F. D. A. Says Baxter’s Surgical Sealant Isn’t All That…

Medical device, pharmaceutical and biotechnology manufacturer Baxter recently received a slap on the wrist by the FDA. The ruckus is centered on one of Baxter's most popular products called Tisseel. Tisseel is a surgical sealant that is used primarily in cardiac bypass surgery in order to curtail bleeding. According to Baxter's website, it is used in several other surgical procedures. While the FDA did not deem Tisseel a dangerous product it was gravely concerned with the manufacturers "overstating" of its effectiveness and use.

The problem of "overstating" the effectiveness or use of a product by a pharmaceutical or drug manufacturer is nothing new. In fact, further investigation into the FDA website reveals that several well known companies like Pfizer, Bayer, GlaxoSmithKline and Johnson & Johnson also received similar warning letters in reference to their marketing practices. Apparently asking the companies to police themselves more carefully isn't working! Warning labels and disclaimers only go so far too. We at westonlawyers.com believe the disclaimers are nothing more than a feeble attempt by the manufacturer to limit their liability if a problem with one of their drugs or medical devices occurs.

For its part in this surgical sealant debacle, parent company Baxter says that the marketing materials in question are "... no longer in use". While a Baxter spokesman denied that the marketing materials misrepresented the efficacy of the product, the FDA disagreed. For our part, will have to go with what the FDA says but it has to take responsibility too. It's important that the agency strictly adheres to and enforces the guidelines that already exist. The regulatory agency has the power to recall dangerous products and warn the public about the side effects of others. We also believe that the agency should review their guidelines regularly and tighten up those that are lax. The welfare and safety of consumers is a top priority of the FDA and thus they should keep their focus where it belongs.

Taking on pharmaceutical giants may seem like a battle of epic proportions and one in which there is no easy victory. Vigilance, persistence and accountability are the keys to protecting consumers. Consumers must be vigilant in their questioning and research of any drugs, surgical procedures or medical devices that are recommended by any medical professional for physician.

Those who have been wrong need to be persistent in their attempts to gain restitution from a manufacturer or physician that is liable for death or injury as a result of their product or procedure. And of course the government as well as other agencies needs to continue to hold companies accountable. The larger they are the more accountable they should be.