What is a medical device?
According to the Medical Devices Regulations 2002, a medical device is defined as "any instrument, apparatus, appliance, software, material or other article whether used alone or in combination, which is intended by the manufacturer to be used for human beings for the purpose of… [among other things]… diagnosis, prevention, monitoring, treatment or alleviation of disease or injury". As one would expect, there are specific conditions applied to the design and application of medical devices and minimum standards of construction, in order to safeguard patient safety, must be adhered to. Some of the most common medical devices are cardiac pacemakers, bladder stimulators, cochlear implants, and diaphragm stimulators. Most of the time, these devices are used as part of a course of treatment which either improves a pre-existing condition, and therefore quality of life for a patient, or rectifies a diagnosis in its entirety. However, there are circumstances in which medical devices have been known to further exacerbate the symptoms experienced by a patient and in some cases, cause new diagnoses entirely.
What can go wrong?
In 2018, a report by the International Consortium of Investigative Journalists, including the British Medical Journal and the BBC, uncovered an alarming failure in the assessment of suitability and safety of medical devices and implants in the UK. This report found that many medical devices such as implants, pacemakers, artificial joints and spinal rods were only tested on pigs or dead bodies and had actually failed in earlier safety tests on baboons. It was alleged that this was not made known to patients receiving those particular devices at the time of treatment. In one case, an elderly patient had received a Nanostim (a wire free pacemaker) which failed shortly after implantation and could not be removed. A replacement had to be inserted with the old one still in place. It was later discovered that the Nanostim had been trialled on humans for a total period of only 90 days, whereas the 2002 Regulations set out that such trials should be conducted over the longer term and should, in many cases, last 10 years or more. Put simply, the product was defective, and the trial period of 90 days was far too short to allow researchers to conclude that it would have failed far sooner after implantation than had been claimed. It is alleged that the patient was not advised of the insufficiency of the trial period that his Nanostim had undergone, before he was advised to proceed with the implant procedure.
Recent medical device cases in Scotland
In Scotland, a number of claims have been raised in recent years on behalf of patients who received Johnson & Johnson vaginal mesh implants between 2006 and 2018. The intended purpose of these vaginal implants was to address the symptoms of urinary incontinence and prolapse, principally in post-menopausal women, and to provide an improved quality of life with fewer active symptoms. Following implantation, many women began to experience serious and distressing side effects, including the mesh eroding through the vaginal wall and in some cases perforating organs. It has been argued that even prior to the launch of the J & J implant in 2006, the company were aware of consistent indications of a high rate of failure, through research, observation and monitoring they had conducted. The product was ultimately withdrawn entirely in 2018, after being used in thousands of operations across the USA, Australia, and the UK. Those pursuing claims against J & J and the healthcare providers who carried out the operations gathered evidence to show that data was available as early as 2006 which indicated that the implants were likely to have a high failure rate, and that a number of women were likely to experience entirely new and distressing symptoms as a result of being implanted with a defective product.
Who is responsible for a defective product - the manufacturer or the doctor?
Claims relating to defective medical products or devices are particularly complex and will require claimants to make arguments in relation to both product liability law and medical negligence law. Turning specifically to the vaginal mesh claims in Scotland as an example, the main focus of this litigation is twofold:-
- In relation to the case against Health Board or other healthcare provider who carried out the operation, the argument made was that there was a failure by clinicians to adequately obtain the informed consent of a patient, by fully discussing and disclosing material risks and alternatives. Those risks (and the likelihood of experiencing them, based on available evidence) must be discussed candidly and openly between doctor and patient. Only if the patient is alive to extent of risk she faces, can it be argued that informed consent was obtained. Electing to proceed with the insertion without full knowledge of the risk, is effectively uninformed consent, and therefore not consent at all. In that scenario, the doctor has breached the duty of care he or she owes to the patient, under common law.
- It was argued that the manufacturers (in this case, J & J) were negligent under common law by aggressively marketing products which had been inadequately tested and further, misrepresenting failure and complication rates following insertion. In this case, arguments were also made under the Consumer Production Act 1987 which required the claimants to prove, beyond reasonable doubt, that the vaginal mesh products were fundamentally defective in nature, by relying on evidence from an expert witness. Put simply, this approach requires a claimant to establish that the safety of the product does not meet the standard which customers are entitled to expect.
Establishing the liability of either (i) the healthcare provider who carried out the operation and failed to advise the patient of the true risks; or (ii) the manufacturer who was not candid about the potential risks, will not be sufficient in isolation to succeed in being awarded compensation. If liability against either (or both) of these defenders were to be proven, the claimant would then also require to address 'causation'. This aspect of the case would relate to whether it could be proven, on the balance of probabilities, that the patient would not have proceeded with the operation had they been adequately and fully advised of the risks and also the alternatives to vaginal mesh surgery. Only if liability is established against one or both defenders, and the Court accepts that this breach of duty caused the claimant to take a decision they would not otherwise have taken, will compensation be awarded.
The future of medical device claims and litigation
The issues raised in the cases referred to above are likely to apply to medical device litigation more generally, whether a claim is being pursued following vaginal mesh insertion, cochlear implants, implantable defibrillators, or urinary catheters. In terms of raising claims for defective or substandard products against the healthcare provider, it will be necessary to prove that the risks were not fully discussed with the claimant prior to the implantation and that, had those risks been fully considered, they would have chosen not to proceed with the surgery. To successfully pursue a claim for product liability against the manufacturer of the product or device itself, it will again be necessary to prove that important information relating to the reliability and safety of the product was either withheld or not made freely available to the claimant in the course of their decision making as to whether to proceed or not at that time.
Claims and litigation relating to medical devices and products are unavoidably complex and require the claimant's lawyers to ingather as much information as possible relating to the safety tests undertaken on the device and also on the process of giving consent, prior to their agreement to proceed with the operation. There may be a legitimate claim against either the healthcare provider who undertook the surgery or the manufacturer who developed the product, and in some cases, both may have a degree of culpability depending on the circumstances and facts of the case. There are also separate considerations in cases where it is alleged that there is a defect with only the specific, individual product or device inserted into the claimant, as opposed to there being a defect or malfunction with an entire category of products or device made by a particular manufacturer. Again, the ingathering of the medical records, the manufacturing records, the relevant safety certificates, the record of consent being taken and all other associated documentation will be crucial in allowing a claimant to firstly take a view on who the proper defender in the claim should be, and thereafter whether there is a basis for such a claim to be successful.
