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product_liability heart_stentDrug coated heart stents were a popular new variation to the formerly bare metal stents. Introduced to the market in April 2003, drug coated heart stents offered an alternative to the metal stents by emitting a drug to reduce risk of the artery clogging again. What was not predicted was that the new drug coated heart stents could increase the risk of blood clots that form around the device and can cause a heart attack.
The FDA issued a warning in July 2003, shortly after the drug coated heart stents entered the market. Reporting the agency had been receiving reports of blood clots in patients that had the drug coated heart stents implanted, the FDA warned of the possible increased risk that had thus far been documented. There had been five deaths among the 34 drug coated heart stents patients that reported blood clots at that time.
Just months after the initial FDA drug coated heart stents warning, the FDA issued another warning. By October 20, 2003, the FDA had received over 290 reports of blood clots associated to the use of the drug coated heart stents. Of the 290 reports, over 60 drug coated heart stents patients died. People were alarmed at the dramatic increase in adverse drug coated heart stents reports that so closely followed the first report.
In addition, more than 50 drug coated heart stents users reported allergic-type reactions and the FDA said that some of the people died, although the exact number was not disclosed. The FDA only received a very small fraction of adverse event reports, and it is believed that a much higher number of people have suffered in response to the drug coated heart stents. An estimated 260,000 drug coated heart stents have been distributed to U.S. hospitals and 180,000 overseas.
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...