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Richard Stengel; Mary v. Medtronic Incorporated

April 16, 2012


Appeal from the United States District Court for the District of Arizona Raner C. Collins, District Judge, Presiding D.C. No. 4:10-cv-00318-RCC

The opinion of the court was delivered by: Wallace, Senior Circuit Judge:



Argued and Submitted

January 13, 2012-San Francisco, California

Before: J. Clifford Wallace, John T. Noonan, and Milan D. Smith, Jr., Circuit Judges.

Opinion by Judge Wallace; Dissent by Judge Noonan


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 Class III medical device for Medtronic's SynchroMed Pump & Infusion System. In 1999, the FDA gave supplemental 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 the catheter tip implanted in his spine. In 2005, Stengel began experiencing ascending paralysis in his lower extremities caused by a granuloma (a type of inflammation) in his spine that had formed at the tip of the catheter. Stengel's doctors surgically removed the hardware and most of the granuloma, but not in time to prevent the granuloma from rendering Stengel permanently paraplegic.

The Stengels' complaint alleged four generic claims under Arizona law: negligence, breaches of express and implied warranties, and strict liability. The district court granted Medtronic's motion to dismiss the complaint on the ground that federal law expressly preempted these claims.

While the motion to dismiss was pending, the Stengels moved for leave to amend their complaint to re-allege the same four claims under the newly-proffered theory that Stengel's injury was caused by Medtronic's failure to implement procedures to evaluate complaints about the pump and failure to report information to the FDA, as was required by FDA regulations. The Stengels alleged that if Medtronic had complied with the regulations, Medtronic would have warned physicians about the newly-discovered danger that the pump might cause inflammation, which would have allowed a quicker diagnosis of Stengel's symptoms and prevented his paralysis. The Stengels' motion for leave to amend was denied on the ground that this "failure-to-warn" claim was impliedly preempted.

We review de novo the district court's holding that all of the Stengels' asserted claims were either expressly or impliedly preempted. Martinez v. Wells Fargo Home Mortg., Inc., 598 F.3d 549, 553 (9th Cir. 2010). We review its denial of leave to amend for abuse of discretion. Alvarez v. Chevron Corp., 656 F.3d 925, 931 (9th Cir. 2011).


[1] In 1976, Congress amended the Food, Drug and Cosmetic Act (FDCA) by enacting the Medical Device Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539 (codified as amended at 21 U.S.C. § 360c et seq.). The MDA added a preemption clause to the FDCA which provides, subject to limited exceptions, that no State . . . may establish . . . with respect to a device intended for human use any requirement-(1) which is different from, or in addition to, any requirement applicable under [the FDCA], and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the FDCA].

21 U.S.C. § 360k(a).

The Supreme Court has examined the extent to which this preemption clause "bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the [FDA]." Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). The Court reviewed the "rigorous" premarket approval process for Class III medical devices:

A manufacturer must submit what is typically a multivolume application. It includes, among other things, full reports of all studies and investigations of the device's safety and effectiveness that have been published or should reasonably be known to the applicant; a full statement of the device's components, ingredients, and properties and of the principle or principles of operation; a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device; samples or device components required by the FDA; and a specimen of the proposed labeling. Before deciding whether to approve the application, the agency may refer it to a panel of outside experts and may request additional data from the manufacturer.

The FDA spends an average of 1,200 hours reviewing each application and grants premarket approval only if it finds there is a reasonable assurance of the device's safety and effectiveness.

Id. at 317-18 (internal citations and quotation marks omitted).

The premarket approval process includes review of the device's proposed labeling to evaluate safety and effectiveness under the conditions of use set forth in the label. Id. at 318. After a device is approved, "the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Id. at 319. Any changes must be made after FDA approval of an application for supplemental premarket approval, "to be evaluated under largely the same criteria as an initial application." Id.

The Court then held that the premarket approval process for Class III devices imposed federal "requirements" applicable to the approved device, that common law tort duties constituted state "requirements," and that the "safety and effectiveness" of the device was the subject of the plaintiff 's common law claims. Id. at 322-23. The Court recognized that section "360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regula- tions" because "the state duties in such a case 'parallel,' rather than add to, federal requirements." Id. at 330, quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996). Because the plaintiff asserted that the defendant's device "violated state tort law notwithstanding compliance with the relevant federal requirements," the Court held their claims to be expressly preempted. Id.

[2] The Stengels' claims, as they appear in the initial complaint, are expressly preempted under section 360k and Riegel. The claims generally challenged the safety and effectiveness of Medtronic's pump without any hint of an allegation that Medtronic's conduct violated FDA regulations. To be successful, the claims would have required the trier of fact, as a matter of state tort law, to conclude that the device should have either been designed differently from what the FDA required through premarket approval, or labeled ...

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