Pinnacle MoM Hips (Part 3)

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Hip Replacement - used with the permission from www.mayoclinic.org
(Hip Replacement Surgery Used with permission of www.mayoclinic.org)

The Patient’s Complaint

Case studies, including this one, help us understand how the Courts have interpreted and applied law, to resolve real world disputes – creating precedents that may be followed in the future.

Depuy developed the Pinnacle metal on metal (MoM) hip, for younger and more active patients needing a ‘robust and durable’ hip replacement, as the result of traumatic injury or osteoarthritis.

Although most of the patients who received the Pinnacle MoM hip were pleased with them, a significant minority – including Ian Haley – developed an Adverse Reaction the Metal Debris (ARMD), as their immune system reacted to metallic wear particles from the hip’s bearing surfaces.

In 2018 a group of 312 patients, including Ian Haley, sued Depuy in the English High Court for compensation, claiming that they were harmed because the Pinnacle MoM hip was ‘legally defective’. So, what can learn from how they presented their case?

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Pinnacle MoM Hips (Part 2)

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Hip Replacement - used with the permission from www.mayoclinic.org
Hip Replacement Surgery (Used with permission of www.mayoclinic.org)

The Patient’s Experience

When delivering product liability training we use case studies help develop people’s understanding of the law, showing how it applies in the real world of product design, manufacturing and marketing.

My last post discussed the design and development of Depuy’s range of artificial hips, including the Pinnacle metal on metal (MoM) hip. Introduced to the market in 2000, the Pinnacle MoM hip was designed to be more robust and durable than alternative designs – making it suitable for younger and fitter patients with a more active lifestyle.

Sadly, the Pinnacle MoM hip’s real world performance was worse than predicted in laboratory tests, and it was withdrawn from the market in 2013.

By 2018 Depuy faced 312 claims for compensation from dissatisfied patients in the UK, who had suffered an Adverse Reaction to Metallic Debris (ARMD) – or wear particles – from the hips’s bearing surfaces. Their claims were heard in the High Court under a Group Litigation Order (GLO) by the Honourable Mrs Justice Andrews, and her written judgement reviews the medical history of the six lead claimants- including Mr Ian Haley

The Patients’ Experience

In 2005 when Ian Haley took early retirement from his job as an operations manager, aged 59, he was looking forward to a long and happy retirement on the golf course. He enjoyed playing golf most days, but had some pain and discomfort in his left hip – which got steadily worse. By 2007 the chronic pain in his hip had become unbearable and he was referred an orthopaedic surgeon in Darlington.

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Pinnacle MoM Hips (Part 1)

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Product Liability Case Study

Hip Replacement - used with the permission from www.mayoclinic.org
Hip Replacement Surgery (Used with permission of www.mayoclinic.org)

Design and Development of Pinnacle Hips

Depuy, now owned by Johnson and Johnson, developed the Pinnacle range of artificial hips for patients debilitated by osteoarthritis or traumatic injury. The Pinnacle design is a modular system, allowing surgeons to build the hip joint for each patient, using a selection of different bearing materials and components – rather like a medical Meccano kit

Key features of the design included:-

  • A CORAIL stem inserted into the the patient’s femur, with cemented and uncemented options
  • At the top of the stem, a ball and socket joint with a choice of different bearing materials, including a metallic or ceramic ball (femoral head) with a metallic, ceramic or plastic lined socket (antebellum). Allowing surgeons to select from of the following types of bearing;–.
  • Metal on Metal (MoM)
  • Metal on Plastic (MoP)
  • Metal on Ceramic (MoC)
  • Ceramic on Plastic (CoP)
  • Ceramic on Ceramic (CoC)
  • When using a plastic or ceramic lined socket, the surgeon could select a 28 mm or 32 mm diameter ball, but a larger 36 mm diameter ball was used with the thinner metallic liner – giving a larger bearing area.
  • In some circumstances, the modular design also allowed the artificial hip joint to be repaired, rather than replaced, if it was damaged.

The target market for the Pinnacle MoM hips included patients who were unsuitable candidates for other older or weaker designs of hip, due to their age, life style or weight. From a design point of view these more demanding patients presented particular challenges with:-

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Judicial Precedents – Examples From the Past

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Judicial Precedents are examples from the past, showing how Judges have interpreted and applied the law in similar circumstances. To make sure the law is applied consistently, judges are required to consider relevant examples – or precedents – when making their own Judgements.

Written Judgement of The Court

So lawyers will search the legal archives looking for previous cases, that they can use as examples to persuade the Judge to rule in their client’s favour. The Judge will be asked to consider, and perhaps reconcile, different interpretations of the Law, or technical arguments found in precedents drawn to their attention.

At the end of the Trail, if the case goes that far, the Judge will produce a Written Judgement reviewing the evidence and arguments presented to them, and explaining how they reached their judgement. Their analyse and interpretation the Law will provide a new precedent, or example that other lawyers can use in future.

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Punitive Damages – to Punish and Deter Wilful Negligence

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Following recent judgements against Monsanto in US Product Liability Cases, we need to understand why the damages were so large – and perhaps more importantly learn how we can avoid similar penalties.

Roundup - glyphosphate base herbicide
ROUNDUP is a glyphosate-based Herbicide – supplied By Monsanto

Facts of The Case

Monsanto, now owned by Bayer AG, have been selling glyphosate-based  herbicides under the ROUNDUP brand name since 1974. On it’s website and in their marketing literature Monsanto claim:-

Glyphosate-based herbicides are supported by one the most extensive worldwide human health and environmental effects databases ever compiled for a pesticide product. Comprehensive toxicological and environmental fate studies conducted over the last 40 years have time and again demonstrated the strong safety profile of the widely used herbicide


https://monsanto.com/app/uploads/2017/07/Glyphosate-benefits-and-safety_public-FINAL.pdf

However, amid growing public concern that powerful herbicides such as ROUNDUP may have undesirable side effects – Monsanto have mounted a vigorous public relations campaign to defend their brand against ‘activist and campaigners’

Monsanto now face over 4,000 claims from people in the USA claiming that exposure to  ROUNDUP has caused various cancers including Non-Hodgkin Lymphoma (NHL).

The first case to reach trail concerned DeWayne Johnson,  a 46 year old groundsman employed by the Benica unified school district in California – a frequent user of Monsanto’s Roundup products from 2012 until late 2015 – who was diagnosed with Non-Hodgkin lymphoma in 2014.

By the summer of 2018, when the case reached trial, Dewayne’s life expectancy was months rather than years – and 80% of his body was covered with lesions.

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Case Study;- Swindon Bus Crash (3 January 2018)

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Swindon Bus Shelter Demolished by Bus

What happened?

On 3 January 2018, a local bus crashed into and demolished a bus shelter on Flemming Way, when the driver lost control as they prepared to move away from the stop. More by luck than judgement, nobody was killed or seriously injured – but the incident provides a useful case study to explore how Product Liability Law works.

By chance I was working in Swindon on the day of the accident – which occurred at the end of the evening rush hour. Walking back to my hotel after delivering a Product Liability Training Course, I arrived on the scene as the recovery crews were starting work. So, as a ‘curious onlooker’, with no role in the investigation – let me share my thoughts with you.

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GDPR Compliant Privacy Policy

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As our new website developed by Deeper Blue will going live this month we have spent some time reviewing and updating our Privacy Notice to ensure that we are compliant with the new GDPR, and our updated Privacy Notice is available here

If you have any questions or comments about this, please get in touch

 

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Improving Problem Solving Capability

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Problem Solving is an Essential Skill

The importance of ‘Problem Solving’ and the ‘Continuous Improvement Process’ has been recognized by quality improvement experts, and management gurus for many years – including Phil Crosby  and William Edwards Deming.  But in the real world of industrial production and management, effective problem solving remains the exception rather than the rule, as managers and political leaders tolerate, or encourage, ‘short-term fixes’ rather than grappling with the underlying causes of our current difficulties.

Phil Crosby set out some basic principles for a problem solving culture, when he argued that:-

  • Quality is Conformance with the Requirements
  • The standard is Zero Defects
  • The measure is the Price of Non-Conformance
  • The method is Prevention
  • The process is Continuous Improvement

Crosby focused on the hidden price of non-conformance to drive continuous improvement, while Deming focused on the use of statistical tools and techniques to identify, control and eliminate the sources of variation in product design and manufacturing. However, Crosby and Deming agreed that there are no prizes for doing the wrong thing more efficiently than your competitors, so we must understand ‘added value’ and market requirements in order to eliminate waste or muda and reduce reduce the price of non-conformance. (more…)

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Experts in Civil Litigation

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When do you need an expert?

If you are involvedPreston Law Centre in a dispute that can not be settled quickly by negotiation, you may be forced to contemplate ‘Legal Action’ – perhaps to obtain compensation or enforce an agreement or contract with your supplier or client. Although you may be convinced that you have a ‘strong case’ based on the ‘known facts’, rushing into Legal Action should be avoided – because the process may prove very time consuming and expensive while causing irreparable damage to your business and personal relationships.

If however, you are contemplating or involved in legal action, you will need to obtain advice from a qualified solicitor who will explain the legal process, and advise you how to proceed. (more…)

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