Case Reports

FDA Black Box, VA Red Ink? A Successful Service-Connected Disability Claim for Chronic Neuropsychiatric Adverse Effects From Mefloquine

Author and Disclosure Information

 

References

Drug of Last Resort

By late 2013, partially on the basis of the boxed warning, the U.S. military declared mefloquine a “drug of last resort.”7,27 The U.S. Army Special Operations Command (USASOC) took the further step of prohibiting use of mefloquine altogether and, according to news reports, directed that medical and command staff assess whether certain personnel experiencing AEs from the drug may mistakenly have been thought to be malingering, have PTSD, or have other psychological problems.28

As the boxed warning and the USASOC order suggest, veterans exposed to mefloquine may have incurred a broad range of neurologic or psychiatric disorders or had others aggravated during military service as a result of their use of the drug. The effects of mefloquine may have confounded the diagnosis of neurologic or psychiatric disorders related to military service.26,29 As these AEs may be a direct result of mefloquine prescribed during military service, those with disabling diagnoses consistent with these effects may be entitled to claim disability compensation through the VA.

Of potential significant relevance to this adjudication process is a memorandum written in early 2012, in which the military conceded:

Some deploying Service members have been provided mefloquine for malaria prophylaxis without appropriate documentation in their medical records and without proper screening for contraindications. In addition, not all individuals have been provided the required mefloquine medication guide and wallet information card, as required by the Food and Drug Administration. 24

Veterans claiming a service-connected disability as a result of their use of mefloquine should therefore not always be expected to have documentation of prescribing in their military medical records. Although the VA could consider denying such claims for absence of proof of a nexus to military service, in light of this memorandum, the VA may need to consider other evidence of plausible exposure, including veteran testimony and deployment history.

It is also conceivable that the VA could consider denying such claims by arguing that the veteran directly contributed to the disability through willful misconduct by not adhering to mefloquine label guidance. However, as this memorandum establishes that mefloquine use was frequently directed without communication of the drug label precautions and warnings, the VA should consider that veterans claiming a service-connected disability frequently will not have known or otherwise been unable to discontinue the medication at the onset of prodromal symptoms.

It is also possible that the VA might deny claims on the basis that the claimed disabilities reflect preexisting conditions. However, as the memorandum establishes, use of mefloquine also was occasionally inappropriately directed to those with documented contraindications to the medication, who would have increased risk of AEs. As a result, veterans with preexisting neurologic or psychiatric conditions or disorders who nonetheless were prescribed mefloquine may reasonably claim these were aggravated during military service.

Conclusion

As this case suggests, in the coming years, as awareness of the chronic AEs of mefloquine increases among the veteran population, claims related to prior use of the drug are likely to increase and become of significant interest to the VA. Veterans with plausible exposure to mefloquine with neuropsychiatric disabilities who have yet to file a claim may be able to do so, and those veterans whose claims for service-connection were unfavorably adjudicated may be able to reopen their claims on the basis of the new material evidence in the 2012 military memorandum and the 2013 boxed warning.

This case report also suggests that service-connected disability claims arising from chronic neuropsychiatric AEs from mefloquine may prove to be of significant financial consequence. Further research to better define both the extent of prior mefloquine use among U.S. military personnel and the nature and prevalence of those chronic neurologic and psychiatric disorders caused by the drug would be helpful in informing improvements in the efficient and fair adjudication of such service-connected disability claims.

Next Article: