The Supreme Court has just ruled that makers of FDA approved medical devices cannot be sued for faulty design. In Riegel vs Medtronic the court held that since Medtronic had jumped thru all the FDA hoops to get their device approved, the company may NOT be be sued for faulty design for the product. Passing the FDA approval process (which is a bear ) is proof that the device was correctly designed, because a large number of impartial (actually hostile) experts have checked the design and found it good.
One small barrier to the "deep pockets" theory of malpractice suits. Be sure to sue someone with money. Medtronics is a successful pacemaker manufacturer and has more money than the average doctor, so sue Medtronics.
We need to take this a step farther. Making and proscribing FDA approved drugs should not be grounds for a malpractice suit, even if the approval is later withdrawn. Drug Vioxx is the case in point here. The maker is fighting off law suit after law suit after the FDA withdrew Vioxx's approval. One of the reasons drugs are so expensive is that the makers need to make enough money to defend against every hungry lawyer in the country.
No comments:
Post a Comment