Judge finds DePuy metal-on-metal hip implant not “defective”25/05/18
This week the Court handed down judgement in what is already being described as a landmark case for product litigation. The Court confirmed that a defect is characterised in a product by the abnormal potential for harm.
The judgment in the test case Gee & Others v DePuy International Ltd (The DePuy Pinnacle Metal on Metal Hip Litigation) has concluded in favour of the defendant manufacturers. There were 312 claimants in the group litigation who brought claims against DePuy in respect of their prosthetic metal hip implants (“Pinnacle prosthesis”). All of the claimants claim to have suffered an adverse reaction to metal wear debris generated by their prosthesis which required them to undergo revision surgery. The question in the test case was whether DePuy were liable to the Claimants in respect of its Pinnacle prosthesis, subject to any development risk defence.
The Claimants argued that the Pinnacle Prosthesis were defective because they had a “tendency” to cause soft tissue damage around the hip known as Adverse Reaction to Metal Debris (“ARMD”), or, in their alternative case an “abnormal propensity” to cause ARMD.
Mrs Justice Andrews concluded:
- That the propensity of a MoM hip to shed metal debris through normal use, to which some patients may suffer an adverse immunological reaction, is not a “defect” in the product with the meaning of the Consumer Protection Act 1987 (“the Act”) or Product Liability Directive 85/374/EEC (“Directive”) and that the MoM prosthesis did not become defective because adverse reactions were recorded.
- In respect of the alternative case, the Claimants failed to prove that the Pinnacle prosthesis did not meet the level of safety that the public were entitled to expect at the time the product entered the market in 2002.
- The NICE 2000 guidance is not a safety benchmark and the data in the UK National Joint Registry was unreliable for the relevant time period.
Impact on future litigation
The decision will not only be influential for other 306 metal on metal claims (the judgment was handed down in respect of the six test claims only) but also other consumer and manufacturer litigation. It will assist both Claimants and Defendants in understanding what makes an appropriate claim as clarity has been given to important issues such as in deciding whether a product meets the correct standard such as risk-benefit and availability.
Mrs Justice Andrews rejected the Claimants’ argument that the potential for damage could amount to a defect under the Act and Directive. In doing so the Court rejected the argument where potential for damage is a normal risk associated with normal use of a product. Instead, it was confirmed the correct position was that:
- A Claimant must establish that there was an abnormal risk in the allegedly defective product.
- In analysing an abnormal risk, the Court can consider comparative products available at the time. (The Claimants had failed to adduce persuasive evidence that the Pinnacle prosthesis had an abnormal risk of revision when compared to other prosthesis available).
- In analysing an abnormal risk, the Court can also consider the expectations of persons generally at the time the prostheses were introduced to the market.
How Capsticks can help
We have assisted a number of surgeons and their indemnifiers in relation to claims brought by Claimants who have been provided with MOM prostheses as well as litigation around PIP implants and transvaginal mesh.
Capsticks have a dedicated team of insurance specialists who can advise in relation to potentially defective products associated product liability claims as well as clinical trials. Please contact Majid Hassan, Ed Mellor or Lucy Wheeler.