Pharmaceutical

Supreme Court denies Teva’s appeal on generic Reglan failure-to-warm ruling

Reglan metoclopramide 349x210 Supreme Court denies Tevas appeal on generic Reglan failure to warm rulingThe U.S. Supreme Court rejected Teva Pharmaceuticals’ request to appeal a 2013 Pennsylvania Superior Court decision and subsequent denial of an appeal claiming that federal law preempted the product liability claims of about 2,300 generic Reglan users.

The claims involving generic versions of the acid reflux drug Reglan, which contains the active ingredient metoclopramide, allege that long-term use of the medication can cause a serious neurological disorder known as tardive dyskinesia. However, plaintiffs argued that nearly 30 percent of generic drug makers failed to warn consumers of the devastating Reglan side effect.

In December, Teva and Morton Grove Pharamceuticals Inc., and their subsidiaries, asked the U.S. Supreme Court to address the previous decision on preemption by the Pennsylvania appellate court. The Superior Court panel was split in its July 2013 decision, which found that most of the Reglan claims – which are pending as part of a mass tort in the Philadelphia County Court of Common Pleas, were not preempted by federal law under the U.S. Supreme Court’s Pliva v. Mensing ruling.

In that case, state failure to warn claims against generic drug makers were preempted because under the Hatch-Waxman Amendments, manufacturers of generic drugs are required to use the same warning labels as their brand name counterparts.

The U.S. Supreme Court is already working through the same issue with Teva Pharmaceuticals involving generic versions of the osteoporosis drug Fosamax and claims that it caused a condition of bone death in the jaw. That petition was denied in January.

Source: Law360