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Fiore v. Collagen Corp.6/25/1996
TOCI, Judge
Plaintiffs Arlene and Richard Fiore ("Fiore") appeal from the summary judgment granted to Collagen Corporation ("Collagen Corporation") in Fiore's products liability action. Fiore sued Collagen Corporation for Arlene's injuries after she received injections of Zyderm Collagen Implant ("Zyderm"), an anti-wrinkle substance manufactured and sold by Collagen Corporation.
The trial court found that a section of the Medical Device Amendments of 1976 ("MDA") preempted Fiore's claims for negligence, strict liability in tort, breach of express and implied warranty, and fraud. It also denied leave to file an amended complaint alleging a violation of the Arizona Consumer Fraud Act after the court had granted summary judgment on the original complaint. We conclude that the MDA does not preempt state common law tort claims and thus reverse the judgment and remand for further proceedings consistent with this opinion. Therefore, we need not resolve whether the trial court erred in denying the motion to file an amended complaint.
I. FACTUAL AND PROCEDURAL BACKGROUND
Collagen Corporation manufactures and distributes products made from a purified form of bovine collagen. One of these products, Zyderm, is injected under the skin to correct or improve soft tissue deficiencies due to disease, trauma, or age. Zyderm is considered a Class III medical device.
Prior to 1976, the United States Food and Drug Administration ("FDA") lacked authority to examine the safety and effectiveness of any medical device before the maker sold the device to the public unless the FDA could convince a court that the device was a drug. Robert S. Adler & Richard A. Mann, Preemption and Medical Devices: The Courts Run Amok, 59 Mo. L. Rev. 895, 910-11 (1994) ("Adler & Mann"). As a consequence of the Dalkon Shield litigation, Congress amended the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-93 (1972), to extend the FDA's jurisdiction to medical devices. Adler & Mann, (supra) , at 911-12 n.84; Michael v. Shiley, Inc., 46 F.3d 1316, 1319 (3d Cir.), cert. denied, 133 L. Ed. 2d 29, 116 S. Ct. 67 (1995). These amendments, codified at 21 U.S.C. §§ 360c through 360l (Supp. 1995), are referred to as the Medical Device Amendments of 1976 or "MDA."
Pursuant to these statutes, the FDA classifies all medical devices. The categories and the corresponding legal consequences of each can be briefly described as follows.
Class I devices, such as tongue depressors, are devices which generally pose little or no threat to public health and are subject only to general controls on manufacturing. See 21 U.S.C. § 360c(a)(1)(A). Class II devices, such as oxygen masks, pose a slightly greater risk of injury to patients, and accordingly, the MDA subjects them to performance standards, post market surveillance, guidelines for use and other appropriate controls. See id. § 360c(a)(1)(B). Class III devices . . . include all devices which are to be implanted into people, which are used to sustain life, or which pose a potentially unreasonable risk of injury. See id. § 360c(a)(1)(C).
Michael, 46 F.3d at 1319-20.
Under the MDA, no company may market or sell a Class III device until it obtains premarket approval from the FDA. 21 U.S.C. § 360e. The sponsoring company must submit "all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective," 21 U.S.C. § 360e(c)(1)(A), a description of the product's ingredients, method of manufacture, and performance standards, as well as any other information requested
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