Stengel
Stengel v. Medtronic, Inc.
Opinion
Lead Opinion
Wallace, J.
Opinion by Judge WALLACE; Dissent by Judge NOONAN.
OPINION
Richard and Mary Lou Stengel brought several state causes of action in Arizona state court against Medtronic Incorporated (Medtronic) for injuries sustained by Richard Stengel (Stengel) from his use of a pain pump manufactured by Medtronic. Medtronic timely removed the case to the United States District Court for the District of Arizona. The district court dismissed the Stengels’ claims as preempted by federal law and the Stengels appealed. We have jurisdiction under 28 U.S.C. § 1291 . We affirm.
I.
Medtronic’s pain pump is a medical device that infuses prescription medication through a catheter into the intrathecal space within the spine to help control severe pain. In 1988, the Food and Drug Administration (FDA) gave premarket approval as a Class III medical device for Medtronic’s SynchroMed Pump & Infusion System. In 1999, the FDA gave supple *1161 mental premarket approval for Medtronic’s SynchroMed EL Pump and intrathecal catheter, which are the versions of Medtronic’s device at issue in this action.
In 2000, Stengel had a Medtronic pump surgically implanted in his abdomen and began receiving medication through…
Dissenting Opinion
Noonan, J.
dissenting:
The issue that this court must address is serious and the magnitude of its potential implications is great:
“Postmarketing Surveillance of Medical Devices-Filling in the Gaps,” Frederic S. Resnic, M.D., and Sharon-Lise T. Normand, Ph.D., February 14, 2012 (10.1056/ NEJMplll4865).
Has Congress or the Supreme Court created such freedom from liability for the manufacturers of such sensitive devices that only in nonexistent cases are the manufacturers subject to suit for damages? Are individuals injured by the malfunction of such devices without remedy against the manufacturers of them? That appears to be the conclusion of this court today with its holding that the MDA explicitly preempts and implicitly preempts any state remedy of damages for violation of a state requirement paralleling the MDA.
This conclusion, astonishing in its comprehensiveness, is equally astonishing in the light of binding federal law as determined by the United States Supreme Court.
The law. In a case involving the defendant in our case, the Court held:
Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 , 116 S.Ct. 2240 , 135 L.Ed.2d 700 (1996).
As the Supreme Court puts it, “common law duties” not…
Opinion
Thomas G. Cotter, Stanley G. Feldman, and Stephen T. Portell; Haralson Miller, Pitt, Feldman & McAnally, P.L.C., Tucson, AZ, for the plaintiffs-appellants.
Michael K. Brown, Ginger F.H. Pigott, and Lisa M. Baird, Reed Smith LLP, Los Angeles, CA, for the defendant-appellee.
Before: J. CLIFFORD WALLACE, JOHN T. NOONAN, and MILAN D. SMITH, JR., Circuit Judges.
Opinion by Judge WALLACE; Dissent by Judge NOONAN.
WALLACE, Senior Circuit Judge:
Richard and Mary Lou Stengel brought several state causes of action in Arizona state court against Medtronic Incorporated (Medtronic) for injuries sustained by Richard Stengel (Stengel) from his use of a pain pump manufactured by Medtronic. Medtronic timely removed the case to the United States District Court for the District of Arizona. The district court dismissed the Stengels' claims as preempted by federal law and the Stengels appealed. We have jurisdiction under 28 U.S.C. § 1291 . We affirm.
Medtronic's pain pump is a medical device that infuses prescription medication through a catheter into the intrathecal space within the spine to help control severe pain. In 1988, the Food and Drug Administration (FDA) gave premarket approval as a…