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Baxter Warned to Cease Making False Claims About the Efficacy of TISSEEL

Mary A. Malarkey, Director of the Office of Compliance and Biologics Quality, representing the Department of Health and Human Services (DHHS) wrote a warning letter dated April 14, 2009 to Baxter International, Inc., with a 10-day demand that Baxter prepare accurate promotional and instructional materials regarding its hemostatic agent TISSEEL®, and inform the DHHS of its plan to disseminate the corrected information to all audiences to whom it originally disseminated the misleading information.

Although the DHHS and FDA found no fault with TISSEEL®, the DHHS warning to Baxter concerned Baxter’s multi-focal effort to present false and unsubstantiated claims that TISSEEL® is more effective than it is, and that it is superior to competing products. The sources cited as evidence of these claims do not, in fact, contain any data, research results or even clinical evidence to back up Baxter’s claims, which were promoted through three channels:

  • TISSEEL® National Accounts Presentation,
  • TISSEEL® General Surgery Brochure and
  • TISSEEL® Cardiac Sell Sheet

Some of the statistics used to indicate the effectiveness of TISSEEL®, as approved by the FDA in 2006, were not only incorrect, but referred to studies done using an earlier FDA approved formulation of TISSEEL® from 1998. These statistics were inflated.

Because physicians make decisions based upon their faith in the accuracy of a pharmaceutical company’s representation of each product it produces, and patients are subject to the decisions of their physicians in situations that occur during surgery, it is imperative that the information be accurate, and not misleading in any way.

If you have been treated with TISSEEL® and have suffered any injuries or consequences because of the decision to use this product, you may be entitled to compensation. The experienced pharmaceutical injury lawyers at Schlichter, Bogard & Denton have long record of successful claims. Please contact Schlichter, Bogard & Denton, pharmaceutical attorneys, for a no-obligation consultation regarding your pharmaceutical injury claim.

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