In the past few months, the U.S. Food and Drug Administration (FDA) has discussed its ideas for postmarket scrutiny of medical devices. Some of these ideas could lead to fewer medical device injuries and fatalities in the future. However, as talk of postmarket surveillance continues, it is important to understand the limitations of postmarket surveillance and how you could still get hurt by a medical device even if the most stringent postmarket surveillance system is established.
Postmarket Surveillance is No Substitute for Pre-Market Research
Our Milwaukee pharmaceutical injury lawyers understand that pre-market research may not catch all medical device defects. Observing the results after the device has been available for use with actual patients is important. However, in order to protect patients from medical device injuries, it is likely necessary to improve pre-market research and the medical device approval process in addition to strengthening postmarket scrutiny.
Postmarket surveillance is meant to make information about patient medical device injuries easier to access, analyze and share. However, the system works by reporting injuries. In other words someone—possibly many people—must already allege they have been hurt by a medical device before any action is taken. It’s clearly not ideal to wait for injuries to occur, if more careful pre-market scrutiny could have prevented the injuries altogether.
Contact a Milwaukee Class Action Lawyer If You’ve Been Injured
If you have been hurt by a medical device approved by the FDA under the current rules, or if you are injured in the future when new postmarket surveillance rules may be in place, then it is important to contact an experienced Milwaukee class action attorney to learn more about your rights. You can reach a Wisconsin medical device injury lawyer today by calling 1-800-800-5678 or 414-223-4800.