Smarter Regulation? Delivering BREXIT…..

Britain has chosen to reassert it’s sovereignty by leaving the European Union, – rejecting the rules and regulations created by unelected bureaucrats in Brussels, – to resume our rightful place as global leaders. But, BREXIT like a messy divorce – is a painful process – with an uncertain outcome.

While the Leave Campaign successfully portrayed the European Union as the problem, they avoided proposing a consistent vision of the desired end state. Instead, they offered voters many alternative – carefully targeted and personalized – visions of Britain’s future.

So, the spectrum of BREXITs proposed included;-

  • A deregulated Singapore on Thames, in which Corporation’s are unrestrained by the burden of regulation. A vision that today underpins proposals for Freeports and Charter Cities – free to set their own rules without Parliamentary interference or democratic scrutiny.
  • Through to….
  • A member of European Free Trade Association (EFTA), with full access to the Single Market, based on mutual recognition of Technical Standards and Product Approvals – like Norway or Switzerland. A form of BREXIT-Lite for those opposed to more radical change.

The deliberate ambiguity of the leave campaign secured 17.4 million votes (51.8% of votes cast) – without a mandate for any particular version of BREXIT – or understanding of it’s practical consequences, even among it’s supporters.

In the political chaos following BREXIT, political drama has distracted attention from the practical consequences of the Policy Decisions and our lack of Strategic Thinking, allowing pragmatic analysis to be dismissed as ‘Remainer Nonsense’ or even worse an ‘Expert Opinion’.

As the intended and unintended consequences of BREXIT start emerging, it’s supporters protest that we have not got the ‘Brexit we were promised’.

So, BREXIT campaigners, like John Longworth claim that:-

Truth is however the Gov & Remainer Parliament have failed (deliberately) to take full advantage of Brexit – Deregulation, business tax cuts, tariff cuts & sourcing outside the EU for example. Best yet to come.

John Longworth on Twitter 21 August 2023

Against this backdrop, the Office of Product Safety and Standards (OPSS) are trying to redesign the UK’s system of product regulation – and our ‘consumer rights’ – if products don’t meet our expectations, or are unsafe.

Following a Call for Evidence in 2021, the OPSS have launched a public consultation – Smarter Regulation: UK Product Safety Review – asking for feedback on their proposed strategy. So, if you have any ‘skin in the game’ as supplier or consumer, you need to respond to the consultation, which closes on 24 October 2023.

Shaped by the BREXIT narrative that ‘European Rules and Regulations’ are bad for you, the emerging policy aims to deliver a ‘fundamental review of the product safety framework’ in the UK, – moving away from the European system of Essential Safety Requirements and Harmonized Technical Standards – with it’s ubiquitous CE marks showing that products comply with European Norms

The Government claim that –

Building on what we have heard – this consultation – sets out an ambitious vision for change. It sets out a new and more proportionate approach, regulating only where necessary and directly focused on potential hazards and harms, whilst ensuring accountability throughout the supply chain.

Public Consultation Page 8

So, it may be unwise to dismiss this a ‘just another consultation’ that won’t change anything!

In the European system of product regulation:-

  • Producers and other ‘economic operators’ – distributors, retailers and online platforms – can only supply products that are safe, and must comply with their obligations under the new European General Product Safety Regulation
  • Products considered ‘higher risk’ are Regulated. So, they must also comply with the Essential Safety Requirements for that type of product.
    • For example, toys should not present a risk of choking, or be made using toxic materials.
    • So, the Essential Safety Requirements reflect our shared knowledge of the risks and hazards that may be presented by particular product categories, as well as the measures that can be taken to control or mitigate those known risks.
  • Technical Experts from industry with experience of product design and manufacturing, then develop Public Standards explaining how you can –
    • Develop a design that complies with the Essential Safety Requirements, or
    • Assess a product to establish if it does in fact comply
  • The European Regulators review the Public Standards developed by industry experts, and may endorse them as ‘Harmonized Standards’, including them in the Official Journal of the European Union.
  • Regulated products, that require CE Marking can then be approved – using the Harmonized Technical Standards to demonstrate that they comply with the Essential Safety Requirements.
  • The European Single Market allows the free movement of products that comply with the ‘Essential Safety Requirements’. So, national governments and regulators can’t introduce additional arbitrary requirements to distort the market or favor their own national interests.
  • However, producers are held strictly liable for any harm caused by the supply of dangerous or unsafe products, and must co-operate with the regulators when they identify unsafe products in the market

The combination of Essential Health and Safety Requirements and Harmonized Technical Standards, to achieve and demonstrate compliance with those requirements, provides objective certainty for producers, regulators and independent assessors, while protecting consumers from unsafe products.

European Union adapts to changes in technology and society, by updating the European Directives and Regulations, when necessary to rebalance the the rights and obligations of consumers and economic operators, and updating Harmonized Standards.

But, the Government argue, the European approach stifles innovation and discourages startup businesses who don’t understand what they are doing – or are unfamiliar with the rules and regulations designed to protect public safety. Observing that ‘where regulation is overly prescriptive it can prevent businesses from trying something new’ – they propose: –

Simplifying our system by aligning legislative definitions and consolidating regulations that are currently split (by product categories) across the framework, and seeking to remove any unnecessary, duplicative or obsolete requirements.

However, the UK could take a more ambitious approach by shifting to a cross cutting hazard-based approach for the majority of products. This would have the aim of significantly reducing the need for, and quantity of, detailed or prescriptive product-specific regulations, whilst ensuring the framework is capable of supporting innovation and dealing with new and emerging risks.

Consultation paper page 15

So, what is being proposed as a ‘long term project’ to revive the the UK post-BREXIT economy will have a substantial and disruptive impact, on thousands of individual producers across dozens of sectors from cosmetics and toys to heavy machinery and electrical goods.

While the Consultation hints at a future strategy and ‘direction of travel’ – without presenting a roadmap, respondents are asked to comment on the following proposals –

  • To exempt certain ‘low risk products’ from the need to demonstrate compliance with the Essential Health and Safety Requirements when they are considered inappropriate for the perceived level of risk. As, there is an obvious desire to find examples of ‘successful deregulation’, to justify the strategy, respondents are asked to identify products that could be ‘deregulated’ and exempted from the current Essential Health and Safety Requirements. (Question 1)
  • The developing a new approach focusing on potential hazards, rather than product categories. This requires an audit of all Essential Safety Requirements, to identify the common design features and hazards mitigated or controlled by the requirements, and the Essential Requirements – if any – that should be retained. So, although the audit will consider the need for any product-specific regulations, the desire to avoid them is implicit in the consultation. (Questions 2 – 6)
  • The covid pandemic demonstrated the need to rapidly procure supplies during a national emergency, when potential suppliers’ products had not been approved as compliant with UK or European Standards. So, the Government are proposing a formal Derogation to exempt such supplies from the regulatory requirements, providing the supplier has an authorized representative in the UK, or the supplier is based here. (Questions 7 – 8)
  • Current regulations require some information to be provided with the product, including user instructions and certificates of compliance. The government are proposing that this information may be provided in a digital format, using QR Codes – or for electronic equipment, on screen – avoiding the requirement for ‘hard copies’. (Questions 9 – 11)
  • Clarifying the the legal obligations of ‘economic operators’ in the extended supply chain, including on-line market places and other importers and and distributors. This could replicate the obligations of economic operators in the new European General Product Safety Regulation, but that relies on compliance with Essential Health and Safety Requirements, and the presumption that compliant products are safe. (Questions 12 – 14)
  • Improving the information provided in on-line listings, so that potential customers can make an informed choice about the products they buy, and assess the safety of products offered to them. This would apply to ‘higher risk products’ that need to comply with the revised essential requirements developed by OPSS to mitigate known risks in their ‘hazard-based’ approach. (Questions 15-16)

So, if these proposal will have an impact on your business or unlock your creative potential, you need to make your voice heard and respond to the consultation, before 24 October 2023.

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Reforming EU Product Liability Law

Picture by Thijs ter Haar – Creative Commons

The European Union is reforming Product Liability Law to ensure it remains ‘fit for purpose’ – rebalancing the rights and obligations of Economic Operators – with our rights as Consumers.

The changes are a response to the increasing; –

  • Use of embedded software in physical products to control their performance.
  • Use of inter-connected products from different suppliers.
  • Importance of digital products and services with their related cyber-security threats
  • Application of Artificial Intelligence and Machine Leaning that may modify the products functional behavior and risk profile, after is has been ‘supplied’.
  • On-line sales and the growth of on-line market places.
  • Desire to promote a ‘circular economy’ in which products can be ‘repurposed’

So, if you supply, maintain or modify products used in Europe, you need to review your policies and procedures, – so that you can comply with your Legal Obligations when the new Regulations take effect, as shown below;-

New Regulation / Directive Status DatedApplies From
Machinery Regulation EU 2023/1230
Machinery Directive 2006/42/EC
Approved 14 June 2023 14 Jan 2027
General Product Safety Regulations (EU) 2023/988
General Product Safety Directive 2001/95/EC
Approved 10 May 2023 13 Dec. 2024
Proposal to update
Product Liability Directive 85/374/EEC

Your Obligations and Potential Liabilities as an Economic Operator will depend on the products you supply and your role in the extended supply chain, as the; –

  • Manufacturer or producer of the product, or it’s components.
  • Authorized Representative of a non-European Manufacturer
  • Importer of ‘foreign products’, from outside the Single Market
  • Brand Owner, when selling ‘Own Brand Products’
  • Distributor or Reseller
  • Distance Seller (on line or mail order sales)
  • On-line Market Place or Sales Platform for ‘independent sellers’
  • A company that performs ‘significant modifications’ to existing products

But, you may have more than one role in the supply chain. If, for example, you manufacture your own products and sell them on-line, while also importing or distributing other accessories or complimentary products. So, you may need to review your product portfolio and business relationships to establish your own obligations for different types of product.

The Machinery Regulation and General Product Safety Regulation are intended prevent harm that could be caused by dangerous or unsafe products in the market place. So, Economic Operators in the extended supply chain must co-operate with one another – and the regulators – to prevent the sale or continued use of dangerous and unsafe products.

Manufactures who are responsible the specification of products placed on the market, must demonstrate that they have ‘assessed the risk of harm’ to users and that those risks have been reduced to an acceptable level. For higher risk products, the EU’s product specific Directives and Regulations, supported by Harmonized Standards, specify the Essential Requirements of ‘safe products’, that can be CE Marked and sold in the EU Single Market.

Having developed a ‘safe design’ – and obtained any relevant CE Marks and design approvals – manufacturers must also: –

  • Provide instructions for the safe use of the product
  • Maintain a Technical File identifying any known risks and the actions taken to mitigate them.
  • Ensure that the products supplied conform with the design intent
  • Record and investigate customer complaints that allege a lack of safety
  • Inform the Regulator if they discover that unsafe products have been supplied, or are in use
  • Report all accidents caused by their product to the regulator

Significantly the new regulations recognize that product performance and safety can rely on intangible software and digital services, that may be modified or changed after a product has been supplied. So, these are now regarded a ‘component parts’ of the products in which they are used, and the producers must assess and mitigate any risk to health and safety that may be caused by software malfunctions or unauthorized changes, – throughout the product life cycle.

The Machinery Regulation will apply for all powered and some manually operated machinery sold for consumer or professional use. For higher risk equipment that is subject to specific regulations and safety standards, compliance with those standards may be used to satisfy parts of the Machinery Regulation.

The General Product Safety Regulation will apply to all products used by consumers or used to deliver a service to them – with the exception of public transport vehicles that are operated operated and controlled by a service provider.

When Europeans consumers are harmed by dangerous or unsafe products, they can claim compensation for the harm caused based on –

  • The Law of Negligence, – based on Fault and a failure to exercise Due Care, or
  • the Product Liability Directive, – Strict Liability, without fault for unsafe products

Proposed changes to Liability Directive will make it easier for individual consumers and groups of consumers to claim compensation. The proposed changes to the Product Liability Directive have been published, but are not finalized,

While Britain’s ‘regulatory alignment with the EU’ after BREXIT remains politically contentious – changes in European Law and Regulations are expected to influences the development of regulations in other global markets – including the UK.

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After BREXIT: What Next?

BREXIT - the end of an era

Leaving the Single Market

The EU’s ‘Single Market’ allows the free movement of goods within the member States, providing they comply with the relevant EU Standards and Regulations. But, this system of ‘Free Trade’ within Europe is underpinned by the harmonization of standards and the mutual recognition of Approval Bodies.

The familiar CE mark is used to identify products that comply with European Standards, and although producers may be able to ‘self certify’ some of their products, ‘regulated products’ must be certified by an independent Approval Authority or Notified Body.

Although it can be time consuming and expensive to obtain product approval, once a product has been approved it can be sold anywhere in the ‘Single Market’ because all member states have adopted the same technical standards. Access to an ‘enlarged domestic market’ across Europe can also bring significant economies of scale allowing companies to grow – and confidently invest in new products.

But BREXIT undermines this system of Free Trade with Europe, and will inevitably create problems because the political choices made by the UK Government will have consequences in the real world.

But what are the consequences of leaving?

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Are you ready for BREXIT?

You may love or despise the the European Union, but we are leaving.

For the last 47 years we have taken our place among the nations of Europe – helping to shape and form its European Institutions – working together to create the Single Market and Customs Union.

Trading relationships have blossomed as:-

  • Rules and regulations have been harmonised
  • Internal tariffs and Customs Declarations have been abolished
  • Hard borders have been removed
  • Supply chains have been integrated

Businesses of all shapes and sizes have learnt to trade with Europe, supplying our goods and services – building relationships with our customers and suppliers across Europe.

But we have taken our freedom to trade with Europe for granted – forgetting or perhaps resenting the harmonised rules and regulations that make that a viable choice.

They saw a mirage that was so clear,
words of caution were project fear,
so they voted to get out of here,
now as Brexit draws near,
reality will start to interfere,
with the vison they held so dear

Phil Stunell 2020

As we come to the end of the ‘transition period’, negotiations with the EU about our future trading relationship are stalled – with ‘No Deal’ now the most likely outcome – UK firms trading with Europe face inevitable disruption.

One problem for UK producers is the way that the EU balances the rights of consumers and producers in the Product Liability Directive, and the General Product Safety Directive. These make producers responsible for the safety of their products, allowing consumers to claim compensation when things go wrong, and requiring producers to work with the regulators to remove unsafe products from circulation.

The practical problem with this approach is that it is impractical for ordinary consumers to sue a producer of imported goods, in for example Taiwan, outside the jurisdiction of the European Legal System.

So the EU directives define the producer as anybody who:-

  • Produces the product or any of it’s component parts, or
  • Incorporates the product in their own product, or
  • Attaches their brand name to the product, or
  • Imports the product into the European Union

Making all producers involved in the supply of defective products jointly liable for any harm caused by them, ensures that consumers can always seek compensation in Europe, where the the EU Directives apply.

By choosing to leave the EU – opting out of the Single Market and Customs Union – we are also rejecting the authority of the European Courts and leaving the EU’s jurisdiction.

But this creates is a problem for UK producers exporting to Europe. After 31 December this year, – their European clients will no longer just be ‘customers’ or ‘distributors’ – they will become importers into the European Union, and therefore a producer of the product.

This means that their European distributors will:-

From a European perspective this ensures that:-

  • Somebody who is subject the Jurisdiction of the European Courts is held accountable for the safety and compliance of the products supplied in Europe
  • So, consumers can bring claims for compensation ‘within Europe’.

This is a non-negotiable principle that underpins the free movement of goods within the EU.

So, if you are exporting goods to Europe and have not already agreed who in Europe will be responsible the safety and compliance of your products in January, you are still not ready for BREXIT!

While the UK Government are encouraging us to ‘Check – Change- Go’ – to some unknown destination – the EU have published a series of detailed and practical guides to Brexit explaining what will change and why.

If you are designing, manufacturing or supplying physical products and want to understand more about Product Liability – why join one of our Product Liability Training courses – now available on-line or in-house.

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Pinnacle MoM Hips (Part 6)

Hip Replacement - used with the permission from
Hip Replacement Surgery (Used with permission of

Estimating the risk of failure

In 2018 Ian Haley was among a group of 312 patients, who sued Depuy in the English High Court because they had an adverse reaction to metallic debris (ARMD) from the hip’s metallic bearing surfaces. So, they claimed that the Pinnacle Hips with a metal on metal (MoM) bearing were legally defective.

Their claim was based on Part 1 of the Consumer Protect Act implementing the European Product Liability Directive in British Law.

In Article 6 the Directive says:-

A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, 

Article 6 (1) of the European Product Liability Directive

The patients’ first claim against Depuy, alleging that the defect was the ‘production of metal wear particles from the bearing surfaces’, is discussed in my previous post.

So now we will turn our attention to the patients’ secondary claim that:-

…”the Pinnacle Ultamet prosthesis had “an abnormal potential for damage, compared with existing established non-MoM total hip replacement prostheses and/or that a large head MoM articulation had an abnormal potential for damage compared to alternative bearing surfaces within the Pinnacle modular system”

Pinnacle Judgement Paragraph 136

The Statistical Evidence

The Judge – Mrs Justice Andrews – established a two stage test for the claimants to satisfy in order to obtain compensation:-

  • Firstly, they must show that the risk of revision surgery – to repair or replace their hip – within 10 years was significantly increased by the use of a Pinnacle MoM hip, compared with alternative products already accepted in the market place in 2002.
  • Secondly, individual patients must show that, on the balance of probabilities their revision surgery was the result of the increased risk, associated with the development of ARMD

Discussing how the first test could be satisfied, Mrs Justice Andrews observed that:-

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Pinnacle MoM Hips (Part 5)

Hip Replacement - used with the permission from
(Hip Replacement Surgery Used with permission of

How to Prove Products are Defective

The 312 patients, including Ian Haley, seeking compensation from Depuy claimed that their Pinnacle Metal on Metal (MoM) hips were defective, because:-

  • Metallic wear particles were shed from bearing surfaces
  • Their immune systems reacted to the metallic debris, causing pseudo tumours to develop, damaging their muscle and bone structure – a process described as ARMD (Adverse Reaction to Metallic Debris)
  • As a result of ARMD, they required revision surgery to remove and replace their Pinnacle MoM hips, in some cases leaving them with a permanent disability

They did not claim that Depuy had been negligent or failed in their Duty of Care. Instead their claim was made under Part 1 of the Consumer Protect Act (CPA), which implements the European Product Liability Directive in British law.

The Directive says that a producer is strictly – without fault – liable for any harm caused by defects in the products they supply to consumers, and defines a defect by saying:-

1) A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:-

a) the presentation of the product

b) the use to which it could reasonably be expected that the product would be put

c) the time when the product was put into circulation

2) A product shall not be considered defective for the sole reason that a better product is subsequently put into circulation

Article 6 of 85/374/EEC as amended by Directive 1999/34/EC

If the patients succeeded in proving that:-

  • The product was defective
  • They suffered the harm
  • The defect cause the harm

Then Depuy would be liable for any damage caused by the defect, unless they could use one of the defence arguments permitted by Article 7 of the Directive.

So, the claimants presented two alternative explanations of the defect.

As discussed in my previous post in their primary claim, which was unsuccessful they argued that:-

  • The defect was the production of metallic wear particles from the bearing surfaces of the hip joint,
  • The harm caused was the need for revision surgery and any resultant disability, pain and discomfort

However, knowing that Depuy might object to that definition of the defect they also presented a second alternative claim, that:-

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ROUNDUP $13 Bn Settlement

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

In 2016 the German chemical company Bayer acquired Monsanto – one of the largest global producers of agricultural chemicals – in a $60 Billion take over. The deal gave Bayer access to the US market with an expanded product range, including ROUNDUP – a glyphosate-based herbicide, – developed by Monsanto.

By 2019 Bayer were facing a growing number of product liability claims, from people arguing that their cancers, in particular Non-Hodgkin Lymphoma (NHL), had been caused by their exposure to ROUNDUP – as discussed in my previous article,

The claims being made were particularly serious, because:-

  • It was alleged that Monsanto’s negligence was wilful and deliberate – allowing claimants to seek punitive damages – designed to punish and deter such reckless behaviour.
  • The first successful claims, in 2019, made Bayer an attractive target for other lawyers working on a no-win-no-fee basis, with many potential claimants who had been exposed to ROUNDUP

It has now been reported that Bayer have reached a negotiated settlement with lawyers representing 125,000 claims about ROUNDUP and and it’s link to cancer.

According to Werner Bauman, Bayer’s Chief Executive:-

“First and foremost, the Roundup™ settlement is the right action at the right time for Bayer to bring a long period of uncertainty to an end, It resolves most current claims and puts in place a clear mechanism to manage risks of potential future litigation. It is financially reasonable when viewed against the significant financial risks of continued, multi-year litigation and the related impacts to our reputation and to our business. The decision to resolve the Roundup™ litigation enables us to focus fully on the critical supply of healthcare and food. It will also return the conversation about the safety and utility of glyphosate-based herbicides to the scientific and regulatory arena and to the full body of science.”

From albawaba

The settlement may mitigate the damage to Bayer reputation caused by prolonged legal arguments – and hopefully get compensation to those who have suffered before they die.

So Bayer have agreed that:-

  • The three cases that have already been decided against Bayer, and are subject to appeal will be ‘decided by the Courts’ in order to establish a precedent and provide legal guidance for the future
  • Bayer will pay $8.8 billion – $9.6 Billion to settle approximately 125,000 current claims, without admission of liability or wrong doing.
  • A further $1.25 billion will be made available to resolve future litigation
  • In addition, Bayer will provide funding of $1.25 billion for a independent Science Panel tasked with determining if exposure to ROUNDUP does in fact increase the risk of Non-Hodgkin Lymphoma.
  • All parties will be bound to accept the Science Panel’s findings which will be published by Bayer on their website when available.

It is difficult to estimate the total cost of the settlement, but based on the published information the costs will exceed $13 billion – but Bayer’s share price, that had slumped by 50% as investor confidence evaporated, may now start to recover.

The Bayer – Monsanto merger shows how important is to consider Product Liability Risks when valuing an acquisition – and that must include an assessment of the management culture and their risk management systems. For Bayer’s senior management team, underestimating those risks has proved to be a ‘near death experience’ and a disaster for Bayer – and their reputation.

To learn more…

To learn more about Product Liability and risk management please contact Phil Stunell or subscribe to our newsletter to receive updates.

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Pinnacle MoM Hips (Part 4)

Hip Replacement - used with the permission from
Hip Replacement Surgery (Used with permission of

Legal Argument – What is a Defect?

In 2018 a group of 312 patients including Ian Haley, who had received artificial hips manufactured by Depuy, sued Depuy in the English High Court claiming that:-

  • The Pinnacle Hips with a Metal on Metal (MoM) bearings were legally defective, because the patient’s immune system reacted to microscopic wear particles from the bearing surfaces of the joint.
  • Typically, their Adverse Reaction to Metallic Debris (ARMD) caused the growth of pseudo tumors in the soft tissue around the joint, and damaged their muscles and bone structure – among other symptoms.
  • Patients with severe ARMD required revision surgery to remove and replace their Pinnacle MoM hips. In some cases leaving them with reduced mobility or a permanent disability.

But, the patients did not attempt to prove that Depuy had been negligent, or failed to exercise their Duty of Care

Instead they based their claim against Depuy on the European Product Liability Directive, which has been implemented in British Law by Part 1 of the Consumer Protection Act (CPA).

So in her written judgement the Judge, the Honourable Mrs Justice Andrews analysed the law, explaining how it should be applied – creating a precedent or example that may be used in future.

The Product Liability Directive

The Product Liability Directive was introduced in 1985, because the European Council recognised that the patch work quilt of legislation across Europe needed to be harmonised to:-

  • Balance the economic interests of consumers and producers
  • Enhance consumer protection

Reading the EU Directive, you will find:-

  • The preamble or Recitals, which explain the European Council’s policy objectives and the purpose of the Directive.
  • Articles, which define the rules to be implemented in the domestic law of the member states.

Although we may be tempted to fast forward through the Recitals – that is a mistake. The Articles are intended achieve the policy objectives explained in the Recitals – so the Articles must be interpreted in a way that achieves, as far as possible, those policy objectives.

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Pinnacle MoM Hips (Part 3)

Hip Replacement - used with the permission from
(Hip Replacement Surgery Used with permission of

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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