The Supreme Court issued their opinion in Riegel v. Medtronic this morning. I’m just starting to read it now and will comment later today about the holding once I have time to digest the case. Scalia wrote the opinion that scares me, but seven justices join Scalia’s opinion so I do not think the holding will be too radical. But I will get back to you later today…
Follow-up note: I just finished the case and will not give a full response today. The quick summary is that we lost. The good news is that Medtronic v. Lohr still appears to be good law and the Supreme Court’s holding (I think) will be limited to medical devices that receive pre-market approval from the FDA (but Scalia even appeared to hedge on that). The Court ignored its own rule of statutory construction not to be “guided by a single sentence or number of sentences” but to instead consider the “provisions of the whole law, and to its object and policy.” Instead, it turned to a few sentences to its liking and ignored what the Court knew was the intent of Congress. Classic Scalia.
I think everyone agrees that there is no suggestion in the legislative history of § 360k(a) that injury victims would lose their only vehicle for recovering compensation for injuries caused by negligent or inadequately labeled PMA devices. Say what you want about the value of legislative history but not a single member articulated the view that this statute would preempt state tort law claims. In fact, a House Report of the bill notes with apparent approval that California already had adopted a regulatory scheme for medical devices which completely contradicts the Court’s holding. The legislative history of the MDA is so in conflict with the Court’s holding that it might as well have made a recent rule that legislative history is never of probative value.
The entire purpose of this statute was patient safety. In fact, as Scalia points out, it was the Dalkon Shield debacle that led to the MDA. Okay, I’m rambling at this point. I’m not proofreading this. I’m just going to hit send. Then, I will go home and play with my kids. When they are in bed, I will send some money to Obama (gee, can you do that online?) and hope that he will help Congress sort out this mess in January.