FDA addresses policies after defective medical device litigation

| Mar 19, 2019 | Defective Medical Device Litigation |

In the wake of harm caused by metal hip and knee replacements and vaginal mesh, people in Texas may be concerned about any harmful side effects that may be present in the medical devices they need. Defective medical device litigation has resulted from the damages certain defective medical devices caused, but can anything be done to prevent these devices from reaching the marketplace in the first place?

For the most part, unlike medications, medical devices do not need to be tested on humans before being used by physicians to treat patients, unless the device’s failure would obviously threaten the lives of patients. However, the U.S. Food and Drug Administration has elevated the risk level of devices that have been reported to the FDA as causing injuries. As of right now, manufacturers legally only need to demonstrate that the device is substantially equivalent to devices already on the market.

However, the FDA is starting to require that certain devices be tested on humans before being sold. An advisory committee meeting was also held in February to address the issue of how mesh should be regulated, in light of the dangers it presents. The FDA has stated that the framework regarding the regulation of medical devices needs to be brought up to date.

Unfortunately, while it is important that medical devices are appropriately tested and regulated, dangerous medical devices are still used by physicians to treat patients. Patients in such situations may need to pursue defective medical device litigation to recover compensation for the damages they suffered. Because such cases can be complex, and patients can anticipate that the companies that design and produce defective medical devices will do all they can to avoid liability, it is important that those pursuing such lawsuits seek the advice they need to understand how the law applies to the facts of their situation before proceeding.