Thousands of patients claim that devices left in them to improve their lives are ruining them. How can this be if there are strict rules regarding medical devices? A loophole allows for medical device manufacturers to get their devices on the market sooner. Is it worth the risk? For these companies and patients, it isn't.
A few patients have brought massive lawsuits directed toward federal regulations. Doris Jones was one of the first to sue. She complained of pain in her arm and lightheadedness. She went to the emergency room to figure out what was going on. A scan found that a Bard filter was placed in her bloodstream to catch blood clots. The filter had fractured and moved toward her heart.
Similarly, Sheri Booker has a similar story. Before a surgery for cancer, doctors implanted a filter into Booker to stop blood clots. Booker got the Bard filter back in 2007. She complained of debilitating pain and went to numerous healthcare providers. Finally, in 2010 a doctor caught something no one else had. There were white spots over her heart. Her Bard filter splintered and part of it lodged in her heart. Booker had open heart surgery and she has regular scans.
Who Is to Blame?
The Food and Drug Administration (FDA) usually has very strict guidelines, especially when it comes medical devices. However, if a device, like the Bard filter, is not considered a moderate-to-high risk device, it need not go through the rigorous clearance process. It is puzzling that an implant leading to the heart is not high risk.
There have been many reports of injuries and deaths of patients that received the Bard filter. Over 3,000 patients have come forward to report their injuries by this filter. Georgia is where most of manufacturing medical devices takes place. Suing these companies and the federal government is an example on how there should be stricter on their guidelines and testing. There is a prevalent weak federal oversight. These prosecutions make the federal government and these companies responsible for these injuries and wrongful deaths.
How Can We Help?
George Tait Law is a personal injury firm that specializes in Medical Malpractice. When you come forward, you help to make a change whether it's to let people know to not go to a certain doctor or to warn of the side-effects you suffered. Anything is a significant help to your community. If you have questions about your situation, call us and we will help as best we can.
George Tait Law and its lawyers are not representing any of the parties mentioned in this article at the time the article was posted. We cited the information in this article.