9.03.2007

N.D. California Notes Split Re Whether PMA Approval Process Creates Specific FDA Requirements for Purposes of MDA Preemption

Per Notmeyer v. Stryker Corp., --- F.Supp.2d ----, 2007 WL 2257113 (N.D.Cal . Aug 06, 2007) (NO. C 06-04096SI):

Subsequent to Lohr, circuit courts have split on the issue as to whether the PMA approval process creates specific FDA requirements for purposes of MDA preemption. Five out of six circuit courts that have faced this issue have ruled that the PMA process creates FDA requirements. See Riegel v. Medtronic, Inc., 451 F.3d 104, 118 (2d Cir.2006); Gomez v. St. Jude Medical Daig Div., Inc., 442 F.3d 919, 930 (5th Cir.2006); Horn v. Thoratec Corp., 376 F.3d 163, 169-70 (3d Cir.2004); Brooks, 273 F.3d at 799; Kemp v. Medtronic, Inc., 231 F.3d 216, 226-28 (6th Cir.2000), reh'g denied, 2001 WL 91119 (6th Cir. Jan. 26, 2001), cert. denied, 122 S.Ct. 48 (2001) ; Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir.1997), cert. denied, 523 U.S. 1020 (1998) . In Mitchell, the Seventh Circuit held: "We agree that the PMA process, as opposed to the 'substantially equivalent' process at issue in [ Lohr ], can constitute the sort of specific federal regulation of a product that can have preemptive effect." Mitchell, 126 F.3d at 911.

Post- Lohr, only the Eleventh Circuit court has explicitly found that the PMA review process does not create specific federal requirements. See Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1375-80 (11th Cir.1999). In Goodlin, the plaintiff sued the manufacturer of a PMA-approved pacemaker lead. The Eleventh Circuit held that "neither the FDA's actual review of a device and its supporting information nor the agency's eventual approval of the device imposes any ascertainable requirement on the device." Id. at 1375. In reaching this holding, the court engaged in a thorough review of Congressional intent, and noted that "several highly publicized incidents involving defective medical devices ... gave rise to Congress's legislation in this area. It would have been inconsistent for the same Congress that enacted these sweeping reforms ... then to preempt product liability suits when those devices caused injury." Id. at 1378. The court continued: "We ... are reluctant to conclude that Congress sought to remove all remedies available to the very class of persons that it sought to protect when it enacted the MDA." Id. at 1379.

Though the Ninth Circuit has not directly addressed this issue post-Lohr, it did address the issue pre- Lohr, in Kennedy v. Collagen Corporation, 67 F.3d 1453 (9th Cir.1995). In Kennedy, the plaintiff brought suit against the manufacturer of a PMA-approved prescription medical device used to treat soft tissue defects. In addressing defendant's preemption argument, the Ninth Circuit stated: "We must address two threshold questions: (1) what constitutes a 'State ... requirement' and (2) what constitutes a 'requirement' under the MDA." Id. at 1457 (quoting case). With respect to the first inquiry, the Ninth Circuit held that state common-law causes of action do not constitute state requirements for the purposes of MDA preemption. See id. at 1459. As discussed above, the Supreme Court in Lohr overruled this first holding of Kennedy. The Ninth Circuit recognized this much in Papike v. Tambrands, Inc., 107 F.3d 737, 741 (9th Cir.1997), stating: "To the extent we concluded in Kennedy that the MDA cannot preempt any state common-law causes of action, the conclusion cannot survive in light of the concurring and dissenting opinions in [ Lohr ]."

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