Why You Might Not Know When Your Implant Is Defective

Headlines are made when major medical device or drug manufacturers issue massive recalls that affect hundreds of thousands of people. The US Food and Drug Administration handles the announcement of every recall differently, regardless of how many people were affected. However, most medical recalls have a common theme; the burden of informing patients is generally placed on the manufacturer. If the manufacturer fails in this duty, or behaves in a negligent manner regarding the recall, patient may have legal recourse if they suffer harm as a result of the defective product.

Georgia Bearden, an 84-year-old resident of Huntsville, Alabama, suffered complications from a recalled pacemaker. She never received a notification from the company, and was not informed by her physician. In total, two years passed before Bearden discovered that her defective pacemaker was responsible for frequent fainting and heart palpitations. She found out about the 2010 recall after being rushed to the hospital when the device failed in 2012.

How medical devices are recalled

Typically, a medical device manufacturer maintains a database of all patients who received a particular device. When a device is recalled, the manufacturer sends a notification letter to the address of record. These databases, however, can be incomplete. Even when accurate records are kept, a simple change in address can prevent a patient from being informed of a serious flaw in their medical device.

How Ms. Bearden is trying to change the law to help patients like her

Now, after having lawsuits against the hospital and device manufacturer dismissed, Bearden is working to change the law. ABC’s WAAY 31 reported, “Now she’s turning her attention to changing the law. She wants it to be mandatory for both the manufacturer and the physician to contact patients for every medical device recall. She hopes to take her fight to Montgomery and on to Washington. ‘We’re gonna sit on the steps until this changes. I’m going to see to that. It’s gonna happen,’ Bearden said.”

Unless Bearden’s efforts bear fruit, untold numbers of victims may suffer because of a flawed recall system. While the FDA maintains a complete list of all recalls, navigating the database is difficult and confusing. Ultimately, when your health or life is at risk because of a defective medical device or product, you have a right to be informed in a timely manner. When that right is violated, a skilled South Carolina medical products liability attorney may be able to help you.

If you or your loved one has been affected by a defective medical device or was not informed of a potential risk, you may be entitled to compensation. The experienced South Carolina defective device attorneys at McGowan, Hood, Felder & Phillips, LLC can evaluate your case and get you the compensation you deserve. Call 803-327-7800 or contact us today for a free consultation.