Drugs & Medical Devices

Drug Coated Heart Stents

In December of 2006 the Food and Drug Administration (FDA) recommended that a warning be issued to doctors and patients stating that the safety of using drug eluting heart stents has only been established in low risk patients. For those higher risk patients, the FDA is not so confident that the benefits outweigh the risks.

The FDA indicates that new studies suggest a small, but significant increased risk of thrombosis (blood clot) in drug-eluting heart stent patients. The FDA said the risks increases a year or more following surgery once patients stop taking blood thinning medications.

A Cleveland Clinic study released on November 29, 2006 indicated that blood clotting, or thrombosis, associated with drug coated heart stents such as Johnson & Johnson’s Cypher Stent is four to five times more likely than with regular metal stents. Late thrombosis associated with stents following angioplasty can lead to heart attacks, stroke and death.

Boston Scientific Corporation and Cordis, a Johnson & Johnson subsidiary company are the only two companies approved to sell the drug-coated versions of the stents which have been placed in about 6 million people worldwide. Boston Scientific has acknowledged a slight increase in clotting associated with its version.

Davis & Feder P.A. is now handling claims for individuals who have suffered a blood clot, heart attack, stroke or death from a Johnson & Johnson Cypher stent or a Boston Scientific Taxus Express Paclitaxel-Eluting Coronary Stent. Mark Davis, P.C., is experienced in pharmaceutical product liability cases and settlements. If you have a drug eluting heart stent and have suffered a blood clot, heart attack, stroke or have a loved one who has died after placement of a drug eluting heart stent, contact us at 1-866-857-8500 or send us an email at contact@markdavispc.com.