An article in the New York Times, written by Fred R. Conrad, made mention to the fact that Medicare bears the burden of the cost of replacing Faulty Heart devices. It points out that the cost to Medicare was $1.5 Billion in a 10 year period.
One device listed as being recalled on the FDA site is the Heartware Ventricular Assist Device; a device that helps the left ventricle of the heart increase its ability to eject blood. The reason stated for the recall is a loose power connection which causes the rear portion of the pumps driveline to disconnect from the front portion of the driveline; allowing moisture to enter the device. The moisture causes electrical issues and causes the pump to fail.
Device recall is costly to patients in terms of their health and finances. The majority of patients with this type of device implanted have an ejection fraction below 25% (normal ejection fraction being 60-65%). These patients, therefore, are completely dependent on the device to maintain their cardiac output and blood pressure. The inability to maintain an adequate cardiac output creates a whole host of metabolic derangements which can ultimately end in multi-system organ failure and/or death.
Patients must go through rigorous testing and approval prior to implantation of the device. The actual implantation is a major surgical procedure performed in patients who are already in a very weakened state. Recalls on these devices place patients at increased risk of surgical complications due to reentry into the chest cavity.
Going through the procedure the first time is a financial burden on the families of the patient. Due to the high probability of a longer recovery time of a second procedure, recalls place these families at increased financial risk.
Finally these types of cases create large amounts of medical records which can place a financial burden on you the attorney. Our legal nurse consulting team can help you sort through and appropriately analyze the voluminous medical records associated with these or any type of medical device related cases. Let us help.
