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DePuy Pinnacle UK Trial Day Two EOD Report
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Hip patients lose battle over ‘defective’ implants
May 22, 2018 | Daily Express
By Giles Sheldrick
HUNDREDS of patients lost their legal battle over allegedly “defective” hip implants yesterday. -
Landmark decision in Metal-on-Metal Hip product liability litigation
May 22, 2018 | Lexology
By Genevieve Isherwood
This morning Mrs Justice Andrews DBE handed down a landmark judgment in the 'biggest ever' products group litigation England and Wales has seen. -
DePuy wins legal battle over 'defective' hip implant
May 22, 2018 | Med-Tech Innovation
By Med-Tech Innovation
Over 300 patients have lost a legal battle with medical device manufacturer, DePuy Synthes, after claiming one of the company’s hip implants were defective. -
HUNDREDS OF PATIENTS LOSE HIGH COURT CASE OVER ALLEGEDLY 'DEFECTIVE' HIP IMPLANTS
May 22, 2018 | Care Appointments
By Jan Colley
In what is believed to be one of the largest "product liability" group actions in the UK, a group of 312 claimants brought High Court proceedings against manufacturer DePuy over allegations relating to the failure of metal-on-metal implants. -
News UK patients lose legal claim that DePuy metal-on-metal hip implant was “defective”
May 22, 2018 | British Medical Journal
By Clare Dyer
More than 300 people who were fitted with a metal-on-metal hip implant that is no longer used have lost a UK group legal action against the US manufacturer.
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Hip patients lose battle over ‘defective’ implants
May 22, 2018 | Daily Express
By Giles Sheldrick
A group of 312 claimants brought High Court proceedings against manufacturer DePuy, alleging failures of its metal-on-metal implants.
Patients claimed they were injured after Pinnacle Ultramet prosthetic hips wore out early, leaving them needing further surgery.
Hundreds of claims against other manufacturers had been on hold pending the outcome of the four-month hearing, which ended when Mrs Justice Andrews ruled that DePuy is not liable.
Samantha Silver, of law firm Kennedys who acted for DePuy, said the ruling “provides manufacturers with confidence that the courts can take into account the benefits and the inherent risks of certain products, for example, in cases where there is a known side-effect or complication and the overall benefits outweigh the risks.
“The decision that the safety of new products should be compared to products existing at the time they are introduced to the market also safeguards the position of those developing potentially life-enhancing technologies in the future.”
But lawyers for the claimants said they were “extremely disappointed” by the judgment, adding “the impact it will have on consumer safety and the ability of consumers to obtain redress cannot be underestimated”.
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Landmark decision in Metal-on-Metal Hip product liability litigation
May 22, 2018 | Lexology
By Genevieve Isherwood
This morning Mrs Justice Andrews DBE handed down a landmark judgment in the 'biggest ever' products group litigation England and Wales has seen.
Today's decision to find for the Defendant in the DePuy Pinnacle Metal-on-Metal ("MoM") hip litigation is one that will have a significant impact on the future of products litigation.
Thousands of patients, all over the world, have been implanted with MoM hip prostheses, many of whom commenced litigation. In England and Wales the claims were primarily brought against manufacturers of orthopaedic devices (but also involved private healthcare providers, NHS Trusts and individual surgeons) and concerned an alleged adverse reaction to the MoM implants.
Ten different manufacturers faced claims from hundreds of individuals, and various Group Litigation Orders were put in place to manage the claims. In late 2015 it was ordered that a trial of preliminary issues should take place in the Group Litigation against manufacturers DePuy and Corin (to be heard together). All other claims were stayed pending the outcome. The trial of the claims against Corin was subsequently vacated and only the DePuy Pinnacle litigation proceeded.
The Claimants' case was that the MoM hip implants were defective under the Consumer Protection Act 1987 ("CPA") - i.e. their safety was 'not such as persons generally are entitled to expect' – because they had suffered an adverse reaction to the metal debris ("ARMD") that is generated from the articulating surfaces of the metal "ball and socket" joints. The threshold for a claim under the CPA is much lower than in negligence as there is strict liability so long as there is a defect in the product and this defect caused injury or damage. It is therefore a powerful tool for Claimants.
In the DePuy Pinnacle litigation the Claimants' primary case on defect was the alleged propensity to produce metal debris. There was also a secondary allegation that the Pinnacle implants required earlier revision than other comparable products.
There had previously been two key decisions in relation to the CPA: A v National Blood Authority in 2001 and Wilkes v DePuy in 2016. National Blood Authority found for the Claimants; and Wilkes found for the Defendant. In reaching their different conclusions (albeit on two very different sets of facts) the judges used widely contrasting methods of analysis. As both decisions were first instance the law on bringing a claim under the CPA remained unclear and somewhat contradictory. Andrews J's judgment given this morning goes some way to clarifying the position (although, as another first instance decision, it does not overturn the previous two).
The decision to find in favour of DePuy should reassure manufacturers (and their insurers). It bolsters an argument (along with Wilkes) that National Blood Authority should be distinguished (or approached with caution), meaning a claim under the CPA should be easier to defend. It also provides much needed guidance on what should be considered a defect under the CPA, what relevant circumstances the Court should take into account when considering a claim under the CPA, and on what basis comparisons to other products should be made. We will be considering these points, and providing guidance on the practical impact of the decision, in our upcoming blog series. However, for now, manufacturers (and insurers) can be content that this landmark decision has gone in their favour.
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DePuy wins legal battle over 'defective' hip implant
May 22, 2018 | Med-Tech Innovation
By Med-Tech Innovation
A decision by the High Court ruled that DePuy’s Ultamet Metal-on-Metal (MOM) Articulation hip replacement was not defective.
The trial involved 312 claimants and took place over four months, during which 40 witnesses, including 21 experts presented evidence.
Claimants argued that the ‘defective’ implants produced metal debris which damaged patients’ surrounding tissues and produced adverse reactions such as pain, difficulty walking, and numbness.
However, judge Mrs Justice Andrews stated that this was a known consequence of the ordinary use of the product, and that material loss occurs in every type of hip implants, no matter the material. This resulted in the decision that the implant is not defective under the Consumer Protection Act 1987.
Claimants also argued that the Ultamet device didn’t perform as well as other non-MOM implants and that it had an “abnormal” potential for causing harm, compared to products that were introduced at the same time, or after.
If successful, the case could have had a serious impact on device manufacturers, as a product’s performance could potentially have to be compared to future alternatives, possibly stifling innovation.
The judge stated that the Ultamet implant should be compared to other prostheses that were on the market at the time the device was introduced. The judge decided that the Ultamet implant performed as well or better than those on the market and had no increased risk of harm.
Judge Andrews also spoke about the way that tabloid press exaggerated the issue, saying: “Phrases such as ‘toxic hip implants’ were used in the tabloid press, and it was suggested in some articles that there were systemic problems, and that metal was poisoning the bodies of patients. Typically, the absence of any scientific research to support the alarmist contentions in the articles or reports would be mentioned, if at all, in the last paragraph.”
Samantha Silver, the partner at Kennedys who led the work for DePuy, said: “The principles established in this judgment apply to all products used by consumers that come within the Consumer Protection Act.
“The decision will have significance for all manufacturers and distributors, not just those in the life sciences industry, as well as their insurers. It provides manufacturers with confidence that the courts can take into account the benefits and the inherent risks of certain products, for example, in cases where there is a known side effect or complication and the overall benefits outweigh the risks.”
“The decision that the safety of new products should be compared to products existing at the time they are introduced to the market also safeguards the position of those developing new, potentially life-enhancing, technologies in the future.”
According to the BBC, lawyers Leigh Day for the claimants said they were “extremely disappointed” and were looking into what next steps could be taken.
"It is genuinely concerning that the DePuy Pinnacle metal-on-metal hip replacement, which no clinician would now use, from a product group the orthopaedic profession has rejected for the serious harm it can cause, is deemed safe by this judgement," the firm said.
In 2013, DePuy decided to remove the Ultamet device from sale, stating low clinician use and decreased sales in the US and Europe.
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HUNDREDS OF PATIENTS LOSE HIGH COURT CASE OVER ALLEGEDLY 'DEFECTIVE' HIP IMPLANTS
May 22, 2018 | Care Appointments
By Jan Colley
In what is believed to be one of the largest "product liability" group actions in the UK, a group of 312 claimants brought High Court proceedings against manufacturer DePuy over allegations relating to the failure of metal-on-metal implants.
The four-month hearing - which centred on Pinnacle Ultamet implants - concerned the preliminary issue of "whether or not the defendant is liable to the claimant, subject to any development risk defence".
On Monday in London, Mrs Justice Andrews ruled that DePuy is not liable to the claimants.
The contested action was brought on behalf of patients who claim to have been injured as a result of the early failure and consequent revision surgery of their metal-on-metal prosthetic hips.
Hundreds more metal-on-metal claims against a number of other manufacturers were put on hold pending the outcome of the trial.
Samantha Silver, of law firm Kennedys who acted for DePuy, said later: "The principles established in this judgment apply to all products used by consumers that come within the Consumer Protection Act.
"The decision will have significance for all manufacturers and distributors, not just those in the life sciences industry, as well as their insurers.
"It provides manufacturers with confidence that the courts can take into account the benefits and the inherent risks of certain products, for example, in cases where there is a known side effect or complication and the overall benefits outweigh the risks.
"The decision that the safety of new products should be compared to products existing at the time they are introduced to the market also safeguards the position of those developing new, potentially life-enhancing, technologies in the future."
The legal teams representing the claimants said in a statement that they were "extremely disappointed" by the judgment.
They said: "This is a complex and lengthy judgment, the implications of which are being carefully considered, however, the impact it will have on consumer safety and the ability of consumers to get redress, cannot be underestimated.
"We are in touch with our clients to discuss what next steps could be taken."
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News UK patients lose legal claim that DePuy metal-on-metal hip implant was “defective”
May 22, 2018 | British Medical Journal
By Clare Dyer
More than 300 people who were fitted with a metal-on-metal hip implant that is no longer used have lost a UK group legal action against the US manufacturer.1
The claimants argued that DePuy International’s Pinnacle Ultamet hip replacement released metal debris into the surrounding tissue and was a defective product under the UK’s product liability law.
But at the High Court in London Mrs Justice Andrews ruled that the adverse reactions of some patients to metal wear debris was a known consequence of metal-on-metal hips and did not amount to a defect under the law.
She also dismissed the claimants’ secondary argument that the implant had an “abnormal” potential for damage because it performed less well than other types of implant. She cast doubt on the reliability of data on revision rates and concluded that there was not enough evidence to conclude that rates for the Pinnacle Ultamet, which was withdrawn from the market in 2013, were materially worse.
The case was brought under the Consumer Protection Act 1987, which brought an EU directive on strict liability into UK law. The law made manufacturers liable without the need for negligence to be proved if they put a defective product on the market.
But Andrews said that the claimants had failed to prove that the hip joint “did not meet the level of safety that the public generally were entitled to expect at the time when it entered the market in 2002” or that it “carried with it an ‘abnormal risk’ of damage, as alleged.”
US litigants who sued over metal-on-metal hips have won millions of dollars in damages. But litigation in the UK against other manufacturers of metal-on-metal implants had been put on hold pending the outcome of the Pinnacle case.
The legal teams from four firms of solicitors representing the UK Pinnacle claimants said in a statement that the impact of the judgment on the safety of consumers and on their ability to get redress could not be overestimated. The statement said, “This is a complex and lengthy judgment, the implications of which are being carefully considered . . . We are in touch with our clients to discuss what next steps could be taken.”
The law firm Kennedys, representing DePuy, said that the judgment “averts what could have been potentially serious implications for product innovation.”
The judge highlighted what she described as “panic” about metal-on-metal hips, fed by “increasingly hysterical media reporting.” She noted that psychologists who gave evidence in the case “agreed that the sensationalist media reports probably did have some effect both increasing the rate of and accelerating the timing of metal-on-metal hip implant revisions.”
She said that media coverage had included a joint investigation by the BBC programme Newsnight and The BMJ, “which referred to ‘poorly regulated and potentially dangerous’ hip devices, and suggested that wear debris might be carcinogenic.”2
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