I commented in the last post about the jury issue in DePirro -- no right to a jury trial in Proposition 65 matters, period. But there's much more, and it's all of interest to, and mostly favorable to, companies defending Proposition 65 matters.
More after the jump.
My general introduction to Proposition 65 appears here,
and our firm's white paper on the subject is here. The DePirro case is about an affirmative defense to this nettlesome litigation. A company can defend against a
Proposition 65 case, even if it exposes persons to a listed chemical
without giving warning, if it can prove either the NSRL defense (for
carcinogens) or the MADL defense (for reproductive or developmental
toxicants). The NSRL defense is established by
proving the exposure poses no significant risk of cancer (i.e., "no significant risk" level, or NSRL) in humans assuming lifetime exposure at the level in question. The MADL ("maximum allowable daily level") defense for reproductive or developmental toxicants is established by showing that an exposure 1000 times the level in question will have no observable effect.
For some chemicals, the State of California has set NSRL or MADL levels by regulation. Whether the State does so or not, however, a defendant company can prove the NSRL or MADL it believes is applicable so long as the scientific proof is based on evidence and standards of "comparable scientific validity to the evidence and standards which form the scientific basis" for listing the chemical in the first place.
Depirro v. Bondo does two things. First, it shows the road map for establishing the NSRL or MADL defense in those instances where the defendant does not contest the toxicity of the chemical and the State has established thresholds. The process is an expensive one for defendants; nonetheless, it is one we believe companies should undertake more often. One of the reasons the Proposition 65 private bounty hunter juggernaut exists is because so few companies are willing to fight back.
Second, the case establishes that the defendant does not have to deal with every possible extreme exposure any consumer might encounter. In other words, the defendant seeking to establish the NSRL or MADL defense does not have to prove that every single consumer exposure to the chemical in question, no matter how extreme or unusual, is below the threshold. In fact, in this case, Alameda Superior Court Judge Bonnie Sabraw looked at exposures to consumers in the "75th to 85th percentiles," found that those exposures were below the MADL, and ruled for the defendant. And the Court of Appeal affirmed, finding that the NSRL and MADL defenses were already difficult enough without requiring that the defendant imagine the circumstances of every conceivable consumer engaged in every conceivable activity.
Companies should remember, however, that the MADL and NSRL defenses can also be established by proving that the chemical in question is simply not a human carcinogen or reproductive/developmental toxicant, so that there is no significant risk or observable effect at any level. This is what our office demonstrated in Baxter Healthcare Corp. v. Denton (2004) 120 Cal.App.4th 333. Many chemicals are listed exclusively because of animal data. Rats aren't humans, and if the mechanism is species-specific, the animal data may not apply. Again, the process of proving this is an expensive one, but in some situations, (medical devices, for example) the impact of a false warning is truly deleterious. If so, building the case for this defense may be worth it.
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