Previous posts here have discussed some real-life lawsuits that have resulted in verdicts awarding compensation to victims of defective medical equipment in Texas and around the country. For example, we discussed cases regarding the use of defective metal-on-metal hip joints, as well as "power morcellators" during hysterectomies. These are just a couple of instances cited by some physicians who are championing a bi-partisan measure in the U.S. House of Representatives that would add some language to the federal statute covering reporting of defective medical devices.
The Food, Drug, and Cosmetic Act is the federal law that gives the Food and Drug Administration its powers of regulation and enforcement in several areas of consumer protection, including that of medical devices and procedures. Under this law, there are certain entities that are defined as "covered device users" that are required by law to report potentially defective medical devices when they encounter them. At the moment, these required reporters include hospitals, outpatient treatment centers, nursing homes and certain other places where surgeries are performed. However, individual doctors are not currently considered "covered device users." A group of physicians are supporting a bill in Congress to change this law.
According to these medical professionals, many of the injuries suffered by patients due to defective medical equipment might have been prevented, because there were indications of problems with these devices that doctors had seen. Even when doctors note these problems, the FDA may not have the information required to take action under the present system, according to proponents of the bill. By adding doctors to the list of required reporters, the bill's supporters hope to use the existing legal structure to help prevent future problems for patients.
Unfortunately, regardless of changes in the law, it is likely that patients will continue to be seriously injured by medical devices that are defective. When injury occurs, one remedy is to look into a civil lawsuit to hold manufacturers and other responsible parties liable for damages.
Source: Medical Economics "Physicians lead charge for defective medical device reporting measures," John Frank, Aug. 25, 2016