Steele v. Collagen Corp.

• Decision Date: 15 May 1997
• Docket Number: No. C021697,C021697
• Citation: 54 Cal.App.4th 1474,63 Cal.Rptr.2d 879
• Court: California Court of Appeals Court of Appeals
• Parties: , Prod.Liab.Rep. (CCH) P 14,955, 97 Cal. Daily Op. Serv. 3683, 97 Daily Journal D.A.R. 6255 Patricia STEELE, Plaintiff and Appellant, v. COLLAGEN CORPORATION, Defendant and Respondent.

Page 879

63 Cal.Rptr.2d 879

54 Cal.App.4th 1474, Prod.Liab.Rep. (CCH) P 14,955,

97 Cal. Daily Op. Serv. 3683,

97 Daily Journal D.A.R. 6255

Patricia STEELE, Plaintiff and Appellant, v. COLLAGEN CORPORATION, Defendant and Respondent.

No. C021697.

Court of Appeal, Third District, California.

May 15, 1997.

Amy Eskin, Hersh & Hersh, San Francisco, Susan A. Allinger, Michael M. Essmyer, and Essmyer & Tritico, Houston, TX, for Plaintiff and Appellant.

Frederick D. Baker, Kathleen D. Patterson, Kirk C. Jenkins, and Sedgwick, Detert, Moran & Arnold, San Francisco, for Defendant and Respondent.

NICHOLSON, Associate Justice.

Federal preemption is a relatively simple concept, especially when Congress has explicitly provided the terms of preemption. (See Brown v. Hotel and Restaurant Employees and Bartenders International Union Local 54 (1984) 468 U.S. 491, 500-501, 104 S.Ct. 3179, 3184-3185, 82 L.Ed.2d 373, 382-383.) It provides order. Instead of having 50 or more standards with respect to a given human pursuit, there is one. When a preemptive federal standard is applied evenhandedly, it provides both the protection of the federal standard and some leeway to develop further state standards where the federal standard does not apply. With respect to medical devices that represent the highest risk to human life, the federal government imposes standards specific to each of those devices, and Congress has declared that the federal standard is preemptive.

Plaintiff Patricia Steele sued defendant Collagen Corporation, the maker of Zyderm Collagen Implants, because she developed an

autoimmune disorder after receiving a test injection of Zyderm. The trial court concluded that all of her causes of action were preempted and granted Collagen Corporation's motion for summary judgment. We reverse and remand because, even though there is an applicable federal regulatory standard of care for the design, manufacture, and marketing of Zyderm, it is unclear whether Steele asserts Collagen Corporation violated the federal regulatory standard of care or it violated a preempted state common law tort standard of care.

PROCEDURE

Steele sued Collagen Corporation alleging causes of action for strict liability, negligence, breach of implied warranty, breach of express warranty, fraud, and negligent misrepresentation against Collagen Corporation. She later amended her complaint adding a cause of action alleging unfair trade practices. The basis of her complaint is that Zyderm caused her to suffer from an autoimmune disorder.

Collagen Corporation moved for summary judgment. It asserted Steele's causes of action are preempted by the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA) because Zyderm was approved by the FDA. (See 21 U.S.C. §§ 360c, 360k.) In its separate statement of undisputed facts, Collagen Corporation claimed it had submitted Zyderm to the FDA for premarket approval and that the FDA had given its approval, certifying that Zyderm "had been shown to be safe and effective for use as recommended in the submitted labeling." Collagen Corporation, however, did not claim as an undisputed fact that it had conformed to all of the requirements arising from the FDA approval. The trial court agreed that Steele's causes of action were preempted. It granted the motion for summary judgment and entered judgment in favor of Collagen Corporation.

Steele appeals.

DISCUSSION

I The Medical Device Amendments

In 1976, Congress enacted the MDA, which provided for the classification and regulation of devices intended for human use. (21 U.S.C. § 360c.) The most stringent controls apply to devices placed in Class III under the MDA. "Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a 'reasonable assurance' that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this 'reasonable assurance,' which is known as the 'premarket approval,' or 'PMA' process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. [Citations.]" (Medtronic, Inc. v. Lohr (1996) 518 U.S. ---- - ----, 116 S.Ct. 2240, 2246-2247, 135 L.Ed.2d 700, 710-711 hereafter Medtronic.)

"Once the product receives PMA [premarket approval], the sponsor of the product may begin to market the product. Any subsequent changes in the product require submission of a PMA supplement application. (21 C.F.R. § 814.39 (1995).) Furthermore, to ensure continued validity of the PMA, the product sponsor is required to submit postapproval reports at one-year intervals, identifying any changes in the device or any reports from clinical investigation or scientific literature concerning the device. (21 U.S.C. 360i; 21 C.F.R. § 814.84 (1995).)" (Scott v. CIBA Vision Corp. (1995) 38 Cal.App.4th 307, 315, 44 Cal.Rptr.2d 902.)

"Not all, nor even most, Class III devices on the market today have received premarket approval because of two important exceptions to the PMA requirement. First, Congress realized that existing medical devices could not be withdrawn from the market while the FDA completed its PMA analysis for those devices. The statute therefore includes a 'grandfathering' provision which allows pre-1976 devices to remain on the market without FDA approval until such time as the FDA initiates and completes the requisite PMA. See 21 USC § 360e(b)(1)(A)[ ]; 21 CFR § 814.1(c)(1). Second, to prevent manufacturers of grandfathered devices from Zyderm is a Class III device that received FDA premarket approval in 1981. In 1991, at the behest of Congressman John D. Dingell, the FDA reconsidered its 1981 approval of Zyderm. Congressman Dingell expressed concern that Zyderm caused adverse reactions in the immune system. After reconsidering Collagen Corporation's application, the FDA determined the market approval for Zyderm was appropriate.

monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also permits devices that are 'substantially equivalent' to preexisting devices to avoid the PMA process." (Medtronic, supra, 518 U.S. at p. ----, 116 S.Ct. at p. 2247, 135 L.Ed.2d at p. 711, fn. omitted.)

II Federal Preemption

Federal preemption is grounded in the Supremacy Clause of the United States Constitution and provides that a state law is preempted if Congress so intends. (Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 516-517, 112 S.Ct. 2608, 2617-2618, 120 L.Ed.2d 407, 422.) Congress may make its intention explicit by including preemptive language in a law or it may imply preemption by the law's structure and purpose. (Id. at pp. 516-517, 112 S.Ct. at pp. 2617-2618,120 L.Ed.2d at pp. 422-423.) Any state law that conflicts with a federal law is preempted. And any state law that invades a legislative field thoroughly occupied by federal law is also preempted. (Ibid.)

Federal laws may preempt not only state legislation but also state common law. Common law damage awards can be a potent method of governing conduct and imposing requirements on manufacturers. (Cipollone v. Liggett Group, Inc., supra, 505 U.S. at pp. 521-522, 112 S.Ct. at pp. 2619-2621.)

There is a presumption against federal preemption. (Cipollone v. Liggett Group, Inc., supra, 505 U.S. at pp. 523-524, 112 S.Ct. at pp. 2621-2622.)

III Preemption Under the MDA

The MDA contains an explicit preemption provision: "[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement [p] (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and [p] (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." (21 U.S.C. § 360k, subd. (a) (hereafter § 360k).)

Construing section 360k, the FDA has promulgated the following regulation: "State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements. ... [p] (1) Section 521(a) [of the act] does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices. [p] (2) Section 521(a) does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act." (21 C.F.R. 808.1(d), italics added.)

Most courts that have dealt with the issue of MDA preemption with respect to Class III devices that have passed through the PMA process, including cases involving Zyderm, have concluded some or all state common law claims are preempted. (See, e.g., Stamps v. Collagen Corp. (5th Cir.1993) 984 F.2d 1416; King v. Collagen Corp. (1st Cir.1993) 983 F.2d 1130; Scott v. CIBA Vision Corp., supra, 38 Cal.App.4th at pp. 318-319, 44 Cal.Rptr.2d 902.)

The United States Supreme Court recently decided a preemption case under the MDA.

                (Medtronic, supra, 518 U.S. ----, 116 S.Ct. 2240, 135 L.Ed.2d 700.)   Consequently, we requested supplemental briefing from the parties on the effect of that case
                

Justice Stevens wrote the lead opinion, which is divided into seven sections. Four other justices, including Justice Breyer, joined him in...