A former Navy SEAL has filed a lawsuit against the company that makes the anti-malarial drug Lariam, or mefloquine, alleging that the medication left him permanently disabled after taking it while serving in Afghanistan.
Andrew Sheets and his wife, Kristie, of Cazadero, California, allege that pharmaceutical giant Hoffman-LaRoche, known as Roche, was aware that the drug caused serious neurological and psychiatric side effects and failed to warn patients of the dangers.
Sheets, who served in the U.S. Navy from 2000 to 2006, said he immediately experienced "violent and tragic nightmares" the first time he took Lariam, during a deployment in 2003. He later developed psoriasis, extreme paranoia, hallucinations, anxiety and suicidal thoughts.
"In February 2017, Mr. Sheets was finally described as permanently disabled by his treating physician because of his debilitating, Lariam-related mental disorders," court documents state.
For more than two decades, Lariam, also known by the generic name mefloquine, was distributed to troops to prevent malaria in endemic countries. At the peak of military use in 2003, nearly 50,000 prescriptions for mefloquine were written by military doctors.
In 2004, however, the Veterans Affairs Department urged doctors to refrain from prescribing it following reports of hallucinations, paranoia and psychosis in some patients who took it. In 2013, the Food and Drug Administration placed the strongest warning label of its kind on the medication -- the "black box" warning informing patients of potentially dangerous and permanent side effects.
The Defense Department had already decreased mefloquine prescriptions by the time the warning was issued. In 2009, the assistant secretary for health affairs issued a policy recommending mefloquine be used only in regions where other options weren't effective against regional malarial strains.
According to the Sheetses' lawyer, Kevin Boyle, the case is significant because it could "vindicate the fact that many veterans are suffering from a legitimate condition" and "ensure that those who are responsible for these serious injuries are held accountable."
"It's difficult to imagine that Roche would have subjected Lariam to any trials without observing the potential to cause serious injuries we now associate with mefloquine toxicity," Boyle said. "Why did Roche pull the drug from the market in 2008, five years before the FDA issued the black box warning?"
Roche stopped selling Lariam in the U.S., but it is still available as a generic, mefloquine, manufactured by another company.
The suit was filed in Sonoma County, California, Superior Court. Veterans in several other countries, including Canada, Ireland and the United Kingdom have filed suits against their governments or settled claims over injuries caused by the medication.
Boyle, an attorney with Panish Shea & Boyle, LLP, of Los Angeles, California, said his client is one of many veterans who have been diagnosed with a psychiatric disorder -- Sheets was dismissed from the service for "adjustment disorder with depressed mood," despite never having a mental health issue before -- who have been injured by taking the drug.
He added that VA physicians, including those at the War Related Injury and Illness Study Center in Palo Alto, California, have indicated Sheets' main symptoms are likely due to mefloquine exposure.
"We are aware that many veterans have been similarly affected and will explore bringing additional suits on their behalf as well," Boyle said.
The Sheetses are seeking "the full amount of damages the law will allow," possibly more than $20 million, he added.
Roche did not return responses to questions by press time.