The state Superior Court has ruled that federal pre-emption only applies to negligent failure-to-warn claims that predate the Food and Drug Administration Amendments Act of 2007 and are based solely on a generic drug's label that was in conformity with the brand-name equivalent's label.
The ruling allows more than 2,000 plaintiffs to proceed with some of their claims against the makers of metoclopramide — the generic version of Reglan — alleging the drug caused them to have an incurable neurological disorder called tardive dyskinesia.
The U.S. Supreme Court ruled in the June 2011 case Pliva v. Mensing that claims against generic drugmakers on the basis that they failed to warn plaintiffs adequately are pre-empted because generic manufacturers are required to use the same warning labels as their brand-name counterparts.
On Monday, the Superior Court ruled 2-1 in four companion cases that a blanket dismissal of all state claims in light of Mensing was improper.
In Hassett v. Dafoe and In re Reglan/Metoclopramide Litigation, the court affirmed in part and reversed in part Philadelphia Court of Common Pleas Judge Sandra Mazer Moss' decisions denying the preliminary objections of defendant drugmakers Pliva Inc. and Teva Pharmaceuticals USA.
Judge Mary Jane Bowes, writing for the majority in those two cases, said that because all of the claims in Mensing predated the FDAAA, post-FDAAA claims are not pre-empted by federal law.
In addition, Bowes said, while the design-defect claims may be pre-empted under the U.S. Supreme Court's ruling from earlier this year in Mutual Pharmaceutical v. Bartlett, it's too soon to tell.
In Bartlett, the Supreme Court ruled that a New Hampshire law requiring drugmakers to design their products reasonably safely for the uses they can foresee also impermissibly required drugmakers to change the warning label on the generic version of the drug sulindac.
"In conclusion, we find that the master complaint contains some pre-2007 negligent failure-to-warn claims that predate the FDAAA of 2007 and that are premised upon the generic manufacturers' failure to strengthen the warnings on their labels," Bowes said. "Where those pre-2007 generic labels conformed to the RLD labels, those claims are pre-empted by Mensing. The design-defect claims may be of the type held to be pre-empted in Bartlett. However, without a careful analysis of the applicable state law, pre-emption of all design-defect claims is premature. The remaining claims either do not sound in failure to warn, arose after the passage of the 2007 act, or involve a generic manufacturer's failure to conform its label to that of the name brand, none of which is pre-empted under our reading of Mensing."
Bowes was joined by President Judge Correale F. Stevens.
Senior Judge William H. Platt, however, filed a concurring and dissenting opinion, arguing that he believes the defendants' preliminary objections should be sustained in light of Mensing and Bartlett.
In a separate case, also captioned In re Reglan/Metoclopramide Litigation, the court ruled 2-1 to affirm Moss' order denying the preliminary objections of defendant drugmakers Morton Grove Pharmaceuticals Inc. and Wockhardt USA, finding that Morton failed to meet its burden of proof for Mensing pre-emption by showing that modifying its warning label would have been impossible.
Platt concurred and dissented in that case as well.
In a fourth case, In re Reglan Litigation, the court ruled 2-1 to grant the plaintiffs' motion to quash defendant drugmaker Wyeth Inc.'s appeal from Moss' order overruling its preliminary objections, saying the company did not meet the separability or irreparable harm prongs of the collateral order test and was therefore precluded from filing an interlocutory appeal.
Platt dissented in that case, saying that while he found the order was appealable as a collateral order, he would have affirmed Moss' original order overruling Wyeth's preliminary objections.
Counsel for the plaintiffs, Howard Bashman of Willow Grove, Pa., called the rulings "good news" for his clients.
Counsel for Teva, Carl Solano of Schnader Harrison Segal & Lewis in Philadelphia; counsel for Morton Grove Pharmaceuticals, Robert L. Byer of Duane Morris in Pittsburgh; and counsel for Wyeth, Robert C. Heim of Dechert in Philadelphia, all could not immediately be reached late Monday afternoon.
Zack Needles can be contacted at 215-557-2493 or firstname.lastname@example.org. Follow him on Twitter @ZNeedlesTLI.
(Copies of the 35-page opinion in In re Reglan/Metoclopramide Litigation, PICS No. 13-2251, the 59-page opinion in Hassett v. Dafoe, PICS No. 13-2252, 17-page opinion in In re Reglan/Metoclopramide Litigation, PICS No. 13-2253, and the 24-page opinion in In re Reglan Litigation, PICS No. 13-2254,are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •