Participation in Clinical Trial is FMLA-Protected, DOL Says

By: Allison B. Williams, Shelby A. Hicks-Merinar

Published: December 12, 2024

Details

On November 8, the Department of Labor (DOL) issued an opinion letter addressing an interesting question under the Family and Medical Leave Act (FMLA): Can an employee take FMLA leave to participate in a clinical trial for experimental treatment? In grappling with this question, the DOL’s opinion dissects two noteworthy issues for employers: (1) whether treatment received through voluntary participation in a clinical study can be covered by the FMLA and (2) whether an individual receiving purposely ineffective treatment (i.e., a placebo) can still qualify for FMLA leave.

In short, the answer to both questions is yes. To reach this conclusion, the DOL unpacked the regulations piece by piece. As a starting point, the employee requesting to take FMLA leave must have a “serious health condition,” which is 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.” 29 U.S.C. § 2611(11). A situation involving “inpatient care” is usually easy for employers to identify for FMLA purposes. However, the “continuing treatment” prong of this test can be more difficult to decipher.

Continuing treatment is defined very broadly, and the regulations have distinguished between the type of “treatment” protected by the FMLA and the type of routine care that ordinarily does not qualify. For example, prescription medication or therapy requiring the use of specialized equipment meets the definition of treatment contemplated by the regulations. In contrast, routine physical examinations or the use of over-the-counter medications generally will not meet the treatment criterion. The type of medical interventions used in clinical trials, according to the DOL, are significant enough to qualify as treatment under the regulations.

On that premise, the DOL made two key points. First, the DOL rejected the idea that “voluntary” treatments are not covered by the FMLA, because, in essence, all medical treatments are voluntary and because employers should not second-guess a health care provider’s judgment that treatment is advisable by questioning whether it is “necessary.” The narrow exception to the broad inclusion of voluntary treatments is for routine cosmetic procedures, assuming such procedures are not treating a serious health condition or do not require further treatments for complications.

Second, the DOL does not consider the efficacy of medical treatments to be a relevant factor in the analysis. Here, the DOL relied on the regulatory provisions that carefully limit the type of inquiries an employer can make regarding an employee’s eligibility criteria. Under the regulations, an employer is permitted only to verify that an employee has a serious health condition as defined by the FMLA and that the condition involves the necessary amount of treatment to qualify for protection. The regulations do not require the employee to disclose specific details about a course of treatment, such as whether the treatment is new or expected to achieve a certain result.

The DOL’s opinion can be illustrated by example:

An employee with lupus receives treatment at least twice a year, and therefore, her condition qualifies as a chronic serious health condition under the FMLA. The employee wants to volunteer to participate in a clinical trial for treatment of the disease. The employee does not know whether the drug she will be prescribed will be an experimental drug or a placebo. Because the treatment, regardless of its efficacy, is to be used for a qualifying serious health condition, the employee may use FMLA leave intermittently for time spent participating in the clinical trial, including recovery time.

The takeaway for employers: Use caution before denying requests for FMLA leave for an employee to change or voluntarily experiment with a new medical treatment. Employers should focus only on an employee’s FMLA eligibility and limit inquiries to whether the employee has a qualifying serious health condition that involves treatment. Denying or restricting leave for voluntary or experimental treatments will expose employers to FMLA liability.

If you have any questions regarding this ruling, please contact the authors or another member of Steptoe & Johnson’s Employment Litigation Team.

 

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