Submit your Product Liability claim details for a free, no obligation case review.
Get Started:
product_liability heart_stentCoronary artery diseases are the leading cause of death amongst men and women in the U.S., as well as in Europe. Every year, 500,000 of the 12.8 million Americans suffering from a coronary artery disease will die. Heart stents are mesh like devices inserted permanently into an artery in order to help keep the artery open. The most recent heart stent development is a drug-coated stent, which has been estimated to be a $3 billion market in the U.S. by the end of 2004.
The latest addition of heart stents has entered the market with much anticipation and has caused competing developers of the drug coated heart stents to dispute over right to technology. Johnson & Johnson was the first company to get approval for the Cypher drug coated heart stent and has joined forces with competitor Guidant to sell. The two companies are planning on devoting around 500 people to the marketing of the Cypher heart stent alone.
In October 2003, the FDA issued its second warning for Cypher heart stent users after receiving reports of heart stent complications. Sales for the Cypher stent began in April 2003, with the first FDA warning following shortly after in July. The Cypher heart stent complications involved reports of blood clots in 34 of the Cypher recipients, including five deaths. By October 2003, the second FDA warning came as the agency counted over 290 reports of blood clots, with 60 cases being associated to the patient''s death.
The Cypher heart stent complications were occurring up to 30 days after the stent was implanted. There were also heart stent complications involving allergic-type reactions, such as pain, hives, fever, and problems with breathing and blood pressure in more than 50 Cypher recipients. Due to the extremely small fraction of actual side effects believed reported to the FDA, the number of actual heart stent complications could be drastically higher.
The latest drug coated stents are believed superior in helping to prevent the arteries from becoming blocked again by scarring. The Cypher heart stent was approved in the spring of 2003, but Boston Scientific''s heart stent is expected to come by the end of March 2004 and is coated with paclitaxel versus Sirolimus used on the Cypher stent. So far, there are no definitive studies indicating if there is a drug-coated stent more superior to another brand or if one poses greater risks of heart stent complications.
A former American Heart Association president described the FDA heart stent complications warnings as a "red flag". It is advised to continue follow up appointments and be aware of any adverse changes if heart stents have been implanted.
Over 2,000 patients every year are suffering avoidable injury and death as a result of stents, small metal devices used to hold open heart arteries, according to two doctors who wrote an editorial published in a leading medical journal.
The ar...
Despite reports of more injuries related to Boston Scientific Corp.’s heart stents, the FDA said they did not plan on taking any further action against the company. Last year, Boston Scientific recalled more than 99,000 Taxus heart stents following re...