Court asks for advice on medical devices cases
on Nov 6, 2006 at 10:02 am
UDATE 3:30 P.M.
The Supreme Court on Monday asked the U.S. Solicitor General to offer the government’s views oin whether federal law bars damage lawsuits against makers of medical devices, when those devices have won federal government approval for marketing. The case is Riegel, et al., v. Medtronic (06-179, petition here, brief in opposition here). The complete Order List can be found here.
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.
The case involves a New York man, Charles R. Riegel, who was seriously injured when a prescription medical device for opening clogged coronary arteries burst during its insertion. The device was the Evergreen Balloon Catheter, made by Medtronic. The Second Circuit Court found the damages claim was preempted because of FDA marketing approval.
Among the cases the considered at its Friday Conference on which it took no action Monday was an appeal by Michael Skakel in a well-known murder case from a high-society neighborhood in Greenwich, Conn. Skakel, now 46, was convicted of the murder of a neighbor girl in 1975, when both were 15 years old. Skakel is a relative of the Kennedy family. His appeal (Skakel v. Connecticut, 06-52, petition here) argues that it is unconstitutional for a state to authorize prosecution for a crime when the period for pursuing charges had expired but was then retroactively extended. He was prosecuted in 2000 for the 25-year-old crime. (UPDATE: The Court will consider this case again at its Conference on Thursday of this week, according to the Court’s electronic docket.)
The Court also took no action on a significant test case on students’ rights, Morse v. Frederick (06-278, petition here), involving a student’s display of a pro-drug banner at a school-related event in Juneau, Alaska. The Court may have held up action on that case because it was asked last week to expedite another student free-speech case, Harper v. Poway School District (05-595), and consider the two cases together (more on this issue here). (UPDATE: The Court will consider the Juneau case again at its Thursday Conference.)
Among the Court’s other orders Monday, it agreed to permit the Solicitor General to take part in the oral argument on two major cases involving the use of race in student assignments to public schools (05-908 and 05-915, many briefs here) and on a key antitrust case, Bell Atlantic Corp. v. Twombly (05-1126).
