Clark, Love & Hutson, PLLC

Texans will have more access to information on medical devices

While dangerous medical devices are receiving more attention in the news these days, it can still be difficult for patients in Texas and across the United States to determine whether a medical device they are considering putting in their body is dangerous or has a history of being defective. Americans should be able to depend on the agencies governing medical devices to inform them when a device causes harm. Unfortunately, until recently this has not been the case.

The U.S. Food and Drug Administration (FDA) has stated that it will end a program that had allowed manufacturers of medical devices to keep reports of harm concealed from U.S. citizens. The program, known as "alternative summary reporting" is two decades old but has collected and kept secret thousands of reports of harm caused by medical devices. The FDA plans to open these records to the public within a matter of weeks.

Officials from the FDA believe more transparency is needed, so medical devices are not "buyer beware." Patients deserve to have the information available about medical devices before deciding whether they wish to undergo procedures to have one placed inside their body. Manufacturers of medical devices will now have to file an individual report every time a person is harmed by their product.

This is good news for people who are considering having procedures to put a medical device such as a breast implant or pacemaker in their bodies. It is important that they have all the information they need to make an educated decision, which includes understanding the risks these devices pose. Unfortunately, this move comes too little too late for those who have already been harmed by defective medical devices. Individuals in such situations may wish to pursue defective medical device litigation. In such a situation, one can argue that the manufacturer of the device breached their duty of care and should be held responsible. By pursuing a lawsuit, injured patients may be able to seek compensation for past and future medical expenses, lost wages and pain and suffering, among other damages.

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