WASHINGTON -- A veteran U.S. Navy SEAL’s lawsuit is the latest against Swiss pharmaceutical giant Roche over claims it failed to properly warn the military about the potential for its anti-malarial drug Lariam to cause lasting neurological and psychiatric injuries.
Andrew Sheets served as a U.S. Navy Seal from June 2000 through August 2006. At the time, he had no history of neuropsychiatric symptoms. During SEAL training, Sheets was determined to have “excellent demeanor or conduct,” and his professional performance was deemed “outstanding.”
He deployed to Afghanistan in October 2003, at which point he – like nearly every other service member deployed to the region at the time – was given Lariam, the brand name for the anti-malarial drug mefloquine.
According to a lawsuit filed in Sonoma County (California) Superior Court, Sheets immediately began experiencing an adverse reaction to the drug.
“The very first night after he took the pill he had intensely violent and tragic nightmares,” the lawsuit reads. “The nightmares lasted about a month. The nightmares usually ended in death – his death and the death of his friends. In repeated nightmares, he was hit or run over by a train or shot or blown up. All these nightmares began prior to any kind of battle stress. He developed psoriasis within thirty days of taking the medication – another clinical sign of Lariam toxicity.”
READ OUR INVESTIGATIONS | Vets say anti-malarial drug they were ordered to take caused devastating side effects
Sheets continued his service until 2006, when he was administratively discharged for an “adjustment order with depressed mood.”
Three years after Sheets left the Navy, the U.S. Army prioritized using other anti-malarial drugs, and in July 2013, the FDA ordered the following “black box” warning – the agency’s strictest measure, reserve for drugs where there’s evidence of a serious hazard – for Lariam:
“Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. Patients, caregivers, and health care professionals should watch for these side effects. When using the drug to prevent malaria, if a patient develops neurologic or psychiatric symptoms, mefloquine should be stopped, and an alternate medicine should be used. If a patient develops neurologic or psychiatric symptoms while on mefloquine, the patient should contact the prescribing health care professional. The patient should not stop taking mefloquine before discussing symptoms with the health care professional.”
Following the FDA’s warning, the U.S. military re-designated Lariam as a drug-of-last-resort.
Although Sheets has been out of the military for 12 years, according to his lawsuit, his condition has not improved, and has in fact worsened.
“He experiences severe paranoia that Al-Qaeda members seek to murder his family in the United States, repeat nightmares ‘reliving’ a delusion of a violent helicopter crash that never actually happened, and chronic depression, anxiety and confusion,” the lawsuit claims.
The suit also claims Sheets’ “Lariam-induced paranoia” has led him to bug his house and surveille his wife’s whereabouts – causing a profoundly negative impact on their marriage.
In February 2017, Sheets was deemed permanently disabled by his treating physician because of his Lariam-related mental disorders.
According to the lawsuit, Roche could have prevented Sheets’ suffering had the company” adequately warned the U.S. military of the risks of Lariam and made a well-designed drug.” The lawsuit also claims Roche knew of the dangers of Lariam going back years prior to Sheets’ first dose, but failed to adequately inform the U.S. military about them because the anti-malarial drug was a lucrative product for the company.
“During the War on Terrorism, over a million U.S. forces fought abroad in Afghanistan, with virtually all being required to take the drug during months-long seasons of endemic malaria,” the lawsuit reads. “In 2003, when Roche had a patent monopoly on the Lariam market, nearly 50,000 prescriptions of Lariam were written by military doctors, equating to over 1 million tablets. With the War in Afghanistan dragging on for years, the market opportunity was vast and demand was strong.”
Roche stopped producing the drug in the U.S. in 2008, and earlier this year divested its interests in the drug altogether to another pharmaceutical company.
Sheets’ lawsuit, which accuses Roche of failure to warn, negligence, deceit by concealment, negligent misrepresentation and concealment and loss of consortium, was originally filed in a California state court this summer, but has been held up for months as Roche attempted to have the case either dismissed or heard in federal court.
Roche has argued in court filings that the case should be thrown out for a number of reasons, among them that Sheets’ injury occurred in Afghanistan – and therefore the court lacks jurisdiction over the case – that the statute of limitations has passed because Sheets filed the complaint 15 years after the first manifestation of his injury, and Roche had no duty to disclose to Sheets individually.
Last Week, U.S. District Judge Jon S. Tigar ordered the case be remanded to the lower court in Sonoma County for a hearing.
In the lawsuit, Sheets and his wife Kristie ask for unspecified damages “in an amount appropriate to punish Roche and deter them from similar conduct in the future.”
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If you've taken mefloquine and believe you suffered psychiatric or physical side effects as a result, we'd like to hear from you. Please email Jordan Fischer and put "mefloquine" in the subject line. Let us know when and where you took the drug, for how long and under what circumstances.