Generic Defendants’ PA Preemption Battle Gets Potential Boost from NJ Judge

The issue of generic-drug preemption continues to be one of the key battlegrounds in pharmaceutical product liability litigation. Recently – as we discussed here – the FDA released a proposed rule that, if adopted, would eliminate the broad preemption of failure-to-warn claims against generic pharmaceutical manufacturers established two years ago by the U.S. Supreme Court in PLIVA v. Mensing.

In the wake of Mensing, multiple courts across the country have taken up efforts by generic pharmaceutical defendants to dismiss failure-to-warn claims, as well as other claims, on the basis of preemption. Generally speaking, the tide of those decisions has run in favor of the generic pharmaceutical defendants, although the generic defendants’ success has not been universal.

As we previously reported, one of the jurisdictions in which the generic pharmaceutical defendants were not successful in getting plaintiffs’ claims dismissed as preempted was the Philadelphia Court of Common Pleas in the context of the consolidated litigation involving metoclopramide. In that litigation, the trial court largely refused to dismiss plaintiffs’ claims as preempted and, in a split decision, the Pennsylvania Superior Court affirmed. Following an unsuccessful bid for reargument, the generic defendants are now seeking to appeal the denial of their motions to dismiss to the Pennsylvania Superior Court.

In addition to challenging the Pennsylvania courts’ refusal to dismiss plaintiffs’ failure-to-warn claims under Mensing, the generic defendants are also challenging the courts’ refusal to apply correctly the U.S. Supreme Court’s opinion in Bartlett v. Mutual Pharm. Co., which extended the preemptive effect of Mensing to design-defect claims as well. Thus far, the Pennsylvania courts have declined to dismiss the metoclopramide plaintiffs’ design-defect claims, despite the holding in Bartlett that appears to foreclose any discussion of the issue, on the basis that Bartlett narrowly dealt with an issue of New Hampshire law that may or may not differ from the laws to be applied to the claims of the various metoclopramide plaintiffs (who hail from various states).

Last month, the generic defendants’ challenge to the Pennsylvania Superior Court’s unwillingness to follow Bartlett received support – albeit discretely – from an unlikely source: Judge Carol Higbee of the New Jersey Superior Court. Judge Higbee, who as one of New Jersey’s designated “multicounty litigation judges” presides over several centralized pharmaceutical product liability litigations – including litigations involving Reglan/metoclopramide and Fosamax/sodium alendronate – issued an unpublished opinion (copy available here) in the Fosamax litigation on the generic defendants’ motion to dismiss the plaintiffs’ claims against them.

Judge Higbee found that, while the plaintiffs could pursue what has become known as a “failure to update” claim against any generic manufacturer that did not update its product label to match the brand-name label, and that the plaintiffs could also pursue what has become known as a “failure to communicate” claim against any generic manufacturer that did not communicate label change information to healthcare providers, the plaintiffs’ general failure-to-warn and design-defect claims were preempted by Mensing and Bartlett.

In particular, in dismissing the plaintiffs’ design-defect claims, Judge Higbee specifically addressed the refusal of the Pennsylvania courts to similarly rule in the metoclopramide litigation that the metoclopramide plaintiffs’ design-defect claims cannot stand post-Bartlett, succinctly stating:

 “The Court respectfully disagrees with this decision.”

It remains to be seen whether this criticism from New Jersey’s Judge Higbee (who has already demonstrated her inclination to allow plaintiffs in her court to pursue exceptions to Mensing preemption) will have any effect on the generic defendants’ efforts to obtain a more favorable result from the Pennsylvania Supreme Court. Given the importance of this issue, however, we will continue to follow what happens.

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