The PIP breast implant affair will be a case study in the product liability context for many years to come. Two significant reports on the matter have been published recently. Sarah Croft of Shook, Hardy & Bacon International LLP considers the conclusions drawn and possible ramifications for future litigation and the regulation of medical devices.
BACKGROUND
The PIP breast implant matter consists of an unusual set of circumstances, as the manufacturer appears to have acted fraudulently, the owner faces criminal charges, the company has gone in to liquidation and there is inadequate insurance cover to meet claims. Some women in the UK are considering litigation but in these circumstances, potential claimants and their lawyers will no doubt look beyond the manufacturer towards the distributors, the clinicians who carried out the procedures and the clinics they worked for as potential defendants. Claimants may focus on contractual remedies under the Sale of Goods Act 1979.
A key focus in any litigation, of course, will be the consequences for health, which flow from the use, as alleged, of non-medical grade gel in the PIP implants. An NHS medical director’s expert group has examined these issues, lead by Sir Bruce Keogh.
Another vital piece of the jigsaw is the role of the regulator. There is frequently a regulatory aspect to product liability claims, particularly those involving pharmaceuticals and medical devices. The regulator’s responsibilities dovetail (or overlap) with those of manufacturers and clinicians. Media commentators have questioned the role of the regulatory authorities and whether enough was done in the UK to identify the problems and communicate them to the public quickly and effectively. Earl Howe has examined the performance of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Department of Health in the PIP context.
EXPERT REPORT ON PIP BREAST IMPLANTS
In June 2012, the NHS medical director’s expert group, lead by Sir Bruce Keogh, published its report on PIP breast implants. The report touches on a number of issues that will be important in litigation involving the implants. The experts found that:
‘… exhaustive worldwide testing of the PIP gel material has not revealed anything that could cause a long-term threat to human health – they are not toxic and not carcinogenic’.
The report made it clear that:
‘… despite extensive toxicology testing, no evidence has yet been found that any of the chemical constituents of silicone gel are potentially harmful… in this respect… PIP silicone gel is no different from the gels used in other implants.’
The group did find, however, that PIP implants do have a significantly higher rupture rate than implants manufactured by other companies and this inferior mechanical strength led the group to consider the implant to be ‘clearly substandard’. This finding is obviously important in the litigation context.
All parties involved will be analysing their contractual documentation carefully, since one possible avenue for claimants is to argue that the surgery was essentially a works and material contract and the goods supplied must be of ‘satisfactory quality’. Claimants may argue that safety is an important part of ‘quality’ and may assert that if goods are of unsatisfactory quality, the consumer is entitled to a repair or replacement within a reasonable time, unless this would be disproportionate. The discussion of the relative qualities of PIP versus other breast implants in the Keogh report is also informative in this regard.
When looking at the report, we must not lose sight of the fact that the gel being used was not of medical grade and had seemingly been used fraudulently. Clinicians and clinics will of course maintain that, so far as they were concerned, they were using a perfectly acceptable product containing a filler approved as needed by the regulator and that this is a complete defence to allegations of defect, negligence or breach of contract.
THE PERFORMANCE OF THE REGULATOR
In response to concerns regarding the role of the regulator, the UK government asked Earl Howe to examine whether the Department of Health and the MHRA acted appropriately both before and after information about problems with PIP implants came to light. His report was published in May 2012.
Lord Howe found that, although the regulator acted reasonably and appropriately and followed scientific and clinical advice, serious lessons must be learned. Calls were also made for improvements to be made by the regulator including:
- identifying ways of gathering better evidence on the safety of devices;
- broadening its approach to analysing reported problems with higher-risk medical devices;
- finding better ways of communicating with the public.
Recommendations were also made for improvements to the operation of the European regulatory system and for health professionals and providers to improve the reporting of problems when they occur.
The report states that the MHRA fulfilled its obligations in terms of reviewing and responding to the incidents reported to them involving PIP breast implants. The regulatory focus was on determining if there were underlying problems with the implants, or if the incidents reported were the expected result of the widespread use of a type of device that has a tendency to fail over time. It is conceded, however, that these investigations were hampered by a lack of reliable and comprehensive information about incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products.
The data collected at the time was not conclusive about a problem with PIP implants but did suggest that ‘a small number of PIP implants were failing more quickly than other types of implant’. The MHRA continued to ‘pursue these concerns actively’ until the significant turning point in the affair was reached in March 2010, when the French regulator inspected the manufacturer and discovered the use of non-approved filler. Lord Howe concluded that until March 2010, there was no evidence available to the MHRA that PIP was not using the approved filler. Nor had the MHRA heard any suggestion from other European regulators that they had any such evidence or suspicion. Lord Howe adds that suspicions up until then related to a possible tendency for early rupture of some implants, perhaps associated with the manufacture of the implant shell although, again, it seems that the evidence was unclear due to lack of data. After the event, a higher rupture rate has now been established by the Keogh report.
After looking closely at the response of the MHRA to the French regulator’s discovery, Lord Howe concludes that there is no evidence that the MHRA acted inappropriately. He concludes that it rightly issued an alert notice and other communications to surgeons and to the public regarding the problem with PIP filler, halted use of the implants in the UK, and tried to work with European and other international regulators to determine what the safety implications were, providing further information as it became available.
LESSONS TO LEARN: RECOMMENDATIONS FOR THE REGULATOR
It is acknowledged by Lord Howe that adverse incident reporting is an inherently imperfect way of collecting data. It relies on all those involved playing their part in full and acknowledging the importance of adverse incident reporting in protecting patient safety. The report makes clear that the MHRA must be able to obtain evidence from a wider and more detailed set of sources, including robust outcomes data from clinicians.
Lord Howe observed that the MHRA had to balance the need to provide full information against the risk of causing undue concern to women when they did not have clear evidence of potential harm. The review finds ‘… no evidence to suggest that the wrong decisions were made based on what was known at the time’. It is recognised that there is a need to ensure that full, clear and accurate information is made available promptly in a way that is easily accessible.
The report contains a number of specific recommendations, some of which have implications for the future regulation of medical devices, including that the MHRA should:
- continue to work with all concerned to promote the best possible understanding of the role of the adverse device event reporting system and to ensure that professionals in particular understand what they have a duty to report – and why;
- ensure that it has clear operating procedures for the periodic review of device incident reports, particularly for higher-risk products; and
- fully support efforts initiated by the European Commission to improve the operation of the regulatory system, with particular regard to higher-risk devices, within the current legal framework and in advance of any specific legislative proposals the Commission brings forward.
WIDER REGULATION FOR COSMETIC INTERVENTIONS
References are made throughout Lord Howe’s report to the further, separate review by Sir Bruce Keogh of the wider system of regulation for cosmetic interventions with a strong focus on what more can be done to protect the interests of patients.
His independent expert group will look at whether a breast implant registry should be re-established to help monitor any problems that occur and perhaps make it easier to trace people affected if there are problems in the future. The Breast Implant Registry was closed in 2005 mainly because, whether for reasons of confidentiality or otherwise, the majority of women registered declined to participate in follow-up research.
THE FINAL WORD?
Lord Howe concludes that nothing about the PIP episode provides evidence to suggest the system for regulating medical devices is fundamentally unsound, or that there needs to be a shift to a system equating to the regulation of pharmaceuticals in the EU, or to the system used to regulate higher-risk devices in the United States. He adds:
‘Very simply, PIP applied for and received approval for their silicone breast implant and then, after receiving approval, fraudulently changed the device to use a non-approved filler material. Putting in place even the most exhaustive testing regime before market authorisation would not have prevented this deliberate fraud taking place once the product was on the market.’
The NHS medical director’s expert group, lead by Sir Bruce Keogh, has now disbanded but officials from the Department of Health and MHRA will continue to monitor developments and issue advice, or reconvene the expert group, as needed. Wider issues over the regulation of cosmetic surgery are currently being examined in the further, separate review also headed by Sir Bruce Keogh.