Wednesday, April 9, 2008
In a recent case over Paxil and Zoloft, the Third Circuit held that plaintiffs’ failure to warn claims (about the risks of suicide) were preempted. The FDA explicitly refused to order the warnings. Consequently, Judge Solviter concluded that the FDA "actively monitored" the possible suicide risk and concluded that the warnings were "without scientific basis and would therefore be false and misleading." Here’s an excerpt of the Legal Intelligencer’s report:
But Sloviter, who was joined by visiting Judge Jane A. Restani of the U.S. Court of International Trade, emphasized that the ruling was a narrow one.
"Our holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires," Sloviter wrote in Colacicco v. Apotex Inc.
In dissent, 3rd Circuit Judge Thomas L. Ambro said he would have allowed both cases to go forward.
"The FDA has for over three-quarters of a century viewed state tort law as complementary to its warning regulations. Only for the last two years has it claimed otherwise," Ambro wrote.
Ambro said the "sea change" in the FDA's position on pre-emption did not come in the form of a formal regulation that was subject to notice and comment, but in a "preamble" to a regulation. The majority, Ambro said, decided to defer to the FDA because the agency has expertise in deciding the "optimal warnings" drug labels should carry -- not too lax, not too alarmist -- and that "state tort lawsuits would disrupt this fine system."
But Ambro said there is "an important contrary view that has prevailed until recently: state tort law complements FDA provisions on drug warnings, in part by eliciting more information than the FDA would glean otherwise from pharmaceutical manufacturers."
That view, Ambro said, "has, I believe, the better argument in terms of legal doctrine on pre-emption, congressional intent and the history of state tort law alongside federal law."
The cases involved were Colaccicco v. Apotex, Inc. And McNellis v. Pfizer, Inc. Here’s a link to the Third Circuit’s Opinion.