Litigation, Investigations and Privilege
Key points
- Following a Supreme Court decision last year, the Irish courts are applying stricter temporal benchmarks in applications to strike out proceedings for delay, providing a further strategic litigation option for companies defending long-running or inactive claims.
- The CJEU has recently confirmed that limitation periods under the Product Liability Directive run from the date of awareness of damage, not from when a condition stabilises or becomes permanent, and has upheld the ten-year longstop — providing welcome certainty for companies facing claims involving progressive or latent injury.
- The HPRA reports a 180% increase in the number of falsified or illegal medicines detained in 2025 compared to the previous year.
- Companies should exercise caution when using AI tools to process documentation containing legal advice, as sharing such material on public or open AI systems may risk waiving privilege over that advice.
Delay in life sciences litigation: a recalibration in approach
Delay in cases progressing is sometimes a feature of civil litigation, particularly in complex, evidence-heavy proceedings. Historically, applications to strike out for delay required proof that the delay was inordinate and inexcusable and that the balance of justice required dismissal. In practice, this produced unpredictable and fact-specific outcomes and such applications were rarely successful unless clear prejudice could be shown. These applications are especially relevant in personal injury and product liability claims that can arise in the life sciences sector, where litigation can involve complex causation, extensive expert evidence, and significant time lapses between product use and alleged injury.
The Supreme Court’s decision in Kirwan v Connors [1] has recalibrated this approach and in the past year the Courts have adopted this new approach, and many successful strike-out applications have been brought. In Kirwan, the Court introduced indicative temporal guidelines: cumulative inactivity of two years will generally be inordinate; delay approaching four years in cases dependent on oral evidence gives rise to a strong presumption of dismissal; and inactivity exceeding five years will ordinarily justify dismissal absent a pressing exigency of justice or compelling countervailing circumstances. The Court also confirmed that a defendant’s silence does not amount to acquiescence and that the obligation to progress proceedings rests with the plaintiff.
From a defence litigation strategy, it is worth carefully considering any periods of delay arising in the prosecution of claims to assess whether there is merit in considering a strike-out application.
[1] Kirwan v Connors [2025] IESC 21
Product liability modernisation and litigation reform in Ireland
TRANSPOSITION: IRELAND ON TRACK
The new EU Product Liability Directive 2024/2853 (the “PLD”) applies to products placed on the EU market or put into service after 9 December 2026. The Liability for Defective Products Act 1991 remains in force for products placed on the market prior to that date.
As noted in our publication Evolving product liability and safety landscape: recent and upcoming regulatory developments in 2025, and The EU rings in new changes for product liability and product safety in 2024, key reforms under the PLD include: expansion of “product” to cover digital files, software, and AI-enabled goods; a new concept of “economic operators” encompassing manufacturers, importers, and distributors; recognition of psychological harm as a ground for damages; extension of the longstop period to 25 years in certain cases; and introduction of a presumption of defectiveness in defined circumstances.
The Department of Enterprise, Tourism and Employment has confirmed that it is their expectation that the transposition deadline of 9 December 2026 is still expected to be met.
CJEU Provides Clarification on Limitation Periods and Procedural Time Limits
The Court of Justice delivered a significant judgment on 26 March 2026 in LF v Sanofi Pasteur SA [2] clarifying the temporal limits for claims under the existing Product Liability Directive in cases of latent or progressive damage. The Advocate General had argued that the ten-year longstop should be set aside as incompatible with the right of access to courts, and that the three-year limitation period should run only from the date on which a progressive disease had “stabilised” or became permanent. The CJEU rejected both propositions.
The Court confirmed that the three-year limitation period commences when the claimant became aware, or ought to have become aware, of the damage, the defect, and the identity of the producer — irrespective of any subsequent evolution of the condition. It held that reference to a “stabilised” medical condition would undermine legal certainty by reference to an undefined criterion which, in the case of progressive illness, could correspond to the date of the claimant’s death. The Court also upheld the compatibility of the ten-year longstop with the right of access to the courts.
The CJEU acknowledged that strict liability places a greater burden on manufacturers and that these burdens must be limited to avoid hindering technological development. The judgment provides clarity to life sciences companies defending claims involving progressive or latent injury, confirming that arguments for delayed commencement of limitation by reference to ongoing symptom development are unlikely to succeed.
[2] LF v Sanofi Pasteur (Case C-338/24)
Collective Redress: Framework and Constraints
In 2025, the first representative action was commenced in Ireland under the Directive on Representative Actions (Directive (EU) 2020/1828) (transposed in Ireland by the Representative Actions for the Protection of the Collective Interests of Consumers Act 2023 (the “2023 Act”), by the Irish Council for Civil Liberties. The case was admitted to the Commercial list of the High Court but is yet to be heard.
As outlined in our 2025 publication Representative Actions in Ireland: 2025 mid-year review, the 2023 Act permits qualified entities (“QE”) to bring representative actions on behalf of consumer groups for alleged infringement of their rights under relevant enactments. From a life sciences perspective, the 2023 Act is potentially significant as the PLD, the medical devices regulation, product safety regime and in vitro medical devices regulation are also in scope of the 2023 Act.
These first proceedings are notably confined to seeking declaratory relief. It is anticipated that, absent reform of the current prohibition in Ireland on third-party litigation funding, representative actions seeking injunctive relief will feature more prominently than those seeking redress. Unless or until that prohibition is abolished, the PLD’s disclosure requirements and eased burden of proof are likely to remain most attractive to litigation funders in jurisdictions where third-party funding is permitted.
Read Representative actions in Ireland: Mid-year 2026 update
Regulatory action: HPRA
Recent activity by the HPRA shows a clear difference between its day‑to‑day regulatory work and more serious investigations or enforcement action. Most interaction with life sciences companies continues to take place through routine, risk‑based reviews and inspections. These programmes are primarily intended to encourage compliance and good practice, rather than to impose penalties.
Where issues or shortcomings are identified, the HPRA’s focus is generally on fixing the problem. This typically involves requiring corrective steps, preventative measures, or improvements to internal quality and compliance systems. Formal enforcement action remains relatively uncommon.
HPRA ENFORCEMENT: RISING DETENTIONS AND AN ESCALATING REGULATORY APPROACH
The HPRA published its 2025 enforcement figures in March, and they make for significant reading for life sciences companies operating in or supplying the Irish market. Some of the key findings are below:
- Over 763,000 dosage units of illegal and falsified medicines were detained in 2025, representing a 180% increase in individual consignments compared to the previous year — rising from 4,950 consignments in 2024 to 13,898 in 2025.
- Before initiating formal prosecution, the HPRA has confirmed that it will typically engage directly with offenders, detain product, and issue formal cautions requiring the cessation of illegal activity. In 2025, 14 voluntary formal cautions were issued.
- However, the HPRA has made clear that where there is significant risk to public health or persistent non-compliance, prosecution will follow — and it initiated one prosecution in 2025 specifically relating to the manufacture and distribution of GLP-1 medicines.
- The HPRA also reported that it shut down or amended 4,762 websites, e-commerce listings and/or social media pages in 2025. It is worth noting that 2,755 of those URL removals were specifically linked to warnings the HPRA issued in 2025 in relation to fraudulent websites and adverts promoting illegal medicines.
dosage units of illegal and falsified medicines were detained in 2025
voluntary formal cautions were issued
the number of websites, e-commerce listings and/or social media pages the HPRA reported to have shut down or amend in 2025
Privilege update
The Fundamentals Remain Solid
Legal professional privilege entitles the holder not to disclose confidential documents to the court, opposing parties, or regulators. It protects confidential communications created for the purpose of giving or receiving legal advice (legal advice privilege) or for the purpose of litigation or a regulatory investigation (litigation privilege), and enjoys constitutional protection under Article 34 of the Constitution. The law in Ireland in this area remains substantively unchanged.
In-house Counsel are not required to meet a higher burden than external counsel to establish privilege, but may only avail of it when acting in their capacity as the company’s legal adviser. Legal advice should be kept separate from business or commercial communications. In the context of competition investigations, communications by in-house counsel are not privileged under EU law.
Artificial Intelligence and Privilege - A New Frontier
The Court of Appeal has recently addressed the use of AI in litigation after the defendant filed submissions containing AI-generated references to non-existent authorities. The Court set out a number of principles that provide general guidance in litigation, including that parties may use AI for research provided they do not mislead the court; that AI use must be disclosed to the court and other parties; and that parties must independently verify the accuracy of all submissions and authorities cited. [3]
The Privilege Risk from AI Use
Many AI providers’ terms of service permit review of user inputs and their use for model training, raising serious concerns about confidentiality. Information input into a public AI system should be treated as published to the world, and privileged advice uploaded to a consumer-grade GenAI system will likely lose its privilege. This waiver of privilege can also have a “domino effect”, extending to related documents flowing from that advice.
[3] Guerin v O’Doherty [2026] IECA 48 at para 72
What's next?
The national legislation transposing the Product Liability Directive 2024/2853 is expected to be enacted in advance of the 9 December 2026 deadline. Life sciences companies should monitor the form and content of the transposing legislation closely, particularly any areas where the Irish implementation may depart from or supplement the text of the PLD.
The Law Reform Commission’s report on third-party litigation funding has not yet been issued and remains awaited at the time of writing. Given that the Product Liability Directive is a “relevant enactment” for the purposes of the Act, any future abolition of the prohibition on third-party litigation funding in Ireland could have significant implications for life sciences companies, potentially enabling funded representative actions seeking redress measures in respect of product liability claims on behalf of large consumer cohorts.
The General Scheme of the Civil Reform Bill published in January 2026 proposes reforms intended to reduce cost and delay in civil proceedings. Key measures include placing judicial review on a statutory footing, narrowing discovery through a targeted production‑based regime, and enhancing judicial case management. Although of general application, these reforms are likely to have particular relevance for regulatory and life sciences litigation, where proceedings are often document‑heavy and long‑running. The Bill is listed for priority drafting in the Government’s Summer 2026 Legislation Programme (PDF 565 KB) published on 14 April 2026.[4]
On 24 June, the Joint Oireachtas Committee on Justice, Home Affairs and Migration published a Report entitled “Pre-Legislative Scrutiny of the General Scheme of the Civil Reform Bill in June 2026” (PDF 449 KB). The Report is broadly supportive civil justice reform but concludes that key parts of the General Scheme of the Civil Reform Bill may create barriers to access to justice and recommends substantial amendments. The final text of the Bill is still awaited but is this is an area to watch.
[4] Department of Justice, Minister Jim O’Callaghan publishes Civil Reform Bill to overhaul judicial review and streamline court processes (Press Release, 6 January 2026), available at https://www.gov.ie/en/department-of-justice-home-affairs-and-migration/press-releases/minister-jim-ocallaghan-publishes-civil-reform-bill-to-overhaul-judicial-review-and-streamline-courts-processes/ (accessed 2026/04/08).
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