Courthouse news reports that a U.S. military veteran filed a federal class action lawsuit Thursday against the makers of an antimalarial drug distributed to military forces, claiming the drug made tens of thousands of veterans permanently sick.
The lawsuit, filed in the Northern District of California by veteran John Nelson, accuses drug makers Roche Laboratories and Genentech of failing to inform the public of severe side effects of mefloquine, carrying the brand name Lariam, a drug given to U.S. service members to help prevent malaria.
The defendants marketed and sold Mefloquine to the U.S. military for service members deployed to Somalia, Afghanistan and other foreign countries for the prevention of malaria. A significant proportion of service members took Mefloquine while deployed to Afghanistan and other foreign countries.
Lariam (pharmacological name mefloquine) is an antimalaria drug discovered by the US Army shortly after the Vietnam War as a result of the US Army’s huge post-Vietnam antimalaria drug discovery program. The drug was subsequently marketed worldwide by F. Hoffmann-La Roche. The first reported trials of mefloquine were in prisoners, and were performed at the Joliet Correctional Center, Illinois, in 1975, and at the Maryland House of Correction in 1976.
There is no question that safe and effective antimalaria drugs were needed in the second half of the twentieth century, once it became apparent that the Plasmodium had developed resistance to the mainstay of antimalaria therapy, namely chloroquine. Chloroquine resistance was observed first in Thailand in 1957, then on the Colombian-Venezuelan border in 1959, and in Kenya and Tanzania in 1978. Within a decade of Lariam being marketed, the safety was in doubt.
In 2013, the Food and Drug Administration required the drug to carry a black box warning due to the severity of its side effects. Roche pulled Lariam from the U.S. market in 2009, but generic versions are still available.
Nelson was a U.S. military service member who was prescribed Mefloquine when deployed to Afghanistan. Upon taking the drug, he immediately began suffering severe and irreversible side effects, which continue to this day. But he had no knowledge that the neuropsychiatric side effects he was experiencing could be due in any way to Mefloquine. The drug insert did not adequately warn of the drug’s toxicity, and U.S. military service members are not typically provided with the drug insert and would be unlikely to receive any such information.
The suit alleges that at at the time they sold the drug to the U.S. military, defendants knew of the substantial danger of severe and irreversible neuropsychiatric side effects of Mefloquine. At that time, there were already widespread reports in the pharmaceutical industry of Mefloquine causing adverse reactions, including symptoms of paranoia, hallucinations, and suicidal ideations. By 1994, Defendants knew or should have known that these adverse reactions were permanent and irreversible. Since that time, numerous scientific studies have confirmed the causal link between Mefloquine and permanent neuropsychiatric effects.
Defendants concealed the scope and nature of the danger and recklessly sold the drug as a safe and effective first-line treatment for malaria prevention. Safer and effective drugs for malaria prevention existed on the market.
But defendants allegedly had no desire to re-brand Mefloquine as a mere secondary or alternative option for malaria prevention, as that would have extinguished its hold on the market and strong demand for it by the U.S. military.
Medical monitoring is a recognized form of relief that allows a plaintiff and class members to obtain diagnostic medical examinations that are funded and/or reimbursed by a defendant when the defendant’s tortious conduct has exposed the plaintiff and class members to harm that proximately causes the need for the comprehensive diagnostic examinations. Plaintiff, individually and on behalf of the Class, seeks medical monitoring as a result of their common exposure to Mefloquine.
In a 2007 Journal article “A lesson learnt: the rise and fall of Lariam and Halfan” the author reviewed the history of the development and distribution of Melfooquine and concluded that it ” seems probable that in the late 1980s and early 1990s the FDA and other national licensing bodies were influenced, perhaps subliminally, by the powerful military-industrial-governmental lobby into over-hasty decisions to approve the marketing of both Lariam and Halfan. These two drugs were authorized for public use on the basis of an incomplete knowledge base, and at too early a stage in the normal cycle of drug development.”
The take-away here – will there be similar litigation, and after-the-fact reports, of similar problems with the current “mandated” COVID vaccines a few decades from now?