The Cordis Precise RX Stent from Johnson and Johnson was recalled by the FDA in May of 2005. This particular stent was designated by the FDA and by Cordis for use in bile duct system, known as a biliary stent. When it was used by doctors in vascular systems it caused serious injuries to patients, including seizures and in some cases, coma.
A stent is a small tubular device that is inserted into an artery to widen it. Basically, it is collapsed into a tiny tube and then enlarged when it is in place. It will increase the diameter of the artery in order to restore or improve blood and oxygen flow and function to organs. It is used, in many cases, for endoscopic procedures like angioplasty, to eliminate clogs in the arteries going to the heart. Many stents are medicated, in other words, coated with a special medication to prevent the body from rejecting the stent and to reduce swelling.
In some cases stents are used in the bile duct system, also known as biliary stents. Essentially, the stent can be used to re-open a duct or artery that may have been closed off, or partially obstructed due to tumor or disease. The idea is to use a biliary stent like the cordis stent to maintain pathways to and from the liver and gall bladder and specifically to maintain the function of the bile duct.
Issues arose when doctors used the Cordis stent in vascular procedures, rather than solely using them for their FDA directed purpose. The problem was quite serious, given that the FDA issued a Class I recall, the most serious recall possible. Cordis responded by issuing a new set of revised instructions to accompany the stent, strongly directing physicians to use the Cordis Precise RX Stent as it was directed to by the FDA.
Despite the recall, and the revised instructions from Cordis about the RX Stent, the company may be liable for any injury to you, or to someone you know for a number of reasons.
Using the Cordis stent system in a vascular system raises many different legal questions depending on your circumstances. For instance, in some cases with the RX Stent, there was in fact product malfunction, which clearly raises product liability issues. In some cases, the Cordis Precise RX Stent was used inappropriately for the bile duct system, rather than the vascular system and could fall under the “failure to warn” or medical malpractice, among other legal concerns.
If you know someone who was a victim of this medical device defect, or of medical malpractice with the Cordis Precise RX Stent, you should contact a reputable and experienced attorney. When you are facing legal issues of this complexity, you need an attorney who is well versed and competent in product liability, specifically in medical device defects or malfunction.
Another important note is to act quickly. Many product liability, and specifically stent lawsuit opportunities and other medical device lawsuit opportunities are lost because of statutes of limitations. Don’t let this happen to you. If you have been injured, you may be entitled to compensation for pain and suffering, loss of pay and reimbursement of medical expenses.