The Department of Labor’s (“DOL’s”) Wage and Hour Division has issued Advisory Opinion FMLA 2024-01-A, which provides that an employee may use leave under the Family and Medical Leave Act (“FMLA”) for the treatment of a serious health condition even when this treatment is provided as part of a clinical trial.
Facts. A medical research organization conducting clinical trials to treat a specific disease became aware that concern about taking time off work was a “significant barrier” to participation in its trials. It asked DOL for confirmation that FMLA leave is available for those participating in such trials “regardless of whether the individual receives the applicable experimental treatment.”
Law. In general, the FMLA entitles eligible employees to up to twelve “workweeks” of leave in a twelve-month period: (i) for one’s own “serious health condition”; (ii) to care for a seriously ill or injured spouse or dependent; (iii) for the birth, adoption or placement of a child; or (iv) to deal with “exigencies” related to their spouse’s military deployment.
The FMLA defines a “serious health condition” as an illness, injury, impairment, or physical or mental condition that involves either inpatient care in a hospital, hospice, or residential medical care facility or “continuing treatment by a health care provider.” Generally, a chronic serious health condition is one which requires visits to a health care provider at least twice a year and continues over an extended period.
Advisory Opinion. DOL noted that “FMLA regulations define ‘continuing treatment’ very broadly, establishing only the general principles that a regimen of continuing treatment includes, for example, prescription medication or therapy requiring the use of specialized equipment, but not, ordinarily, routine physical examinations, or over-the-counter medications ‘that can be initiated without a visit to a health care provider.’” It then stated that the medical interventions generally involved in clinical trials are similar to these examples, often involving prescription medication, equipment, or other significant interventions. The fact that such interventions may be experimental (or involve the use of placebos) “does not suggest otherwise, as the regulatory definition does not contain any requirement that the treatment meet a certain level of efficacy or that it achieves a certain result.”
Accordingly, the fact that treatment is considered optional, voluntary, or elective—as may generally be the case with clinical trial participation—is not a factor in the determination of whether an employee may take FMLA leave to receive treatment. The Advisory Opinion states that it is not relevant whether a course of treatment is new, experimental, a placebo, or proven to meet certain criteria for efficacy.
The Advisory Opinion also noted that the FMLA regulations do not permit an employer to inquire into the effectiveness of a particular treatment for purposes of determining whether an employee may take FMLA leave to receive that treatment.
The Advisory Opinion can be found at: https://www.dol.gov/sites/dolgov/files/WHD/opinion-letters/FMLA/2024_11_08_01_A.pdf