Mensing Generic Preemption Decision Awaited in New Jersey
In 2011, the US Supreme Court’s landmark decision in PLIVA v. Mensing altered the world of pharmaceutical product liability litigation, holding that claims challenging the adequacy of warnings provided by generic drug makers were preempted. The basic underpinning of the Supreme Court’s opinion was that, under federal law, a generic pharmaceutical had to be the same — and provide the same warnings — as the branded drug, and that any deviation by a generic manufacturer would run afoul of federal law. Mensing involved claims against makers of metoclopramide – the generic version of Reglan – that the plaintiffs allege caused them to develop tardive dyskinesia, a disorder characterized by involuntary, repetitive facial grimaces and tongue and limb movements.
In the months that have followed since Mensing was decided, many courts around the country have heard so-called “Mensing motions” brought by generic drug manufacturers facing similar metoclopramide claims, as well as claims involving a number of other generic pharmaceuticals. In response, many plaintiffs have sought to assert various new claims that they claim are not based on allegedly inadequate warnings. Although not unanimous, the overwhelming trend of such decisions has been on the defense side, with more than thirty decisions granting dismissal against only a handful of cases allowing a few new claims to proceed. An excellent scorecard of many of these decisions can be found on the Drug and Device blog.
As is generally the case with such motions, the defense argued that Mensing is a sweeping decision that should be read and applied broadly to preempt all claims based on the adequacy of generic drug labeling, regardless of how creatively plaintiffs may seek to dress up such claims. The plaintiffs, on the other hand, sought to parse and narrow Mensing and to offer Judge Higbee various ways to sidestep the clear portent of the Supreme Court’s decision, such as that the generic drug makers could have sent “Dear Doctor” letters when their drug labeling was updated, could have more quickly conformed their labels when the FDA-approved label was strengthened, could have petitioned the FDA to effect a label change, and could have undertaken other efforts to communicate to doctors that the warnings for metoclopramide had been changed.
Judge Higbee reserved her ruling and, to date, it remains to be seen whether New Jerseywill join the growing mass of courts that have afforded Mensing a broad application, or whether Judge Higbee will offer the plaintiffs a refuge similar to what the Philadelphia Court of Common Pleas did on this same issue several months ago. Given New Jersey’s status as a center of pharmaceutical drug litigation, together with the challenges that pharma defendants have traditionally faced in her courtroom, all eyes will continue to focus on the Garden State.