French drug major Sanofi (Euronext; SAN) has reached a $40 million settlement in a US lawsuit accusing it of misleading investors about the safety of a weight loss pill that the US Food and Drug Administration linked to suicidal thoughts.
The all-cash settlement was disclosed in a court filing on Thursday, reported Reuters, and requires approval by US District Judge George Daniels in Manhattan. It resolves claims that arose after the US FDA advisory committee on June 13, 2007 urged that the agency reject Sanofi's drug rimonabant, known by the trade names Acomplia and Zimulti, on concern that using it could increase suicidal thinking and depression.
European regulators had approved use of rimonabant prior to the FDA panel action, but sales were later suspended. Plaintiffs led by the Hawaii Annuity Trust for Operating Engineers accused Sanofi of touting the drug as a possible “blockbuster” to treat obesity, with only mild side effects. But they said Sanofi concealed clinical tests that showed a statistically significant increase in suicidal thoughts among people taking the drug.
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