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Medical Report by Dr Alastair H Bint

Dated
5th January 2009

Area of Expertise
General Practice

On behalf of the Claimant
Mr. A Brown

Instructing Solicitors
Ison Harrison Solicitors, Duke House 54 Wellington Street, Leeds

Subject
Adverse effects suffered as a result of treatment received in connection with heroin
addiction.

Written by
Dr Alastair Bint, St Lukes Surgery, Warren Road, Guildford, UK, GU13JH




Contents
Paragraph Number Paragraph contents
Page Number
Appendices

Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX Report
1. Introduction
1.01
The Expert

I am Dr Alastair Halford Bint. My specialist field is General Medical Practice.
Full details of my qualifications and experience entitling me to give expert
opinion evidence are in appendix 1.
With relevance to this case, I routinely perform minor surgical procedures,
such as implants, in General Practice and I am very experienced in the
management of wound care and of possible allergic or infective reactions. I do
not have experience using Naltrexone implants and have therefore confined
my expert opinion to duty of care standards and general wound care.
1.02 Summary background of the case
The case concerns Mr A Brown, a patient of Dr Blue, of the ‘xxxxxx’ who was treated for heroin addiction using a Naltrexone implant, an unlicensed medication, inserted into the abdominal wall. Mr Brown developed a serious infection requiring surgery and leaving him with an open wound requiring ongoing medical treatment.
1.03 Summary of my conclusions
The use of the implant seems reasonable and Mr Brown signed a consent form acknowledging that it was unlicensed and accepting the risks involved. However, the management of his subsequent problems appears to be below a reasonable standard. Dr Blue, of the xxxxxxxx has provided no written record for parts of his subsequent management. This falls below the reasonable standard of record keeping required for medical practice. Despite there being no substantiating records from Dr Blue, there is evidence to suggest that Dr Blue administered a steroid injection into the wound. If the wound was infected at the time the steroid injection was administered, then such an injection is likely to have made the wound worse. In this case administering an injection in this way would be below an acceptable medical standard of care.
1.04 The parties involved
Mr A Brown: patient and Claimant Dr Blue of xxxxxx, Isle of White: defendant. 1.05 Technical terms and explanations
I have indicated any technical terms in bold type. I have defined these terms
when first used and included them in a glossary in appendix 3.
Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX The instructions and issues raised
To comment on the level of care provided by Dr Blue in relation to his duty of care and on the standard of wound management care. My investigation of the facts, history of events
Mr Brown was 24 years old when these proceedings began. He has a history of illicit poly-substance abuse from the age of 12 years old and had seen by a number of drug clinics and had suffered a number of failed detoxification programs. Mr Brown consulted Dr Blue at the ‘xxxxxx’ on 2nd June 2006, at that stage it
was noted he was using heroin, crack cocaine and cannabis. He had also been
on an episodic methadone program and subutex program via several different
drug rehabilitation clinics. There was also mention that he had used oral
Naltrexone medication. He was seen several times by Dr Blue over the next
few days and on the 9th June 2006 it was decided to try a Naltrexone implant.
On the 12th June 2006, Dr Blue inserted a ‘Sherman Naltrexone implant’ into the abdominal wall of Mr Brown. On that day, Mr Brown signed a consent form, recognising that this was an ‘unlicensed medication and although they may be used to treat patients legally, no assurances can be offered regarding their effectiveness, safety or duration of action and treatment is undertaken at patients own risk’. Also in the signed consent form is a list of possible side effects including ‘infection at the site of implant’, ‘rejection (immunological and mechanical)’ and ‘allergic reaction’. The consent form also mentions ‘in rare circumstances the implant may need to be removed surgically which would require an exploratory operation under General Anaesthetic in a hospital operating theatre’. On the 13th June 2006, Mr Brown saw his GP who noted ‘site not infected’. On the 20th June 2006, Mr Brown saw the GP practice nurse and his stitches were removed and it was noted ‘wound healed’. On the 6th July 2006 Mr Brown telephoned Dr Blue to advise that still had problems with the implant site. Dr Blue offered to see Mr Brown that coming weekend and in the meantime prescribed antibiotics and a steroid cream. On the 12th July 2006 Mr Brown consulted Dr Blue at the Lifeback Clinic and Dr Blue noted ‘only minimal infection of wound, needs antibiotics only’. Flucloxacillin antibiotic was prescribed. Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX The next day, on the 13th July 2006, Mr Brown consulted his GP with a
widespread rash over the implant site. The diagnosis was ‘allergic urticaria’
but also ‘mild cellulitis’. The Flucloxacillin antibiotics prescribed by Dr Blue
were changed to Erythromycin antibiotics and antihistamines were prescribed.
It appears that thereafter the wound settled.
On the 16th November 2006, Mr Brown telephoned Dr Blue to advise that he was still using heroin. He was to consider using oral Naltrexone with a plan to get back to Dr Blue in the New Year. On the 2nd March 2007, Dr Blue inserted the second Naltrexone implant into Mr Brown. A consent form detailing the possible risks and side effects, identical to the initial implant consent form, was signed by Mr Brown. On the 5th March 2007, Mr Brown consulted his GP and it was noted that the implant ‘area was red and blistered.’ He was prescribed antibiotics and a steroid cream. Mr Brown consulted his GP on a daily basis with ongoing blistering and rash and the GP telephoned Dr Blue on the 8th March 2007 and was advised to inject steroid into the wound. The GP was not happy to do this and asked that Dr Blue manage the problem. The GP recorded in the notes that Mr Brown was to go to Dr Blue that night. There are no records from Dr Blue or the Lifeback clinic regarding any further consultations past the 5th March 2007 so no record of any steroid injection being given. Mr Brown has signed a witness statement stating that he received a steroid injection from Dr Blue. On the 13th March 2007, Mr Brown consulted his GP, who noted that the implant scar was now necrotic and that there was a generalised rash, felt to be an allergic reaction. For the next few weeks Mr Brown attended the GP surgery for regular dressing changes to his wound and then on the 20th April 2007 he attended the Accident and Emergency centre at Hillingdon Hospital as the wound had deteriorated. He was admitted to hospital that day. On the 23rd April 2007 at Hillingdon Hospital, Mr Brown underwent a General Anaesthetic operation to debride the infected and necrotic wound and to remove of the implants. Mr Brown has since suffered a prolonged period of wound problems. Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX 4 My opinion

4.01
Mr Brown had a history of multiple drug habits and failed detoxification programs. The use of a Naltrexone implant by Dr Blue seems a reasonable action but a definitive opinion on its appropriateness should be sought from an expert with experience in the use of Naltrexone implants. Mr Brown was fully counselled appropriately on the risks involved including allergic reaction and infection. There is evidence to suggest that Mr Brown had an allergic reaction to his first implant, but it may also have been a postoperative infection, or in fact, a mixture of both. Given that the wound, having initially healed, continued to cause problems for a number of weeks after implant insertion, this would suggest that of the two possibilities, allergy to the implant was the most likely cause. It is however impossible to tell for certain, as his treatment was a combination of antibiotics, steroid cream and antihistamines, which successfully covered and treated both possibilities (antibiotics treat infection, steroid cream and antihistamines treat allergy). Some months later, at the request of Mr Brown, Dr Blue proceeded with the second Naltrexone implant. Whether this was a reasonable action or not, given Mr Brown’s experience with his first implant, will need to be determined by an expert experienced in the use of Naltrexone implants. Similarly to the first implant, the second implant wound showed signs of
allergy and infection and was being treated with antibiotics, antihistamines
and steroid cream.
In his witness statement, Mr Brown states that a steroid injection took place and that Dr Blue performed it. There are no written records from the Dr Blue regarding this. If this injection did take place, then the lack of any clinic records detailing this treatment is, in my view, wholly below an acceptable standard of record keeping. A steroid injected into an infected wound will make that wound worse. It would not always be necessary to swab a wound but if there is any doubt as to whether the wound may be infected, then antibiotics and a swab should be taken. Indeed, if a wound is infected, one should question whether a steroid injection should be used at all, but if it is to be used then antibiotics should also be administered prior to and after the injection. It is my view that administering a steroid injection into an infected wound without adequate precaution is therefore below an acceptable standard of medical practice. After the steroid injection, it is clear that the wound deteriorated, eventually becoming necrotic and requiring operative debridement. It was some seven weeks after the implant was inserted before it was eventually removed. Dr Blue was not equipped for General Anaesthetic, and this is reasonable for a small clinic. Dr Blue did, however, have a duty of care to arrange necessary implant extraction in a timely manner as to minimise the deterioration of the wound. There are no notes available from Dr Blue for this period of time but Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX one must question whether the implant should have been removed earlier and an opinion on this should be sort from an expert experienced in the use of Naltrexone implants.
5 Statement of compliance

(a) I understand that my overriding duty is to the court, both in preparing reports and in giving oral evidence. I have complied and will continue to comply with that duty. (b) I have set out in my report what I understand from those instructing me to be the questions in respect of which my opinion as an expert is required. (c) I have done my best, in preparing this report, to be accurate and complete. I have mentioned all matters which I regard as relevant to the opinions I have expressed. (d) I consider that all the matters on which I have expressed an opinion lie within my field of expertise. (e) I have drawn to the attention of the court all maters, of which I am aware, which might adversely affect my opinion. (f) In preparing and presenting this report I am not aware of any conflict of interest actual or potential save as expressly disclosed in this report. (g) In respect of matters referred to which are not within my personal knowledge, I have indicated the source of such information. (h) I have not included anything in this report which has been suggested to me by anyone, including the lawyers instructing me, without forming my own independent view of the matter. (i) Where, in my view, there is a range of reasonable opinion relevant to the opinions I express, I have indicated the extent of the range in the report. (j) At the time of signing the report I consider it to be complete and accurate. I will notify those instructing me if, for any reason, I subsequently consider that the report requires any alteration, correction, or qualification. (k) I understand that this report will be the evidence that I will give, if required, under oath, subject to any correction or qualification I may make before swearing to its veracity. (l) I have attached to this report a statement setting out the substance of all the facts and instructions given to me which are material to the opinions expressed in this report or upon which those opinions are based. Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX 6 Statement of truth

I confirm that insofar as the facts stated in my report are within my own knowledge I have made clear which they are and I believe them to be true, and that the opinions I have expressed represent my true and complete professional opinion.

Signed by Dr Alastair Bint
Dated
Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX
Appendix 1
Consulting room: St.Lukes Surgery, Tel; 01483 510041
Mobile: 07771 910198
email: [email protected]
Fax: 08704173978

My experience and qualifications:

Current Position
I am a full time NHS GP and trainer of foundation doctors in General Practice. I am Chairman of the South West Thames faculty of the Royal College of General Practitioners and I sit on the executive committee for postgraduate General Practice education in Kent, Surrey and Sussex. I have worked as clinical lead and sit on the Guildford Practice Based Commissioning board, one of the roles of which is appraising clinical pathways and protocols. I am a commentator for the Royal College of GPs on ethical and medico-legal issues.
I routinely perform minor surgical procedures in General Practice and have
experience working on larger operations, having spent considerable time working in
Accident and Emergency departments as a Senior House Officer and as a Staff Grade.
I am well experienced in the management of wound care and possible allergic or
infective reactions.
I do not have experience using Naltrexone implants and have therefore confined my
expert opinion to duty of care and of general wound care.
Qualifications:
MRCGP, Membership of Royal College of General Practitioners, 2003.
DRCOG, Diploma from Royal College of Obstetricians and Gynaecologists, 2002.
DFFP, Diploma from Faculty of Family Planning, 2002.
DGM, Diploma in Geriatric Medicine, Royal College of Physicians, 2001.
MBChB, Bachelor of Medicine and of Surgery, Edinburgh University, 1998.
Professional Memberships:
General Medical Council number 4546883
Medical Defence Union number 307265G
Royal College of General Practitioners number 53602
Faculty of Family Planning and Reproductive Healthcare number D015276


Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX Appendix 2
List of documents examined
1. GP held records
2. Hospital records from Hillingdon Hospital NHS Trust
3. Records from ‘xxxxxxxx’
4. Letter of instruction from Ison Harrison solicitors dated 17th December 2008
5. Signed witness statement made by Mr A Brown
Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX Appendix 3
Explanation of medical terms
Methadone; a prescribed controlled drug used as a substitute in heroin addiction.
Naltrexone; a prescribed controlled drug used as a substitute in heroin addiction
primarily for use in the prevention of relapse in detoxified patients. It is available in
tablet and implant form.
Subutex; a prescribed controlled drug used as a substitute in heroin addiction
Allergic urticaria; a distinct rash found in patients allergic to a particular agent.
Cellulitis; infection of the skin often demonstrated by a painful, hot, red rash.
Report By Dr Alastair Bint, Expert General Practitioner 5/01/2009 XXXXX

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