Prosthetics and Osseo-integration

A bit of background

Approximately one million amputations are reported around the world each year. As at 2017, 57.7m people globally have been living with traumatic amputation¹. One US lawyer’s website suggests that “at least” 30,000 traumatic amputations occur in the USA every year².

Amputations can be necessary due to illness/disease as well as trauma. A study of the incidence of lower limb amputation in patients aged between 50 and 84 in England found that, between April 2003 and March 2009, there were 25,312³.

The number of patients with either amputation or limb deficiency attending specialist rehab centres in the UK is estimated to be between 55,000 and 60,000, costing about £60m a year⁴.

Prosthetics

The cost of dealing with amputation claims has risen enormously over the last 20 years and this has largely been driven by advances in prosthetic hardware and the systems which control them. They have become more lightweight, easy to operate, adaptable, multi-functional and, last but not least, expensive. An entirely non-systematic search on Google produced no fewer than 28 different companies ranging from well-known providers such as Ottobock to small start-ups in the USA, so the market is there.

By way of an example Ottobock makes the Michelangelo bionic hand, which is controlled by signals from the user’s brain. This has been fitted to a an injured person in the UK and, according to the Healthcare Global website, cost £47,000.⁵ The LUKE arm system is a modular arm/shoulder available in the USA⁶ which has been pleaded at a cost of £242,000 per 5 year cycle.

It is almost inevitable that a claim for privately-funded prosthetics will be made, rather than via the NHS. The claimant is likely to be able to obtain a technologically more advanced prosthetic via the private route and the availability of cosmesis privately is also an attractor. In law, the claimant is not restricted to seeking support from the state and is able to recover the cost of a privately-funded prosthetic (and its replacements over time) so it is not difficult to see why a claimant would go down this route. The cost of all this pleaded in a schedule of loss will add considerably to the overall cost of settling the claim.

A few cases highlight the issues:

M v T (2014) (Settlement)

This case is an example of how need drives damages. The final agreed figure for prosthetics was £1.6m.

The claimant (C), 28 year-old male, suffered an above knee amputation. The most significant issue between the parties was the value of the prosthetic limbs C said he required. C claimed for 14 different prosthetic limbs including on and off-piste ski limbs, on and off-piste snowboarding limbs as well as limbs for mountain biking, rollerblading, swimming and running. The total claim for future prosthetics came to £1,957,811. In addition there was a claim for ancillary costs including liners, sleeves, on piste prosthetic adjustment, travel to prosthetic appointments and so on totalling £917,366. In response D allowed £1,032,105 for future prosthetics and £77,317 for future ancillary prosthetic costs. Whilst the claim for the BiOM iWalk was eventually agreed between the parties' respective prosthetic experts (replacing a standard ADL limb), there was a significant dispute regarding the remaining prosthetic limbs. D argued that C would not be able to maintain so many limbs. In response C called evidence from his treating prosthetist who confirmed that he thought he could maintain at least 10 prosthetic limbs and that C was very keen to return to as many of his previous sporting activities as possible.

Tomasz Zagdanski v City Scrap Ltd (2015)(Settlement)

C suffered a traumatic amputation when his arm was caught in rollers on a conveyor belt. This was a case in which C was advised he was a candidate for a new bionic arm and TMR procedure . He was awarded £1.75m including £110,000 for PSLA. This case is an example of how “eye-catching” technology can drive cost in these claims.

Swift v Carpenter [2018] EWHC 2060 (QB)

You will all know of this case because of the subsequent appeal of the first instance decision relating to accommodation claims. In fact all but the damages for accommodation costs were decided at first instance. Agreement to an overall lump sum award was upheld by the judge rather than a lump sum and PPO. C had suffered crush injuries to both feet and lower legs. She underwent a left below knee amputation. The right leg and foot were retained, although she suffered from stiffness and pain. The judge awarded a total of just under £4.1m including £913,299 for aids and equipment, including a “daily” prosthetic limb, a water activity limb and a sports activity limb among other items. C’s successful appeal on the capital accommodation question added another £801,913 net.

Osseo-integration (direct skeletal fixation)

This is the scientific term for bone ingrowth into a metal implant. An artificial implant is permanently, surgically anchored and integrated into bone, which then grows into the implant. The process involves gradual and increasing loading of the implant after it is fitted before any prosthesis is attached.

The advantages of osseo-integration are, according to the HSS website:

• improves mobility (control of the prosthetic leg);
• improves proprioception (awareness of the position of the limb in space);
• reduces nerve pain;
• eliminates common problems associated with sockets, e.g.
  • pinching;
  • sweating;
  • poor fit or need for frequent refitting;
  • poor ability to control the prosthesis;
  • lack of patient confidence due to mobility challenges;
  • nerve pain;
  • skin, irritation, sores and ulcers.

Having said this, there are limitations placed upon the recipient:

• They must have reached full skeletal maturity (between age 20 and 69);
• They must weigh less than 100kg;
• Must be a non-smoker;
• Absence of vascular disease;
• No history of osteoporosis;
• The residual stump must be longer than 16cms;
• No significant pre-existing conditions;
• Not on anti-coagulant drugs;
• No significant psychological issues.

Even if all that looks OK, there are disadvantages to the procedure:

• Time from consultation to surgery is over a year;
• Transhumeral (above elbow) amputee cases take longer because they are usually more complex;
• The rehab for lower-limb patients takes over a year;
• For upper-limb patients it is even longer, up to two years.

The cost of the surgery is between £40,000 and £80,000, with extra cost for the “interface” components which need to be replaced typically every 2-3 years and the rehab following. It is not available on the NHS as yet; two private centres operate in the UK.

Due to the cost it is perhaps unlikely that the NHS will ever elect to provide such surgery and the procedure is unsuitable for many, so the take-up may continue to be low as well.

Valuation

The JC Guidelines contain several sections relating to damages for injuries causing or necessitating actual or potential amputation, but they are not always clearly indicated. The following tables compiled from entries in Chapter 7 of the JC Guidelines, 16^th edition, bring all the disparate entries together.

Upper limbs:

Lower limbs:

Tactics

• In terms of expert evidence, the opinion of a consultant in rehab medicine/orthopaedic surgeon and a prosthetist will be needed to examine what is being proposed on behalf of the claimant.
• It is necessary to understand the technology and the difference it can potentially make to the claimant.
• Obtaining research papers is important – what is the evidence base for the items being claimed for?
• Where appropriate, challenge the number of prosthetic limbs/replacement cycles/period of use. The question for the defence is whether the claimant is claiming for something that he or she will never actually use. This is a difficulty for the defendant: the court will usually take the view that, if the evidence is that a particular prosthetic will improve the injured party’s life, the award should be made, within reason.
• Identify the reducing effect of provision of prosthetics on future care/earnings claims.
• Bear in mind the provisions of the Serious Injury Guide and remember that the object of the exercise is as set out in Wells v Wells – i.e. full compensation of the claimant.

Next issue - Dealing with spinal injury claims.

If you would like any assistance in dealing with amputation claims, please contact a member of our Complex Injury Team.

¹ https://www.physio-pedia.com/Amputations

² https://www.swoperodante.com/traumatic-amputation-injuries-causes-stats/

³ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4265106/

⁴ https://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-d/d01/prosthetics-review/

⁵ https://healthcareglobal.com/technology-and-ai-3/ground-breaking-bionic-hand-fitted-uk

⁶ https://www.mobiusbionics.com/luke-arm/