New Jersey Court Backs Mensing Preemption

Several weeks ago, we discussed the issue of Mensing generic drug preemption and the anticipated decision from Judge Carol Higbee, who is presiding over the consolidated Reglan and metoclopramide litigation pending in Atlantic County.  As readers may recall, generic preemption is a battleground issue now in pharmaceutical litigation, as generic pharmaceutical defendants seek to take full advantage of the U.S. Supreme Court’s favorable ruling last year in Mensing, and plaintiffs’ attorneys try creatively to limit and narrow the scope of Mensing preemption.

Judge Higbee has now ruled, and the result is a good one for defendants:  all counts of the plaintiffs’ complaints against the generic manufacturers are dismissed, with the exception of any claims made against any generic manufacturer of metoclopramide tablets that did not change its label to match the brand-name label.

In reaching this decision – and joining the growing majority of courts across the country to do the same – Judge Higbee recognized that the plaintiffs’ claims were primarily based on allegations that the generic manufacturing defendants had failed to provide proper warnings or information.  It is precisely this kind of claim that Mensing holds preempted, because under federal law, a generic drug manufacturer is required to provide the same labeling as the FDA-approved branded drug labeling.  A state tort claim that would require a generic drug to carry labeling different than what is required under federal law is quite properly preempted.

As Judge Higbee recognized, so long as a generic manufacturer updated its labeling to match the FDA-approved branded labeling, state claims based on any alleged inadequacy of that labeling are preempted.  Judge Higbee also ruled that the plaintiffs’ creative attempts to evade Mensing – arguing that the generic manufacturers had a separate and independent duty to communicate additional information about their product through means such as “Dear Doctor letters” or to suspend sales of an otherwise FDA-approved drug – were incompatible with the federal regulatory scheme and likewise preempted.

This decision is important to the generic pharmaceutical industry, which has a large presence inNew Jersey, because it demonstrates that yet another court – one that plays a prominent role in mass pharmaceutical litigation – has recognized the broad preemptive effect of Mensing.  As decisions such as this continue to mount, the battle over this issue will no doubt increasingly migrate to Congress, where efforts are being made to undo Mensing.

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