- Volume, Volume, Volume: In 2025, the plaintiffs’ bar will continue to rely on massive numbers of cases to exert leverage on defendants. Currently, 95% of multidistrict litigation cases (MDLs) have over 1,000 plaintiffs; only 5% of MDLs have fewer than that number. Consolidated state court proceedings reflect a similar ratio. The number of litigants, particularly when coupled with the tendency of many judges to push settlement rather than to decide cases on the merits, will leave defendants with a difficult choice: pay significant settlements for meritless cases or spend considerable sums to defend them indefinitely.
- Economic Loss Class Actions: In 2025, the plaintiffs’ bar will look to expand their use of economic loss class actions to try to deliver high verdicts or lucrative high-dollar settlements without the specific causation challenges of personal injury suits. Personal injury suits are typically aggregated into mass torts like MDLs or consolidated state court proceedings due to the individualized nature and cause of each patient’s injuries. Nevertheless, plaintiffs are attempting to change the dynamic from hard-to-prove personal injury suits with individualized causation and other issues to easier-to-prove class actions based on purported “economic losses” to class members that purchased drugs or medical devices but have not experienced a physical injury, with aggregated class-wide economic damages that can dwarf individual personal injury damages. This approach reduces the burdens on the plaintiffs’ bar and enables increased control over client selection, while still allowing for potential windfalls.
- Reproductive Health Care Impact: In 2025, continued uncertainty in connection with reproductive health care will impact everyone. In the wake of Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215 (2022), reproductive health care will remain at a crossroads for all parties: patients, health care providers, pharmaceutical and medical device manufacturers, regulators, and the judiciary. We anticipate that there will be increased litigation pushing the boundaries on a wide variety of topics, such as: (a) whether frozen embryos are people under criminal and tort laws and (b) the criminal and civil consequences of prescribing and providing contraceptive drugs and other reproductive health care and devices. The end of last year provided a preview: In December 2024, the attorney general of Texas, which has effectively banned abortions, sued a New York doctor who was accused of prescribing abortion pills to Texas women.
- Loper Bright Impact: In 2025, litigants will begin to see the impact of Loper Bright and the end of Chevron deference. On June 28, 2024, the U.S. Supreme Court held that courts reviewing agency actions pursuant to the Administrative Procedure Act must exercise their own independent judgment and “may not defer to an agency interpretation of the law simply because the statute is ambiguous.” Loper Bright Enters. v. Raimondo, 603 U.S. 369, 144 S. Ct. 2244, 2273 (2024). In light of this decision, there is likely to be increased interest among FDA-regulated parties to challenge FDA’s interpretations of the Food, Drug & Cosmetics Act, among other statutes, and to fill the anticipated regulatory void that may result from this decision. Additionally, reduced deference to FDA may have negative impacts on defendants’ longstanding defenses based on federal preemption doctrines. As a result, tort litigation is likely to become even more expensive, as parties will be forced to litigate additional regulatory issues that once were subject to a great degree of deference, and parties will be subject to the uncertainty of a lack of uniformity across different jurisdictions.
- Expansion of Express Preemption Under 21 U.S.C. § 360k(a): In 2025, litigants may see further expansion of the preemption defense. The doctrine of express preemption has long been an important tool in the defense toolkit for manufacturers of Class III medical devices. However, only 10% of medical devices fall in this category. Class I and Class II devices, in contrast, together constitute nearly 90% of all medical devices marketed in the United States and, until relatively recently, federal preemption has rarely applied to these devices. Some courts, however, have begun to expand their understanding and application of the express preemption provision of 21 U.S.C. § 360k(a) in finding that it applies in the context of Class II devices. In Dickson v. Dexcom, Inc., 2024 WL 3417392 (W.D. La. July 15, 2024), for example, the court determined that federal preemption applied to a Class II device that had received de novo classification. Manufacturers may benefit if the underlying reasoning gains traction.
About the authors:
Daniel I.A. Smulian is a shareholder in the firm’s New York office and a member of the firm’s Pharmaceutical, Medical Device & Health Care Litigation Group and Appeals & Legal Issues Group. Dan focuses his practice on defending medical device and pharmaceutical companies in all phases of products liability litigation. He also represents clients in complex commercial cases, including trade secrets disputes and consumer class actions. Dan also has experience in all phases of litigation, including briefing, depositions, expert discovery, trials, and appeals.
Alena M. Markley is an associate in the Litigation Practice of the firm’s New York office. Alena focuses her practice on medical device products liability litigation, defending medical device companies in cases ranging from single-plaintiff actions and multi-district litigations throughout the country in state and federal courts. Alena is experienced in virtually all phases of litigation, including pre-suit negotiations and investigations, pretrial motion practice and pleadings, fact and expert discovery, trials, and appeals.