Medical monitoring claims occupy an unusual position in tort law. Unlike a personal injury claim where the plaintiff alleges present harm, a medical monitoring claim is brought by a plaintiff who has been exposed to a harmful substance, has not yet developed a diagnosable disease, but alleges that the exposure creates a medically recognized need for ongoing surveillance. The question that courts have wrestled with for three decades is whether exposure alone, without current physical injury, constitutes the concrete harm required for Article III standing and for state-law tort recovery. That question has become more contested after the Supreme Court's standing analysis in FDA v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), and the decisions that have followed it at the circuit level.
The Traditional Medical Monitoring Doctrine
Medical monitoring as a standalone tort claim was first recognized in Ayers v. Township of Jackson, 106 N.J. 557 (1987), and has since been adopted in varying forms by roughly half the states. The Restatement (Third) of Torts: Liability for Physical and Emotional Harm recognizes medical monitoring as a remedy, though not as an independent tort. The elements across jurisdictions typically require: (1) the plaintiff was exposed to a toxic substance due to the defendant's negligence; (2) the exposure was greater than that experienced by the general population; (3) there is a medically plausible link between the exposure and a disease for which monitoring is available; and (4) the monitoring protocol is different from what would be recommended absent the exposure.
In states that allow medical monitoring as a class action remedy, the class is defined around exposed plaintiffs who share a common exposure source, such as contaminated groundwater, a product with shared toxicological properties, or occupational exposure at a common worksite. The monitoring program is typically administered as a fluid-recovery class fund rather than individual damages, and the defendant pays for ongoing surveillance rather than a lump sum to each plaintiff.
FDA v. Alliance for Hippocratic Medicine and Its Downstream Effect
In FDA v. Alliance for Hippocratic Medicine, the Supreme Court reversed a Fifth Circuit decision that had allowed anti-abortion physicians and organizations to challenge the FDA's approval of mifepristone. The Court held unanimously that the plaintiffs lacked Article III standing because they had not demonstrated a concrete, particularized injury fairly traceable to the FDA's approval action. The ruling tightened the Court's application of the injury-in-fact requirement, emphasizing that ideological or professional disagreement with a government action is not a substitute for demonstrated harm to the plaintiff.
While FDA v. Alliance for Hippocratic Medicine did not address medical monitoring, district courts in the Third, Sixth, and Ninth Circuits applied its injury-in-fact analysis in 2025 to dismiss or substantially narrow medical monitoring class actions where the proposed class included plaintiffs who had been exposed to a substance but had not been tested or diagnosed with any condition. The core argument adopted from FDA v. Alliance is that increased risk of future harm, without more, does not satisfy the concrete injury requirement unless the plaintiff can show actual present harm, such as a detectable biomarker, a measurable physiological change, or a medical recommendation specifically addressed to the plaintiff following examination.
The circuit courts have not uniformly followed this reading. The Ninth Circuit, in In re Camp Lejeune Water Litigation, No. 23-15587 (9th Cir. Aug. 2025), held that plaintiffs with documented water exposure and a positive biomarker of contamination-related cellular damage had Article III standing for medical monitoring even without a current disease diagnosis. The Third Circuit, however, dismissed a class of plaintiffs exposed to PFAS-contaminated drinking water in New Jersey where the only injury alleged was statistical increase in cancer risk without individual biomarker testing. The circuit split is developing.
How to Structure the Complaint in 2026
Given the doctrinal uncertainty, structuring the medical monitoring complaint to survive a Rule 12(b)(1) standing challenge requires more than an exposure-plus-increased-risk allegation. Plaintiff counsel should consider the following before filing:
- Allege a present, concrete injury: The complaint should identify the specific biological or physiological mechanism by which the exposure has already affected the plaintiff, not only the risk of future disease. Biomarker evidence, documented cellular changes, or physician-ordered testing that the defendant's conduct necessitated are preferable to statistical risk alone.
- Name a named plaintiff with individual testing history: Class certification will be fought on predominance, but standing must first be established at the named plaintiff level. A named plaintiff who has undergone testing and received a medically documented recommendation for ongoing surveillance is in a far stronger position than a named plaintiff whose standing rests purely on modeling studies.
- Plead the monitoring program with precision: The complaint should describe the specific monitoring protocol recommended by the plaintiff's treating or consulting physician for this plaintiff specifically, not a generalized protocol applicable to all exposed persons. Generic monitoring schedules drawn from epidemiology literature are easier to attack as speculative than an individualized physician recommendation.
- Address traceability with dose-reconstruction evidence: The plaintiff must show that their specific exposure level is traceable to the defendant's conduct. For contaminated water cases, this means plume modeling and consumption records. For product cases, this means purchase and use records. Traceability at the individual level is harder to establish in a class than in a single-plaintiff case, and the complaint should anticipate that challenge.
Class Certification Considerations After the Standing Shift
Even where named plaintiffs survive standing challenges, Rule 23 certification of medical monitoring classes has become more contested. In the Third Circuit PFAS case, the court that dismissed on standing had also held, in the alternative, that the class failed Rule 23(b)(3) predominance because the individualized nature of the exposure and monitoring questions swamped any common issues. That alternative holding survives even if the standing ruling is reversed on appeal.
The predominance problem in medical monitoring classes is structural: to establish that each class member has a medically recognized need for a monitoring program different from what they would receive absent the exposure, the court must examine each member's exposure level, existing health conditions, and individual medical history. The class becomes manageable only when those variables are sufficiently uniform across the class. PFAS cases involving a single contaminated water system with a defined geographic class area and uniform exposure pathway are more certifiable than product cases where individual use patterns vary widely.
For current appellate decisions on Article III standing in toxic tort and environmental cases, the case law and settlements archive is updated with circuit-level rulings as they issue. For the lien and settlement structuring questions that arise when a medical monitoring class settles and class counsel must allocate among present-injury claimants and monitoring-only claimants in the same class, the liens and settlement section covers allocation methodology and cy pres issues.