FDA Concerned Women Not Equally Included in Medical Device Testing
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Medical device manufacturers such as DePuy, Johnson & Johnson, and Stryker repeatedly neglect comprehensive device testing in women. Our product liability litigation team continually represents women injured by implants which are poorly designed for women and fail at higher rates than for men.
Does the Food and Drug Administration (FDA) test devices? No, they rely on tests done by the manufacturers. However, the FDA now reports women may not have been included equally in clinical post approval studies of many medical devices. According to the FDA, it is essential to adequately include the participation of women when analyzing these devices which are used to treat certain diseases. In order to properly examine the outcomes and possible harmful results, there need be a proportionate input of women in these clinical trials as women may react differently than men. Failure to include women can create a gender bias within these post-approval studies.
Until January 2013, the inclusion of women may have been overlooked and the sex differences regarding the safety and effectiveness of these devices not properly studied. Going forward, women need to be ensured that their sex specific predominance to particular diseases be measured equally to men when studying medical devices effectiveness. The Rheingold firm's settlement and verdict history shows that the larger percentage and size of personal injury awards reflects the disproportionate affect this testing bias has on women. Contact us to talk to Sherri Plotkin or Melissa Mendoza if you feel you have been injured by a defectively designed medical device.