In a front page story, the New York Times reported on the “life-or-death decisions” being made by patients who have implanted defibrillators that could misfire and need to be monitored, fixed, or removed. The defibrillators – medical devices made by Medtronic and St. Jude Medical – are subject to damaged leads and can cause shocks if they malfunction. The Times says “heart device specialists have struggled for months to determine how best to treat patients with damaged leads,” and “there is no easy fix: removing the wires can be dangerous, but so can leaving them in.” The FDA has recommended some patients have imaging done to see whether their leads are affected, “but the guidelines did little to settle the matter after some doctors questioned the wisdom of the advice.” Patients, meanwhile, are “caught in the middle.”
From the American Association for Justice news release.