[Source: Health and Life Sciences Law Daily, November 16, 2007 - AHLA]
Fortune Magazine (11/16, Simons) reports, "The world's third-largest drug company, Sanofi-Aventis is facing a shareholder lawsuit for allegedly hyping a weight-loss pill that eventually failed to pass FDA muster." The class-action lawsuit alleges "that Sanofi's statements regarding anti-obesity drug, Zumulti, 'were materially false and misleading' because they 'concealed data concerning Zumulti's propensity to cause depression.'" The lawsuit "calls into question the expectations investors have regarding any yet-to-be-approved drug. Since 2004's Vioxx (rofecoxib) withdrawal, the FDA has been under pressure to be more safety-minded." However, some legal experts "contend that cases such as the one filed against Sanofi are difficult to prove." John Coffee, professor of law at Columbia Law School, said that in cases like this one, "plaintiffs need to prove there was an intent to defraud, not just woeful misjudgment."
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Jeanne Whalen, in WSJ Health Blog, discusses the FDA's concerns with Sanofi-Aventis’s diet pill: "Sanofi-Aventis’s weight-loss pill rimonabant ran into trouble with the FDA this summer over concerns about the pill’s psychiatric side effects, such as suicidal thinking. Now the drug, dissed by advisers to FDA but sold in Europe and Latin America, is getting knocked in an analysis that concludes it increases a person’s risk for depression and anxiety." Continue reading
