The nationwide battle over federal preemption in connection with generic drugs continues, with manufacturers of generic metoclopramide in Pennsylvania seeking to reargue the denial of their appeal challenging the court’s refusal to find the claims against them preempted.
Since the 2011 Supreme Court opinion in PLIVA, Inv. v. Mensing, the issue of preemption in tort suits against manufacturers of generic pharmaceuticals has been an important issue. In short, preemption arises under the federal requirement that generic drug labeling must be the same as the FDA-approved labeling of the reference-listed drug, and therefore generic drug makers cannot provide a warning different than the FDA-approved warning. For this reason, state-law claims based on an allegedly inadequate warning conflict with federal law and are thus preempted.
Earlier this year, generic drug preemption was further strengthened by the Supreme Court’s opinion in Mutual Pharm. Co. v. Bartlett, which not only confirmed Mensing’s failure-to-warn dictates, but extended Mensing’s preemptive effect to design-defect claims, as well as the claim that generic pharmaceutical companies could be held liable for electing not to stop selling a generic drug for which the FDA-approved label was allegedly inadequate.
In the past several years, generic drug manufacturers have successfully moved in a number of litigations across both state and federal courts to dismiss failure-to-warn, design-defect, and other claims based on Mensing (and, recently, based on Bartlett as well). While their success has been widespread, it has not been universal, as some courts have credited plaintiffs’ efforts to carve-out types of claims to escape preemption. (For some of our prior discussions on the issue of Mensing preemption, you can go to the August 20, 2013 post here, the July 22, 2013 post here, the July 18, 2013 post here, and the June 25, 2013 post here.)
One of those courts was the Court of Common Pleas in the consolidated Reglan/Metoclopramide litigation pending in Philadelphia, Pennsylvania, in which Judge Sandra Mazer Moss largely rejected in September 2011 the generic defendants’ efforts to dismiss the nearly 2,300 suits of plaintiffs who claim to have been injured by generic metoclopramide. The generic defendants appealed Judge Moss’s rulings to the Pennsylvania Superior Court, which issued its rulings in July 2013.
In a divided decision, two members of the three-judge panel upheld Judge Moss’s decision, offering a number of reasons why they believed plaintiffs’ claims should be allowed to survive Mensing and Bartlett.
Last month, the defendants filed an application for reconsideration or reargument en banc, seeking further review of these issues, which defendants contend have “put Pennsylvania on the wrong end of a lopsided nationwide consensus” as to the scope of generic preemption. In their application, the defendants assert that the Pennsylvania Superior Court misapplied Mensing and Bartlett and improperly relied on the Supreme Court’s preemption analysis in other, non-generic drug circumstances. The defendants also argue that the Superior Court, in attempting to draw distinctions to avoid preemption, misapprehended that plaintiffs’ claims are all based on an alleged failure to warn, which is precisely the kind of claim rejected in Mensing. Finally, the defendants explain that the Superior Court failed to recognize that, under Bartlett, plaintiffs’ design-defect and “stop selling” claims must be rejected.
It remains to be seen, of course, whether defendants’ application for reconsideration or reargument will be granted and, if so, whether a decision more favorable to the defendants will be forthcoming. While a victory for defendants would be a further nail in the coffin of generic-drug liability, the issue of preemption in generic drug litigation will remain a vitally important one about which all who practice in or follow pharmaceutical litigation should continue to be aware.
Mensing-Preemption Battle Continues in Pennsylvania as Defendants Seek Reargument of Denial of Appeal
The nationwide battle over federal preemption in connection with generic drugs continues, with manufacturers of generic metoclopramide in Pennsylvania seeking to reargue the denial of their appeal challenging the court’s refusal to find the claims against them preempted.
Since the 2011 Supreme Court opinion in PLIVA, Inv. v. Mensing, the issue of preemption in tort suits against manufacturers of generic pharmaceuticals has been an important issue. In short, preemption arises under the federal requirement that generic drug labeling must be the same as the FDA-approved labeling of the reference-listed drug, and therefore generic drug makers cannot provide a warning different than the FDA-approved warning. For this reason, state-law claims based on an allegedly inadequate warning conflict with federal law and are thus preempted.
Earlier this year, generic drug preemption was further strengthened by the Supreme Court’s opinion in Mutual Pharm. Co. v. Bartlett, which not only confirmed Mensing’s failure-to-warn dictates, but extended Mensing’s preemptive effect to design-defect claims, as well as the claim that generic pharmaceutical companies could be held liable for electing not to stop selling a generic drug for which the FDA-approved label was allegedly inadequate.
In the past several years, generic drug manufacturers have successfully moved in a number of litigations across both state and federal courts to dismiss failure-to-warn, design-defect, and other claims based on Mensing (and, recently, based on Bartlett as well). While their success has been widespread, it has not been universal, as some courts have credited plaintiffs’ efforts to carve-out types of claims to escape preemption. (For some of our prior discussions on the issue of Mensing preemption, you can go to the August 20, 2013 post here, the July 22, 2013 post here, the July 18, 2013 post here, and the June 25, 2013 post here.)
One of those courts was the Court of Common Pleas in the consolidated Reglan/Metoclopramide litigation pending in Philadelphia, Pennsylvania, in which Judge Sandra Mazer Moss largely rejected in September 2011 the generic defendants’ efforts to dismiss the nearly 2,300 suits of plaintiffs who claim to have been injured by generic metoclopramide. The generic defendants appealed Judge Moss’s rulings to the Pennsylvania Superior Court, which issued its rulings in July 2013.
In a divided decision, two members of the three-judge panel upheld Judge Moss’s decision, offering a number of reasons why they believed plaintiffs’ claims should be allowed to survive Mensing and Bartlett.
Last month, the defendants filed an application for reconsideration or reargument en banc, seeking further review of these issues, which defendants contend have “put Pennsylvania on the wrong end of a lopsided nationwide consensus” as to the scope of generic preemption. In their application, the defendants assert that the Pennsylvania Superior Court misapplied Mensing and Bartlett and improperly relied on the Supreme Court’s preemption analysis in other, non-generic drug circumstances. The defendants also argue that the Superior Court, in attempting to draw distinctions to avoid preemption, misapprehended that plaintiffs’ claims are all based on an alleged failure to warn, which is precisely the kind of claim rejected in Mensing. Finally, the defendants explain that the Superior Court failed to recognize that, under Bartlett, plaintiffs’ design-defect and “stop selling” claims must be rejected.
It remains to be seen, of course, whether defendants’ application for reconsideration or reargument will be granted and, if so, whether a decision more favorable to the defendants will be forthcoming. While a victory for defendants would be a further nail in the coffin of generic-drug liability, the issue of preemption in generic drug litigation will remain a vitally important one about which all who practice in or follow pharmaceutical litigation should continue to be aware.
H. Lockwood Miller III
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