– A federal judge threw out a lawsuit against the maker of an anti-malarial drug blamed for causing psychotic behavior and neurological damage to U.S. servicemembers, ruling that the case had no right to be filed in California.
The proposed class-action case brought last year by an Army veteran accused Roche Laboratories Inc. and Genentech Inc. of intentionally misleading the Department of Defense and the Food and Drug Administration about the dangers of mefloquine, the generic version of the drug Lariam.
Similar cases had been brought in Canada and Australia, but the lawsuit in federal court in Northern California was the first large-scale case of its kind in the U.S., attorneys said.
The U.S. military, which developed the drug during the Vietnam War, was once its largest user to combat malaria. It was given to hundreds of thousands of troops sent to Afghanistan and Somalia.
Roche, which was granted the intellectual property rights and won FDA approval for Lariam in 1989, said it manufactured its last lots for U.S. distribution in 2005. Those drugs expired in 2008 – a year before the company’s 2009 merger with Genentech.
The Pentagon continued to distribute generic versions of the drug, though elite Army units were ordered to stop using mefloquine in 2013 after the FDA put a black box warning on it after it was found to cause permanent brain damage in rare cases. The warning said it caused side effects such as dizziness, loss of balance and ringing in the ears that could become permanent.
The Army has mainly replaced mefloquine with drugs found to be safer.
John Nelson of Florida brought the suit after he said he became permanently disabled from taking the drug during his Army service from 2005 to 2015. Nelson said he never experienced any neuropsychiatric symptoms until he began taking mefloquine just before being stationed in Afghanistan.
U.S. District Court Judge Trina Thompson ruled in San Francisco on Monday that Nelson had sufficiently alleged that the manufacturer knew about dangers of the drug and did not warn the U.S. military.
But the judge said it was a stretch to apply a California law that holds name brand manufacturers responsible for warnings on the generic version of their drugs. Nelson never lived in California and Roche and Genentech were only headquartered in the state for two months while he took the drug overseas in 2009.
“It would be unfair for plaintiff to be able to bring his claims in California and, by virtue of the state’s innovator liability doctrine, he would be extended greater rights than he would be granted in his own state of residence, Florida,” Thompson wrote.
The judge noted that other possible venues – New Jersey, where Roche had been based, and Florida, where Nelson lives and Kentucky, Oregon and Tennessee where he lived previously – either don’t have similar laws that would extend liability to the original manufacturer of a generic drug or have courts that have issued opinions making such a finding unlikely.
Roche issued a one sentence statement asserting that lawyers were “forum shopping” and said it was pleased the court found the case didn’t belong in a California court.
Nelson said his symptoms went from vivid stimulating dreams that disrupted his sleep and made him anxious to having panic attacks, paranoia, insomnia and twice tried to take his own life, the lawsuit said. He was diagnosed as depressed and later as bipolar, though medications, including antipsychotics, did not help.
After attending a conference in 2020 about effects of anti-malarial drugs, Nelson suspected he may have experienced mefloquine toxicity and pursued testing that confirmed the diagnosis.
The lawsuit sought unspecified damages for negligence, failure to warn users, and fraudulent misrepresentation, among other claims. It also sought to have the companies pay for medical monitoring of those who took the drug to understand the impacts.
Attorneys for Nelson did not immediately respond to a request for comment.
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