Unsafe at Any Speed

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Photo Credit: Sicnag, CC BY 2.0 https://creativecommons.org/licenses/by/2.0, via Wikimedia Common

When Ralph Nader’s book Unsafe at Any Speed – The Designed-in Dangers of the American automobile was published in 1965, it challenged the political consensus that the automotive manufacturers – Ford, GM and Chrysler – could be trusted to develop and market ‘safe products’, without any need for federal regulation.

By 1965, the steadily rising toll on American roads had reached 47,084 fatalities / year – which had become the socially accepted price of the freedom to travel and resultant economic prosperity.

Source: Motor Vehicle Traffic Fatalities and Fatality Rates, 1899-2023

When asked, ‘industry experts’ argued that, – these deaths and associated injuries were the unfortunate result of poor highway design, inadequate driver training or lax law enforcement, or reflected the growing popularity of ‘affordable motoring’, – in fact anything that would deflect attention from the ‘inherent safety’ of their products.

So, the suggestion that cars should be designed to be ‘crash resistant’ to protect people, – occupants or pedestrians, – in the event of an accident was quickly dismissed because, – the potential benefits were minimal, – it wasn’t technical feasible and the costs of implementation would be extortionate.

Besides, the industry already knew how to sell cars – and that certainly didn’t involve discussing safety in the showroom. Customers who had been persuaded that the real problem was other people’s poor driving – were simply unwilling to pay for unnecessary ‘safety features’.

According to the industry, ‘Regulation’ was completely unnecessary, – it would limit customer choice, stifle creative innovation and increase costs, without solving the problem. So, they argued that regulation should be limited to the harmonization of the rules in different States, adopting the minimum specification of products already in the market as a new common standard. Even attempts to mandate the technical requirements – such as seat belts or collapsible steering columns – for vehicles owned and operated by Federal Agencies was, apparently, an example of ‘federal overreach’ into the affairs the individual States, threatening the US constitution.

So, drawing on his experience as a lawyer seeking compensation for accident victims, Ralph Nader explained how the industry was using it’s economic and political power to suppress the information that consumers needed to assess the safety of new models, or select a ‘safer car’.

The Chevrolet Corvair introduced in 1960 was an interesting, but particularly controversial case study.

Developed to compete with lighter and cheaper European vehicles, such as the VW Beetle, and expand the market for ‘family cars’ the Corvair had:-

  • A unique air cooled, 2.2 Litre, horizontally opposed 6 cylinder engine engine – known as a flat 6 – installed in the rear of the car, with the fuel tank in the front luggage compartment.
  • But, with the engine at the rear, the vehicle was ‘tail heavy’ and could develop severe over-steer during cornering, that many driver would be unable to control.
  • So, to reduce the risk of over-steer, Chevrolet recommended that the front tyre pressure should be reduced to 15 psi – (compared with a more normal 30 psi at the rear) without explaining the dangers of over-inflating the front tyres to drivers.
  • The Corvair had a simple wishbone rear suspension, with a coil spring and damper on each side. So, the camber angle of the rear wheels would change as the load on the suspension varied, but during extreme cornering the outside rear wheel could ‘tuck under’ the body making, making the vehicle unstable.

From Chevy Corvair – The Weird, Quirky, Cheap and Yeah COOL Compact

According Ralph Nader, the 1960 Corvair was inherently unsafe because –

  • During normal driving, the Corvair could develop severe over-steer causing the driver to loose control and spin out of control.
  • While, the rear suspension geometry could cause the Corvair to spontaneously roll-over during a fast lane change maneuvers or brisk cornering – when the outer rear wheel ‘tucked under the body’ – jacking up the rear of the car.

Within months of the Corvair’s launch specialist companies had developed an after-market kit of parts to improve the Corvair’s handling and reduce the risk of spontaneous roll-over accidents. But it later emerged, a similar modifications proposed by Chevrolet engineers had been rejected by the company as too expensive to fit in production.

So Nader argued, before the vehicle launch Chevrolet –

  • Knew about the risks of over-steer, loss of control and spontaneous roll-over.
  • Knew how to mitigate or eliminate the risk.
  • Made a conscious choice to sell an ‘unsafe product’ to maximise their profits.
  • Took no action to warn consumers about the known risk.

But, many of the other design choices made by Chevrolet also increased the risk of death or injury in the event of a crash, for example –

  • Seat belts and seat belt anchorages were not provided, or available as optional equipment.
  • So, in a crash the unrestrained occupants would strike the the hard surfaces of the vehicle interior, which had protruding knobs and switches that could cause traumatic injuries.
  • The steering column – a strait shaft – was connected to the steering box, mounted on the chassis in front the front wheels. So, in minor frontal impacts the column and steering wheel could be driven like a spear into the driver’s chest causing fatal injuries.
  • The position of the fuel tank, in the front luggage compartment increased the risk of fuel leaks and fires in frontal impacts

Nader argued that the problems with Corvair were a symptoms of fundamental problem in an unregulated market economy, companies will sacrifice public safety to maximise their profits. But by, controlling consumers’ access to information and buying political influences, Ford, GM and Chrysler had also become unaccountable for that ‘trade-off’.

So, the only just cure would be effective federal regulation of design standards with mandatory product recalls when vehicles were found to be unsafe.

For Corporate America this was an intolerable heresy, attacking very the foundations of their economic and political power. To them it it was obvious that federal regulation and enforcement would ‘destroy jobs’, ‘stifle investment’ and weaken the America’s global power. After all they had created employment for millions of people – and unlike this unpatriotic, socialist upstart, talking about social justice and the right to life – they knew how the create wealth!

However, the book’s publication proved to a pivotal moment in the the history of automotive safety, leading to the introduction of the first Federal Motor Vehicle Standard (FMVS) and a system of mandatory product recalls that has evolved into the TREAD ACT. But perhaps, the most significant changes have been driven by public access to information about the safety of particular models – allowing customers to evaluate product safety when choosing a new car, in turn creating a market demand for safer products.

Recent statistics shows how the significant improvements in vehicle design – to make them ‘crash resistant’ and the the development of new technologies – such as stability control and anti-lock braking – have in fact reduced the fatality rate (deaths / million miles travelled) – but the this has been partially offset by increases in the population and total miles travelled since 1965.

Source Fatalities and Fatality Rates.pdf

But this raises some important questions –

  • Would any of these improvements in safety since 1965, have been achieved without Federal Regulation?
  • Does an unregulated free market give companies sufficient financial incentives to invest in public safety?
  • What level of safety should we expect from fully autonomous vehicles?

In 2025, under the current US administration, Corporate America is reasserting control of the political and economic agenda, while regulations designed to hold them accountable are being rolled back, in the belief that ‘regulatory freedom’ will ‘Make America Great Again’. So, many of the arguments used in the past to block federal regulation of the automotive industry are now being revived, as we contemplate the application AI and other technologies.

Product Liability Law and Regulation are about striking the right balance between the rights of individuals and their suppliers who provide the the goods and services we rely on, – as consumers or employees and investors. But, in a democracy, who should have the political and economic influence to ‘control the narrative’ and set political priorities?

To Learn More…..

We deliver Product Liability Training for engineers and and engineering managers, that will explain the law and show how you can identify, control and mitigate product liability risks using a quality management system based on ISO 9001 and / or IATF 16949.

To arrange training for your team, please contact Phil Stunell

For a deeper understanding of the Corvair controversy, you can read Ralph Nader’s book and watch this video….

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How a snail changed the law…

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Your Duty of Care and Negligence

Mr Stevenson’s factory in Paisley, making soft drinks – lemonade and ginger beer – for local shops and cafes in Scotland was a hive of activity, with grates of empty bottles stacked in the yard waiting to be refilled.

Then, one day in 1928, a snail crawled into one of the dark glass bottles – where it was drowned in ginger beer – slowly decomposing as the sealed bottle was dispatched to the Wellmeadow Cafe, run by Francis Minghella, just in time for the Glasgow Trade Fair – one of the busiest weeks of the year.

After attending the Glasgow Trade Fair, Miss Donoghue met one of her friends for chat, – and to catch up with all the local gossip – in the Wellmeadow Cafe. Where Miss Donoghue’s friend bought their refreshments, an ice cream for herself and a ‘Scotsman Float’ – ice cream in ginger beer – for Miss Donoghue.

So, as Francis Minghella served his guests, he poured half the bottle of ginger beer into the the Scotsman’s Float – and left the rest on the table for Miss Donoghue.

As they chatted to one another, Miss Donoghue’s friend, topped up the Scotsman’s Float – and the decomposing snail appeared from the bottle of ginger beer. Shocked and horrified by the sight of the rotten snail on her ice cream, Donoghue complained to the cafe owner – Francis Minghella – who apologetically explained that –

  • He didn’t now that the Ginger Beer was contaminated, but had relied on his supplier – Mr Stevenson – to supply the ginger beer
  • Inspecting the bottle on the table confirmed that it carried Mr Stevenson’s brand markings and printed label, which did not warn the consumers – or cafe owners – that it may contain added protein or decomposing snails.
  • Because it was a dark glass bottle their was no practical means of inspection that could have detected the decomposing snail, before he served it to his customer.

So, while he was very sympathetic, Francis Minghella couldn’t accept responsibility for the contamination that, unknown to him, was concealed by the dark glass bottle. When consulted, his solicitor would later confirm that a shop keeper who had sold a tin of rotten salmon was found not guilty – because there was no practical means of inspection that would have enabled him to identify the problem – setting a legal precedent that protected the cafe owner.

So, when Miss Donoghue required hospital treatment for gastro enteritis, she consulted a local lawyer, who helped her prepare her case against Mr Stevenson for negligence in the production of the ginger beer consumed by Donoghue. But the prevailing wisdom and legal precedents in Scots and English Law – most recently expressed in Mullins V AG Bar – was that a supplier’s Duty of Care – obligation to prevent harm –

  • Was strictly limited, to the people who were in a contractual relationship with the supplier, unless
  • The dangerous nature of the product was being concealed with the intention of deceiving the customer, or
  • The supplier failed to warn people of the intrinsic danger of products such as explosives.

So, Donoghue’s case was based on –

  • The moral argument that – a supplier should owe a Duty of Care – obligation to prevent harm – to people who use or consume their product – independent of any contractual relationship with them.
  • The use of dark glass bottles that prevented consumers conducting an effective inspection of the contents, concealed the danger of contamination, which should created a relationship of trust between the supplier (Mr Stevenson) and consumer (Miss Donoghue)

In 1932, the legal arguments (Donoghue V Stevenson) reached the House of Lords – where 5 Law Lords we asked to decide –

  • Does a manufacturer have a Duty of Care to avoid causing harm to members of the public who consume or use their products?

While Stevenson continued to dispute the facts of the case, Donoghue’s legal arguments were persuasive and by majority of 3 – 2 the Court decided in her favor setting a precedent that changed the Law.

In the Court’s Judgement, Lord Atkins concluded that; –

“A manufacturer of products, which he sells in such a form as to show that he intends them to reach the ultimate consumer in the form in which they left him, with no reasonable possibility of intermediate examination, and with the knowledge that the absence of reasonable care in the preparation or putting up of the products will result in an injury to the consumer’s life or property, owes a duty to the consumer to take that reasonable care.”

However, he also went further defining our General Duty of Care – independent of any contractual relationships – when wrote; –

“The rule that you are to love your neighbor becomes in law, You must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbor. Who, then, in law, is my neighbor? The answer seems to be – persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts or omissions which are called in question.”

So, this judgement set an important precedent in British law, imposing a Duty of Care on manufacturers to consider the effects their products have on the consumer and take reasonable care to prevent any reasonably foreseeable harm. So, Lord Atkin’s explanation of our Duty of Care – and by extension Negligence – is the foundation on which we can develop our understanding of modern product liability law.

In Donoghue V Stevenson, the use of a dark glass bottle, – concealing the fault and preventing the consumer conducting an effective inspection of the product, – meant that Donoghue was forced to rely upon Stevenson’s Quality Management System. This was sufficient to persuade the Court that Stevenson owed the Donoghue a Duty of Care.

Now, defects may go undetected by consumers – because specialist skills and expert knowledge are needed to assess their safety products relying on software and microprocessors. So, consumers are once again deprived of the opportunity to inspect the product – and must rely on the supplier’s quality assurance processes.

So, recognizing that claimants may find it difficult to assess the safety of some products or prove it they are defective, – the new European Product Liability Directive (EU) 2024 / 2853 allows the Court to presume a product is defective, if the manufacturer withholds the evidence needed to assess it’s safety, or due to technical complexity – or lack of data – the consumer faces ‘excessive difficulty’ in establishing the existence of a specific defect. In those circumstances

To Learn more…..

The Product Liability Training we deliver is designed for engineers and engineering manager responsible for product design and development, manufacturing operations, supply chain management and after market support.

Please contact Phil Stunell to discuss your requirements and arrange your training.

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EU Product Liability Directive (EU)2024/2853

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Photo © European Union 2017 – European Parliament

Replacing Directive 85/374/EEC

In 1985 the European Union adopted the first Product Liability Directive (85/374/EEC), allowing consumers harmed by dangerous or unsafe products to claim compensation from the producers, if they can show that:-

  • The Product was Defective, – failing to provide the level of safety that consumers are entitled to expect, considering all the circumstances.
  • The consumers has suffered an actual harm– including physical injury or damage to personal property, but excluding pure economic or commercial losses.
  • The Defect or lack of safety caused their loss or injury

Directive 85/374/ EEC also introduced the principles of:-

  • Strict Liability for Product Defects, so that claimants do not need to show the producer was negligent or knew about the lack of safety.
  • Joint Liability – making brand owners, manufacturers and their component suppliers jointly responsible for any harm to consumers caused by defects or the lack of safety, allowing consumers to take action against any or all of them.

To ensure that claims can be pursued and settled in a European Court, Importers and the Authorized Representatives of foreign manufacturers are also held liable, as producers, for any defective products they supply in Europe. However, other distributors and retailers, who have not modified the product or used their branding to sell the product, can normally avoid liability for product defects by identifying their European supplier who is liable.

However, the producer’s liability for defects is not an absolute liability. So the Directive 85/374/EEC established the arguments that may be deployed to avoid the producer’s liability, when a defective product has caused loss or injury:-

  • We were not a Producer of the defective product or any of it’s component parts, and have not applied our branding to the the product supplied.
  • The defect did not exist when the product was supplied, but has been introduced or created by some unauthorized change or damage after the product left our control.
  • The defect, or lack of safety, could not have been detected, when the product was supplied due to the limits of scientific and technical knowledge at that time. (Known as the development risk defense, this argument may be limited or excluded by the national law of member states, for some or all products)
  • The defect or lack of safety is not in the component we supplied, but due to the design and production of the product in which it was integrated.
  • The defect or lack of safety in the component we supplied, is the result of following the instructions given by our client who is also a producer. (This defense protects companies who ‘make to drawing’ from any liabilities that might arise due to poor design, providing they followed their client’s instructions.)
  • The defect was the inevitable result of compliance with a legal requirement. Although we may find conflicting legal requirements in different regulations, so far I have been unable to find any case studies to illustrate this argument.

Although primary (unprocessed) agricultural products were excluded from the scope of the original directive, this was amended by Directive 1999/34/EC. So, the Directive 85/374/EEC now applies to electricity and all physical products or component parts that are moveable, even when they are incorporated in an immovable object or structure.

Since 1985, our traditional supply chains have been transformed by globalization and the development of on-line sales channels, while public expectations of safety and the risk profile of products have changed as new technology is developed and adopted.

So, the European Union had introduced a new Product Liability Directive (EU) 2024/2853

When will the New Product Liability Directive be published?

The new Product Liability Directive (EU) 2024/2855, was published in the Official Journal of European Union on 18 November 2024

When will the Product Liability Directive come into force?

The new Directive came into force 8 December 2024, 20 days after it was published in the Official Journal of European Union.

When will the New Product Liability Directive take effect?

The New Product Liability Directive (EU) 2024/2855 will apply to all products supplied in the European Union on or after 9 December 2026.

The old Product Liability Directive 85/374/EEC will continue to apply to any claims related to products that are supplied before the New Directive takes effect.

Why have the EU adopted a New Product Liability Directive?

The Recitals or Preamble at the front of the Directive, paragraphs 1 – 64, explain the purpose of the new legislation and its Legal Intent. So, the Courts will interpret the law to achieve the purpose as explained in those Recitals.

However, the new Directive addresses the following concerns:-

  • The introduction of new technology, in particular Software and Machine Leaning, into products that may be interconnected has changed the risk profile of typical products. So, the new Directive defines software as a product, and component part of any product in which it is integrated.
  • Many products interact with and may be controlled by Software Applications and Services that may modify the products behavior or risk profile. So, these are now defined as Related Service and fall within the scope of the new Directive.
  • Software vendors and Service Providers may be responsible for product defects that harm consumers. So, they are now considered to be ‘manufacturers’ or ‘component suppliers’, jointly liable for any lack of safety they introduce into products that rely on their ‘digital components’ or services.
  • The characteristics and risk profile of products may be changed after they have been put into service, by software updates or physical modifications. So, the new Directive makes a manufacturer who approves or authorizes changes to products already in service, liable for any defects or lack of safety that may be introduced by the change.
  • Independent operators may make unauthorized changes or updates to products already in service, changing their risk profile or introducing new risks to users. So, such modifications are regarded as ‘new products’ manufactured by the economic operator who made the change.
  • As the ‘circular economy develops’ an increasing number of products and components may be repurposed at the ‘end of life’, and incorporated in new products. So, the Directive says that products that have undergone ‘substantial modification’ or been adapted for a use that is outside the scope of original manufacturer’s risk assessment, will be regarded as new products made by the company that modified them.
  • The scope of the Directive now includes all products that have been supplied, or put into service, within the Single Market, including those are put into service by the manufacturer for their own use.
  • The definition of defect, – a failure to achieve the level of safety people are entitled to expect, – has not changed, but their is a new presumption that products that don’t comply with Union Law (CE marking / type approval etc) or the National Law of a Member State are Defective.
  • The potential harms that create a ‘recoverable loss’, have been extended to include psychological trauma, and the loss or corruption of data that is not held for ‘commercial purposes’, in addition to death, physical injury and material damage to private property.
  • People making claims for compensation must still prove that the product was defective, they have suffered an actual loss, and that the defect caused their loss. But, as the claimant may need access to information held by the producers to make their case-
    • The the Directive introduces the ‘Rights of Discovery’ and an obligation to disclose relevant information, for both claimants and defendants. (This is already recognized in UK law, but will now become mandatory throughout the EU Single market)
  • The Courts may also presume the product was defective and unsafe when:-
    • The defendants withhold the evidence required to assess it’s safety or identify a defect.
    • The product does not comply with the requirements of EU or National Law that are intended to reduce the risk of the harm suffered by the claimant.
    • The claimant demonstrates that the damage was caused by an obvious malfunction of the product during reasonable foreseeable use or misuse.
    • If due technical complexity, technical knowledge, or a lack of data create excessive difficulties for claimants trying to prove the existence of a defect.
  • The causal link between the proven defect and harm caused may also be presumed when
    • The damage caused is of kind that is typically caused by the defect in question.
  • Where the Court has presumed that the product is defective, or the defect caused the damage, the burden proof is reversed, so the manufacturer must prove that the product was not defective and did not cause the damage.

Other changes in the new Directive may enable and encourage groups of consumers with similar complaints to bring claims using Group Litigation or Representative Actions, while the EU will establish a public database of Product Liability Judgements.

While new Product Liability Directive (EU) 2024/2853 and General Product Safety Regulation (EU) 2023/988 will apply to all products supplied within the EU single market – including Northern Ireland, the UK Government have not explained how they plan to update UK legislation following Brexit.

Your next steps….

The new Product Liability Directive EU 2024/2853 and recently adopted General Product Safety Regulation EU 2023/988 are major reforms of consumer right and product regulation. Designed to improve consumer protection. they create new obligations and legal risks for economic operators in the extended supply chain. So, you and your management team, need to understand the law and how it will change your supply chain relationships .

Although some of the most obvious impacts involve software vendors and companies providing Related Services, these changes will affect everybody supplying products in the European Single Market.

So, if you need help, our Product Liability Training – designed for engineering managers – has been updated to reflect the recent changes in European law. Why not give us a call?

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Smarter Regulation? Delivering BREXIT…..

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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.

(more…)
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Reforming EU Product Liability Law

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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;-

(more…)
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After BREXIT: What Next?

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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?

(more…)
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Are you ready for BREXIT?

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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)

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

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:-

(more…)
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Pinnacle MoM Hips (Part 5)

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

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:-

(more…)
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