Medical Device Recalls in the UK

Medical Device Recalls in the UK

Medical device recalls in the UK rarely make headline news and, when they do, details are often imprecise or vague – leaving the thousands of people potentially affected by a faulty medical device to seek out information relative to their personal situation. A lack of information – or worse still, a supply of incorrect information – can be the cause of significant concern for patients who have had the recalled medical devices fitted. In many cases, this concern is justified.

In 2011, the British Medical Journal published a report which showed that 447 medical device alerts were issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) between 2005 and 2010 – 44 percent of which were considered to have “a reasonable probability of causing serious adverse health consequences or death”. Not all of these “alerts” resulted in medical device recalls, but the figures give an alarming impression of the volume of faulty medical devices in the UK.

Compensation for Injuries Caused by Medical Device Recalls

If a patient has suffered an avoidable injury, or the preventable deterioration of an existing condition due to a faulty medical device, he or she may be entitled to claim compensation for injuries caused by medical device recalls. The value of claims for injuries caused by recalled medical devices will depend on the extent of the injury, whether the damage caused by the faulty medical device can be reversed and the patient´s age and general state of health before the medical device was first used.

Unlike most other personal injury claims, it is not always essential to have sustained an injury or the deterioration of an existing condition in order to claim compensation for injuries caused by medical device recalls. Precedents exist in law which enable patients to claim compensation where it can reasonably be expected that the patient will suffer an “adverse reaction” based on historical evidence collected from patients implanted with similar recalled medical devices.

Claims for Injuries Caused by Recalled Medical Devices

Claims for injuries caused by recalled medical devices are most often made against the manufacturer of the faulty medical device. Medical device manufacturing companies have to hold compulsory public liability insurance to protect themselves against producing a faulty product and the consequences it makes to a patient´s quality of life when the product fails or is responsible for a secondary health issue developing.

Exceptions to this procedure apply if the faulty medical device was imported from outside the EU – in which case the importer is most often liable – or if a fault developed in a medical device as it was being implanted by a surgeon – making the surgeon liable, unless there was a design fault in the medical device which made it more complicated than could reasonably be expected for the medical device to be implanted safely and without risk of injury.

Time Limits for Making Claims for Medical Device Recalls

In the UK, claimants have three years from the date an avoidable injury or preventable deterioration of an existing condition has been diagnosed in which to make a claim for injuries caused by medical device recalls. Some patients have previously been under the misconception that if any injury has occurred more than three years after a faulty medical device has been implanted, they are not entitled to compensation. However it is the “date of knowledge” of an injury that is important in medical device recall compensation claims and not necessarily the date of an injury.

The exception to the above rule is if the injury caused by a recalled medical device has been sustained by a child. Children (or “minors”) cannot instruct a solicitor or commence legal action until they reach the age of eighteen – from when they then have three years to initiate a compensation claim. Parents or guardians can make a claim for injuries caused by medical device recalls on the child´s behalf, acting as a “litigation friend” at any time up until the child becomes an adult; but all compensation settlements for children will have to be approved by a court before payment can be made.

Further Information about Medical Device Recalls in the UK

If you believe that you have been injured or suffered the deterioration of an existing condition due to a medical device which has been recalled in the UK, you are advised to speak with your doctor immediately. Your doctor should be aware of any medical device recalls in the UK which could affect your health and be able to provide treatment for the condition you are presently suffering from as well as suggesting an appropriate course of action to prevent future injury.

It will also be in your best interests to discuss your situation with a solicitor once you have spoken with your doctor. A solicitor will be able to compile accurate information relating to the recall of a medical device, determine whether you have a claim for compensation for injuries caused by recalled medical devices which is worth your while to pursue and, if so, inform you whether it is advisable to join other people in a collective action against the faulty device manufacturer or to make an independent compensation claim for injuries caused by a recalled medical device.


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