Whether it is a metal hip, pelvic mesh or other medical device, it is not unknown for these products to be defective. Unfortunately, consumers in Texas and elsewhere usually do not know a medical device is defective until they have been harmed by it. The federal government recognizes this problem and has a means for addressing it.
Under certain circumstances, the U.S. Food and Drug Administration has the ability to impose a ban against selling, distributing and manufacturing a medical device. This is an important way to stop dangerous or defective medical devices from being prescribed to or used by patients. Certain elements must be met for the FDA to issue a medical device ban.
First, the device itself must be meant to be used by humans. Second, based on all available information on the device, the device must either:
- Substantially deceive users regarding its benefits, or
- Pose a substantial and unreasonable risk of harm that could not be prevented by changing the label on the device
These bans are important, but, unfortunately, they may come too little, too late for people already harmed by defective medical devices. When a person is harmed by a defective medical device, they may want to pursue a lawsuit. When it comes to defective medical device litigation, oftentimes the focus is on proving that the company that manufactured the device put it in the hands of consumers without performing sufficient clinical testing. There may be other arguments a person can use as well. Since each case is unique, those interested in such lawsuits should make sure they understand how the law applies to their situation.