Stent Lawsuits News

Stents are considered to be a major medical breakthrough as they involve a much lower degree of invasive surgery. They are small, expandable wire mesh tubes that are inserted permanently into arteries to keep them open. Arteries can become blocked when plaque builds up on the inner walls constricting the flow of blood throughout the body. Stents act as a scaffold so the blood can flow through the artery carrying necessary oxygen. Drug-eluting stents contain medication that helps reduce the chance that arteries will become blocked again or cause an inflammatory response. In addition to coronary arteries, stents are used on other blood vessels, the common bile duct, the esophagus, trachea or large bronchi, and the uterus. Before insertion, the stent is collapsed into a small diameter, and is then inserted in the body through a main artery in the groin. It is threaded up to the narrowed section of the artery with a small catheter. When it reaches the right location, it is expanded using an inflatable balloon that pushes the plaque out of the way. After the balloon is deflated, the stent is held in place by it own tension. They are usually inserted using endoscopy, a medical procedure where a small scope is inserted in the body often through a natural opening. Drug-eluting stents slowly release drugs such as paclitaxel into the artery wall around the stent. Stents that are left in the body are eventually covered by epithelial tissue. Stents are a great solution for patients with advanced diseases who would not be able to tolerate more invasive surgery.

Three major stent manufacturers are Boston Scientific, Guidant Vascular which is now owned by Abbott Laboratories, and Johnson & Johnson's Cordis. All have been involved in stent recalls for various reasons described below.

Boston Scientific Coronary TAXUS Stent:

Boston Scientific voluntarily recalled 85,000 to 500,000 TAXUS Express2 stents on July 16, 2004. They had only been on the market since March, 2004. There had been reports of one death and 18 serious injuries, and in an earlier stent system known as Express2, there were at least two deaths and 25 serious injuries. The main issue was that the balloon on the delivery catheter for the stent failed to deflate. This greatly interfered with removing the balloon after putting the stent in place, and led to serious patient complications. Emergency coronary bypass surgery had to be performed or patients died. Boston Scientific blamed production problems as the cause of the defects. The problem was first noted after only one month of being on the market. Changes were quickly made to the balloon design, but on July 2, 2004 the company recalled 200 systems it had already shipped. These were part of a production batch in which the hole between the catheter and the balloon was too small, possibly because the plastic material was stretched during a laser welding process used in manufacturing. Boston Scientific previously reported other cases in which the balloons seemed to stick to the stents, possibly because of the drug coating, and were difficult to withdraw.

Patients who have already received these stents are not at risk, as the problem only occurs during insertion. The recall was a setback for Boston Scientific as the TAXUS Express2 stents are coated with drugs that reduce the chance of scar tissue appearing which can reclog the blood vessels. If you received a TAXUS stent during this time period or after, and had to undergo emergency bypass surgery or incurred other injuries, you may be elgible for compensation. And if a family member died as a result of the stent malfunctioning, you should certainly seek legal advice. As of this writing, the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System is still actively marketed by Boston Scientific, as there were only specific production lots that contained the defects.

According to the Federal Drug Administration, the TAXUS Express2 Stent should not be used in patients:

• who cannot tolerate angioplasty, or
• who have an allergy to the drug paclitaxel, related drugs or the polymers used to coat the stent,
• who have a blockage in the coronary artery that will not allow complete inflation of the balloon or proper placement of the stent, or
• who cannot take aspirin or blood-thinning medicine.

Cordis Precise RX Stent
Instructions for the Cordis PRECISE RX stent were recalled by the U.S. Food and Drug Administration for a very different reason. This was a class I recall which is the most serious as it involves situations where there is a reasonable probability that a product will cause injury or death. The PRECISE RX stent was designed to drain the biliary tract, which are ducts leading from the liver and gallbladder, and keep the bile duct open. The FDA had approved the use of the stent to treat obstruction of the bile duct due to malignancies. However, Cordis, a division of Johnson & Johnson, issued revised instructions to physicians on March 29, 2004 stating that its Precise RX Nitinol Stent Transhepatic Biliary System could be used in vascular systems as well. This had never been approved by the FDA. In the company recall dated May 7, 2004, Cordis reported it was aware of nine patient injuries, including seizures and coma, as well as seven incidents of the stent malfunctioning in connection with the use of the device outside its approved functions. According to the FDA, air may be introduced into the patient through the stent, causing an air embolism resulting in a stroke.

On May 4, 2004, Cordis sent a sent a follow-up notification to physicians advising them to limit the use of the stent to FDA-approved uses only. The stent's labeling now contains a warning that the safety and effectiveness of the device for use in the vascular system have not been established.

The parent company, Johnson & Johnson, also had production problems when it rolled out its Cypher drug-coated stent in 2003. In October of that year, the Food and Drug Administration issued an advisory linking these stents to more than 60 deaths, but said the number was in line with the expected rate and they decided not to issue a formal warning to doctors.

The Cordis Precise RX Nitinol Stent Transhepatic Biliary System is still being sold as a stent used to treat the biliary tract. If you were injured because of the stent being inserted for vascular systems or other unapproved uses, you should seek legal advice for possible compensation.

A company of the caliber of Johnson & Johnson that has been manufacturing medical devices for over a hundred years, should have been aware that they needed to obtain FDA approval before issuing instructions to physicians stating it was acceptable to use a bile duct stent in a coronary artery.

Guidant Multi-Link Vision Stent
At one time, Guidant was the largest manufacturer of stents. One of its vascular products, the Multi-link Vision stent, was used to prop open coronary arteries after a blockage had been cleared. At the time of its approval by the U.S. Food and Drug Administration on July 16, 2003, Guidant claimed this new stent could be used to treat more challenging blockages and did not appear to allow reclogging as much as other stents. However, problems were noted with the Multi-link Vision stent in the Fall of 2003 because some of the devices had failed to meet manufacturing specifications and had difficulty staying in place. On October 8, 2003 Guidant issued a partial, voluntary recall of the stent because certain manufacturing lots had failed in quality tests. Patients who had already received the stent were not affected by the recall as the problem would only occur during insertion. A few months previous to this recall, Guidant pleaded guilty to ten felonies and agreed to pay $92.4 million in civil and criminal penalties regarding their Ancure stent. This was to settle charges that it withheld information about 2,600 Ancure stent malfunctions that had been linked to at least twelve deaths and 2,400 insertion failures.

On April 21, 2006, Abbott Laboratories announced it acquired Guidant's vascular business, which created one of the leading global vascular device companies. At the same time, Boston Scientific acquired the remainder of Guidant Corporation. The Multi-link Vision cobalt chromium tent system has been integrated into Abbott's product set, and advanced research is underway for a drug-eluting stent on this platform called XIENCE V.

If you or a member of your family was injured from a Guidant Multi-link Vision stent, you may want to pursue a lawsuit case evaluation with an attorney who specializes in this area. For additional information on stents and how they are used, please visit www.fda.gov/hearthealth/treatments/medicaldevices/stent.html.