Fiore v. Collagen Corp.

• Decision Date: 25 June 1996
• Docket Number: CA-CV,No. 1,1
• Citation: 187 Ariz. 400,930 P.2d 477
• Parties: , Prod.Liab.Rep. (CCH) P 14,663 Arlene FIORE and Richard Fiore, Plaintiffs-Appellants, v. COLLAGEN CORPORATION, a Delaware corporation, Defendant-Appellee. 94-0375.
• Court: Arizona Court of Appeals

Page 477

930 P.2d 477

187 Ariz. 400, Prod.Liab.Rep. (CCH) P 14,663

Arlene FIORE and Richard Fiore, Plaintiffs-Appellants, v. COLLAGEN CORPORATION, a Delaware corporation, Defendant-Appellee.

No. 1 CA-CV 94-0375.

Court of Appeals of Arizona Division 1, Department A.

June 25, 1996.

Review Denied Jan. 14, 1997.

Essmyer & Tritico, L.L.P. by Michael M. Essmyer, Houston, Texas, and Law Office of Clinard J. Hanby by Clinard J. Hanby, The Woodlands, Texas, and Begam, Lewis, Marks & Wolfe by Cora Perez, Phoenix, for Plaintiffs-Appellants.

Beck, Redden & Secrest, L.L.P. by Joe W. Redden, Jr., Curt Webb, Houston, Texas, and Teilborg, Sanders & Parks, P.C. by John C. Gemmill, Phoenix, and Sedgwick, Detert, Moran & Arnold by Frederick D. Baker, San Franciso, CA, for Defendant-Appellee.

OPINION

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, --- U.S. ----, 116 S.Ct. 67, 133 L.Ed.2d 29 (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 by the FDA, 21 U.S.C. § 360e(c)(1)(B)-(G). Following review by a panel of medical experts and a favorable recommendation, the FDA may approve the application.

Additionally, the FDA's regulations permit it to require warnings or instructions on the product's labels and to regulate the manufacturing processes. 21 C.F.R. § 814.82, 820.100-101. The FDA may require the product's sponsor to notify the public of a newly-discovered danger, to replace the device, or to refund its purchase price. 21 U.S.C. § 360h. The FDA's continuing authority also requires manufacturers to report deaths or serious injuries from use of a Class III device. See 21 C.F.R. § 803.24(a)(1)(i). The Act does not, however, authorize the FDA to require companies to compensate victims for either medical expenses or pain and suffering caused by a device failure. See Mears v. Marshall, 137 Or.App. 390, 905 P.2d 1154, 1160 (1995) (no private right of action).

On April 30, 1980, Collagen Corporation filed a premarket approval application for Zyderm. A panel of experts reviewed the application and imposed a number of conditions on Collagen Corporation. ¹ In July 1981, the FDA issued an order permitting Collagen Corporation to market Zyderm. In 1991 and 1992, the FDA reviewed the premarket approval application and concluded that its initial approval of the application was appropriate.

In 1986 or 1987, Arlene Fiore received Zyderm injections. She filed this products liability action against Collagen Corporation and her doctor in February 1993, alleging that Collagen Corporation knew or should have known that the human immune system views Zyderm as a foreign protein, and thus Zyderm provokes significant immune and autoimmune reactions. The complaint stated that after the injections, Arlene suffered serious physical and emotional injury and was diagnosed with an autoimmune disease and other related conditions. The complaint alleged claims against Collagen Corporation (1) for negligence in developing, testing, manufacturing, inspecting, labeling, marketing, promoting, advertising, selling and distributing Zyderm; (2) for strict liability; (3) for breach of express and implied warranties that Zyderm was safe, fit, and proper for cosmetic use; and (4) for negligent or fraudulent representations of Zyderm's safety and fitness to Fiore, her physicians, the FDA, and the general public.

Collagen Corporation successfully moved for summary judgment on the theory that 21 U.S.C. §§ 360c through 360ss and the FDA regulations preempted all of Fiore's claims. ² Fiore then moved for leave to file an amended complaint alleging a claim against Collagen Corporation for violation of the Arizona Consumer Fraud Act, A.R.S. sections 44-1521 through -1534 (1994). The trial court denied the motion as untimely. We have appellate jurisdiction pursuant to A.R.S. section 12-2101(B) (1994).

II. DISCUSSION

A. Standard of Review

We review de novo the trial court's interpretation of a statute. Chaffin v. Commissioner of the Ariz. Dep't of Real Estate, 164 Ariz. 474, 476, 793 P.2d 1141, 1143 (App.1990). In reviewing the trial court's grant of summary judgment, we view the evidence and all reasonable inferences in the light most favorable to the nonmoving party. Hill v. Chubb Life Am. Ins. Co., 182 Ariz. 158, 160, 894 P.2d 701, 703 (1995).

B. Federal Preemption Doctrine in the Context of Cigarette Regulation

The preemption doctrine derives from the Supremacy Clause of the Constitution which states: "This Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. Art. VI, Cl. 2. Thus, federal laws or regulations supersede conflicting state laws. See Hillsborough County v. Automated Medical Lab., Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 2375, 85 L.Ed.2d 714 (1985).

Numerous federal circuit and district courts have relied upon the preemption doctrine to eliminate or restrict state common law causes of action against manufacturers of medical devices. Many of these decisions adopted the reasoning of the United States Supreme Court in Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992). Cipollone held that federal statutes regulating cigarette advertising and labeling evidenced a congressional intent to preempt at least some state tort claims. Id. at 517-19, 112 S.Ct. at 2618. The Court thus found precluded some causes of action based on Cipollone's death from lung cancer. Id. at 522-24, 112 S.Ct. at 2621.

Federal law does not supersede state regulation, however, "unless that [is] the clear and manifest purpose of Congress." Id. at 516, 112 S.Ct. at 2617 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)). Further, "Congress' enactment of a provision defining the pre-emptive reach of a statute implies that matters beyond that reach are not pre-empted." Id. at 517, 112 S.Ct. at 2618. ³

In Cipollone, the Court "narrowly" construed the language of the 1965 Act regulating cigarette labeling and advertising "in light of the presumption against the pre-emption of state police power regulation." Id. The 1965 Act expressly provided for preemption and stated in part, "No statement relating to smoking and health, other than the statement required by section 4 of this Act, shall be required on any cigarette package." It also provided, "No statement...