August 23, 2006
Warnings Cases Galore!
(Or can two count as "galore"?)
Couple of interesting recent products cases.
In the first [PDF], the Michigan Supreme Court held (over two dissenting votes) that a hair oil manufacturer was not liable for failing to warn about the risk of organ failure from ingestion of the hair oil, concluding that the fact that ingestion raised a material risk was obvious to a reasonably prudent user. The purchaser's eleven-month-old child ingested the product and died of organ failure about a month later. The product carried warnings against spraying it near flame, but did not have any warnings about ingestion or about keeping it away from children.
Of note, the court concludes that the user need not understand the specific risks -- only that there are material risks associated with the conduct (here ingestion). The dissent focuses on this, asserting that the majority has let the defendant off the hook based on the notion that knowing one risk is equivalent to knowing all risks. The opening to the dissent:
Michigan consumers beware: If you know or should know that there is any material risk from using or accidentally misusing the product you buy, then the manufacturer of that product now has no duty to warn you of any risk at all, even when the potential harm you knew of is not the harm you ultimately suffer. Stated differently, if you know or should know that if, for example, you accidentally drink or inhale a product, you may become ill, then you are charged with knowing that if you accidentally drink or inhale that product, you could die. And the manufacturer need not warn you of either of those risks—illness or death. According to the majority, the obviousness of any material risk, such as that of illness, is identical to and has the same effect on your behavior as the obviousness of all risks, including death.
In another case, Judge Kennedy of the District Court for the District of Columbia dismissed [PDF] a putative class action against various dairy and retail defendants, contending that milk producers should have warned against gastrointestinal symptoms from lactose intolerance. The plaintiffs contended that, though lactose intolerance is common, it is frequently unknown by those who suffer from it:
Notwithstanding the vast number of people allegedly afflicted with lactose intolerance, plaintiffs insist that the extent to which people suffer from this condition has been minimized by the milk industry and “the government’s marketing efforts.” Id. ¶ 6. Plaintiffs maintain that defendants, with the aid of the government, have propagated the myth that milk is a necessary part of a healthy diet while simultaneously stifling information about the incidence of lactose intolerance.
The plaintiffs sought warnings such as these:
WARNING—IF YOU EXPERIENCE DIARRHEA OR STOMACH CRAMPS AFTER CONSUMING MILK, YOU MAY BE LACTOSE INTOLERANT. CHECK WITH YOUR PHYSICIAN.
WARNING—LACTOSE INTOLERANT INDIVIDUALS MAY EXPERIENCE BLOATING, DIARRHEA, OR OTHER GASTROINTESTINAL DISCOMFORT FROM CONSUMING MILK. CHECK WITH YOUR PHYSICIAN.
The court dismissed the case based on preemption, noting that labeling of food is within the realm of agencies, and citing the experience with olestra:
In 1996, FDA approved olestra as a food additive. Food Additives Permitted for Direct 7 Addition to Food for Human Consumption; Olestra, 61 Fed. Reg. 3118 (Jan. 30, 1996). As part of this approval process, FDA determined that there was “a reasonable certainty of no harm” with respect to olestra consumption. Id. The determination was made notwithstanding the possibility that olestra consumption could cause “a broad range of GI [gastrointestinal] symptoms, including loose stools, cramping and bloating, fecal urgency, oil-in-the toilet, and anal leakage.” Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra, 68 Fed. Reg. 46,403, 46,408 (Aug. 5, 2003). FDA “appli[ed] the statutory standard of ‘safe,’ [and] concluded that none of these effects is harmful to health.” Id. Given this conclusion, the court sees no reason why the symptoms of lactose intolerance—very similar to those exhibited by olestra consumption—should raise any safety concerns. Consequently, the court finds that there is no basis upon which to invoke the safety exception to the FDCA preemption clause. The court concludes, therefore, that plaintiffs’ complaint must be dismissed in light of the express preemption clause in the FDCA.
The court also concluded that there was no duty to warn under Restatement provisions, noting that there is no duty to warn about common and well-known allergies.
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Tracked on Sep 8, 2006 8:55:34 PM