Medical Product Liability

Question

15:24:00

Asked by

To ask His Majesty’s Government whether they plan to raise the statutory limitation period for bringing a claim for medical product liability from 10 years to 20.

My Lords, our sympathies remain with those affected by faulty medical devices, and I pay tribute to the campaigners on these issues. The UK product liability legislation has been in place since 1987. My department is undertaking a review of this legislation and we will set out next steps in due course. Following this review, should we believe that changes are necessary, we will bring forward the necessary primary legislation to ensure that it remains up to date and fit for purpose.

My Lords, tens of thousands of women have been impacted by defective medical devices, such as certain contraceptive or breast implants or vaginal mesh. Men are impacted too through hernia mesh and hip replacements. The current 10-year statutory limit starts from the moment of manufacture, not use. Symptoms may take many years to become known, and that can be compounded by frequent misdiagnosis. Of course, we need to ensure that new and innovative products reach market, but the current limit means that many people are simply timed out of making claims for often life-changing impacts from faulty products. I am really pleased to hear the Minister confirm that this will be reviewed. As part of the review, can the Minister agree to meet campaigners from the Raise the Limit campaign to discuss this further?

My Lords, I understand that my noble friend Lady Merron is planning to engage with those groups representing the patients who have been affected and to follow up on The Hughes Report and listen to their experiences. We will be contacting those groups in due course.

My Lords, do my noble friend the Minister and ministerial colleagues in her department and the Department of Health intend to meet the Patient Safety Commissioner in the interim, while these issues are being discussed? As the noble Baroness has said, these particular issues to do with breast implants and other medical devices have, in some areas, been found to be deficient.

My Lords, we very much welcome the appointment of Dr Henrietta Hughes as the Patient Safety Commissioner. We have been looking at the details of her work and hope to come back in due course, particularly on the report that she produced in February. I understand that my noble friend Lady Merron has already met the Patient Safety Commissioner; she has been on a joint visit with her and plans to meet her again in the future.

My Lords, there are over 600,000 medical devices used in the United Kingdom. Worldwide, there are probably over 2 million medical devices being used. People obviously want the devices as soon as they are available on the market without having been tested medically first. I am pleased to hear the Minister say that the Government intend to review the legislation, particularly as it applies to class 3 devices; they are mostly implant devices and cause most of the damage, including the mesh and other implanted devices. Can the Minister confirm that the Government will look in a stratified way as to where the legislation should apply and to what category of device?

My Lords, we have already done considerable work on this, and I pay tribute to the noble Baroness, Lady Cumberlege, for her original work on this, as well as now to the Patient Safety Commissioner. We are looking in detail at these issues and will continue to do so. I should make it clear, however, that should we make any changes to the legislation, it will require—as I understand it—primary legislation. It will not in any case be retrospective, so all we can do is look at products going forward. Obviously, patient safety is our primary concern and is absolutely at the forefront of our mind in taking these issues forward.

My Lords, in discussing patient safety, I pay tribute to my noble friend Lady Cumberlege for all her work on patient safety and medical devices over the years. I think noble Lords were very reassured to hear from the Minister that the Government are going to review the timeframe on medical product liability. Is she able to give us a bit more detail about that process, perhaps including timeframes, and what the process will entail, including consultation and who will be consulted?

The Government are reviewing our product liability law but, as I say, making those changes requires primary legislation. Before we do that, we will consult all the appropriate parties to ensure that any updates we make to our product liability legislation continue to give the best protection to consumers and patients. It is of course important that we liaise with colleagues in the Department of Health and Social Care to ensure that any specific concerns about medical products are taken into account. That review is ongoing and will be underlined by full consultation.

My Lords, the review mentioned by the Minister is very welcome. One major element will be that, on many occasions, women who make complaints in medical settings are not listened to in the way we would want. We have seen many reviews of maternity and other services where women’s fears, concerns and complaints have been ignored. This is a very important element because, since that will take time, it makes the time for complaints even longer. I hope that will be taken on board.

The noble Baroness makes a very important point: women’s voices have often not been heard in the past and we are absolutely determined to make sure that they are in the future. We will take steps to reach out, to make sure that everybody feels that if they have a concern or complaint, it is taken seriously. I know my colleagues in the Department of Health will absolutely follow that up.

My Lords, in other areas of the law of limitation of actions, courts do not necessarily have a hard and fast line: the court is given a discretion to disapply the limitation period depending on the particular circumstances. Does the Minister think that that would be a helpful way of dealing with what can be a real injustice?

I bow to the noble Lord’s greater knowledge of this issue. My understanding is that any changes we want to make will require primary legislation, and that claims under the current legislation cannot be made more than 10 years after the product which caused the damage was supplied. There may be exceptions to that and perhaps the noble Lord and I could discuss that outside.

My Lords, does this cover generic medicines too?

The product liability legislation covers all types of products, not just medical products, so I am sure generic medicines will be covered by it as well.

My Lords, the Minister makes the important point that primary legislation will be needed and that it cannot be retrospective. Can she give a commitment to those people who will be suffering from a possible product defect or failure that the primary legislation will be brought forward in this Parliament?

As I say, this is a matter for our colleagues in the Department of Health and I know that they will be taking these concerns into account. For the time being, all I can say is that they will be looking at the issues and coming forward with legislation that they think is most appropriate to address these issues.

My Lords, I do not wish to add unnecessarily to the list of concerns, but only last week the EU, after many years, amended its product liability directive, and there is now a 25-year limit for latent personal injuries from products. We are in a position where, if you are going to market, you will potentially go to market in the UK rather than in the EU because, as the Minister said, it is not retrospective. I impress on her the urgency of this, because we are completely out of step with our EU neighbours.

As the noble Baroness rightly says, the EU is proposing to extend the limit for claims to 25 years in cases where the latency of a personal injury prevented the claim being brought within 10 years. As I say, this will apply only to products placed on the market following the introduction of the necessary legislation by member states. Again, I say that, sadly, it will not be retrospective, but we are of course looking at what is happening in the EU and talking to our EU partners.