Opinion ID: 771658
Heading Depth: 2
Heading Rank: 2

Heading: Failure to comply with FDA regulations claim

Text: 59 Sometime after the pleadings were filed, Brooks began to assert that Howmedica had violated, or had failed to comply with, FDA regulations. We are mindful of our liberal pleading rules, see, e.g., Fed. R. Civ. P. 8(a)(2), (e)(1), as well as the Supreme Court's acknowledgment in Lohr that such claims often arise late in the life of a products liability action, see Lohr, 518 U.S. at 494-95. As a result, we construe Brooks's complaint to raise a negligence per se claim based upon Howmedica's alleged violation of FDA regulations. Lohr makes clear that this type of state-law claim against a medical device manufacturer would not be preempted. See id. at 495-96. Howmedica concedes as much. 60 Minnesota law recognizes a common law action for negligence per se stemming from a defendant's violation of FDA regulations. See Femrite v. Abbott Northwestern Hosp., 568 N.W.2d 535, 539 & n.4 (Minn. Ct. App. 1997). Femrite requires a plaintiff, such as Brooks, to prove both that she belongs to the class of persons that the regulation is intended to protect, id. at 539, and that the defendant in fact violated the applicable FDA regulations, see id. at 542. The latter question is one of law, appropriate for disposition on summary judgment. See id. (Considering these FDA documents, and the record as a whole, we conclude as a matter of law that the physicians' implantation of the screw devices in appellants' surgeries was a permissible off-label use not in violation of FDA regulations.); cf. Bammerlin v. Navistar Int'l Transp. Corp., 30 F.3d 898, 900 (7th Cir. 1994) (The meaning of federal regulations is not a question of fact, to be resolved by the jury after a battle of experts. It is a question of law, to be resolved by the court.) (citations omitted). 61 We have no doubt that Brooks belongs to the class of persons whom the FDA intends to protect by promulgating labeling regulations. Brooks, like many nurses and surgical technicians, was regularly exposed to Simplex and its concomitant chemical byproducts. FDA labeling regulations are designed to promote safe and effective use of medical devices such as bone-cement. Howmedica cannot seriously contest Brooks's membership in the protected class. 62 Despite proving membership in the protected class, however, Brooks's claim founders on the second element -- violation of FDA regulations. As we explained above, Howmedica fully complied with the FDA's labeling requirements at the time that Simplex was approved for use in 1971. In the intervening years, Howmedica altered Simplex's package and package insert to accommodate changes recommended by the FDA. As Howmedica indicated in its briefs, every word on the Simplex package and package insert has been formally approved by the FDA. It is folly to suggest, therefore, that Howmedica violated FDA regulations in labeling Simplex. As the district court pointed out, Brooks neglected to develop any support in the record (or in her argument) that Howmedica violated FDA regulations. 3 We have scoured the record and the pertinent case law independently and located no additional support for Brooks's claim. 63 Because Brooks has not demonstrated any violation of FDA labeling requirements, her Minnesota-law negligence per se claim fails as a matter of law. We therefore affirm the district court's summary judgment in favor of Howmedica as to this aspect of Brooks's complaint. DISPOSITION 64 We reverse the district court's judgment that Brooks's state-law failure-to-warn claim is preempted by federal law. We affirm the court's judgment in favor of Howmedica as to Brooks's claim that Howmedica neglected to comply with federal regulations. We remand the matter for further proceedings consistent with our opinion.