Dallas McMillan's Blog

A review into the PiP breast implant scandal has found that, although the regulator acted appropriately and followed scientific and clinical advice, there is room for improvement and serious lessons must be learned.

Health Minister Lord Howe’s report into PiP breast implants has looked at whether the UK regulator – the MHRA – and the Department of Health acted appropriately both before and after information about the problems with these implants came to light.

The report states that the MHRA and the Department of Health must learn lessons so that they can continue to improve their approach to communicating with affected individuals and the general public, particularly around issues that cause such understandable anxiety. They must ensure that full, clear and accurate information is made available promptly in a way that is easily accessible and reflects the concerns that weigh so heavily on the lives of patients who are affected by doubts over the safety of specific medical devices.

The role of the MHRA is to monitor all incidents that are reported to it, make sure that these incidents are investigated fully and that any necessary action is taken. The evidence shows that the regulator did this but that improvements are needed in its communication and data collection and the whole European system and processes for gathering and analysing data where concerns arise.

Lessons need to be learnt by the MHRA, the Department of Health and the wider system so it can uncover problems early, be better placed to take robust action and provide clarity for the public should anything like this happen in the future.

An eleven-year-old girl has been awarded around £11 million in compensation for serious injuries she suffered at birth, reports the Guardian.

Milly Evans was born in Lincoln County Hospital. Her family claim that during labour her heart beat was not adequately monitored, and therefore medical staff did not notice quickly enough that she had an abnormal heart beat and was in distress. Milly was born with cerebral palsy and cannot speak. She will be dependent on care for the rest of her life.

According to the Guardian, the United Lincolnshire Hospital NHS Trust had admitted liability for Milly's injuries, but contested the level of damages being sought. An agreement has now been reached, and Milly will be paid a lump sum of £5.9 million and receive annual payments for the rest of her life, to help meet the costs of her ongoing care requirements.

A breast implant register, more stringent checks and product traceability, and a pre-market authorisation system are among the measures proposed by the European Environment and Public Health Committee to prevent a recurrence of the PIP defective breast implants case. The resolution was passed unanimously.

An estimated 400,000 implants made by the French manufacturer Poly Implant Prothèse have been sold worldwide. These implants were widely used in the UK, France, Spain and Germany. However, the number of women who have received them is unknown.

The resolution has called for "increased traceability of implanted medical devices", and for "increased coordination between Member States when it comes to reporting and warning about serious side effects or damage done" by these devices.

It also says that patients' associations, patient groups and health care professionals must be encouraged to report all adverse events and harmful effects of these devices without being hampered by a great deal of red tape.

The resolution asks the European Commission to introduce a pre-market authorisation system for certain medical devices and to do more to ensure patients are aware of breast implant risks.

MEPs have also called for the introduction of an implant recipient's passport, stating the implant's specific characteristics and its potential adverse effects, and the introduction of a breast implant register in each Member State. These registers should be interconnected and allow for the exchange of information when needed, for example in cases where important defects are detected in implants.

A system of collective redress should also be put in place to help patients obtain compensation when medical devices go wrong.

Tightening the law on the criminal liability of partnerships and reforming the law on unincorporated associations will be the dual focus of a recently launched UK Government consultation.
 
The Government is seeking views on proposals put forward by the Scottish Law Commission.
 
Reforming the criminal liability of partnerships in Scots law was suggested after the tragedy of the Rosepark nursing home fire in Lanarkshire in 2004 in which 14 residents lost their lives.
 
The case against the care home operators failed in the courts because of a loophole which prevented the prosecution of a partnership once it had been dissolved.
 
The proposed change would ensure all Scottish partnerships could be held to account if they commit crimes and prevent them escaping prosecution for potentially serious offences by dissolving.
 
The consultation will also look at a separate issue of attributing legal personality to non-profit making unincorporated associations where they meet certain statutory criteria.
 
Without this reform, a member of a charity, club or other unincorporated association could find themselves held personally liable for someone injured at an event it has organised, for an act for which they are not personally culpable, exposing them to personal financial risk.
 
The Commission's proposals would provide organisations with limited liability to ensure individual members or office-bearers could not be held personally liable for any damage or offence caused by the organisation as a whole.

The Consultation closes on 2nd July 2012.

Children will be exposed to greater risk of harm if important safety measures for adventure activities in Scotland are watered down, a not-for-profit campaign group has warned.

Because the existing licensing regime in Great Britain is going to be abolished, the Scottish Government is considering whether to replace it either with new regulations, a voluntary accreditation scheme or a voluntary code of practice.

“In making this important decision, the Scottish Government needs to look back on the tragedy of Lyme Bay, in England, in 1993,” said David Bott, president of the Association of Personal Injury Lawyers.

“When we consider the deaths of those four teenage canoeists, it is difficult to see how anyone could consider it right to reduce these important safety measures.”

The impending abolition of the current licensing regime, which is run by the Adventure Activities Licensing Authority was recommended by the UK Government's Lord Young of Graffham, who, in his report Common Sense, Common Safety, referred to it as an unnecessary “cost and burden on business.”

Donald Brydon, Chairman of Royal Mail Group, has announced the launch of an independent inquiry to be led by Sir Gordon Langley into the prevalence and consequences of attacks by dogs on postal workers in the UK, with the objective of making recommendations to address them.

There are between three and a half thousand and four thousand dog attacks on Royal Mail employees each year, resulting in injuries - many severe, - and considerable trauma. 

Despite significant organisational effort to control employee exposure, and an outstanding and ongoing campaign - Bite Back, led by the CWU - the number of attacks remains unacceptably high. The inquiry will look more widely than just at primary legislation and therefore will look beyond current proposed amendments to the Dangerous Dogs Act.

The inquiry will:

• seek to ascertain why so many employees are subject to dog attacks whilst delivering mail,
• consider the background and human consequences of continuing dog attacks on postmen and postwomen,
• consider existing relevant laws and regulations and the extent to which they are adequate and  enforced,
• consider any relevant actions taken by other employers in the UK or elsewhere, and
• make recommendations with a view to achieving a reduction in attacks.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated advice to surgeons that patients with a particular type of metal-on-metal hip replacement should be monitored annually for the life of the hip replacement.

This updates previous advice from April 2010 that patients with this type of hip replacement need only be monitored for a minimum of five years after their operation.

The updated advice is included in a new MHRA Medical Device Alert that has been issued to clinicians for the management of patients with these hip implants to minimise the risk of having to undergo further surgery to correct complications.

Dr Susanne Ludgate, Clinical Director of the MHRA, said:

“Clinical evidence shows that patients have a small risk of suffering complications from having metal-on-metal hip implants. These implants have in most cases completely transformed the lives of patients who in the past were subject to increasingly severe pain and progressive lack of mobility."

She went on to say that: “By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided.”

A Cardiff company has been fined for putting the health of demolition workers at risk after a building survey failed to identify the presence of asbestos.

Between 15th and 25th January 2010 PHH Environmental (UK) Ltd was commissioned to produce an asbestos survey on the soon to be demolished Old Castle Cinema in Merthyr Tydfil.

Merthyr Tydfil Magistrates' Court heard that PHH's client relied on this survey to help its demolition company plan the work. But once demolition was underway, workers discovered asbestos and found they had disturbed it.

PHH Environmental (UK) Limited pleaded guilty to breaching Section 3 (1) of the Health and Safety at Work etc Act 1974. The company was fined £5,000 and ordered to pay costs of £3,000.

HSE inspector Steve Richardson investigated the case. He said:

"Anyone carrying out refurbishment or demolition work relies upon accurate asbestos surveys to reduce the risk of them being exposed to deadly asbestos fibres. It is essential that those surveys are comprehensive, intrusive and undertaken by competent persons - if not lives are needlessly put at risk."

When asbestos fibres are inhaled they can cause serious diseases which are responsible for around 4,000 deaths a year.

In an overhaul of victims’ services, up to £50 million would be generated from offenders to help create a speedier, more supportive system for victims of serious crime.

Criminals will be forced to fund victims' support services and those with unspent convictions could be banned from claiming compensation, under new proposals announced by Justice Secretary, Kenneth Clarke.

The planned shake-up, which is now out to public consultation, includes:

• Ending payments for minor injuries such as sprained ankles, cuts and grazes and speeding up payments for serious injuries;
• Greater funding for victims' support services, better targeted at those most in need;
• Stopping criminal injuries compensation payments to people with unspent convictions - totalling at least £75million over the past decade;
• Banning criminal injuries compensation payments to people who have been resident in the UK for less than 6 months (except for UK and EU/EEA nationals);
• A simpler route of complaint and redress for victims;
• Giving new Police and Crime Commissioners a key role in deciding the priorities for local victims' services;
• Ensuring more voluntary victims' organisations have access to long-term funding.

The Government will also, for the first time, compensate British victims of terrorist atrocities abroad on the same basis as victims of terrorism in Britain. Those with ongoing disabilities from attacks after 2002 will also receive financial support.

Following recent concerns regarding French Poly Implant Prostheses implants, the Government has announced a review, led by Professor Sir Bruce Keogh, the NHS Medical Director, to look at the arrangements for ensuring the safety of people seeking cosmetic interventions such as breast implants and dermal fillers.

In addition, the Care Quality Commission is to conduct a swift review of private clinics that offer cosmetic surgery. They will look at whether they meet essential levels of safety and quality and at the information and support they provide to their patients. Where a provider does not meet these requirements, the CQC has a wide range of enforcement powers that it can use to protect the safety of patients.

Professor Sir Bruce Keogh, said:

“The safety of people who decide to have cosmetic surgery or a cosmetic intervention is my sole aim. The vast majority of practitioners in the cosmetic industry are professional and well skilled – but I’m concerned that the sector as a whole does not have the systems for monitoring the results for patients and alerting us to possible problems.

“I will work with the industry to improve regulation and governance and increase consumer confidence.”

A consultation on the development of a safety system for adventure activities in Scotland has been launched by the Minister for Commonwealth Games and Sport, Shona Robison.

The Scottish Government is considering the best way forward for Scotland in light of the UK Government's plan to replace the statutory Adventure Activities Licensing Authority (AALA) with a new voluntary code of practice.

The AALA was established in 1995 to licence caving, climbing, trekking and watersports operators after four young people lost their lives canoeing at Lyme Bay in Dorset.

The consultation seeks views on three proposals:

• Adopting the model proposed by the UK Government - this would see the current licensing regime replaced with a voluntary code of practice. This would remove the costs and bureaucracy associated with licensing but end the current inspection regime.
• Introducing a non-statutory, voluntary accreditation scheme - this would still include an element of inspection and accreditation, however, public bodies would only be able to promote and encourage compliance not enforce any scheme.
• Introducing a statutory scheme - this would see the continuation of an inspection and statutory scheme for Scotland, although an appropriate body would need to be identified to carry out its functions

Ms Robison, Minister for Commonwealth Games and Sport, said:

“The UK Government's proposed abolition of the AALA has implications for Scotland. Any safety system developed for adventure activities in Scotland would need to meet the needs of Scottish providers and users whilst being robust and proportionate."

"That's why I want to hear views on whether a statutory inspection and licensing regime should be maintained or if a new approach should be adopted and would encourage anyone with an interest to have their say on what should be put in place."

A woman from Edinburgh has been awarded compensation after slipping on a wet floor in a branch of the Royal Bank of Scotland, reports the BBC.

The 65-year-old sustained a soft tissue injury to her ankle, and was unable to work for three weeks.

The wet floor was caused by a leak coming from an upstairs flat, which had existed for a number of months. Bank staff had placed a bucket to try to catch the drips, which were falling near the area used by queuing customers.

In defending the claim, the Royal Bank tried to argue contributory negligence, saying that if the woman had paid more attention she would have seen that the floor was wet. This argument was rejected by the judge however, who said that the bank had “adopted a cavalier approach to the risk presented by the leak,” and awarded the woman £7,500 compensation.

Many of you will have read recently in the Press about the compensation claim brought by a visitor to Niddrie Golf Club against both the Golf Club itself and the member golfer whose wayward tee shot hit him in the eye.

1. Summary of Case

The golfer visiting Niddrie Golf Club, Mr. Phee, was at the time of his accident walking on a path between the 6th green and 7th tee with the rest of his group.  Mr. Gordon meanwhile (a member of the golf club) was playing off the 18th tee.  Mr. Gordon tee’d off and unfortunately hit a poor tee shot which went way off-line and struck Mr. Phee in the eye.  Mr. Gordon had apparently shouted “fore” when he realised the direction in which his ball was heading.

Mr. Phee suffered a serious eye injury and raised a compensation claim in the Court of Session in Edinburgh.  After the Hearing on Evidence, the Court decided that Mr. Gordon was 70% to blame for the accident on the basis that (a) he was over-confident and had over-estimated his golfing skill, (b) in taking reasonable care for the safety of Mr. Phee he should have waited until Mr. Phee was further out of reasonable range of his tee shot before playing his shot.  Shouting “fore” was too late:  by that time Mr. Gordon had already been negligent.  The Golf Club was held 30% liable to Mr. Phee, on the basis that it had not carried out any risk assessment ,with the result that the Club had failed to put up relevant warning signs in that area of the golf course.  Mr. Phee meanwhile was held not at all to blame.  It was believed by the Court that he had ducked to an extent on hearing the shout “fore”.  It appears however that he would not have been blamed at all by the Court even if had he instinctively looked up in reaction to the warning.

2. What are the legal implications for normal Club Golfers?

This case is a timely warning to golfers.  I suspect virtually all golfers have in the past taken the decision to hit shots on several occasions when other players have been well within range of the shot, particularly if the shot was badly hooked or sliced.  Sometimes it is golfers ahead or golfers playing adjoining holes who are in range, but of course it is the golfer’s own playing partners who are closest and most obviously at risk.  All golfers have  a duty to take reasonable care when playing.  In analysing whether or not a golfer has taken reasonable care, the Court  will look carefully at the whole surrounding circumstances including (a) the distances and angles between the golfer and others, (b) the level of skill of the golfer, (c) the terrain of the course, and (d) the extent to which other people (including fellow golfers, groundsmen and members of the public for example on public paths or nearby roads) were within a reasonable distance of both the intended line of the shot and of shots veering off the intended path. 

In my view the only safe approach from a legal point of view is for golfers to be extremely vigilant, patient and as careful as possible on the course.  If in any doubt, the golfer should wait an additional period of time before hitting a shot, to ensure all others are completely out of range, whether it is other golfers, groundsmen working on the course or members of the public walking across the course or on public paths or driving on nearby roads.

3. What about Personal Insurance cover?

As can be seen from the liability incurred by Mr. Gordon to the unfortunate Mr. Phee, liability of golfers to third parties can arise at any time during a round of golf.  Furthermore, due to the nature of the game, injuries can be severe and potential liability can therefore be for a large five or even six figure sum, as was the case with Mr. Gordon’s liability to Mr. Phee.

As a result, all golfers would be well advised to ensure they have adequate personal insurance cover against potential liability.  You might wish to check with the Secretary of your own Club, as the Club’s own employers’/public liability insurance policy may extend to cover your own personal liability to third parties when playing golf. You should check carefully as to whether the terms of any such Club insurance cover provides a sufficient level of cover for you.  For example, this insurance cover could well be restricted to covering you playing on your own particular course only.  It might well not extend to cover you playing away from your own Club.   Note also that if you golf abroad, it is unlikely that the Golf Club insurance policy provides you any cover at all.  Your own travel insurance policy may or may not provide adequate cover. 

The simplest and safest way overall may well be to consider taking out your own personal golf insurance policy.  There are several insurers I understand offering a policy at a premium cost.

4. What about the legal position of Golf Clubs?

(a)    Duty of care of Golf Clubs

As can be seen from the attached case report, Golf Clubs have a duty to take reasonable care to ensure that no-one is injured by reason of the layout and condition of the golf course under their control.  Golf Clubs need to carry out a formal and comprehensive risk assessment on a regular basis of the course and assess the dangers to golfers and others created by their course.  Such an assessment should in turn lead to all reasonable steps being taken to prevent injuries to golfers, groundsmen, and members of the public. Common safety measures will include warnings signs on tees and on pathways between holes which are in range of tee shots and other general play, and also installation of bells for golfers to ring when reached, for example, when players behind have a “blind” shot.  Often the layout and alignment of holes need to be altered to reduce risk of injury to golfers and the public.  Fences are commonly put up to protect adjoining roads and properties.

Particular consideration needs to be given to dangers created by man-made hazards on the course.  An example of a man-made danger which I believe is often overlooked by Golf Clubs is the danger created on fairways by winter holes on temporary greens.  If these are not in use I believe they should be filled in, roped off or clearly signed.    Golf buggies are a more common sight on courses, many of which are hilly and not originally designed to cater for them.  Golf Clubs need to be careful here.  Are routes for buggies properly sign-posted?  Are potentially dangerous areas clearly marked?  Are bridges wide enough and do they have raised edges?

(b)     Can Golf Clubs by sued by their own members?

The answer depends on the way in which the Club is constituted.  If the Club is a traditional form of Club (an unincorporated society or association) then the answer is no.  This is because a member claiming against such a Club is from a legal point of view effectively suing him or herself.  In these circumstances a member could also not sue the Club trying to hold them liable for the negligence of an employee or servant of the Club who caused injury, and would be able only to sue the negligent individual personally.  Such a claim might or might not be covered by the Golf Clubs’ employers’ liability insurance. 

If on the other hand the Club is formed as a Limited Company, then it has a separate legal personality and can be sued by its own members.  A Club in these circumstances can also be held liable to the members for the negligence of its employees and servants. 

Note that visitors to a Golf Club can always sue the Club he/she is visiting as well as the golfer or negligent employee personally, as did Mr. Phee in the attached case. Here it does not matter how the Club is constituted.  

My fellow Litigation Partner, David McElroy and myself will be only too pleased to answer any queries on your behalf regarding the above or with regard to any personal injury compensation claim.

Gordon Bell
Partner and Law Society Accredited Specialist in Personal Injury Claims
Tel 0141 333 6750

As part of its Eighth Programme of Law Reform, the Scottish Law Commission conducted a short-term project on partnership criminal liability, the results of which have now been published in the Commission's Report on the Criminal Liability of Partnerships.

The project was prompted by the failed prosecution following the fatal fire at the Rosepark nursing home in 2004. The nursing home was run by a partnership, which was dissolved after the fire, and attempts to indict the dissolved partnership, and/or the members of it, in relation to the causes of the fire were unsuccessful. It became clear that the traditional concepts of the law of partnership did not fit easily into the modern regulatory structure within which many of these organisations operate.

The Commission's report addresses this problem and recommends that it should remain competent to prosecute a partnership during a period of five years following its dissolution.

The Report also includes a draft Bill which would give effect to its recommendations.

In 2003, the Scottish Law Commission and the Law Commission published their joint report on Partnership Law. This recommended comprehensive reform of the law of partnership, including the circumstances and effects of dissolution. The Scottish Law Commission's preferred long-term solution to the issue identified in the Rosepark case would be the implementation by the UK Government of the recommendations in the joint report on Partnership law.

A woman from Norfolk has been awarded over £9 million in compensation for injuries she received as a child, reports the BBC.

The woman, who is now aged 23, was hit by a car at the age of seven. She almost died as a result of the accident, and suffered severe brain damage that altered her personality and left her needing the constant supervision of two carers.

The insurers of the car driver had been found liable, and the woman has finally been awarded a lump sum of £2,875,000, plus index-linked annual payments of £191,758 for the rest of her life.

A housebuilder has been fined £20,000 after a young boy was seriously injured when some timber roof trusses fell onto him.

The eight year old boy was playing with friends when they got into an unsecured storage area on a construction site near Paisley. The development was nearing completion and the housebuilder, BDW Trading Ltd, had sold some of the finished houses and there were people living in them while work continued on the remaining homes. The young boy and his family had moved into one of these new houses.

As the children were playing in the storage area, some timber roof trusses fell onto the boy, trapping him underneath.

The boy sustained a serous injury to his liver and had abdominal bleeding, and was kept in hospital for eight days. In the months following the incident, he developed a number of anxiety-related symptoms such as nightmares and poor concentration.

An investigation by the Health and Safety Executive (HSE) found that the construction site was only partially fenced, and as a result there was a large gap at the side and rear which meant that the site could be easily accessed by members of the public, including children.

The investigation also revealed that the roof trusses had, at some point, been stacked upright which made them unstable and more likely to fall over.

After the hearing, HSE Inspector Gerry McCulloch said:

"BDW Trading Ltd knew that families were living right next to of the construction site, and as such the safety of children should have been a primary consideration.

"If the company had taken the straightforward precaution of fencing off the construction site, the children would not have been able to get into the area and this young lad would not have received potentially life-threatening injuries."

A Fatal Accident Inquiry (FAI) has found that the death of a woman who fell down a mineshaft might have been avoided if emergency services had rescued her sooner, reports the BBC.

The 44-year-old woman had fallen down the disused shaft in East Ayrshire in 2008. She suffered severe injuries to her chest area and was hypothermic, but her rescue was delayed by the fire service for around six hours because of health and safety concerns. She suffered a heart attack and died as she was finally being brought to the surface.

According to the BBC, the Sheriff leading the inquiry said that the woman's death may have been avoidable if the rescue services had taken a number of "reasonable precautions."

A golfer has been awarded just under £400,000 in damages after he lost an eye in an accident on a golf course in West Lothian, reports the BBC.

The 44-year-old had been walking from one hole to the next when he was hit on the head by a ball struck by a golfer on the 18th tee. The impact caused so much damage that he now wears a prosthetic eye.

Anthony Phee sued both the golfer responsible for hitting the ball and Niddry Castle golf club for damages. The defendants had claimed contributory negligence, saying that Mr Phee looked up when he heard the shout of 'fore', however the judge rejected this and instead accepted evidence that Mr Phee had tried to shield his head. He ruled that the golfer hitting the ball was 70% liable for the accident, and the golf club 30% liable.