Drug Eluting Stents Made By Cypher and Taxus Associated With Blood Clots, Heart Attack And Death

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Stents Made By Cypher And Taxus Associated With Blood Clots, Heart Attack And Death

STENTS MADE BY CYPHER AND TAXUS ASSOCIATED WITH BLOOD CLOTS, HEART ATTACK AND DEATH

[Introduction: If you or a loved one had injuries consisting of a blood clot or heart attack which you believe may have resulted from a stent that was implanted, you may have a lawsuit that should be pursued. Although our lawyers who handle drug eluting stent lawsuits are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our drug litigation and medical product liability lawsuits are national in scope, and our lawyers who handle these suits are prepared to file lawsuits and litigate drug eluting stent cases, claims and lawsuits across the country. Therefore, regardless of what state you're from, please fill out our inquiry form on this web site or email us so that Ashcraft & Gerel, LLP can have a lawyer familiar with the litigation over drug eluting stents contact you to discuss your claim and the potential for a lawsuit.]

Stents are small, lattice-shaped, metal tubes that are inserted permanently into arteries. They are used to hold open arteries that have narrowed due to plaque build-up caused by atherosclerosis. When artery walls thicken, the pathway for blood narrows. This can slow or block blood flow. Stents are used frequently to treat blockages in the blood vessels of the heart. Once in place, stents help hold the arteries open so that the heart muscle gets enough blood. As the body accepts the stent, it grows heart vessel tissue over it. Stents can be made of metal only (bare metal stents) or they can be coated with small amounts of drugs that are released over time to help keep the arteries from being blocked again (drug-eluting stents, abbreviated as DES).

More than 6 million people worldwide have gotten the drug coated stents, including about 3 million in the United States. At least 800,000 new patients get the stents each year, making them the most common device used to treat heart disease and one of the most common medical procedures of any kind.

Data from recently released studies suggests a small but significant increased risk of stent thrombosis (blood clots) in patients who have drug-eluting stents. Stent thrombosis results in death or heart attack in the majority of cases.

The United States Food and Drug Administration (FDA) had raised concerns about the safety of the TAXUS and CYPHER brand stents as early as September 14, 2006. In its "Statement on Coronary Drug-Eluting Stents" the agency stated: "FDA has been closely monitoring DES since they came to the United States market in 2003 and 2004 - and will continue to do so. We are aware of recent data suggesting a small but significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients treated with DES ... The small but significant increase in the rate of death and myocardial infarction observed in these studies was noted in patients followed 18 months to 3 years after stent implantation."

These concerns regarding the safety of DES stents lead the FDA to convene a meeting of a special 21 member Circulatory Systems Devices Advisory Panel. The two-day meeting that concluded on December 8th, 2006 resulted in a recommendation to issue new warnings to doctors and patients informing them that the safety of the devices has not been established. As a result of the December meeting the FDA's September 14, 2006 statement was updated.

At present there are two drug-eluting stents approved by the FDA in the United States:

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System - manufactured
by Boston Scientific, Natick, Massachusetts. Approved: March 4, 2004.
CYPHER™ Sirolimus-eluting Coronary Stent - manufactured by Cordis
Corporation - Miami Lakes, Florida. Approved: April 24, 2003.

The advisory committee panel of experts concluded that these stents are associated with an increased risk of blood clots, heart attacks and death for a great number of patients receiving the devices. The panel observed that the majority of the patients receiving the DES stents were outside the group of relatively low-risk patients for whom the stents were originally tested and approved. This “off-label” use of the devices in populations where the safety and efficacy of the stents has not been demonstrated, comprises over 60 percent of the DES stent patients.

These patients tend to be sicker and have more complicated conditions, such as diabetes, multiple blockages and blockages in narrower arteries, that may make them riskier candidates. The panel also recommended that patients who have gotten the stents take anti-clotting drugs for at least a year to reduce their risk.

At present the FDA is offering the following advice to patients on its website dedicated to Questions and Answers on Coronary Drug-Eluting Stents:

FDA believes the vast majority of these devices are safe and help millions of people. In rare cases, a blood clot can form inside the stent, which can lead to heart attack or death. These events usually occur in the first 6 months after receiving a stent, but recent information suggests that they can happen later. At this time, not enough is known about which patients or patient groups are more likely to have clotting problems. FDA is convening a meeting of outside experts to evaluate new information about the clotting problem. This new information, together with ongoing and planned studies, will help FDA make recommendations to improve patient care. FDA will make its recommendations available to the public as soon as possible.
In the meantime, if you have questions about your current heart medications, talk to your cardiologist. If you receive a drug-eluting stent, your doctor will prescribe certain medications (aspirin and Plavix) to prevent the risk of clotting in the stent. It is important that you continue your medications as prescribed. If another physician or health care provider recommends changes in your medications (such as before a colonoscopy or dental procedure), check with your cardiologist first.

If you think you or a loved one may have suffered an injury or damages as a result of a Taxus or Cypher stent, you owe it to yourself to speak to an experienced medical device - stent attorney to see if you have a case and to discuss the possibility of bringing a lawsuit to recover for your damages and injuries. The attorney will be able to ascertain if you have a claim for which a lawsuit can be pursued and whether the case and lawsuit can be brought to a successful settlement, verdict, award or other recovery, and the experienced lawyer will be able to advise you on any deadlines for bringing your legal claim for damages. Please contact the law firm of Ashcraft & Gerel, LLP to discuss your case with an experienced medical device - stent lawyer in our Medical Device Litigation Department.

The lawyers at Ashcraft and Gerel, LLP have been leaders in pursuing lawsuits involving unsafe drugs and medical devices. Our attorneys have successfully brought about verdicts, settlements, awards or other recoveries in lawsuits on behalf of clients who have been injured by Fen-Phen, Rezulin, Propulsid, Phenylpropanolamine (PPA), Baycol, breast implants, AIDS tainted blood and many other drugs and medical devices.

We have a toll free number to reach an attorney to answer your questions with regard to your specific case. That number is 1-800-829-7037. Please ask to speak to Robert Samet, and he will place you in touch with one of our stent lawyers. If you would prefer, please feel free to e-mail us or complete the help inquiry form on this web site. Please be sure to include your name, address, telephone number (if you wish to be called), email address and the exact nature of your question, so that our lawyer can provide you with the specific information you seek about stent lawsuits.

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*IMPORTANT: It is important to note that there are few instances when any two states agree on issues within a given field of the law. This document is intended to provide only an overview of claims involving stents in general, and it is not intended to substitute for the advice you would receive on your claim from experienced attorneys or be relied upon in the handling of a particular case or lawsuit. The rules and principles set forth in this article may vary from state to state. Drug lawsuits and medical product liability lawsuits are fraught with danger to the inexperienced lay person, as well as to the inexperienced lawyer. It is strongly recommended that any injured victim of a drug eluting stent reading this page who is not already represented by an experienced lawyer, immediately seek an attorney to determine whether he or she has a claim for which a lawsuit can be filed.