In Re Vaccine Cases

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.; 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 (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 authority to implement The Act. Therefore the complaint does not…