Sanofi Settles Pays $40 Million in Settlement
According to Reuters, Sanofi, the fourth largest pharmaceutical company world-wide in prescription drug sales, disclosed a $40 million dollar, all-cash settlement in a court filing on Thursday. Claims were brought against Sanofi after the U.S. FDA advisory committee encouraged the rejection of their drug, rimonabant, which was found to increase suicidal thoughts.
Rimonabant Information and Warnings
- Rimonabant goes by the tradenames of “Acomplia” and “Zimulti”. On June 13, 2007 the FDA issued its plea to Sanofi to discontinue sales of the drug after clinical testing indicated a drastic increase in suicidal thoughts and depression for those who took the drug.
- Sales and use of the drug were approved by regulators in Europe, but once the U.S. FDA issued its warning, sales were suspended.
- Up to the end of January 2008, 673 Adverse Drug Reaction reports (reporting 1971 individual reactions) had been received with rimonabant in the United Kingdom. 423 reports were serious.
- Four reports had a fatal outcome (one completed suicide, one sudden death of unknown cause, and two cases of myocardial infarction)
About the Rimonabant Lawsuit
- Plaintiffs led by the Hawaii Annuity Trust for Operating Engineers led a class of plaintiffs that brought accusations against Sanofi for falsely promoting rimonabant as a potential breakthrough to battle obesity, with few adverse side effects. They also accused the company of concealing clinical trial data that indicated there was a risk of suicidal thoughts and depression.
- In 2004, with the release of clinical trial data conducted by Sanofi, rimonabant was hailed as a wonder pill that not only helped patients shed excess weight, but could also help patients overcome addiction to tobacco and cocaine while ensuring a healthy heart and increased fertility.
- However, the release of the FDA advisory committee recommendation resulted in Sanofi's shares in Europe and American depository receipts in the United States to drop in price.
- Court documents indicated that claims brought against Gerard Le Fur, the former chief executive, and Hanspeter Spek, an executive vice president of pharmaceutical operations, were also resolved in Thursday’s settlement.
- According to lawyers who represented the plaintiffs, “the settlement, in light of all the risks, was exceedingly fair, and represented a high percentage of the total damages suffered by the class.”
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