ParfumGigi@aol.com

22 février, 2008 13:59

http://www.supremecourtus.gov/orders/courtorders/110606pzor.pdf

The Court granted review in no new cases.

The appeal in the Riegel case argues that, since the Court’s key ruling allowing medical device damage lawsuits in Medtronic v. Lohr ten years ago, the lower courts have grown deeply divided on the impact that Food and Drug Administration approval has on claims made under state laws. The Lohr case did not involve the impact of the rigorous FDA "pre-marketing approval" process, but rather a less exacting analysis by FDA of a medical device — the process of clearing a device that is "substantially equivalent" to a device that was marketed before 1976, when Congress enacted the Medical Device Amendments.

Another reason the case should be reviewed, the appeal argues, is that the Solicitor General has switched positions on whether FDA pre-market approval does preempt state law claims against the device makers. When the government’s views on that were solicited by the Court in 1998, it supported the right to pursue state law claims.The Court did not grant that case, Smith Industries v. Kernats, 96-1405. But the government has changed its mind, in a recent filing in the Third Circuit Court, and now argues for preemption, the appeal said. Monday’s invitation for the Solicitor General’s current views presumably will clear this up.