Over 300 patients have lost a legal battle with medical device manufacturer, DePuy Synthes, after the group claimed one of the company’s hip implants was defective.
Hip replacement
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.