Vets Sue Vets for Using Antimalarial Drug to Treat Psychosis

 


LOS ANGELES (AP), -- A federal judge dismissed a suit against the manufacturer of anti-malarial drugs that were accused of causing psychotic behavior in servicemembers and neurological damage. The case was not allowed to be filed in California.

A former Army soldier brought a class-action suit against Roche Laboratories Inc. and Genentech Inc. last year. The case alleged that they intentionally misled the Department of Defense and Food and Drug Administration about mefloquine, a generic version of Lariam.

Although similar cases have been filed in Australia and Canada, the lawsuit brought by the federal court in Northern California was unique in its scope, attorneys stated.

It was the largest user of the drug to fight malaria. It was used by hundreds of thousands of soldiers who were sent to Somalia and Afghanistan.

Roche was granted the intellectual rights to Lariam and received FDA approval in 1989. Roche stated that it produced its last U.S.-bound lots in 2005. These drugs were discontinued in 2008, one year prior to Genentech's merger in 2009.

Although the Pentagon continued to distribute generic versions, elite Army units were told to stop using mefloquine after the FDA placed a black box warning. The FDA found that it could cause permanent brain damage in very rare cases. Side effects like dizziness, loss balance, and ringing in your ears could be permanent.

The Army has mostly replaced mefloquine by safer drugs.

John Nelson, Florida filed the suit after he claimed he was permanently disabled by taking the drug during his Army Service from 2005 to 2015. Nelson claimed that he didn't experience any neuropsychiatric symptoms before he started taking mefloquine shortly before he was stationed in Afghanistan.

Trina Thompson, a U.S. District Court judge, ruled Monday in San Francisco that Nelson had adequately alleged that the manufacturer knew of the dangers of the drug but failed to warn the U.S. Military.

The judge said that it was too far to apply California's law that holds drug manufacturers of name brands responsible for warnings about generic versions. Nelson was not born in California, and Roche and Genentech had only been based in California for two months when he purchased the drug in 2009.

Thompson stated that it would be unfair for plaintiffs to be allowed to file their claims in California. However, the state's innovative liability doctrine would grant him greater rights than what he would have in Florida.

The judge pointed out that there are other potential venues, including New Jersey where Roche was based and Florida where Nelson lives, as well as Kentucky, Oregon, and Tennessee where Nelson lived before. These laws either do not extend liability to the original manufacturer or have opinions that make such a finding unlikely.

Roche released a brief statement stating that lawyers were "forum-shopping" and that it was happy the court decided the case did not belong in California.

According to the lawsuit, Nelson claimed that his symptoms changed from vivid stimulant dreams that disturbed his sleep and made it anxious to panic attacks, paranoia and insomnia. He also tried to end his life twice. Although he was later diagnosed with depression and bipolar disorder, he did not receive any medication, including antipsychotics.

Nelson was at a conference about the effects of anti-malarial drugs in 2020. He suspected that he might have suffered mefloquine poisoning and sought testing which confirmed his suspicions.

Unspecified damages were sought for negligence, failures to warn, fraudulent misrepresentation, and other claims. The lawsuit also demanded that the companies pay for medical monitoring to ensure that the effects of the drug were understood.

Nelson attorneys did not respond immediately to a request for comment.

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