Stents are small medical devices used to prop open and offer support to arteries that would otherwise be collapsing. They keep blood and oxygen flowing to important bodily organs and throughout the body and they have saved many lives. In some cases, though, a stent will malfunction, and the patient may be able to file a product liability suit based on the stent medical device defect.
When a stent is inserted, it is done so in its collapsed state and it therefore incredibly tiny. This allows the stent to be inserted into occluded arteries and then enlarged into the correct size.
Boston Scientific is one of the industry leaders in stent production. The Boston Scientific Taxus stent, their drug eluting stent, was enlarged with the use of a tiny balloon. As the tine balloon inflated, it would enlarge the Taxus stent to the correct size, and then the balloon would be deflated and removed. In several cases, the balloon failed to deflate and became nearly impossible to remove. This kind of malfunction caused the blockage of the artery and then prompted further corrective surgery to remove the balloon.
According to Angioplasty.org, over “…1.1 million of these stents (combined) have been placed worldwide; there have been 95 confirmed reports of non-deflation problems, including 3 deaths and 43 serious injuries.” The serious injuries were related to the fact that these patients were forced to have more invasive surgery, like bypass heart surgery, to remove the balloon and solve the initial problem that the stent was supposed to treat. Boston Scientific stated that, "…impeded balloon deflation can result in significant patient complications, including coronary artery bypass graft surgery and death"
In 2004, when the problem was made clear, the Boston Scientific Taxus stent was recalled. Boston Scientific identified that the problem existed on the production floor and that the problem was specific to the mechanical failure of the balloon, not with the drug coating on the Taxus stents, or with the stents themselves. Once the production flaw was discovered, over 100,000 Taxus stents (drug eluting) and Express2 (non-drug eluting) stents were recalled from various medical facilities.
Because the problem was specifically isolated, patients who have a Boston Scientific Taxus Stent implanted already do not need to worry. The malfunction occurred in deployment, and had nothing to do with the stent itself. Although the quick actions by Boston Scientific mitigated some of the potential damage caused by their production defect, the serious production problem does make Boston Scientific liable for the injuries caused to the victims of the medical device defect. If you were affected by a Boston Scientific Taxus Stent malfunction, or you have a loved one who was affected, you should speak to a qualified product liability or medical device attorney as soon as possible.
Like all medical device defect and product liability lawsuits, there is a statute of limitations enforced and if you don’t act efficiently, you may lose your opportunity to receive compensation and redress from Boston Scientific. Make sure you hire a qualified attorney who understand this kind of law and can get you the redress you deserve.