Editorial: Applications for Service of Claim Form - Aidan Ellis, Temple Garden Chambers

31/07/18. CPR 7.5(1) requires a claimant to serve his / her claim on the defendant within four calendar months of the date of issue of the claim form. Where claims are approaching limitation, this effectively gives the claimant a bonus of four months in which to investigate and perfect the claim. In personal injury claims, for example, the four month period can be used to obtain the necessary medical or other expert evidence.

That can be frustrating for the defendant. First, it means that the third anniversary of an accident does not bring any certainty to the defendant, who must instead wait a further four months to see whether any claims have been issued. Second, it alleviates any pressure on the Claimant because the evidence can be considerably improved in that four month window.

A potential remedy is offered by CPR 7.7 which provides that where a claim has been issued but not yet served, the defendant may serve a notice on the claimant requiring service within 14 days and, if service is not forthcoming, may apply to the court which may dismiss the claim or make any order it thinks just. There is surprisingly little jurisprudence on the application of this provision. Perhaps that is because it is unlikely that the many claims would be dismissed as a result of this provision; where the claimant is simply taking advantage of the additional four month period permitted by the Rules it is unlikely to be just to dismiss the claim. Applications under this rule are likely to be stronger where there is an extensive history of correspondence, where no defined case has been formulated pre-action or where there is a significant delay on the claimant’s part which is likely to be hard to justify. In appropriate cases, it may be beneficial for defendants to make greater use of this provision in order to discover whether proceedings have been issued, to flush out the claimant’s pleaded case and expert evidence at an earlier stage or simply to try to deny the claimant the uninterrupted indulgence of an extra four months to formulate the claim.

Aidan Ellis
Temple Garden Chambers

Image ©iStockphoto.com/serggn

Metal on Metal hips and the Consumer Protection Act 1987 (Part Two) - James Bell, Hodge Jones & Allen

27/07/18. The statistical data arguments

The recorded 10-year CRR for the Pinnacle Ultamet Prosthesis in the NJR is 13.98% - which more than double the CRR in the NJR for all external comparators, including the latest and best MoP hips .This was described as the “high water mark of the claimant’s case”.

The 13.98% figure was over three times greater than the 4.18% failure rate for the best MoP hips in the 2017 NJR report.

But the next question was how much reliance could be placed on the figure of 13.98% in the NJR database as a true measure of the risk of revision of the Pinnacle Ultamet?

The court found that the 13.98% revision rate had been skewed due to the 2010/2011 “toxic hip” media panic. This hysterical media coverage was identified by the court as having had a very substantial effect on the revision rate of the Pinnacle hip.

The court found that “media reports of possible adverse consequences from MoM protheses had the potential to cause a so-called “nocebo” effect in some patients, whereby the expectation of symptoms becomes self-fulfilling. This could manifest itself in heightened anxiety, causing patients to monitor themselves more closely, and in patients noticing and remembering symptoms that they might otherwise have missed or disregarded. It could also lead to a subjective perception of increased pain and/or a loss of function; a misattribution of pain; and/or an increased willingness on the part of some patients to seek help, or to consent to revision surgery.”

Even worse, there was a ‘nocebo’ effect on the surgeons also – who were often quick to revise hips in 2010/2011 due to the fear of what damage could be caused by cobalt-chrome debris in an unrevised MoM hip. Accordingly, if a patient developed somatic pain as a result of reading the adverse media coverage, and reported it to their surgeon, it might well be enough to convince the surgeon, particularly an ultra-cautious one, to perform a revision.

Ironically, the design of the Pinnacle modular system which made it relatively straightforward to swap the head and/or liner also had a part to play in this.

Also four “outlier” surgeons were identified as being surgeons who had been very cautious indeed with their patients and had revised their patients Pinnacle hip patients at an early stage on a very frequent basis. The “surgeon outlier” effect alone would suggest that the Pinnacle had a CRR of somewhere between 10% and 11% rather than 13.98% as alleged.

Additionally the Pinnacle hips were designed for younger, active patients (i.e allowing for a good range of movement). The NJR also contains data for hip devices designed for and implanted into older, more sedentary patients that will almost certainly remain in situ for the patient’s entire lifetime.

The relevance of the 10% failure rate is that National Institute for Health and Care Excellence (NICE) guidance in April 2000 stated:

“Using the most recent available evidence of clinical effectiveness, the best prostheses (using long term viability as the determinant) demonstrate a revision rate (the rate at which they need to be replaced) of 10% or less at 10 years. This should be regarded as the current “benchmark” in the selection of prostheses for primary Total Hip Replacement”.

But note that this was a benchmark for NHS surgeons– not a line upon which a product either should be labelled either as “defective” or “not defective”.

The figure of a CRR of 10% at 10 years took no account of the higher failure rates for implants in younger and more active patients.

The judge found that it “did not follow that a hip prosthesis that turned out to have a higher failure rate at 10 years than the target set by NICE fell below the entitled expectation of safety, even if the aim for the future was that clinicians working in the NHS would select for use the best prostheses….”

The judge ruled that if a product had a failure rate of 12% or 13% at 10 years that would not necessarily make it “defective” as defined by the CPA 1987. But the court suggested that “…if hip product A failed at 50% within 10 years because of some common characteristic that caused them to fail, and at least 90% of all other types of prosthesis that were available at the time that product A came on the market would last for 10 years or more, one could more easily reach the view that prosthesis A not only failed to meet performance expectations but also fell below the standard of safety that the public generally was entitled to expect.”

The engineering case

Finally, it was alleged by the claimants that there were design defects with the Pinnacle product. This was dealt with very briefly in the judgement. The judge found that “the Pinnacle system, taken from the evidence as a whole...was a well-designed product with many positive engineering features”.

At the start of the trial, the claimants relied upon expert engineering evidence that criticised various design features of components used within the Pinnacle system. Some of these criticisms turned out to have been based on a mistaken factual premise and were withdrawn. Those that remained were dismissed. The claimant’s engineering expert, Professor Gill was found to have given evidence, which “…when taken at face value, was seriously misleading.” The judge also commented that he did not have “any confidence in him as a reliable independent expert”.

The lead claimants

The medical records of six lead claimants were reviewed as part of the trial. These were patients who had their Pinnacle hips revised. Their case were analysed in close detail and four of the six were found to actually have not suffered ARMD, their hips having being revised based on an abundance of caution. This probably indicated to the judge the unreliability of using NJR data on wider scale.

What lessons can be learnt from this litigation?

It is not enough to assert that the harm produced by a product is in fact the defect complained of. The judgement ruled that the claimant’s argument (the propensity to cause ARMD being the defect) taken to its logical conclusion essentially meant that all MoM prostheses would be deemed defective, irrespective of design or the amount of metal debris they produced. Further, no manufacturer would be able to avail themselves of the development risk defence because the risk of metal debris was a known one.

A product has to be very much worse than comparator products before it can be defined as defective. A few percentage points worse over a period of 10 years is not enough.

This case has also shown the limitations of using national hip registers to win a legal case. Simply relying on bald CRR data alone cannot of itself prove that a hip prosthetic is defective unless the failure rate is much much higher than similar products.

The Pinnacle hip simply cannot be said to be defective product on the evidence available. It is not performing as well as a new hip prosthesis available in 2017 but of course hindsight cannot be part of the assessment of safety under the CPA 1987. As of 2002, when it was released to the market, the Pinnacle was performing broadly in line with the standards of the time. The product was judged on the standards applicable upon its release in 2002 – not the standards of 2013 when it was withdrawn from sale.

Also, it was simply not a provably bad product according the NJR and SHAR data collated over its market lifespan in the years 2002 – 2013. The NICE benchmark of a 10% risk of CRR over 10 years is nothing more than that - a benchmark. The NJR is not meant to be used a legal measure of defectiveness for the purposes of CPA 1987.

I would suggest that in order to win a defective hip or knee prosthetic case the claimant must to be able to prove that the device is very demonstrably poor according to NJR or SHAR data. Also, even in such cases, a suitable allowance must made for a large portion of the data to be deemed to be corrupt by the trial judge.

In future cases, the claimants will also need to show, with robust engineering evidence, that there is an identifiable design or manufacturing defect that has caused the harm alleged. Identifying the harm that has been caused as the defect complained of is not sufficient.

Ide v ATB Sales Ltd [2008] EWCA Civ 424 makes clear that this evidence of failure does not have to be beyond reasonable doubt clear cut evidence of negligent manufacturing. But there must be a good explanation of the mechanism of failure that is readily understandable and logical, backed up with good expert evidence with all other possibilities of non-defective failure excluded.

James Bell is a partner in the medical negligence team at Hodge Jones & Allen Solicitors.

Image ©iStockphoto.com/studiocasper

No Advocacy, then no Advocate’s Fee in fixed Recoverable Costs Cases - Elaine Pitt, Keoghs

24/07/18. Jean Crawshaw v Alfred Dunhill Limited

County Court Sheffield, 16 November 2017 before District Judge Bellamy

Background

Whilst attending a golf tournament, the claimant tripped over unmarked cables and sustained injury. A claim was intimated against the organiser of the event and it became necessary to issue a pre-action disclosure application. In the event, the documentation was disclosed and so the application was resolved without the need for a hearing.

Upon settlement of the claim, an issue arose as to the appropriate costs of the PAD application.

The Issue

The Court of Appeal had already determined in Sharp v Leeds City Council [2017] EWCA Civ 33 that the fixed costs regime applies to PAD applications and so Type A/B costs at Table 6 applied. The issue was whether the claimant was entitled to recover “advocates costs” where no advocacy had been required.

The Rules

CPR 45.29H (1) provides that the fixed costs of an interim application shall be for a sum equivalent to one half of the applicable Type A and Type B costs in Table 6 or 6A, which costs are defined at CPR 45.18(2):

Type A costs are the legal representative’s costs and are fixed at £250

Type B costs are the advocate’s costs and are fixed at £250

The term “advocate” is defined at CPR 45.18(3) as “a person exercising a right of audience as a representative of, or on behalf of, a party”.

Outcome

The court found that, there having been no advocacy, there was no entitlement to an advocate’s costs. The court agreed with the defendant’s submissions that:

• The word “applicable” in CPR 45.29H(1) would not be needed if the rules intended A and B costs to be recoverable in every case.

• The rules would simply provide for one fixed fee to cover all applications if that was the intention.

• Legal Representative’s costs and Advocate’s costs have been intentionally separated

• In Sharp – referred to above – the Court of Appeal awarded only Type A costs in identical circumstances

• The separation of legal representative’s and advocate’s costs incentivises parties to settle – were there not a reduced cost attached to doing so, there would be no such incentive.

Comment

This commonsense decision saw an end to claimants seeking to rely on an earlier and much publicised (and much criticised) decision in Skowron v Rollers Roller Disco, where Type A and B costs were awarded in these circumstances.

Elaine Pitt
Keoghs

Image cc flickr.com/photos/jurvetson/5314774452