In a defeat for Johnson & Johnson, a federal judged ruled the drugmaker will have to defend against lawsuits charging it failed to properly warn that its over-the-counter Motrin pain reliever can cause Stevens-Johnson Syndrome and a deadlier form of the disease known as Toxic Epidermal Necrolysis. The judge refused to dismiss two lawsuits brought by parents who claim their children were harmed.
Since 1983, J&J's McNeil Consumer Healthcare unit has listed possible links on prescription labeling for Motrin, and more explicit warnings were required by the FDA in 2006 after a Citizen's Petition sought either removal or enhanced labeling. The labeling for over-the-counter versions of Motrin - for adults and children - lists possible reactions, but neither disease is mentioned specifically. The diseases can cause blindness, massive skin loss, blisters and burns, massive scarring and damage organs.
In arguing to have the lawsuits dismissed, J&J maintained that its hands were effectively tied, because the FDA did not require the sort of language that the families insist should have appeared in the labeling. And to have added such warnings would have created an instance of preemption, in which complying with both state and federal laws would have been impossible, J&J argued.
Premption is the notion that FDA approval or rulings supercede state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued two years ago before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness (see here).
In a 31-page opinion, US Magistrate Court Judge Maria Velez wrote that federal law does not preempt the labeling claims made by the families. She cited two reasons. One, the FDA did not reject the warnings the families say should be required. And while the FDA denied the 2006 Citizen's Petition, it "is not clear evidence that the FDA would have prohibited in 2009 the warning plaintiffs allege is required."
In particular, Velez cited accumulating evidence of adverse reactions. When the FDA scoured its database, the agency found 49 reports of SJS and TEN related to Motrin from 1975 through 2005. After discovery began for the lawsuits, McNeil produced 117 adverse event reports, and 87 were received prior to June 2009, just before each child was given Motrin.
"McNeil could have – and plaintiffs argue should have – evaluated the new data, and/or analyzed the overall data and added a stronger warning; and because of the new data, the FDA’s response can no longer be treated as clear evidence that the agency would not have approved a change to the Motrin labels," Velez wrote.
In a footnote to one of its court filings, Velez pointed out that J&J also argued there was no duty to warn of "idiosyncratic risks." The health care giant notes that "SJS and TEN are exceedingly rare diseases with unknown causes, and that recent studies show that there is no statistically significant correlation between the disease and the use of ibuprofen," Velez wrote.
However, she added that J&J lawyers misapplied the case they cited to make this point. In the case, the "unusual susceptibility of the consumer is, generally, recognized as a complete defense where the manufacturer did not know and had no reason to know that a very few users of his product might be injured,” Velez wrote in citing the earlier case. Then, however, she skewers J&J.
"Here, it is undisputed that since 1983, McNeil’s labeling for its prescription Motrin products has listed SJS as having a “probable causal relationship” with ibuprofen, and the FDA has clearly stated that “NSAIDs, including ibuprofen, are known to cause SJS and TEN.” Obviously, McNeil knew that users of its product might be injured; therefore, even if there is 'unusual susceptibility' in this case, it is not a complete defense to plaintiffs’ failure to warn claim."
gavel pic thx to walknboston on flickr
1 Comment
Interesting case.
As Ed suggests, it seems to hang on the fact that FDA _did_ require the relevant warnings on prescription strength Motin, but not on OTC. I wonder: Was the company or FDA aware of any evidence that suggested that these AEs were more likely in rx strength than OTC.
If not, it seems like a disconnect, despite FDA's own review of the Citizen's petition. And, if there is truth in that, it comes down to whether company took knowing advantage of what they knew was such a disconnect at FDA.
The rest of the company's arguments appear to me to be clearly countered by the Levine decision.