A St. Clair County consumer fraud class action lawsuit claims the manufacturer of Ketek, an antibiotic used to treat adults with respiratory infections, fraudulently misrepresented the drug's health and safety risks to the Food and Drug Administration.
Jessica Kent of Belleville is the proposed class representative seeking damages over the purchase price of Ketek for persons in Illinois and New Jersey.
"This action is not a products liability action nor is it an action seeking recovery for personal, psychological or emotional injury and does not involve the physical or mental condition of the named plaintiff nor any class member," states the complaint filed Feb. 28.
Represented by Christopher Cueto of Belleville and Robert Salim of Natchitoches, La., the complaint alleges French pharmaceutical Sanofi-Aventis U.S. engaged in a campaign of "over-promoting Ketek in written marketing literature, in written product packaging, and in direct to consumer advertising via written advertisements and television commercial ads."
"Defendant's over promotion of the product was undertaken by touting the safety and efficacy of Ketek while concealing, misrepresenting, and actively downplaying the serious, severe and life-threatening risks of harm to users of Ketek, when compared to comparable or superior drug therapies," the complaint states.
Telithromycin, sold under the brand name Ketek, was approved by the European Commission in July 2001 and subsequently went on sale in Europe in October 2001. In the U.S., telithromycin was approved by the FDA for sale and marketing in April 2004.
According to the complaint, the defendant submitted to the FDA safety and efficacy results from a Ketek study that it knew to be false. Among other things, the complaint alleges that the study violated numerous protocols by enrolling fictitious subjects, reporting data on patients who never participated in or completed the study, obtaining analysis of blood samples from persons other than patients enrolled in the study and falsely documenting results and other study data.
"...Sanofi Aventis knew that that prices which it charged for Ketek were far in excess of the fair market value Ketek would have had but for Sanofi Aventis' omissions, suppressions, and/or concealments," the complaint states.
Attorney Salim's website had this to say about his litigation experience: "Over the last thirty years of practicing personal injury law, Mr. Salim has obtained many million dollar-plus verdicts. He is well acquainted with the intricate process of instigating litigation against manufacturers of Fen/Phen, Baycol, Ephedra, Welding Rods, Vioxx, Bextra, Zyprexa, Risperdal, Seroquel and more.
"He has become associated with many illustrious attorneys across the United States, combining their many resources to create a formidable team against such behemoth companies as Merck, Pfizer, AstraZeneca, and many more."
Christopher Cueto was co-plaintiffs' attorney in a suit filed against Sanofi Aventis in November 2007 in St. Clair County Circuit Court on behalf of 47 claimants seeking damages for personal and economic injuries.
His brother, Lloyd A. Cueto, is a St. Clair County Circuit judge.