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A California judge has ruled that a chemical used to keep medical plastic flexible no longer needs to bear a warning that it may cause cancer. It’s the first time in the 16-year history of Proposition 65 that a manufacturer’s affirmative legal action has resulted in an exemption to a mandated warning. Attorneys who litigate Prop 65 cases on behalf of manufacturers hailed the decision because it established declaratory judgment as a vehicle for getting exemptions from warnings and set the standard of proof as preponderance of the evidence, rather than the higher hurdle of clear and convincing evidence. The suit was brought by Baxter Healthcare Corp. of Deerfield, Ill., a supplier of intravenous fluid bags, dialysis equipment, catheters and other equipment. DEHP, or di(2-ethylhexyl)phthalate, has been used since the 1960s to keep medical equipment soft and pliable. It is the only chemical approved by the Food and Drug Administration for that purpose. Prop 65 requires a warning on any potential human carcinogen, even if its risk was determined from animal testing. Nearly 800 chemicals from testosterone to lead carry the warnings. Baxter’s attorneys demonstrated in a 10-day case before Sacramento County Superior Court Judge Talmadge R. Jones that the process that causes DEHP to trigger cancer in mice does not operate in humans. Therefore, it does not pose a significant risk of human cancer, regardless of the level of exposure, and needs no warning. Baxter v. Denton, No. 99CS00868 (Sacramento Co. Super. Ct.). Baxter used medical experts and research by the World Health Organization’s International Agency for Research on Cancer, which does not consider DEHP a human carcinogen. The burden was on Baxter to show that DEHP poses no significant risk of cancer in humans, said lead counsel Michael S. Marcus, a partner in the Washington, D.C., office of Akin, Gump, Strauss, Hauer & Feld. EXPENSIVE WIN Carol Brophy, a San Francisco attorney who represents manufacturers in Prop 65 litigation, credited Baxter with pioneering the challenge. “You don’t have to wait to get sued; you can go to the court and ask for a declaratory judgment,” said Brophy, a partner in Nossaman, Guthner, Knox & Elliott. But she noted that it came at a price. She estimated that Baxter spent as much as $6 million on the case. A Baxter spokeswoman would not comment on the cost of litigation. Should the state decide to appeal, it would seek review of the use of preponderance of evidence as the standard of proof. A decision on an appeal will be made early next year, said Deputy Attorney General Susan L. Durbin. Jones wrote that he used the standard of proof that Baxter championed because Prop 65 does not specify a standard and the measure was already weighted in favor of the state: “To impose a higher standard of proof would be to tip the statutory balancing of interests even further in favor of the public than the statutes do themselves,” he wrote. Lawyers disagree on whether the decision will trigger a wave of similar litigation. “Logically there would be,” Marcus said, “because many other substances could be shown to not pose a significant risk of cancer in humans.” But Durbin and Colleen Heck, chief counsel for the state Office of Environmental Health Hazard Assessment, said making a case for other chemicals would be difficult because few have been subject to the research DEHP has undergone.

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