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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.
Upper Respiratory Fiasco
Ketek, or telithromycin, is a ketolide antibiotic used primarily to treat upper respiratory infections. When Sanofi-Aventis applied to the FDA for approval of Ketek, the Agency's Anti-Infective Drug Advisory Committee requested further study of potential risks. That study was, in the words of the Second Circuit, "a fiasco," involving fraud that was unprecedented in scope and scale.
Ketek was approved nonetheless, with risks of liver failure mentioned by the FDA and Sanofi-Aventis, but not included in the label's warnings section. In 2006, a Ketek prescription was written every four or five seconds, but the drug was soon connected to several cases of liver failure, including two that ended in death. A year later, the FDA severely limited the drug's use.
Class Action Fails on Causation
Soon after Ketek was pulled for many uses, several health benefits plans filed a class action against Sanofi-Aventis under state consumer protection laws and the Racketeering Influenced and Corrupt Organizations Act. They claimed that Sanofi-Aventis had violated RICO by associating with the "fiasco" study to fraudulently represent Ketek as safe. The drug's approval was, they alleged, the act of a criminal racket and no doctor would have approved it had the true risks been revealed.
The courts disagreed, however, refusing to certify the class. Such claims of fraud aren't susceptible to generalized proof, the Second Circuit reasoned, since individual physician decision making disrupted the causal chain. As the Second Circuit explained, "the ultimate decision regarding which drug will be prescribed to a patient rests entirely with the patient's doctor."
The decision was an almost rote application of the circuit's ruling five years ago in UFCW Local 1776 v. Eli Lilly. There, health benefit plans had made similar claims against Eli Lilly, arguing that the pharmaceutical company had misrepresented Zyprexa's safety. Yet, as here, the individual decision making of physicians broke the causal chain, preventing generalized proof from being used to demonstrate injury. The Zyprexa case doesn't foreclose generalized proof in pharmaceutical class actions altogether, the court took pains to note, but it certainly does here.