stating that jury’s finding that manufacturer breached implied warranties was preempted because accepted standards for design and manufacture of products under state law may deviate from FDA’s determinations in PMA process
How later courts described this case
- stating that jury’s finding that manufacturer breached implied warranties was preempted because accepted standards for design and manufacture of products under state law may deviate from FDA’s determinations in PMA process
- noting, without expressing a view on the validity of the regulation, that “[d]espite the reference in 21 C.F.R. § 808.1(d)(1) to laws of general applicability, we hold that the statutory language of § 360k preempts Michael’s claims for breach of the implied warranties of merchantability and fitness[.]”
- stating that it is “satisfied that the pre-emption discussion and holding [in Cipollone] represents the [Supreme] Court’s current pre-emption analysis”
- explaining that it was "satisfied that the preemption discussion and holding [in Cipollone ] represents [this] Court's current preemption analysis”
Written by the judges who cited it.
Later courts went against this
Overruled on other grounds by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
46 F.3d 1316, 1335 (3d Cir. 1995) (a party may justifiably rely on statements made by one with superior knowledge), overruled on other grounds in Medtronic, Inc. v. Lohr, 518 U.S. 470
Abrogated on other grounds by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
This Court, however, is bound by Michael v. Shiley, 46 F.3d 1316 (3d Cir. 1995), abrogated on other grounds, a preRiegel decision holding that the MDA does not preempt a breach of express warranty claim that was based on statements found on product packaging.
The opinion
SUR PETITION FOR REHEARING
March 7, 1995
The petition for rehearing filed by appel-lees in the above-entitled case having been submitted to the judges who participated in the decision of this Court and to all the other available circuit judges of the circuit in regular active service, and no judge who concurred in the decision having asked for rehearing, and a majority of the circuit judges of the circuit in regular active service not having voted for rehearing by the court in banc, the petition for rehearing is denied. Judge Roth would have granted the petition for rehearing.