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Product Safety: California Proposition 65 Return to Practice Areas & Industries

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For companies that manufacture or sell products in California, Proposition 65, a law that relates to the disclosure of certain chemicals in products, raises a host of compliance issues and potentially expensive litigation claims. Complying with the law means keeping up with the new amendments and judgments regarding Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, that surface every month. To mitigate the risk of pricey Proposition 65 litigation and settlements, clients including manufacturers, distributors and retailers turn to Duane Morris.

Drawing on the resources of an international firm with a national product safety and compliance bench, Duane Morris lawyers experienced with Proposition 65 claims counsel companies, identifying potential exposure, offering informed risk-management audits and tools for compliance and, if necessary, efficiently litigating claims.

While Proposition 65 does not ban the use of any particular chemicals, it does mandate that (1) businesses may not discharge certain chemicals into sources of drinking water, and (2) businesses must provide a "clear and reasonable warning" before exposing people to minute quantities of specified chemicals that are potential carcinogens or reproductive toxins. California published and regularly updates "The List" of chemicals "known to the state to cause cancer or reproductive toxicity"—on the website of the California Office of Environmental Health Hazard Assessment (OEHHA) ( The list currently has more than 800 chemicals and continues to grow.

Proposition 65 can be very costly to businesses selling products in California. The law's unique enforcement scheme, which empowers plaintiffs to file a Proposition 65 lawsuit against a business that fails to provide the requisite warnings and rewards the filer with a share of any penalties resulting from a settlement or judgment, also allows a plaintiff to file suit even if he or she has suffered no harm and has never been to the defendant's premises or used its products. These matters call for an experienced Proposition 65 legal team.


Services Available

Duane Morris lawyers have defended a wide variety of products manufactured, distributed, sold or insured by our clients on Proposition 65 matters and more generally. We also counsel clients on regulatory, labeling, packaging and marketing issues to help manage risk and avoid litigation. In addition to issues particular to Proposition 65, we advise clients on product safety compliance, reporting, recalls and penalty proceedings before the U.S. Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA) and their state counterparts, and other regulatory agencies.

Range of Experience

Areas in which our attorneys have experience on California Proposition 65 matters include:

  • advising and representing manufacturers, importers and distributors of products, including jewelry, apparel, toys, art materials, sporting goods, electronics and other consumer products in claims and litigation;
  • conducting risk-management audits of Proposition 65 exposures;
  • counseling clients on safe harbors such as providing a "warning," which might include a sign on the front door of a plant or involve labels, packaging, store shelves, websites, catalogs or in other contexts;
  • responding to an enforcement notice from the California Attorney General, county district attorneys and other law-enforcement officials, or by private bounty hunters seeking to recover attorneys' fees and their share of statutory penalties;
  • helping companies negotiate settlements and consent decrees in public and private enforcement actions.

Articles Authored by Lawyers at this office:

New Jersey Trial Court Grants Summary Judgment in Accutane Mass Tort Cases
James J. Ferrelli, April 14, 2015
In an opinion issued on April 2, 2015, the Honorable Nelson C. Johnson, JSC, granted the motion of defendants Hoffmann-LaRoche, Inc. and Roche Laboratories, Inc. for summary judgment in the In re Accutane Multicounty (mass tort) Litigation (MCL) on the grounds that the defendants' post-April 2002...

Drug Quality and Security Act Does Not Apply to Veterinary Compounding
Patrick C. Gallagher,Rachael G. Pontikes,Alison T. Rosenblum, March 30, 2015
While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications. There has been some confusion in the industry, but veterinary compounded medications are still regulated...

FDA Establishes the Office of Pharmaceutical Quality
, March 03, 2015
In a press conference earlier this year, Dr. Janet Woodcock, head of the U.S. Food and Drug Administration's (FDA) pharmaceutical division, stated that the FDA has been working on "establish[ing] consistent quality standards for all drugs, whether brand name or generic" over the past 10...

FDA Issues Additional Guidances on Implementation of Drug Supply Chain Security Act
, March 03, 2015
The U.S. Food and Drug Administration (FDA) continues to publish draft guidance implementing the Drug Supply Chain Security Act (DSCSA). This Alert highlights key facts on three recent draft Guidance for Industry, which focus on: interoperable exchange of information, annual reporting by wholesale...

Pennsylvania Supreme Court Adopts New Standards for Strict Liability Claims
, February 17, 2015
On November 19, 2014, the Pennsylvania Supreme Court issued its much-anticipated decision in Tincher v. Omega Flex, Inc. (No. 17 MAP 2013), in which it addresses the proper standard under Pennsylvania law for strict liability claims relating to allegedly defective products. Although the court...

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act
Carolyn A. Alenci,Frederick R. Ball, December 10, 2014
Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution...