The Food and Drug Administration in June recalled SynchroMed implantable drug pumps made by Medtronic Inc. The following day, Medtronic announced that 14 deaths had been associated with the device.
Medical device failures occur less than 1 percent of the time, according to a report by CBS. But tens of millions of Americans have medical devices implanted in their bodies. Given these numbers, even a fraction of a percent equals thousands of injuries and wrongful deaths a year.
In 2012, the FDA recalled 49 medical devices.
Consumer Reports pointed out the following concerns regarding medical devices:
- Medical devices often are not tested before entering the market.
- No system is in place that allows government, researchers or patients to find out about device failures. As an expert noted, “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t.”
- Until there are major changes in the system, patients have few ways to protect themselves.
Manufacturers are required to report adverse medical device events to the FDA. After this occurs, the FDA can recall a device. Unfortunately, by this point, thousands of people may already have the device inside their bodies and many may have already suffered injury or death.
Lawyers at David Resnick & Associates, P.C.
If you or a family member has suffered a serious injury from a medical device failure, the New York personal injury law firm of David Resnick & Associates, P.C., may be able to help. Contact our offices and let us fight for the compensation you deserve.
- Consumer Reports
- FDA: 2012 Medical Device Recalls
- FDA: Medical Device Reporting
- FDA: Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls