Another potential medical scandal
As concerns around M6-C spinal implants emerge, Lisa Abrahams, Senior ATE Account Manager at ARAG explores how complex clinical negligence claims highlight the importance of specialist legal support and access to appropriate ATE insurance.
Protection for complex clinical negligence claims
Some of the most important work that ARAG’s after-the-event policies support arises in emerging areas of clinical negligence, where the scale of a problem and likely duration of claims may be less certain, a pattern of liability may not have been established and underwriting can be more challenging.
In such complex and inevitably expensive cases, insuring the potential costs becomes all the more important for both clients and the firm, but often more difficult to secure.
The worrying sequence of events around the global safety notification and UK patient recall of a specific type of medical device, the M6-C spinal implant, has introduced us to a relatively new cause of claim, on which one of our business partners is doing important work.
Back trouble
Penningtons Manches Cooper is advising clients who have received an M6-C implant and may have experienced complications, if the device has failed or worn prematurely. Investigations are also focused on whether clients were appropriately advised about the need for surgery, suitability of the implant and the potential risks associated with the implant that were known at the time.
One of the first signs of trouble with the device came six years ago, when its manufacturer updated guidance in Australia, warning that it could be harmful and recommending annual checks. It was not until February last year that the implant was withdrawn from sale, globally.
In January this year, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued safety guidance, advising trusts and hospitals to contact all patients with the implant, so that they can be actively monitored. This monitoring will include an annual X-ray to check for failure and other potential problems with the implant and surrounding bone.
Urgent attention
It’s important that any patients who have had such an implant are assessed as quickly as possible, especially if they have any new or unexpected symptoms, such as pins and needles, weakness in their arms or legs, increasing neck pain or any signs of infection.
Even if patients do not have any symptoms, monitoring may reveal the need for further investigations, revision surgery and significant follow-up care.
Lyndsey Skibinski is a senior associate in the medical negligence team at Penningtons Manches Cooper leading the investigation into these implant patients:
“This is a potentially huge public health issue with thousands of patients affected. It is crucial that anyone who has this implant gets a scan to identify any problems and continues with recommended annual monitoring.
Most of the people approaching us have had the implant in place for between eight and nine years and have now been diagnosed with significant bone loss, abscesses or loosening of the device.
Many will need complex surgery to remove the implants which poses the risk of paralysis or long-term chronic pain. We are currently investigating the legal options open to those we are advising to see how we can secure justice for the trauma and suffering they are experiencing, and also to recover funding for future treatment and rehabilitation.”
Myself and Emma Wilson are attending the Spinal Cord Injury Conference this week and we hope to learn more about the different types of spinal injury and how our policies can support victims on their paths to recovery.
Disclaimer: all information in this article was correct at time of publishing.
