Prop 65 Lindane Litigation

The Attorney General has lost his suit alleging that the manufacturer of Lindane, a head lice treatment, violated Prop 65.  People v. Alpharma USPD, Inc., SF Superior no. 992915.

The AG claimed that the product, listed as a carcinogen, exposed users to more than a lifetime's allowed exposure to lindane in one use.  The product, a prescription pharmaceutical, is distributed with a package insert which contains FDA-approved language discussing the results of carcinogenicity studies.  The patient package insert does not contain any cancer warning.  The AG claimed that the package insert was inadequate under Prop 65, because it did not contain a "warning," and the failure to include any warning at all in the patient package insert created a violation of Prop 65.

Alpharma moved for summary judgment, contending in part that, under the Prop 65 regs (22 CCR §12601(b)(2)), the FDA's approval of its package insert complied with its obligation under Prop 65.  The regulation provides that "[f]or prescription drugs, the labeling approved or otherwise provided under federal law and the prescriber's accepted practice of obtaining informed consent shall be deemed to be a clear and reasonable warning."

On May 17, 1999, Judge Garcia of the San Francisco Superior Court granted Alpharma's motion, holding that, by the express terms of the regulation, Alpharma complied with Prop 65 by providing federally-approved warnings, and the company "has no further duties under Proposition 65, including, but not limited to, any duty to provide point of sale warnings or other warnings beyond the approved FDA labeling."

This page last updated July 1999