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First do no harm: outcomes from the Cumberlege Review

"Their testimonies haunt me. Their bravery compels me to right their wrongs." Baroness Cumberlege

As the third annual Women’s Rights in Healthcare event moved online this year, in the form of weekly webinars throughout autumn, the first in the series took a closer look at the Cumberlege Review and discussed the ‘First Do No Harm’ report.
 
The report followed the investigation into the consequences of the use of sodium valproate, an anti-epileptic drug that has resulted in birth defects when used during pregnancy, Primodos, a hormone-based pregnancy test used in the 1960s and ‘70s, and vaginal mesh surgery, used to treat pelvic organ prolapse and urinary incontinence.
 
Maria Panteli, partner from the Leigh Day medical negligence team, discussed the implications of the Review with Boz Michalowska-Howells, head of product safety and consumer law, and Zahra Nanji, a solicitor investigating potential claims arising from defective medical devices and pharmaceuticals.
 
Maria Panteli explained that the report from the Independent Medicine and Medical Devices Safety Review, published in July 2020, was a long-awaited and very welcome outcome for thousands of women and their families who have been significantly affected by the use of these particular medical interventions and have campaigned for decades for their experiences to be heard.
 
Zahra Nanji provided historical context by describing how a lack of understanding about women’s health needs is commonplace in the healthcare landscape, explaining: “The issues go back not just decades, but centuries, that female exclusion at the point of medical trials and testing has resulted in women’s diseases often being missed entirely, misdiagnosed or simply termed a ‘mystery’.”
 
For the women who shared their experiences for the Review, common themes emerged: a lack of information to make informed choices, a struggle to have their voices heard and their accounts believed, feelings of guilt and abandonment, and not knowing who to turn to when things went wrong.
 
The First Do No Harm Report makes nine clear recommendations to ensure redress and to prevent these events from occurring again including: establishing the role of an independent Patient Safety Commissioner, formation of  a Redress Agency to administer decisions by looking at systemic failings rather than blaming individuals, a central patient database to allow research and audit device safety and patient reported outcomes, greater transparency of the financial relationships between clinicians and medicines and device manufacturers, and a government task force to implement the Review’s recommendations.
 
Boz Michalowska-Howells explained how Leigh Day lobbied peers ahead of the second reading in  the House of Lords of the Medicines and Medical Devices Bill and summarised the debate, quoting from Baroness Cumberlege’s impassioned opening, as she recalled her experiences of talking with hundreds of affected women:
 
“Their testimonies actually haunt me. Their bravery compels me to right their wrongs…The root cause was the failure of the healthcare system as a whole - and by some in the medical profession - who ignored the concerns of women and their families.”

The House strongly supported the call for a Patient Safety Commissioner and a Redress Agency. Lord Phillip Hunt and Lord Dan Brennan, in particular, were vocal proponents of implementing the Report’s recommendations.
 
Boz and her team have been working closely with sodium valproate campaign groups and wrote on their behalf to Secretary of State for Health and Social Care, Matt Hancock, to advise on membership of the task force, to ensure that any proposals are based on collective experience and relevant research, and that schemes meet not only the current needs of patients, but are sufficiently responsive to cater for unforeseen circumstances in the future.
 
Maria focused more closely on sodium valproate, the impact of Fetal Valproate Spectrum Disorder (FVSD) on families, the failings in the healthcare system, how the redress proposed by the Review might apply to them, and how litigation may still be the route for some.

By outlining the timeline of events from when possible harm was first acknowledged for sodium valproate, through to the most recent NICE guidelines in 2018, Maria showed that there had been many opportunities for medical professionals to be aware of potential harm of using the drug.
 
In particular, in 2004, the first NICE guidelines on the management of epilepsy were published, recommending that women needed accurate information and individualised counselling to make informed decisions.  The updated guidelines in 2012 contained specific advice about the risk of malformation and neurodevelopmental impairments with the use of sodium valproate.
 
Despite the efforts of a Pregnancy Prevention Programme launched in 2018 to address the ongoing level of risk, and another update of NICE guidelines in the same year, women are still becoming pregnant while on valproate without any knowledge of the risks. Estimates suggest there are hundreds of women affected every year.
 
Mothers with children who have FVSD face immense challenges caring for their child and navigating access to additional support and care, while still having to manage their own epilepsy. Many of the children have complex health needs and require 24-hour care; sadly, there is no cure or improving prognosis. Understandably, families are fearful of what the future holds for their child.

As Maria observed in closing the webinar:

“Women and their children have been let down by the healthcare system. Health professionals did not - and in some cases still do not - inform them of the risks.  Health regulators have not done enough to make them do so.

“These awful consequences are as a result of women, once again, being overlooked and not listened to. The report is incredibly important, and it is imperative that the government and healthcare system takes note to ensure that women and their families are not harmed in this way - and on such a scale - again.”
 

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Boz Michalowska
Medical devices Product safety Consumer law Financial claims Emissions claims

Bozena Michalowska Howells

Bozena joined Leigh Day in 1997, was made a partner in 2003 and is head of the firm's product safety and consumer law team.

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Maria Panteli
Birth injury Brain injury Cerebral palsy Spinal injury Surgical negligence

Maria Panteli

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Zahra Nanji
Medical devices Medicines

Zahra Nanji

Zahra Nanji is an associate solicitor in the consumer law team.