Author Archives: H. Lockwood Miller III

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…

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New Jersey Supreme Court Denies Another MultiCounty Litigation Application Without Explanation

In a notice posted earlier this week, the New Jersey Supreme Court has denied another application seeking centralization of cases under New Jersey’s established multicounty litigation procedures.  Unfortunately, this denial — rendered with respect to cases involving DuraPro brand toilet supply lines — offers no analysis or explanation for why the Court rejected the application.  The denial by the Court — similar to prior denials — again references comments received with respect to the application for centralization without providing any discussion of those comments, or…

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Its Flu Season – Remember the National Childhood Vaccine Injury Act

It is getting to be flu season – with the annual barrage of public-service announcements about the importance of getting this year’s flu vaccine.  Vaccines were also in the news recently on reports of a polio outbreak in Syria. Vaccines also end up the subject of lawsuits, including the recent decision from the United States Court of Appeals for the Federal Circuit in Tembenis v. Sec’y Health & Human Servs., (October 28, 2013), available here, which ruled that future lost earnings cannot be awarded…

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Pennsylvania Court Rejects Bid to Reargue Mensing Denial

Last month, we reported on the attempt by several generic manufacturers of metoclopramide to seek reargument before the Pennsylvania Superior Court on the issue of whether the claims against them are preempted under the jurisprudence of the United States Supreme Court’s opinion in PLIVA, Inc. v. Mensing and its progeny. The generic manufacturers’ bid for reargument was rejected by the Pennsylvania Superior Court last week, meaning that the Superior Court’s prior divided decision that upheld the trial court’s refusal to dismiss the claims as preempted…

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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…

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Accutane Recusal Fight Headed to NJ Supreme Court

We, like others, have been following the ongoing saga of Hoffman-La Roche’s efforts to secure the recusal of Judge Carol Higbee from her role presiding over the centalized multicounty litigation involving Accutane.  Last month, we noted that the Apellate Division had denied Hoffman-La Roche’s attempt to force Judge Higbee’s recusal.  Hoffman-La Roche, as reported by, among others, Law360 (registration required), continues to push this issue, and has now asked the New Jersey Supreme Court to review its request.  A copy of Hoffman-La Roche’s brief is…

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New York Federal Court Upholds “Failure to Update” Theory

For those who follow pharmaceutical litigation, the issue of preemption – as discussed primarily by the U.S. Supreme Court in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, as well as in a host of other state and federal court opinions – continues to be an important battleground.  Although most courts have rejected the plaintiffs’ efforts to pursue failure-to-warn claims against generic drug manufacturers, based on the generic drug makers’ federal law “duty of sameness,” under which a warning label for a…

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Centralized Status Rejected for Tylenol Liver-Injury Suits

The New Jersey Supreme Court has rejected yet another application — again by a defendant — for centralization under Rule 4:38A.  As we previously noted, Johnson & Johnson earlier this year submitted an application seeking centralization of all suits alleging liver damage from the ingestion of Tylenol in Middlesex County.  J&J’s application came on the heels of the establishment of a federal MDL on the same issue. In a notice dated last month and released last week, the NJ Supreme Court rejected J&J’s request. …

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Appellate Division Rejects Bid to Recuse Accutane Judge

Law360 is reporting (registration required) that the New Jersey Appellate Division has rejected Hoffman-La Roche’s attempt to recuse Judge Carol Higbee from her role presiding over the centralized multicounty litigation involving Accutane.   We previously discussed Roche’s efforts here, here, here, and here. According to the Law360 article, Roche intends to continue down this path and challenge the Appellate Division’s refusal to review its application.  Given New Jersey’s strong and well-established centralized multicounty litigation program, it is doubtless that many practitioners in…

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Preemption Defense Not Completely Dead for Branded Drugs

As all who follow drug and device law know full-well, the 2009 decision from the United States Supreme Court in Wyeth v. Levine represented a significant setback for brand-name drug manufacturers seeking to defend failure-to-warn claims on preemption grounds.  In Levine, the court held that state law failure-to-warn claims involving brand-name drugs are not preempted, unless there is “clear evidence” that the Food and Drug Administration (FDA)  would not have approved whatever labeling change forms the basis for the failure-to-warn claim.  Such a standard…

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