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COMMITTEE DENTAL AMALGAM MANUFACTURERS AND DISTRIBUTORS DENTSPLY INTERNATIONAL v. JAMES STRATTON (08/05/96)

filed: August 5, 1996.

COMMITTEE OF DENTAL AMALGAM MANUFACTURERS AND DISTRIBUTORS; DENTSPLY INTERNATIONAL, INC., PLAINTIFFS-APPELLEES,
v.
JAMES STRATTON, DR., INTERIM DIRECTOR OF THE OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT; DANIEL E. LUNGREN, ATTORNEY GENERAL OF THE STATE OF CALIFORNIA, DEFENDANTS-APPELLANTS, AND ENVIRONMENTAL LAW FOUNDATION, INTERVENOR-APPELLANT.



Appeal from the United States District Court for the Southern District of California. D.C. No. CV-93-01439-RMB. Rudi M. Brewster, District Judge, Presiding.

Before: Harry Pregerson, Thomas G. Nelson, Circuit Judges, and Eugene F. Lynch, District Judge.*fn* Opinion by Judge Pregerson.

Author: Pregerson

PREGERSON, Circuit Judge:

The defendants, Dr. James Stratton, Acting Director of the California Office of Health Hazard Assessment, and Dan Lungren, the Attorney General of the State of California (collectively the State"), and the intervening party, Environmental Law Foundation ("ELF"), appeal the district court's grant of summary judgment in favor of the plaintiffs, Committee of Dental Amalgam Alloy Manufacturers and Distributors and Dentsply International, Inc. (collectively the "manufacturers"). The district court held that, as applied to dental amalgam, the Medical Device Amendments to the federal Food, Drug and Cosmetics Act ("MDA"), 21 U.S.C. § 321-394, preempt California's Safe Drinking Water and Toxic Enforcement Act of 1986 ("Proposition 65"), Cal. Health and Safety Code §§ 25249.5-25249.13. The district court had jurisdiction under 28 U.S.C. § 1331. This court has jurisdiction under 28 U.S.C. § 1291. We reverse.

BACKGROUND

Proposition 65 was passed by the voters of California in 1986. Proposition 65 mandates that the public be informed about products that pose a health risk. Proposition 65 specifically states:

No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.

Cal. Health & Safety Code § 25249.6.

Similarly, Congress enacted the MDA "to assure the reasonable safety and effectiveness of medical devices intended for human use." Kennedy v. Collagen Corp., 67 F.3d 1453, 1455 (9th Cir. 1995) (citing H. Conf. Rep. No. 1090, 94th Cong., 2d Sess. reprinted in 1975 U.S. Code Cong. & Admin. News 1070, 1103). Manufacturers of medical devices are required to register each medical device with the federal Food and Drug Administration ("FDA") prior to commencing manufacture. 21 U.S.C. § 360(c). Failure to register a device is punishable by fines, penalties, and/or imprisonment. 21 U.S.C. § 333.

The MDA grants the FDA broad authority to regulate medical devices. 21 U.S.C. § 371(a). Under the MDA, the FDA must classify medical devices into three categories, according to the level of regulatory control the FDA determines is necessary to ensure the safety and effectiveness of each device. See 21 U.S.C. § 360c. Medical devices which pose little or no threat to public health are classified as Class 1 devices and are subject to only "general controls" related to their manufacture. See 21 U.S.C. § 360c(a)(1)(A); 21 C.F.R. § 860.3(c)(1). Medical devices which involve some risk of injury are classified as Class II devices and are subject to "special controls," including performance standards, use guidelines, and post-market surveillance programs. See 21 U.S.C. § 360c(a)(1)(B); 21 C.F.R. § 860.3(c)(2). Medical devices that pose a high risk of injury or that are implanted in the body are classified as Class III devices and must receive premarket approval from the FDA. See 21 U.S.C. §§ 360c(a)(1)(C), 360(e); 21 C.F.R. §§ 814.1 (c), 860.3(c)(3).

Dental amalgam is used by dentists to restore teeth. On July 1, 1990, pursuant to Proposition 65, the State of California listed mercury as a chemical known to cause reproductive harm. 22 Cal. Code of Regulations § 12000(c). As a result, consumer warnings for dental amalgam are now required. This requirement is satisfied through "general methods such as labels on consumer products, inclusion of notices in mailings to water customers, posting of notices, placing notices in public news media, and the like, provided that the warning accomplished is clear and reasonable." Cal. Health & Safety Code § 25249.11(f).

On September 21, 1993, the manufacturers filed this action seeking a judgment declaring Proposition 65 preempted by the MDA as it applied to dental amalgam. On November 5, 1993, the State filed a motion to dismiss or, in the alternative, for summary judgment. The manufacturers responded by also filing a motion for summary judgment. On August 25, 1994, the district court denied the State's motion and granted the manufacturers' motion for summary judgment on preemption grounds. The district court entered judgment in the manufacturers' favor on September 27, 1994.

Both the State and ELF timely filed separate notices of appeal. On October 11, 1994, the State initiated its appeal. ELF initiated its appeal on October 18, 1994. Both appeals were consolidated on January 6, 1995.

Discussion

I. STANDARD OF REVIEW

We review de novo "the district court's grant of summary judgment on a pure question of law, in which there are no disputed facts." Kennedy, 67 F.3d at 1455 (citing Turner v. Prod, 707 F.2d 1109, 1114 (9th Cir. 1983)). Further, where, as here, the validity of a statute is being challenged, there must be a showing "that no set of circumstances exists under which the . . . [statute] would be valid. Chemical Specialties Mfrs. Ass'n, Inc. v. Allenby (" Allenby "), 958 F.2d 941, 943 (9th Cir. 1992) ("'the fact that the . . . Act might operate unconstitutionally under some conceivable set of circumstances is insufficient to render it wholly invalid'") (quoting United States v. Salerno, 481 U.S. 739, 745, 95 L. Ed. 2d 697, 107 S. Ct. 2095 (1987)). Thus, to find that Proposition 65 is preempted by the MDA, we "must determine that all possible consumer product warnings that would satisfy Proposition 65 conflict with provisions of the" MDA. Id. (emphasis added).

II. WHETHER DENTAL MERCURY IS A "MEDICAL DEVICE" UNDER THE MDA

The district court assumed that dental amalgam is regulated by the MDA as a "medical device" because its two component parts - dental mercury and amalgam alloy - are classified by the MDA. As the district court explained:

The court need not consider whether the FDA is treating dental amalgam as a device, whether it believes it is regulating dental amalgam, or whether it intends to regulate dental amalgam. The court finds, as a matter of logic, that any regulation of dental mercury will, ipso facto, regulate any product containing dental mercury, including dental amalgam. Therefore, this court's ruling extends to dental amalgam. The court need not reach amalgam alloy as Proposition 65 does not regulate it.

Thus, as a threshold matter, we must decide whether the district court was correct in holding that the MDA applied to dental amalgam. Congress defined ...


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