Prop 65 Preemption Update

Dowhal v. SmithKline Beecham (Nicotine Patch Litigation)

On July 10, 1998, Chief Assistant Attorney General Rod Walston issued an informal opinion letter concluding that FDA warning requirements for nicotine delivery products (gum and similar products) preempted Prop 65. FDA's Murray Lumpkin had written to the state noting that the Prop 65 listing for such products was based on FDA labeling for the products, which were formerly prescription. FDA had approved modified warnings when the product was allowed to be sold without prescription, using language that indicated that "nicotine can increas your baby's heart rate," and directing pregnant and nursing mothers to seek the advice of a physician. Lumpkin stated that forcing manufacturers to use Prop 65 safe harbor language could cause the products to be misbranded under federal law, and that the current warning was clear and reasonable.

Walston's letter indicated that he considered the specific regulatory language to have preemptive effect, even though federal law does not have a preemption clause. Walston relied on the need for national uniformity, and stated that the FDA Modernization Act's provision exempting Prop 65 from preemption for OTC drug warnings did not apply, because this form of preemption predated the Modernization Act.

On August 23, 1999, Paul Dowhal filed an enforcement action against SmithKline Beecham, McNeil Consumer Products, Pharmacia & Upjohn, Alza Corp., and a number of retailers, alleging that the defendants violated Prop 65 by failing to warn of exposures to nicotine in gum and patches.  In a memorandum filed on September 1, Dowhal argued that Prop 65 was not preempted by federal law, although it did not mention the AG's letter.

Trial Court Finds Enforcement Action Preempted

On March 12, 2001, Judge David Garcia of the San Francisco Superior Court granted the defendants' motion for summary judgment on federal preemption.  As stated in the opinion, "This case presents an unusual circumstance: Defendants have been expressly forbidden by the federal government from using the pregnancy warnings that Plaintiff contends are required by state law."

Since both federal and state requirements "cannot be satisfied simultaneously, conflict preemption exists and the state requirement must yield."  The court noted that the case presented "a real conflict, not a hypothetical one," as FDA had specified warning language and had forbidden the defendants from using the Prop 65 warning.  Garcia also held that the defendants could not be required to put the Prop 65 warning in their advertising, as such a ruling would "frustrate the purpose" of Federal law "and FDA's requirement that label warnings accurately reflect the known health effects associated with a particular product."

FDA Weighs in on Appeal, and the AG Responds

On the eve of oral argument, and in a highly unusal move, the United States appeared as amicus curiae on behalf of the defendants in the appellate court (Dowhall v. Smithkline Beecham, First Appellate District, Division 5, no. A094460). FDA asserted that the Prop 65 enforcement action was preempted, because plaintiff's claims directly conflicted with FDA's determination that the Prop 65 warnings would render the products misbranded under federal law. FDA stated that its determination was preemptive, even though the Modernization Act carved out an exclusion to preemption for Prop 65, because of the misbranding issue.

The AG, in an about-face from his pre-trial position, filed an amicus brief supporting the plaintiff, and arguing that the case was not preempted, at lest as of March 2001 (before FDA's definitive letter of 8/17/2001 rejecting Dowhall's citizen petition and determining the misbranding issue). The AG took the position that the court could still award penalties for violations before August 2001, and urged the appellate court to allow the trial court to determine whether the FDA's letter actually preempted this enforcement action.

FDA had argued that the August letter immunized the defendant's conduct before that date. It also asserted that liability in this case would seriously undermine its efforts to encourage consumers to quit smoking. As the brief argued:

Strengthening the warnings about the consumption of nicotine in these nicotine replacement therapy products carries an obvious risk of discouraging consumers from using the products. Such a warning could increase the risk that consumers would be exposed to the much greater health risks of inhaled tobacco smoke.

Court of Appeal Finds No Preemption

"We do observe, nevertheless, that respondents’ attempts to comply with their state obligations under Proposition 65 have been hindered by a federal bureaucracy that, at least since the enactment of the Modernization Act of 1997, was either unwilling or unable to recognize the limited scope of its authority. It also appears that respondents were further hindered by the FDA’s admitted failure to issue 'definitive advice' about what it deemed to be an appropriate warning label until its August 17, 2001 letter in response to appellant’s citizen’s petition. We must leave for another day the issue of whether respondents’ efforts to satisfy the FDA limit or preclude their liability under Proposition 65."

A concurring opinion disagreed with the majority’s analysis, but held that there had been no showing of actual conflict.

Supreme Court Accepts Review

On October 23, 2002, the California Supreme Court accepted the defendants' petition for review (no. S109306). Chief Justice Ronald George recused himself, but the remaining 6 justices all voted to accept review. By granting the petition, the court has made the published appellate decision no longer citable as authority in California courts.

You can now download the appellants' [defendants'] opening brief and the respondent's [plaintiff's] brief.

Court Finds Enforcement Action over Mercury in Vaccines Preempted

In a May 16, 2003 ruling, Judge Victoria Chaney of the Los Angeles Superior Court sustained the defendants' demurrers to a Proposition 65 enforcement action alleging exposure to mercury and methylmercury, and their compounds, from thimerosal in various childhood vaccines. The court found that the injunctive relief requested by plaintiff would conflict with the strictly controlled labeling requirements for vaccines under the Federal Food, Drug & Cosmetic Act, as well as the Vaccine Act, which limits liability for failure to warn based on allegedly inadequate FDA-approved labeling. You can read more about the vaccine litigation.

Occupational Exposures

On September 24, 1997, the Ninth Circuit issued its opinion in Industrial Truck Assn v. Henry (no. 95-56405), finding that Prop 65 was partially preempted by the federal Occupational Safety and Health Act. The court ruled that the OSH Act preempted any state occupational law that was not incorporated into a state occupational safety plan and approved by OSHA was preempted. Since not all of the Prop 65 regulations governing occupational exposure were included in the Title 8 regulations conditionally approved by OEHHA, the court held that Prop 65 was preempted as applied to a claim that the manufacturers and distributors of diesel forklifts had failed to provide clear and reasonable warning for occupational exposures. The court specifically held that the state could not enforce Prop 65 through the Prop 65 regs for such workplace exposures, unless and until the state submits those regulations to OSHA as part of the state plan.

On October 10, 1997, the state moved for a limited rehearing before the Ninth Circuit. While not challenging the main preemption holding, the state argued that the issue of whether forklift manufacturers were required to give warning under the State Plan was not before it, and not briefed by the parties, and that requiring the District Court to enter summary judgment in plaintiffs' favor was improper. The opposition to the petition for rehearing argued that these issues were properly before the Court of Appeals and should be rejected.

Medical Devices

In Committee of Dental Amalgam Manufacturers v. Henry, the Ninth Circuit ruled that Prop 65 was not preempted by the Medical Device Act Amendments of 1976 to the Food, Drug and Cosmetic Act. Following the reasoning of the U.S. Supreme Court's decision in Medtronic, Inc. v. Lohr, (95-754), the Ninth Circuit held that the FDA had not issued any specific requirements applicable to dental amalgam, and that the application of a general law such as Prop 65 was not preempted by the federal act.

Hazardous Substances in Consumer Products

People v. Cotter & Company, decided March 31, 1997, held that Prop 65 was not preempted by the Federal Hazardous Substances Act. Cotter and Company was sued by the Attorney General for alleged violations of Prop 65 with respect to spray paint. The parties settled, but agreed to allow the Court of Appeal to decide the preemption question.

The court rejected the defendant's reliance upon a number of common law tort failure to warn claims, and largely followed the 1992 decision of the Ninth Circuit in CSMA v. Allenby. The Allenby ruling held that Prop 65 was not preempted by federal labeling statutes, since the state act could be satisfied by point of sale signs, which it considered to not be labeling under federal law. Significantly, the Cotter court rejected an advisory opinion by the General Counsel of the Consumer Products Safety Commission which determined that Prop 65 point of sale signs were labeling under FHSA, as "clearly erroneous." The court also held that Cotter failed to prove that point of sale signs were not a valid method of complying with Prop 65, as it required the defendant to establish a "physical impossibility" of complying without labeling.

Cotter, now known as TruServ Corporation, filed an unsuccessful petition for writ of certiorari in the US Supreme Court, seeking review of the decision of the Court of Appeal.

Tobacco

Courts in San Francisco and Los Angeles have ruled that pending enforcement actions over exposure to second-hand smoke from cigars and cigarettes are not preempted by federal law. See more details in the tobacco page.

This page last updated 6/8/03