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.
Added by initiative measure, Proposition 65, approved November 4, 1986, effective January 1, 1987.
Editor's Notes- For legislative findings, declarations, severability, and effective date of initiative, see the Note to Ch 6.6 (H & S C §§ 25249.5 et seq.).
Cross References: Exemption from warning requirement: H & S C § 25249.10.
Definitions: H & S C § 25249.11.
Collateral References: 12 Witkin Summary (10th ed) Real Property § 911.
NOTES OF DECISIONS
California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), H & S C § 25249.6, provides that 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 H & S C § 254249.10, which provides that warnings are not mandated where the federal law governs the warnings to a specific exposure. Therefore, the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (MDA), 21 USCS §§ 321 to 394 preempted Proposition 65. Committee of Dental Amalgam Alloy Mfrs. v. Henry (1994, SD Cal) 871 F Supp 1278, 1994 US Dist LEXIS 15566.
As applied to dental amalgam, the Medical Device Amendments to the federal Food, Drug and Cosmetics Act (21 USCS §§ 321-394) do not preempt California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65, H &S C §§ 25249.5-25249.13). The consumer warning requirement under Proposition 65 is not specific enough to trigger preemption because it is not the kind of requirement that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements. Also, the FDA's failure to impose a warning requirement on dental amalgam was not, by itself, preemptive. Committee of Dental Amalgam Mfrs. & Distribs. v. Stratton (1996, CA9 Cal) 92 F3d 807, 1996 US App LEXIS 19189.
In an action alleging a violation of the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, based on defendant dentists' failure to warn employees and patients that “silver fillings” contained mercury and mercury compounds, which were reproductive toxins, the trial court misapplied the burden of producing evidence in granting a defense motion for summary judgment. Defendants, who invoked the exposure exemption to the warning requirement (H & S C §§ 25249.10(c), 25249.6), had an initial burden of production to make a prima facie showing that the affirmative defense applied. Because defendants made no such showing, the burden did not shift to plaintiff to raise a triable issue. Consumer Cause, Inc. v. SmileCare (2001, 2nd Dist) 91 Cal App 4th 454, 110 Cal Rptr 2d 627, 2001 Cal App LEXIS 628.
Under H & S C § 25249.6, which prohibited the knowing and intentional exposure of any person to a cancer-causing chemical without first providing a warning, products which were noncarcinogenic, but which caused a chemical reaction when ingested that increased natural levels of testosterone, which could cause cancer, did not expose a consumer to cancer within the meaning of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Consumer Cause, Inc. v. Weider Nutrition Internat., Inc. (2001, 2nd Dist) 92 Cal App 4th 363, 111 Cal Rptr 2d 823, 2001 Cal App LEXIS 737.
Cal. Prop. 65, which was enacted at H & S C § 25249.6 and required nicotine replacement therapy products to be labeled with a warning that the products contained a chemical known to cause reproductive toxicity, directly conflicted with the labeling requirements of the Food and Drug Administration for such products and, therefore, were preempted by the federal law despite the savings clause at 21 USCS § 379r(d)(2) of the Food and Drug Administration Modernization Act of 1997, Pub. Law No. 105-115, 111 Stat. 2296. Dowhal v. SmithKline Beecham Consumer Healthcare (2004, Cal) 32 Cal 4th 910, 12 Cal Rptr 3d 262, 88 P 3d 1, 2004 Cal LEXIS 3040.
Action under Proposition 65, H & S C § 25249.5 et seq., was not ripe when the trial court entered a consent judgment that specified the warnings to be given if necessary in the future because plaintiff had admitted that the stainless steel surgical devices involved, which contained nickel, did not violate Proposition 65. H & S C § 25249.6 allows enforcement action where there is a violation or threatened violation, and not on the chance that there may one day be a violation. Consumer Cause, Inc. v. Johnson & Johnson (2005, Cal App 2nd Dist) 132 Cal App 4th 1175, 34 Cal Rptr 3d 258, 2005 Cal App LEXIS 1495.
Whether or not posting signs in dental offices would have been a more dependable means of warning patients than including inserts in the packages that could be read only by the dentists or their assistants, the manufacturer had fulfilled its obligations under H & S C §§ 25249.6, 25249.11(f), and 25249.12, if the insert that accompanied its product came within any of the safe harbor provisions. Given the professional obligations of those to whom the information on the insert was directed, there was no basis to assume that such a person was not likely to read and understand the warnings, even though the warning was not ideally placed. Environmental Law Foundation v Wykle Research, Inc. (2005, 1st Dist) 134 Cal App 4th 60, 35 Cal Rptr 3d 788, 2005 Cal App LEXIS 1798.
Consumers' lawsuit alleging that manufacturers of vaccines failed to warn of exposure to a toxic substance as required by Health & Saf. Code, § 25249.6, lacked merit because the standard warnings approved under federal law are deemed clear and reasonable warnings for prescription drugs by Cal. Code Regs., tit. 22, § 12601(b)(2)(A), which was validly enacted in accordance with Health & Saf. Code, § 25249.12, subd. (a); obtaining informed consent provided a specific warning beyond the requirements of Health & Saf. Code, § 25249.11, subd. (f), and there was no conflict with the provisions of Health & Saf. Code, § 25249.10. Vaccine Cases. William F. Bothwell v. Abbott Labs. (2005, Cal App 2nd Dist) 134 Cal App 4th 438, 36 Cal Rptr 3d 80, 2005 Cal App LEXIS 1840.
Nothing in the regulations or the final statement of reasons in support of the Safe Drinking Water and Toxic Enforcement Act of 1986, Cal. Health & Safety Code §§ 25249.8 and 25249.11 required an exact identity of medium. Moreover, as remedial statute, the Act had to be broadly construed to effectuate its remedial purpose; the conditions only had to be substantially identical, not absolutely identical. As You Sow v. Conbraco Indus., (2005) 135 Cal App 4th 431, 37 Cal Rptr 3d 399, 2005 Cal. App. LEXIS 2025.
Award of attorney fees of more than $ 540,000 was unconscionable in an action by parties a shell entity that alleged exposure under H & S C § 25249.6, to carcinogens that were commonly present pretty much everywhere, such as in furniture and paint and electric lights. Consumer Defense Group v. Rental Hous. Indus. Mbrs. (2006) 137 Cal App 4th 1185, 40 Cal Rptr 3d 832, 2006 Cal App LEXIS 407.