Quoted from http://www.bnet.com/blog/drug-business/fda-approved-an-antibiotic-based-on-bogus-data-8212-but-the-courts-don-8217t-care/7460
FDA Approved an Antibiotic Based on Bogus Data — but the Courts Don’t Care
By Jim Edwards | February 18, 2011
The Ketek antibiotic scandal at Sanofi-Aventis (SNY) is receding into ancient history (if you agree that 2007 is “ancient”), so it’s not until you read this new class action ruling that you are reminded just how cynical and broken the pharmaceutical business can be.
Basically, Sanofi knew in October 2001 that one of its main researchers on the drug was probably faking her data. That researcher was indicted for research fraud in April 2003. Yet in April 2004, the FDA approved Ketek for sale even though both it and Sanofi knew the data on which the approval was based was entirely bogus. In 2007, after 53 cases of liver failure including four deaths, the FDA all but withdrew Ketek from the market.
If that hasn’t got your blood boiling, the judge’s ruling in the case will: He holds that Sanofi can’t be sued by health benefit providers for defrauding them of prescription costs because each patient who received the drug was seen by a doctor. The doctor’s decision to write a Ketek prescription removes the “proximate cause” necessary to establish that the plaintiffs paid for the drug based on fraud — even though the only reason the drug was on the market was because of Sanofi’s fraud, and individual doctors are in no position to know whether drugs are backed by fraudulent data or not.