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The Vaccine Litigation

One of the current hot areas in pharmaceutical litigation has been over claims of exposure to mercury from thimerosal, a preservative that has been used in many products, and especially commonly used as a preservative in multi-dose vials of childhood vaccines. Since mercury is a Prop 65 listed chemical, it seemed inevitable that an enforcement action would be filed seeking civil penalties and injunctive relief to require warnings of such exposures. Following statewide coordination of all cases involving alleged injuries or exposures to thimerosal in vaccines in the Los Angeles Superior Court, plaintiffs filed their Master Complaint No. 3 on January 21, 2003.

The defendants, vaccine and thimerosal manufacturers and distributors, filed their demurrer to the complaint on March 4, 2003. The demurrer made several arguments in support of the defendants' claim that the Prop 65 enforcement action must be dismissed. The defendants asserted that the plaintiffs' claims were barred by the prescription drug "safe harbor" in 22 Cal. Code Regs. § 12601(b)(2), which provides that:

For prescription drugs, the labeling approved or otherwise provided under federal law and the prescriber’s accepted practice of obtaining a patient’s informed consent shall be deemed to be a clear and reasonable warning.

The defendants asserted that the plaintiffs were collaterally estopped from relitigating the effect of the safe harbor regulation by the ruling in People v. Alpharma, in which the Attorney General had lost on the very same issue.

The defendants further argued that the comprehensive regulation of vaccines through the Public Health Act, Federal Food, Drug & Cosmetic Act, and the Vaccine Injury Compensation Act preempted the Proposition 65 enforcement action. The defendants asserted that a finding of liability under Proposition 65 would conflict with the federal review, approval, and strict control over vaccine labeling.

The defendants also asserted that plaintiffs' 60-day notice did not contain a certificate of merit, and did not adequately identify the products at issue in the litigation. They filed a separate motion to strike, seeking to strike plaintiffs' jury trial demand, and to remove allegations of injuries and toxicity from the complaint that were unrelated to the Prop 65 enforcement action.

The plaintiffs' oppposition to the demurrer responded that the prescription drug regulation did not address the language of the Prop 65 warning, and could not be read to create an "exemption" to the law. The plaintiffs argued that there was no express preemption of state law for vaccines, and that prior case law had routinely found no preemption of state law for vaccines, or Prop 65 by federal law under most circumstances. Their opposition to the motion to strike did not respond to the jury trial issue, but argued that the toxicity of mercury was relevant to remedies.

On May 16, 2003, Judge Victoria Chaney of the Los Angeles Superior Court issued her order sustaining the demurrer. She found that "[t]he plain language of the regulation provides a safe harbor for prescription drugs carrying an FDA-approved label from the warning requirements of Proposition 65." She also rejected plaintiffs' argument that CHWA exceeded its authority in adopting the safe harbor, deferring to the agency's "interpretation of the regulation as being reasonably necessary to furthering the purposes of Proposition 65." In light of her ruling, she found no reason to consider whether the ruling against the Attorney General on the same issue acted as collateral estoppel to plaintiffs' claims.

Judge Chaney also sustained the demurrers on federal preemption grounds. She found that plaintiffs' demand for an injunction changing their FDA-approved labels "creates a conflict between the FDA mandate and the injunction sought by plaintiffs to change that labeling." She rejected arguments that the warning could be given by signs in doctors' offices, because the FDA governs all product information materials related to prescription drugs."

In the final portions of her ruling, Judge Chaney stated that the 60-day notices were not required to contain certificates of merit, and sustained the demurrers to the unfair competition cause of action, as it was solely premised upon the alleged violation of Prop 65.

You can download the following documents

This page last updated 6/8/03