Will Ketek Manufacturer Escape Liability?

New York, NYA recent decision by the United States District Court in the Eastern District of New York has ruled against class-action status in a lawsuit by plaintiffs against Sanofi-Aventis, the manufacturer of Ketek. The latter is an antibiotic that was brought to market under questionable circumstances and was found to be harmful, with 53 reported cases of liver failure and four deaths by 2007—just three years after the drug was brought to market.

In his ruling on the class-action status of the case, the presiding judge ruled that the manufacturer cannot be held accountable, and therefore cannot be sued for fraud due to the fact a patient having been written a prescription for Ketek by a doctor effectively removes the "proximate cause" required to establish that fraud had occurred.

Jim Edwards, blogging on BNET February 18, did not hide his disdain for the situation.

"Basically, Sanofi knew in October 2001 that one of its main researchers on the drug was probably faking her data," Edwards writes. "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."

A timeline illustrates the rocky road to market for Ketek. Following their failure to win approval for Ketek in June of 2001 from the US Food and Drug Administration (FDA), Sanofi initiated Study 3014. That undertaking proved to be problematic for the reasons noted above, along with various deviations from good practice and protocol that rendered the study results unreliable.

And yet, Edwards reports, an FDA advisory committee meeting on January 8, 2003, voted 11-1 to approve Ketek for market without being aware of concerns surrounding the Study 3014 data. The allegation is that both Sanofi and those FDA officials aware of the problems with Study 3014 withheld that information from the panel.

In the end, the FDA voted later that month to decline yet again approval for Ketek, presumably due to its knowledge of problems with the study data. The indictment noted above occurred a few months later, in April 2003, and the doctor at the center of the study controversy spent more than four years behind bars.

A year later, amidst questions over whether or not the FDA relied on the questionable data, Ketek was approved. Less than two years later, the FDA, due to a series of adverse events reports, issued a warning with regard to liver failure associated with the use of Ketek—finally withdrawing approval of Ketek in February of 2007 for all indications save for pneumonia.

"Clearly, the only reason this drug was on the market was because Sanofi submitted data it knew was bogus to the FDA," Edwards writes. "The only reason Ketek prescriptions were ever written was because of this fraud. Yet, according to the ruling, because doctors use independent judgment when writing prescriptions there is no proximate cause between Sanofi's fraud and the health benefits being paid out."