Hi there, sorry for the slight delay in posting an answer, but I had
no sooner typed it out in Word (unsaved of course) than my computer
crashed. It’s been that sort of day.
Throughout this answer, remember that Google Answers and I are not
giving you legal or medical advice. This answer simply collates
information available in the public domain. You say you are being
represented by a solicitor, and it is to him/her you should go for
legal advice.
A very thorough and simple website that outlines the procedure and
experience of a claim for clinical negligence can be found here (
http://www.medicalclaims.co.uk/ ), the information on which is
provided by the Journal of Medical Litigation. That site also refers
to another website which provides more legalistic resources at a cost,
which can be found here ( http://www.medneg.com ), although this link
did not work when I tried it. Another good website is that of the
Action for Victims of Medical Accidents, a registered charity (
http://www.avma.org.uk/ ).
The citation for the case you requested is:
Mann v Wellcome Foundation Ltd and Others; Close v Wellcome Foundation
Ltd & Others, Queen’s Bench Division, 87 NJ 938, 87 NJ 227, 20 January
1989
Unfortunately a transcript of this case is not available online, but
you should be able to view a hard copy using the information above.
Your solicitor will be able to do this, but if you do get stuck then
go to your local university law library and they may well be able to
help you, even though you are presumably not a student there. I
located the case using LexisNexis Professional, a commercial legal
database, and so although I can view the case online I cannot email it
to you or post it here without being in breach of my licence
conditions.
I should also make it clear that I have not read the case from
beginning to end, due to the fact it runs to about 50,000 words, and
is very complex. It does however look like you should try and get your
hands on a copy. The case concerns two claimants who attempted to
claim damages for their profound deafness alleged to have been caused
by neomycin administered through a spray to severe burns that they
sustained when they were very young infants in 1968. The case seems to
rest on the health authority’s duty to make dosage instructions more
emphasised to the doctors administering the antibiotic. The claimants
fail, since at the time there was not sufficient research available to
the health authority that would give them cause to do this.
These facts will probably not match your own, but there is a lot of
legal and medical discussion of the deafness caused by that family of
antibiotics, and gentamicin gets a mention. There is also a good
analysis of the likely damages to be calculated, as well as the
potential liability of the health authorities, spray manufacturers,
the antibiotic manufacturers, the individual doctors, the company that
provided the manufacturer’s research facilities, and even the company
that distributed the spray to hospitals.
That more or less sums up the case, but I do recommend you read it,
although it is complex it should be still be comprehensible to someone
with a non-legal background. It will also provide a number of starting
points for your solicitor to start constructing his case, should he
not have reference to this case already.
I have also done some research to try and find information on
gentamicyn, which I have found is often spelled “gentamicin”. It
sounds as though you already know quite a bit, but here are the basics
anyway:
The British National Formulary (the book that doctors use to get drug
and dosage information) entry for gentamicin is as follows:
“Indications: septicaemia and neonatal sepsis; meningitis and other
CNS infections; biliary-tract infection, acute pyelonephritis or
prostatitis, endocarditis (see notes above); pneumonia in hospital
patients, adjunct in listerial meningitis (Table 1, section 5.1)
Cautions: pregnancy (Appendix 4), renal impairment, infants and
elderly (adjust dose and monitor renal, auditory and vestibular
function together with serum gentamicin concentrations); avoid
prolonged use; conditions characterised by muscular weakness;
significant obesity (monitor serum-gentamicin concentration closely
and possibly reduce dose); see also notes above; interactions:
Appendix 1 (aminoglycosides)
Contra-indications: myasthenia gravis
Side-effects: vestibular and auditory damage, nephrotoxicity;
rarely, hypomagnesaemia on prolonged therapy, antibiotic-associated
colitis; also reported, nausea, vomiting, rash; see also notes above
Dose: by intramuscular or by slow intravenous injection over at
least 3 minutes or by intravenous infusion, 3–5 mg/kg daily (in
divided doses every 8 hours), see also notes above
CHILD up to 2 weeks, 3 mg/kg every 12 hours; 2 weeks–12 years, 2 mg/kg
every 8 hours
Streptococcal or enterococcal endocarditis in combination with other
drugs, 80 mg twice daily
Endocarditis prophylaxis, Table 2, section 5.1
By intrathecal injection, seek specialist advice, 1 mg daily
(increased if necessary to 5 mg daily)
Note. One-hour ('peak') serum concentration should be 5–10 mg/litre
(3–5 mg/litre for streptococcal or enterococcal endocarditis);
pre-dose ('trough') concentration should be less than 2 mg/litre (less
than 1 mg/litre for streptococcal or enterococcal endocarditis)”
I have included the whole thing since it’s not possible to link to
directly individual entries on their website. However, rather than
rely on that quote you MUST check their website at http://www.bnf.org
for the latest version. One thing I note from the above is that it
only seems to be used now for very serious conditions such as
bacterial meningitis and septicaemia.
The Vestibular Disorders Association ( http://www.vestibular.org/ )
have a discussion and fact sheet on ototoxicity that is useful, and
they have a separate page discussing the use of gentamicin (
http://www.vestibular.org/gentamicin.html ).
I have also found journal articles which you may find interesting.
Again, the problem you face is that the information on your subject is
produced only for healthcare professionals who have more traditional
means of finding it out; comprehensive dissemination on the web is
therefore rare. You can’t look at these journals online, but they do
look rather relevant and you can probably obtain copies through your
local library service or your local university library. Remember that
if you’re on a no-win no-fee basis with your solicitor, with a linked
insurance policy, that you may as well let your solicitor incur any
expenses in doing research as these will be either recoverable from
the other side in the event that you win, or covered by your
Conditional Fee Arrangement and insurance policy if you lose.
Some of these journals look fairly heavy, and probably go way beyond
your purposes, but it really depends on how much you wish to learn on
the subject. I found these titles through Science Direct, and they are
in reverse date order.
- http://www.sciencedirect.com
Hearing loss following intratympanic instillation of gentamicin for
the treatment of unilateral Meniere's disease, The Journal of
Otolaryngology, Volume 31, Issue 2, April 2002, Pages 106-111
Kaplan, Daniel M; Nedzelski, Julian M; Al-Abidi, Aziz; Chen, Joseph M;
Shipp, David B
Abstract: OBJECTIVE: To determine the incidence, extent, and time
course of hearing loss following instillation of intratympanic
gentamicin using a predetermined fixed protocol for incapacitating
unilateral Meniere's disease and to determine whether such loss is
associated with any identifiable risk factors. STUDY DESIGN: A
retrospective analysis of all patients treated with intratympanic
gentamicin between 1988 and 1998 using American Academy of
Otolaryngology-Head and Neck Surgery reporting guidelines (1985 and
1995). A predetermined regimen using a fixed dose (gentamicin 26.7
mg/mL administered three times daily for 4 consecutive days) was used.
METHODS: The records of patients treated with this particular protocol
were reviewed. The relationship between pretreatment hearing acuity,
pretreatment bithermal caloric response, duration of symptoms, and
previous treatment to post-treatment hearing were analyzed with
respect to hearing. RESULTS: Complete vestibular and audiologic data
over a minimum 2-year follow-up were available for 85 individuals.
Sixty-three patients (74.1%) had unchanged or improved hearing, and 22
patients (25.9%) realized hearing loss. In 80% of the latter, it
occurred during the first month post-treatment. When hearing acuity at
the 1-month post-treatment interval remained unchanged (91.1%), it was
likely to remain so over the next 23 months. A significantly higher
incidence of profound hearing loss was noted in patients who developed
hearing loss in the first month, as compared with those who developed
hearing loss at a later period (p = .0207, relative risk = 1.5).
Re-treatment was not associated with hearing loss. The only
identifiable risk factor for developing hearing loss was pretreatment
hearing acuity stages 3 and 4 (pure-tone average > 40 dB) (p = .022,
relative risk = 1.5). CONCLUSION: Hearing loss is a recognized
complication of treatment with intratympanic gentamicin, occurring in
approximately 26% of individuals. In those individuals in whom hearing
acuity has remained unchanged after the first month interval,
significant worsening of hearing is unlikely, and patients can be
reassured accordingly.
- Unpredictable hearing loss after intratympanic gentamicin treatment
for vertigo. A new theory, Acta Oto-Laryngologica, Volume 121, Issue
1, January 2001, Pages 42-44
Walsted, A
Abstract: A new hypothesis is advanced suggesting that unpredictable
cases of profound hearing loss after intratympanic gentamicin
treatment (IGT) may be caused by decreased patency of the
communication routes between the inner ear and the cerebrospinal
fluid, primarily of the cochlear aqueduct. A tympanic displacement
analyzer, which can indirectly analyze inner ear and intracranial
pressure changes and can also evaluate the efficiency of communication
between these two compartments, was used. Two cases are presented: in
the first, a patient who became deaf after IGT showed signs of
decreased patency of the communication routes with the tympanic
membrane displacement (TMD) test; in the second, a patient without
hearing damage after IGT had efficient communication evaluated by the
TMD test. These preliminary findings are in accordance with the
proposed pathophysiology. If future clinical studies confirm the
present theory and findings, it may prove possible to predict and
prevent deafness after IGT and possibly also after systemic
aminoglycoside treatment.
- Topical gentamicin-induced hearing loss: a mitochondrial ribosomal
RNA study of genetic susceptibility, The American Journal of Otology,
Volume 17, Issue 6, November 1996, Pages 850-852
Chen, J M; Williamson, P A; Hutchin, T; Nedzelski, J M; Cortopassi, G
A
Abstract: Mitochondrial ribosomal RNA mutation has been shown to
predispose affected individuals to aminoglycoside-induced hearing loss
(AIHL). An A-to-G nucleotide substitution at the 1555 position within
the 12S ribosomal RNA gene has been identified with a maternally
inherited pattern in affected Asian pedigrees. The aim of this study
was to identify the frequency of this DNA polymorphism in subjects who
appear to show hypersensitivity to topical (middle ear) application of
aminoglycoside. In this pilot study, 10 subjects with AIHL were
recruited. Eight underwent vestibular ablative therapy with middle ear
instillation of gentamicin for disabling vertigo, and two were treated
with topical antibiotic drops for otitis media in the presence of a
tympanic perforation. DNA samples were extracted, and polymerase chain
reaction (PCR) technique was used for gene amplification and
purification, searching for 1555 A-to-G substitution in the 12S
ribosomal RNA gene. None of the subjects demonstrated this specific
mutation.
- Local administration of gentamicin caused hearing loss,
Lakartidningen, Volume 89, Issue 26-27, June 24, 1992, Page 2374
Reychman, M; Jannert, M
- Hearing loss and inner ear changes in a patient suffering from
severe gentamicin ototoxicity, Archives of Oto-Rhino-Laryngology,
Volume 228, Issue 2, 1980, Pages 113-121
Tange, R A; Huizing, E H
- Profound bilateral sensorineural hearing loss during gentamicin
therapy, The Journal of Laryngology and Otology, Volume 91, Issue 6,
June 1977, Pages 511-516
Moffat, D A; Ramsden, R T
Abstract: A case of profound bilateral sensorineural deafness
occurring during gentamicin therapy is presented. Considerable
recovery of the hearing in the right ear was observed but the left ear
remained "dead". Electrocochleography confirmed the end-organ nature
of the damage. Apart from the profound sudden deafness the unusual
feature of this case was the total absence of vestibular effects. The
ototoxic effects of gentamicin are discussed including the
predisposing factors. While the incidence of ototoxicity with
gentamicin is low (2-3%) this figure will only remain acceptable if
the use of the drug is restricted to those patients who might die or
suffer severe morbidity without it. The factors which make
side-effects more likely to occur should always be borne in mind and
due attention paid to the monitoring of renal function and serum
antibiotic levels.
- Proceedings: Hearing loss due to gentamicin therapy, ORL; Journal
for Oto-Rhino-Laryngology and Its Related Specialties, Volume 37,
Issue 6, 1975, Pages 359-360
Huizing, E H; Carrière
- A case of gentamicin accentuated hearing loss, The Journal of
Laryngology and Otology, Volume 82, Issue 9, September 1968, Pages
803-808
Stephens, S D
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I hope that my answer matched what you were looking for. Really, the
legal case which you wanted is a must-read, but can’t be produced or
considered in depth here. I’m sure it will open up a few more avenues
of research for you.
Good luck with your claim
jumpingjoe-ga |
