First Minnesota Lawsuit Over Cypher Stent Implant
Posted: Monday, October 15th, 2007 at 9:26 am
A man has filed the first Minnesota lawsuit in relation to problems experienced as a result of using the Cypher stent implant by Johnson and Johnson. Over fifty thousand patients have received these stent implants and the Food and Drugs Administration has received many reports of clots or thrombosis in those with the implants.
One attorney that is representing the plaintiff stated: “We hope that a side benefit of bringing this case will be to determine why these stents failed, so that doctors and patients can make more informed decisions.” The stent was approved in 2003 by the FDA, and is manufactured by a subsidiary of Johnson and Johnson.
The manufacturer of the stents did issue warning letters just months after its approval in 2003, explaining that the stent could lead to blood clots. This came after nearly fifty reports of clotting were received by the FDA in relation to patients that had recently had one of these stents implanted.
The FDA has stated that the risk of clotting increases with off label use of the implants as opposed to the stent being used as directed. Recent studies have suggested that longer term use of drug coated stents can lead to increased risk of clotting.
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