Adverse incidents involving medical device recalls rose 13% in 2010 reaching 10,280 (according to regulatory agency, Medicines and Healthcare). In order to safeguard patients from medical device recalls, manufacturers are responsible for testing the safety of their products—but many fall short. As federal regulators move to tighten oversight of recalled medical devices, one ubiquitous and troubling device—automated infusion pumps that intravenously deliver drugs (like pain meds, insulin and cancer treatments)—still plagues the industry. A common, and potentially deadly error, is dispensing an inaccurate dose of medicine, e.g., instead of two units of a drug an infusion pump has been known to dispense 22 units.
Complications of Recalled Medical Devices
Pulling a medical device recall product off the market is one thing, but removing it from the bodies of thousands of patients is more complicated—and dangerous. Faulty Medtronic’s heart defibrillator cable was a medical device recall implanted in 150,000 people in the U.S. and a quarter-million worldwide from 2004-2007 before it was recalled because of five deaths. Now victims face the tough decision whether to undergo risky and costly surgery to replace the recalled medical device or risk the cable cracking and seriously injuring them. Already four patients have died during extractions of the medical device. And even experienced cardiologists at well-regarded hospitals, consider the procedure challenging because of its potential damage to a vein or the heart, which can cause extensive bleeding.
Seeger Weiss’ highly experienced medical device attorneys understand what it takes to pursue tort litigation of this nature. Contact us today if you have been victimized by a medical device recall.