The opinion of the court was delivered by: RUDI BREWSTER
Plaintiffs' motion for summary judgment, defendants' and intervenor's motions to dismiss, or in the alternative for summary judgment, and defendants' motions to strike the declaration of David Link and for additional discovery, were heard before the Honorable Rudi M. Brewster on May 16, 1994. Stanley Landfair, Esq., and Carol Brophy, Esq., appeared for plaintiffs; Susan Fiering, Esq., appeared for the State defendants; James Wheaton, Esq., and Alice Chang Kaufman, Esq., appeared for the intervenor defendant. The court continued these motions for supplemental briefing and further review. Upon further consideration of the moving and responding papers, the supplemental briefs and submissions,
the court hereby GRANTS summary judgment for plaintiffs on the issue of preemption, DENIES plaintiff's motion for summary judgment on the Commerce Clause claim, and DENIES defendants' motions.
Plaintiffs brought this declaratory and injunctive relief action seeking a determination that a California state statute, the California Safe Drinking Water and Toxic Enforcement Act of 1986 ("Proposition 65"), Cal. Health & Safety Code §§ 25249.5 - 25249.13, is preempted by the Medical Device Amendments ("MDA") of 1976 to the Federal Food, Drug and Cosmetic Act ("FFDCA"), 21 U.S.C. §§ 321 -394, in so far as Proposition 65 imposes warning requirements for dental mercury that are different from or in addition to requirements under the MDA. Plaintiffs also contend that Proposition 65 violates the Commerce Clause.
§ 25249.6. Required warning before exposure to chemicals known to cause cancer or reproductive toxicity
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, except as provided in Section 25249.10.
§ 25249.10. Exemptions from warning requirement
The State of California has listed dental mercury as a "chemical known to the state to cause . . . reproductive toxicity."
All medical devices are classified under the MDA. Dental mercury is a Class I device regulated by the MDA. See 21 C.F.R. § 872.3700(b). The federal Food and Drug Administration ("FDA") has defined dental mercury as "a device composed of mercury intended for use as a component of amalgam alloy in the restoration of a dental cavity or a broken tooth." Id. Amalgam alloy is a Class II device. See 21 C.F.R. § 872.3050. Dental amalgam, which is the combination of dental mercury and amalgam alloy, is not a "device" under the MDA. However, to the extent that its two component parts are regulated by the MDA, dental amalgam is, ipso facto, regulated by the MDA.
All medical devices, whether Class I, II, or III, are subject to "general controls." See 21 U.S.C. § 360c(a)(1)(A). The general controls include a provision for labeling and warnings. See 21 U.S.C. § 352(f). Section 352(f) states:
A drug or device shall be deemed to be misbranded --
. . . Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.
The Secretary has promulgated regulations exempting prescription devices from the requirement of clause (1). See 21 C.F.R. § 801.109.
Section 801.109 states, in relevant part:
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from section 502(f)(1) [352(f)(1)] of the act if all of the following conditions are met:
(1) (i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and
(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.
In addition, the statute provides that the FDA has the authority to impose any necessary warning requirements on medical devices. See 21 U.S.C. § 360h(a). ...