Before a manufacturer of medical products can sell each new product they devise, they must test it and have it approved by the Food and Drug Administration. This is typically a slow and thorough process with many studies done on safety.
It gives the U.S. population good protection against unsafe product designs, sloppy manufacturing, unsafe packaging and inadequate labeling. Most of us assume that once the FDA has approved a product, or a procedure using a given product, that it will be safe for us.
If a person is harmed by such a tested and approved product, a natural response might be to sue the manufacturing company, and this has been done many times in various states. A recent case was that of one Charles Riegel, who had a medical procedure using a catheter to unclog an artery. The catheter burst during the procedure, injuring him, although not fatally. He died later, in 2004.
Lawsuit Against Medtronic, Inc.
His family brought a lawsuit against Medtronic, Inc in Minneapolis, the catheter manufacturer, claiming that it had an inadequate warning label and a design defect. This case was ruled on today, February 20, 2008, by the Supreme Court. It ruled against Charles Riegel’s family in an 8-1 decision, saying that State lawsuits cannot be brought against FDA-approved products if they would seek to impose requirements that differ from the FDA’s requirements.
Seven federal appeals courts have also ruled that state lawsuits on approved medical devices cannot go against federal law. The Bush administration has also supported this view, saying that jury verdicts in favor of such plaintiffs would require manufacturers to change designs or labels which had already been approved by the FDA.
Please contact us for a free case evaluation if you think you or a loved one have been injured by a medical device.