holding, prior to Buckman, that common law suits premised on fraud-on-the-FDA could not be reconciled with the Sixth Circuit’s earlier holding that there is no implied right of action for a violation of the Federal Food, Drug and Cosmetics Act
How later courts described this case
- holding, prior to Buckman, that common law suits premised on fraud-on-the-FDA could not be reconciled with the Sixth Circuit’s earlier holding that there is no implied right of action for a violation of the Federal Food, Drug and Cosmetics Act
- holding that “it is the totality of the design, manufacturing processes, and labeling — when coupled with the prohibition against modifying them — that represents the specific federal requirement ‘applicable [under the MDA] to the device’ ”
- holding provision of Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act that prohibited states from imposing requirements “different from, or in addition to” federal requirements was express preemption clause
- stating that “the information submitted to and approved by the FDA in both the ... PMA and as modified by the ... PMA supplement comprise the specific federal requirements”
Written by the judges who cited it.
The opinion
MOORE, Circuit Judge,
concurring.
I agree with the majority that pursuant to our decision in Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090 (6th Cir.1997), the FDA’s approval of the Model 4004M PMA Supplement and the FDA’s conditions of approval imposed on the 4004M pacemaker lead constitute a specific federal requirement, thereby triggering the possibility of preemption under 21 U.S.C. § 360k(a) of the Kemps’ state law claims to the extent that the state law claims are different from or in addition to the federal requirements.
I also agree that the specific federal requirements established by the FDA approval of the Model 4004M do not include a requirement as to the thickness or coverage of the platinum sputter barrier. Because Mrs. Kemp’s negligence claim is premised on a failure of the device to achieve a uniform thickness of the platinum sputter barrier, her negligence claim is preempted; a jury could not find in favor of Mrs. Kemp on the negligence claim without imposing a requirement “different from, or in addition to” the federal requirement. 21 U.S.C. § 360k(a)(l).
I agree as well with the more general principle stated by the majority that “a claim premised on the violation of FDA requirements established for a Class III device through the PMA process is not automatically preempted.” Maj. Op. ante at 230. Thus as the majority recognizes, a claim for negligence per se premised on the absence of a platinum sputter barrier as required by the FDA approval would not be preempted because the state claim would not impose requirements different from or additional to the federal requirements.
The claim that Medtronic committed a fraud on the FDA by improperly failing to submit certain tests and laboratory data to the FDA during the approval process raises federalism concerns. Rather than force the analysis of this claim into the preemption framework of § 360k(a) and Medtronic, Inc. v. Lohr, 518 U.S. 470 , 116 S.Ct. *238 2240 , 135 L.Ed.2d 700 (1996), I would instead focus on the peculiar nature of this claim. It appears from Kemp’s appellate brief that she asserts that, because of alleged misrepresentations by Medtronic to the FDA, the FDA erroneously approved the 4004M, and she should therefore be able to recover damages on a state-law fraud claim. A determination in favor of Kemp on this fraud claim would effectively set aside the entire FDA approval process. Not only would litigants be able to explore and challenge the administrative decision-making process of the federal agency, but also conflicts could easily arise between the results of state-law fraud litigation and federal enforcement through federal civil and criminal penalties for false or misleading submissions to the FDA. See, e.g., 21 U.S.C. §§ 831 (q)(2), 333.
In any event, Kemp fails to point to any Ohio law upholding the viability of a “fraud against a federal agency” claim for damages to an individual user of a product. The case cited by Kemp, Dutton v. Acromed Corp., 117 Ohio App.3d 804 , 691 N.E.2d 738 (1997), does not characterize the claim as a claim of fraud on the FDA but rather involves a claim of misrepresentation of a medical device’s approval status to the affected individual. Such traditional fraud claims certainly are not preempted by § 360k(a) or by Lohr , which explained that “[n]othing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.” Lohr, 518 U.S. at 495 , 116 S.Ct. 2240 . Moreover, allowing a state fraud claim for misrepresentations made to the patient would not conflict with our decision in Bailey v. Johnson, 48 F.3d 965 (6th Cir.1995), holding that the federal Food, Drug and Cosmetic Act does not impliedly provide a private federal cause of action for a violation of its provisions, since that state fraud claim would be premised on using the federal law as a behavioral standard as endorsed by the Supreme Court in Lohr . Kemp’s fatal problem is that her fraud claim on appeal is solely presented as a claim of fraud on the FDA rather than fraudulent misrepresentations to her.
In sum, I disagree with the majority’s theory regarding the claim of fraud on the FDA but agree nonetheless with the conclusion that that claim must be dismissed. I agree with the conclusion that the negligence per se claim raised by Kemp is preempted because of the particular nature of her claim. I agree that we need not address the issue of whether § 360k preempts a claim of breach of a duty to warn patients of risks discovered after FDA approval of a device.