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Ketek Lawsuit Filed in Illinois, Says Sanofi-Aventis Knew of Liver Failure Side Effects

Nov 28, 2007 | Parker Waichman Alonso LLP

Ketek users injured by the defective drug have filed suit against Sanofi-Aventis in Illinois.  The 47 plaintiffs involved in the Ketek lawsuit claim that Sanofi-Aventis knew that Ketek put users at an increased risk of increased risk injuries or death from liver failure and hepatic injury.

Ketek, a powerful antibiotic, was approved by the Food & Drug Administration (FDA) in 2004 to treat sinus infections. This approval came despite serious concerns with the way clinical trails of Ketek had been conducted. Because cheaper antibiotics, like amoxicillin, were already available to treat sinus infections, the FDA required Aventis to design a study showing that Ketek would work at least as well as existing treatments before it could be approved. Aventis eventually signed up 1800 private physicians to participate in these clinical trails. These doctors were given $400 for every patient they convinced to participate in the Ketek study. That huge financial incentive was too much for some doctors to resist. When the FDA audited Ketek study participants, they found one family doctor in a small Alabama town had signed up 407 patients for the study.  The doctor’s entire staff was enrolled in the trail. It even appeared that some of the patient signatures on consent forms where forged. That Ketek Clinical trial doctor was eventually convicted of fraud and sentenced to prison. The FDA also visited several other sites with high numbers of participants, and found serious irregularities at every one.  In October, the FDA issued Sanofi-Aventis a warning letter for failing to respond to problems with Ketek clinical trials.

Shortly after its approval, Ketek was linked to serious side effects, including sometimes fatal liver damage. The FDA eventually confirmed 53 cases of liver failure in patients using Ketek, including five deaths. This past February, the FDA finally added black box warnings to the Ketek label and severely restricted its use.

The 47 plaintiffs involved in the Ketek lawsuit come from Illinois, North Carolina, South Carolina, Tennessee, Indiana, Arizona, Florida, New York, Pennsylvania, Kansas, Missouri, West Virginia, Utah, Maine, Delaware, Iowa, Texas, Arkansas, Virginia, Georgia, Mississippi and New Jersey.  They allege that Ketek is a defective and dangerous pharmaceutical product.  The complaint states that Sanofi –Aventis “engaged in deception, fraud, false pretense, false promise, misrepresentation, or the knowing, concealment, suppression, or omission of material facts regarding the risks of harm associates with the use of Ketek...," The suit claims that Sanofi-Aventis intentionally concealed from the FDA results of a study which showed serious harm associated with the use of Ketek.

The Ketek lawsuit, which was filed in St. Clair County Circuit Court on Nov. 15, seeks damages for personal and economic injuries.