The Atlanta Journal-Constitution spotlighted litigation against medical device maker Bard as “the latest of hundreds of thousands involving medical devices blamed for sickening or killing patients, cases that point to a weak federal oversight system for some sensitive devices.” According to the article, the Food and Drug Administration “clears some sensitive ones for marketing to the public after they’ve been tested on animals or machines,” then tracks reported deaths, injuries, and malfunctions afterward; but “the government has recognized that the tracking is flawed.” Jeffrey Shuren, director of the FDA’s Center for Radiological Devices and Health, told the Atlanta Journal-Constitution, “The system for the most part works fairly well…but that does not discount the importance [of] being vigilant about addressing safety issues particularly as technologies continue to evolve.” Critics also point to a power morcellator used in gynecological procedures which was “on the market for two decades before FDA recognized the extent of danger it posed in spreading undiagnosed cancer.”

From the news release of the American Association for Justice.