Health technologies rely on incredibly small tolerances to ensure their safety. Even the smallest crack can be fatal. Medtronic, Inc. learned this the hard way when lawsuits forced the company to recall the leads it manufactured for defibrillators and other types of health equipment in 2007[1]. However, advances in micro CT (Computed Tomography) technology may reduce the health risks for affected patients.
In the three years following the 2004 start of production on Medtronic’s Sprint Fidelis leads, approximately 268,000 patients received implanted defibrillator devices that used the components. Six years later, an estimated 170,000 patients continue living with the risk of these potentially defective parts.
Cracked Leads Threaten Lives
Defibrillators work by sensing abnormal heart rhythms and sending electrical currents to correct irregularities. Failing to deliver current, producing too much current or under stimulating heart muscle are all potential hazards from defective leads. These failures can be fatal.
Micro CT Technology May Offer New Hope
Because of the dangers specific to defibrillator implants, doctors have been reluctant to remove devices that may or may not be defective. Micro CT technology may open the possibility of scanning implanted devices to determine if defects exist in the first place. Doctors can then weigh the risks of removing the defective devices against the risks of malfunction.
Although micro CT technology was first developed in the early 1970’s, recent advances have made the technology more powerful and more accessible. CT scans create three-dimensional images by taking x-rays at multiple angles. Computers fit the images together, combining information to create a single, detailed, three-dimensional model.
The first micro CT scanner was constructed in 1993[2]. Advances since then have created higher resolution images and faster scans. Some machines can perform scans in as little as six seconds, making them practical for production lines.
Preventing Medical Device Malfunctions
Such scans could prevent failures like those caused by the Medtronic leads from happening in the first place. At a price tag ranging between $200,000 and $400,000[3], the cost would be far less than the millions medical companies could face in lawsuits.
Settled Medtronic Case
Compare the cost of such scanners with Medtronic’s settlement of the Sprint Fidelis case. Although the Multi District Litigation was recently dismissed, the manufacturer settled the claims in advance of the ruling, fearing a poor outcome. The company agreed to pay $268 million, not including legal defense costs. In 2007, the company paid out $114 million in a previous defective leads lawsuit. Had a scan like the one made possible by micro CT technology been available, it could have saved Medtronic hundreds of millions of dollars. More importantly, it could have saved lives.
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If you suffered an injury because of a defective medical device made by Medtronic or another manufacturer, contact our office. Our attorneys will review your case free of charge and help you understand your legal rights to compensation. You may be eligible to recover damages for medical expenses, lost wages and pain and suffering.
[1] http://www.nytimes.com/2010/10/15/business/15device.html[2] http://discoverysedge.mayo.edu/de07-4-biotech-ritman/index.cfm[3] http://www.nytimes.com/2011/01/02/business/02novel.html
