Medical Malpractice

Medical Device Error

Based on information acquired by the Institute of Medicine, more than one million people are seriously harmed per year by faulty medical devices in the US. Just in 2002, the Food and Drug Administration heard in excess of 11,000 reports of hazardous circumstances surrounding medical devices.

A medical device is a tool specifically used to diagnose, treat, or prevent diseases. Examples include:

• Stethoscopes
• Wheelchairs
• Thermometers
• Stents
• Kidney dialysis machines
• Pacemakers
• Surgical tools
• Heart defibrillators
• Home pregnancy tests

When medical devices hit the market, problems associated with them typically can be explained one of three ways:

• Device problems -- flaws from the fabrication process, mechanical or electrical malfunctions, or faulty material used to manufacture the device. Manufacturers of a defective device or the company who lends its name to the device could potentially be held liable for any injuries sustained by consumers if they are able to prove that the damage is directly attributable to the faultiness of the instrument.
• Usage problems -- stem from design irregularities, poor labeling, incorrect or confusing instructions, or insufficient packaging. Usage problems can also be caused due to the lack of experience and knowledge that the person assisting you with treatment has with the product. It is usually difficult to pin the blame on someone in a usage case because they are not usually cut and dry.
• Clinical problems -- probably the trickiest circumstances to prove since a patient's preexisting medical disorder (e.g., allergy) may cause the device to do more harm than it does to benefit that person.

Product recalls and warnings

By 12/21/05, 35 instances of product failure involving five fatalities were reported in patients wearing the Guidant Ventak Prizm 2 and Contak Renewal defibrillators. It became apparent that the apparatuses can short circuit, which may trigger heart attack and death in those fitted with the devices.

In a notice revealed to the public on 6/21/05, the US Food and Drug Administration alerted Medtronic Emergency Response System, a division of Medtronic, Inc., that its lack of interest in fixing problems with its assembly process or in investigating grievances concerning its LifePak 12 external defibrillators could result in the company coming to terms with civil and legal. Countless Americans rely on external defibrillators to keep their hearts beating naturally.

If you or someone you love has been injured from a medical device used during the course of treatment, you should contact a medical malpractice attorney who is familiar with medical device liability cases. Whether the device does not function properly or is simply used incorrectly, these injuries are often preventable. Find out if you deserve to be compensated for the damages you have incurred.