A Bellevue, Washington software developer, Dennis Montgomery, underwent surgery for a brain aneurysm in 2013. The treatment required the use of a medical device known as the “Penumbra Coil 400.” The Penumbra Coil 400 and other similar coil devices are the primary method used to treat brain aneurysms. Normally, all goes well, and the patient relies on use of the coil for recovery; but when a medical device is flawed, the negative effects can be catastrophic.
This was the case for Montgomery. The coil used for treatment was only placed 90% of the way into the aneurysm, with the other 10% of the device getting stuck inside of Montgomery’s intracranial artery. From this position, the doctor should have been able to remove the coil with little to no issue. Instead, the device detached itself prematurely, and caused Montgomery to suffer a stroke. Montgomery has since filed a lawsuit against the makers of the device, Penumbra, as well as the hospital where the surgery took place.
The lawsuit seeks damages for medical costs, along with various other economic damages. The stroke has seriously affected Montgomery’s life, particularly his ability to work. Software development requires an intense degree of thought and mental capacity, any injury to the brain can severely limit cognitive function. The lawsuit claims that Montgomery’s ability to continue work has suffered, and he experiences pain on a regular basis. The lawsuit also names the hospital as a defendant. The hospital allegedly failed in its duty to provide the patient with products that are functional and “free of defects.”
Investigation from the lawsuit revealed that the FDA had instated a Class I recall on the Penumbra Coil 400 in 2011. A Class I recall on a medical device means that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” The reasoning behind the FDA’s recall was that the device could slip out of place, allowing for premature detachment, which can lead to serious injury or death. This is precisely what happened in the case of Montgomery. The coil device used on Montgomery was manufactured in the same year as the recall, and held an expiration date of August 31, 2013. The lawsuit aims to find out if this device was included in the recall, and also if newer versions of this device still have the same problem.
Much of the public perception of medical malpractice rests on doctors failing to perform their duty correctly. However, hospitals also owe a duty to the patients as well, and that duty is to ensure that the supplies that doctors have at their disposal are safe to use. In the case of Dennis Montgomery, the hospital may have been negligent in their failure to provide a safe medical device for him.
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