Michelle Donnelly against Johnson & Johnson Medical LTD (Court of Session)

Factual and Procedural Background

This opinion concerns two connected applications brought by the Applicant against the Defendant, a medical products manufacturer. The first application sought authorisation for the Applicant to act as the representative party in group proceedings under the Civil Litigation (Expenses and Group Proceedings) (Scotland) Act 2018 ("the 2018 Act"). The second application sought permission to bring group proceedings under the same Act. The claims relate to alleged defects in hernia mesh products designed and supplied by the Defendant, used in the treatment and repair of abdominal hernias. The group register at the time contained seventeen named claimants with claims involving five different mesh products. The summons alleged negligence and statutory liability under the Consumer Protection Act 1987, asserting the products were defective in design and inadequately warned of material risks. The Defendant opposed both applications.

Legal Issues Presented

1. Whether the Applicant should be authorised as a suitable representative party under the 2018 Act.
2. Whether permission should be granted to bring group proceedings under section 20(5) of the 2018 Act, including:
1. Whether all claims raise issues that are the same, similar, or related (commonality test).
2. Whether there is a prima facie case.
3. Whether group proceedings constitute a more efficient administration of justice than individual proceedings (superiority test).
4. Whether the proposed proceedings have real prospects of success.

Arguments of the Parties

Applicant's Arguments

• The 2018 Act provides a flexible framework for managing multi-party litigation efficiently, with broad case management powers.
• Rule of Court 26A.11(5) sets out criteria for refusing permission, but the test for a prima facie case is low, requiring only serious questions to be identified.
• Generic medical evidence relating to the development and risks of the hernia mesh products can be led once, saving time and expense.
• The Applicant, having nursing experience and supported by specialist legal advice and indemnity funding, is a suitable representative party.
• The group issues should be defined broadly as claims arising in Scotland from the use of certain hernia mesh products manufactured by the Defendant.

Defendant's Arguments

• The benefits of group proceedings apply only if the application is appropriate for such procedure, which requires identifying common or similar issues among claims.
• The claims lack clarity on how the products are defective or whether different products share the same defects, complicating issue definition.
• Preliminary issues such as prescription and limitation periods are fact-specific and likely to require individual determination, undermining suitability for group proceedings.
• Professional bodies support the safety and efficacy of hernia mesh generally, suggesting the need for precise identification of alleged defects.
• The variety of products and their differing characteristics mean that findings on one product may not apply to others, reducing commonality.
• The Applicant lacks demonstrated ability to critically engage with legal advice, raising concerns about the effectiveness of representation.
• Concerns were expressed regarding the funding arrangements and potential financial exposure associated with the commercial supporter of the Applicant.
• Given the relatively small number of claimants, individual proceedings with case management would be more efficient and appropriate.

Table of Precedents Cited

Precedent	Rule or Principle Cited For	Application by the Court
Mackay v Nissan Motor Co Ltd [2024] CSOH 68	Prima facie case requires only that a serious question is identified; low threshold for merits assessment.	The court applied this low test to determine that serious issues were raised but found other criteria unmet.
Thompsons Solicitors Scotland v James Finlay (Kenya) Ltd 2022 SLT 731	Concerns about suitability of representative party; distinction between solicitor and client roles.	The court considered the Applicant’s suitability, finding reliance on legal advice acceptable but noting the importance of ability to engage.
Bridgehouse v BMW 2024 SC 270	Low bar for appointment as representative party; no special qualifications required.	Supported the conclusion that the Applicant was a suitable representative party despite limited expertise.
Hastings v Finsbury Orthopaedics Ltd [2022] UKSC 19	Findings on one product may not apply to different products; importance of product-specific analysis.	Used to illustrate difficulties in establishing common issues across multiple distinct products.
Gilchrist v DePuy International [2023] CSIH 47	Inner House confirmed that differences between products prevent easy read-across of findings from lead cases.	Supported the court’s conclusion that product differences undermined suitability for group proceedings.
Milligan v Jaguar Land Rover Automotive plc 2025 CSIH 16	Confirmed sequential approach: representative party approval before permission to bring group proceedings; low test for suitability.	The court followed this approach and applied the low suitability test to the Applicant.
AB & Others v Ministry of Defence 2012 UKSC 9	A prescription or limitation defence may present a common issue suitable for group proceedings.	The court accepted that prescription/limitation issues could be common but recognized they weighed against group proceedings here.
McCluskey v Scott Wilson Scotland Ltd 2025 CSIH 26	Lead case determination binds other cases; case management orders can be replicated across multiple actions.	The court noted that case management powers could efficiently handle common issues outside group proceedings.

Court's Reasoning and Analysis

The court first considered the suitability of the Applicant as representative party, applying the factors in rule 26A.7(2) and relevant precedent. Despite the Applicant’s limited expertise beyond nursing experience, the court found her suitable, noting the low threshold and the availability of specialist legal advice.

Turning to the permission to bring group proceedings, the court applied the statutory and procedural criteria under the 2018 Act and Rule of Court 26A.11(5). The court accepted the existence of prima facie claims with real prospects of success and acknowledged common factual issues, such as the implantation of hernia mesh products and the body’s inflammatory response. However, the court found the commonality test unmet because the claims involved five distinct mesh products with significant differences in design, application, and risk profiles, making it unlikely that a single common issue could be identified across all claims.

The court also found the Applicant’s proposal insufficiently developed, lacking a clear definition of common issues and failing to exclude claims likely caused by clinical negligence. It noted that prescription and limitation defences were fact-specific and likely to require individual consideration, further undermining suitability for group proceedings.

Regarding efficiency, the court was not persuaded that group proceedings would be more efficient than individual actions given the relatively small number of claimants and the complexity arising from differing products and individual circumstances. The court highlighted existing case management tools available in individual proceedings that can achieve efficient resolution of common issues without the need for group proceedings.

Overall, the court emphasized the importance of clearly defined group issues to avoid inefficiency and wasted expense, and found that the Applicant had not met the necessary criteria for permission to bring group proceedings.

Holding and Implications

The court REFUSED the Applicant’s application for permission to bring group proceedings under Rule of Court 26A.

Consequently, the court also REFUSED the application to authorise the Applicant as representative party, although it would have granted that authorisation had permission for group proceedings been appropriate.

The decision directly affects the parties by preventing the claims from proceeding as group proceedings at this stage. The court indicated that individual proceedings with case management would be more appropriate and efficient given the circumstances. No new precedent was established beyond the application of existing principles to the facts of this case.