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Generics’ Duty to Warn: Supreme Court Decision in Mensing May Reach Beyond Pharmaceutical Industry
The 5-4 June 23, 2011 Supreme Court decision in Pliva v. Mensing (131 S. Ct. 2567 U.S. 2011; 2011 U.S. LEXIS 4793 ), in which the Court found that state law failure to warn claims against generic drug manufacturers were preempted under federal law will have far-reaching effects for the pharmaceutical industry as well as other industries, experts say.
Plaintiff attorneys, defense counsel and a judge shared their views on the impact of the decision at a seminar titled The Mass Torts Judicial Forum with Hon. Marina Corodemus (ret.) held on June 27 in Philadelphia.
Calling it a “critical decision,” plaintiff attorney Michael London of Douglas & London PC said it affects more Americans than any decision in recent years. He said the court “is rewarding inaction with immunity” and adopted the federal duty of sameness. “That’s this new federal duty -- and I’m going to quote from the decision -- ‘regulations require that the warning labels of a brand name drug and its generic copy must always be the same. Thus generic drug manufacturers have an ongoing federal duty of sameness,’” said London.
The Mensing case was on appeal from the 5th and 8th circuits, which held that the failure to warn claims of two individuals who allegedly suffered neurological disorders as a result of taking generic Reglan (a digestive tract drug) were not preempted. The court found that if the generic drug manufacturers had independently changed their labels to strengthen the warnings, they would have been in violation of the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels. Therefore, the court said that it was impossible to comply with both state and federal law.
Additionally, the Court rejected the argument by the plaintiffs/respondents that the manufacturers’ preemption defense fails because they failed to request that the FDA change the corresponding label on the brand name drugs.
Defense attorney Richard “***” Dean of Tucker, Ellis & West, who represented Actavis, Inc. in the case throughout its history,also spoke at the conference.
“Basically, [the Court] said ‘we’re not going to play conjecture games’, ‘we’re not going to play what-if games’. This is significant, because in the past—and in most of the Supreme Court jurisprudence—the ‘impossibility’ preemption defense was deemed to be a very demanding defense with a high burden, and that if a party opposing preemption could show some way that there could not be a conflict, that would be sufficient,” said Dean.
Plaintiff attorney Christopher Seeger of Seeger Weiss drew attention to the portion of the majority opinion, penned by Justice Clarence Thomas, which noted that the generic manufacturers had made no attempt to get the brand manufacturer to change its warning label.
“In fact there was no effort along those lines,” Seeger said. “So I thought that was fascinating to get to the impossibility argument, without even an effort of trying.”
Dean responded that one of the significant outcomes of the decision was that “the proof issues on impossibility are far different than they were [before the decision].”
Strengthening of Warning
London pointed to the Supreme Court’s comment that it was “certainly possible” that if generic manufacturers had asked the FDA for help, eventually the agency could have gotten the brand manufacturer to strengthen its warning.
He likened the court’s finding to public service announcements by the Transportation Safety Authority where travelers are told, “if you see something, say something.”
“Here generics are told, ‘if you see something, nah, you don’t need to do anything right now—and you’re free with immunity’,” he said.
The decision will most likely have an effect on litigation in other industries.
“There certainly are some interesting things here and I think the most interesting thing may well be outside of pharma. I think this whole issue of preemption and whether federal agencies are going to basically overtake the state police powers is an interesting issue,” said Judge Carol Higbee of the Superior Court of New Jersey.
“This is a decision that is not just about pharmaceuticals. This is a constitutional law decision on the impossibility defense that transcends pharmaceuticals. It’s going to be the subject of a lot of comment by constitutional scholars, because I do think the Supreme Court did something dramatic here and we’re going to be seeing a lot of litigation from other industries that follow on to the principles that are set forth in this decision,” said Dean.