The Manufacturers of Food and Drug Administration (FDA) approved medical devices CANNOT be sued if the devise causes an injury.Â The Supreme Court decision was handed down Wednesday, February 20th according to a New York Times article.
Â Medtronic, a company that makes heart devices, can breathe a big sigh of relief.Â Charles Riegel cannot.Â Apparently a balloon catheter burst as he was having a heart procedure done, causing severe and permanent injuries.Â
The FDA gave pre-market approval.Â They approved a heart device for children even though the childrenÂ had a survival rate of less than 50%. Â No state can add any rules or regulations even though the State regulations would have prevented the injury and had been passed into law.
Mr Rigel has died and Medtronic no longer makes the product.Â The Supreme court has reversed the previous 1996 direction and has now cutailed the state’s right to protect its citizens and helped protect corporate profits.Â According to their website, Medtronic made $12.3 Billion last year alone.Â
“Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”Â –Â Edward Kennedy