Metal on Metal: Product Liability Review; Medical Implants03/11/22
At our webinar on 29 September, we reviewed Product Claims in a healthcare setting, which can arise as:
- a pure product liability claim
- a combination of a clinical negligence claim and associated product liability claim; which may involve producer arguments, where a surgeon has combined two components in an unapproved way
- a combination of negligence, product liability and contract claim; which can be seen, for example, in a claim against a hospital following a treatment package for cosmetic procedures.
The key principles are found in the Consumer Protection Act 1987 (“the Act”) provisions and then interpreted by case law.
A claimant has the option of bringing a claim in tort. This can be complicated where the relationship between the claimant and the producer is unclear and the limitation period for a claim for personal injuries is three years and not the 10 year longstop available under the Act.
For statutory claims, strict liability applies. There is no need to prove negligence or fault, however, a claimant still has to prove that there was a defect which caused the alleged damage. If a claimant is able to prove this, the Act confirms that liability will attach to any of the following:
a) the producer
b) any person who holds themselves out to be the producer of the product (e.g. via branding)
c) an importer or supplier.
These issues have been seen in healthcare settings in litigation such as the PIP breast implant claims and more recently in metal-on-metal (“MoM”) hip implants. Hospitals or surgeons individually could be deemed to be a “supplier” of these products.
The Question of Defect
Following the cases of Wilkes v DePuy, Gee v DePuy and Hastings v Finsbury Orthopaedics (a Supreme Court decision) the current state of play is:
- safety is the key test, but no medical product can be absolutely safe
- the potential benefits of a product have to be balanced against risk
- assessment of the standard of safety that the public is entitled to expect is an objective approach
- there is no absolute liability for the harm caused by a harmful characteristic. The natural propensity of all hip prostheses to eventually fail was not found to be a defect, and nor was their propensity to shed particulates as a result of wear
- expressions of professional concern about a product are not necessarily indicative of defect, nor is a manufacturer’s decision to remove a product from the market. These are matters for factual evidence.
Hospitals may control the range of prosthetics available to surgeons, meaning surgeons have a limited choice to offer to patients. It is important therefore that hospitals retain the following:
- Instructions for Use (IFUs) – ideally kept within the records of the patient
- individual surgeon statistics for a particular surgery
- relevant safety alerts from the Medicines and Healthcare products Regulatory Agency (MRHA)
- consider and action any representations from surgeons or staff about the selection of products available
- all correspondence with manufacturers on product use/withdrawal.
Surgeons will need to consider:
- ensuring that they have adequate insurance cover for product liability claims
- retaining IFUs in the medical records and documenting discussion of the warnings from the IFUs with patients as part of the consent process. These may be difficult to obtain the contemporaneous version years down the line
- keep detailed correspondence with regard to any concerns raised by practitioners/end users regarding selection of prostheses.
How Capsticks Can Help
Capsticks are routinely instructed to assist insurers and their insureds in relation to product liability claims both as individual claims and within group actions.
We can assist with the management of these claims and can advise in relation to minimising the risk of claim within a hospital setting. For any further guidance relating to the issues discussed, please contact Sarah Bryant or Majid Hassan.