Medical Device Injuries
According to the Institute of Medicine, over a million Americans are severely injured each year by events involving medical devices; in 2002 alone, the US. Food and Drug Administration received more than 111,000 reports of adverse events involving medical devices (U.S. FDA Consumer Magazine, July-August 2003). If you have been injured while a medical device was deployed during your medical treatment, you should consider consulting with a NC medical device liability attorney who can advise you about the possible merits of your case.
Whether the device fails to operate properly or is used incorrectly, many of these injuries are preventable. It may be advisable consult a NC medical device liability lawyer in this type of case.
What is a Medical Device?
A medical device is an instrument used for the diagnosis, treatment, or prevention of disease. Stethoscopes, wheelchairs, thermometers, stents, kidney dialysis machines, or pacemakers are all examples of commonly used medical devices. Other medical devices less commonly thought of include surgical tools, heart defibrillators, and home pregnancy test kits.
Once a medical device goes to market, problems with them generally fall into three categories: device problems, usage problems, and clinical problems. Device problems include manufacturing defects, mechanical or electrical failures, or problems with the material used in the manufacture of the devices. Manufacturers of devices with problems may be held liable for personal injuries resulting from them if once can prove that the injury was caused due to a problem with the device itself.
Usage problems with medical devices can result from design defects, mislabeling, inaccurate or misleading instructions, or poor packaging. They can also arise because of inadequate training of the individual using the device during your medical treatment. In the case of usage problems, liability can be difficult to sort out. The counsel of an experienced personal injury lawyer can be of great benefit in such a case.
A clinical problem with a medical device can be extremely difficult to prove because a patient's existing medical condition, such as an allergy or other pre-existing condition, may make the device harmful for him to use.
Guidant Defibrillators Recalled Due to Patient Deaths
As of December 21, 2005, a total of 35 clinical failures, including 5 patient deaths, have been reported in patients implanted with Guidant’s Ventak Prizm 2 and Contak Renewal defibrillators. The units can develop a short circuit, which could lead to cardiac arrest and death in patients with the implants. The devices are supposed to …
Medtronic did not fix LifePak 12 flaws
In a letter made public June 21, 2005, the U.S. Food and Drug Administration warned Medtronic Emergency Response System, a unit of Medtronic, Inc., that its failure to correct manufacturing problems or investigate complaints regarding its LifePak 12 external defibrillators may force the company to face civil and legal penalties. External defibrillators deliver powerful electrical shocks to the chest in order to restore the heart’s natural rhythm.
