- within Transport topic(s)
- 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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.