Taxus and Cypher Heart Stent Recalls

The Taxus and Cypher Stents are drug eluting stents (DES), also known as medicated or drug-coated stents. They are unlike bare metal stents because they are coated in medications that are intended to prevent restenosis (reblocking of the artery). Manufacturers of these stents include Boston Scientific (Taxus stents) and Cordis, a subsidiary of Johnson & Johnson (Cypher stents). Medicated stents are increasingly common, representing approximately 88% of all stents sold in the U.S. in recent years. Two recent studies have linked medicated stents with side effects such as thrombosis and necessary long-term antiplatelet medication in order to prevent thrombosis. The studies also found that the drug-coated stents may result in a higher death rate due to cardiac events such as heart attack when compared to metal stents without a drug coating. Blood clots may occur up to thirty days after the heart stent was implanted. 

A stent is a tiny mesh wire or plastic tube which is used to keep arteries and blood vessels open following surgical procedures. Permanent insertion of these drug coated devices after surgeries has become more common, as the drug coated stents prevent scarring of the arteries therefore keeping the arteries from narrowing. In fact, it has been estimated that as many as 6 million people worldwide have received drug coated stents.

In addition to suffering from serious blood clots in the stents, also known as stent thrombosis, patients may also be at risk for the following injuries:

• Rupturing of the blood vessel at the point of insertion
• Allergic reactions to the drug coating or sent materials
• Subacute Thrombosis
• Tear in the artery
• Clogging of the stent
• Heart attack

If you or a loved one has suffered from these, or any other serious side effects as a result of a drug coated Taxus stent please contact Nadrich & Cohen right away to discuss your case with an experienced stent blood clot attorney.

Companies that manufacture or sell medical devices and products must be held accountable for any injuries or fatalities which occur as the result of a dangerous or defective product. The Law Offices of Nadrich & Cohen is a national products liability law firm with extensive experience representing seriously injured clients against large corporations who have unnecessarily caused harm to patients and consumers. Our team of skilled defective medical device attorneys are investigating cases involving Taxus stents which may have caused innocent people to suffer from serious blood clots and other dangerous side effects.

Taxus Stents In The News

Agency Reviews Stent Coverage

The agency that controls Medicare and Medicaid payments is considering restricting its coverage of drug-coated cardiac stents because of safety concerns.

Drug-coated stents, which prop open clogged arteries and slowly release a chemical to keep them from closing up again, have recently come under fire because of fears that they increase the risk of blood clots over the bare-metal stents that they have largely replaced. Some studies suggest that the clotting is especially apparent when the coated variety is used "off label" in high-risk patients -- often diabetics and those who have had heart attacks -- even though the Food and Drug Administration hasn't approved the devices for use in these patients.

Now, the Centers for Medicare & Medicaid Services, or CMS, says it is considering reopening its decision about how broadly to cover the stents. An agency spokesman said such a process, known as a National Coverage Determination, could result in restricting coverage of the stents to FDA-approved uses, keeping coverage the same, or something in between.

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Drug-Coated Stents Show Use Risk

Study Says Devices by J&J, Boston Scientific Present A Higher Danger of Clots

October 24, 2006
By Sylvia Pagán Westphal
Wall Street Journal

Both major brands of drug-coated stent pose a higher risk for patients of developing blood clots months later than do traditional metal stents, according to data presented at a big cardiology meeting this week.

Boston Scientific Corp., the largest manufacturer by market share of cardiac stents, had already acknowledged a small but statistically higher risk of clots for its Taxus stent. But Johnson & Johnson, second in the stent market, had stated that, while the number of stent clots was numerically higher for its Cypher stent, the difference wasn't statistically significant.

In response to the latest findings, a J&J spokesman said the data "are subject to interpretation by a number of methodologies, some of which may yield significant differences at certain time points." The company also said that data from the company's trials would be presented today based on "new standardized definitions" of stent clots, known in medical parlance as stent thrombosis. The definitions have been created by a consortium of academics, manufacturers and regulators, and the analysis "will provide important insights into the thrombosis rates for the Cypher stent," the company said.

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Doctors Rethink Widespread Use of Heart Stents

October 21, 2006
By Barnaby J. Feder
New York Times

The medical community is having second thoughts about stents.

Tiny metal sleeves placed in arteries to keep blood flowing, stents have become such a popular quick fix for clogged coronary vessels that Americans will receive more than 1.5 million of them this year.

And stents are a big business, generating $6 billion a year in sales for their makers and thousands of dollars in fees for each procedure performed by the specialists implanting them.

But now stent sales are falling and some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.

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Study: Blood-clot risks higher in drug-coated stents

Friday, September 08, 2006
BY MARK JEWELL
Associated Press

Boston Scientific found a slightly higher risk of blood clotting in patients implanted with its newer drug-coated stents compared with older bare-metal ver sions, a company spokesman said yesterday.

The medical device maker reported the finding of its own new study to the U.S. Food and Drug Administration shortly after completing an analysis in late June, and met with the agency Aug. 1 to discuss the finding, company spokesman Paul Donovan said. Its shares fell 3.3 percent in trading yesterday.

The Natick, Mass.-based company reviewed previous clinical data involving 3,500 patients to compare rates of clotting in patients with its Taxus stent compared with older stents that are not coated with drugs.

The drug coatings are intended to help prevent formation of scar tissue that can form new blockages after surgery to implant stents, which are metal-mesh tubes that prop open coronary arteries. But recent studies, including findings released Sunday at the World Cardiology Congress in Barcelona, Spain, have indicated drug-coated stents carry a higher risk of rare instances of potentially fatal blood clots.

Boston Scientific's review confirmed that a higher risk exists in Taxus, the company's top-selling product and one of just two drug- coated stents on the U.S. market. While the stents are often credited with helping prevent heart attacks and bypass surgery, the review found a statistically significant higher rate of so-called "late stent thrombosis," or clotting, with Taxus in a period beginning six months after surgery compared with bare-metal stents.

"We have seen a slight increase in late stent thrombosis, which a number of studies have clearly shown to be a class effect common to drug-eluting stents," Donovan said. "The important point is we have seen no increases in heart at tacks or deaths."

Nearly 6 million people worldwide now have the drug-lined ver sions from the two dominant drug- coated stent makers, Boston Scientific and Johnson & Johnson's Miami Lakes, Fla.-based Cordis unit.

New Brunswick-based J&J has said it sees no statistically significant risk of late thrombosis in Cy pher.

Some of the blood-clotting concern stems from the fact that bare- metal stents allow heart cells to naturally grow to cover the stent after surgery, providing a natural biological lining. Drug-coated ver sions can prevent tissue growth, which helps prevent blockages but apparently leaves exposed metal that can act as a clot magnet.

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Boston Scientific confirms stent clot risk

Thursday September 7, 2006

Boston Scientific Corp. confirmed Thursday there is an increased risk of blood clots with its drug-coated Taxus stent, a device used to keep arteries open after surgery.

Internal analysis confirmed recent findings of a 3,500 patient study, according to a spokesperson for the medical device maker, based in Natick, Mass. While this recent analysis confirms earlier findings, it found no increased risk of heart attack or death, said a Boston Scientific (NYSE: BSX) spokesperson.

Drug-coated stents have gained in popularity because they prevent arterial scarring after implantation, which may cause arteries to narrow again. Nearly 6 million patients worldwide have received coated, or "drug-eluting," stents in recent years, and the market is worth more than $5 billion a year. Taxus and Johnson and Johnson's Cypher stent are the market leaders.

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Cardiologists Question the Risks in Using Drug-Coated Stents

By Reuters
September 5, 2006

BARCELONA, Spain, Sept. 4 — The booming market for drug-coated stents is encountering questions from heart specialists about the devices’ long-term safety.

Controversy about the tiny, wire-mesh tubes used to prop open clogged arteries has been fueled by studies being discussed at the World Congress of Cardiology here, with suggestions that they carry a higher risk of potentially fatal blood clots than older, bare-metal stents.

Drug-coated stents are now used in more than 90 percent of procedures in advanced economies like the United States and Switzerland. But some cardiologists say they will be more cautious about their use in the future.

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If we accept your case, we will represent you on a contingency basis which means our fee is solely contingent on obtaining a successful recovery for our stent victims. Please immediately contact an experienced attorney at Nadrich & Cohen or click here to complete an internet inquiry for assistance at no cost or obligation to you. Otherwise, please call us at (800) 718-4658.