Kennedys secures major ruling for manufacturers and insurers in landmark group litigation

DePuy International Ltd’s ULTAMET® Metal-on-Metal (MOM) Articulation, a total hip replacement prosthesis, is not defective under the Consumer Protection Act 1987 (the Act), the High Court has ruled today in a decision likely to affect many hundreds of other claims against manufacturers of MOM hip implants in the UK and the EU generally.

The decision, in what is one of the largest product liability group actions in recent years, averts what could have been potentially serious implications for product innovation.

Kennedys acted for DePuy in a group action brought by more than 300 claimants. It led to a four-month trial, the first of its kind in the UK, during which the court received evidence from over 40 witnesses, including 21 experts ranging in discipline from orthopaedics to engineering, and behavioural psychology to statistics.

In a comprehensive judgment of 170 pages, the Honourable Mrs Justice Andrews DBE found that although a MOM product would, by its very nature, produce metal wear debris – which in turn might cause an adverse reaction in some patients – that was not in itself a defect for the purposes of the Act.

She agreed with DePuy’s argument that a known consequence of the ordinary use of a product could not amount to a defect, and said this aspect of the claimants’ case was “untenable”.

Applying the claimants’ logic to this case could have rendered all hip implants defective under the Act, as material loss produced by wear occurs in every type of hip implant (whatever their bearing surface: metal or polyethylene), with the potential to cause an adverse reaction.

The claimants’ secondary argument was that the ULTAMET Articulation had an “abnormal” potential for damage, based on data which they asserted showed that it didn’t perform as well as other non-MOM prostheses which were introduced at the same time as, or even after, the ULTAMET Articulation. The claimants’ arguments here, if successful, could have had a potentially serious impact upon manufactures’ appetite for innovation - where a new product’s performance was compared not only to existing comparables, but also to future alternatives.

The judge directed that hindsight has no place in the formulation of the expectation of safety, and that ULTAMET should be compared to other prostheses that were on the market at the time the ULTAMET was introduced. Having considered the evidence in detail, the judge concluded that the ULTAMET performed as well as or better than those other prostheses and had no increased risk of harm. Indeed, Andrews J described ULTAMET as “a well-designed product with many positive engineering features”.

Finally, the judge also raised an important public health issue by highlighting “the panic about MOM hips that was engendered in consequence of the increasingly hysterical media reporting”.

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.

Further, she noted that “the expert psychologists agreed that the sensationalist media reports probably did have some effect both in increasing the rate of, and accelerating the timing of MoM hip implant revisions”.

Kennedys Partner Samantha Silver, 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.”

Amantha Silver Square
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.

It is not yet known whether the claimants will appeal the decision.