‘The Modern-Day Version of Agent Orange’: Hoffmann-La Roche, Genentech Hit with Class Action Over Antimalarial Drug

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Hoffmann-La Roche and Genentech face a proposed class action over their alleged failure to warn United States military service members of the “substantial and irreversible” neuropsychiatric dangers of the antimalarial drug mefloquine. 

The 46-page suit against the pharmaceutical companies says that mefloquine, sold under the brand name Lariam, is now recognized as one of the most dangerous malaria prevention drugs on the market, with a toxicity likened to “the modern-day version of Agent Orange in scope and scale.” According to the complaint, mefloquine has left at least tens of thousands of veterans, including many deployed to Somalia, Afghanistan and other foreign countries, “severely and permanently sick.” 

The lawsuit alleges Hoffmann-La Roche and Genentech knew of the significant neuropsychiatric side effects of mefloquine at the time the drug was sold to the United States military. The companies are also alleged to have known even before the sale of mefloquine began in 1989 of the risk of brain toxicity from the chemical family to which the drug belongs. At that time, the case says, widespread reports in the pharmaceutical industry stated mefloquine caused adverse reactions with symptoms of paranoia, hallucinations and suicidal ideations, the suit claims. The lawsuit alleges that Hoffmann-La Roche, at the time it sought FDA approval for mefloquine, chose to pursue study designs it knew or should have known would mask the “true incidence of the drug’s psychiatric side effects.” 

“By 1994, Defendants knew or should have known that these adverse reactions were permanent and irreversible,” the case charges. “Since that time, numerous scientific studies have confirmed the causal link between Mefloquine and permanent neuropsychiatric effects.” 

Nevertheless, Hoffmann-La Roche and Genentech, the lawsuit alleges, concealed the scope and nature of the dangers of mefloquine and recklessly sold the drug to the military as a safe and effective first-line treatment for malaria prevention. According to the lawsuit, the companies were aware that military service members deployed abroad and prescribed mefloquine would be incapable of receiving adequate onboarding and follow-up assessments crucial to taking the drug safely. Moreover, Hoffmann-La Roche and Genentech, the suit alleges, knew that any immediately apparent side effects of taking mefloquine, including anxiety and restlessness, would be “confused and/or attributed to the natural effects of war” yet continued to sell the drug and its generic equivalents to the military anyway. 

“The prospect of wartime profits led Defendants to recklessly continue to market and sell the dangerous and flawed antimalarial drug to the U.S. military,” the suit alleges, adding that it was only after the FDA put a black-box warning on mefloquine in 2013 that the military changed its prescription policies for the treatment, characterizing it as a drug of last resort for malaria prevention. 

The lawsuit states that evidence of mefloquine toxicity to the central nervous system dates back to the mid-1940s, when synthetic quinoline derivatives used as antimalarials and related to the modern-day treatment caused irreversible central nervous system toxicity. According to the case, studies had linked the use of antimalarial quinoline derivatives to neurological degeneration in humans and animal subjects, concluding that the drugs induced highly localized degenerative changes associated with functional derangement. 

According to the lawsuit, the plaintiff, who served in the United States military from 2005 through 2015, attended in February 2020 a Washington D.C. conference at which he met a leading researcher of mefloquine toxicity and learned about the extensive literature supporting the causal link between mefloquine and the symptoms he experienced upon his deployment to and use of the treatment in Afghanistan. The lawsuit contends that the plaintiff and proposed class members who’ve taken mefloquine are in need of medical monitoring above and beyond what could be considered routine.

The lawsuit looks to cover all U.S. military service members who took mefloquine, including under the brand name Lariam and any generic equivalents, and experienced prodromal neuropsychiatric symptoms during use of the drug.

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