PA Court Ignored SCOTUS in Reglan Ruling

On July 29, the state superior court ruled that, at least for the time being, federal pre-emption only applies to negligent failure-to-warn claims that predate the FDA's 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.

In June 2011, the U.S. Supreme Court ruled in 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. Nevertheless, the Pennsylvania superior court ruled 2-1 in Hassett v. Dafoe, and three other companion cases, that a blanket dismissal of all state claims in light of Mensing was improper.

The ruling allowed 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 Ruling

In Hassett 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 is 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 impermissibly required drugmakers to change the warning label on the generic drug sulindac. (See “Supreme Court Holds State-Law Design-Defect Claims Against Generic Pharmaceutical Manufacturers Are Preempted” on page 1 infra.)

“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 added that it would be “premature” to dismiss post-FDAAA of 2007 claims without a “thorough pre-emption analysis.” 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.

Analysis

Plaintiffs' attorney Stephen A. Sheller of Sheller P.C. in Philadelphia, who is not involved in the Reglan litigation, said he believed the superior court's ruling would allow failure-to-warn suits to proceed against the makers of risperidone, the generic version of the antipsychotic drug Risperdal, because it was approved by the FDA in 2008. Likewise, Sheller said, post-FDAAA failure-to-warn claims against the makers of generic versions of the cholesterol drug Lipitor and the acne medication Accutane would now be able to proceed in light of the superior court's Reglan ruling. Sheller lauded the court's ruling as a “just result” that, unlike Mensing, provides a remedy for injured plaintiffs.

But other attorneys think the court's decision in the Reglan litigation flew in the face of Mensing and failed to fall in line with similar rulings by other states. James M. Beck, an attorney in Pittsburgh-based Reed Smith's life sciences health industry group, who also was not involved in the Reglan litigation, said the court unnecessarily complicated the issues dealt with in Mensing and Bartlett and “deliberately closed its eyes” to the Supreme Court's reasoning, separating itself from the vast majority of courts across the country.

Beck specifically pointed to the majority's holding that Bartlett did not specifically pre-empt “absolute liability” claims ' those that claim a drug was defective and unreasonably
dangerous even when used correctly and with the proper warnings. According to Beck, the court referred to this theory as “strict liability,” which Pennsylvania does not recognize in pharmaceutical cases. Regardless, Beck said the ruling defied Bartlett, which held that claims are pre-empted in cases in which a drugmaker would have to stop selling a drug altogether in order to comply with both state and federal law.'

Beck also took issue with the superior court's refusal to consider, without a “thorough'” analysis, whether post-FDAAA claims are pre-empted. In a footnote, the majority said the plaintiffs had argued that the FDAAA required generic manufacturers to propose stronger labeling in some cases, which the FDA can unilaterally approve under 21 U.S.C. 355(o)(4). But Beck said the FDA issued guidance July 30, one day after the court's rulings came down, clarifying that 21 U.S.C. 355(o)(4) still does not permit a generic drug to have a different warning label than its brand-name equivalent. “There is currently no way to get around the sameness requirement,” Beck said.

A Separate Case

In a separate case, also captioned In re Reglan/Metoclopramide Litigation, the superior 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.

Zack Needles is a reporter for The Legal Intelligencer, an ALM sister publication of this newsletter, in which this article also appeared. Reach him at [email protected].'

The Pennsylvania Superior Court's recent decision not to apply blanket pre-emption to failure-to-warn claims against the makers of the generic version of acid reflux drug Reglan ignores U.S. Supreme Court precedent and makes Pennsylvania an outlier among the other states that have ruled on similar issues, some attorneys said.

But others said they thought the superior court got it right and that the ruling may now clear the way for other pharmaceutical mass tort litigation to proceed. Some also noted that the ruling could ultimately lead to a 3-3 stalemate in the state supreme court because newly appointed justice and former Superior Court President Judge Correale F. Stevens would be forced to recuse, having sat on the lower court panel.

Background

On July 29, the state superior court ruled that, at least for the time being, federal pre-emption only applies to negligent failure-to-warn claims that predate the FDA's 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.

In June 2011, the U.S. Supreme Court ruled in 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. Nevertheless, the Pennsylvania superior court ruled 2-1 in Hassett v. Dafoe, and three other companion cases, that a blanket dismissal of all state claims in light of Mensing was improper.

The ruling allowed 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 Ruling

In Hassett 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 is 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 impermissibly required drugmakers to change the warning label on the generic drug sulindac. (See “Supreme Court Holds State-Law Design-Defect Claims Against Generic Pharmaceutical Manufacturers Are Preempted” on page 1 infra.)

“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 added that it would be “premature” to dismiss post-FDAAA of 2007 claims without a “thorough pre-emption analysis.” 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.

Analysis

Plaintiffs' attorney Stephen A. Sheller of Sheller P.C. in Philadelphia, who is not involved in the Reglan litigation, said he believed the superior court's ruling would allow failure-to-warn suits to proceed against the makers of risperidone, the generic version of the antipsychotic drug Risperdal, because it was approved by the FDA in 2008. Likewise, Sheller said, post-FDAAA failure-to-warn claims against the makers of generic versions of the cholesterol drug Lipitor and the acne medication Accutane would now be able to proceed in light of the superior court's Reglan ruling. Sheller lauded the court's ruling as a “just result” that, unlike Mensing, provides a remedy for injured plaintiffs.

But other attorneys think the court's decision in the Reglan litigation flew in the face of Mensing and failed to fall in line with similar rulings by other states. James M. Beck, an attorney in Pittsburgh-based Reed Smith's life sciences health industry group, who also was not involved in the Reglan litigation, said the court unnecessarily complicated the issues dealt with in Mensing and Bartlett and “deliberately closed its eyes” to the Supreme Court's reasoning, separating itself from the vast majority of courts across the country.

Beck specifically pointed to the majority's holding that Bartlett did not specifically pre-empt “absolute liability” claims ' those that claim a drug was defective and unreasonably
dangerous even when used correctly and with the proper warnings. According to Beck, the court referred to this theory as “strict liability,” which Pennsylvania does not recognize in pharmaceutical cases. Regardless, Beck said the ruling defied Bartlett, which held that claims are pre-empted in cases in which a drugmaker would have to stop selling a drug altogether in order to comply with both state and federal law.'

Beck also took issue with the superior court's refusal to consider, without a “thorough'” analysis, whether post-FDAAA claims are pre-empted. In a footnote, the majority said the plaintiffs had argued that the FDAAA required generic manufacturers to propose stronger labeling in some cases, which the FDA can unilaterally approve under 21 U.S.C. 355(o)(4). But Beck said the FDA issued guidance July 30, one day after the court's rulings came down, clarifying that 21 U.S.C. 355(o)(4) still does not permit a generic drug to have a different warning label than its brand-name equivalent. “There is currently no way to get around the sameness requirement,” Beck said.

A Separate Case

In a separate case, also captioned In re Reglan/Metoclopramide Litigation, the superior 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.

Zack Needles is a reporter for The Legal Intelligencer, an ALM sister publication of this newsletter, in which this article also appeared. Reach him at [email protected].'