Cumberlege Report

Allan Dorans Excerpts

Thursday 3rd February 2022 Westminster Hall

[Allan Dorans (Ayr, Carrick and Cumnock) (SNP)]

May I take the opportunity to thank the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this very important debate?

The Cumberlege report makes nine strategic recommendations, and I will speak later on recommendation 3—to establish an independent redress agency. Other hon. Members have spoken eloquently this afternoon on the devastating effects of vaginal mesh implants and the drug sodium valproate, but on behalf of my constituent Nan McGradie and other individuals and families tragically affected, I will highlight specifically the dreadful harm caused by the drug Primodos.

In January 1975 my constituent, Nan, was prescribed two Primodos tablets as a pregnancy test by her doctor. It was subsequently confirmed that at that time she was about seven or eight weeks pregnant. There is considerable evidence indicating that those women who took the drug, prescribed by their GPs, and were pregnant at the time gave birth to babies with serious birth defects, including deformities and disabilities, missing limbs, cleft palates, brain damage, and damage to internal organs. In some cases the women miscarried or had stillbirths.

At the time, in 1975, Primodos had already been banned for use as a pregnancy test for five years in Norway and Sweden. When my constituent’s daughter, Michelle, was born in August 1975, it was immediately discovered that she had a hole in her diaphragm, which had allowed her bowel and spleen, part of her liver and kidney to be forced into her chest cavity, crushing her lung. Michelle was not expected to live, but thanks to the skills of our NHS she survived and is now 46 years of age. Throughout her life, Michelle has endured numerous operations and surgeries and long, long periods of hospitalisation, has suffered severe health issues, including breathing difficulties, a weakened immune system, numerous bowel obstructions and inflammatory bowel infections, and has been unable to conceive children. The effects of those debilitating physical and psychological medical and extremely challenging health conditions suffered by Michelle for the last 46 years just cannot be adequately described in words.

Let me return to the recommendations in the Cumberlege report and specifically recommendation 3, which states:

“A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”

The final Government response to it states:

“We do not accept this recommendation. We do not believe that a redress agency would make products safer and support our commitment to patient safety. We also believe it is already possible for government and others to provide redress where this is considered necessary, the government therefore has no plans to establish an independent redress agency.”

The decision by Government not to establish a new agency is callous and cruel and takes no account of the suffering or experience of the people who suffered as a result of a failure by successive Governments to protect them. It was the Government’s responsibility to protect people. The decision not to establish an agency has resulted in anger, frustration and great sadness for all, but especially those affected by the tragic consequences of vaginal mesh implants, sodium valproate and Primodos. Those feelings are perhaps best illustrated by direct quotes from those most affected by the Government failures. They include members of the patient reference group set up under the Cumberlege report. That was designed to be a forum for the Government to listen to the views of the people affected.

The people who took part in meetings of the patient reference group agreed that if the recommendation for an independent redress agency is not taken forward, those harmed by such medicines and medical devices, both in the future and in the past, will never get justice. They strongly rejected the notion that litigation was a viable substitution for a redress agency or as an acknowledgment that patients have suffered harm. Many people just do not know where to seek redress for harm, and many cannot access legal services, primarily because of the cost. It should be noted that many of the victims of such circumstances were women born in the 1950s. They have already been punished financially by the Government’s robbing them of their pensions.

On 24 June 2021, a Minister attended a meeting to listen to those on the patient reference group sharing their experiences of the harm that they suffered. The group also shared the harrowing and distressing experience of their families, which elicited only platitudes from that Minister. The group were advised that litigation was the right way to obtain redress, even though that Minister was fully aware of the cost implications of funding legal action against the Government, whose regulators were responsible for the avoidable harm to those families. The immediate response from that Minister regarding litigation confirmed that she obviously had not listened, as there was neither empathy nor acknowledgment of the dreadful effects suffered by the families.

The patient reference group also felt strongly about the high emotional strain of the few successful cases, and expressed anger about the trauma that individuals and their families are forced to go through to obtain sufficient finances to survive, especially when their daily lives have already been made difficult through no fault of their own. Many expressed anger and insult about public money being repeatedly mentioned as a barrier to redress, and used the term “guilt trip” in response. Many members of the group also felt patronised. Group members clarified that an independent redress agency would provide a place for harmed individuals to recoup the costs incurred by medical failings, and felt strongly that not having a redress agency is “a massive failing” by the Government.

The patient reference group was set up to gather and understand the views of the people most affected, but the Government have clearly not listened. Ministers advising litigation to obtain redress is a disgrace that shames this Government. They fail to accept, or even acknowledge, any moral responsibility for any failings. Immeasurable damage has been done to the individuals and families who have been failed by successive Governments’ lack of action and failure to prevent harm. The Government’s approach has been nothing less than reprehensible and a national disgrace. Setting up an independent redress agency is the right thing to do, and the Government should do it now, without any further delay.

Although the Cumberlege report is appropriately called “First do no harm”, the Government, medical bodies and pharmaceutical companies have not only done harm, but continue to do so by failing to address ongoing issues and the concerns of those affected. The Government now have the opportunity to right those tragic historic wrongs, and I urge them not only to implement the recommendation relating to an independent redress agency, but to implement in full and without further delay all the other outstanding recommendations in the Cumberlege report.

I pay tribute to Baroness Cumberlege and her team for producing the “First do no harm” report, and to Mrs Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests and vice-chair of the patient reference group, for campaigning tirelessly for over 40 years for justice for the Primodos children and families. I also pay tribute to the hon. Member for Bolton South East (Yasmin Qureshi) for her exceptional support for the campaign, as chair of the APPG on hormone pregnancy tests, and to all others who have been involved in campaigning for justice, representation and support for those tragically affected by the consequences of vaginal mesh implants, sodium valproate and Primodos.