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Can FDA-approved medical devices contain design defects?


Nowadays, many residents of New Jersey are living longer than ever thanks to the help of various medical devices. Whether a device helps a patient's heart or helps a person manage his or her diabetes, these devices may prove lifesaving, in addition to making everyday life much easier for those who need them. However, at times these devices are at the center of products liability controversies that involve danger to patients and consumers.

There are many different types of medical devices that, if not manufactured or labeled correctly, can pose a threat to people in New Jersey and throughout the nation. These devices may be pacemakers, prosthetics, implants or even surgical instruments that do not perform as needed. Additional devices that may be familiar are stents, defibrillators, intrauterine birth control devices and more. Regardless of the exact type of device, if its defect harms or claims the life of a patient, a products liability lawsuit may result. Readers may have heard of lawsuits involving harmful transvaginal mesh, faulty hip replacements parts or errors in robotic surgery.

Despite the fact that these products are often very carefully reviewed by the Food and Drug Administration, they can still prove to be dangerous medical devices if something goes wrong in the manufacturing, initial design process or in the later marketing efforts. A flaw at any one of these stages can lead to medical device recalls, injury to patients or both. It may be possible in some cases for lawsuits to be pursued even against FDA-approved medical devices that contain design defects or other harmful errors.

Those who have been harmed, or suspect they may have been hurt, by faulty medical devices may want to take their case to an attorney. A law firm that has handled medical device-related products liability cases in the past may be a crucial resource during an overwhelming time.

Source: FindLaw, "Faulty Medical Devices," accessed April 30, 2016

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