only to the requirements stated in the general controls and their attendant regulations. Neither party has cited a preemption case involving a Class I device, and the court has found none. Therefore, it appears that there is no authority directly on point. Defendants argue that if the general controls regulating a Class I device can be preemptive, "the mere act of designating an item as a medical device would automatically deprive the states of all regulatory power over" that item. As a result, the argument goes, there would be no need for the word "specific" in § 360k(a) and § 808.1(d).
It is not dispositive that dental mercury is only a Class I device or that this court will be the first to find preemption in a case involving a Class I device. Since all medical devices are subject to the general controls, the court is just as persuaded by cases analyzing the preemptive effect of general controls on Class II or Class III devices. It appears to the court that the parties have cited only two published cases addressing the preemptive effect of general controls, and both cases found preemption. See Mendes v. Medtronic, 18 F.3d 13 (1st Cir. Mar. 9, 1994) (§ 801.109 preempts state tort claim based on manufacturer's failure to warn of pacemaker's latent defects); Hunsaker v. Surgidev Corp., 818 F. Supp. 744 (M.D. Penn. 1992) (§ 360h preempts state tort claim based on manufacturer's failure to notify of defects), aff'd, 5 F.3d 1489 (3d Cir. 1993).
Therefore, for the reasons stated here and in Mendes and Hunsaker, the court hereby finds that Proposition 65's warning requirements, when imposed on dental mercury or products containing dental mercury, are different from, or in addition to, specific MDA requirements applicable to dental mercury or products containing dental mercury, and consequently are preempted.
B. Requirement of General Applicability
Alternatively, defendants argue that Proposition 65 is merely a state requirement of "general applicability" that "affects" devices but is not a "requirement applicable to a device" within the meaning of the MDA. See 21 C.F.R. § 808.1(d)(1). The court rejects the notion that Proposition 65 is akin to electrical codes or the Uniform Commercial Code. A state warning requirement relating to the safe use of chemicals is more akin to a state tort law relating to the safety of products and their use, see Needham v. Int'l Playtex, Inc., 1989 U.S. Dist. LEXIS 800 (E.D. Ky. 1989), than it is to general codes which relate to the safety of public space or to the legal rights of consumers.
IV. Commerce Clause
Plaintiffs claim that Proposition 65 violates the Commerce Clause. To determine whether a state statute violates the Commerce Clause, a court must examine "whether the State's interest is legitimate and whether the burden on interstate commerce clearly exceeds the local benefits." Brown-Forman Distillers v. New York, 476 U.S. 573, 579, 90 L. Ed. 2d 552, 106 S. Ct. 2080 (1986). A court may properly strike down a state statute if its purpose is to disfavor interstate commerce, if its benefits are illusory or insignificant, or if the particular means chosen to achieve its goals are "irrational, arbitrary or unrelated to those goals." Alaska Airlines, Inc. v. City of Long Beach, 951 F.2d 977, 984 (9th Cir. 1991).
Plaintiffs' motion for summary judgment on this claim fails for two reasons. First, plaintiffs' have not submitted sufficient evidence for this court to rule, as a matter of law, that Proposition 65 places an unconstitutional burden on interstate commerce. Second, this issue is riddled with genuine issues of material fact. For instance, ELF argues that plaintiffs' claim that compliance with Proposition 65 is unduly burdensome lacks credibility in light of a recent voluntary settlement agreement in Environmental Law Foundation v. Jeneric/Pentron, San Francisco Superior Court No. 957039 (Dec. 13, 1993). However, John C. Miles, president of plaintiff Dentsply Int'l, Inc., and Gordon Cohen, president of Jeneric/Pentron, have submitted declarations stating that compliance with Proposition 65 is so burdensome that they may have to relocate their businesses to another state. See Miles Decl.; Moran Decl., Exh. 4. Cohen states that Jeneric/Pentron was forced to settle with ELF.
Based on Brown-Forman, Alaska Airlines, and the evidence submitted, the court cannot now say, as a matter of law, that Proposition 65 does or does not violate the Commerce Clause. Therefore, plaintiffs' motion for summary judgment on their Commerce Clause claim is DENIED, without prejudice.
For the foregoing reasons, the court hereby orders that:
1. Plaintiffs' motion for summary judgment on its declaratory and injunctive relief claims based on preemption is GRANTED;
2. Plaintiffs' motion for summary judgment on its declaratory relief claim based on a violation of the Commerce Clause is DENIED;
3. Defendants' motion to dismiss, or in the alternative, for summary judgment, is DENIED;
4. Intervenor defendant's motion to dismiss, or in the alternative, for summary judgment, is DENIED;
5. Defendants' motions to strike and for additional discovery are DENIED.
IT IS SO ORDERED.
DATED: AUG 23 1994
UNITED STATES DISTRICT JUDGE
JUDGMENT IN A CIVIL CASE
Decision by Court. This action came to trial or hearing before the Court. The issues have been tried or heard and a decision has been rendered.
IT IS ORDERED AND ADJUDGED
That the court hereby orders that this court's order filed on 8/24/94, and bearing the caption "ORDER GRANTING PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT ON ISSUE OF PREEMPTION; DENYING PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT ON ISSUE OF COMMERCE CLAUSE VIOLATION; DENYING DEFENDANTS' AND INTERVENOR'S MOTIONS TO DISMISS OR FOR SUMMARY JUDGMENT; AND DENYING DEFENDANTS' MOTIONS TO STRIKE AND FOR DISCOVERY," be amended by this order. Sections IV and V(2) of the 8/24/94 order are amended to reflect that the plaintiffs' motion for summary judgment on its declaratory relief claim based on a violation of the Commerce Clause is denied as moot.