Hormone Pregnancy Tests

Maria Caulfield Excerpts

Thursday 7th September 2023 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I thank the hon. Member for Bolton South East (Yasmin Qureshi) for securing the debate and all right hon. and hon. Members who have taken part in it. We cannot help but be moved by the many cases that have been brought forward this afternoon. This is the first time I have been able to speak either in this Chamber or in Westminster Hall on Primodos because, as many Members have said, there were legal proceedings that ended in May. The claimants had until 11 August to make an application for permission to appeal, which they did not do in that time, so today is my first opportunity since that legal action to speak on it. A second claim is being issued by those who believe that they were harmed by hormone pregnancy tests, against Bayer/Schering. That claim was stayed pending the outcome of the first case and, given that the first claim was struck out by the court, there are now discussions regarding the next steps with that claim. However, I am free to speak today on the issues that we have discussed in the debate.

I want to be clear, as a Minister who is responsible for patient safety, that the patient safety element is the most pressing and important part of my role. Baroness Cumberlege is also a constituent of mine, so hon. Members can be assured that she lobbies outside Parliament as well as inside.

Baroness Cumberlege conducted a review, and the Government have accepted and made progress on most of those recommendations. As has been said, an apology was issued by Government Ministers at the time when they responded to that report. We have appointed an independent Patient Safety Commissioner, and Henrietta Hughes is doing an outstanding job holding the Government to account.

I will touch on the issues around redress in just a moment. We have set up the mesh centres for those affected by pelvic mesh; I meet regularly with those female campaigners to hear their feedback on the effectiveness of those centres, and there is work going on to review that. The MHRA itself is revising its practice as a result of Baroness Cumberlege’s report.

[Dame Angela Eagle]

I think the Minister for her generosity in giving way, but this sounds like a typical civil service-drafted speech, if I may say so, mentioning everything but the issue we are talking about. We are not talking about mesh; we are talking about Primodos, and we want to hear about redress. Can she now please address those points?

[Maria Caulfield]

I can show the hon. Lady my remarks—they are on the back of this paper, and I have been writing them down during this debate. I am only two minutes into my speech and I am addressing some of the points that were made. I will of course come on to Primodos as well.

It is important to recognise that we did take those issues in Baroness Cumberlege’s review seriously. We could not look at the issue around Primodos at that time because of the legal case, which I have touched on, but there have been some reviews. My hon. Friend the Member for Mid Norfolk (George Freeman) was here just before this debate. In his time as Minister for Life Sciences, he took the campaigns and the evidence around Primodos so seriously that he set up the expert review in 2014 to look at the evidence that was in place. I hear very loudly this afternoon some concerns about that expert working group and that maybe evidence was either misinterpreted or not looked at, but that expert working group did look at the evidence at that time and also issued a public call for evidence.

[Sir Mike Penning]

The so-called expert group changed the remit that it was given, with no recourse, as I understand it, to any Minister for permission to do so. It changed the terms of what it was supposed to look at, which is not what it was asked to do in the first place.

[Maria Caulfield]

I hear my right hon. Friend and, as I said, I will come on to that specifically towards the end of my remarks.

There were further evidence reviews. Hon. Members have touched on the evidence from Heneghan et al., and from Brown et al. in 2018. Those were looked at, and again there was no evidence of causality found in those reviews.

[Hannah Bardell]

Will the Minister give way?

[Maria Caulfield]

I will, but I need to make some progress on addressing the points made.

[Hannah Bardell]

Causality is one of the key issues here, because it is very difficult to prove. The only way it can be proven is if those tests were done on pregnant women, and we all know that would be utterly ridiculous and absurd. However, we do know that there was association, and the bar has been set so high that it has become impossible for people to get justice. That responsibility lies at the door of the Government. Thalidomide campaigners were able to settle with the company. We need to look at how we can make that happen for Primodos campaigners, but the Government also need to look at lowering the bar.

[Maria Caulfield]

I take the hon. Lady’s point that causality is a high bar. I am just going through the fact that there have been a number of reviews of the evidence so far. Baroness Cumberlege, when she set out the remit for her review, also stated from the outset that she would not be able to touch on causality for many of those reasons. There have been a number of reviews of the evidence, but I hear from right hon. and hon. Members some concerns that those reviews still have not got to the bottom of the issues that the families and those affected by Primodos feel that they have faced.

On the next steps, I have heard hon. Members. I heard my right hon. Friend the Member for Chipping Barnet (Theresa Villiers), who was clear about the drug being taken even after evidence had emerged. I heard from my hon. Friend the Member for Stourbridge (Suzanne Webb) about the effect on her constituent Helen and her family. I heard from my right hon. Friend the Member for North East Somerset (Sir Jacob Rees-Mogg) about his experience in Government and why these things often take so long. And, of course, I heard my right hon. Friend the Member for Maidenhead (Mrs May), who set up the Cumberlege review in the first place. My hon. Friend the Member for Leigh (James Grundy) has lobbied me hard outside this place on behalf of his constituent Marie Lyon and the many others who have been affected.

Now that we are in between the first and—potentially—second court cases, I am keen to meet and get to the bottom of right hon. and hon. Members’ concerns.

[Mrs May]

I wonder whether the Minister might clarify one point about the second court case. The Government were a party to the first court case; that was the argument that they used for being unable to come to a decision. Are the Government a party to the second court case? If not, the second court case seems to me irrelevant.

[Maria Caulfield]

I will come to that in a minute. We are in between cases, and I want to make progress while we do not have a live case. Discussions are ongoing at the moment.

I am the Minister with responsibility for patient safety, and on this matter, I, rather than officials, wrote my speech. We all know that tragic events and accidents can happen, but I am weary of meeting families up and down the country who are victims of the injustice in the health service at the moment. I and the Secretary of State met the families at the Countess of Chester Hospital only last week. I met the families from Tees, Esk and Wear valleys, whose young children died by suicide. I met, as you will know, Mr Deputy Speaker, the families whose children died in east Kent, where there was an inquiry. I met Janet and Emma, the sodium valproate campaigners from In-FACT—the Independent Fetal Anti-convulsant Trust—and the women who lead the mesh campaign. I hear day in, day out about the injustice that many have to face, and about the fight to get answers to basic questions when things go wrong.

I am very happy to say from the Dispatch Box that I will meet the all-party parliamentary group, the hon. Member for Bolton South East, and other hon. Members who have taken part in the debate. I am very happy to commit to a meeting with my hon. Friend the Member for Leigh and with Marie Lyon, as well as with any other families who wish to meet, to discuss the Primodos case. If there are concerns that evidence was left out or not scrutinised, or that evidence in previous reviews is disputed, I am very happy to look again at that evidence and to leave no stone unturned until we absolutely get to the facts of the matter.

The right hon. Member for Kingston and Surbiton (Ed Davey) mentioned the letter that has gone out to those taking part in court cases. I do not want people to be in a position where they feel that they cannot get justice simply because they cannot afford to, so I commit to looking at that matter and addressing the points that he made as soon as I get to the Department.

I do not want to come back to the Dispatch Box to discuss the issues around Primodos on an ongoing basis. If patients feel that there has been an injustice, and that there is evidence to support that, I am very happy to look at it again. There may be future court cases, as my right hon. Friend the Member for Maidenhead said, but we are at a point where we can look at that now.

[Mrs May]

I am sorry; I did not say that there may be future court cases. The Minister herself referred to a second court case, and I asked a simple question about whether the Government would be a party to that case. I am grateful, and I am sure that the families will be grateful, that the Minister has opened the door to sitting down with and hearing directly from the families and campaigners. She says that she is prepared to look at any evidence that comes forward. The Cumberlege review is the evidence; it sets it out very clearly. That is all the Government need.

[Maria Caulfield]

To be specific on that point, the Government are involved in a second claim. We are not sure whether that claim will go forward—discussions about that are ongoing. As the appeal timed out on 11 August, I am happy to commit today to looking at the evidence and the Cumberlege review. Baroness Cumberlege is my constituent, and I am sure she will be pushing me for that.

[Ed Davey]

To follow on from the point made by the right hon. Member for Maidenhead (Mrs May), the Cumberlege review has concluded. There are recommendations. Is the Minister saying from the Dispatch Box that the Government are not accepting those recommendations? We want to hear that they are going to implement those recommendations, not hear more evidence—implement them!

[Maria Caulfield]

Finger pointing is not exactly effective. As I set out at the beginning of my remarks, we have accepted the majority of those recommendations. We could not accept the Primodos ones while there was an ongoing court case. I have given my commitment from the Dispatch Box to review the outstanding recommendations in relation to Primodos, because I want to get to the bottom of this once and for all and provide justice for the families. I have heard from Members across the House about their concerns and the outstanding recommendations of the Cumberlege review, and my commitment is to look at those now.

[Hannah Bardell]

It seems to me that we are caught up in a quagmire of bureaucracy. We have had the Cumberlege review. We know what the results are. The Government said incessantly that they would not address the Primodos matter because of the court case. We now know that the court case was, in some respects, flawed, because the complainants and victims were not able to take their case forward as their information was withheld by the legal firm. As the right hon. Member for Kingston and Surbiton (Ed Davey) said, they are now being treated in a hostile manner by the Government by being told that they will be sued for over £10 million if they take another case forward. That is an utterly preposterous situation. If the Minister really wants to get to the bottom of it, she needs to implement fully the Cumberlege review and ignore the nonsense that has gone on in the courts.

[Maria Caulfield]

I do not want to test your patience, Mr Deputy Speaker, because I know that I am over time, but I have made the commitment to review the Cumberlege recommendations for Primodos patients. For those who have been affected by sodium valproate and mesh, we are making huge progress. Only this week, we introduced a statutory instrument so that sodium valproate can only be dispensed in the manufacturer’s original packaging. We have the pregnancy prevention programme, which is drastically reducing the number of babies born to those taking sodium valproate. We are installing the registry, so that women on sodium valproate are better cared for and not taking that medication. Now that 11 August has passed and the claim was not followed up, I am looking at the Primodos recommendations as well. My commitment is to come back to the House and update Members on the progress on those matters.

--- Later in debate ---

[Maria Caulfield]

Will the hon. Lady give way?

[Yasmin Qureshi]

We want to sit down with the Minister, and we want her to say to us, “This is what we are going to do about the Primodos case.” We do not want the Minister to tell us the problems. We want a system of redress right now—that is what we want from the Minister—and I hope that when we have that meeting, she and her officials will present to us the practical action they are going to take so that all the people who have been suffering for decades and decades actually get justice. We want her to tell us not about what has happened before or about the court cases, but about the actions she will take based on what the Cumberlege review said. [Interruption.] The Minister is muttering, but in the past it has sometimes taken us months and months to get a meeting with Ministers. I am glad that she has reassured us, and I hope that we will get a meeting in the next couple of weeks and that her and her officials will present a concrete plan for how to get redress for the victims. [Interruption.]

[Yasmin Qureshi]

I am sorry; I did not realise the Minister was asking to intervene. I give way.

[Maria Caulfield]

I just wanted to reiterate that I have pledged to meet the APPG and all its members. I have also pledged to look at the recommendations specifically in relation to Primodos. I think it is important to meet the families and the APPG, so that we can make progress on this issue.

[Yasmin Qureshi]

I thank the Minister for that intervention. I look forward to meeting her and her officials, and to a great scheme that will help the victims of Primodos. I remind her that if we do not get our meeting, or if we do not get a satisfactory result, we will be back again—all of us. We have been fighting for the past 10 or 12 years, and we will continue to fight this campaign, because the whole House is united behind it. I hope we will get positive news at our next meeting.

Question put and agreed to.

Resolved,

That this House notes that children were born with serious deformities due to the hormone pregnancy test drug Primodos, which was taken by expectant mothers between 1953 and 1975; further notes that official warnings were not issued about Primodos until eight years after the first reports indicated possible dangers; observes that the report by the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests in 2017 was inconsistent with other academic reports; notes that the Independent Medicines and Medical Devices Safety Review, First do no harm, found that Primodos caused avoidable harm; further notes that the Government has refused to acknowledge the recommendations by the Independent Medicines and Medical Devices Safety Review relating to Primodos families; and calls on the Government to fully implement the recommendations in the Independent Medicines and Medica al Devices Safety Review and to set up a redress fund for families affected by Primodos.