Punitive Damages: Failure To Warn

Posted in Products Liability on May 25, 2011

Johnson & Johnson v. Superior Court, (Second District, January 20, 2011) — Cal.Rptr.3d —-, 192 Cal.App.4th 757, 2011 WL 169407, 11 Cal.Daily Op. Serv. 1918, 2011 Daily Journal D.A.R. 2268
A boy who developed a serious skin condition as a result of a severe adverse reaction to an over-the-counter (OTC) pain reliever filed a products liability action against the manufacturer of the drug and its parent company, alleging that the defendants had failed to provide adequate warnings of the risks to consumers. The plaintiffs complaint asserted a claim for punitive damages, contending that the defendants had long known of the risk of the syndrome suffered by the plaintiff, but had misrepresented study results to the FDA in obtaining approval for the drug.

The Defendants moved for summary adjudication of the punitive damages claim, arguing that the product’s label had been approved by the FDA consistent with FDA regulations, and that regardless of whether they could or should have said something more explicit, their “FDA-approved labeling cannot conceivably evidence despicable conduct or a conscious disregard for safety.” The trial court denied the motion, and the Court of Appeal denied the defendants’ petition for a writ of mandate, holding that the evidence raised a triable issue of fact as to whether the manufacturer failed to warn, and whether there was a conscious disregard for safety:

“Real party’s point is that petitioners knew of the risk, and showed conscious disregard for safety by waiting for the FDA to require labeling changes, rather than making those changes on their own and then seeking approval. As discussed above, federal regulations permit labeling changes without FDA approval to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.” That being the case, and given all of the circumstances involved here, there are triable issues of fact regarding whether McNeil’s FDA-approved labeling could evidence despicable conduct or conscious disregard for safety. The relevant federal regulations place the burden on manufacturers to ensure their drug labeling is adequate at all times, regardless of FDA approval of existing labeling.
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Petitioners argue that, in any event, “the difference between a label that warns of the risk of a severe allergic reaction and instructs users who develop an allergic reaction to stop taking Motrin and seek medical help right away, and one that warns of severe allergic reaction that may include skin reddening, blisters and rash, surely does not evince conscious disregard of safety or despicable conduct, let alone clear and convincing evidence of conscious disregard or despicable conduct.” On the contrary, we conclude that there is arguably a significant difference between a general warning of “allergic reaction” versus a description of the specific symptoms associated with the rare but potentially fatal conditions at issue here. We are not prepared to decide as a matter of law that the difference in labeling was unimportant, or that real party’s injury would still have occurred had the labeling been changed. The focus of the petition is not causation-whether the failure to warn was a substantial factor in bringing about real party’s injury-but solely whether the failure to warn is sufficient to show malice so as to support punitive damages.
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Suffice it to say that we conclude triable issues of fact remain as to whether petitioners’ provision of the information was done in a manner that would sufficiently call it to the FDA’s attention, particularly given the severity of the harm which can result from SJS/TEN.”