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For years, nicotine gums and patches designed to wean smokers off cigarettes have carried warnings advising expectant mothers that the over-the-counter products could increase the heart rates of unborn children. Consumer advocate Paul Dowhal, however, thought that wasn’t strong enough. So in 1999 he sued the manufacturers, insisting that warnings on Nicorette gum, as well as NicoDerm CQ and Nicotrol patches, comply with California’s Proposition 65 by identifying nicotine as a chemical known to “cause birth defects or other reproductive harm.” Only that way, he argued, would pregnant women be fully aware that cigarette replacement products could be as risky to their children’s health as smoking. Dowhal lost at trial, but prevailed on appeal. On Monday, Dowhal’s case reaches the California Supreme Court — not on the relative risks of nicotine and smoking, but to decide whether the Food and Drug Administration’s less stringent regulations trump Prop 65, the state’s 18-year-old Safe Drinking Water and Toxic Enforcement Act. Manufacturers, backed by the U.S. Department of Justice, say a victory for Dowhal could not only expose them to state suits, but federal prosecution as well for violating the Food, Drug and Cosmetic Act’s rules against “misbranding” — and put mothers-to-be at risk by scaring them with over-the-top labels that could discourage attempts to stop smoking. Dowhal and state officials, meanwhile, insist that extra warnings would do nothing more than give women all the information they need to make informed choices. “If the manufacturers have their way, truthful information will be withheld from consumers,” Oakland-based Deputy Attorney General Susan Fiering wrote in an amicus curiae brief filed by the state AG’s office. “This is not the outcome intended by Congress when it originally enacted the FDCA, and it is not the outcome intended by Congress when it preserved Proposition 65 from pre-emption by federal law.” Prop 65 was passed in 1986 to ban the release of toxic substances into drinking water and require warnings on products that may cause cancer, birth defects or other reproductive harm. It also allowed private attorneys to file suit to enforce the law. The ruling could potentially affect a host of warnings provided under Prop 65. The AG’s office and Dowhal’s lawyers at San Francisco’s Lexington Law Group contend that Congress specifically exempted Prop 65 from federal pre-emption in the 1997 Food and Drug Administration Modernization Act, which established national uniformity in the regulation of non-prescription drugs. “Congress exempted Proposition 65 from pre-emption,” Lexington partner Mark Todzo wrote in court papers, “because the primary objective of this state law — to protect the people of the state of California ‘against chemicals that cause cancer, birth defects or other reproductive harm’ — is fully consistent with, and in fact complements, the FDCA’s primary objective — ‘to protect consumers from dangerous products.’” Todzo said Prop 65′s exemption was part of a compromise between California and Congress, “and now years later FDA is saying, ‘No, that’s not what it meant.’” Morrison & Foerster partner James Bennett, who will argue the manufacturers’ position, declined to comment. MoFo’s brief states that Congress — while adopting a specific exemption for Prop 65 and no other state measure in the nation — intended to exempt California from imposing requirements that are different from, but not in conflict with, federal law. “To accept that Congress has exempted a state law from ordinary conflict pre-emption,” partner Maria Chedid wrote, “is to accept the untenable premise that Congress designed the governing federal law to ‘defeat its own objectives, or potentially, as the court has put it before, to ‘destroy itself.’” Nicorette gum and NicoDerm CQ patches, manufactured by GlaxoSmithKline Consumer Healthcare, and Nicotrol patches, made by McNeil Consumer Products Co. and Pharmacia & Upjohn Inc., were originally available only by prescription. All three are now sold over the counter. During the course of the current litigation, the FDA changed its own labels in 2001 to suggest that pregnant women try quitting cigarettes without using Nicorette or other products, even though the agency believes gums and patches are safer than smoking. But it has never adopted the warning Dowhal seeks. “However,” the federal warning states, “the risks to your child from this medicine are not fully known.” In assisting the FDA in its turf battle with California, the DOJsaid the FDA refused Dowhal’s proposed warning because it mislabeled the products. “That warning overstated the known risks of product use by equating the hazards posed by small amounts of nicotine delivered by means other than through inhaled smoke with the risk of smoking,” Justice Department lawyer Peter Maier, of Washington, D.C., wrote in an amicus curiae brief. He also said that Prop 65′s additional warning could discourage pregnant women from using the products, thereby exposing them and their unborn children to the greater risk of smoking. Dowhal’s lawyer, Todzo, called that argument insulting. “That’s a very offensive perspective on what pregnant women can and cannot understand,” he said. “If the concern is that you want people to know that smoking is worse than use of the products, then you tell them it’s worse. “Is it misleading,” he added, “to tell someone the truth about the known risks of nicotine?” San Francisco Superior Court Judge David Garcia ruled in favor of the manufacturers, but in 2002 the First District Court of Appeal reversed, pointing to congressional debates in which senators seemed to expressly exempt Prop 65. “[The manufacturers] have not cited, and we are not aware of, any case that holds a court can ignore Congress’ clearly articulated and directly applicable express intent to pre-empt, (or as here, to ‘save’ a particular state statutory scheme from pre-emption) based on analysis of what Congress impliedly intended to do,” Justice Barbara Jones wrote. “We will not be the first.” The case, Dowhal v. SmithKline Beecham Consumer Healthcare, S109306, is being widely watched. Besides the U.S. attorney general, amici curiae for the manufacturers include the Consumer Healthcare Products Association, the Cosmetic Toiletry and Fragrance Association, the Grocery Manufacturers of America, the Pharmaceutical Research and Manufacturers Association and the California Medical Association. Dowhal has the backing of not only the California AG, but also Public Citizen, a consumer advocacy organization with offices in Washington, D.C., California and Texas. For reasons not explained, Chief Justice Ronald George and Justice Marvin Baxter will not participate in the Dowhal argument. Subbing for them will be First District Justice Patricia Sepulveda and Arthur Scotland, presiding justice of Sacramento’s Third District.

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