Transvaginal mesh implants independent review: final report

Chapter 7: Legal Judgements

Update Since Interim Report

Legal proceedings in relation to claims for personal injury, the safety of specific mesh and tape devices, and lack of appropriate information regarding possible complications have been raised in a number of countries, including the United States and in the UK. There are a greater number of cases raised in Scotland than in England and Wales.

Since publication of the interim report, the number of claims in relation to the use, by NHSScotland, of vaginal implants in women with SUI and POP has increased to 426 (as at February 2017). The data in this chapter have been updated to reflect this.

7.1 Evidence availability

Legal proceedings in relation to claims for personal injury, the safety of specific mesh and tape devices, and lack of appropriate information regarding possible complications have been launched in both the United States and in the UK as well as other countries worldwide.

In Scotland, the main focus of such litigation is twofold, firstly, in relation to the cases against the Health Boards, the claim is that there was a failure by clinicians to adequately obtain patients' informed consent by fully discussing and disclosing material risks and alternatives. In relation to the case against the manufacturers, the Pursuer is seeking to establish that the manufacturers were negligent under common law by aggressively marketing products which had been inadequately tested and further, misrepresenting failure and complication rates.

The case against the manufacturers can also be brought under the Consumer Protection Act 1987, which requires the Pursuer to establish that a defective product has been manufactured. The statute describes a "defective product" as one in which the safety of the product does not meet the standard which consumers are entitled to expect. This can include the safety of materials and components within the product, any instructions and/or warnings needed in using the product, and what the expected use of the product might be. This is an objective test and all these factors must be taken into account. In order for a manufacturer to be held liable it must be established that:

• they manufactured the product;
• that the product was defective (as defined in statute);
• and the defect caused injury.

Once liability is established, it is not necessary to also establish that the manufacturer was negligent (although separate proceedings to show negligence under the common law may also be pursued).

7.2 Methods

Given that legal proceedings in relation to the use of mesh and mesh tape are still on-going in Scotland, it is not appropriate to discuss the detail of these extant cases at this time. Rather, the NHS Central Legal Office was asked to provide an overview of current legal proceedings in Scotland. In the results section that follows, any counts of cases which are fewer than five cases have been discounted to avoid any possible data protection breach. All manufacturer and device names have also been removed for confidentiality reasons.

7.3 Results

7.3.1 Litigation in Scotland

As at early February 2017, there were 426 claims in relation to the use of vaginal implants in women with SUI and POP involving NHS treatment. There are additional claims and actions involving only private treatment, but figures in that regard are not available. Of these claims, 390 actions have now been raised in the Court of Session.

Due to the number of actions relating to vaginal implants, the Court of Session fixed a specific procedure for dealing with these actions. When the Court issued its direction about the procedure, defences were required to be lodged in the first 168 cases involving Health Boards by 22 September 2016. Following on from that deadline, the Court indicated that a group of lead cases will be identified from those in which defences have been lodged. All other cases are likely to be frozen pending the outcome of the lead cases.

Of the 168 cases involving Health Boards being considered by the Court of Session, in which defences have been lodged, there were 114 cases associated with mesh tapes for SUI. Of these, 88 involved the use of transobturator mesh tapes, and 31 cases that involve the use of retropubic mesh tapes. There are five cases involving the use of both types of tape. There are 73 cases that involve the use of mesh implants for the treatment of POP. In total, 23 of the 168 cases involve multiple implants.

7.3.2 Litigation in the USA

Data from the US Judicial Panel of Multidistrict Litigation has been used to summarise the situation in the US, as at the end of July 2015. The number of US lawsuits in relation to the use of vaginal implants in women with SUI and POP is estimated at 100,000. The majority are litigated in Federal Courts (Multidistrict Litigation, MDL). These cases are only raised against the manufacturer and do not involve the health care provider or doctor as a party to the action.

So far, 18 trials (relating to 24 patients) have reached verdict or settlement during trial (see below). 11 of the cases related to POP procedures, ten of which related to vaginal mesh implants and one where the POP procedure was combined with an SUI mesh tape. In this combined case and in four of the solely POP procedures, a jury reached a verdict in favour of plaintiffs. No jury verdicts were in favour of the manufacturer and in the remaining six cases, the manufacturer reached a settlement during the trial.

For SUI procedures, one case related to retropubic mesh tape. The case did not reach trial, the Judge directed that the case found in favour of the manufacturer prior to trial commencement. Six cases related to transobturator mesh tapes. Jury verdicts in favour of the plaintiffs were found for five cases and, in a single case, in favour of the manufacturer.

One manufacturer settled thousands of claims in an out of court settlement without accepting any liability.

In presenting data from the US, it should be noted that the legal tests against which these cases were judged are not those set out in the Consumer Protection Act (1987) that is applicable in Scotland.

7.4 Interpretation

• Legal cases relating to possible clinical negligence and product liability are underway in Scotland and other countries.
• Whilst clinical negligence and product liability may be established for specific cases, generalising from these in the context of this review is difficult given the evolving nature of the evidence and the fact that each case will have its own specific set of circumstances.