In 2003, Guidant voluntarily recalled one of its vascular stent products, specifically, the Multi-Link Vision Stent. The reason for the recall was that a manufacturing defect was found in the stents. After being implanted in the vascular system, the Guidant Multi-Link Vision Stents were not staying in place. This not only complicated their functionality, it also caused serious complications and potential problems in many patients.
A stent is a small hollow mesh tube inserted into an artery to improve circumference and support. In some cases, a stent is used after the removal of a blockage, while in others, it is merely inserted to improve blood and oxygen flow to a given system or organ in the body. Stents are manufactured in two ways – drug eluting and non-drug eluting. Drug eluting stents are coated with special medication to reduce swelling and sometimes to improve circulation. Non-drug eluting stents are not coated with medication.
Although stents are considered to be very safe in most instances, there have been some reported problems. In some cases, a stent might fail to function properly either during implant or after the fact. Additionally, some stents are designed for specific systems and then used improperly by physicians. Finally, some patients can have allergic reactions to medications used in drug eluting stents.
In the case of the Guidant stent the implantation and initial functionality was deemed safe and successful, but in some cases the stent failed to maintain its position in the artery. The potential damage caused by this failure could be catastrophic. Not only are there inherent dangers to a stent moving in the artery, but the specific part of the artery it was implanted to support might collapse, cutting off blood and oxygen flow.
Rather than medical malpractice, this kind of product failure aligns more closely with product liability. In this case, Guidant specifically blamed problems during manufacturing for the functional failure of the Multi-Link Vision Stent. This is one of the clear subsections of the product liability guidelines. Essentially, although the product design was sound, the implementation on the manufacturing floor was substandard and therefore the product was defective, and dangerous.
In a case like this, Guidant may be liable for damage caused to any patients who experienced failure due to a defective medical device. This is a specific kind of product liability, so if you have been a victim of this kind of defective stent, you should contact a reputable and experienced attorney.
By contacting an attorney who has experience in the medical device field, or in medical malpractice, you will ensure that your case is handled properly. This kind of lawsuit can be complicated and multi-faceted and should be pursued only by someone experienced. Additionally, if you have been injured by a defective Guidant Stent, you need to act quickly. The medical device defect statutes are different state to state, but all states have statutes of limitations. Thankfully, that statute of limitations does not begin until the illness or injury is identified, so if you have been injured, you may still have a window of opportunity to seek redress.
The manufacturing issue with the Guidant Stent may mean that Guidant is liable for damages to you or your family.