Q&A: Drug and medical device litigation
November 2025 | SPECIAL REPORT: HEALTHCARE & LIFE SCIENCES
Financier Worldwide Magazine
November 2025 Issue
FW discusses drug and medical device litigation with Christian Di Mauro at Hogan Lovells Studio Legale, Eric Alexander at Holland & Knight LLP and Alison Dennis at Taylor Wessing.
FW: What recent trends and developments have shaped the drug and medical device sector? How have these trends contributed to litigation risk?
Di Mauro: From a product law perspective, the pharmaceutical and medical device sectors in Italy have undergone significant evolution in recent years, particularly with the adoption of the EU Product Liability Directive (PLD) and the European Artificial Intelligence (AI) Act. The PLD introduced provisions that are more favourable to plaintiffs, simplifying the process of proving defects and causation in complex products. It also extended the statute of limitations for latent damage and expanded the scope of compensable damages. Conversely, the AI Act has imposed stringent compliance requirements on pharmaceutical companies developing or deploying advanced AI-based medical devices, creating additional regulatory burdens. As a result, companies operating in this sector are likely to face increased exposure to liability claims in the coming years. Furthermore, the recent reform of Italy’s class action and collective proceedings framework has amplified the risk of large-scale liability claims, particularly for manufacturers of drugs or medical devices alleged to have caused widespread harm. While the number of class actions filed against life sciences companies in Italy remains relatively low, businesses must now be prepared to defend against coordinated legal actions, which could carry substantial financial and reputational risks.
Dennis: Politicians are increasingly saying that regulation is a bad thing and that they will be reducing the regulatory burden on companies. Companies’ response is to pare back on post-market regulatory compliance as this cuts costs. Post market is where the litigation risks are to be found as they generally only arise once products are on the market or in clinical trials. Regulation in the post-market space has not, in fact, decreased. Companies are therefore running higher risks. Although regulation has not changed, we have seen regulatory authorities increasingly underfunded and understaffed, including the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA). This means that enforcement actions are not always being taken or not being followed through. Companies are thus emboldened to take even greater risks. If underfunded regulators are required to choose which matters to pursue, they will likely do so on a political basis, depending on the issues that look the worst for politicians. Thus, while the probability of regulatory action has decreased, the probability of a substantial and significant legal enforcement action in the event that a company or particular issue is singled out by a regulator is higher.
Alexander: Continuing recent trends include targeting alleged contamination and trace chemicals in common drugs, focusing on alleged lack of biocompatibility of materials used in implanted medical devices, targeting blockbuster drugs without a signature risk or cohesive theory, and the use of litigation funding to drive advertising and case collection campaigns. Two more recent and emerging issues are the politicisation and rethinking of established public health positions and the targeting of ‘products’ that utilise software and AI. Contamination theories have not been particularly successful, except in collecting a large number of cases. Focusing on suppliers for devices can highlight the tension between business practices and litigation risk. The full impact of changes to FDA policies related to the current secretary of health and human services remains to be seen, but some recent cases have echoed these changes. Courts seem to be expanding traditional tort theories to accommodate liability for social media platforms, self-driving cars and other tech-driven ‘products’.
“Companies should undertake an internal investigation to establish the facts and prepare a chronology of events, which is always useful when needing to respond in litigation.”
FW: When litigation arises, what key preparatory steps should legal teams take? What are some of the typical challenges encountered in drug and medical device cases?
Dennis: It is imperative that companies preserve their documents by placing a litigation hold on all relevant documents, emails and other pertinent information held by the company and anyone under its control. Companies should check their insurance provision to see whether the matter would be covered and then follow the notification requirements if it is. The insurer might want to appoint their own lawyers. Determining how the rules of privilege apply to the documents held by the company is important. This is likely to mean limiting the internal team of individuals who are a party to the correspondence about the case and involving external lawyers on all correspondence relevant to the matter. Companies should undertake an internal investigation to establish the facts and prepare a chronology of events, which is always useful when needing to respond in litigation.
Alexander: Early steps applicable to litigation involving drugs and devices are largely the same steps that are advisable for any litigation: placing litigation holds, fact finding, hiring counsel and, as needed, advising insurers. Because large-scale product liability litigation against drug and device manufacturers can often intersect with regulatory actions, governmental investigations and other litigation, there is a particular need to get the early steps right, including corporate relations and government relations resources. With national litigation, companies should track advertising, litigation funding and filings around the country, and should set a strategy in terms of where cases will proceed, such as in a single federal multidistrict litigation. The challenges of these cases largely depend on the scope of litigation, but the industry is generally unpopular with jurors and considered a profitable target for the plaintiff bar, both of which increase the need for early consideration of a litigation-wide resolution strategy.
Di Mauro: In the event of drug or medical device litigation, in-house legal teams should act promptly to retrieve and preserve all relevant technical, regulatory and vigilance documentation. This information should be shared without delay with external counsel appointed to represent the company, enabling the development of an effective and comprehensive defence strategy in a timely manner. The recent reforms to the collective proceedings framework, combined with evolving European Union (EU) product liability standards, are expected to increase both procedural complexity and potential exposure. To address these challenges, companies must adopt a proactive approach that includes thorough case mapping, early engagement of expert witnesses, and systematic reviews of recall procedures and field safety notice communications.
FW: How do existing legislative and regulatory frameworks affect liability for product-related injuries linked to drugs and medical devices?
Di Mauro: In Italy, the civil liability framework for damages caused by drugs remains an unsettled issue. In a recent ruling, the Supreme Court confirmed that lower courts currently have significant discretion in determining which liability regime to apply. Courts may choose between the ordinary fault-based civil tort liability regime under article 2043 of the Civil Code, the aggravated liability regime for defective consumer products under article 114 of the Consumer Code or the strict no-fault liability regime applicable to operators engaged in inherently dangerous activities under article 2050 of the Civil Code. However, the Supreme Court emphasised that this discretion must be exercised within the boundaries of legal certainty and the internal consistency of the national legal system. In addition, beyond the EU-wide challenges introduced by the Medical Device Regulation and In Vitro Diagnostic Regulation, along with their implementing legislation – which impose stringent safety, vigilance and post-market obligations on pharmaceutical companies – the recently updated PLD is expected to further impact litigation risks. By easing the burden of proof for claimants and expanding the scope of recoverable damages, the PLD is likely to result in increased litigation exposure for companies operating in this sector.
Alexander: Some foregoing trends feed into the increasing mistrust of FDA and ‘mainstream’ science by potential plaintiffs and jurors. Plaintiffs benefit from any weakening of the FDA’s traditional positions or doubt cast on long-held scientific positions. For instance, pre-emption defences available to many claims against these companies may weaken even without further Supreme Court rulings. In addition, there has been a trend for states to strengthen their consumer protection laws, both by legislation and court interpretation, and weaken product liability acts that provided strong defences to many drug and device manufacturers. The ‘public nuisance’ theory that has been a basis for some significant litigation against manufacturers of drugs, such as in opioid litigation, has largely been rejected by appellate courts, but state legislatures may override those decisions. Some courts’ expansion of liability for software, including in software-driven devices, is connected to a perceived gap in the regulatory framework covering software as a medical device.
Dennis: In the UK, liability for defective drugs and devices products arise under three mechanisms. First, the strict liability regime pursuant to the Consumer Protection Act 1987 (CPA) which, until the end of the Brexit transition period, implemented EU Directive 85/374 EEC on liability for defective products, the PLD. Second, tortious actions in negligence for breach of a duty of care or for breach of a statutory duty. And third, through a breach of relevant contracts, the rights and obligations of which may be determined to some extent by the Sale of Goods Act 1979, the Supply of Goods and Services Act 1982 and the Consumer Rights Act 2015, depending on the contract type. Claimants commonly bring claims under all three mechanisms. A negligence claim requires a claimant to establish fault on the part of a person who owes them a duty of care, which can be more difficult to prove compared to the strict liability imposed on manufacturers – and certain other actors in the supply chain – under the CPA. With strict liability, if a product is found to be defective and caused the injury, then liability will be founded without any need to prove fault. Note that in future the similar regimes under EU law will be changing as result of the EU General Product Safety Regulation 2023/988 (GPSR) and the new EU PLD, together reshaping the liability framework. The GPSR does not apply to devices used by healthcare professionals on patients, but does if the patient uses the product themselves. The PLD should be in effect in all EU countries from December 2026. That new regime takes into account compliance of the product, device or medicine with the regulatory requirements. This includes rebuttable presumptions in favour of consumers of defectiveness and a causal link where proof of causality is difficult.
“The direction of the FDA and other federal agencies may lead to increased litigation as to vaccines and other medical products that have long been considered safe and effective.”
FW: How critical is expert testimony in drug and medical device litigation? How has the role of expert witnesses in these cases evolved over time?
Alexander: Expert testimony is critical in drug and medical device litigation. In general, rules governing the admissibility of scientific and other expert opinion testimony have tightened over time, including with changes to the Federal Rule of Evidence 702 in 2023, but the approach of trial judges has been looser. In many of the cases, plaintiffs advance a novel or not widely accepted scientific position – that the drug causes an injury despite human studies showing no increased risk – and many judges have allowed juries to hear both sides, even if the plaintiffs’ evidence should have been excluded. There is a trend toward excluding junk science and experts who largely recap all the evidence in a party’s favour. Also, juries are increasingly unlikely to accept opinions based solely on the qualifications of the expert witness. Thus, there is an even higher premium on experts who can explain the issues and their opinions in such a way that the jury can understand them.
Dennis: Expert testimony in medical device litigation includes discussing how a device or medicine might have interacted with the patient and caused or not caused the complained of injury. There is also expert regulatory testimony, which examines whether there is an actual or technical breach of the regulations. In contract claims, testimony will cover foreign law, while in contractual claims for milestones and other licensing payments, accountancy experts will be engaged to testify.
Di Mauro: The majority of drug and medical device litigation cases, particularly those involving product safety-related compensation claims, are decided based on the technical assessments conducted by court-appointed experts (CTUs). These assessments may be carried out either during preliminary technical appraisal proceedings or directly within the merit proceedings. CTUs play a pivotal role in shaping the outcome of such cases, as judges heavily rely on their findings when rendering decisions. At the same time, party-appointed experts are instrumental in scrutinising and challenging any methodologies or interpretations that may have been erroneously adopted by CTUs, thereby ensuring a balanced and accurate evaluation of the issues at hand.
FW: Could you share any recent drug or medical device cases that have stood out to you? What practical insights can be drawn from the way these cases were decided?
Dennis: Defective products which were included in the UK’s Independent Medicines and Medical Devices Safety Review continue to be litigated. These products are sodium valproate, causing birth defects, Primodos, oral hormone pregnancy tests causing birth defects, and vaginal mesh, which caused significant internal injuries and pain and has been difficult to reverse. These cases date back many years. Primodos was used between 1958 and 1978 and yet getting to the truth of the matter has taken decades since to establish what was known by the companies promoting and selling these products. The ‘state of the art’ at the time a device is on the market is important as is the knowledge of companies about the issues and the timing of that knowledge. The ability of companies to prevaricate and hide evidence and knowledge indicates that, if governments had the patients’ interests at heart, they would legislate in the event of multiple drug or device failures for dawn raid style enforcement actions similar to those under competition law, rather than waiting for the slow grind of product liability litigation to expose the truth.
Di Mauro: A notable recent case is the ruling issued by the Court of Justice of the EU in March 2025 concerning D-mannose. The court was tasked with determining whether D-mannose – a substance used to prevent E. coli bacteria from adhering to bladder cells – should be classified as a medical device or a medicinal product, as each classification entails the application of a distinct regulatory framework. In its decision, the court concluded that D-mannose qualifies as a medicinal product, reasoning that it exerts a “pharmacological action”, even though this action is reversible and specifically targets bacteria rather than human cells. The key takeaway from this ruling lies in the court’s interpretation of “pharmacological action”, which now includes even temporary molecular interactions as sufficient grounds to classify a product as a medicinal product. For companies developing products in borderline areas, this decision serves as a clear signal: in cases of regulatory uncertainty, both regulators and courts are increasingly inclined to classify a product as a medicine, thereby subjecting it to a more stringent regulatory framework. Consequently, manufacturers are strongly advised to conduct thorough evaluations of their products’ key characteristics to avoid unexpected reclassifications, which could significantly impact regulatory obligations and market strategies.
Alexander: Two 2024 state supreme court decisions undercut plaintiff theories in litigation after the defendants had already paid out very large settlements. In Shears, a transvaginal mesh case, the West Virginia Supreme Court required plaintiffs to show a feasible alternative design to sustain a design defect claim, which is a requirement that runs contrary to suing every manufacturer of every transvaginal mesh. In an opioid litigation case generally known as Trumbull County, the Ohio Supreme Court rejected a public nuisance claim tied to the manufacture or distribution of a product, the main theory in the entire litigation. These cases support forcing appellate decisions on key issues rather than seeking early global resolution when plaintiffs may have leverage. Although not a drug or device case, the 2024 US Supreme Court decision in Loper Bright, which ended deference to federal agency decisions, has impacts in a number of areas, including a range of litigation involving drug and device companies.
“The recent reform of class actions represents one of the most significant legislative developments poised to reshape the pharmaceutical and medical device litigation landscape in Italy.”
FW: What advice would you offer to drug and medical device companies on managing the litigation process, from initiation to resolution?
Alexander: When litigation over a company’s drugs or devices starts, there needs to be a realistic evaluation of how large it will be, whether it will involve investigations or other types of litigation, and what the key drivers will be for the size of the litigation and how the company will do. These are part of developing an early plan, albeit one that needs some degree of flexibility, for the likely end game. How many trials will be necessary to get a favourable resolution? Are there key legal issues that will need to be decided by an appellate court to assess the litigation? Is there a way to limit the number of cases that get filed, especially if the products at issue are still marketed? Much like preparing for a trial from the start of a case, it is important to look at the end from the start. The days of merely being reactive and deciding on the plan years into the litigation are gone.
Di Mauro: In recent years, litigation in Italy’s life sciences and healthcare sector has primarily centred on product liability, particularly concerning defective medical devices and other healthcare products. However, there is a growing recognition of additional areas that could give rise to healthcare-related class actions, including data privacy and security, environmental, social and governance (ESG) issues, and even antitrust matters. To proactively address the challenges posed by the evolving regulatory landscape and to mitigate potential litigation risks, businesses should adopt an integrated approach that brings together legal, compliance, quality and communication functions. This integration will enable companies to anticipate and manage litigation risks throughout the entire product and service lifecycle. Key priorities should include strengthening data governance practices, enhancing ESG reporting and reinforcing product safety protocols. When litigation becomes a possibility, companies should implement early response strategies to address potential claims effectively. These strategies should include crisis communication planning, cross-border defence coordination, and the adoption of systematic and pragmatic policies for assessing the merits of claims. Additionally, careful evaluation of settlement opportunities for particularly complex or high-risk cases can help minimise financial and reputational exposure.
Dennis: Medical device companies should have someone with overall responsible for managing the litigation internally. They should also provide a support team to that individual – mentally as well as practically. The sounding board of a more senior lawyer is always helpful to maintain some objectivity. It is also important to determine how privilege applies in the country or countries in which the litigation is taking place. Companies need to decide their ‘internal team’ for the purpose of maintaining that privilege. The use of technology is also key, to collate, search and store relevant documents. At regular intervals, companies should look at the bigger picture to determine whether continuing with the litigation or settlement will, overall, be better for their organisation. In doing so, they should always take into account the ‘distraction factor’ as well as the public relations noise in the market while litigation is ongoing.
FW: How do you see drug and medical device litigation evolving in the coming years? Are any forthcoming legislative or regulatory changes likely to have an impact?
Di Mauro: The recent reform of class actions represents one of the most significant legislative developments poised to reshape the pharmaceutical and medical device litigation landscape in Italy. From a procedural perspective, the coexistence of the new class action framework under the Italian Code of Civil Procedure and the representative action provisions within the Italian Consumer Code is expected to further drive the growth of collective litigation. Simultaneously, the introduction of the updated PLD is likely to strengthen claimants’ positions, providing injured parties with enhanced opportunities to seek compensation from manufacturers for harm caused by defective products. Moreover, cross-border coordination is becoming an increasingly important factor in this evolving landscape. Pan-European consumer organisations are playing a more active role, and businesses operating across multiple jurisdictions may face parallel or coordinated legal proceedings. This trend underscores the need for companies to adopt robust legal strategies to navigate the complexities of collective and cross-border litigation effectively.
Dennis: The biggest changes in litigation practice are likely to come from technology and particularly AI. For example, AI could in future be used to ‘objectively’ determine settlement amounts for individuals in class actions once the principle of liability has been determined by a judge. The judge could approve the ‘rules’ that the AI tool uses in making that decision. Additionally, AI can of course be helpful with the document review process. This could be undertaken with court oversight rather than each side providing their own perspective on the documents. This would be a more inquisitorial way of operating rather than adversarial, which would be a new way forward for common law jurisdictions, and might be a way to speed up the trial process, and maybe even to achieve better ‘justice’.
Alexander: The direction of the FDA and other federal agencies may lead to increased litigation as to vaccines and other medical products that have long been considered safe and effective. Similarly, the pre-emption defence, which is particularly important in litigation involving Class III devices, may weaken. Litigation over alleged trace contaminants will probably continue, even though these theories have not succeeded in the Zantac and Valsartan litigations. In terms of key regulatory and legislative changes, the FDA may issue another proposed rule on laboratory developed tests or Congress may amend the Food, Drug and Cosmetic Act, either of which could change the regulatory requirements for these products, spurring litigation. Also, the FDA currently regulates AI as a medical device; however, it is likely that as the technology develops, more nuanced FDA regulations regarding medical devices containing in whole or in part AI will evolve. The FDA recognises the use of AI in drug development and its policies will continue to evolve with the technology. As AI is utilised more in clinical trial and with devices, more litigation is bound to ensue surrounding the products’ development, safety data and promotion.
Christian Di Mauro is head of Hogan Lovell’s Italian litigation practice and leader of the Italian life sciences group, with a strong focus on product compliance, product liability and general commercial disputes. He works alongside international and Italian clients on product crisis arising out of safety and quality issues, defending product liability claims, liaising with market surveillance authorities, and handling product related regulatory and criminal investigations. He can be contacted on +39 02 720 252 328 or by email: christian.dimauro@hoganlovells.com.
Eric L. Alexander is a litigation and dispute resolution attorney in Holland & Knight’s Washington, DC office and team leader of the product liability – life sciences team. Mr Alexander focuses his practice in the area of product liability litigation for pharmaceutical and medical device companies. His practice has a particular focus on multidistrict litigation and other serial product liability and mass torts. He can be contacted on +1 (202) 469 5640 or by email: eric.alexander@hklaw.com.
Alison Dennis is recognised as a top regulatory and transactional life science lawyer in Europe. She works with mid-sized and large medical device and pharmaceutical manufacturers, helping them to design new product offerings to meet regulatory requirements and to facilitate product commercialisation across the UK and EU. She frequently negotiates optimal positions for pharma and medical device companies with regulators such as competent authorities, notified bodies and industry bodies with voluntary codes. She can be contacted on +44 (0)20 7300 4725 or by email: a.dennis@taylorwessing.com.
© Financier Worldwide
Q&A: M&A in the healthcare and life sciences sector
The high-stakes future of healthcare consolidation and regulation
Adapting to legislative and policy changes in the life sciences sector
Update to the European rules on advertising medicinal products
Recognition of the subjectivity of the concepts of personal data and pseudonymisation
Why intellectual property due diligence matters