Global Class Actions

Since they appeared on the French legislative landscape in 2016, health-related class actions have remained quite rare. This is notably due to the stringent conditions that must be met to qualify as a class action.

On this basis, 2024 has been an interesting year as the French Supreme Court was given the opportunity to redefine the contours of a health-related class action.

Under French law, class actions take place in two phases: the first concerns the admissibility of the action, the activation of liability, and the definition of the group, while the second phase focuses on the individual compensation of the claimants. The French Supreme Court ruled on May 2nd, 2024, that, in the case of a health-related class action, the judge in charge of procedural matters (before a ruling on the merits is contemplated) is competent to order an investigative measure, provided that such measure is limited to technical aspects that help clarify the issues this judge must address during the initial phase of the proceedings. 

This decision may thus result in an even longer first phase of health-related class actions due to the time needed for some investigations that may be necessary before analyzing the merits of the class action. Claimants wishing to receive swift compensation will likely continue to resort more often to another procedural path, e.g. collective action (i.e., an accumulation of individual claims in the same court proceedings). 

Although few health-related class actions have been initiated since 2016, the upcoming years could mark a turning point for class actions in the health sector.  

These past years have seen French plaintiffs’ Counsel slowly increasing their presence in the media and resorting to new commercial techniques such as class action websites. They see more opportunities in litigation funding, especially regarding foreign claimants bringing claims before the French Courts. With expanding visibility on social media, these Counsels can encourage thousands of individuals to initiate proceedings.  

The entry into force of Directive No. 2024/2853 on liability for defective products, the revision of the 1985 Product Liability Directive, which will apply to products placed on the market or put into service from 9 December 2026, will also contribute to a change in the landscape. This will broaden the list of professionals who may be held liable, introduce new criteria for assessing product defectiveness, and establish presumptions to facilitate the claimants’ access to evidence. This should therefore facilitate claimants’ actions, and thus potentially also class actions. 

Although the framework for collective redress has been gradually evolving, Germany has not yet seen widespread class actions for product liability in the healthcare sector. The key legal basis for class actions in Germany is the new consumer rights enforcement act (Verbraucherstreitbeilegungsgesetz (VDuG)), which implements EU Directive 2020/1828. This legislation facilitates representative actions for civil disputes involving large numbers of consumers against a company, including product liability claims. Art. 2 of EU Directive 2020/1828 specifically refers to class actions in lawsuits regarding EU Directive 85/374 (now EU Directive 2024/2853, Product Liability Directive (PLD)) and the Medical Device Regulation 2017/754 (MDR). 

In practice, the VDuG’s legal instruments have mainly been used in cases related to the energy and banking sectors since their implementation. Product liability claims involving claims for personal injury are, in our opinion, often not suitable for class action proceedings since they require detailed individual assessments when it comes to causality or individual damage. Also, the Action for Redress (Sec. 15 (1) sent. 1 VDuG) is only admissible if the claims of the consumers concerned by the action are essentially the same, which often does not apply to cases under the PLD. Further issues must be taken into account with respect to the interaction between the Action for Redress and the new PLD: For instance, the applicability of the presumption of causality (Art. 10 (3, 4) PLD) in class actions is questionable. Also, the defendant’s ability to refute the presumption (Art. 10 (5) PLD) cannot be determined without an evaluation of the individual case. This ambiguity raises questions about the suitability of class actions in such cases.

As we navigate the evolving landscape of class actions in the life sciences and healthcare sector, the year 2024 has brought significant developments in Germany. Here are the key takeaways and trends that companies should be aware of as we look toward 2025 and beyond: In 2024, Germany’s approach to class actions in the life sciences and healthcare sector remains distinct from other EU countries. Unlike jurisdictions where class actions for product liability claims, particularly for personal injury, are more common, Germany still relies on individual or mass proceedings to handle such cases. 

Looking ahead to 2025 and beyond, with the growing prevalence of mass litigation, we are on the threshold of a wave of class actions that will require not only legal precision but also strategic risk management.

For companies, this means not only identifying mass-action risks in a timely manner but also proactively hedging them through compliance and precise contract drafting in order to minimize economic and reputational damage. Preventive strategies and close alignment between compliance and legal advice will be crucial not only to minimize risks but also to strengthen stakeholder trust in an increasingly demanding legal environment. 

To prepare for these developments, companies in the life sciences and healthcare sectors should focus on strengthening their internal processes for handling consumer claims, complaints, and potential litigation. This also includes ensuring transparency in product information and improving the management of customer relationships. Companies should also closely monitor legal developments, particularly related to EU directives and evolving case law on product liability and causality, to ensure they remain compliant and can respond proactively to future legal challenges. In this context, it is particularly vital to monitor the impact of the new PLD on class actions, especially with regard to the issues outlined above. Since the PLD must be implemented by December 2026, it remains to be seen how national law will change in this regard, in particular German Product Liability Law (Produkthaftungsgesetz), and what impact this will have on mass litigation in product liability cases in Germany. 

Despite Italy being among the EU jurisdictions having implemented a quite complex class actions legal framework (with two different, although interconnected sets of rules), the number of class actions brought in Italy, notably against life sciences companies, is very limited. Only two class actions, both brought against medical device companies, have been certified since the first law on class actions entered into force in 2008. Consumer associations have rather chosen mass tort litigation (i.e., grouped actions) to bring claims against life sciences companies. One of the above-mentioned two class actions was brought in 2024 by two consumer associations to seek compensation for damages suffered as a result of the delayed implementation of a recall campaign of an allegedly defective medical device.

This is a leading case not only due to the cause of action introduced (i.e. compensation for damage allegedly caused by a delayed recall campaign), but also and most importantly because of the type of procedure pursued, i.e. the interim injunctive relief with the application of penalties set forth by the Italian civil procedure rules as a way to obtain monetary redress without substantiating any damage possibly suffered by the members of the class. Indeed, through the interim injunctive relief proceedings, consumer associations may seek a Court’s order imposing upon the defendant a deadline to complete the recall campaign. Violation of such a deadline may trigger the application of penalties to be paid to the consumer associations. The above case has paved the way for consumer associations to use the class actions mechanism more effectively, notably seeking injunctive relief, which may trigger the application of penalties. Already in 2024, we have seen consumer associations following the same path in litigation involving other industries. 

We may expect that in 2025 and beyond life science businesses will be involved not only in consumer protection/product liability litigation but also in relation to a variety of legal issues including cases involving allegations of anti-competitive practices, such as price-fixing, market manipulation, or abuse of dominant market positions, as well as breaches of patient data privacy or inadequate data security measures. All those cases will likely be pursued through the recourse to class action mechanisms.

Indeed, both the class action regime under the civil procedure code and the representative actions rules under the consumer code recently adopted contain several pro-plaintiff provisions including those easing the claimant’s burden of proof (i.e. use of statistic data and presumptions, as well as the disclosure order), which could encourage the recourse to class actions. Moreover, consumers and consumer associations will increasingly look at the way in which economic operations (e.g., manufacturers, importers, distributors) implement recall campaigns in case of product defects or non-compliance to seek redress through class actions and/or representative actions, both injunctive and on the merits.

Recent cases have shown that this will be a major battleground. Indeed, both regulators and judges increasingly scrutinize how economic operators assess the safety risk, identify and implement the necessary corrective measures. In this respect, the new product liability directive, once implemented in Italy, will allow judges to infer the defect of a product also from the fact that the product was subject to recall campaigns, even voluntary. An effective risk mitigation strategy should be based on a thorough analysis of the litigation risks at every phase of the product cycle. To this purpose, the different business functions (i.e., R&D, quality, marketing, regulatory, communication, and legal) should constantly collaborate. 

We haven’t seen a particular increase in collective actions being initiated (or announced to be initiated) in the Life Sciences and Health Care industry either. Although the class action mechanism under the WAMCA remains an important tool to handle these kinds of mass claims, no major increase in the use of the collective actions mechanism for the handling of these claims in 2024. 

We don’t expect particular trends in 2025 that affect the Life Sciences and Health Care industry. It remains important, though, for clients in this industry sector to closely watch the activities of some of the most active claim organizations that are active in this area. 

Significant collective actions against life sciences companies have been a main pillar of the UK litigation landscape for decades. These have targeted a broad range of products over the years: from vaccines to blood products and orthopedics to antidepressants. While there has been a rapid expansion of other forms of class action in the UK, facilitated by a growing ecosystem of specialist claimant law firms and litigation funders, the steady stream of claims against life sciences businesses has remained relatively constant, including in 2024.  

While many of the new wave of consumer and competition claims are supported by a litigation funder, the life sciences claims tend not to be. They often represent a more significant financial investment, and therefore risk, for the claimant firms willing to take them on. But there are plenty of claimant firms willing to do so. Any widely used product for which there is a suggestion of a new side-effect, or that is subject to a recall, is at risk of becoming the next target of claimant firms. 

Life sciences products will continue to be a natural area of focus for claimant firms in 2025 and beyond, particularly as areas of technological innovation bring new areas of risk. For example, new weight-loss drugs are being widely used and receiving a great deal of publicity, so claimant firms will be watching closely. Also, as AI tools become increasingly integrated into life sciences products and services, and as those products and services become more widely available, we expect claimant firms to identify additional areas of opportunity in which to try and initiate claims. 

We have seen many claims brought using the formal opt-in ‘group litigation’ procedure in the life sciences sector (GLOs). However, it is also an area where the English court has shown willingness to use its wide case management powers to find alternative, informal mechanisms for handling group claims (sometimes called a ‘GLO-lite’ procedure). This is often because claimant numbers, while still significant, do not reach a level where the additional costs added by the full group litigation mechanism are proportionate. These claims still represent material risk and expense for defendants. For defendants, the absence of a GLO (or other formal grouping of the claims) can be helpful in trying to demonstrate that there is no true common issue across the claims. The trend towards ‘GLO-lite’ structures seems likely to continue into 2025 and beyond.

In 2024, we saw several important shifts regarding life sciences and health care litigation. First, we saw some strong results for the preemption defense in Life Sciences litigation, particularly in the consumer protection class action context. For example, in the In re Oral Phenylephrine Marketing and Sales Practice Litigation MDL, we, on behalf of client RB Health US LLC, and our co-defendants obtained an important win at the motion to dismiss stage on over-the-counter preemption grounds. There, after an FDA advisory committee voted in September 2023 that oral phenylephrine (a common in ingredient in over-the-counter cold and flu medications) is not effective as a nasal decongestant, plaintiffs began filing consumer class action lawsuits across the country bringing claims for fraudulent and deceptive marketing practices under state consumer protection statutes, even though the OTC product monograph mandates or authorizes virtually all of the statements the plaintiffs challenged as false or misleading. The defendants filed a joint motion to dismiss in a “test case” involving New York law and federal civil RICO, arguing, among other things, that the plaintiffs’ claims were expressly preempted by the express preemption provision of the FDCA’s OTC regulations. On October 29, 2024, the Court granted the motion, concluding that all of the plaintiffs’ state law claims are expressly preempted by the OTC monograph and federal regulations. While Plaintiffs are now appealing the decision and FDA subsequently announced that it is proposing to remove oral phenylephrine as an active ingredient for relevant products, this nevertheless is a strong OTC preemption decision and is a rare win on an early dispositive motion in the MDL class action setting. 

We also experienced similar recent success in the District of Massachusetts for client AMAG Pharmaceuticals, Inc., the manufacturer of Makena, a progestin hormone treatment that was indicated to reduce the risk of preterm birth in certain pregnancies. In April 2023, the FDA withdrew Makena’s approval after a confirmatory study failed to confirm the drug’s efficacy. Shortly thereafter, an Ohio-based health and welfare fund filed a class action asserting claims under RICO and several dozen state consumer protection laws on behalf of a nationwide class of insurers and other third-party payors who purchased or paid for Makena prior to the withdrawal, arguing that AMAG should have stopped marketing the drug once the study results were released. We moved to dismiss, and the Court found all of Plaintiffs’ claims preempted by federal law – because the challenged marketing statements were consistent with Makena’s FDA-approved labeling, AMAG could not have used the FDA’s Changes Being Effective (CBE) process to unilaterally change the label to remove Makena’s only approved indication, and AMAG was not required to stop marketing the product prior to the FDA’s withdrawal of that approval. The Court also held that the named plaintiff, as an indirect purchaser, lacked statutory standing under RICO and failed to plead its fraud-based claims with the requisite particularity under Rule 9(b).

Two additional important shifts in class action litigation involve the numerosity and adequacy requirements for class certification under Rule 23. Typically, classes with over 40 class members meet Rule 23’s numerosity requirement. However, in the In re: EpiPen Direct Purchaser Litigation decision in the District of Minnesota, the district court declined to certify an antitrust and RICO class with over 40 members because it found that joinder was not impracticable. This follows recent precedent in the Third Circuit, taking a similar approach. The In re EpiPen decision also demonstrates that courts may be unwilling to certify a class where some putative class members ultimately benefit from the alleged conduct at issue in the lawsuit. In the In re EpiPen case, the Court found that joinder was not impracticable after holding that (1) there is no presumption that numerosity is satisfied just because the putative class exceeds 40 members; and (2) the individual class members had damages large enough to justify non-class treatment, particularly where a staggering 93% of the total damages were attributable to three absent class members. This is a significant development because it demonstrates that class certification may be denied even in classes with more than 40 members. On adequacy, the Court found that there were conflicts between the class representatives and absent members because some absent members benefited from the conduct that was alleged to have caused harm. On this point, the Court rejected Plaintiff’s Hanover Shoe and Illinois Brick arguments that it is irrelevant whether a direct purchaser ultimately benefits from the alleged harm, noting that Hanover Shoe and Illinois Brick do not apply to Rule 23. This is a noteworthy ruling because it means that a defendant may be able to challenge the inclusion of plaintiffs in the class who ultimately benefit from the alleged conduct. 

In January 2025, the U.S. Supreme Court agreed to answer a hotly-contested question in class action litigation, which will have substantial impact throughout the life sciences U.S. litigation space: “Whether a federal court may certify a class action pursuant to Federal Rule of Civil Procedure 23(b)(3) when some members of the proposed class lack any Article III injury.” The answer to that question has been the subject of intense litigation, especially in consumer and other class actions affecting pharmaceutical and other life sciences companies, and there is currently a three-way circuit split over the issue. The Supreme Court heard oral argument in the case (Laboratory Corporation of America Holdings, dba Labcorp v. Luke Davis, et al., Case No. 22-55873) on April 29, 2025, during which the justices asked several questions about procedural issues associated with the various orders in the trial court related to the class definition.  If the Supreme Court moves beyond those procedural issues and addresses the merits of what is required for class certification, its decision may significantly impact cases where, for one reason or another, there is reason to believe that some members of the proposed class are not injured within the meaning of Article III of the U.S. Constitution.