Bloomberg News reports that the Supreme Court has agreed to hear a case against Medtronic that could determine whether patients have the right to press product-liability lawsuits against firms with FDA-approved products. The court has declined to hear five similar cases since 2001. Medtronic and the device industry argue that FDA approval shields firms from liability lawsuits, and many lower courts have agreed. (This applies to PMA products; suits have been allowed toÂ proceed against 510(k) and pre-1976 products, which are less rigorously reviewed.) The case involves a patient who had a Medtronic catheter burst inside of him during an angioplasty, and then required bypass surgery. Medtronic says the doctor was using the catheter off-label.