In Re Vaccine Cases

36 Cal. Rptr. 3d 80, 134 Cal. App. 4th 438, 2005 Daily Journal DAR 13675, 2005 Cal. Daily Op. Serv. 10028, 2005 Cal. App. LEXIS 1840
CourtCalifornia Court of Appeal
DecidedNovember 28, 2005
DocketB168163
StatusPublished
Cited by22 cases

This text of 36 Cal. Rptr. 3d 80 (In Re Vaccine Cases) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Vaccine Cases, 36 Cal. Rptr. 3d 80, 134 Cal. App. 4th 438, 2005 Daily Journal DAR 13675, 2005 Cal. Daily Op. Serv. 10028, 2005 Cal. App. LEXIS 1840 (Cal. Ct. App. 2005).

Opinion

Opinion

KITCHING, J.

I. INTRODUCTION

Plaintiffs allege that defendants, manufacturers of vaccines, violated The Safe Drinking Water and Toxic Enforcement Act of 1986 (Health & Saf. Code, § 25249.5 et seq.; 1 The Act or Proposition 65). Plaintiffs allege that defendants exposed them and other consumers to substances known to the State of California to cause cancer or reproductive toxicity without providing the “clear and reasonable warning” required by section 25249.6. Based on this alleged statutory violation, plaintiffs also allege a violation of the unfair competition law 2 (sometimes UCL; Bus. & Prof. Code, § 17200 et seq.). Plaintiffs appeal from a judgment of dismissal entered after the trial court sustained a demurrer to their complaint without leave to amend.

We affirm the dismissal of the first cause of action for violation of The Act on two grounds. First, we conclude that California Code of Regulations, title 22, section 12601, subdivision (b)(2)(A) (hereafter Regulation 12601(b)(2)(A)), which defines “clear and reasonable warning” for prescription drugs, is a valid exercise of the lead administrative agency’s statutory *445 authority to implement The Act. Therefore the complaint does not allege that defendants failed to satisfy the “clear and reasonable warning” requirement of section 25249.6. Second, we conclude that plaintiffs’ complaint did not comply with the presuit notice requirements of section 25249.7, subdivision (d)(1). These conclusions provide independent grounds to affirm the dismissal of the first cause of action for violation of The Act.

We also affirm the dismissal of the second cause of action for violation of the unfair competition law. Plaintiffs brought their UCL cause of action against two groups of defendants. Because plaintiffs failed to give the first group of three defendants the presuit notice required by section 25249.7, subdivision (d)(1), plaintiffs could not and did not name these three defendants in their first cause of action for violation of The Act. As to the second, larger group of defendants named in the first cause of action, the first cause of action was dismissed because no violation of Proposition 65 occurred. Thus as to both groups of defendants, no statutory violation provided the “unlawful .. . business act or practice” to form the basis for a UCL violation. Therefore plaintiffs had no UCL cause of action, and we conclude that the trial court properly dismissed the UCL cause of action as to all defendants. We affirm the judgment of dismissal.

II. STANDARD OF REVIEW

“Our task in reviewing a judgment of dismissal following the sustaining of ... a demurrer is to determine whether the complaint states, or can be amended to state, a cause of action. For that purpose we accept as true the properly pleaded material factual allegations of the complaint, together with facts that may properly be judicially noticed.” (Crowley v. Katleman (1994) 8 Cal.4th 666, 672 [34 Cal.Rptr.2d 386, 881 P.2d 1083].)

HI. FACTUAL AND PROCEDURAL HISTORY

1. The Complaint: Plaintiffs filed the operative complaint on January 24, 2003. The complaint alleged that plaintiffs Bruce Bothwell and Claire Bothwell, the parents of plaintiffs William F. Bothwell and Katrina Bothwell, purchased immunization vaccines containing thimerosal, a mercury-based preservative. The complaint identified numerous defendants engaged in designing, manufacturing, marketing, distributing, selling, or otherwise placing vaccines in the stream of commerce and which did business in the State of California. These defendants included Abbott Laboratories, Inc.; American Home Products Corp.; Aventis Pasteur, Inc.; GlaxoSmithKline; King Pharmaceuticals, Inc.; Medeva Pharmaceuticals; CellTech Pharmaceuticals; Merck & Co., Inc.; Sigma-Aldrich, Inc.; Spectrum Manufacturing Corp.; Bergen Brunswig Corp.; Eli Lilly & Co.; McKesson Medical-Surgical,Inc.; and Priority Healthcare Corp.

*446 The complaint alleged that The Act, enacted as Proposition 65, required “clear and reasonable warning” to an individual before exposing that individual to chemicals listed by the State of California as causing cancer, birth defects, or other reproductive harm. The complaint alleged that on July 1, 1987, the State of California listed methylmercury in California Code of Regulations, title 22, section 12000 as a chemical known to cause reproductive and/or developmental harm, making methylmercury subject to the “clear and reasonable warning” requirement of section 25249.6.

Plaintiffs alleged that on July 1, 1990, the State of California officially listed mercury and mercury compounds in California Code of Regulations, title 22, section 12000 as chemicals known to cause reproductive harm, making mercury and mercury compounds subject to the warning requirements 12 months later and thus subject to the “clear and reasonable warning” requirement of section 25249.6.

The complaint alleged that since 1983, although familiar with the dangerous propensities of thimerosal and mercury, defendants placed vaccines containing thimerosal in the stream of commerce without adequate warnings and despite the availability of a substitute preservative. The complaint alleged that many children have developed and been diagnosed with mercury poisoning due to exposure to thimerosal from vaccines. The complaint alleged that many adults were exposed to mercury from thimerosal and vaccines at levels that violate federal exposure guidelines.

Plaintiffs alleged that in the 1980’s, a Food and Drug Administration (FDA) regulation required removal of thimerosal from over-the-counter products due to safety concerns. In the Federal Register on December 14, 1998, the FDA published a notice requesting vaccine manufacturers to provide data on mercury content in their vaccines.

The complaint alleged that since July 1, 1988, one or more thimerosalbased vaccines were sold or administered to individuals in California without their first receiving a clear and reasonable warning.

The complaint alleged that other products do not contain thimerosal and vaccines do not require it, showing that thimerosal exposure and resulting injuries were not necessary to the production or use of defendants’ vaccines.

Plaintiffs alleged that pursuant to Proposition 65, on November 19, 2001, they served 60-day notices of violations on public enforcement agencies and on defendants, informing them that exposures to carcinogens or reproductive toxins occurred in California due to use of defendants’ toxic chemicals without clear and reasonable warnings. No prosecutors commenced an action against any defendants named in the complaint.

*447 The first cause of action alleged a violation of section 25249.6 against all defendants except Eli Lilly & Co., McKesson Medical-Surgical Inc., and Priority Healthcare Corp. This cause of action alleged that defendants violated section 25249.6 et seq.

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36 Cal. Rptr. 3d 80, 134 Cal. App. 4th 438, 2005 Daily Journal DAR 13675, 2005 Cal. Daily Op. Serv. 10028, 2005 Cal. App. LEXIS 1840, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-vaccine-cases-calctapp-2005.