Medical Device Update -- Are Coated Stents Lawsuits Going to Be Filed?

Anapol Schwartz Weiss Cohan Feldman and Smalley has initiated legal analysis of articles and editorials in the November 16, 2006 issue of the New England Journal of Medicine discussing the emerging medical issue of late (after more than one month) restenosis (blocked heart arteries) with coated stents. Could these devices cause an increased risk for heart attacks and sudden cardiac death and be the subject of lawsuits?

Philadelphia, PA (PRWEB) November 28, 2006 -- Articles and editorials in the November 16, 2006 issue of the New England Journal of Medicine discussed the emerging medical issue of late (after more than one month) restenosis (blocked heart arteries) with coated stents. Could these devices cause an increased risk for heart attacks and sudden cardiac death?

Recently, studies question whether the use of drug-eluting (coated) stents in patients with complex lesions, multiple vessel disease or diabetes increases rather than decreases the risk of restenosis. Just months ago, Wall Street thought these medical devices, sold by Johnson & Johnson, Boston Scientific and Abbott Laboratories, would generate $5.4 billion in annual sales. Long term studies reveal persistent incomplete healing of the stented vessel due to ongoing inflammatory and immunologic reaction in the vessel wall. This occurs because of the prolonged exposure and reaction to the drug. Instead, using a coated balloon during angioplasty, alone, may solve this problem.

More studies are needed. Coated stents, on this data alone, in our opinion, ought not be considered defective nor was their use below the standard of acceptable medical care

we shall continue to monitor this potential safety issue.

According to Anapol Schwartz, "More studies are needed. Coated stents, on this data alone, in our opinion, ought not be considered defective nor was their use below the standard of acceptable medical care," said Sol Weiss, Esq., partner in charge of this medical device litigation.

The Circulatory System Device Panel of the FDA will hold two days of hearings on December 7 and 8, 2006 in Gaithersburg, Maryland. More information may come out of those hearings. Weiss advised that "we shall continue to monitor this potential safety issue."

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