Transvaginal mesh implants independent review: interim report

Chapter 7: Le gal Judgements

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.

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 to adequately consent the patient by discussing 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 tape are still ongoing 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

At the end of July 2015, there were 368 claims in relation to the use of vaginal implants in women with SUI and POP. Of these, the largest number (258 cases) was being heard in the Court of Session.

Of the cases being considered by the Court of Session, there were 120 cases associated with mesh implants for SUI. Of these, 45 were related to transobturator mesh implants, with 33 of the cases considering medial-to-lateral procedures and the remaining 12 cases lateral-to-medial procedures. There were six cases that arose from retropubic mesh implants, with both down-up procedures and up-down procedures represented (NB the specific number of these cases by type of procedure has not been published to protect patient confidentiality). The remaining 69 cases are awaiting categorisation as the mesh devices can be used for either surgical approaches. Of these, 55 cases are for a mesh device from a single manufacturer.

Vaginal mesh implants represents the largest proportion of POP procedures with 75 cases. Of these, 48 of the cases relate to a device which has now been withdrawn from the market. The remaining 27 cases relate to six devices, produced by four manufacturers. Of the other POP procedures, fewer than five cases relate to abdominal implants and 13 cases relate to devices which can be used either vaginally or abdominally. Overall, there were 96 POP mesh claims, though less than five relate to devices used for treatment of rectal prolapse or where the devices was not made of polypropylene.

Finally, there were a further 42 cases where the categorisation of procedures was not complete.

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 stress urinary incontinence (SUI) and pelvic organ prolapse (POP) is estimated at 100,000. The majority are litigated in Federal Courts (Multidistrict Litigation, MDL).

So far, 18 trials (relating to 24 patients) have reached verdict or settlement during trial (see below). POP procedures related to 11 of the cases; ten of which related to vaginal mesh implants and one where the POP procedure was combined with an SUI mesh implant. 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 implants. 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 implants. 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.

In presenting data from the US, it should be noted that the legal tests against which these cases were judged are not those described above. The legal tests assessed within Federal Courts in the US differ from those in Scotland.

7.4 Interpretation

• Legal cases relating to possible negligence or product liability are underway in Scotland and other countries.
• Whilst negligence or product liabilities may be established for specific cases, generalising from these in the context of this review is difficult given the evolving nature of the evidence.