I am trying to get a grasp on what this actually means:
Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.
On the one hand, I like the comfort zone that FDA approval would provide to makers of medical devices, but on the other hand, I don’t like that it appears that there will be no real means for redress for those damaged by faulty products. What happens in the case in which a company lies its way to FDA approval (or, given the corruption and cronyism and incompetence of this administration, someone on the FDA does not do due diligence and approves a faulty product) and someone is hurt by their product? Is the family just screwed? I am notoriously bad at interpreting the outcomes of legal cases, so fill me in.