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Regulation of Defective Medical Devices

Posted on in Defective Medical Devices

Every month the Food and Drug Administration (FDA) recalls several products and devices as unsafe for consumption. Many of these never make news, and very few of these ever make a big splash in the mainstream media. This makes determining whether or not you've been affected by a defective product or device difficult.

According to a University of Akron publication, proving that a defective medical device has negatively affected you can be tricky. “The courts seem reluctant,” the paper states,” to find liability without a clear showing of negligence, whether the defendant is the doctor, the hospital, or the manufacturer of the product.” Regardless of FDA efforts to list and regulate the use of devices deemed defective or harmful, thousands of patients are still affected every year.

In 2008, Congressional hearings were held to determine regulatory procedure for medical devices, in an effort to curb the number of people affected each year. The FDA first received the governmental mandate to regulate medical devices in the 1970s. At that time, according to the U.S. Governmental Printing Office (GPO), the Medical Device Amendment was approved, “a statute whose explicit purpose was, 'to provide for the safety and effectiveness of medical devices.'” The law was revisited in Congress in 2008 after the Supreme Court decided in Riegel vs. Medtronic Inc. that “this law preempts State tort claims when a medical device causes harm.” In 2008, concerned members of Congress stated that this ruling “means complete immunity from lawsuits for corporations that endanger consumers with unsafe devices.”

According to GovTrack, the Medical Device Safety Act of 2009 stalled in Congress when its author, Sen. Edward Kennedy, died. For consumers, this means that federal law preempts state law when it comes to defective medical devices—not all patients who suffer loss because of a defective medical device have a case that will stand up in court.

If you or someone you know has been affected by a defective medical device in Illinois, don't go through it alone. Contact Newland & Newland, LLP today.

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