The Solicitor General has just weighed in today with his amicus curiae curiae brief in Riegel v. Medtronic, Inc., No. 06-179 (U.S. filed May 2007). You can read the brief here. (hit the “download” button to get the PDF)
The Solicitor General recommends against the Court accepting the appeal (“certiorari” is the technical term) because the decision of the Second Circuit, finding all but a couple of minor claims preempted, was “correct.”
Specifically, the Solicitor General argues:
(1) FDA pre-market approval (“PMA”) of a Class III device imposes federal “requirements” as meant by §360k(a) of the Medical Device Amendments (“MDA”) to the FDCA. PMA is in no way comparable to the less rigorous form of marketing clearance at issue in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
(2) Lohr recognized the FDA’s “significant role” in defining the preemptive scope of the MDA and gave “significant weight” to the Agency’s construction of the statute.
(3) PMA represents an Agency judgment concerning safety and efficacy. Once the FDA granted PMA, the manufacturer could not make any safety-related changes to its device without a supplemental application requiring further FDA approval.
(4) Common law product liability claims can impose “requirements” under §360k(a). Because those claims allege that the PMA device is “defective,” those requirements would be “inconsistent’ with the FDA’s requirements imposed via PMA. Thus the conflicting tort claims are expressly preempted.
(5) The FDA’s PMA involved rigorous review of the adequacy of product labeling/warnings.
(6) FDA’s “current judgment” reflects the withdrawal of the proposed rule that was the basis for the Agency’s contrary position in an amicus brief (Kernats) filed with the Court in 1998. The FDA has adopted different risk-management principles since 1998.
(7) There is no contrary appellate authority more recent than 1999, thus conflicting authority does not merit certiorari. All recent appellate authority is consistent with the Second Circuit and with the FDA’s current view of preemption.