ICN Parmaceuticals, Inc. v. State

Opinion

The issue we resolve is a narrow one: Is the Department of Health Services (DHS) statutorily precluded from issuing hazard alerts

ICN Pharmaceuticals, Inc. (ICN) is the manufacturer of ribavirin, a medication used to treat critically ill infants and young children. DHS, and DIR, pursuant to an interagency agreement, established the Hazard Evaluation System and Information Service (HESIS). Hazard alerts are issued by the HESIS unit. In December 1990 DHS authorized issuance of a HESIS hazard alert warning pregnant health care workers to avoid exposure to ribavirin aerosol. DIR’s involvement with the ribavirin hazard alert does not appear on the record. On December 6, 1990, ICN sought ex parte writ and injunctive relief to prevent the DHS from issuing the proposed hazard alert. Following the denial of its application, ICN appeals.

Mootness

The Attorney General contends the case is moot and urges us to dismiss the appeal. Apparently the hazard alert was disseminated throughout the state following ICN’s unsuccessful attempt to restrain DHS. As a result, the Attorney General argues any damage suffered by ICN cannot be remedied by resolution of this appeal and consequently our disposition would not affect the rights of the parties before us. ICN alleges the case is not moot because DHS will disseminate another HESIS alert before or during the next dangerous winter season.

This appeal raises two distinct issues. The first is whether the trial court abused its discretion by denying ICN’s ex parte application for a temporary restraining order. In its moving papers, ICN alleged ribavirin was the only medication approved by the United States Food and Drug Administration (FDA) for the treatment of hospitalized infants and young children with respiratory syncytial virus (RSV), a sometimes fatal respiratory illness. Since ribavirin is administered in aerosol form through an oxygen tent, hood, or face mask, small quantities of the substance may escape into the environment. ICN asserted the release of the alert might dissuade health care workers from administering ribavirin and thereby endanger the health and welfare of critically ill infants and young children “during the very season when the deadly RSV virus is most prevalent.”

ICN forecasts grim, perhaps deadly, consequences following release of a hazard alert. The accuracy of those predictions can now be determined since

Both DIR and DHS have statutory mandates to safeguard the health and safety of California workers. Both are charged with establishing programs on occupational health and disease prevention, predicated on research and education. Health and Safety Code section 429.11 directs DHS to “establish and thereafter maintain a program on occupational health and occupational disease prevention.” Similarly, a division of DIR “shall maintain an education and research program for the purpose of providing in-service training of division personnel, safety education for employees and employers, research and consulting safety services.” (Lab. Code, § 6350.)

Although both departments act to protect the health of the state work force, the Legislature sought to coordinate their services. DHS is directed to provide “technical assistance in matters of occupational disease prevention and control to the Department of Industrial Relations and other governmental and nongovernmental agencies, organizations, and private individuals.” (Health & Saf. Code, § 429.11, subd. (a) (4).) Moreover, DHS must “implement ... a continuing research and development capability and a repository of hazardous substances capability which will reinforce and strengthen the administration of the California Occupational Safety and Health Act of 1973, Part 1 (commencing with Section 6300) of Division 5 of the Labor Code . . . .” (Health & Saf. Code, §429.11, subd. (b) [CalOSHA].) DHS is to avoid duplication of activities of DIR and other state departments and agencies. (Health & Saf. Code, § 429.12.)

This statutory scheme of coordination of services does not subjugate DHS to the impotent role suggested by ICN. To the extent CalOSHA and article 13 of the Health and Safety Code blur the functions of DIR and DHS, the Legislature clarified the manner in which the departments were to accumulate and disseminate information on toxic materials and harmful physical agents. Labor Code section 147.2 is dispositive: “In accordance with the provisions of Chapter 2 (commencing with Section 6350) of Part 1 of Division 5 of this code and Section 429.11 of the Health and Safety Code, the Department of Industrial Relations shall, by interagency agreement with

ICN contends the following language set forth in section 147.2 confers exclusive authority to DIR: “The Director of Industrial Relations shall appoint an Advisory Committee to the repository. . . . The Advisory Committee shall meet on a regular basis at the request of the director. The Committee shall be consulted by, and shall advise the director at each phase of the structuring and functioning of the repository and alert system with regard to, the procedures, methodology, validity, and practical utility of collecting, evaluating, and disseminating information concerning hazardous substances, consistent with the primary goals and objectives of the repository.” This language does suggest DIR is to assume a lead role in the coordinated effort to collect and disseminate information regarding toxic and harmful materials. It does not, however, prevent an interagency agreement between DIR and DHS from designating DHS as the repository. To say that the director of DIR should appoint an advisory committee to keep DIR informed about the “structuring and functioning of the repository and alert system” is not to say DHS cannot assume the role of the repository.

ICN relies heavily on various provisions of the Hazardous Substance Information and Training Act (Lab. Code, § 6360 et seq.) enacted in 1980. It points to the legislative intent “to ensure the transmission of necessary information to employees regarding the properties and potential hazards of hazardous substances in the workplace” (Lab. Code, § 6361, subd. (b)) and the applicability of the act to all employers, sellers, and manufacturers (Lab. Code, § 6362). Neither of these sections state or imply DIR is responsible for implementing the legislative objectives. They merely express the broad scope of the undertaking and the legislative commitment to inform California workers of potential risks of hazardous substances.

Interestingly, the act requires the director to include in the list of hazardous substances those “for which an information alert has been issued by the

We have determined that the Legislature did not limit the authority to issue information and/or hazard alerts exclusively to DIR, but established a complementary system whereby DIR and DHS share responsibility for improving the health and safety of the California workplace. Specifically, DIR and DHS are authorized to establish a repository of information by interagency agreement on the potential risks of exposure to toxic materials and harmful substances. There is nothing in the legislation to preclude DHS from acting as the repository and, in that capacity, from issuing and disseminating alerts according to the terms of the agreement.

The judgment is affirmed.

Marler, Acting R 1, and Nicholson, J„ concurred.