How to Determine Whether You Have a Defective Medical Device

If you have an implanted medical device such as a pacemaker, an artificial knee or hip, a stent, an IVC filter or any other type of medical device, you might wonder what happens if the device turns out to be defective. People who have defective medical devices may be able to take legal action against the device manufacturer if the defective product causes them to have an injury. Whether the product’s defect is in its design, manufacture or marketing, the manufacturer owes a duty of care to its end consumers to create a product that will be safe and effective and do what it is designed to do.

Who can recall a medical device?

The U.S. Food and Drug Administration (FDA) has oversight over medical device manufacturers. The FDA can issue a recall of a medical device when it learns that there is a problem with the device which requires correction or removal. A correction, according to the FDA, addresses a problem with a medical device in the place where it is used or sold. An example of a correction would be when a pacemaker, which had wireless communication capabilities required an update to its communications software, patients were required to visit their doctor’s office to receive the software upgrade. Removal addresses a problem with a medical device by removing it from where it is used or sold. An example of a removal would be when metal-on-metal hip replacements were recalled due to a design defect, many had to be removed from patients’ bodies.

A medical device manufacturer, distributor or any other responsible party may voluntarily recall a device and then notify the FDA. The FDA reviews the strategy that the company is going to follow to address the problem, assess the health hazard the product poses, and if the problem violates FDA law.

Ways to stay up-to-date on drug and medical device recalls

The FDA has a drug and medical device recall page which also includes market withdrawals and safety alerts for the past 60 days. You can also sign up to receive email notifications about new recalls in your inbox. You can get recall alerts by following the FDA on Twitter @US_FDA. If you really want to stay up-to-the-minute on what’s happening with the FDA, you can subscribe to their Drug Safety Podcasts, which provide emerging safety information about drugs along with the release of Drug Safety Communications.

If you have a medical device that has been causing you discomfort, pain or other complications and you suspect it might be defective, seek medical attention right away, check with your doctor and the FDA about the status of the device. If you are interested in pursuing compensation for your injuries, you should speak to a medical device attorney about your case today.

At McGowan, Hood, Felder & Phillips, LLC, we have a team of trusted and experienced South Carolina defective medical device lawyers that is here to help you recover compensation when you have suffered an injury from a defective medical device. You are welcome to a call us today at 803-327-7800 or complete our online contact form now.

Related:

• How to Decide Whether to File a Defective Medical Device Lawsuit
• Shoulder Implant Recalled Over High Risk of Fracture