Claire Levene
Solicitor
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Solicitor | Medical Negligence
Medical Device Claims: The Medtronic LVAD Scandal
It has been reported that doctors at Freeman Hospital (Newcastle Hospitals NHS Foundation Trust) and Harefield Hospital (Guy’s & St Thomas’ NHS Foundation Trust) continued to recommend and implant a Medtronic Left Ventricular Assist Device (LVAD) — the HeartWare HVAD — despite knowing that this device was linked to a higher rate of patient deaths than an available alternative.
Both hospitals are among the leading transplant centres in England.
What Is a Left Ventricular Assist Device (LVAD)?
According to the British Heart Foundation, an LVAD is a mechanical device that helps the heart pump blood around the body when it is too weak to do so on its own.
It is not an artificial heart — it does not replace the heart, but works alongside it.
Some LVADs are used long-term as a bridge to transplant, supporting patients with advanced heart failure who are waiting for a donor heart or who are temporarily unsuitable for transplantation. They may also help reverse certain conditions that would otherwise prevent patients from being added to the transplant list.
While NHS England does not recommend the use of LVADs for patients ineligible for transplant due to other health issues, these devices are used this way in some other countries.
In the UK, an LVAD may still become a long-term treatment option for certain heart failure patients simply due to the limited availability of donor hearts.
Who Are Medtronic?
Medtronic is a global leader in medical technology, developing and engineering healthcare devices for complex and challenging conditions.
The company produced the HeartWare HVAD, the device at the centre of the recent Freeman and Harefield Hospital scandal.
Other medical devices developed and manufactured by Medtronic have been subject to recall because of concerns regarding their safety. These include:
- Pipeline Vantage embolisation devices
- DLP Aortic Root cannulas
- Becker and Exacta External Drainage and Monitoring Systems
- MiniMed 600 and 700 series insulin pumps
NHS Medtronic LVAD Scandal
According to the BBC, despite concerns raised as early as 2018 by NHS cardiologists about the safety of the Medtronic HeartWare HVAD, consultants at Harefield and Freeman Hospitals continued to use and recommend the device until 2021.
Shockingly, half of the patients fitted with the device died within three (3) years.
The BBC also reported that leading cardiologists at both hospitals were paid consultants for Medtronic, and both institutions were aware of this.
An alternative device, the HeartMate III (manufactured by Abbott), was known to deliver significantly better outcomes for patients, both in terms of survival and complication rates.
For more details, read the full BBC report.
BBC ReportLegal Claims Involving Medical Devices
Legal claims involving medical devices can arise in several contexts, including the following:
1. Defective Medical Devices
Where a patient suffers injury or death due to a defective medical device, it may be possible to bring a claim for compensation.
Strict time limits apply. Claims must be brought within three (3) years of the injury or the date the patient became aware of it, and within ten (10) years of the product being first placed on the market, whichever is sooner.
Because this is a complex area of law, we would always recommend seeking legal advice at the earliest opportunity if you believe that you may have a claim.
2. Substandard Medical Advice or Treatment
A poor outcome alone does not mean a medical device is defective. Where the device itself is not at fault, no claim can be made against the manufacturer.
Patients may sometimes experience complications despite appropriate treatment. However, if the product chosen by the surgeon was unsuitable, or if the technical management or performance of the surgery fell below an acceptable standard, a claim may be brought against the treating doctor or NHS Trust.
3. Failure to Obtain Informed Consent
Before proceeding with any treatment, including the use of a medical device, doctors must ensure patients are fully informed of:
- All available treatment options
- The associated risks and benefits
- The reasons for recommending a particular option
If a patient is not properly advised, any consent obtained is not valid.
Treating a patient without valid consent constitutes negligence, and may also amount to a criminal offence.
How We Can Help
Our solicitors at Phoenix Legal have extensive experience in claims involving medical devices, including:
- Defective product claims
- Substandard care and treatment
- Failure to obtain informed consent
Telephone 0151 306 3694 to speak to a member of our team and explore whether we can help you bring a claim for compensation on a no win, no fee basis.
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