Shine Lawyers wins case against mesh implant manufacturer

Shine Lawyers needed evidence of the efficacy and safety (or harm) of mesh implants. Consultants from the Statistical Consulting Centre performed epidemiological analyses and provided expert testimony in court.

The outcome

Shine Lawyers won a class action on behalf of hundreds of women who experienced complications after receiving polypropylene mesh implants. The implants were designed to treat pelvic organ prolapse and stress urinary incontinence.

In November 2019, the Federal Court of Australia found that the implants were not fit for purpose. The Court also found that the manufacturers, Johnson & Johnson and its subsidiary Ethicon, were negligent.

In proving their case, Shine Lawyers used statistical evidence provided by the Statistical Consulting Centre. The Centre’s director, Professor Ian Gordon, acted as an expert witness during the trial in Sydney.

In September 2022, it was announced Shine Lawyers had negotiated a $A300 million settlement to support affected women with their recovery.

The need

Shine Lawyers filed the class action against Johnson & Johnson and Ethicon in 2012. The trial was held from July 2017 to February 2018. To support its case, Shine needed expert analysis and testimony from qualified biostatisticians and others.

The solution

Shine Lawyers engaged the Statistical Consulting Centre in 2016.

Consultants from the Centre carried out meta-analyses of epidemiological studies. They looked at 438 studies in which implants were used to treat stress urinary incontinence. They also looked at 130 studies where implants were used to treat pelvic organ prolapse. They assessed the efficacy and safety of the Johnson & Johnson implants and compared them with those of alternative interventions for the same conditions.

Professor Gordon described the findings in an expert witness report, which Shine Lawyers submitted to the Court.

During the trial, Professor Gordon acted as an expert witness for Shine Lawyers. He explained the results of the Centre’s meta-analyses. He provided his expert opinion on the evidence, including commentary on evidence presented by other experts.

The Court’s decision was handed down in November 2019. Ruling in favour of Shine Lawyers, the judge made frequent reference to Professor Gordon’s written and verbal testimony.

Johnson & Johnson and Ethicon appealed the decision in the Federal Court. It was dismissed in March 2021. They then applied for special leave to appeal the decision to the High Court of Australia. That application was dismissed in November 2021.

The platform

The Statistical Consulting Centre provides statistical advice and support to businesses, government, research institutions and other organisations. Consultants are skilled at communicating statistical findings to different audiences.

The support provided in this project included:

• Meta-analysis – using statistical methods to synthesise the results of many individual research studies, with the goal of obtaining an overall conclusion.
• Acting as an expert witness – writing expert witness reports, providing sworn testimony in court and undergoing cross-examination.

Contact us

If you have a research problem that could be solved by the Statistical Consulting Centre, contact:

Deborah Maillardet
Email: dmai@unimelb.edu.au
Phone: +61 3 8344 6995

Partners

Shine Lawyers

Publication

Gill v Ethicon Sàrl (No 5) [2019] Federal Court of Australia 1905