avoid stressing the tooth. It is clear that pins have the potential to cause damage to teeth, as the tooth is stretched as the pin is placed, because the pin is bigger than the hole. This stretching can lead to microcracks within the dentine, which are thought to be routes for eventual microleakage. A further problem is that when pins are placed, the site used is usually lost for the lifetime of the tooth. It can, on occasion, be possible to place a large pin in the pinhole vacated by the removal of a pin. This would be unusual, and the usual consequence of replacing a restoration retained with pins is that new pins would be placed in different sites. There are only a small number of possible sites in a tooth for a pin, and using sites when unnecessary removes options for the future restoration of the tooth. There has been a trend towards the use of resin composite restorations (which are tooth coloured) to restore back teeth, for aesthetic reasons for the potential for a strong tooth and because of the concerns of some over mercury and silver toxicity. In the following discussion, I will discuss the possible use of different dental materials, which could explain the clinical and radiographic appearances of this patient. However, there is no information in the clinical notes on the type of composite used, whether bonding to dentine was attempted, and with which system if one was used. There is no indication whether a liner or base was used, and if it was, what material was used. There are some potential benefits from the use of resin composite in back teeth, as it is possible to gain functionally useful bonding of resin composite to enamel. The potential for bonding resin composite to dentine is promising but not yet shown to be as durable as the bond from resin composite to enamel. The usual presentation of such dentine bonding agents is in the form of one or several resins that flow well, due to lack of filler. Filler is usually added to improve mechanical properties such as strength and abrasion resistance. Bonding resins are not designed to be external restorative materials, but a link in the protected inner of teeth. A problem that the lack of filler raises is that the bonding agents are not radio-opaque. Excellent isolation and drying is required for the bonding of resin composites to enamel. Some (including myself) consider the placement of rubber dam to be very useful in controlling moisture during restoration placement, especially for resin composite restorations as moisture contamination will prevent effective bonding. There is some argument as to the need for dry dentine in bonding procedures, as dentine presents different problems to enamel, in that it is normally moist from the cellular components within it. However, gross contamination with fluid is universally unacceptable. Rubber dam was not used in this clinical treatment, even though my clinical examination revealed multiple sub-gingival margins, which would pose difficult problems for moisture control. The radiographs clearly show that enamel margins are present at every interproximal margin. It should therefore have been possible to gain an effective and strong bond to enamel at the gingival margin if there had been adequate moisture isolation. Bonding to teeth raises the possibility of force transfer across the bond between the tooth and the restoration, leading to a strong restored tooth. The use of composite resin in small cavities does not in general require additional retention, such as pins, as the strong and durable bond to enamel is able to retain the restoration effectively. There are at least four teeth in this category from my clinical examination (27, 25, 24, 14). In combination with my comments at the top of page 14, I consider that the use of pins in these 4 teeth was inappropriate, and the use of the pins perplexes me. The edges of the restoration, being sealed to the tooth, would also prevent leakage between the tooth and the restoration. Leakage at the edge of restorations is undesirable clinically, and leads to staining at margins. Microleakage and staining is widely held to be a precursor to undesirable events such as sensitivity to external stimuli, development of caries, and pulpal death. Staining at the margins of composite restorations in this case was found on 8 teeth (16, 14, 24, 25, 26, 36, 46 and 47). One tooth required root canal therapy after placement of a resin composite restoration (46). This may not have been due to the placement of a composite restoration, as the clinical notes suggest that the 46 had a cracked cusp. This is an unfortunate clinical occurrence that can give problems for the pulp of the tooth. It is clear that pins do not strengthen restorations, but act as sites of weakness for the restoration. It is not a credible argument to claim that pins strengthen fillings. A through and through defect (ie. pin on the occlusal surface) is more potentially damaging to the restoration than a pin placed with a capping of material. Pin perforation of the occlusal surface of restorations was present on 9 teeth, on a total of 12 occasions (16, 16, 14, 24, 25, 26, 27, 37, 36, 46, 46, 46). The exposure of a pin also allows for the possibility of fluid passage between the pin and the restoration. The initial stages of this are visible as evidenced by the staining on 46 buccally. Furthermore, the pin occupies some space that could be occupied with a cohesive mass of filling. Thin flashes of filling around a pin are susceptible to fracture, as seen on the palatal side of 16. The exposure of a pin also raises the problems of differential wear, as the metal of the pin is much less susceptible to wear than the resin composite restoration. When significant composite has been lost, the pin can act as a localised destructive abrasive agent on the opposing teeth. Pins are seen protruding on the surface of 9 teeth (16, 14, 24, 25, 26, 27, 37, 36, 46). I would not expect to see wear of opposing teeth in less than two years, but there is the suggestion of wear on the mesio-buccal cusp tip of the 37 related to the pin in the centre of the mesial marginal ridge of the 27. (I will confirm or refute this suggestions when I have viewed the SEMs.) The perforation of pins through the occlusal surfaces of the restorations is, in my opinion, undesirable. There are already clinical problems with these restorations: staining around a pin, fracture of resin composite material around a pin, differential wear of pin and composite, possible damage to opposing teeth. It is my opinion that the standard of the restorations with regards to pin perforation is grossly unsatisfactory. The radiographic appear of multiple radiolucencies around the margins of recently placed restorations is unusual. The OPG of late 1996 shows several instances of this when the restorations were only months old, even though an OPG is not an ideal view for detecting radiolucencies around restorations. The radiolucencies are present in both sets of bitewing radiographs taken more recently (early to mid 1998). It is unusual for such an appearance to be present on a well placed restoration, as it would be indicative of a poorly fitting restoration. Possibilities for this appearance are an absence of restorative material (a space), or demineralised (carious) dentine or restorative material that is not radioopaque (perhaps unfilled bonding resin or a liner). A space could be caused by material not being placed in the cavity with appropriate packing force, or difficulty packing around obstructions such as pins. Resin composites have a tendency to stick to instruments, and as such, if not appropriately packed, can be withdrawn from the cavity between incremental placements. There are also problems with composite shrinking on setting, and if the composite was well attached to occlusal enamel, which is more easy to isolate, the material could contract away from the less well retained gingival half of the cavity. Although contraction of resin composite on setting is an accepted phenomenon, the actual size of the change is small, and would be difficult to show radiographically. The most likely cause, in my opinion, of the radiolucency beneath the restorations is that there was moisture contamination in the gingival portion of the cavity, with resulting absence of bond, and maintenance and widening of a gap on curing of the resin composite. There is also the possibility that there is a material that is not radioopaque under the restorations, such as a bonding resin or liner or carious dentine. A radiolucent restorative material would, if present, have given resistance to probing, whereas carious tooth tissue would not. The major reason that I do not accept the presence of restorative materials is the excellent correlation between the radiographic appearance and my clinical examination by probing. There are ten sites on 8 teeth where I made the clinical diagnosis of caries (7) [17, 16, 24, 25, 25, 26, 36] or ? caries (3) [26, 46, 47]. There is radiolucency at the margin between restoration and tooth of 10 teeth from the most recent bitewings [17, 16, 14, 24, 25, 26, 27, 37, 36, 47]. There is radiolucency at the margin between restoration and tooth of 5 and possibly 6 teeth, on an OPG taken perhaps three months after the restorations were placed [16,? 14, 25, 26, 27, 47]. Another possibility is that there was a material present at the time of restoration placement, but that it disappeared with the passage of time. There has been discussion about the dissolution of liners based on Calcium Hydroxide, with the appearance of a radiolucency beneath restorations. If this were the case here, the existence of radiolucencies at the margin of the filling would imply that a soluble material was placed in continuity with the oral environment, which then dissolved. Such a placement would be incompetent. Every tooth where I made the clinical diagnosis of caries had a radiolucency at the same site. I conclude that the radiographic appearance of radiolucency at the margins of the restorations was due to an absence of material [a gap] or due to residual caries, which was evident on a radiograph taken soon after restoration placement, or due to new caries. The clinical presentation is grossly unsatisfactory: either caries was left in multiple sites, or the conditions for caries were created at the time of restoration placement and caries has since developed in less than two years. Furthermore, a radiograph was taken after the placement of the restorations that should have raised questions as to the quality of the treatment, and given the operator an opportunity to reassess the work. It is my opinion that the quality of the provision of work in terms of marginal fit was grossly unsatisfactory, and far below an acceptable standard. It is also my opinion that the failure to reassess the restorative work with the information from the OPG was grossly negligent. There is a further consideration. There is clear radiographic evidence of caries into dentine on the Bitewings from Drs Campbell (Jan 1998) and Mighalls (May 1998), namely on the distal of 27 and the distal of 37. The OPG of September 1996 suggests distal caries in 27, and gives clear evidence of distal caries in the 37. There is some suggestion from the charting of 13/01/1998 that mesial and distal caries were been diagnosed in the 27. I can see no evidence from the charting of 16/12/96 that caries was diagnosed in either the 27 or the 37. It is my opinion that there were almost certainly established carious lesions in the 27 and the 37 at the time of treatment in June 1996. These lesions were have been visible on good quality bitewing films taken as part of the treatment plan in 1994 and/or 1996. There was an obvious appearance of distal caries in the 37 and a suggestion of caries in the 27 in the OPG of September 1996, even though an OPG is not the best view for dental caries. Both 27 and 37 received mesial-occlusal restorations on the 22/06/96. It would have been appropriate to restore the distal lesions at the same time as the MO restorations were placed. It is my opinion that it was negligent to not look for and diagnose caries in the distal of the 27 and 37 as part of the treatment plans for this patient. Furthermore, it was unsatisfactory to not restore 27 and 37 during restoration of other parts of the same tooth. Periodontal and contact point considerations The nature of the contact points indicates that there are significant irregularities around the restorations placed. The shredding of the floss means that there are sharp areas either on the tooth or the restoration. It is possible that the surface of the restoration is now abrasive, but it was my clinical finding that the shredding defects were found at the bottom of the interproximal boxes. There is good agreement between sulcular bleeding, shredding defects and probing deficiencies. The poor standard of interproximal restoration is associated with gingival bleeding problems, which may be a precursor to more definitive periodontal problems. I consider that the food packing in the 25-36 area is due to plunger cusp action from the mesio-buccal cusp of the 36 as the 25-26 contact was satisfactory to floss. This situation is exacerbated by the deep fossae in the 25 and 26. It is not possible for me to comment on whether there was an open contact at placement. The interface of the restoration with the periodontium has not been well managed, but is not grossly unsatisfactory. It would be possible to remedy most of the problems with oral hygiene and restoration smoothing if the restorations were otherwise satisfactory."
"Endodontic considerations The clinical records reveal endodontic treatment occurred on five visits in early 1997 (30/01/1997, 05/02/1997, 10/02/1997, 14/02/1997 and 18/02/1997). The clinical records show only one working length for the entire treatment sequence, namely 20 mm. No canal is specified, although the intra-treatment periapical radiograph shows a file in the distal canal of the 46. There would normally be three canals present in this tooth, two mesial, and one distal. There would appear to be no measurement of the mesial canals. The periapical film taken by Dr Mighals reveals that the distal point is 3 mm through the apex, and that the mesial point is 1 mm through the apex. There may have been an elongation of the apical foramen as the line of the point does not follow the root curvature. I consider the use of rubber dam to be mandatory for endodontic treatment for two reasons: cleanliness of the operating field, and safety from losing potentially dangerous instruments and irrigants. The use of rubber dam would appear to be easy in this case. There is no radiographic evidence of a rubber dam clamp. Ms Ciccone has no recollection of the use of rubber dam, and it would normally be a memorable occurrence. My opinion is that the radiographic appearance of the root filling in the 46 is unsatisfactory, and I would seek an opinion on the advisability of retreatment. The lack of use of rubber dam is unsatisfactory."
"Occlusal considerations The patient has reported that food remains on the occlusal surfaces of the teeth after eating. She also links the development of a grinding habit with the placement of the many white fillings, and she now wakes with a gritty feeling in her mouth in the morning. She has soreness in some of her chewing muscles. My clinical findings are that 17, 27, 37 and 47 are tender to percussion, and that there is tenderness in both masseter muscles, and all sections of both temporalis muscles. There is a minor forward slide between retruded contact position and intercuspal position. The two upper third molars are buccally placed relative to the lower third molars. There is contact on the left pair, marked by a small facet, which disengages quickly on lateral excursion. There is an extended contact on lateral excursion of the right pair, evident by a wear facet. In the clinical notes of the end of 1994, it is planned to remove all four third molars, with which I would concur. This was not performed. The continued presence of the third molar teeth clouds the issue of triggers for abnormal grinding and the development of muscle pain. The form of the first and second molar restorations on their occlusal surfaces is deficient, with an excessive concavity. The contact between the posterior teeth is most commonly between the buccal cusp tip of the lower with the central fossa of the upper tooth. Specifically, on the left, the disto-buccal cusp of the 37 contacts the central fossa of the 27 restorations and the mesio-buccal cusp of the 37 contacts the mesial marginal ridge of the 27 restoration. The disto-buccal cusp of the 36 contacts the central fossa of the 26 restoration and the mesio-buccal cusp of the 36 contacts the mesial marginal ridge of the 26 restoration. The mesial side of the mesio-buccal cusp of the 36 contacts the distal marginal ridge of the 25 restoration. All of the occlusal contacts on the left side (except for 28/38 if they were in contact at that stage) were rearranged with resin composite restorations. This is a comprehensive occlusal scheme renewal. All of the involved restorations were replaced on 22/06/1996. To control the occlusal scheme well for three pairs of teeth at one sitting is extremely demanding clinically, and would require a high level of skill and planning to do well. The occlusal scheme on the right follows similar patterns for the second molars. The disto-buccal cusp of the 47 is in the central fossae of the 17 restoration and the mesio-buccal cusp of the 47 is on the distal marginal ridge of the 16 restoration. The 46 has no occlusal contact with the upper teeth, missing contact by over 1 mm on the disto-buccal cusp. The 44 buccal cusp tip sits in the mesial fossa of the 14 restoration. Similar to the restoration of the left side, all of the upper posterior teeth were restored at one visit, on 18/06/1996. This again would be a difficult technical feat. The 46 and 47 were restored on 22/06/96, at the same time as seven restorations were placed on the left. In laterial excursion, the most firm contact between pairs of teeth was on the second molars, which is an unusual design for the occlusal scheme. There is a general principle that the control of sideways movement of the mandible is best undertaken by more anterior teeth, particularly the canines. Another accepted form of arranging the contact of teeth in laterial excursion is that several teeth on the side to which the mandible moves contact, which shares load between teeth. This is known as group function. I am not aware of any philosophy of occlusal schemes that would design contact between second molars as the guiding contact in laterial excursion. Several occlusal schemes specifically try to avoid such an occurrence, on the basis that molars do not react well to sideways forces. The clinical presentation here is that the second molars are tender to percussion, which is an indication that they were receiving excessive functional loads. This is not a desirable occlusal scheme. How can this have happened? The occlusal surfaces of the restorations placed are excessively concave. A possible reason for the occlusal arrangement is that the restorations were placed out of contact, and the teeth erupted until they came into contact. This would represent a lack of care in placement of the restoration. The resulting close intercuspation would lead to cuspal inclines that were the steepest in the mouth on lateral excursion. This would lead to the second molars taking on the guidance of the mandible in lateral excursion [which is now present]. These pairs of contacts are the firmest in the mouth as measured with shimstock. If the second molars were in the relationship now found at the time of restoration replacement, the cusp tips of the involved teeth should have been shortened, and the fossae made more shallow. This would have decreased the cuspal inclines. To not do so would have exhibited a lack of care in planning. There are clear facets on the left canine pair, and on the left first premolar pair where the teeth have worn each other in the movement of the lower jaw from central to left position. There are also clear facets on the right upper canine and lower first molar. It is not possible to say whether these facets were present before or after posterior restoration placement. Ms Ciccone gives a history of developing grinding habits after the placement of the multiple resin composite restorations. Some authorities believe that contacts such as posterior molar guidance are capable of initiating grinding problems, which may lead to tooth and muscle soreness. There are multiple possible reasons for the current occlusal scheme, and the subsequent development of a grinding habit. There are complicating factors present here such as badly placed third molars, and anterior teeth that already show some wear. The clinical history of Ms Ciccone (from Form B) indicates that she had some problems that may have been complicated by the way her teeth met. It is possible that the sensitivity and soreness of teeth following the resin composite restoration placement could have acted as a trigger for grinding. It is not possible to be precise about the exact proportions of factors that have led to the problems that Ms Ciccone is experiencing. However, it is clear that: 1. The second molar teeth are receiving too much lateral load, and it would be desirable for this load to be placed further forward in the mouth. 2. The present intercuspation and hence load distribution has been determined by the occlusal morphology created in the placement of the multiple resin composite restorations. 3. The placement of multiple restorations at one sitting is a very difficult procedure to do well, and maintain control of occlusal contacts. It is my opinion that the occlusal scheme has not been designed well, and has led to an unacceptable pattern of tooth contacts, which require at least reshaping of the fossa walls of the upper teeth. There has either been a lack of care in planning the occlusal scheme, or a lack of care in placement of restorations. Either option represents an unsatisfactory outcome."
"Summary I consider that the use of pins in 27, 25, 24, and 14 was inappropriate. It is my opinion that the standard of the restorations with regards to pin perforation was and is grossly unsatisfactory. It is my opinion that the quality of the provision of work in terms of marginal fit was and is grossly unsatisfactory, and far below an acceptable standard. It is also my opinion that the failure to reassess the restorative work with the information from the OPG was grossly negligent. It is my opinion that it was negligent to not look for and diagnose caries in the distal of the 27 and 37 as part of the treatment plans for this patient. Furthermore, it was unsatisfactory to not restore 27 and 37 during restoration of other parts of the same tooth in June 1996. The interface of the restoration with the periodontium has not been well managed, but is not grossly unsatisfactory. It would be possible to remedy most of the problems with oral hygiene and restoration smoothing if the restorations were otherwise satisfactory. My opinion is that the radiographic appearance of the root filling in the 46 is unsatisfactory, and I would seek an opinion on the advisibility of retreatment. The lack of use of rubber dam is unsatisfactory. It is my opinion that the occlusal scheme has not been designed well, and has led to an unacceptable pattern of tooth contacts, which require at least reshaping of the fossa walls of the upper teeth. There has either been a lack of care in planning the occlusal scheme, or a lack of care in the placement of restorations. Either option represents an unsatisfactory outcome. My conclusion is that nearly every aspect of treatment that Ms Ciccone received was of an unsatisfactory standard. The unsatisfactory treatment was provided in several areas of dentistry, and repeatedly in some. There was a lack of satisfactory investigation and diagnosis in the initial treatment plans. Some aspects of the treatment were grossly unsatisfactory and at least one was grossly negligent. An undergraduate student performing at this level would not graduate." (Emphases added.)
" ... In my view, I believe that the restorations were not of an adequate standard and need to be re done. 2. I do not consider that the treatment shows a wanton disregard for the well being of Ms Antonella Ciccone, but rather a standard of dental restorative treatment that is less than ideal. This problem is not uncommon with the use of composite resins in posterior tooth restorations in the hands of the average general dental practitioner. As a specialist prosthodontist, I am referred a lot of patients with problems similar to Ms Ciccone. 3. In my experience, the general dental community has problems with the management of composite resin restorations in the posterior segments, due to a generalised lack of understanding of the difficulty associated with correct placement of these materials. 4. I believe re-doing these restorations would provide Ms Ciccone with an acceptable result. I note she appears to complain of TMJ pain, but also note: 5. * Ms Ciccone has had a bruxing habit for many years * she complained of TMJ pain on her first appointment with Dr Campbell It is difficult to attribute this problem to Dr Campbell's treatment. ... 8. Leakage is a less than intact/sealed margin, with evidence of stain penetration, caries or sensitivity. Peter Wilson's report goes into these concepts in great detail. Clearly it is not desirable and indicates that the treatment result was less than ideal. 9. By referring to sensitivity in my report I mean that the patient has teeth that are sensitive to thermal responses. Again, it is less than ideal and represents a less than ideal clinical outcome. 10. I note that Dr Wilson goes through each site analysing whether or not there is a carious lesion. There is no need to go into the level of analysis Dr Wilson has provided. This is an in depth examination of whether or not caries is present. There are many different ways of detecting caries that all have pluses and minuses. Each method can be criticised and the subject of intense debate. It can also be debated whether or not a particular carious lesion requires restoration or just fluoride treatment. The end result is that the restorations are not satisfactory and need to be replaced. 11. In relation to standard of care. I am cautious about comparing students with practitioners. Students are taught the latest techniques, working in a controlled environment with case selection. This is an entirely different world to a general practitioner in private practice and it is dangerous to conclude that there has been gross negligence simply on the basis that had the work been presented by a student, that student would have failed. 12. In this case, Dr Campbell's restorations exhibit common problems."
"In my opinion, Dr Campbell's management of Ms Ciccone was not up to the generally accepted standards of the dental profession. Nevertheless, the management and outcome was within the boundaries of other treatment outcomes I have seen in the course of my practice. I do not regard the management to be the result of anything more than minor deficiencies in practice. The deficiencies are not so serious or so far from accepted standards as to take Dr Campbell's management beyond the boundaries of common practice. I have regularly seen instances of general practice care at the same standards shown in this case. ... I am influenced in forming the view that Dr Campbell's management of Ms Ciccone was not significantly below the standards of the profession by the fact that the resultant problems can be readily rectified. In order to produce an acceptable outcome, five restorations should be replaced. Only one of these is probably due to leakage around the filling. The others are due to the loss of contour which may not be attributable to Dr Campbell's initial treatment, but rather to the subsequent wear. Taking the most generous approach, from the viewpoint of the patient, one might argue that two or three further restorations require replacement but, in my opinion, they are likely to last for a couple more years without replacement. Assuming the replacement of five restorations, the approximate total cost would be $1,000."
"1. I am the appellant in these proceedings. I have just under 30 years experience in the practice of dentistry. I have worked as a general practitioner on my own account for the whole of my career. Determination of the Dental Board of Victoria made 1 September 1998 2. I refer to the decision handed down by the Dental Board of Victoria. This document forms exhibit `DTL1' to the affidavit of David Leggart sworn 4 September 1998. I do not believe that my treatment of Ms Antonella Ciccone was grossly negligent. In summary, the treatment criticised was: * placement of 9 composite fillings in June 1996 that had deteriorated and needed replacement in or about May 1998 * endodontic treatment of tooth 46 in February 1997. 3. I concede that the treatment I gave Ms Ciccone was less than ideal. The composites broke down faster than you would normally expect, requiring adjustment or replacement some two years later. This is not a good treatment outcome, but one that I believe is not uncommon given that composite restorations can be severely compromised by the following factors: (i) an unusual occlusion, which I believe Ms Ciccone had. This can place an unusual amount of stress on the composite fillings and cause them to break down at an early stage; (ii) the composite resin used for these fillings may have been of an inferior quality; (iii) my curing light used at the time of performing these restorations may not have been functioning properly; (iv) Ms Ciccone may have an unusual propensity for decay. 4. The early breakdown of composite resin fillings is a reported and not uncommon problem. The material is not as durable as other materials but has significant cosmetic advantage, being the colour of natural enamel. In Ms Ciccone's case, an additional factor was her failure to complete the treatment plan. Cuspid guidance occlusion was to be established in visits subsequent to her last visit to me. I believe that the failure to complete the treatment plan contributed to the early breakdown of the composite resin material. 5. In relation to the endodontic treatment, it is clearly that I over instrumented a canal of tooth 46 and that I did not use a rubber dam during the procedure. I accept the Board's criticism in relation to rubber dams and will use one for all endodontic procedures from now on. In relation to over instrumenting the canal, I regret this occurred but it is a risk associated with the procedure. I note that this tooth is currently symptomless and, although further work may be required, I believe that the tooth can be conserved. 6. In the circumstances, whilst I admit that the treatment provided to Ms Ciccone was not optimal, I say that the deficiencies are not unusual. The treatment outcome is certainly not so severe as to justify a finding that the treatment was grossly negligent or that I am guilty of professional misconduct."
"... 6. In my view, as expressed in my report of 9 July 1998, the dental management of Ms Ciccone was extremely poor. She suffered from considerable distress and discomfort following the placement of the fillings by Dr Campbell. The clinical diagnosis of caries at seven sites, less than 2 years after filling replacement, is a grossly unsatisfactory outcome. The management shown by Dr Campbell was very seriously below the boundaries of common practice and he would not graduate from being an undergraduate student if he performed at this level. 7. In respect of paragraph 6 thereof, it is a widely held belief, with which I concur, that the placement of resin composite restorations requires more skill than amalgam fillings. It is therefore reasonable to expect that practitioners who choose to specialize in this area and use such a material should exercise skill above that needed for amalgam fillings. It is clear that Dr Campbell did not exercise the required level of skill in that regard and he appears to have been working beyond his capabilities in a difficult area of dental surgery. ... 19. I do not accept Dr Goodhart's view that the resultant problems can be readily rectified, as this implies a trivial outcome of the treatment provided by Dr Campbell. Ms Ciccone will have to undergo approximately 10 hours of corrective treatment to replace the restorations and root-filling, the total cost of which I would estimate to be between $3000 and $4000. Had the treatment performed by Dr Campbell been satisfactory, most of that treatment would only have required episodic attention over the following 10 or fifteen years after placement, if at all. However, the quality [of] treatment provided by Dr Campbell is such that corrective treatment will now need to be performed in an unacceptably short period after placement. 20. The view of Dr Goodhart that five fillings need to be replaced is supported neither by my report nor by the report of Dr Clausen, who actually examined the patient. 21. Further, Ms Ciccone, who is now 31 years old, will potentially face ongoing complications from the problems caused by the grossly inadequate dental work performed by Dr Campbell. From my first hand observations, the loss of dental tissue that has been caused by the caries associated with the fillings will not return, and can only be replaced. In consequence of the very poor quality of fillings provided by Dr Campbell, Mr Ciccone requires replacement of nearly all of the restorations provided by Dr Campbell. It has already been suggested by Dr Clausen, in his first report, that one tooth may need to be restored with a crown. I agree that this is a possibility, and further suggest that it is possible that several teeth may eventually need to be restored in this manner. Such treatment would probably be required more quickly than would have otherwise been the case if the treatment of Dr Campbell had not failed so quickly. 22. It is not, unfortunately, possible to predict the full ramifications of the poor treatment provided by Dr Campbell during the lifetime of Ms Ciccone. However, a tooth can only be restored a finite number of times, and a less than 2 year cycle between restorations is not acceptable."
"Unless the substance is in Schedule 8 or 9 of the poisons schedule there is no requirement for this Department to authorise the import. Unless the product is of biological origin quarantine clearance is not required. It is therefore possible for the products DMSA and DMPS to be legally imported into Australia by patients for personal use. Because it is difficult for patients to locate an overseas supplier of these products. I am prepared to permit your company to arrange the importation of DMSA and DMPS in modest quantities on behalf of individual named patients without being considered a sponsor of the products under the Therapeutic Goods Act. This is at all times subject to compliance with the laws of the States and Territories of Australia. You may use this letter as evidence of this arrangement in any dealings with Customs. You may also keep on hand a modest (retail rather than wholesale) quantity of the drugs against future orders, but every delivery of drug from you to a patient or dentist must be against a specific prescription for a single patient. At no time must the availability of this product be promoted or advertised because to do so would be a contravention of the Therapeutic Goods Act which forbids the promotion of unregistered drugs. In the event of evidence of promotion of the product this arrangement will be reviewed and will also be drawn to the attention of the Dental Board in the particular State. I would draw your attention to the general undesirability of the management of systemic conditions by dental surgeons. You should be aware that unregistered drugs may have hazards which may not be immediately apparent and it is therefore essential for your own legal protection that individuals who request you to arrange these personal imports have it clearly explained to them that the drugs are not registered in Australia and that the Commonwealth Government does not recommend the use of unregistered drugs in this setting. I am enclosing the relevant NHMRC document which may help to clarify the government's position on this health issue. Consideration of this issue raises the problem of supply of the drugs for patients for whom there is more robust evidence of mercury poisoning e.g. industrial or accidental mercury poisoning. The TGA is likely to approve the use of these drugs under these circumstances under the conditions of individual approval on the Special Access Scheme. The TGA strongly recommends evaluation and registration of these products should demand increase to the point where such a course might be commercially viable. We have a capacity to reduce the fee under certain conditions of lack of commercial viability. It might be worth your while to discuss this with us in due course. Finally, the use of unregistered drugs with or without TGA knowledge or approval is fraught with medico-legal risk. In your own interests I recommend that you discuss this issue with a lawyer who is conversant with drug regulatory policy. I enclose some reference material which you may find useful." (Emphasis added.)
"Some two years ago we tried negotiating with the TGA to obtain a clearance to supply DMPS and DMSA to the Medical and Dental Practitioners in Australia. The costs involved with registration combined with the small market potential meant that registration was not economically feasible. We initially requested a waiver of the requirement and this was refused. Secondly we applied for the registration of a Dentist under section 19.5 of the Act only to find that Dentists have no standing under the Therapeutic Goods Act. The final approach was to seek Ministerial approval however the Minister's Office was not willing to override the existing law in this instance but did direct the TGA to assist us in some practical way. The previous Head of the TGA, Dr Malcolm Wright was highly critical of the legislation and knew that the high costs of registration and the long delays in the process means that many useful drugs are being kept out of Australia thus prolonging the illnesses of some patients. In the case of the Chelation of Heavy Metals in the body, the problem is exacerbated by the fact that the Medical Profession as a whole do not recognize that amalgams are the cause of the symptoms being treated and therefore it is not possible for the TGA to approve a cure if there is no problem. In spite of all the above Dr Wright recognized that some people believe that Mercury Amalgams are causing their problems and that if by treating them in what appears to be a safe way they are helped, then, the TGA should not stand in their way. He therefore recommended that Rainbow Pharmaceutical & Health Pty Ltd be the agent to act on behalf of these individuals for their personal importation of the drugs. Obviously it is impractical for us to place an order each time a patient requires product and this too was recognized by Dr Wright. Accordingly he suggested that we import supplies against a group of names to be treated. It is then required that at some stage we receive documentation signed by the patients receiving the products to indicate that they have received the drug, are aware it is unregistered if a small amount was kept in stock pending an application. What this does mean however is that for your protection (and ours) we introduced a procedure that follows these guidelines. Accordingly we suggest that the attached form be completed for each patient requiring the drugs and that you retain one copy with the patient's file and return one copy to us for our files. While this does create a little more paperwork for us all it is a legitimate method of obtaining the drugs at reasonable prices on a regular basis."
"I .......................................................................................................................... (Patients Name) of ........................................................................................................................ (Address) Authorize the above named company to import the drugs listed below which have been prescribed for my personal use by: ................................................................................ for the testing and treatment of Heavy metal Poisoning I am aware that while these drugs are not registered in Australia they are widely used for this purpose overseas and accept all liability in relation to their use in my case. Signed .............................................................................. Patient Witnessed ........................................................................ Prescriber Dated .......................................................... 19 DMPS ..................................... DMSA ....................................."
"I am a surgeon dentist specializing in Oral Medicine and Toxicology. Over the past seven years I have had several hundred patients referred to me suffering from high levels of mercury and lead and our research, which is enclosed, indicates that their mercury amalgam fillings are the greatest source of the mercury. I have been replacing the mercury fillings with composite resin, but unless the mercury and lead are chelated from the body, many of the symptoms do not improve. Our literature search of Medline showed that in Austria, Germany and Russia the testing and chelation of mercury and lead is best done with the: Sodium Salt of Dimercaptopropane-1-sulphonate (DMPS) and Dimercapto succinic acid (DMSA). In Australia Dimercaperol (BAL) and d-Penicillamine have been used but there are often toxic side effects. With DMSA and DMPS few side effects have been reported. DMPS has been shown to be a reliable product for testing patients through provocation testing which transfers mercury and lead from the organs to the blood stream and into the urine. DMPS is available from HEYL Pharmaceutical in Germany, the leading manufacturer of heavy metal antidotes. The company is approved as a manufacturer of Pharmaceutical products by the German Health Department and DMPS is registered by them as an approved drug for this purpose. DMSA is the only substance removing significant quantities of mercury from the brain. It is cheaper than DMPS and is most appropriate for the chelation of heavy metals as demonstrated by our research and research in other centres throughout the world. DMSA is available from Thorne Research Inc in the USA which is also a recognized Pharmaceutical Company under regular inspection by the FDA. Rainbow Pharmaceutical and Health Pty Ltd (Rainbow) are the Australian Agents for both of these companies and have agreed to import these products on my behalf. In discussions with Rainbow they have indicated that the costs of Registration is prohibitive in relation to the small quantities of product which I would use. They have agreed to seek registration should the future volume warrant it. As our research, carried out in New Zealand, demonstrates that it is essential to use these products for minimal side effects , I seek your approval to have the products imported for me under section 19.5 of the Act in accordance with section 12 in the regulations. Please find attached details of the products together with a recommendation on my suitability to use this drug from the Australian Society of Oral Medicine and Toxicology. I look forward to your prompt response as I am currently treating a number of patients requiring this treatment."
Campbell
Dental Board of Victoria [1999] VSC 113
(1972) 20 FLR 234
(1989) 16 NSWLR 197