It has been well documented in BC Disease News that the government initially intended to introduce fixed fees for clinical negligence claims worth at least £100,000 from 1 October 2016 with a consultation on the plan being due since autumn 2015. Whilst this deadline for implementation has been and gone and we are still awaiting the publication of the consultation (which is said to be imminent), it has been revealed this week that the Department of Health (DoH) has amended its position.

The Civil Procedure Rule Committee (CPRC) held a meeting in July, the minutes of which have recently been released,[i] and they reveal that the DoH now only intend to introduce fixed recoverable costs for those clinical negligence cases worth up to £25,000.

Amanda Stevens, chair of the CPRC sub-committee, reported the news and noted that these claims comprised approximately 60% of all clinical negligence claims. She said:

‘The material worked up by the subcommittee on a draft protocol and illustrative rules would be amended accordingly. The date of publication of the consultation was unknown’.

Organisations such as, the Association of Personal Injury Lawyers (APIL), the Law Society and the Society of Clinical Injury Lawyers have been lobbying the government since these proposals were announced in August 2015, accusing the DoH of being irresponsible. It is thought that this change in approach will be seen as a significant win for them.

APIL president, Neil Sugarman stated:

‘…it would show that the government has listened to arguments that a quarter of a million pounds is not a low-value case, and that cases of such magnitude do not suit a fixed process. A fixed-fee system for cases up to £25,000, however, could be workable. The fees would have to be fixed at a level which makes the work viable, and the process itself must also be fixed’.

He continued:

 ‘Other conditions, such as admission of liability and requirement of just one medical report would need to be met for such a scheme to be effective. This would give the Department of Health the opportunity to reduce costs for the NHSLA, control defendant behaviour and secure representation for injured patients by specialist lawyers at a fair rate of pay’.

Whether or not the government will actually implement this new limit for fixed fees in clinical negligence claims remains to be seen and will not be known for certain until the publication of the consultation paper which we await with anticipation.

In the recent judgment of Merrix v Heart of England NHS Foundation Trust (Birmingham District Registry, 13 October 2016), Regional Costs Judge District Judge Lumb considered the extent to which the costs budgeting regime in CPR Part 3, fettered the powers and discretion of the Costs Judge on detailed assessment under CPR Part 47.

DJ Lumb pointed out at the start of his judgment, that:

‘Both processes share a common objective to identify reasonable and proportionate costs. However, looking from opposite ends of a procedural timeline they are not necessarily focussed on exactly the same thing’.

The matter was a preliminary issue in a clinical negligence claim and the defendant was the paying party. The claimant submitted that a budget fixed the amount of recoverable costs and can be reduced only if the paying party can show good reason to depart from it. This, it was said, was the meaning behind the words in CPR r. 3.18 which states:

‘In any case where a costs management order has been made, when assessing costs on the standard basis, the court will –

a)    Have regard to the receiving party’s last approved or agreed budget for each phase of the proceedings; and

b)    Not depart from such approved or agreed budget unless satisfied that there is good reason to do so.

Therefore, said the claimant, if her costs are claimed at or less than the figure approved or agreed for that phase of the budget then they should be assessed as claimed without further consideration.

The defendant’s position was that the Costs Judge’s powers and discretion are not fettered by the budgeted figure for the phase but that the budget is but one factor to be considered in determining reasonable and proportionate costs on assessment. Additionally, it pointed out that costs budgeting was not intended to replace detailed assessment, if this were the case then there would be no test of proportionality for these costs, which is carried out at the detailed assessment stage.

Before giving his judgment, DJ Lumb noted that:

‘Although aspects of costs budgeting have been considered in a number of authorities there appears to be no direct case authority on the relationship between costs budgeting and costs assessment. The debate in the legal profession concerning this issue reflects wide-ranging views and interpretations and the parties in the present case have taken entrenched positions which can only be described as polar opposites’.

Having regard to this, he concluded that the defendants must be correct in its submission that costs budgeting was not intended to replace detailed assessment and that the receiving party’s last agreed or approved budget is just another factor that the Court will have regard to. This the judge said, was clear from the fact that the Rules Committee did not make changes to CPR Parts 44 and 47 to give importance to the budget. Further evidence that there was no intention to preclude the availability of detailed assessment can be found in the Practice Direction. PD 3E which expressly states that in budgeting the Court is not carrying out a detailed assessment in advance. DJ Lumb stated:

‘The words “in advance” must mean that this will be available at the conclusion of the case. PD 3E also states that the hourly rates and time to be expended are for guidance purposes only to assist the Court in setting a budget. The time to consider those in detail must therefore come later, at assessment’.

Instead, he stated that, what must have been intended was that effective costs and case management would greatly reduce the need for detailed assessment of some or all of the parties’ costs by ensuring that the costs budgets were within the range of reasonable and proportionate costs for each phase. In so doing the scope for disagreement should be reduced to a level where a paying party would be unwise to risk incurring the significant costs of the detailed assessment process for what would only be limited potential gains.

Therefore he concluded that the strict answer to the question in issue in this case was that the powers and discretion of a costs judge on detailed assessment are not fettered by the costs budgeting regime save that the budgeted figures should not be exceeded unless good reason can be shown. However, he added:

‘… the full answer to the issue is more nuanced than the defendant’s position of “open season” and complete discretion to attack a bill on detailed assessment, and the claimant’s opportunistic attempt to impose a straight-jacket on the costs judge and claim a fixed figure’.

Therefore, he granted permission to appeal and the claimant representative has said it is considering its position on the matter. 

The World Health Organisation (WHO), in 2007, published a review which identified seven studies suggesting that sleep disruption may be carcinogenic to humans. A number of studies suggested an association between shift work and breast cancer. However, the University of Oxford, funded by the UK Health and Safety Executive, Cancer Research UK and the Medical Research Council, has recently found that ‘working night shifts has “little or no effect” on a woman’s risk of developing breast cancer.[i]

The review looked at data from 10 different countries and pooled the evidence of three large UK-based studies of post-menopausal women, The Million Women Study, EPIC-Oxford and the UK Biobank.

In all three studies, participants were asked about their employment and whether their job involved working night shifts. The answers were categorised into:

• never/rarely
• sometimes
• usually
• always
  

The participants were followed via records linked to the NHS Central Registers which provide information on cancer registrations and deaths. The outcomes of interest in this analysis were the first diagnosis of breast cancer or death from breast cancer.

Overall, it was found across the three studies, that there was no significant link between night shift work for any number of years and risk of breast cancer. Even when combining these results with the seven non-UK studies included in the previous 2007 WHO review, there was still no evidence that night shift work was associated with breast cancer.

The research did point out that the studies reviewed were all observational studies and so the possibility that other health and lifestyle factors associated with night-shift work, such as obesity or smoking, could increase breast cancer risk still can’t  be ruled out.

We review the evidence further in a future feature.

“Despite being regularly referred to as the ‘gold standard’, pure tone audiometry, as it currently stands, has a very high degree of potential error, particularly in a clinical environment.”

Marine and Technology Faculty, Southampton Solent University, 2015

“A single determination of hearing threshold level at any frequency must be recognised as only a guess of unknown accuracy.”

“For an individual test subject, a single audiogram is an unconfirmed determination of that individual’s state-of-hearing in both ears.  Put more starkly, a single audiogram is a guess.”

Institute of Sound & Vibration Research, University of Southampton, ISVR Technical Report No. 336, 2015

INTRODUCTION

If audiometry is properly carried out in accordance with the British Society of Audiology’s (BSA) recommended procedures for pure tone audiometry,^[i] then can NIHL be reliably diagnosed based on a single audiogram?

Can NIHL claims handling schemes based upon a single audiogram simplify and speed up the claims process and reduce claim costs?

In a seminar held this week by the Manchester Law Society on NIHL claims (‘What’s all the noise about Noise Induced Hearing Loss’^[ii]), Dominic Weir of Slater & Gordon, Karen Jackson of Roberts Jackson, Zoe Holland of Zebra LC^[iii] and HHJ Gore QC advanced arguments in favour of a ‘single trusted audiogram’ during a panel discussion. Such arguments also appear to be finding increasing favour in the defendant community.

In this feature we consider audiometric reliability and the diagnosis of NIHL and why, in our view, single audiometry handling schemes would lead to more paid NIHL claims and re-ignite a currently declining market.

AUDIOMETRIC VARIABILITY

Pure tone audiometry has now been in use for over 90 years and has been described as the ‘Gold Standard’ for the assessment of hearing thresholds. Nevertheless it is accepted not to be a precise science - measurements are susceptible to errors, which may lead to variability in the results, and a lack of reliability.  Stephens (1981)^[iv] found 38 sources of error in audiometric testing. 

The American Academy of Otolaryngology - Head and Neck Surgery,^[v] list the variables in 4 principle categories and we set out some examples of the sources of error below:

1. Physical variables
1. Improper calibration of audiometer
2. Improper placement of earphones
3. Type of earphones and earphone cushions used
4. Excessive ambient noise levels in test rooms
2. Physiological variables
1. Tinnitus
2. General health of subject, presence of fatigue, colds and ear wax
3. Collapsed ear canals caused by earphone pressure
3. Psychological variables
1. Motivation of subjects
2. Attitude to testing
3. Experience in test taking
4. Methodological variables
1. Tester competence
2. Testing technique
3. Order of presentation of frequencies

Measures such as calibration of the test environment, equipment and procedure to ISO standards can reduce the risk of errors.  There are both British and international standards for the test procedures.  The BSA has published recommended procedures for pure tone audiometry which are in accordance with the International & British Standard BS EN ISO 8253-1.  However, despite the use of these standards and recommended procedures, measurement variability is still inevitable. It is entirely normal to have 5 to 10dB differences in thresholds - in either direction - between properly conducted hearing tests.

This measurement variability has long been recognised. Chapter 5, section 5.2.3.1 of the Black Book, ^[vi] states that:

• Repeatability varies from person to person;
• Repeatability is best at 1 and 2 kHz and poorer outside these limits, especially at 6 kHz;
• With 5 dB measurement steps then audiometric variability within the same test (intra-test variability) may be within +/- 5 dB.

As was stated by HHJ Inglis in the Nottingham Textile Litigation judgment at 1^st instance,^[vii] at paragraph 103:

“The central tool in diagnosis is the audiogram. Audiograms are taken in steps of 5 dB at each frequency. They are variable and not generally exactly repeatable. Where 2 audiograms taken at about the same time vary, the results where there is variation may reasonably be averaged if the difference is not more than 10 dB. Up to 10 dB is therefore an acceptable margin of error”.

It is important to remember that this degree of ‘acceptable margin of error’ can occur where 2 audiograms are performed entirely properly by experienced audiologists within a proper test environment and calibrated equipment and applying BSA recommended procedures in testing.

If one test (or both) is not properly conducted then the margin of error and variability in measured thresholds between tests can be far greater. Some sources of audiometric error can result in better than actual hearing - so for example where a patient can see the audiometer and when a test signal is applied or there is a lack of variation in the test signals so the patient anticipates hearing a sound rather than actually doing so. The vast majority of errors however increase the measured hearing thresholds - in other words show hearing worse than it actually is. As stated by Lawton (1991)^[viii]:

‘…systemic errors [in pure tone audiometry] usually work to elevate the threshold, to make the hearing appear less acute than it really is’.

However, a series of studies carried out by the Maritime and Technology Faculty of the Southampton Solent University between 2013-2015^{[ix] [x] [xi]},suggest that the degree of accuracy of properly conducted audiometry is actually worse than previously thought.

One of these studies aimed to assess how measurements might vary between audiometers in a laboratory environment due to any calibration differences. Calibration requirements of audiometers are set out in various national and international standards,^[xii] to ensure their sound outputs are within tolerances of -/+3 dB at frequencies 125Hz-4 kHz and +/-5dB at higher frequencies. Therefore 2 properly calibrated audiometers can differ in their sound outputs by up to 6 dB-10 dB dependent on frequency tested.

The study looked at the variability in sound output from 4 different types of audiometer which had all undergone proper laboratory calibration within the last 3 months. The sound output from the audiometers was measured using a Head and Torso Simulator (HATS) - as pictured below.

Picture; Bruel and Kjaer Head and Torso Simulator^[xiii]

The HATS accurately replicates the size and shape of the human head and ears and allows the accurate measurement of sound which would be presented to the ear of a person undergoing audiometry - rather than the measured hearing thresholds of the person. In this way many of the environmental and the subjective sources of error which can occur are avoided.

All the audiometers which used TDH39 headphones were fitted by a qualified audiometrist to the HATS. Three of the audiometers used supral-aural (sit on the outside of the ear) THD39 earphones and one used THD39 earphones with attenuating cups. Attenuating cups are noise excluding cups which can be fitted around the earphones to exclude external noise and are particularly recommended where the ambient noise level of the test environment is not ideal and commonly used in industrial screening situations.

Picture: THD39 earphones

Picture: Attenuating audiocups

Sound was presented to the HATS using each of the 4 audiometers across the frequencies of 250 Hz, 500 Hz, 1 kHz, 2 kHz, 4 kHz and 6 kHz at assumed sound outputs of 30 dB, 50 dB and 80 dB. Both ‘ears’ were tested and tests were repeated 3 times with the headphones removed and replaced between each test.

In theory each audiometer should present identical tones with the HATS recording the same outputs. Surprisingly the measured outputs of the audiometers, which were apparently presenting the same sound frequency and level to the HATS, showed a high degree of test-retest variability - both within the same audiometer, between the different audiometers and between left and right ‘ears’.

The differences between the means outputs of each of the audiometers were between 3 and 12 dB. The variation in produced tones was greatest both within and between audiometers at 6 kHz with a maximum difference of 20-21 dB - far outside the calibration tolerances of 10dB. The results are reproduced in the table below.

Table: Minimum, maximum, difference and mean measured sound outputs at test levels & frequencies

The audiometer using attenuating cups had greater variation than the other audiometers in the study.  It also had a significantly higher output level than the other audiometers at a number of frequencies.  The authors suggest that a reason for this might be that the use of attenuating cups creates a calibration error.  The attenuating cups themselves are likely to introduce a degree of resonance, which will change the frequency response of headphones to the ear.

Further identified causes of variation were the different headband designs and tensions.  The audiometer that performed the most consistently was the audiometer with the tightest headphones.  These effects are likely to be greater in real world environments due to variability in the sizes and shapes of human heads.  In addition, the artificial head used in this study remained still, whereas human heads will probably move during testing, which could cause greater variations.

The authors also commented on the difficulty of positioning the attenuating cups over the ears, due to reduced visibility of the transducer part of the headphone.  This variation is also likely to occur in real subjects, which demonstrates a difference between the ‘calibrated’ set up and the ‘clinical’ set up.  It is suggested that the position of the headphones is particularly significant at 6 kHz.

The authors concluded^[xiv] that:

(i) To improve the accuracy of audiometry, headband tension needs to be sufficiently high to ensure good coupling between the ear and headphone and different headphones or tensions may be appropriate to different sizes of head;

(ii) Attenuating cups significantly increase variability and should be avoided;

(iii) The high proportion of people with threshold shifts at 6 kHz could be linked to the variation in performance of the headphones when placed slightly differently or with insufficient tension on the ears;

(iv) You can expect variations of up to 21 dB in hearing thresholds at some frequencies if tested in different clinics. You can also expect a high degree of variation for different tests within the same clinic using the same audiometer. ‘Real world’ differences are likely to be greater than shown in the study;

(iv) The degree of variability found within the study is sufficient to cause misdiagnosis of NIHL on a single audiogram;

(v) Despite being regularly referred to as the ‘gold standard’, pure tone audiometry, as it currently stands, has a very high degree of potential error, particularly in a real world environment.

The same authors then followed this study by looking at the variation of measurements in both laboratory conditions and real world/clinical conditions. The methodology for testing laboratory conditions was as described above using the HATS. To test in a clinical/real world environment 13 people were recruited from the University community - some with normal hearing and some with hearing problems. Testing was carried out by a qualified audiometrist in accordance with the BSA recommended procedures for PTA using 3 different audiometers and TDH39 headphones. As expected the variation in clinical conditions (for the 13 test subjects) was even greater than for a laboratory conditions (using the HATS).          

At the key frequencies of 3, 4 and 6 kHz the mean differences were between 5-12 dB but the maximum differences were 15 dB, 20 dB and 30 dB respectively. The results are reproduced in the table and figure below.

Table and figure: Maximum and mean variations in sound outputs

The authors stated:

‘All frequencies had a maximum error of at least 15 dB in the clinical tests, which brings into question the accuracy of clinical pure tone testing as the primary mode of hearing screening, as this degree of error is sufficient to cause misdiagnosis’.

CONCLUSIONS

When using the CLB Guidelines^[xv] as a diagnostic framework for NIHL, small differences in hearing thresholds matter. A 5-10 dB difference at a single threshold can change a +diagnosis to a –diagnosis.

The Institute of Sound & Vibration Research in a 2015 Technical Report,^[xvi] summarised the position on diagnosis of NIHL based on a single audiogram as follows:

“A single determination of hearing threshold level at any frequency must be recognised as only a guess of unknown accuracy.”

“For an individual test subject, a single audiogram is an unconfirmed determination of that individual’s state-of-hearing in both ears.  Put more starkly, a single audiogram is a guess.”

The recent studies by Southampton Solent University suggest that the typical variability of pure tone audiometry is greater than previously thought. Differences far greater than the 10 dB ‘accepted margin of error’ may in fact be typical. These differences arise even where the audiometry is performed in accordance with BSA Recommended procedures for pure tone audiometry. Where audiometry is sub-standard then expect the differences to be even greater and showing worse than true hearing thresholds.

Let’s consider the findings of these recent studies in the context of the current NIHL market:

1. Claims volumes have been falling over the last 12 months - see 144 of BC Disease News (here) and the UK Deafness Working Party Report.^[xvii] Anecdotally all insurers appear to be reporting significant falls in claims volumes;

2. The hearing of many claimants is difficult to distinguish from those typical of an aged population which has not been exposed to noise - see our analysis of some 10,000 claims in edition 124 of BC Disease News (here), where around 50% of claimants arguably had no more than normal hearing for a non-exposed/aged population;

3. Nearly 60% of claims involved notches/bulges of between 10-19dB. Or, expressed another way, 60% of claims are diagnosed based on notches/bulges that are within the range of normal audiometric error which could disappear on repeat testing;

4. In many cases, if there is any NIHL is it sufficient to give rise to damages? Applying the new LCB Guidelines on disability,^[xviii] then up to 1/3^rd claims arguably have such NIHL that is so small as to be considered de minimis. (Full details on the LCB Guidelines and their impact can be found in the BC Legal Guide here);

5. The quality of claims appear to have deteriorated over the last few years. More claims are spurious and more successfully defended - see the above report;

6. Analysis of claimant audiograms shows that + diagnosis of NIHL applying the CLB Guidelines has increased from c.50% in 2011 to c. 90% today. Simple CLB diagnostic tools offer little safeguard to defendants in today’s market-analysis must be far more sophisticated. A defendant’s ability to obtain repeat audiometry and its own medical evidence is a key mechanism to control the market and ensure the current high repudiation rates are maintained.

In our view, single audiometry handling schemes would:

(i) result in over-diagnosis of NIHL;

(ii) lead to reduced repudiation rates and more claims paid;

(iii) provide much needed cash flow to claimant organisations, and:

(iv) re-ignite a currently declining market.

Ask yourself what are the benefits of adopting a single audiometry handling scheme in the current market?

In a future feature we look at the results of repeat audiometry obtained by BC Legal. In what % of claims is the audiometry consistent and reliable such that diagnosis can be validated? In what % of claims does repeat audiometry show thresholds significantly different from the claimant audiometry? In how many of such claims does the repeat audiometry provide a defence on causation?

We reported in last week’s edition of BC Disease News that the long-awaited consultation on raising the small claims limit and removing general damages for low-value soft-tissue injuries has been delayed, it seems, indefinitely. However, this week it has been reported that a group of Conservative MPs will next week lobby the justice secretary, Elizabeth Truss, to follow through with the proposed personal injury reforms.  The group of 10 backbench MPs are eager to point out that this is a delay rather than a cancellation and are due to meet with Ms Truss early next week. [i]

Elsewhere, the Association of British Insurers (ABI) Motor Conference was held this week in which former Labour justice secretary, Lord Falconer, was a guest speaker. He said few people in Parliament were focused on personal injury reform given Brexit, and predicted that Truss would be similarly distracted from the issue. Instead he said, that insurers should focus on investing in fraud detection and taking legal action against those that commit fraud.

The ABI published its report ‘Lifting the Bonnet on Car Insurance’ this week, which sets out what motor insurance premiums pay for. The report highlights that bodily injury claims make up 37% of insurers’ costs despite accounting for only 9% of total motor claims. Given these figures, it is likely that insurers will continue to lobby for the reforms with the ABI putting them at the top of its list of five action points it set to ensure a ‘fairer deal for honest customers’. The full report and the ABI’s five action points can be found here.

A research study published in the journal, Occupational and Environmental Medicine has suggested that genetically modified enzymes used in food, perfumes, medicine and cleaning products are ‘potent allergens’ and should be tested like other potentially hazardous chemicals.[i]

In the study, researchers took blood samples from 813 workers routinely exposed to genetically modified enzymes from working in the food, drinks, chemicals, detergents and pharmaceutical industries. In just under a quarter of the blood samples, they found antibodies, which are proteins produced in response to the presence of the GM enzymes. The most commonly detected antibodies were derived from exposure to alpha amylase, stainzyme, and pancreatinin, which are predominantly used in detergents and home care products. Further to this, the researchers examined a subgroup of 134 workers and found around a third of them had possible allergic symptoms such as runny nose, eye irritation or shortness of breath.

The highest levels of sensitisation was produced by alpha amylase, with antibodies showing up in 44% of workers exposed to it, followed by stainzyme (41%) and pancreatinin (35%). These three genetically modified enzymes are all predominantly used in detergents, cleaning products and homecare products.

These results led the researchers to conclude that:

‘Genetically engineered enzymes are potent allergens eliciting immediate-type sensitisation…The assessment of allergenicity should be mandatory for all new products…Enzymes should be tested like any other potentially hazardous chemical’.

The use of enzymes has increased over recent years, particularly within the food industry as it is used to boost flavours and aromas, including in low-fat foods. As well as creating artificial flavourings, industrial applications for enzyme technology range from cheese ripening through speeding up the baking process to enhancing the power of detergents and medicines.

This week Slater & Gordon (S&G) has released its annual report for 2015/16 which discloses that since its restructuring, the firm has reduced headcount in its UK business by 16% with 640 redundancies.

We reported in edition 135 of BC Disease News on S&G’s UK restructure plan which involved major city centre offices being consolidated in order to create three principal divisions of fast-track personal injury claims, serious and specialised personal injury law and general law. The annual report states that the strategic priorities of S&G are now ‘building market share and improving operating leverage in the serious and specialist practicing division and growing market share and scale in selected areas of general law’.

This restructuring is set to be completed by the first quarter of 2017 but the report was silent on how this would affect staff numbers.

The full annual report can be found here.

A personal injury firm which handles NIHL claims has entered administration and has been reported to have been absorbed into another practice.

ProLegal Limited, based in Canary Wharf, now named Prolegal Solicitors, is thought to have transferred ownership to Gordon Dadds.

The accounts for the year 2013 show that turnover had fallen from £4.5m to £3.82m within 12 months, suggesting that the firm was struggling to adapt to the reforms in the personal injury market.

It is unknown whether Prolegal Solicitors will continue to handle any NIHL claims.

This month, the University of California, Irvine and SUNY Downstate Medical Centre researchers have created a model, demonstrating how economic globalisation may create stressful employment factors in high-income countries, contributing to cardiovascular disease.

Cardiovascular disease has become a global epidemic, which is now responsible for approximately 30% of deaths worldwide. Mortality rates have been declining in advanced industrialised nations, however, some risk factors, including obesity and diabetes, have been increasing everywhere.

Researchers have been investigating the social causes of CVD, including work-related factors, and say they have produced a strong body of evidence documenting the effects of work environments and the mechanisms of psychosocial job stressors. Stressors can produce chronic biologic responses, such as hypertension, and promote unhealthy behaviours, which all increases the risk of contracting CVD.

In edition 120 of BC Disease News we looked at the relationship between stress at work and hypertension, with the body of evidence showing no causal association.

The Health and Safety Executive (HSE) has recently released a five year strategy which sets out wide-ranging measures to further improve Great Britain’s health and safety track record. The strategy is entitled ‘Helping Great Britain Work Well’ and consists of six priority themes which the HSE say they will focus on over the coming five years.

The six strategic themes include:

1. Acting together: Promoting broader ownership of health and safety in Great Britain.

2. Tackling ill health: Highlighting and tackling the costs of work-related ill health.

3. Managing risk well: Simplifying risk management and helping business to grow.

4. Supporting small employers: Giving SMEs simple advice so they know what they have to do.

5. Keeping pace with change: Anticipating and tackling new health and safety challenges.

6. Sharing success: Promoting the benefits of Great Britain’s world-class health and safety system.

The HSE claim that wider recognition is needed of the business benefits that come with proportionate approaches to risk and that too many small and medium enterprises are still unaware that straightforward advice and simple guidance is available that can help them manage their health and safety responsibilities. The HSE say that one way to tackle this problem is to ‘horizon scan’ and ‘design-in’ effective risk management of new or emerging technologies and business models.

More information on each of the strategic themes can be accessed here.

Speaking at a recent Law Society conference, District Judge Etherington made some noteworthy comments regarding the importance of witness statements for trial success and identified them as the number one area for improvement among litigators.

His main gripe was with those firms that leave the preparation of witness statements to the most junior members of staff without providing adequate supervision and without checking their work.

It was recommended that all litigators familiarise themselves with the Chancery Guide to Witness Statements here.

In edition 109 of BC Disease News we examined new mesothelioma research. Now we can report that in August 2016, a unique drug derived from the Caribbean Sea squirt has shown promise in stopping the growth of mesothelioma tumour cells.

Researchers at the University of Vienna in Austria have discovered that trabectedin, a toxin the coral-like animal uses against predators, may be an effective mesothelioma treatment. Group leader at the University of Vienna, Walter Berger, has said it looks “very promising” at this point.

In the study, published by the Molecular Cancer Therapeutics journal in early August, Berger’s team focus on the development of novel strategies for therapy-refractory cancers, such as mesothelioma, brain tumours and lung cancer. The study demonstrates how trabectedin serves as an effective chemotherapy-like agent, which targets DNA and has been delivering an immune response. It also showed good synergy when combined with cisplatin, a cytotoxic drug currently used in chemotherapy for cancer treatment.

Trabectedin could prove to be a major development in the treatment of malignant pleural mesothelioma. .

Five sites in Italy are currently conducting the only clinical trial involving trabectedin and mesothelioma. Early results are again said to be promising.

Elsewhere, there is new evidence that manipulating the process of protein synthesis inside cancer cells could be vital to improving outcomes for certain mesothelioma patients^.

A new study, published in the Journal of the American Medical Association (JAMA) Oncology suggests that using a drug to lower the levels of the amino acid, arginine, can slow the spread of pleural mesothelioma and extend survival in patients who are deficient in a particular enzyme.

Malignant mesothelioma is highly resistant to most kinds of cancer treatments and patients are often at a loss as to what to try next when chemotherapy, surgery and radiation fail. This new study suggests that the new type of therapy could help conventional treatments to work more effectively.

The JAMA Oncology research demonstrates the importance of arginine, an amino acid necessary for mesothelioma cells to produce the proteins that allow them to live and replicate.

A multi-centre, randomised clinical trial demonstrated that 68 of 201 mesothelioma tumours were deficient in argininosuccinate synthase (ASS1), an enzyme necessary for arginine synthesis. In ASS1-deficient patients, using a drug to artificially reduce the amount of arginine in the body made their malignant mesothelioma cells more responsive to the effects of standard chemotherapy treatments. After four months of weekly doses of the arginine-lowering drug, more than half of the 68 mesothelioma patients experienced stability.

Elsewhere, this month, a new case report has led to researchers’ optimism about the potential benefits of a highly targeted radiotherapy technique called Intensity Modulated Radiotherapy (IMRT) in people with malignant pleural mesothelioma. IMRT is a form of radiotherapy that allows radiologists to precisely deliver radiation in a shape that conforms to the shape of a mesothelioma tumour. This is important because mesothelioma tumours grow on the pleural membrane and tend to be irregularly shaped, which makes it difficult to treat them with less conformal radiotherapy techniques. Furthermore, tumours are typically located adjacent to critical organs such as the lungs and heart. Radiotherapy plans must take this into account to protect tissues from radiation damage.

The Italian case report details the treatment of a 73-year-old mesothelioma patient who was administered a potentially lethal dose of radiation into his tumour, following a relapse 10 months after a surgery and chemotherapy. He suffered no serious side effects from the high dose of radiation and there was no progression in the mesothelioma in the 14 months after the IMRT. The patient is still alive 32 months after diagnosis.

Finally, it is not only the treatment of mesothelioma which has seen recent developments, it has also recently been reported that breath screening may aid in detecting early mesothelioma.

In a study at Ghent University, researchers analysed the breath of 66 study participants, including 23 with malignant pleural mesothelioma, for volatile organic compounds.

The study found that people with mesothelioma (and those who have been exposed to asbestos) tend to exhale different levels of volatile organic compounds than healthy people do.

According to a summary of the study published in the Journal of Breath Research, the test was 76% accurate at distinguishing the mesothelioma patients from either the asbestos-exposed people or the healthy controls.

When it came to distinguishing between the asbestos-exposed people and those with mesothelioma, the test had an 87% accuracy.

At present, there is no reliable way to screen for mesothelioma. Belgian researches say they are hopeful that breath analysis may improve the odds. The paper concludes:

“Breath analysis by MCC/IMS allows malignant pleural mesothelioma patients to be discriminated from controls and holds promise for further investigation as a screening tool for former asbestos-exposed persons at risk of developing malignant pleural mesothelioma.”

The study could prove vital in the future early detection of mesothelioma in patients which may improve survival rates.

In edition 138 of BC Disease News we reported on one of the unfinished elements of Lord Justice Jackson’s civil reforms, the new format bill of costs. In April, LJ Jackson advocated for the new format to be used from October 2017 but recommended that this should be decoupled form the J-Codes to make it more palatable to the profession.

It has been announced this week that the updated Practice Direction 51L, in force from 3 October 2016, will extend the voluntary pilot of the new format for a further year, ‘with a view to establishing a mandatory form of bill of costs to apply to all work done after 1 October 2017’.

The Civil Procedure Rule Committee are scheduled to meet in May 2017, where they will review the pilot scheme and aim to fix the mandatory form with changes expected to be made to alleviate concerns raised about the existing form’s reliance on J-Codes. This reflects the concerns expressed by LJ Jackson earlier this year.

It has been reported that most of the criticisms about the new format bill of costs have been aimed at the J-Codes, with them being described as too complicated, labour-intensive and causing time spent on costs to increase by at least 100%.

The revised practice direction which can be accessed here, aims to simplify the new format.

The HM Courts and Tribunal Service has released an important note in relation to Tomlin Orders which came into effect this week. The note states that from 3^rd October 2016, a Court Associate of the Royal Courts of Justice will approve and seal Tomlin Orders only if:-

- The Order is headed ‘Tomlin Order’

- The Order concerns only a claim for money (i.e. debt or damages including any interest and costs)

- No other relief (e.g. injunction) has been sought

- The request for sealing includes a signed solicitors’ statement with the following wording:

‘We certify that the only relief sought in this claim/counterclaim is the payment of money including any interest and costs, and that no ancillary relief has been sought at any stage’.

- The proceedings are stayed without any time limit (not discontinued or dismissed)

- The Order includes permission to apply

- The Order refers to an attached schedule or to a dated schedule/agreement (which may be confidential) which is held in a specified place. If the Order refers to an attached confidential schedule it will be returned as no confidential schedules will be accepted by the court.

The note specifies that if the Order does not meet these requirements it will be returned for correction and re-submission.

For further information on the correct wording of a Tomlin Order please see the full note here.

This week has seen the start of a new legal year, marking the beginning of the Michaelmas Term for the High Court, Court of Appeal and Supreme Court. These courts have been in vacation since 29^th July 2016 and have heard no trials or appeals.

Elizabeth Truss, the Lord Chancellor formally opened the legal year at Westminster earlier this week. With the start of the new judicial year, we anticipate an increase in the volume of interesting and noteworthy judgments which we will continue to report on.