Law calls for more "guardians" against defective medical devices

A bill currently under consideration by Congress is calling for more guardians against defective medical devices. The term "guardians" refers more specifically to "covered device users", a legal term defined within the Federal Food, Drug and Cosmetic Act. These users include those who are legally required to report defective devices to the Food and Drug Administration (FDA).

This law would require that the term be extended to include physicians.

Aren't doctors already required to report defective devices? Unfortunately, the answer is no. The current law requires that hospitals, nursing homes, outpatient treatment facilities and ambulatory surgical facilities report these devices. It does not specifically include physicians.

What led to this proposal? The main example used to push for passage of this bill involves a device that is used to break down fibroids in women. The device, known as the power morcellator, was found to spread uterine cancer cells amongst patients.

Medical professionals advocating for this bill note that it may have reduced the issues reportedly connected to previous defective devices like pelvic mesh and cardioverter defibrillator. A director of women's cardiovascular services with the University of California states that the issues with the defective devices were reported by physicians working with the device. However, the FDA did not act on these reports. The bill is designed to better ensure the FDA takes these complaints into consideration.

Will the proposal become law? A recent article in Medical Economics discusses the proposal's chances, noting two potential outcomes.

The first analysis of the bill's chances of success involves the bill being considered on its own. If this is the case, advocates for the bill's passage believe the odds are high that the bill will succeed.

On the other hand, there is a chance the bill will be combined with other pieces of legislation. Instead of being presented on its own, it would be part of the 21st Century Cures Act, a complex piece of legislation. If this is the case, the odds of passage are not as high.

What can victims do? Regardless of the passage of this bill, legal remedies are available for victims who are injured due to the use of a defective device. One option involves holding those accountable for the injuries through a personal injury lawsuit.

This lawsuit can serve a number of purposes for the victim. First, it is a means to hold the guilty party responsible for their wrongdoing. Second, it provides an opportunity to deter others from making similar mistakes. Finally, it can also lead to monetary awards. Victims often incur bills for medical needs, rehabilitative expenses and prescription costs due to these injuries. These awards can help cover these costs. 

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