Speakers Agree Mensing Decision Will Reach Beyond Generic Pharmaceuticals

“This is a decision that is not just about pharmaceuticals.  This is a constitutional law decision on the impossibility defense that transcends pharmaceuticals,” said Richard “Dick” Dean of Tucker, Ellis & West, of the June 23, 2011 Supreme Court decision in Pliva v. Mensing (131 S. Ct. 2567 U.S. 2011; 2011 U.S. LEXIS 4793).

“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, who spoke at the The Mass Torts Judicial Forum with Hon. Marina Corodemus (ret.) held on June 27 in Philadelphia, sponsored by HB Litigation Conferences.  Dean represented defendant Actavis throughout most of the litigation.

Michael London of Douglas & London PC agreed that the decision is significant and said it affects more Americans than any decision in recent years.

The issue on appeal in Mensing was whether 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 said, in a 5-4 decision, that if the generic drug manufacturers had independently changed their labels to strengthen the warnings, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels. The court reasoned 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.

“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.

“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.