If you came down with bronchitis a few years ago, there was a fair chance that your doctor would prescribe Ketek, an antibiotic produced by the French pharmaceutical giant Sanofi-Aventis. That was, until 2007, when the FDA banned the use of Ketek for sinusitis and bronchitis, finding that it was too risky for those diseases and giving it the strongest warning possible -- a so-called "black box" warning -- for certain permitted uses.
The changes came after a year-long FDA investigation which found that the drug could result in severe liver damage. Following the FDA's action, a consortium of health plans sued Sanofi-Aventis for racketeering, arguing that the company fraudulently failed to disclose risks. Their case didn't make it far, however, having been tossed out by the Second Circuit last Friday for failure to establish causation.